BILLING UPDATE New Telephone Consultation Codesomr.dgtlpub.com › 2011 › 2011-03-31 › pdf ›...

March 2011Volume 78 Number 3

www.oma.org

OMA Annual General MeetingFeatured events, seminars and workshops,

Section program listing, registration form

EditorialOur role in the health care system

Election Theme PosterNew office display poster promotes health care

as top election issue — order details inside!

Healthy LivingOMA partners with CBC to promote healthy

lifestyles and illness prevention among Ontarians

Practice ManagementTop five secrets to running a great practice

Insurance UpdateOvercoming common false impressions about

obtaining insurance

PM41

1445

07

Dedicated to Doctors. Committed to Patients.

New Telephone Consultation Codes

BILLING UPDATE

OMR Full 43 copy.pdf 1 11/25/2009 3:04:17 PM

Committee Chairs

Agreement

(OMA-Ministry of Health and

Long-Term Care)

Agreement Board Co-ordinating Committee Dr. S. Wooder

Forms Committee

Dr. A. Studniberg

Joint Committee on the Schedule of Benefits Dr. P. Conlon

Medical Audit Oversight Committee

Dr. D. Hellyer

Medical Services Payment Committee

Dr. D. Weir

Physician LHIN Tripartite Committee

Dr. T. Nicholas

Physician Services Committee

Dr. S. Wooder

Workplace Safety & Insurance Board Steering Committee

Dr. J. Tracey

Governance

Board Governance Committee (Board Co-ordinating Committee) Dr. M. Toth

Annual Meeting Planning Committee

Dr. S. Strasberg

Audit Committee Dr. R. Mann

Awards Committee Dr. D. Bach

Board Planning Committee Dr. M.S. Kennedy

Budget Committee Dr. S. Wooder

Committee on Committees Dr. R. Mann

Council Committee on Structure & Bylaws

Dr. J. Willett

Nominations Committee Dr. S. Strasberg

Staffing Committee Dr. V. Walley

Health Policy

Health Policy (Board Co-ordinating Committee) Dr. S. Chris

Revalidation Committee Dr. A. Kapur

Member Services

Member Services (Board Co-ordinating Committee) Dr. V. Walley

Physician Health Program Advisory Committee Dr. D. Puddester

Quality Management Program-Laboratory Services Advisory Council Dr. V. Walley

Public & Political Advocacy

Communications Advisory Committee (Board Co-ordinating Committee) Dr. S. Wooder

Outreach to Women Physicians Committee

Dr. R. Forman

(OMA Section Chairs, see page 6)

Executive, Board, Council, Committee Chairs

Executive Committee

President

Dr. M. MacLeod, London

President Elect

Dr. M.S. Kennedy, Thunder Bay

Past President

Dr. S. Strasberg, Downsview

Chair of the Board

Dr. D. Weir, Toronto

Honorary Treasurer

Dr. S. Wooder, Stoney Creek

Secretary

Dr. V. Tandan, Hamilton

Board of Directors

District

1 Dr. D.J. Hellyer, Windsor

2 Dr. M. MacLeod, London

Dr. M. Toth, Aylmer

3 Dr. C. Cressey, Palmerston

4 Dr. D.M. Goodwin, Niagara Falls

Dr. V. Tandan, Hamilton

5 Dr. S. Whatley, Mount Albert

Dr. J. Tracey, Brampton

6 Dr. J. Ludwig, Peterborough

7 Dr. A. Steacie, Brockville

8 Dr. G. Beck, Ottawa

Dr. A. Kapur, Ottawa

9 Dr. P. Bonin, Sudbury

10 Dr. M.S. Kennedy, Thunder Bay

11 Dr. S. Chris, North York

Dr. C. Jyu, Scarborough

Dr. C. Pinto, Etobicoke

Dr. S. Strasberg, Downsview

Dr. A. Studniberg, Scarborough

Elected by Council

Dr. A. Donohue, Ottawa

Dr. W. Tanner, Toronto

Dr. V. Walley, Toronto

Dr. D. Weir, Toronto

Dr. S. Wooder, Stoney Creek

Academic Representative

Dr. R.K. Edwards, Kingston

CouncilChair

Dr. A. Hudak, Orillia

Vice-Chair

Dr. E. Barker, Wiarton

7 Editorial: our role in the health care system The health care system might be broadly described as the soft and hard

infrastructure that provides care to patients. It includes the bricks and mortar,

the administrative support, government legislation, policy, funding, and the

health care professionals who directly provide care. It is vast and increasingly

complicated. In fact, health care may now be the most complicated decision-

making environment.

10 OMA partners with CBC to promote healthy living The OMA recently initiated a new and exciting partnership with the CBC

that aims to promote healthy living among the people of Ontario and across

Canada. The OMA is working together with the CBC to take part in various

popular programs, and reach out to patients with medical information and

expertise to assist people in improving their health and preventing illness.

14 OMA 2011 Annual General and Council Meeting The OMA Annual General and Council Meeting will take place April 28 - May 1

in Toronto. Featured events include the 12th Annual Women’s Health Care

Seminar, the Adam Linton Memorial Luncheon, Medical Billing and Retirement

Planning seminars, and the OMA Awards, Presidential Installation and Gala

Dinner/Dance. Section program listings, and information regarding registration

and hotel reservations, are set out in the Calendar of Events.

28 Electronic medical records: Elliot Lake Family Health

Team — patient care innovators The Elliot Lake Family Health Team (ELFHT) uses an electronic medical

record (EMR) to help offer timely and better co-ordinated patient care. ELFHT

physicians credit EMR for improvements in preventive care, patient safety, lab

test ordering/obtaining results, and overall practice efficiency.

30 OMA statement on smoking cessation drugs The OMA recently issued a public statement expressing support for the

provincial government considering covering the cost of smoking cessation

drugs. Ontario doctors have been strong advocates and long-time supporters

of providing smoking cessation drugs to patients who want to quit, but can’t

afford the drugs that can help them.

32 Changes to Special Diet Allowance: what physicians

need to know The Ontario government is introducing changes to the Special Diet Allowance

(SDA) effective April 1, 2011. These changes include revisions to the SDA

schedule of eligible medical conditions and the application form. A summary of

the changes is provided, along with links to online resources.

March 2011 Volume 78 Number 3

www.oma.org

20 Billing Update:

New Telephone

Consultation Codes

Interpretive Bulletins developed

by the bilateral Education and

Prevent ion Committee (EPC)

offer general advice and guid-

ance to physicians on specific

billing matters. This month, the

EPC provides comprehensive

information about eight new fee

codes introduced in the Schedule

of Benefits for telephone consul-

tations regarding a patient. Four

of the new codes are referred to

as “Physician to Physician” tele-

phone consultations; the other

four are for telephone consulta-

tions arranged through CritiCall

Ontario. The codes are explained

in detail, including a summary

chart, along with general and pay-

ment requirements, and practical

examples of how to use the codes

in day-to-day practice.


www.oma.org

OMA Annual General MeetingFeatured events, seminars and workshops,

Section program listing, registration form

EditorialOur role in the health care system

Elecection Theme PosterNew office display poster promotes health care

as top election issue — order details inside!

Healthy LivingOMA partners with CBC to promote healthy

lifestyles and illness prevention among Ontarians

Practice ManagementTop five secrets to running a great practice

Insurance UpdateOvercoming common false impressions about

obtaining insurance

PM41

1445

07

Dedicated to Doctors. Committed to Patients.


BILLING UPDATE

Publications Mail

Agreement # 41144507

Undeliverables, please return to:

Ontario Medical Review

150 Bloor St. West, Suite 900

Toronto, Ontario M5S 3C1

FEATURES

March 20113ONTARIO MEDICAL REVIEW

Chronic kidney disease is a major health problem, affecting up to 2.3 million Canadians.1

Hypertension and diabetes are individual risk factors for nephropathy; having both together increases risk even further.1,2

Both hypertension and diabetes are leading causes of renal failure;3

that’s why Novartis is committed to actively researching preventionof nephropathy in this high-risk population.

Novartis: Dedicated to kidney protection in patients with hypertension and diabetes.

Getting the pulse on kidney protection.

References: 1. Levin A, Hemmelgarn B, Culleton B et al. Guidelines for the management of chronic kidney disease. CMAJ 2008;179:1154-62. 2. Petit W, Jr. and Adamec C. The encyclopedia of endocrine diseases and disorders. New York, NY: Facts on File, Inc.; 2005. 3. National Kidney Disease Education Program. Chronic kidney disease overview. Available at: www.nkdep.nih.gov/professionals/chronic_kidney_disease.htm. Accessed January 12, 2011. © Novartis Pharmaceuticals Canada Inc. 2011

44 Practice Management: top-five secrets to running

a great practice Hiring skillful and friendly staff, implementing high-quality telephone and

computer systems, developing a good physical plant, and providing excellent

service are among the key aspects of a great medical practice.

47 Doctor’s Business: cohabitation agreements and

marriage contracts Although a cohabitation agreement or marriage contract may not be at the

forefront when a couple begins to reside together, or starts planning for their

wedding day, there are particular circumstances where spouses may wish to

consider entering into a domestic agreement.

50 Insurance Update: overcoming common false

impressions about obtaining insurance Common misconceptions regarding the need for insurance, and the cost of

obtaining it, may prevent physicians from taking critical steps to help protect

their health and that of their family, and to mitigate potential financial risk.

COLUMNS


Editor

Jeff Henry

Managing Editor

Elizabeth Petruccelli

Associate Editor

Matthew Radford

Advertising/Circulation Co-ordinator

Kim Secord

Production Co-ordinator

Angelica Santacroce

Classifieds Co-ordinator

Margaret Lam

Art Direction

Artful Dodger Communications Inc.

Publisher’s Notes

Published 11 times yearly by the

Ontario Medical Association

150 Bloor St. West

Suite 900

Toronto, Ontario

M5S 3C1

Tel. 416.599.2580 or

Toll-free 1.800.268.7215

Fax 416.340.2232

E-mail: [email protected]

OMA website: www.oma.org

ISSN 0030 302X

Any opinions expressed in articles and

claims made in advertisements are

the opinions of the authors/advertisers

and do not imply endorsement by the

Ontario Medical Association.

The Ontario Medical Review welcomes

readers’ views. Letters to the editor

should be addressed to Ontario Medical

Review, 150 Bloor St. West, Suite

900, Toronto, Ontario M5S 3C1; fax

416.340.2232; e-mail: jeff.henry@oma.

org. Note: letters may be edited for

space and clarity. Please include name,

address and daytime phone number.

(Additional “Publisher’s Notes” appear

on page 71)


www.oma.org

CAPSULE NEWS

9 Section on General & Family Practice J.J. Lynch Memorial Lecture: “Your Practice Website: is it time now?” – April 29

12 OMA Physician Leadership Program applications due May 7

26 Make health care the #1 issue in the Ontario election! Order your new OMA office display poster today

33 12th Annual OMA Women’s Health Care Seminar, April 28

34 OMA Corporate Hotel Directory offers preferred rates for members

42 Complimentary Medical Billing Seminar, April 29

DEPARTMENTS1 OMA Executive, Board, Council,

Committee Chairs

6 OMA Section Chairs

8 Readers’ Views

38 Board of Directors Report: February 2-3, 2011

39 In Memoriam

41 Health Policy Report

66 Classifieds

72 Medectoon

72 Advertisers’ Index

Addiction Medicine Dr. R. Cooper

Allergy and Clinical Immunology

Dr. B. Wong

Anesthesiology Dr. J. Watson

Cardiac Surgery Dr. V. Rao

Cardiology Dr. W. Hughes

Chronic Pain Physicians Dr. H. Jacobs

Clinical Hypnosis Dr. M. Dales

Clinical Teachers Dr. R. Edwards

College and University Student Health

Dr. D. Lowe

Community Health Centre & Aboriginal Health Access Centre Physicians

Dr. I. Tamari

Complementary and Integrative Medicine

Dr. R. Banner

Critical Care Medicine Dr. M. Warner

Dermatology Dr. S. Gupta

Diagnostic Imaging Dr. M. Prieditis

Emergency Medicine Dr. M. Haluk

Endocrinology and Metabolism

Dr. J. Shaban

French-Speaking Physicians Dr. T. Dufour

Gastroenterology Dr. D. Baron

General and Family Practice Dr. R. Male

Genetics Dr. L. Velsher

Geriatrics and Long-Term Care Dr. A. Baker

GP Psychotherapy Dr. D. Cree

Group Practice Dr. G. Maley

Hematology and Medical Oncology Dr. P. Kuruvilla

Hospitalist Medicine Dr. K. Rhee

HSO Physicians Dr. J. Craig

Hyperbaric Medicine Dr. A.W. Evans

Independent Physicians

Dr. J. Szmuilowicz

Infectious Diseases Dr. N. Rau

Internal Medicine Dr. M. Wilson

Interns and Residents Dr. C. McNeil

Laboratory Medicine Dr. C.M. McLachlin

Medical Students

Ms. C. Nowik, Mr. K. Cullingham

Nephrology Dr. B. Nathoo

Neurology Dr. R. Yufe

Neuroradiology Dr. S. Symons

Neurosurgery Dr. F. Gentili

Nuclear Medicine Dr. C. Marriott

Obstetrics and Gynecology Dr. B. Mundle

Occupational and Environmental Medicine Dr. M. Cividino

Ophthalmology Dr. N. Nijhawan

Orthopedic Surgery Dr. D. MacKinlay

Otolaryngology - Head and Neck Surgery

Dr. O. Smith

Palliative Medicine

Dr. A. Franklin

Pediatrics Dr. H. Yamashiro

Physical Medicine and Rehabilitation

Dr. D. Berbrayer

Plastic Surgery Dr. D.S. Woolner

Psychiatric Hospitals, Schools

Dr. J. Fareau-Weyl

Psychiatry Dr. D. Brownstone

Public Health Physicians Dr. H. Shapiro

Radiation Oncology Dr. G. Morton

Reproductive Biology Dr. C. Librach

Respiratory Disease Dr. H. Ramsdale

Rheumatology Dr. P. Baer

Rural Practice Dr. R. Dawes

Sleep Disorders Dr. A. Soicher

Sport and Exercise Medicine Dr. W. Elliott

Surgery, General Dr. A. Maciver

Surgical Assistants Dr. D. Esser

Thoracic Surgery Dr. R. Zeldin

Urology Dr. F. Papanikolaou

Vascular Surgery Dr. D. Szalay

Section Chairs


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EDITORIAL

ONTARIO MEDICAL REVIEW March 20117

HEALTH CARE SYSTEM” — THREE SMALL, BUT VERY POWERFUL, WORDS. AND, AT THE SAME TIME, WORDS

WITHOUT MUCH DEFINITION OR MEANING.

The health care system might

be broadly described as the

soft and hard infrastructure

that provides care to patients.

It includes the bricks and mor-

tar, the administrative support,

government legislation, policy,

funding, and the health care

professionals who directly pro-

vide care. It is vast and increas-

ingly complicated. In fact, health

care may now be the most

complicated decision-making

environment.

Physicians have tradition-

ally seen the patient in front of

them as their sole responsibil-

ity. We have at times used the

term “system” in a derogatory

manner, in a very real way sug-

gesting that the “system” is a

problem, and it is someone

else’s job to fix it. Doing so

has conveniently allowed us

to divorce ourselves from the

health care system, and avoid respon-

sibility for our decisions and choices

within it.

We, physicians, are not well inte-

grated into the health care system. This

is a theme I have touched on before,

and I return to it now. Largely we have

worked in the system or alongside it,

without truly understanding our integral

role.

We have responsib i l i ty to our

patients and to the health care system.

As such, the decisions we make

should be viewed through the

lens of the patient and the sys-

tem.

It is t ime that physicians

become included in both the

discussion and the decision-

making around health care

spending, and have the respon-

sibility, accountability, auton-

omy and authority that doing so

mandates.

We are patient advocates.

That part of our role is intrin-

sic and obvious. What is often

ignored is our responsibility

to the system, and all of the

patients that are not ours. It

is our ethical responsibility to

advocate for change in the way

that care is delivered, even if,

sometimes, that is contrary to

our personal interests.

We have so much to contrib-

ute to the system if we choose

to do so. We know that citizens trust us

to do so, and expect us to do so.

Are we willing to meet the challenge?

Dr. Mark MacLeod

OMA President

Our role in the health care system

“

ONTARIO MEDICAL REVIEW 8 March 2011

READERS’ VIEWS

Electronic Medical Records

Dear Editor:

Having read the art ic le, “Ontar io

Physicians Describe How the Benefits

of EMRs Outweigh the Challenges”

(January 2011 OMR, pp. 20-21), I am

a physician who wholly endorses this

concept. I have used computers every

day in my practice for almost 20 years

as a family physician.

Your article encourages physicians

to change to this paradigm. However,

I find it rather vague, in that there were

no actual EMR products mentioned.

Are these physicians using Practice

Solutions, Healthscreen, OSCAR EMR,

etc.? Or, are they using a homemade

version of Access, Word and Excel?

You also failed to mentioned the pit-

falls of EMR: computer and network

problems; program bugs and crashes;

and horrific service providers.

Many older physicians will not use

computers because of perceived high

cost of maintenance (in the United

States, an amount of $10,000 to

$20,000 a year for IT is an acceptable

overhead!), and generally slowing their

workflow through typing and mouse-

clicking layers of menus.

In the next article, you should review

the top-10 EMR programs with an unbi-

ased approach. Also, include which

laboratories include an HL7 download

website. Many labs require you to dial in

via modem to download the lab reports.

EDT (Electronic Data Transfer) is a

16-year-old program to transfer OHIP

billings, and is only accessible to individ-

ual physicians via ancient long-distance

bulletin board system-type modem-

ing to Kingston (think 1980s-1990s

pre-Web times). They still don’t have

Internet access.

Many IT support providers are trying

to get funding without finished, tested

products. I have a few horror stories

from a few colleagues.

I am using an open source clinical

management system with appoint-

ment/billing/EMR and Lab HL7 down-

load developed by McMaster University

in 2002. I installed it myself and it’s free

(at zero cost) from Sourceforge. It’s not a

perfect program, but usable. However,

it requires a moderate amount of com-

puter programming knowledge so most

physicians require a third party to do it.

Thank you, and keep up the encour-

aging work.

Ian Pun, MD

Scarborough

Letters to the Editor should be addressed to:


150 Bloor Street West

Suite 900


Fax: 416.340.2232


The Ontario Medical Review welcomes

readers’ views. Please supply your name,

address and daytime phone number. Note:

letters may be edited for space and clarity.

Inquiries should be directed to OMA

Legal Services:

Jim Simpson

Tel. 416.340.2940 or 1.800.268.7215, ext. 2940


Robert Lee

Tel. 416.340.2934 or 1.800.268.7215, ext. 2934


Adam Farber

Tel. 416.340.2894 or 1.800.268.7215, ext. 2894


Jennifer Gold

Tel. 416.340.2889 or 1.800.268.7215, ext. 2889


In need of medical-legal advice?OMA Legal Services can provide advice to members

on the following issues relating to practice:

practice plan development and support

assistance

clinics or other institutions as employees or

independent contractors

physician structures

FEATURE


healthy

livingOMA Partners with

CBC to Promote

FEATURE

The OMA recently initiated a

new and exciting partnership

with the CBC that aims

to promote healthy living

among the people of Ontario

and across Canada.

d a

ship

ario

The OMA has joined the CBC’s

“Live Right Now” campaign,

which is a national health pro-

motion effort featuring program-

ming on the CBC media network

that encourages Canadians to

make healthy choices and live

healthier lives.

Drawing on our significant

experience and leadership in

the health promotion field, the

OMA is working together with

the CBC to take part in various

popular programs and reach out

to patients with medical infor-

mation and expertise to assist

people in improving their health

and preventing illness.

Physicians from across the

province are sharing their per-

spective and providing helpful

lifestyle improvement tips.

An online “Doctor’s Office,”

access ib l e f rom the OMA

home page, features a blog

that appears weekly as part of

the Live Right Now program-

ming and covers a wide range

of health topics of interest to

people looking to make health-

ier choices, as well as a calorie

counting game.

Members are encouraged to visit:

www.cbc.ca/liverightnow/the-doctors-office.html

to learn more


With OMR Classifieds, your message...

Hits Home!OMR classified advertising reaches

29,000+ physicians, interns, and

medical students every issue.

The Ontario Medical Review publishes

classif ied advert isements in the

following categories:

RATES:

each line approximately 35 characters;

$5 per line thereafter; $5 for each line

billed at $20 per issue.

DEADLINES:

of cancellation and/or changes to

existing advertisements must be

submitted in writing no later than the

10th of the month prior to the month

of publication.

REGULATIONS: The Ontario Medical

Review reserves the right to make

The Ontario Medical Review

to comply with the provisions of the

assumes no responsibility or endorses

any claims or representation offered or

urges readers to investigate thoroughly

any opportunities advertised.

For more information, please contact:

[email protected]

ONTARIO MEDICAL REVIEW 12

ATIVAN is useful for the short-term relief of manifes-tations of excessive anxiety in patients with anxiety neurosis. It is also useful as an adjunct for the relief of excessive anxiety that might be present prior to surgical interventions. Anxiety and tension associ-ated with the stresses of everyday life usually do not require treatment with anxiolytic drugs.

ATIVAN is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma, and in those with known hypersensitivity to benzodiazepines.

Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodi-azepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnea, throat closing or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a benzodiazepine should not be rechallenged with the drug.

ATIVAN is not recommended for use in depressive neurosis or in psychotic reactions. Because of the lack of sufficient clinical experience, lorazepam is not recommended for use in patients less than 18 years of age. Since ATIVAN has a central ner-vous system depressant effect, patients should be advised against the simultaneous use of other CNS depressant drugs. Patients should also be cautioned not to take alcohol during the administration of lorazepam because of the potentiation of effects that may occur. ATIVAN should not be used during pregnancy. Since lorazepam is also a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential. ATIVAN should not be administered to breast-feeding women, unless the expected benefit to the mother outweighs the potential risk to the infant.

Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.

Excessive sedation has been observed with loraz-epam at standard therapeutic doses.

The most frequently reported adverse reaction to ATIVAN was drowsiness. See prescribing informa-tion for complete adverse reaction information.

The lowest effective dose of ATIVAN should be pres-cribed for the shortest duration possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of lorazepam should be avoided and a gradual, dose-tapering schedule followed after extended therapy.

ATIVAN should not be administered to individuals prone to drug abuse. Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

OMA Physician Leadership Program

Applications Due May 7!

The OMA Physician Leadership Program is now accepting applications for

the Second Cohort, which is scheduled to begin in September 2011. There

are 25 spots available and applications are due May 7.

The Physician Leadership Program aims to foster and develop leadership

potential, insights and capacities, which leverage the impact of physicians

as health-care system and organizational leaders. The program aspires to

create a stronger community of physician leaders and change agents who will

influence the transformation of the Ontario health-care system and act as

effective advocates for quality patient care.

The Second Cohort will encompass 90 hours of study, including in-class

modules, an independent project, readings, and executive coaching. The

development journey will commence September 22, 2011, with a virtual

launch and program orientation followed by six 2-day in-class modules

culminating in a 2-day leadership retreat June 15-16, 2012.

The program overview and schedule, application form, and “how to apply”

instructions are located at www.oma.org in the Member Programs and

Services section.

For additional information, please e-mail: [email protected].

As a service to its members, the OMA has obtained discount

rates for hotels throughout Metro Toronto and regions across the

province. The directory appears on pages 34-35 of this issue,

and is available on OMA WebLink (www.oma.org/member) under

“Member Discounts.”

If you have any questions, please contact:

OMA Conference Planning

Tel. 416.599.2580, or 1.800.268.7215, ext. 3461


OMA opens the door tohotel discounts

CORPORATE HOTEL DIRECTORY

Quick-dissolving sublingual formulation*1

1** Clinical signifi cance unknown.

Convenient

ATIVAN sublingual: A quick-dissolving, convenient formulation*

See prescribing information and study parameters on page

Quick dissolving

ONTARIO MEDICAL REVIEW

131st OMA Annual General and Council MeetingCalendar of Events

Thursday, April 28 – Sunday, May 1, 2011

Toronto Marriott Downtown Eaton Centre Hotel, Toronto, Ontario

Pre-registration is required for all meetings. The registration form appears on page 17 of this issue,

or you may register online at: www.oma.org/member/news/events/pages/agm.aspx

March 201114

NEW THIS YEAR!

*The registration desk for Council will be open on Thursday and Friday, April 28 – 29. Delegates and observers do

not have to wait until Saturday morning to check-in. Members who attend meetings on Thursday and Friday will no

longer have to register twice.

*A Pre-Council Policy Session on e-Health will be held on Friday afternoon, April 29. Council delegates are encour-

aged to attend. (Please see page 15 for more information regarding this session.)

0900 – 1630 12th Annual Women’s Health Care Seminar, “Women’s Health and International Medicine” (see pp. 15 and 33 for more details)

Throughout the Day Section Annual Meetings (see p. 16 for more details)

*NEW 0730 – 1700Annual Meeting and *Council Registration (see p. 16 for more details)

0730 – 1700 Annual Meeting and *Council Registration (see p. 16 for more details)

Morning and Evening Section Annual Meetings (see p. 16 for more details)

0900 – 1530 EPC Medical Billing Seminar (see pp. 15 and 42 for more details)

0900 – 1200 and 1300 – 1600 Retirement Planning Seminars (see p. 15 for more details)

1200 – 1400 Adam Linton Memorial Feature Luncheon (see p. 15 for more details)

*NEW 1400 – 1700Pre-Council Policy Session on e-Health (see p. 15 for more details)

1800 – 1930 Council Orientation Session (see p. 15 for more details)

0730 – 1700 Council Registration (see p. 16 for more details)

0900 – 1700 Annual Meeting of Council (see p. 16 for more details)

1230 – 1330 Council Luncheon

1830 – 2400 Awards Presentations, Presidential Installation, Gala Dinner/Dance (see p. 15 for more details)

0730 – 1200 Council Registration (see p. 16 for more details)

0900 – 1300 Annual Meeting of Council (see p. 16 for more details)

1300 Council Luncheon (lunch will be available to go for those who are unable to remain)

SUMMARY OF EVENTS

Thursday,April 28

Friday,April 29

Saturday,April 30

Sunday,May 1


12TH ANNUAL WOMEN’S HEALTH CARE SEMINAR

– THURSDAY, APRIL 28

The OMA Outreach to Women Physicians Committee

presents the 12th Annual Women’s Health Care Seminar,

“Women’s Health and International Medicine.” This year’s

event features a keynote address by Maureen McTeer on

women’s health and sustainable development in the develop-

ing world. (Please see page 33 for more details.)

EDUCATION AND PREVENTION COMMITTEE (EPC)

MEDICAL BILLING SEMINAR – FRIDAY, APRIL 29

The Education and Prevention Committee (EPC), in conjunc-

tion with the OMA, will host educational billing sessions on

Friday, April 29 from 0900 – 1530. The plenary session, begin-

ning at 0900, will focus on recent changes to the Schedule of

Benefits (and what they mean to you), the importance of your

OHIP Billing number, legal requirements for electronic medi-

cal records, billing resource options, and other topics. Two

breakout sessions are planned. The first begins at 1020 and

is for Family/General Practitioners. This session will focus on

common billing questions or errors. The second is an after-

noon session, from 1400 – 1530, dedicated to physicians in

Primary Care models (e.g., FHG, FHN, FHO). (Please refer to

page 42 for the registration form.)

RETIREMENT PLANNING SEMINARS

– FRIDAY, APRIL 29

Retirement Planning 0900 - 1200

The OMA is holding an information session on Retirement

Planning on Friday, April 29 from 0900 – 1200. Topics covered

include: “Insuring” a healthy financial retirement; investment

planning for retirement; and fundamentals of winding down a

practice. Spouses are welcome!

Retirement: Life After Medicine 1300 - 1600

Are you considering retiring but do not have any post-retire-

ment lifestyle plans? Or, have you already retired and feel like

something is missing? The Ontario Medical Association will

be hosting a “Life After Medicine” workshop that focuses on

what to do after you retire. Topics include: making your retire-

ment more enjoyable; replacing lost fulfillment from no longer

practising medicine; and dealing with unanticipated issues.

Dr. Alan Roadburg will be our featured speaker.

ADAM LINTON MEMORIAL FEATURE LUNCHEON


The 19th annual Adam Linton Memorial Feature luncheon and

lecture will be presented on Friday, April 29 from 1200 – 1400,

as part of the Annual General Meeting. The lecture honours

the memory and accomplishments of Dr. Adam Linton, OMA

President from June 1991 to January 1992. Dr. Linton was a

nationally-renowned educator who spent much of his time

working to improve Ontario’s health care system. The lecture

will be presented by Allan Gregg, Chair of Decima Research

and a member of CBC News “At Issue” panel. Mr. Gregg is

also host of “Allan Gregg in Conversation With” on TVO, and

is a contributor to The Walrus.

There is no charge for this event, thanks to a generous

contribution from the Canadian Medical Association and its

subsidiary, MD Management.

PRE-COUNCIL POLICY SESSION ON e-HEALTH


The OMA is holding a special pre-Council session on Friday,

April 29, from 1400-1700, that will bring Council delegates

together to focus on a single emerging policy issue. In a depar-

ture from their customary policy-setting role which confirms

the end result of the policy process and is driven by motions,

this session will allow members of Council to exchange ideas

and provide guidance in the formative stage of OMA policy

genesis. The topic for this special policy session is e-Health,

with an emphasis on issues of importance to physicians and

their patients, such as: responsibility for health information

in an e-environment; patient access and “control” over their

information; and how we ensure that the e-Health policy and

technical infrastructure meets physicians’ and patients’ needs.

Significant decisions will be made about e-Health in the

short term and medium term, and it is important that Ontario’s

physicians have a clear vision of what the system should look

like and how organized medicine can best contribute to it.

This session will help to inform us as we continue to engage in

this new and challenging area.

COUNCIL ORIENTATION SESSION – FRIDAY, APRIL 29

The Chair and Vice Chair of Council will be holding a Council

orientation session for delegates. The session will focus on

providing participants with: a) information on their role as

Council delegates, and; b) information on the process for

developing and submitting motions to Council. The session

will be held on Friday evening, April 29, from 1800 – 1930.

ANNUAL MEETING OF COUNCIL

– SATURDAY, APRIL 30 AND SUNDAY, MAY 1

Council is the governing body of the OMA. The power to vote

and put forward resolutions is limited to Council Delegates,

elected by the members of each OMA Branch Society, District

and Section. However, any OMA member who registers is

entitled to attend the meeting as an observer.

AWARDS PRESENTATIONS, PRESIDENTIAL

INSTALLATION AND GALA DINNER/DANCE

– SATURDAY, APRIL 30

This event will take place at The Carlu, 444 Yonge Street (at

College), 7th floor.

OMA members are invited to join in celebrating the many

contributions and accomplishments of our medical col-

leagues. The evening commences at 1830 with the awards

presentations and presidential installation. A brief reception

will follow at approximately 1930, and dinner will be held at

approximately 2000. A dance will take place after dinner, fea-

turing the music of the band “Music Spectrum.”

The gala dinner is presented, in part, by a generous contri-

bution from the Canadian Medical Association and its subsid-

iary, MD Management.

March 201115

FEATURED EVENTS


ANNUAL MEETING AND COUNCIL REGISTRATION

To register for meetings on Thursday and Friday, April 28

and 29, please complete and return the registration form

that appears opposite. Members may also register online at:

www.oma.org/member/news/events/pages/agm.aspx

To register for Council on Saturday April 30 and Sunday,

May 1, please contact Nelson Sawyer, Membership

Operations, at 416.599.2580 or 1.800.268.7215, ext. 2235,

or e-mail: [email protected]

HOTEL RESERVATIONS

Rooms have been reserved at the Toronto Marriott

Downtown Eaton Centre Hotel at the rate of $199 for either

single or double occupancy. You may telephone the hotel

directly at 416.597.9200 or 1.800.905.0667. When reserv-

ing, please indicate that you are attending the meetings of

the Ontario Medical Association to ensure you receive the

preferred rate. The deadline for reservations is March 27,

2011. After this date, reservations will be accepted on a

space-available basis only.

NOVEMBER 2011 COUNCIL MEETING AND

ANNUAL MEETING 2012

Both meetings will be held in Toronto at the Toronto Marriott

Downtown Eaton Centre Hotel:

March 201116

Pre-registration is required for all meetings. Please complete and return the registration form that appears opposite, or you

may register online at: www.oma.org/member/news/events/pages/agm.aspx. Your Section flyer outlining agenda items will

be distributed in the coming weeks.

SECTION PROGRAM LISTING (Note: this schedule is preliminary and may be amended)

GENERAL INFORMATION

CHRONIC PAIN

Friday, April 29

& Scientific Session

0830 – 1200

(Sponsors: TEVA and

Purdue)

GENERAL AND FAMILY

PRACTICE

Friday, April 29

0900 – 1200

1700 – 1900

GP PSYCHOTHERAPY

Friday, April 29

- 0900 – 1100

CME: Cognitive

Behavioural Analysis

System of

Psychotherapy (CBASP):

Dr. Sian Rawkins

1100 – 1200

HSO PHYSICIANS

Friday, April 29

& Dinner

1830 – 2130

LABORATORY

MEDICINE

Thursday, April 28

(OMA office)

1300 – 1700

NEPHROLOGY

Friday, April 29

& Dinner

1800 – 2130

NEUROLOGY

Friday, April 29

& Dinner

1800 – 2100

ONTARIO

PSYCHIATRIC

HOSPITALS &

HOSPITAL SCHOOLS

Friday, April 29

& Scientific Session

Meeting

1000 – 1130

OPHTHALMOLOGY

Friday, April 29

(Executive Members Only)

0900 – 1200

& Dinner

1800 – 2100

PALLIATIVE MEDICINE

Friday, April 29

1830 – 2130

PHYSICAL MEDICINE

AND REHABILITATION

Friday, April 29

0745 – 1200

- 0745 – 0800

Introduction:

Dr. David Berbrayer

- 0800 – 0900

Developments in

Interdisciplinary Pain

Management:

Dr. David Corey

- 0900 – 1000

The CPSO Peer

Assessment —

Don’t Fret it!:

Dr. Perry S. Tepperman,

Dr. Dinesh Kumbhare,

Ms. Nanci Harris

- 1000 – 1100

Diagnosis and

Management of Toxic

and Acquired Adult-

Onset Myopathies:

Dr. Steve Baker

- 1100 – 1200

Concussion: Diagnosis,

Management and

Prevention:

Dr. Charles H. Tator

1400


131st OMA Annual General Meeting

Registration FormPre-registration is required for all meetings. Registration must be received by April 15, 2011.

17 March 2011

Please complete one registration form per person attending and return to:

Jennifer Csamer, Conference Planning, Ontario Medical Association, 150 Bloor

Street West, Suite 900, Toronto, ON, M5S 3C1, or fax to 416.340.2244.

You may also register online at: www.oma.org/member/news/events/pages/

agm.aspx. (Note: To register for the OMA Council Meeting, April 30 - May 1,

contact Nelson Sawyer, OMA Membership Services, at 416.599.2580 or

1.800.268.7215, ext. 2235; or via e-mail at [email protected])

Name (surname, first name)

Address

City/Province Postal Code

Office Tel. No. Fax No.

E-mail

Please indicate any special needs

SEMINARS AND WORKSHOPS

Thursday, April 28

12th Annual Women’s Health Care Seminar

12th Annual Women’s Health Care Luncheon

12th Annual Women’s Health Care Reception

Friday, April 29

Education and Prevention Committee (EPC) Medical Billing Seminar

(Space is limited at this event. Please refer to the separate registration

form that appears on page 42 of this issue)

Retirement Planning Seminar

Retirement: Life After Medicine

Adam Linton Memorial Feature Luncheon

(Please be advised that seating for this luncheon is limited and expected

to fill up quickly, due to the lecture by special guest Allan Gregg. Tickets

will be allocated on a first-come, first-served basis.)

Pre-Council Policy Session on e-Health

Council Orientation Session

SECTION MEETINGS

Scientific/ Business/ Lunch/ Educational Meeting Dinner

Thursday, April 28

Laboratory Medicine (to be held at OMA office)

Friday, April 29

Chronic Pain

General and Family Practice @ $50

GP Psychotherapy

HSO Physicians

Nephrology

Neurology

Ontario Psychiatric Hospitals & Hospital Schools

Ophthalmology

Palliative Medicine

Physical Medicine & Rehabilitation

AWARDS CEREMONY, PRESIDENTIAL INSTALLATION,

GALA DINNER/DANCE

Saturday, April 30 @ $100

Total ____________________

Please indicate any special dietary requirements:

Payment method: Cheque* Visa Mastercard

*Cheque Payable to the Ontario Medical Association

Account number Expiry date

Name of card holder

Signature

FACED WITH PAIN*

IN HIS STRUGGLE WITH NEUROPATHIC PAIN

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aay y y y y nononono

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ivivivivivivivvivviviieee e e eeee

fofofofofofofofoffoffofoaaaa a aa aaaaaallllllllllllllllllll

nnnn n n nn nneueueueueueueueueueue

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esesesesesesesesessee....

DEMONSTRATED SIGNIFICANT RELIEF IN PAIN AND PAIN-RELATED SLEEP DIFFICULTIES IN NEUROPATHIC PAIN1

Pregabalin: fi rst-line treatment for chronic

neuropathic pain2

First treatment indicated in Canada for adults for the management of pain associated with

fi bromyalgia1

Demonstrated powerful, rapid and sustained pain relief1, 3-5

In neuropathic pain (NeP):• Sustained pain relief (starting at week 2 for LYRICA 150-600 mg/day, n=141; p<0.05 vs. placebo, n=65) was demonstrated throughout

a 12-week study in patients with DPN or PHN5

Also in fi bromyalgia:• In a 14-week study, LYRICA demonstrated signifi cant pain reduction as early as week 1 (p<0.05 for all doses). Mean changes in pain

scores at the end of the study for LYRICA-treated patients were signifi cantly greater versus placebo (300 mg/day, n=183: -1.75, p=0.0009; 450 mg/day, n=190: -2.03, p<0.0001; 600 mg/day, n=188: -2.05, p<0.0001; placebo, n=184: -1.04)3

• In another study of 26 weeks’ duration of patients who initially responded to LYRICA during a 6-week, open-label phase, 68% of those who continued on their optimized dose (n=279) maintained a treatment response versus 39% of those on placebo (n=287). The time to loss of therapeutic response was longer in the LYRICA group (p<0.0001)4

Demonstrated effective in relieving pain-related sleep diffi culties1, 6

In NeP:• LYRICA reduced sleep disturbances across several studies in DPN and PHN, of 8-12 weeks duration1

Also in fi bromyalgia:• In a 13-week study, LYRICA reduced overall MOS-Sleep Scale scores signifi cantly more at the end of the study vs. placebo (300 mg/day:

-19.1, p=0.0174; 450 mg/day: -20.41, p=0.0026; 600 mg/day: -19.49, p=0.0101; placebo: -14.29)6

Flexible dosing across all indications1†

LYRICA (pregabalin) is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury in adults. LYRICA is indicated for the management of pain associated with fi bromyalgia in adults. The effi cacy of LYRICA in the management of pain associated with fi bromyalgia for up to 6 months was demonstrated in a placebo-controlled trial in patients who had initially responded to LYRICA during a 6-week open-label phase.

LYRICA is contraindicated in patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.

The most commonly observed adverse events ( 5% and twice the rate as that seen with placebo) in the recommended dose range of 150 mg/day to 600 mg/day in PHN and DPN patients were: dizziness (9.0-37.0%), somnolence (6.1-24.7%), peripheral edema (6.1-16.2%), and dry mouth (1.9-14.9%) and were dose related; in SCI patients: somnolence (41.4%), dizziness (24.3%), asthenia (15.7%), dry mouth (15.7%), edema (12.9%), constipation (12.9%), amnesia (10.0%), myasthenia (8.6%), amblyopia (8.6%), and thinking abnormal (8.6%); in fi bromyalgia patients: dizziness (37.5%), somnolence (18.6%), weight gain (10.6%), dry mouth (7.9%), blurred vision (6.7%), and peripheral edema (6.1%). In LYRICA-treated fi bromyalgia patients, the most commonly observed dose-related adverse events were: dizziness (22.7-46.5%), somnolence (12.9-20.7%), weight gain (7.6-13.7%), peripheral edema (5.3-10.8%). The most commonly observed adverse events in the PHN, DPN, SCI and fi bromyalgia patients were usually mild to moderate in intensity. Discontinuation rates due to adverse events for LYRICA and placebo, respectively, were 9% and 4% in DPN, 14% and 7% in PHN, 21% and 13% in SCI, and 20% and 11% in fi bromyalgia. There was a dose-dependent increase in rate of discontinuation due to adverse events in DPN, PHN and fi bromyalgia patients.

There have been post-marketing reports of angioedema in patients, some without reported previous history/episodes, including life-threatening angioedema with respiratory compromise. Caution should be exercised in patients with previous history/episodes of angioedema and in patients who are taking other drugs associated with angioedema.

In clinical trials and in post-marketing experience, there have been reports of patients, with or without previous history, experiencing renal failure alone or in combination with other medications. Caution is advised when prescribing to the elderly or those with any degree of renal impairment.

There have been post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, and constipation) in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with LYRICA, primarily in combination with other medications that have the potential to produce constipation. Some of these events were considered serious and required hospitalization. In a number of instances, patients were taking opioid analgesics including tramadol. Caution should be exercised when LYRICA and opioid analgesics are used in combination, and measures to prevent constipation may be considered, especially in female patients and elderly as they may be at increased risk of experiencing lower gastrointestinal-related events.

Dosage reduction is required in patients with renal impairment (creatinine clearance <60 mL/min) and in some elderly patients as LYRICA is primarily eliminated by renal excretion.

Please see Prescribing Information for complete Warnings and Precautions, Adverse Reactions, Dosage and Administration and patient selection criteria.

† Please consult Prescribing Information for complete Dosage and Administration instructions.

See prescribing information and study parameters on page 64


INTRODUCTIONWhat is the Education and Prevention Committee (EPC)?The Ministry of Health and Long-Term Care and the Ontario Medical Association (OMA) have jointly established the

Education and Prevention Committee (EPC). The EPC’s primary goal is to educate physicians about submitting OHIP

claims that accurately reflect the services provided and that are in compliance with the law.

What is an Interpretive Bulletin?Interpretive Bulletins are prepared jointly by the Ministry and the OMA to provide general advice and guidance to

physicians on specific billing matters. They are provided for education and information purposes only, and express the

Ministry’s and OMA’s understanding of the law at the time of publication. The information provided in this Bulletin is based

on the October 1, 2010, Schedule of Benefits – Physician Services (Schedule). While the OMA and Ministry make every

effort to ensure that this Bulletin is accurate, the Health Insurance Act (HIA) and Regulations are the only authority in this

regard and should be referred to by physicians. Changes in the statutes, regulations or case law may affect the accuracy

or currency of the information provided in this Bulletin. In the event of a discrepancy between this Bulletin and the HIA or its

Regulations and/or Schedule under the regulations, the text of the HIA, Regulations and/or Schedule prevail.

Education and Prevention Committee Interpretive Bulletin - Volume 9, No. 2


20

PurposeThe purpose of this Interpretive Bulletin is to provide physi-

cians with information on eight new fee codes introduced in

the Schedule for telephone consultations regarding a patient.

What is a telephone consultation?A telephone consultation is a service whereby one physician

(the referring physician), based on his or her professional

knowledge of a patient, requests the opinion of another

physician competent to give advice in the field (the consul-

tant physician) by telephone.

Four of the new codes are referred to as “Physician to

Physician” telephone consultations and the other four are for

telephone consultations arranged through CritiCall Ontario.

These services are only eligible for payment to a physi-

cian who does not receive payment through some other

funding model for participation in the telephone consul-

tation (e.g., salary, stipend, or Primary Care/Alternate

Payment Program/Alternate Funding Program models). In

other words, if you receive funding to provide these ser-

vices through another Ministry funding program, you are

not eligible for direct payment of these codes; however, the

service may be shadow-billed if part of the alternate funding

contract/program.

What is the difference between a Physician to Physician and a CritiCall telephone consultation?

Physician to Physician telephone consultation

use when the referring physician intends to continue with

the care, treatment and management of the patient and

initiates the telephone consultation (K730, K731, K734

and K735).



21

CritiCall Ontario arranged telephone consultation

the teleconferences are arranged through CritiCall

Ontario for the purposes of management of the patient

and/or transfer of care to the consultant physician (K732,

K733, K736 and K737).

The referring physician and the consultant physician

may be:

-

gency department (ED); or

These new fee codes are described in further detail on

pages A27 – A30 of the Schedule.

How do I know which code to use?Provided you have met all the payment requirements, if you

are the referring physician and:

If you are the consultant physician and:

Note: you do not need to be a specialist to be a “consultant

physician.”

General requirements applicable to these telephone consultation servicesWhile the Constituent and Common Elements of insured

services (described in the General Preamble) apply, these

telephone consultations also include the following for the:

Note, however, that required elements and payment

requirements for consultations as defined in the Schedule’s

General Preamble do not apply to these telephone con-

sultations.

Payment requirementsPhysician to Physician

These services are only eligible for payment when:

(does not need to be continuous);

-

cally present in Ontario at the time of the call; and

her own medical record for the patient, which includes:

- patient’s name and health number;

- start and stop times of the discussion;

- name of the referring and consultant physicians;

- reason for the consultation; and

- opinion and recommendations of the consultant

physician.

Physician to Physician CritiCall arranged

you are on duty

in a hospital

you are not on

duty in a

or ED, use K730 K732


you are on duty

in a hospital

you are not

on duty in a

or ED, use K731 K733


Referring

physician

Consultant

physician

The transmission of relevant data (including

history and laboratory and/or diagnostic

tests, etc.) and any other services rendered

that are necessary to obtain the advice of

the consultant.

Reviewing relevant

data provided by

the referring physi-

cian as well as all

services necessary

to provide an opin-

ion, advice and rec-

ommendations on

patient care, treat-

ment and manage-

ment to the refer-

ring physician.

Reviewing relevant

data provided by

the referring physi-

cian as well as all

services necessary

to provide advice

on patient manage-

ment to the refer-

ring physician.

June 20101ONTARIO MEDICAL REVIEW




22

Please note that each physician submitting a claim for a

telephone consultation must maintain his or her own record

that documents the telephone consultation.

These services are not eligible for payment unless all of the

above conditions are met. These services are also not eli-

gible for payment:

opinion and/or recommendation for patient treatment or

management;

rendered by the consultant physician on the same day

or the day following the telephone consultation for the

same patient when the purpose of the call is to discuss

a transfer of care for the patient; or

- arrange a face-to-face or telemedicine consultation or

procedure;

- arrange for diagnostic investigations; or

- primarily discuss results of diagnostic investigations.

CritiCall Ontario These services are only eligible for payment when:

CritiCall Ontario and subject to its requirements;

in Ontario at the time of the telephone consultation; and

record for the patient that:

- states the patient’s name and health number

- identifies the referring and consultant physician(s)

- states the reason for the consultation and the opinion

and recommendation(s) of the consultant physician; and

- notes that it was arranged through CritiCall Ontario.

(Please see “Summary — Physician to Physician and

Criticall Ontario Telephone Consultations,” on page 24.)

ExamplesExample 1 — Physician to Physician telephone

consultation (office to office)

Dr. A is a family/general practitioner (FP/GP) in Ontario

who has a patient with depression on medication who has

deteriorated recently. The patient saw Dr. B, a psychia-

trist in another Ontario city, six months ago. Dr. A would

like to consult with Dr. B to update Dr. B on the patient’s

condition and ask for management advice. Dr. A speaks

by telephone with Dr. B regarding the patient’s symptoms.

The conversation includes the patient’s history, present-

ing complaints, and results of a recent laboratory test. The

call lasts for 15 minutes, and Dr. B provides some advice

on adjustment of medications. Dr. A records all required

information in his patient’s medical record, including Dr. B’s

opinion and treatment advice, as well as the start and stop

time of the call. Dr. B creates a record for the patient, and

also records all required information, including the advice/

opinion given to Dr. A regarding the patient, as well as the

start and stop time of the call. What can be billed to OHIP in

this circumstance?

As payment requirements have been met, Dr. A is eligible

for payment of K730, and Dr. B is eligible for payment of

K731.

Example 2 — Physician to Physician telephone


Dr. Z is a FP/GP who has sent a patient to have a Doppler

vein thrombosis (DVT). Dr. Z calls the radiologist (Dr. Y)

after the test has been rendered, inquiring what the result

of the test was. The radiologist advises that the patient

does not have DVT. What can be billed to OHIP in this

circumstance?

Dr. Y and Dr. Z are not eligible for payment of a telephone

referral or telephone consultation as the purpose of the call

was to discuss the results of the diagnostic tests.



Dr. L is a psychiatrist. One of his more complex patients

with schizophrenia has become increasingly agitated and

Dr. L is concerned about adding in another drug due to

some underlying medical concerns. He consults by tele-

phone with Dr. M, a colleague who is an expert in psycho-

pharmacology. Both physicians are in Ontario at the time

of the call. Their conversation includes the patient’s history,

presenting complaints, and a discussion on the patient’s

medication and dosages, as well as the side-effects. The

call lasts for 13 minutes, and Dr. M provides his opinion on

the cause of the unusual side-effects and advice on adjust-

ment of medications, including prescribing olanzapine for

the agitation. Both physicians record all of the required

information in a medical record for the patient, including Dr.



M’s opinion and advice, as well as the start and stop time

of the call. What can be billed to OHIP in this circumstance?

As payment requirements have been met, Dr. L is eligible

for payment of K730, and Dr. M is eligible for payment of

K731. If either Dr. L or Dr. M are not in Ontario at the time of

the call, neither physician is eligible for payment of the tele-

phone consultation.


conference (office to office)

Dr. X, a comprehensive care FP/GP, has a patient with

chronic back pain and past history of opiate abuse. Dr.

X contacts Dr. C, a chronic pain focus practice FP/GP

with an interest in addiction, to inquire as to how best to

manage the patient. Dr. C spends 14 minutes outlining

investigations, exercises, medication and recommended

follow-up, thereby permitting Dr. X to treat the patient

and avoid using an opiate. Both physicians record all

of the required information in a medical record for the

patient, including Dr. C’s opinion and advice, as well as

the start and stop time of the call. What can be billed to

OHIP in this circumstance?

As payment requirements have been met, Dr. X is eligible

for payment of K730, and Dr. C is eligible for payment of

K731. If either Dr. X or Dr. C are not in Ontario at the time of

the call, neither physician is eligible for payment of the tele-

phone consultation.

Example 5 — CritiCall arranged telephone consultation

Dr. E is an emergency department physician at a commu-

nity hospital who assesses an intubated comatose patient

with a subarachnoid hemorrhage. The patient requires an

urgent referral to a neurosurgical centre. Dr. E contacts

CritiCall Ontario and discusses the case with Dr. N, a neu-

rosurgeon, who agrees to accept the patient in transfer.

Dr. I will be managing the patient during the transfer to

the neurosurgical centre and participates in the telephone

consultation.

Advice is provided by Dr. N about the pre-transfer and peri-

transfer management of the patient, and Dr. E, Dr. I and Dr.

N record in their respective records details of the patient,

the reason for the call, and the opinion and recommenda-

tions of the telephone consultation. What is eligible for pay-

ment in this circumstance?

Dr. E is eligible to claim a telephone consultation as a refer-

ring physician (K732), and both Dr. I and Dr. N are eligible

to claim as consultant physicians for the CritiCall Telephone

Consultation (K737).

Example 6 — CritiCall telephone consultation and

patient not transferred

participate in a telephone consultation arranged by CritiCall

Ontario. The physicians have a discussion of the relevant

medical history and current clinical status of the patient. Dr.

N is also able to review the CT scan through the PACS sys-

tem. Dr. N advises that neurosurgical intervention is not rec-

ommended and palliative measures should be initiated. A

patient transfer to the neurosurgical centre does not occur.

Dr. I also participated in the telephone consultation in the

event the transfer would occur. What is eligible for payment

in this circumstance?

Dr. E is eligible to claim a telephone consultation as a refer-

ring physician (K732), and both Dr. I and Dr. N are eligible

to claim as consultant physicians for the CritiCall Telephone

Consultation (K737). Transfer of the patient is not a pay-

ment requirement for a CritiCall telephone consultation.

CritiCall telephone consultations are eligible for payment

when rendered for the purpose of discussing the manage-

ment of the patient and/or transfer of the patient to another

physician (i.e. the consultant physician).

Example 7 — Telephone consultation not arranged by

CritiCall

Dr. E assesses the same patient described in Example 5.

He contacts Dr. F, the neurosurgeon on-call at the regional

centre, directly and arranges for transfer of the patient for

further management. What is eligible for payment in this

circumstance?

A CritiCall telephone consultation is not eligible for pay-

ment to either Dr. E or Dr. F, as the telephone consultation

was not initiated through CritiCall Ontario for the pur-

pose of discussing the management of the patient and/

or transfer of the patient to another physician. A Physician

to Physician Telephone consultation is also not payable

to either of these physicians, as the purpose of the tele-

phone consultation was to arrange for transfer of the

patient’s care.



Summary – Physician to Physician and CritiCall Ontario Telephone Consultations

– Referring physician – K730

– Consultant physician – K731



Physician – other than a

To obtain advice from the con-

sultant physician for a patient

that the referring physician

intends to continue the care,

treatment and management of.

To discuss the management of

a patient and/or the transfer of

care to the consultant physician.

Purpose of call (reason referring

physician initiates call)

The referring physician and con-

sultant physician must both be

physically present in Ontario.

The referring physician and the

patient must both be physically

present in Ontario.

Location of patient and

participant physician(s)

– 1 referral claim (K730 or K734)

– 1 consultant claim (K731 or K735)

– 2 referral claims total by the same

or another physician (K732 or

K736)

– 3 consultant claims total by dif-

ferent physicians (K733 or K737)

Daily maximum claims for

an individual patient

(i.e. a health number)

– Subject only to the patient level maximums above (e.g., if 2 physicians

submit K730 on the same day for the same patient, only the first claim

processed by the claims processing system will pay); otherwise no

maximums.

Maximum claims for an

individual physician on a

single day

– 10 minutes (may be non-continu-

ous but must be same day)

– No minimumMinimum time required





Physician on duty in a

Physician to Physician CritiCall Ontario



Your feedback is welcomed and appreciated!The Education and Prevention Committee welcomes your feedback on the Bulletins in order to help ensure that

these are effective educational tools. If you have comments or questions on this Bulletin, or suggestions for future

Bulletin topics, etc., please submit them in writing to:

Physician Services Committee Secretariat

150 Bloor Street West, 9th Floor


Fax: 416.340.2961; E-mail: [email protected]

Dr. Jane MacNaughton, Co-Chair

Dr. Larry Patrick, Co-Chair

Education and Prevention Committee

The PSC Secretariat will anonymously forward all comments/suggestions to the Co-Chairs of the EPC for review

and consideration.

For specific inquiries on Schedule interpretation, please submit your questions IN WRITING to:Health Services Branch

Physician Schedule Inquiries

370 Select Drive, P.O. Box 168

Kingston, Ontario K7M 8T4

Order Your New OMA Office Display Poster Today!

The posters are complimentary to OMA members. Please contact the OMA Response Centre via e-mail

([email protected]), or call 416.599.2580 or 1.800.268.7215 to order copies, or follow the links on the

Campaign home page (https://www.oma.org/Mediaroom/Pages/PolicyPlatform.aspx).

Make Health Care the #1 Issue in the Ontario Election

So are Ontario’s doctors. They have a plan to improve our health care system. But they need your help.

In this fall’s provincial election, let the candidates know: there is no issue more important than health care.

Learn more at oma.org.

If you don’t have one, download a QR code reader for your smartphone. Scan the code to read Ontario’s doctors’ plan to improve health care.

ONTARIO’S DOCTORSYour life is our life’s work

The OMA has launched a provincewide

communications campaign that aims to

keep health care top of mind among voters

and candidates for the upcoming October

provincial election. As part of the Association’s

ongoing strategic communications efforts,

the campaign includes a new segment of the

popular Life’s Work advertisements, which are

running on television (CTV, CBC), in the Globe

and Mail and Toronto Star, as well as regional

newspapers and radio.

Physicians are encouraged to get involved

and show support for improved health care in

Ontario by displaying a new OMA office poster

shown opposite. The 11” x 17” colour poster

reinforces physicians as leaders in health care,

and encourages patients to ensure that health

care is a priority issue in the next provincial

election.


OMA Physician’s Guide to Third Party and Other

Uninsured Services: 2011 Edition Online

The 2011 edition of the “OMA Physi-

cian’s Guide to Third Party and Other

Uninsured Services” is now avail-

able online for member reference and

download (https://www.oma.org/

Member/Resources/Documents/

ThirdPartyGuide.pdf).

This document is a valuable prac-

tice resource and provides guidance

for physicians and off ice staff on

uninsured and third party requested

services, suggested fees, relevant poli-

cies, and interpretations of pertinent

regulations.

Note that the suggested fees listed

in the 2011 Guide are 4.17% higher

than 2010, and these higher rates took

effect on January 1, 2011. Also, the

Scale of Grading and Remuneration of

Salaried Physicians (which is published

on page 23-24 of the Guide) has been

increased by 4.17%, effective January

1, 2011.

Printed versions will be provided to

members upon request. If you would

like to receive a printed version, please

submit your request via e-mail to:

[email protected].

Quest ions about the contents

of the “OMA Physi cian’s Guide to

Third Party and Other Uninsured

Services,” or suggestions for future edi-

tions, may be submitted to the OMA

Department of Economics via e-mail at:

[email protected].

FEATURE


ELFHT began using an EMR when it

opened in mid-2007, following the

amalgamation of three family practices.

Dr. James Chau, a family physician with

a geriatric focus, sums up his experi-

ence: “The EMR keeps me much more

on top of what’s happening with each

patient. It has helped me be a more

effective and efficient physician.”

He explains the greatest benefit he

has seen: “The EMR has a big impact

on preventive care. It provides the abil-

ity to track when people had their last

mammogram, Pap or other screening

test. We have a much more complete

chart with no gaps.”

Dr. Christine Pun, IT Lead for the

ELFHT, sums up the benefits she has

experienced: “The biggest advantage is

the instant access to everything about

the patient. I don’t have to go around

looking for information, it’s all in one

place.”

Victoria Luckham, the ELFHT phar-

macist, consults with patients for medi-

cation reviews, counsels on smoking

cessation, discusses safe and appro-

priate use of natural health products

as well as answering drug information

questions from patients, allied health

professionals and physicians. She says:

“I don’t have to run around looking for

paper charts. All documentation is in

the EMR, which is very helpful. Because

I see the health history as a snapshot,

for instance cholesterol levels over the

last year, I can show patients the co-

relation between medication use and

their test results.”

Patient safety also improves with

EMR use. Ms. Luckham notes that

when new guidelines on ACE inhibitors

and ARBs came out in 2009, she used

the EMR to find all ELFHT patients tak-

ing both medications, and notified their

physician for potential follow up. In the

paper world, she does not believe she

would have been able to do this.

More effective patient encounters

and follow up

Electronic charting with an EMR has

helped ELFHT staff access information

for effective encounters, and has facili-

tated patient follow up — with some

interesting and unexpected results.

Dr. Chau describes how EMR alerts

help him improve preventive care:

“Right at the top of the patient chart, the

EMR shows the tests that are due. We

March 201128


Elliot Lake Family Health Team —

patient care innovatorsby OntarioMD Communications

ELLIOT LAKE, LOCATED NORTH OF THE TRANS-CANADA HIGHWAY BETWEEN SUDBURY AND SAULT STE.

MARIE, IS BRINGING A PIONEERING SPIRIT TO PATIENT CARE. THE ELLIOT LAKE FAMILY HEALTH TEAM (ELFHT)

USES AN ELECTRONIC MEDICAL RECORD (EMR) FUNDED BY EHEALTH ONTARIO AND THE ONTARIO TELEMEDICINE

NETWORK TO HELP OFFER TIMELY AND BETTER CO-ORDINATED PATIENT CARE.

Elliot Lake and its Family Health TeamElliot Lake is a mining town that reinvented itself in 1987 as a retirement des-

tination, and is now the Canadian community with the highest percentage of

seniors. The main family health practice is the Elliot Lake Family Health Team

(www.elfht.com), which includes 13 physicians, three registered nurses, a

nurse practitioner, a pharmacist, a dietitian, a social worker, as well as a part-

time respiratory therapist and chiropodist. A total of 10,000 residents are ros-

tered with the FHT, out of a population of 13,500.

Pierrette Brown, ELFHT Executive Director, is enthusiastic about their

innovations combined with the FHT approach: “This is the best thing that has

happened to health care since I became a nurse in 1974. Now, we share the

load so that people don’t fall through the cracks.”



29 March 2011

see that very clearly at the start of the

encounter and can initiate the discus-

sion right off the top to ensure all the

preventive measures are looked after

properly.”

Another benefit Dr. Chau appreci-

ates is the ability to see whether tests

have been carried out: “The EMR

shows when tests are ordered and

when someone does not complete their

blood work, imaging or something else,

we will see that those results are miss-

ing. When they come back, we can ask

why it wasn’t done or what happened.

That’s made a big difference.”

All test results are stored in the

patient’s electronic record. Most of the

tests are done by the local community

laboratory, and the results are automat-

ically sent directly to the EMR. Other

tests are scanned into the EMR once

received in paper format.

An unexpected but welcome ben-

efit is improved follow up through tele-

phone communications. Dr. Chau

explains: “With paper, when a patient

called, we’d get a paper stuck in the

chart sent to us. It may or may not have

fallen out and might not be in the right

order when we received the chart. Now,

everything’s in the EMR and if we end

up sending back a message, every-

thing’s documented. I have always

received a lot of calls from patients,

and with the EMR, patients are actually

calling more. They know if they leave

me a message, it will get to me. It has

improved communications and I think

patients appreciate that they’re getting

more feedback when they call in.”

Ontario Telemedicine Network

and EMR

Dr. Pun appreciates the Ontar io

Telemedicine Network (OTN) videocon-

ferencing service, enabled by eHealth

Ontario’s network, that lets her patients

access specialist care without leaving

their community: “I get the encounter

summary note in the EMR the day of

the visit and can act on it quickly,” says

Dr. Pun.

Jessica Wright, RN, the ELFHT OTN

co-ordinator, attends each patient OTN

session and enters the summary into

the patient’s EMR.

Ms. Wright explains how patients

appreciate the service: “They all love

the fact that they have better access

to specialists and don’t have to drive to

see them. They find it amazing and say

‘who would have thought I’d be seeing

a doctor over the TV!’”

One of the reasons she chose to

work at ELFHT was precisely its inno-

vative approach: “As a recent grad, I

knew all the things I studied in school

were happening here, and I wanted the

opportunity to put them into practice,”

says Ms. Wright.

What’s Next

The Elliot Lake Family Health Team

continues to explore ways to expand

EMR use to improve its ability to deliver

quality patient care and practice effi-

ciently.

Dr. Pun notes that they are looking

at having an encounter form open auto-

matically as soon as a patient signs in

at reception so the chart is open and

available for the physician before the

encounter starts. They are also looking

at standardizing forms and templates

for all physicians to make it easier to

cover each other’s patients.

Ano the r enhancement be ing

explored is the use of voice recogni-

tion software so physicians reduce the

amount of keyboarding required.

Summing up his EMR experience,

Dr. Chau says: “I couldn’t live without

an EMR. When you make the switch-

over, it can take some effort to adapt at

first, but it’s well worth the effort in the

long run in terms of how much it helps

you improve patient care and your own

practice.”

The EMR Adoption column is provided by

OntarioMD, a subsidiary of the OMA, that

manages Ontario’s EMR Adoption Program,

funded by eHealth Ontario. For more infor-

mation on EMR Adoption, visit www.ontari-

omd.ca, e-mail emrfunding@ontariomd.

com, or call toll-free 1.866.744.8668. If

you would like a physician Peer Leader to

answer your questions, a free service for

physicians, e-mail peer.leader.program@

ontariomd.com. The deadline for applying is

September 30, 2011.

Ontario Telemedicine Network at ELFHTOntario Telemedicine Network is another key service at the Elliot Lake Family

Health Team. Patients come to ELFHT and use the telemedicine studios for

medical appointments with specialists or other health-care professionals any-

where across Ontario via videoconferencing. It is used for 70 to 80 sessions

per month, allowing patients, who may be quite ill, to avoid a minimum two-

hour trip to a regional centre, and a much longer trip if the consulting physician

is further away. This is especially valuable in winter, when snow, ice and wind

can make roads dangerous.

Use the OMA’s Continuing Medical Education Locating Service to find the right CME opportunity for you.

With access to thousands of courses, conferences and cruises worldwide, we can customize a list of professional development opportunities for you.

You can also search our database and list of quality websites focusing on Canadian CME opportunities.

For more information, contact Information Management:tf: 1.800.268.7215, ext. 2915 e-mail: [email protected]: http://www.oma.org/Benefits/CMELocating.aspx

Navigating Your CME Opportunities


The Ontario Medical Associat ion

recently issued a public statement

expressing support for the provincial

government considering covering the

cost of smoking cessation drugs.

“These medications are proven to

at least double the success rates for

people who want to quit when other

approaches don’t work,” said OMA

President Dr. Mark MacLeod in a

February 14 media release.

Ontario’s doctors have been strong

advocates and long-time supporters

of providing smoking cessation drugs

to patients who want to quit, but can’t

afford the drugs that can help them.

For more than two years, Ontario’s

doctors have called for the addition of

these smoking cessation medications

to the Ontario Drug Benefit Plan and

including them in other public and pri-

vate insurance plans in order to reach

the patients who need this help.

The negative impact that tobacco

products and cigarettes have on the

health-care system and society is no

secret.

“Tobacco-related disease currently

costs the Ontario health system $1.6

billion annually and kills more than

13,000 Ontarians every year. Which

is why earl ier this year, Ontario’s

doctors included several key recom-

mendations in our provincial elec-

tion platform, Better care. Healthier

patients. A stronger Ontario,” said Dr.

MacLeod.

In addition to a broader cessation

system, Ontario’s doctors are calling for

a reduction in the number of tobacco

outlets, a moratorium on sale of new

tobacco products, and a comprehen-

sive contraband control strategy.

“As physicians, we want to help our

patients quit smoking,” Dr. MacLeod

stated, adding, “We believe that pro-

viding medicines that can help them

quit will pay big dividends for their

health, and ultimately save our health-

care system much more money in the

end.”

30 March 2011

Grant Thornton LLP. A Canadian Member of Grant Thornton International Ltd

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At Grant Thornton LLP, we understand the unique challenges facing medical professionals today. So why not call upon a team of Canada-wide advisers with experience helping you meet those challenges head on. Professionals like Stephen R. Binder, BA, CA, and a partner in our North Toronto office. For over 35 years, Stephen has helped his clients in the medical profession thrive. Whether it’s through strategic and operational planning to help ensure success of the practice, or assisting with the exit strategy when the time comes to hand the business to the next generation—and everything in between—that’s Stephen’s commitment to his clients. It’s ours too, which is why we’re thrilled to have him on our side. Give us a call today and put our side to work for you.

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Audit Tax Advisory

OMA statement on smoking cessation drugs:physicians pleased to learn government may cover medication costs

FEATURE


A fact sheet entit led “Changes to

the Special Diet Allowance: What

Physicians Need to Know” and a

Sample Form are posted on the

OMA website (https://www.oma.org/

Member/Resources/Issues/Pages/

dietallowance.aspx).

A brief summary of the changes is

provided below.

Highlights

SDA schedule of eligible medical

conditions and the application form.

All current SDA recipients will be

required to submit a new applica-

tion form by July 31, 2011. The new

application forms were to be mailed

to recipients beginning February 1,

2011.

medical conditions reflect the rec-

ommendations of the Special Diets

Expert Review Committee, which

included physicians, nurses, and

clinical dieticians.

booking appointments with their

physician to have the new form com-

pleted. The new form includes modi-

fied consents for both the physician

and patient, which are described on

the fact sheet.

Social Services will be monitoring

SDA utilization in order to identify

unexpected or highly improbable

trends in the medical conditions

indicated on the application form

and, where justified, will request

and review medical records related

to determining eligibil ity for the

SDA.

OHIP billing code (KO55) for the new

form are unchanged.

-

cation form is currently combined

with the SDA application form (Form

#3059/3060). Effective February 1,

(Form # 3109/3116) will come into

effect.

OHIP billing code (KO56) has been

assigned to this form. Applications

form will continue to be processed

until March 31, 2011.

For additional details regarding

changes to the Special Diet Allowance,

please refer to the fact sheet on the

OMA website (https://www.oma.org/

Member/Resources/Issues/Pages/

dietallowance.aspx).

March 201132

Changes to Special Diet Allowance—

what physicians need to know:fact sheet and sample form available online

THE ONTARIO GOVERNMENT IS PLANNING TO INTRODUCE CHANGES TO THE SPECIAL DIET ALLOWANCE (SDA),

Do you have an OMA-related

question and don’t know who to

contact?

Send us an e-mail at [email protected] or call 1.800.268.7215 and

press 0.

Women’s Health and

International MedicineApril 28, 2011 • 9 a.m. – 4:30 p.m. • Toronto Marriott Downtown Eaton Centre Hotel

The 12th annual Women’s Health Care Seminar is complimentary to OMA members, and

has been accredited in previous years for CME credits. To register, visit www.oma.org/

member/news/events/pages/agm.aspx, or contact Jennifer Csamer at 1.800.268.7215,

ext. 3461, or via e-mail ([email protected]).

Featuring Maureen McTeer on women’s health and

sustainable development in the developing world

Text box

DIRECTORY

May 20101

This is where a Kicker would go

The main headline of the Feature

articles would go here

This is where the heading sub would go

by Whomever

INTRO PARAGRAPH HERE

March 201134

THE OMA CORPORATE AFFAIRS AND PLANNING

DEPARTMENT HAS NEGOTIATED AN EXTENSIVE

LISTING OF PREFERRED 2011 RATES FOR OMA MEMBERS

AT HOTELS LOCATED THROUGHOUT ONTARIO.

OMA

CORPORATE

HOTEL

DIRECTORY

2011 EDITION

To ensure you receive the rate quoted

in this directory, please state that you

are an OMA member at the time of

booking a reservation.

Note that the rates quoted in this

directory are not always the lowest

available rate at the time of booking.

Many hotels will offer special rates

at certain times of the week or year.

Please inquire when making your

reservation to ensure you receive the

lowest possible rate.

Also note that most rates quoted in

this directory are subject to availability,

thus you may be offered the “best

available rate” if the hotel has sold out

of the type of room for which the OMA

has contracted. Rates are quoted for

standard accommodation, unless

otherwise noted.

To ensure a late arrival guarantee, a

credit card number must be given at

the time of booking a reservation.

All rates listed in this directory are

effective from January 1, 2011 to

December 31, 2011, unless otherwise

noted, and are subject to applicable

taxes.

Please note, you may be asked to

present corporate identification at the

time of check-in, so remember to carry

your OMA membership card with you.

The 2011 OMA Corporate Hotel

Directory may be accessed online

year-round in the “OMA Advantages

(Affinity & Discounts)” area of the OMA

WebLink site (www.oma.org).

For further information on preferred

hotel room rates for OMA members,

please contact the OMA Corporate

Affairs and Planning Department at

416.599.2580; 1.800.268.7215 or

[email protected]


OMR_HotelDirectory_Mar11.indd 1 3/7/11 12:36 PM

FEATURE

BARRIE

Holiday Inn

BELLEVILLE

Ramada Hotel, Resort and

Conference Centre

BRANTFORD

Best Western Brant Park Inn

BURLINGTON

Homewood Suites by Hilton

CAMBRIDGE


Cambridge-Waterloo

COLLINGWOOD

Tyrolean Village Resorts at Blue

Mountain

CORNWALL

Best Western Parkway Inn &

Conference Centre

GANANOQUE

Colonial Resort & Spa

GRIMSBY

Casablanca Winery Inn

GUELPH

Delta Guelph

HAMILTON

Sheraton Hamilton Hotel

KINGSTON

Ambassador Conference Resort

Four Points Hotel & Suites by

Sheraton Kingston

Holiday Inn Kingston-Waterfront

KITCHENER-WATERLOO

Best Western St. Jacobs Country Inn

Delta Kitchener-Waterloo

Hampton Inn & Suites by Hilton

Holiday Inn Kitchener-Waterloo Hotel

& Conference Centre

Radisson Hotel Kitchener Waterloo

LONDON

Delta London Armouries

Hilton London


Residence Inn by Marriott, London

Downtown

StationPark All Suite Hotel

MISSISSAUGA

Delta Meadowvale-Mississauga

Delta Toronto Airport West

Hilton Garden Inn Toronto Airport

Hilton Garden Inn Mississauga/

Toronto Airport


Toronto-Mississauga

MUSKOKA & AREA

Delta Grandview – Huntsville

Delta Rocky Crest – Muskoka

Delta Sherwood – Port Carling

NIAGARA FALLS

Crowne Plaza

Sheraton on the Falls

NIAGARA ON THE LAKE

Hilton Garden Inn

Niagara-on-the-Lake

Pillar and Post

Prince of Wales

Queen’s Landing

OAKVILLE


Toronto-Oakville

OTTAWA

Albert at Bay Suite Hotel

Best Western Victoria Park Suites

Brookstreet Resort

Delta Ottawa Hotel and Suites

Fairmont Chateau Laurier

Holiday Inn Hotel & Suites Ottawa

Downtown

Lord Elgin Hotel

Minto Suite Hotel

Novotel Ottawa

Ottawa Marriott

Sheraton Ottawa

Westin Ottawa

PETERBOROUGH

Holiday Inn Peterborough Waterfront

SARNIA

Holiday Inn Sarnia/Point Edward

SAULT STE. MARIE

Delta Sault Ste. Marie Waterfront

Hotel and Conference Centre

SUDBURY

Hampton Inn by Hilton

Holiday Inn


THUNDER BAY

Valhalla Inn Thunder Bay

TORONTO (GTA)

Cambridge Suites Hotel Toronto

Cosmopolitan Toronto

Courtyard by Marriott Downtown

Toronto

Delta Chelsea-Downtown Toronto

Delta Markham

Delta Toronto East

Doubletree by Hilton Toronto Airport

Fairmont Royal York

Four Points by Sheraton Toronto

Airport


Airport West


Lakeshore

Four Seasons

Hampton Inn by Hilton Toronto Airport

Corporate Centre

Hilton Garden Inn Toronto/City Centre

Hilton Garden Inn Toronto/Vaughan

Hilton Suites Toronto/Markham

Conference Centre & Spa

Hilton Toronto

Homewood Suites by Hilton Toronto

Airport Corporate Centre

Homewood Suites by Hilton Toronto-

Markham

InterContinental Toronto Centre

InterContinental Toronto Yorkville

Le Meridien King Edward

Marriott Toronto Airport

Metropolitan Hotel

Novotel Toronto Centre

Pantages Hotel

Park Hyatt Toronto

Radisson Suite Hotel Toronto Airport

Renaissance Toronto Hotel Downtown

Sheraton Centre Toronto

Sheraton Gateway Hotel

Sheraton Toronto Airport Hotel &

Conference Centre

The Old Mill Inn

The Sutton Place

Toronto Marriott Downtown

Eaton Centre

Westin Harbour Castle

WINDSOR

Hilton Windsor


OMR_HotelDirectory_Mar11.indd 2 3/7/11 12:36 PM

Colour Information:

Creative (D i /AD/CD)

Now available

VIMOVO® and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies. © AstraZeneca 2011

02/12

VIMOVO is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed (as with other modifi ed-release formulations of naproxen). For patients with an increased risk of developing cardiovascular (CV) and/or gastrointestinal (GI) adverse events, other management strategies that do NOT include the use of NSAIDs should be considered fi rst. Use of VIMOVO should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events.VIMOVO, as a NSAID, does NOT treat clinical disease or prevent its progression.VIMOVO, as a NSAID, only relieves symptoms and decreases infl ammation for as long as the patient continues to take it. Evidence from naproxen clinical studies and postmarket experience suggest that use in the geriatric population is associated with differences in safety.VIMOVO is contraindicated in the peri-operative setting of coronary artery bypass graft surgery (CABG); in women in the third trimester of pregnancy or who are breastfeeding; in patients with severe uncontrolled heart failure, known hypersensitivity to naproxen, esomeprazole, substituted benzimadazoles or to any of the components/excipients; history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs; active gastric/duodenal/peptic ulcer or active gastrointestinal bleeding; cerebrovascular bleeding or other bleeding disorders; infl ammatory bowel disease; severe liver impairment or active liver disease; severe renal impairment or deteriorating renal disease; known hyperkalemia and in children and adolescents less than 18 years of age.

WARNING Risk of cardiovascular (CV) adverse events: ischemic heart disease (IHD), cerebrovascular disease, congestive heart failure (HF) (NYHA II-IV) Naproxen is a non-steroidal anti-infl ammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing NSAIDs such as naproxen, which is a component of VIMOVO (naproxen/esomeprazole), to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV). Use of NSAIDs such as naproxen, which is a component of VIMOVO, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure. Randomized clinical trials with VIMOVO have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing VIMOVO.Risk of gastrointestinal (GI) adverse events Use of NSAIDs such as naproxen, which is a component of VIMOVO, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).

The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly.The recommended daily dosage of VIMOVO is 375/20 mg or 500/20 mg (naproxen/esomeprazole) twice a day. The most commonly reported adverse reactions for VIMOVO were erosive gastritis (7.2%), dyspepsia (11.8%) and gastritis (6.5%). See the Product Monograph for full contraindications, warnings, precautions, dosing and administration.

Reference: VIMOVO® Product Monograph. AstraZeneca Canada Inc. January 13, 2011.

See prescribing summary on page


BOARD REPORTSummary of resolutions

Corporate

-

Health Policy

-

-

-

Member Services

-

-

Committee Appointments

Medical Professional Liability

Committee

OntarioMD Board

Ontario Health Technology

Advisory Committee

Correction: The OMA Board of Directors

recently appointed Dr. Kevin Smith to the

Education and Prevention Committee.

Incorrect information appeared in the

January 2011 OMR (p. 34).

OMA Board of Directors Meeting

February 2-3, 2011

Aldis, John Sydney Woollatt

Port Hope

University of Western Ontario, 1950

December 2010 at age 95

Beck, Ivan Thomas

Kingston

University of Geneva, 1949

November 2010 at age 86

Butt, William Joseph

Woodstock

University of Western Ontario, 1949


Colapinto, Ronald Frank

Toronto

University of Toronto, 1955

January 2011 at age 79

Daniell, Shane

North York

McMaster University, Class of 2013

September 2010 at age 24

Feher, Peter J.

North York

McGill University, 1959


Grewal, Brinderajit Singh

Brockville

Rajasthan University, 1989


Haddad, Derrick Antonio

Kitchener

University of London, 1964


Kyle, Joseph Leland

Niagara Falls



Murty, Gummuluri Appala N.

Dunrobin

Andhra Unversity, 1965


Rajput, Natwarlal D.

Delhi

University of Bombay, 1968


Sadler, Bruce Guy

Brockville

Queen’s University, 1953


Sutherland, Norman Gregor

Pembroke

University of Glasgow, 1964


Tam, John Chun-Ho

Don Mills




IN MEMORIAMThe OMA would like to express condolences to the families and friends of the following members.

The OMA publishes brief notices about deceased members as a service to their colleagues. Information concerning these members should

be sent to [email protected].

Insurance Check-Up... Have You Had One Lately?

Surprisingly, many physicians have not reviewed their insurance coverage in several years.

Your health is not the only thing that changes over time. Events take place during a lifetime that can alter your financial situation.

MarriageChildrenBuying a home and/or cottagePractice matures and income increasesRetirement.

Your insurance may not have kept pace with your changing needs. A regular review of your insurance is essential to providing adequate protection for you and your family. The OMA provides the services of professional non-commissioned Insurance Advisors.

Contact OMA Insurance today by phone (1.800.758.1641 / 416.340.2918) or e-mail ([email protected]) and arrange to have your insurance needs reviewed.

The best time to find out if you have enough insurance is before you need it.

Project1:Layout 1 3/7/11 6:02 AM Page 1


Advanced AccessThe OMA and the Ministry of Health and

Long-Term Care are working together

to expand the use of advanced access

scheduling in physician practices

throughout Ontario.

Physicians who employ advanced

access principles in their practice

are able to schedule an appointment

for their patients within a short time,

usually the same day. The benefits

of advanced access are well pub-

lished, and include improved quality of

care and clinical outcomes, and also

improved patient, provider and staff

satisfaction.

Advanced access has been effec-

tively implemented in other provinces,

such as British Columbia and Alberta,

and throughout the United States,

Australia and the United KIngdom.

In the coming months, more details

will be made available through infor-

mation sessions, articles in the Ontario

Medical Review, and a survey to physi-

cians.

OMA Staff Contact: Peter Brown (ext. 2989)

Framework Strategy for Strengthening Primary Health CareIn June 2010, participants in a Health

Forum at McMaster University identi-

fied an opportunity for a planning group

to work towards developing a frame-

work strategy for strengthening primary

health care in Ontario.

As a member of this planning group,

the OMA is actively supporting the

development of a framework strategy

for primary health care that focuses

on strengthening accountability and

governance, while enhancing quality,

access and efficiency. Experts, includ-

ing front-line practicing family physi-

cians, are currently being engaged

in the process of drafting the content

of the framework, to be debated at a

Summit in spring 2011.

OMA Staff Contact: Peter Brown (ext. 2989)

Update on Models and Processes of Delivery for Specialty CareThe OMA has embarked on a process

to examine innovative delivery mod-

els and processes of specialty care,

and determine whether they address

current problems in the system. It is

desirable to have delivery models that

contribute to a quality system that is

patient-centred, cost-effective, and

beneficial and satisfying to physicians.

The OMA Health Policy Department

has produced a draft paper enti-

tled “OMA Principles and Ideas for

Consideration: Models and Processes

of Delivery for Specialty Care.” A

reference panel, composed of spe-

cialist physicians, was convened to

provide input to the paper. The panel

was chaired by Dr. Stephen Chris,

Chair, OMA Health Policy Committee.

The draft paper has been sent to the

field for input from OMA Sections,

the reference panel, other interested

physicians, and health system stake-

holders.

As an initial step in the process, a

background paper, “OMA Background

Paper on Models and Processes

of Delivery for Specialty Care,” was

produced and is now available on

the OMA website at: https://www.

oma.org/Resources/Documents/

M o d e l s o f D e l i v e r y f o r S p e c i a l t y

CareBkgrnd20101222.pdf.

Staff Contact: Aura Hanna (ext. 3054)

March 201141

Advanced Access

Framework Strategy for Strengthening Primary Health Care

Update on Models and Processes of Delivery for Specialty Care

by OMA Health Policy Department

HEALTH POLICY REPORTA summary of current health legislation and policy developments

© 2011 Pfi zer Canada Inc. Kirkland, Quebec H9J 2M5

CADUET® C.P. Pharmaceuticals International C.V. owner/ Pfi zer Canada Inc., Licensee

TM Pfi zer Inc., owner/Pfi zer Canada Inc., Licensee

Pr

Covered by most provincial formularies*

* See respective Formularies for details (not covered in BC, AB, PEI).

Education and Prevention Committee

Complimentary Medical Billing SeminarFriday, April 29, 2011

Toronto Marriott Downtown Eaton Centre Hotel

9:00 – 10:10 Plenary Presentation (all physicians)This presentation by the Ministry of Health and Long-Term Care is for all physicians, regardless of specialty or experience, and will include:

10:10 – 10:20 Break

10:20 – Noon Breakout Session 1 for Family/General Practitioners and New Physicians

Noon – 2:00 Adam Linton Memorial Feature Luncheon

2:00 – 3:30 Breakout Session 2 for Primary Care Physicians

This session is intended only for physicians participating in a primary care model (i.e. FHG, FHN, FHO).

NOTE: The seminar is open only to physicians and all events are available on a first-come, first-served basis. To register, please complete and fax the form below to 416.340.2244 by April 15, 2011.

Name (surname first) ______________________________

Address ______________________________________

City _________________ Postal Code _______________

Phone _______________________________________

Fax _________________________________________

E-mail _______________________________________

Specialty _____________________________________

Please register me for:

FHN FHO )

must register in order to attend the luncheon)

The Education and Prevention Committee (EPC) is a joint committee of the Ontario Medical Association and the Ministry of Health and Long-Term Care.

42 March 2011ONTARIO MEDICAL REVIEW

HELPING YOU ACHIEVE A BETTER BALANCEThe OMA Physician Health Program is a confidential

service for physicians, residents, medical students

and their family members who may be experiencing

problems ranging from stress, burnout, emotional

or family issues, through to substance abuse and

psychiatric illness. The OMA Professionals Health

Program is a confidential service provided to health

professionals.

Confidential Toll-Free Line 1 800 851 6606

php.oma.org

Good Health Matters

PHP_OMR_Ad_09_Final2.qxd:Layout 1 6/9/09 12:01 PM Page 3


Top-five secrets to running

a great practiceby Grant Lum, MD, CCFP, Dip Sport Med

PRACTICE MANAGEMENT

What is a great practice? Is it one where the patients are happy and well

served? Where all staff members are welcoming and friendly, and seem

genuinely happy to be doing their jobs? Is it one where the doctors feel at ease that

everything that is supposed to happen to support their work is done almost without

their asking, and on time? For most practices, the answers to these questions are

Yes, Yes, and Yes again!

The best-run practices require several

key elements in order to achieve all of

these goals. But how do they do it?

Here are the top-five secrets to running

a great practice.

1. Hire great people

Hire a great office manager, and let

him or her handle day-to-day opera-

tions. Set clear and concise goals for

your practice. This can be achieved by

developing an office policy manual for

both employees and physicians. Don’t

get in the way of the office manager

by sweating the details. Have input

into designing the systems that will be

used, but don’t micromanage.

Listen to your front-desk staff —

they’re on the front lines, and they know

what works and what doesn’t. Ask for

their help to make things more efficient.

Hire good people to give advice —

lawyer, accountant, human resources

consultant, benefits/pension/tax plan-

ner, architect, contractor. Just like

referring a patient to a good surgeon,

hiring a specialist in each of these areas

to give you advice will always leverage

their greater knowledge, insight and

experience to help you find the best

solutions.

2. Establish great systems and a

comfortable environment

Your telephone system is likely the

first point of contact for anybody get-

ting in touch with you or your practice.

Establish good protocols for your staff

to follow — when to interrupt you, and

more importantly, when not to. Make

sure messages are detailed and clear,

and include phone call time in your

weekly schedule so that it doesn’t inter-

rupt a busy patient day.

Your computer system is also vitally

important. A strong recommendation

would be to invest in an electronic med-

ical record (EMR) system, and also in

adequate training for the staff and the

physicians. The rewards in terms of

time saved in looking for charts alone

will repay the investment.

Invest in your physical plant. Spend

time, effort, and reasonable amounts of

money in the construction of the office,

arrangement and choice of furniture,

equipment, etc. Don’t forget that you’ll

live in the office for about eight to 10

hours per day, or more. Make it func-

tional, but also make it comfortable.

3. Make a commitment to constant

improvement

Take notes on the processes and pro-

tocols that are working, and those that

are not, and set aside time to review

those notes monthly. Again, ask for

input from your front-line staff.

4. Remember that medicine is a

service industry

We’re here for our patients, so it’s


PRACTICE MANAGEMENT

important to show up on time, and

be polite to your staff as well as your

patients. One of the most important

elements to success is having a good

attitude. It’s difficult for patients to tell

whether their physician is really empa-

thetic, but they can tell if he or she is

polite, and it is often this trait that gives

patients confidence that they are get-

ting good care. You must not only

exhibit professional skills, you must also

be able to maintain a good rapport with

your staff and patients.

5. Have fun!

If you’re not having fun, then do some-

thing different — change something

in your practice, your office, or your

attitude. Medicine is a calling, not just

a job. It’s that great sense of purpose

that drives us to become physicians in

the first place. Having the privilege to do

the work you always imagined yourself

doing should be fun. Except, perhaps,

for the paperwork!

Take the “Twelve Points Office

Efficiency Test” below to see if you

are running a great practice (Source:

Secrets of the Best-Run Practices by

Judy Capko).

Any practice can qualify as a best-

run practice if you put a bit of time into

thinking about it and making plans to

improve it. You’ll recoup your effort

many times over!

Dr. Grant Lum, MD, CCFP, Dip Sport Med

is the medical director of Athletic Edge

Sports Medicine.

The Practice Management column is pro-

v ided by the OMA Member Serv ices

Department. Do you have a topic or ques-

tion you would like to see appear in the

Ontario Medical Review? Please let the

Practice Advisory Service team know at

416.340.2911, or 1.800.268.7215, ext. 2911,

or e-mail: [email protected].

Twelve Points Office Efficiency Test

Efficiency Questions Yes/No

1. Is the staff working late?

2. Is office morale down?

3. Is staff turnover more than 15% annually?

4. Are charges posted within five weeks from date of service?

5. Are there more than five claim inquiries of rejection on the biller’s desk?

6. Are more than 20% of your accounts received aged more than 90 days?

7. Do you experience more than 10 abandoned telephone calls per day?

8. Do you fail to respond to telephone messages within two hours?

9. Do physicians get interrupted (for non-emergencies) in the exam room?

10. Do physicians have yesterday’s charts on their desk when they arrive in the office each morning?

11. Are employee performance reviews overdue?

12. Do patients wait in the reception room more than 15 minutes before they are called in for their appointment?

If you answered yes to more than three of these questions, your office efficiency needs to be addressed.

Source: Secrets of the Best-Run Practices, Judy Capko, 2nd ed. Phoenix, MD: Greenbranch Publishing; 2010.

Ontario Medical Student Bursary Fund7th Annual Fundraising Golf Tournament

Friday, June 17th, 20117:45 a.m. Shotgun Start

Angus Glen Golf ClubHost site of the 2002 & 2007 Canadian Open

$400 per ticket / $1,600 per foursome. Price includes: 18 holes of golf with cart, breakfast, lunch, and participation in golf contests with great prizes!! Partial tax receipts will be issued to those who pay directly to OMSBF.

ALL PROCEEDS FUND STUDENT BURSARIES FROM OMSBF.

Call Sandra Zidaric, Senior Campaign Director, at 1.800.268.7215 ext. 2985 or 2259 to register or become a sponsor. Or visit http://omsbf.oma.org

RESERVE NOW! LAST YEAR’S TOURNAMENT SOLD OUT EARLY!

Special thanks to our sponsors:

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Cohabitation agreements and marriage contracts:

when to consider entering into a domestic agreement

by Kevin Power, LLB

DOCTOR’S BUSINESS

A lthough a cohabitation agreement or marriage contract may not be at the

forefront when a couple begins to reside together, or starts planning for their

wedding day, there are particular circumstances where spouses may wish to consider

entering into a domestic agreement.

Cohabitation agree ments and marriage

contracts tend to be more prevalent in

second marriages. Couples who are

previously divorced or separated, and

have children from an earlier marriage,

may wish to organize their affairs in

such a manner as to protect items they

wish to leave to their children.

These agreements are also common

where a wealthier spouse is bringing

significantly more to the union in the

way of assets, or where a spouse is

bringing a home into the relationship.

Cohabitation agreements and mar-

riage contracts are forms of domestic

agreements. The Family Law Act allows

spouses to enter into domestic con-

tracts. They may agree upon provisions

in their domestic agreement which will

prevail over the provisions set out in the

Family Law Act.

Two persons who are cohabiting

or intending to cohabit, and are not

married, may enter into a cohabitation

agreement. In the cohabitation agree-

ment they may agree on their respec-

tive obligations during the relationship,

upon separation, or upon death. If the

parties to a cohabitation agreement

marry, then the agreement becomes a

marriage contract.

Two persons who are married, or

intending to marry, may enter into a

marriage contract. They may enter a

marriage contract in which they agree

on their respective rights and obliga-

tions during the marriage, or upon sep-

aration, or upon death.

In both the cohabitation agreement

and the marriage contract, parties may

agree upon ownership in, or division of,

property, spousal support obligations,

the right to direct the education and

moral training of their children, and any

other matter in the settlement of their

affairs.

Parties are not able to determine

custody and access of children in a

cohabitation agreement or a marriage

contract. Similarly, parties cannot pre-

determine child support under the Child

Support Guidelines for children of the

marriage.

The starting point in considering

whether to enter into a cohabitation

agreement or marriage contract is to

consider what would happen in the

future, in certain circumstances, with-

out an agreement.

Non-married spouses have different

property rights than married spouses.

The property and matrimonial home

provisions under Parts I and II of the

Family Law Act do not apply to non-

married spouses. Married spouses

have a right to claim an equalization and

rights in a matrimonial home, includ-

ing possessory rights. Non-married

spouses do not have the right to an

equalization, or the rights in a matrimo-

nial home.

While non-married spouses do not

have the property rights under the

Family Law Act, at common law they

may advance claims for property on the

basis of a constructive trust or unjust

enrichment.

For unmarried spouses, they need to

rely upon judge-made law to address

property issues arising on the break-

down of the relationship. A resulting or

constructive trust claim can be made

on the basis of contributions during the

marriage to a property, such as a house


or a business which is in the name of

one spouse alone. The non-tit led

spouse would claim an ownership inter-

est on the basis of his or her monetary

and/or non-monetary contributions.

The recent Supreme Court of Can-

ada decision in Kerr v. Barranow and

Vanasse v. Seguin (2011) SCC 10

(CanLII), released in February 2011,

reviews the law on trust and unjust

enrichment claims. The court found

that “Cohabitation does not, in itself,

under the common law of unjust enrich-

ment, entitle one party to a share of

the other’s property or any other relief.

However, where wealth is accumulated

as a result of joint effort, as evidenced

by the nature of the parties’ relationship

and their dealings with each other, the

law of unjust enrichment should reflect

that reality.”

Constructive trust and unjust enrich-

ment claims can lead to lengthy and

expensive proceedings upon separa-

tion, and expose property, such as a

home, cottage or business, to an own-

ership interest by the other spouse. A

cohabitation agreement, in dealing with

property, can address how the par-

ties intend to hold property during the

relationship, and the rights to property

upon separation. It may also provide for

a release of any future constructive trust

or unjust enrichment claims.

Married spouses may wish to alter

the equalization provisions in a mar-

riage contract. The equalization provi-

sions contained in the Family Law Act,

which would otherwise apply upon a

separation of married spouses, can be

avoided or altered by a marriage con-

tract.

Parties can choose to avoid the

equalization altogether and remain

separate as to property. Ownership of

property would determine the property

division. There would be no obligation

to equalize the gains made by a spouse

during the marriage. In a situation where

a spouse enters a relationship with sig-

nificantly more wealth than the other

spouse, he or she may wish to limit an

equalization during a short-term mar-

riage. Parties can negotiate to limit the

equalization provisions early in a mar-

riage, but if the length of the marriage

ends up surpassing a certain duration,

then the equalization provisions under

the Family Law Act would apply.

Parties can also alter certain provi-

sions of the equalization under the

Family Law Act. A spouse who owns

a house at the date of marriage should

consider the equalization provisions of

the Family Law Act. If the spouse sells

that home during the marriage, and the

parties are not residing in that residence

on the date of separation, the spouse

would be able to deduct the value of

48 March 2011

DOCTOR’S BUSINESS

Are you thinking of starting or adding to your family?

Take advantage of the Pregnancy and Parental Leave Benefit Program (PPLBP) which allows you to

take paid time away from your practice. Part of the wonder of parenting is experiencing the changes your child

goes through during his or her first few months at home. Don’t miss out on these precious milestones — apply

for the PPLBP.

To find out more information about this program, including eligibility requirements, please visit https://www.

oma.org/Benefits/Pages/PPLBP.aspx or call 1.800.268.7215, ext. 2896 or 416.340.2896.

Learn and grow together.


DOCTOR’S BUSINESS

the home as of the date of marriage

as part of the equalization calculation.

If the home becomes a matrimonial

home — meaning a home that the par-

ties reside in on the date of separation

of the parties — then the value of the

home on the date of marriage will not

be deductible as part of the equalization

calculation. A marriage contract can

help ensure that the spouse will get a

deduction for a house that he or she is

bringing into the marriage, similar to the

deduction the spouses would get for

other date of marriage assets.

Similarly, the equalization provisions

in relation to excluded property could

result in a spouse losing a deduction

for an inheritance if the money from the

inheritance is used towards the mat-

rimonial home. For example, if a party

takes money from an inheritance to pay

down the mortgage on the matrimonial

home, the party will lose the deduction

he or she would have for the inheri-

tance. Parties can enter into a mar-

riage contract both before and during

a marriage, and a spouse intending to

use his or her inheritance in this fashion

may wish to consider the benefits of a

marriage contract to protect the inheri-

tance.

In relation to spousal support, under

Part III of the Family Law Act, the defini-

tion of a spouse includes both married

spouses and two persons who are not

married but have cohabitated continu-

ously for a period of not less than three

years. Parties may wish to consider

including spousal support provisions in

a domestic agreement.

For parties entering into second mar-

riages where there is no contemplation

of children in the marriage and the par-

ties are seeking to keep separate as to

property, they may wish to consider a

waiver or release of spousal support. A

careful analysis should be done to see

whether such a release is appropriate in

the circumstances.

Courts generally do not interfere

with property settlements contained in

domestic agreements. The courts do

retain jurisdiction to set aside domestic

agreements. The courts can intervene

in certain circumstances if the sup-

port contained in these agreements is

unconscionable. In situations such as a

long-term traditional marriage, waivers

of spousal support are more at risk to

being set aside by a court. The more

unconscionable the circumstances,

a court may step in and set aside the

support release.

The Family Law Act provides certain

technical requirements for the comple-

tion of domestic contracts. A party may

seek to set aside a marriage contract if

there is not full and frank financial dis-

closure, if a party did not understand

the nature or consequences of the

agreement, if there is duress, or if the

terms of the agreement are unconscio-

nable.

There are a number of court deci-

sions in which domestic agreements

are set aside for failure to make proper

financial disclosure. It is important for

parties to make disclosure of signifi-

cant assets and significant liabilities. In

a cohabitation agreement or marriage

contract this is sometimes done by

way of a net worth statement included

as part of the domestic agreement.

Spouses can also exchange sworn

financial statements, depending upon

the circumstances, as well as other

supporting documentation.

To ensure the integrity of any cohab-

itation agreement or marriage contract,

it is important that each spouse obtain

appropriate independent legal advice to

fully understand the benefits and obli-

gations of these agreements. This step

also helps to ensure that the domes-

tic agreement is properly competed,

which can help protect the agreement

from being set aside in the future.

Kevin Power is a partner with the law firm

of Coutts Crane and practises family law

and civil litigation. This article is intended to

provide general information to readers and

does not constitute legal advice.

Doctor’s Business is a monthly feature pro-

vided by Richard White, FSA, FCIA, CFP,

retirement, estate and employee benefits

consultant.


Misconceptions and insurance:

overcoming common false impressions about obtaining

insurance for physicians, their families and practices

by OMA Insurance Services

INSURANCE UPDATE

In today’s hectic society, we often find ourselves overloaded with obligations that

consume our time, energy and attention. This creates the ideal opportunity to

procrastinate, particularly when it comes to tasks that mitigate indefinite outcomes —

like purchasing insurance. Yes, it is a word that is rarely associated with excitement,

but “insurance” is really the only word that can be used to help us when something

unexpected happens.

We instinctively take measures to pro-

tect our home and our possessions

by installing locks on doors and win-

dows, and purchasing home insurance.

However, we often don’t take equally

important steps to protect ourselves

from situations that can seriously

impact our good health, and potentially

deplete our life savings.

According to Kanetix, a Canadian-

based online insurer (www.kanetix.ca),

35% of Canadians do not insure them-

selves to protect their lifestyles, finances,

or loved ones. While the rationale for not

obtaining insurance may vary from per-

son to person, OMA Insurance Advisors

Judy Wood and Glen Johnson have

found that, among physicians, the rea-

sons typically fall into three main catego-

ries: perceived lack of insurance need,

perceived insurance expense, and per-

ceived difficulty in obtaining insurance.

Not only are these perceptions often

incorrect, they may prevent physicians

from undertaking critical measures

that can help protect their own health

— and that of their family — in times of

need, as well as mitigate potential finan-

cial disaster.

1. “I don’t need insurance”

According to Ms. Wood, “I don’t need

insurance” is the reason cited most

often by young physicians for not

obtaining insurance. This is a common

misconception that can have potentially

devastating consequences.

“These physicians bel ieve that

because they are young, healthy, and

don’t have any dependents, they don’t

need insurance,” says Ms. Wood. “But

how would they pay their bills if they had

to stop working due to serious illness or

injury, or couldn’t even start working in

the first place? It can happen. I know of

a person just out of medical school who

had a serious accident over the sum-

mer that made starting work impos-

sible. Many believe that prescriptions,

medical treatments, rehabilitation and

other expenses will all be covered by

provincial health insurance. They’re not.

“Is it fair to your dependents or

spouse that they should absorb funeral

costs and all outstanding debts if you

die suddenly, or if they need to provide

constant care should you become seri-

ously disabled?,” asks Ms. Woods.

“These are really important consid-

erations, and topics that should be dis-

cussed with your family members, as

they are the ones who will have to deal

with economic hardship if you have no

insurance protection.”

2. “Insurance is expensive”

Generally, the amount you pay for insur-

ance is based on your age and health.

The longer you wait, the more you will

pay to buy insurance.

“And, as most of us know, the

years tend to pass quickly,” says Glen

Johnson. “If you leave it too late, you

can find yourself in the unfortunate

position of being uninsurable.”


INSURANCE UPDATE

Mr. Johnson adds, “The cost of

waiting isn’t always about higher pre-

miums because you’re older. Too

often it’s about health changes. You’re

healthy and then you have a stroke, or

are diagnosed with cancer or diabe-

tes. You’re healthy and drown while

on vacation, or die in a car accident.

Again, it’s hard to imagine, and tough

to think about, but it can — and does

— happen. That’s why it’s important

to take action now.”

3. “Insurance is a hassle to obtain”

One of the many benefits of OMA

membership is easy access to insur-

ance plans through OMA Insurance

— exclusive, flexible plans designed

to address the unique lifestyle, income

and practice needs of physicians.

“OMA Insurance Advisors do not

work on commission,” explains Ms.

Wood, “which means we can take the

time to listen, explain, answer questions

and offer objective advice and custom

solutions to protect you, our member,

with no pressure. We’re here for you —

before, during, and after the purchase

— we work only for physicians.”

Whether you are in medical school,

just starting practice, or well estab-

lished in your career, OMA Insurance

has more than 50 years of experience

designing comprehensive protection

plans that meet your current and future

needs — at affordable prices.

If you decide to acquire OMA life

or disability insurance while in medi-

ca l school , no medica l exam or

health questions are required. With

some OMA plans, the Guaranteed

Insurability Option offers the oppor-

tunity to increase coverage at a later

date, again with no medical under-

writing. And, because the OMA is a

not-for-profit association, members

3,500 1,250

Accuro®EMR.

Since starting development in 2002 with a Physician Advisory Team from 7 different specialties, Accuro EMR has evolved to have the preferred workflow for Specialists and GPs.

Across Canada, Optimed’s Accuro users are and .

For a workflow demonstration

www.CanadianEMR.ca

are eligible for premium refunds.

Ms. Wood reminds physicians

that the important thing is to get the

ball rolling: “Instead of taking time to

think about purchasing insurance after

receiving the information, complete

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Modified Release Tablets 375 mg enteric-coated naproxen/20 mg immediate release esomeprazole & 500 mg enteric-coated naproxen/20 mg immediate release esomeprazole

Prescribing Summary

Patient Selection Criteria

THERAPEUTIC CLASSIFICATION: NSAID and H+, K+-ATPase inhibitor INDICATIONS AND CLINICAL USE: Adults: VIMOVO (naproxen/esomeprazole) is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed (as with other modified release formulations of naproxen). For patients with an increased risk of developing cardiovascular (CV) and/or gastrointestinal (GI) adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Use of VIMOVO should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). VIMOVO, as a NSAID, does NOT treat clinical disease or prevent its progression. VIMOVO, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. Geriatrics (>65 years of age): Evidence from naproxen clinical studies and postmarket experience suggest that use in the geriatric population is associated with differences in safety (see WARNINGS AND PRECAUTIONS; Special Populations and Product Monograph, CLINICAL TRIALS). Pediatrics (<18 years of age): VIMOVO should not be used in children or adolescents under 18 years of age. The safety and efficacy of VIMOVO in this population has not been established.CONTRAINDICATIONS: VIMOVO is contraindicated in: the peri-operative setting of coronary artery bypass graft surgery (CABG) (although VIMOVO has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications); the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition; women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants; patients with severe uncontrolled heart failure; patients with known hypersensitivity to naproxen, esomeprazole, substituted benzimadazoles or to any of the components/excipients (see DOSAGE FORMS, COMPOSITION AND PACKAGING); patients with history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance–rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) (fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind [see WARNINGS AND PRECAUTIONS; Hypersensitivity Reactions, Anaphylactoid Reactions]); patients with active gastric/duodenal/peptic ulcer, active GI bleeding; patients with cerebrovascular bleeding or other bleeding disorders; patients with inflammatory bowel disease; patients with severe liver impairment or active liver disease; patients with severe renal impairment (creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see WARNINGS AND PRECAUTIONS; Renal); patients with known hyperkalemia (see WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance) and children and adolescents less than 18 years of age.

Safety Information

WARNINGS AND PRECAUTIONS:

Serious Warnings and PrecautionsRisk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (See WARNINGS AND PRECAUTIONS; Cardiovascular). Naproxen is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Caution should be exercised in prescribing NSAIDs such as naproxen, which is a component of VIMOVO (naproxen/esomeprazole), to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV). Use of NSAIDs such as naproxen, which is a component of VIMOVO, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see also WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance). Randomized clinical trials with VIMOVO have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing VIMOVO. Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS, Gastrointestinal and Product Monograph, CLINICAL TRIALS) Use of NSAIDs such as naproxen, which is a component of VIMOVO, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).

General: Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. VIMOVO, which contains naproxen, is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see DRUG INTERACTIONS; Drug/Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs). VIMOVO should not be used concomitantly with other naproxen containing drugs since they all circulate in plasma as the naproxen anion. Concomitant administration with atazanavir or nelfinavir is not recommended (see DRUG INTERACTIONS). In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena), and/or when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.Special Populations: Pregnant Women: VIMOVO is CONTRAINDICATED for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and the potential to prolong parturition (see TOXICOLOGY). Caution should be exercised in prescribing VIMOVO during the first and second trimesters of pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryofetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. VIMOVO, which contains naproxen, is not recommended in labour and delivery because naproxen-containing products, through their prostaglandin synthesis inhibitory effect, may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. Nursing Women: See CONTRAINDICATIONS. Pediatrics (<18 years of age): See CONTRAINDICATIONS. Geriatrics: Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding. For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. Of the total number of patients who received VIMOVO (n=1157) in clinical trials, 387 were ≥65 years of age, of which 85 patients were 75 years and over. No meaningful differences in efficacy (reduction in gastric ulcer rates or pain relief) or safety were observed between these subjects and younger subjects. Elderly patients in the VIMOVO group compared with the naproxen group (n=426) were consistently observed to have significantly lower gastric ulcer rates, 1.5% vs 28.5% in patients ≥65 years of age (p<0.001), and 0% vs 19.2% in patients ≥75 years of age (p=0.019). VIMOVO non-inferiority to celecoxib for pain relief was maintained in elderly patients >65 years of age, generally considered to be at greater risk of GI side effects. The incidence of adverse events was generally consistent between age populations (see WARNINGS AND PRECAUTIONS; Gastrointestinal and Product Monograph, CLINICAL TRIALS).


ADVERSE REACTIONS: Adverse Drug Reaction Overview: Since VIMOVO contains both naproxen and esomeprazole, the same pattern of undesirable effects reported for these individual substances may occur. The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly. Other common adverse reactions include dyspepsia, stomach pain, nausea and vomiting. Common reactions seen with esomeprazole in clinical trials include headache, diarrhea, flatulence, abdominal pain, nausea, vomiting and dizziness, which are thought to be causally related. The most commonly reported adverse reactions with VIMOVO are erosive gastritis, dyspepsia and gastritis. No new safety findings were identified during VIMOVO treatment compared to the established safety profile for the individual substances. To report a serious or unexpected reaction to this drug, you may notify Health Canada by toll-free telephone: 866-234-2345 or toll-free fax: 866-678-6789.

Administration

Dosing considerations: VIMOVO must be swallowed whole with water, and not split, chewed or crushed. VIMOVO should be taken at least 30 minutes before meals. VIMOVO does not allow for administration of lower daily doses of naproxen or esomeprazole. If a lower daily dose of either naproxen (i.e. ≤750 mg/day) or immediate-release (IR) esomeprazole (i.e. ≤40mg/day) is more appropriate, alternate therapy should be considered. Since VIMOVO is a combination product, carefully consider the implications of any dosing schedule on both components. Recommended dose and dose adjustment: For osteoarthritis/rheumatoid arthritis/anklyosing spondylitis, the recommended daily dosage of VIMOVO is 375/20 mg (naproxen/esomeprazole) twice daily or 500/20 mg (naproxen/esomeprazole) twice daily. Dosing Considerations in Special Populations: Geriatrics: See WARNINGS AND PRECAUTIONS; Special populations. Pediatrics (<18 years): VIMOVO is not recommended for use in pediatric patients (see CONTRAINDICATIONS).Dosage Forms and Packaging: VIMOVO contains an enteric-coated (EC) naproxen core and immediate-release (IR) esomeprazole film coat. The formulation is designed to release the active ingredients in a sequential fashion: esomeprazole is rapidly released in the stomach followed by the delayed release of naproxen in the small intestine. VIMOVO (naproxen/esomeprazole) 375/20 mg tablets are yellow, oval film coated tablets printed “375/20” in black ink on one side; 500/20 mg tablets are yellow, oval film coated tablets printed “500/20” in black ink on one side. VIMOVO tablets contain the following non-medicinal ingredients: carnauba wax, croscarmellose sodium, glycerol monostearate, hypromellose, iron oxide black, iron oxide yellow, macrogols, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, methyl parahydroxybenzoate, polydextrose, polysorbate, povidone, propylene glycol, propyl parahydroxybenzoate, silica colloidal anhydrous, titanium dioxide and triethyl citrate. VIMOVO 375/20 mg or 500/20 mg tablets are supplied in HDPE bottles of 60 tablets.SUPPLEMENTAL PRODUCT INFORMATIONWARNINGS AND PRECAUTIONS: Carcinogenesis and mutagenesis: There is no evidence from animal data that either naproxen or esomeprazole are carcinogenic or mutagenic. In the long-term repeat-dose/carcinogenicity studies with omeprazole, gastric enterochromaffin-like (ECL) cell carcinoids were noted in the rat, but not the mouse or dog. It has been demonstrated that this is a result of an indirect mode of action, rather than being a direct effect of omeprazole on the ECL-cells; prolonged acid suppression leads to prolonged hypergastrinemia, provoking ECL cell hyperplasia, which eventually progresses into ECL cell carcinoids (see Product Monograph, TOXICOLOGY). Treatment with esomeprazole for up to 1 year in more than 800 patients has not resulted in any significant pathological changes in the gastric oxyntic endocrine cells. Short-term treatment and long-term treatment with the racemate, omeprazole, capsules in a limited number of patients for up to 11 years have not resulted in any significant pathological changes in gastric oxyntic endocrine cells. Cardiovascular: Naproxen is a non-

steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of

cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.

The risk may increase with the duration of use. Patients with cardiovascular disease or risk factors for

cardiovascular disease may be at greater risk. Caution should be exercised in prescribing VIMOVO, which

contains naproxen, to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal

disease, such as any of the following (NOT an exhaustive list): Hypertension, dyslipidemia/hyperlipidemia,

diabetes mellitus, congestive heart failure (NYHA I), coronary artery disease (atherosclerosis), peripheral

arterial disease, smoking, creatine clearance <60 mL/min or 1 mL/sec. Use of NSAIDs such as naproxen, which is a component of VIMOVO, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above. Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing VIMOVO, should hypertension either develop or worsen with its use. Use of NSAIDs such as naproxen, which is a component of VIMOVO, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renally-mediated mechanism (see WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance). For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration. Endocrine and Metabolism: Corticosteroids: VIMOVO is NOT a substitute for corticosteroids. It does NOT treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids (see DRUG INTERACTIONS; Drug-Drug Interactions, Glucocorticoids). Gastrointestinal: Serious GI toxicity (sometimes fatal), such as ulceration, inflammation, perforation, obstruction and gastrointestinal bleeding, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs, such as naproxen, which is a component of VIMOVO. While VIMOVO has been shown to significantly decrease the occurrence of gastric ulcers compared to EC-naproxen alone, ulceration and associated complications can still occur. Minor upper GI problems, such as dyspepsia, commonly occur at any time. Health care providers should remain alert for ulceration and bleeding in patients treated with VIMOVO, even in the absence of previous GI tract symptoms. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered (see WARNINGS AND PRECAUTIONS; Special Populations, Geriatrics). Patients should be informed about the signs and/or symptoms of serious GI toxicity and instructed to discontinue using VIMOVO and seek emergency medical attention if they experience any such symptoms. The utility of periodic laboratory has NOT been demonstrated, nor has it been adequately assessed. Most patients who develop a serious upper GI adverse event on NSAID therapy have no symptoms. Upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue, thus increasing the likelihood of developing a serious GI event at some time during the course of therapy. Even short-term therapy has its risks. Caution should be taken if prescribing VIMOVO to patients with a history of ulcer disease or gastrointestinal bleeding. If GI bleeding or ulceration occurs, VIMOVO should be discontinued immediately and appropriate treatment sought. Other risk factors for GI ulceration and bleeding include the following:

Helicobacter pylori infection, increased age, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status or concomitant therapy with any of the following: Anti-coagulants (e.g. warfarin); anti-platelet agents (e.g. ASA, clopidogrel); oral corticosteroids (e.g. prednisone); Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, fluoxetine, paroxetine, sertraline). In studies comprising patients who were older than 50 years of age and/or had a prior history of peptic ulcer, VIMOVO was shown to significantly lower gastric ulcer rates compared to EC-naproxen, regardless of concomitant therapy with low-dose ASA (see Product Monograph, CLINICAL TRIALS). Gastrointestinal symptomatic response to therapy with VIMOVO does not preclude the presence of gastric malignancy. Genitourinary: Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with a NSAID. Should urinary symptoms occur, in the absence of an alternate explanation, treatment with VIMOVO should be stopped to ascertain if symptoms disappear. This should be done before urological investigations or treatments are carried out. Hematologic: NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from hemophilia or platelet disorders should be carefully observed when VIMOVO is administered. Anti-coagulants: Numerous studies have shown that the concomitant use of NSAIDs and anti-coagulants increases the risk of bleeding. Concurrent therapy of VIMOVO, which contains the NSAID naproxen, with warfarin requires close monitoring of the international normalized ratio (INR). Even with therapeutic INR monitoring, increased bleeding may occur. Anti-platelet Effects: NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike acetylsalicylic acid (ASA), their effect on platelet function is quantitatively less, or of shorter duration, and is reversible. NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. Anti-platelet therapies (e.g. ASA) should NOT be discontinued (see DRUG INTERACTIONS; Drug-Drug Interactions, Acetylsalicylic Acid (ASA) or other NSAIDs). Blood dyscrasias: Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of NSAIDs are rare, but could occur with severe consequences. Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. Hepatic/Biliary/Pancreatic: With NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Chronic alcoholic liver disease and probably other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown, but caution is advised when high doses are required. It is prudent to use the lowest effective dose. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with this drug. Severe hepatic reactions including jaundice and cases of fatal hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop (e.g. jaundice), or if systemic manifestations occur (e.g. eosinophilia, associated with rash, etc.), this drug should be discontinued. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation. Hypersensitivity Reactions: Anaphylactoid Reactions: As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to naproxen, a component of VIMOVO. In post-marketing experience, rare cases of anaphylactic/anaphylactoid reactions and angioedema have been reported in patients receiving naproxen. VIMOVO, which contains naproxen, should NOT be given to patients with the ASA-triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking ASA or other NSAIDs (see CONTRAINDICATIONS). ASA-Intolerance: VIMOVO, which contains naproxen, should NOT be given to patients with complete or partial syndrome of ASA-intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction (see CONTRAINDICATIONS). Cross-sensitivity: Patients sensitive to one NSAID may be sensitive to any of the other NSAIDs as well. Serious skin reactions: See WARNINGS AND PRECAUTIONS; Skin. Immune: See WARNINGS AND PRECAUTIONS; Infection, Aseptic Meningitis. Infection: Naproxen, a component of VIMOVO, as with other NSAIDs, may mask signs and symptoms of an underlying infectious disease. Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue diseases, etc.) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication. Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. diff colitis. Decreased gastric acidity due to any means, including any proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter and possibly C. diff. Neurologic: Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as naproxen, a component of VIMOVO. If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness. Ophthalmologic: Blurred and/or diminished vision has been reported with the use of NSAIDs. If such symptoms develop, VIMOVO, which contains naproxen, should be discontinued and an ophthalmologic examination performed. Ophthalmologic examination should be carried out at periodic intervals in any patient receiving VIMOVO for an extended period of time. Peri-Operative Considerations: See CONTRAINDICATIONS; Coronary Artery Bypass Graft Surgery. Psychiatric: See WARNINGS AND PRECAUTIONS; Neurologic. Renal: Long term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute interstitial nephritis, hematuria, low grade proteinuria and occasionally nephrotic syndrome. Renal insufficiency due to NSAID use is seen in patients with pre-renal conditions leading to reduction in renal blood flow or blood volume. Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function. Patients at greatest risk of this reaction are those with pre-existing renal insufficiency (GFR <60 mL/min or 1 mL/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin-converting enzyme inhibitors, angiotensin-II receptor blockers, cyclosporin, diuretics, and those who are elderly. Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. Even patients at risk who demonstrate the ability to tolerate a NSAID under stable conditions may decompensate during periods of added stress (e.g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state. Caution should be used when initiating treatment with NSAIDs, such as naproxen, a component of VIMOVO, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre-existing kidney disease. Advanced Renal Disease: See CONTRAINDICATIONS. Fluid and Electrolyte Balance: Use of NSAIDs such as naproxen, a component of VIMOVO, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure and exacerbation of congestive heart failure. Thus, caution should be exercised in prescribing VIMOVO in patients with a history of congestive heart failure, compromised cardiac function, hypertension, increased age or other conditions predisposing to fluid retention (see WARNINGS AND PRECAUTIONS; Cardiovascular). Use of NSAIDs such as naproxen, a component of VIMOVO, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concomitant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporin, or some diuretics. Electrolytes should be monitored periodically (see CONTRAINDICATIONS). Respiratory: ASA-induced asthma is an uncommon but very important indication of ASA and NSAID sensitivity. It occurs more frequently in patients with asthma who have nasal polyps. Sexual Function/Reproduction: The use of naproxen as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of VIMOVO, which contains naproxen, should be considered. Skin: In rare cases, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme have been associated with the use of some NSAIDs. Because the rate of these reactions is low, they have usually been noted during post-marketing surveillance in patients taking other medications also associated with the potential development of these serious skin reactions. Thus, causality is NOT clear. These reactions are potentially life threatening but may be reversible if the causative agent is discontinued and appropriate treatment instituted. Patients should be advised that if they experience a skin rash they should discontinue their NSAID and contact their physician for assessment and advice, including which additional therapies to discontinue.SPECIAL POPULATIONS:Hepatic Insufficiency: VIMOVO is not recommended for use in patients with severe hepatic impairment due to increased risk of NSAID associated bleeding and/or renal failure (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS; Hepatic/Biliary/Pancreatic). In patients with mild to moderate hepatic impairment VIMOVO should be used with caution and hepatic function closely monitored. Renal Insufficiency: VIMOVO is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see


CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS; Renal). In patients with mild to moderate renal impairment VIMOVO should be used with caution and renal function closely monitored. Poor Metabolizers: The CYP 2C19 and CYP 3A4 isozymes are responsible for metabolism of esomeprazole. The CYP 2C19 isozyme, which is involved in the metabolism of all available proton pump inhibitors, exhibits polymorphism. Some 3% of Caucasians and 15-20% of Asians lack CYP 2C19 and are termed “poor metabolizers”. At EC-esomeprazole steady state (40 mg for 5 days), the ratio of AUC in poor metabolizers to AUC in the rest of the population is approximately 2. Dosage adjustment of VIMOVO based on CYP 2C19 status is not necessary (see DOSAGE AND ADMINISTRATION and Product Monograph ACTION AND CLINICAL PHARMACOLOGY; Pharmacokinetics, Special Populations).MONITORING AND LABORATORY TESTS:Patients on long-term treatment with VIMOVO should have their blood pressure monitored regularly and an ophthalmic examination should be carried out at periodic intervals (see WARNINGS AND PRECAUTIONS; Cardiovascular and Ophthalmic). Hemoglobin, hematocrit, red blood cells (RBCs), white blood cells (WBCs), and platelets should be checked in patients on long-term treatment with VIMOVO. Additionally, concurrent therapy with warfarin requires close monitoring of the international normalized ratio (INR) (see WARNINGS AND PRECAUTIONS; Hematology). Serum transaminase and bilirubin should be monitored regularly during VIMOVO therapy (see WARNINGS AND PRECAUTIONS; Hepatic, Biliary, Pancreatic). Serum creatinine, creatine clearance and serum urea should be checked in patients during VIMOVO therapy. Electrolytes including serum potassium should be monitored periodically (see WARNINGS AND PRECAUTIONS; Renal). Monitoring of plasma lithium concentration is recommended when stopping or starting VIMOVO therapy.ADVERSE REACTIONS:Since VIMOVO contains both naproxen and esomeprazole, the same pattern of undesirable effects reported for these individual substances may occur. The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly. Other common adverse reactions include dyspepsia, stomach pain, nausea and vomiting. Common reactions seen with esomeprazole in clinical trials include headache, diarrhea, flatulence, abdominal pain, nausea, vomiting and dizziness, which are thought to be causally related. The most commonly reported adverse reactions with VIMOVO are erosive gastritis, dyspepsia and gastritis. No new safety findings were identified during VIMOVO treatment compared to the established safety profile for the individual substances.Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Adverse event data is provided from controlled studies using VIMOVO, involving 2317 patients ranging in duration from 3-12 months. Patients received either 500/20 mg of VIMOVO twice daily (n=1157), 500 mg of enteric-coated (EC) naproxen twice daily (n=426), 200 mg of celecoxib once daily (n=488), or placebo (n=246). All adverse reactions, regardless of causality, occurring in ≥2% of patients from two 6-month randomized, double-blind, parallel-group controlled clinical studies (Study 301 and 302) conducted in patients at risk of developing NSAID-associated ulcers compared to EC-naproxen are presented in the below table.Table 1: Adverse Reactions, regardless of causality, occurring ≥2% in arthritisa patients at risk of NSAID-induced ulcers from Studies 301 and 302 (pooled, 6 months duration)

Preferred term (sorted by SOC) Percentage of Subjects With Adverse Events

VIMOVO (500/20 mg) BID(n=428)

EC-naproxen 500 mg BID(n=426)

Gastrointestinal disorders

Gastritis Erosive 19.4 38.0

Dyspepsia 18.0 26.8

Gastritis 17.1 14.1

Diarrhea 6.1 5.2

Gastric Ulcer 5.6 23.7

Abdominal Pain Upper 5.6 8.7

Nausea 5.1 4.9

Hiatus Hernia 4.2 5.9

Abdominal Distension 3.7 3.8

Flatulence 3.7 3.1

Esophagitis 3.5 7.5

Constipation 2.6 2.8

Abdominal pain 2.3 1.6

Erosive Duodenitis 2.1 11.7

Abdominal pain lower 2.1 2.6

Duodenitis 1.4 7.3

Gastritis hemorrhagic 1.2 2.1

Gastroesophageal reflux disease 0.9 3.5

Duodenal ulcer 0.7 5.4

Erosive esophagitis 0.5 5.6

Infections and infestations

Upper respiratory tract infection 4.9 3.8

Bronchitis 2.3 1.9

Urinary tract infection 2.3 1.4

Sinusitis 1.9 2.1

Nasopharyngitis 0.9 2.3

Musculoskeletal and connective tissue disorders

Arthralgia 1.2 2.3

Nervous system disorders

Headache 2.6 1.4

Dysgeusia 2.1 1.4

Respiratory, thoracic, and mediastinal disorders

Cough 2.3 2.6

a Studies also included 23% patients with chronic musculoskeletal conditions requiring ongoing NSAID therapy

Patients taking VIMOVO had significantly fewer pre-specified NSAID-associated upper GI adverse events (including duodenal ulcers) (53.3%) compared to patients taking EC-naproxen alone (70.4%). As well, patients taking VIMOVO had significantly less discontinuations due to adverse reactions compared to patients taking EC-naproxen alone (7.9% vs. 12.5% respectively). The most common reasons for discontinuations due to adverse events in the VIMOVO treatment group were upper abdominal pain (1.2%, n=5), duodenal ulcer (0.7%, n=3) and erosive gastritis (0.7%, n=3). Among patients receiving naproxen alone, the most common reasons for discontinuations due to adverse events were duodenal ulcer 5.4% (n=23), dyspepsia 2.8% (n=12) and upper abdominal pain 1.2% (n=5). The proportion of patients discontinuing treatment due to pre-specified NSAID-associated upper gastrointestinal adverse events (including duodenal ulcers) in patients treated with VIMOVO was 4.0% compared to 12.0% for patients taking EC-naproxen (p<0.001).Adverse reaction data for VIMOVO, regardless of causality, occurring in ≥2 % of patients, and greater than placebo from two 3-month randomized double-blind, placebo-controlled clinical studies conducted in patients with osteoarthritis of the knee are presented below.

Table 2: Adverse Reactions, regardless of causality, occurring ≥2% in patients with osteoarthritis of the knee from Studies 307 and 309 (3 months duration)

Preferred term (sorted by SOC) Percentage of Subjects With Adverse Events

VIMOVO (500/20 mg) BID(n=490)

Celecoxib 200 mg QD(n=488)

Placebo(n=246)

Gastrointestinal disorders

Dyspepsia 8.4 10.7 12.2

Diarrhea 5.5 2.9 3.7

Abdominal Pain Upper 4.1 4.3 3.3

Constipation 3.5 2.0 1.2

Nausea 3.5 3.1 3.7

Nervous system disorders

Dizziness 3.1 0.8 2.0

Headache 2.7 3.7 5.3

General disorders and administration site conditions

Peripheral edema 3.1 1.2 1.2

Musculoskeletal and connective tissue disorders

Arthralgia 1.4 2.9 1.6

Back pain 1.2 2.9 2.0

Respiratory, thoracic and mediastinal disorders

Cough 1.4 0.6 2.8

Infections and infestations

Sinusitis 1.0 1.2 2.4

Similar percentages of subjects receiving either VIMOVO or celecoxib withdrew from these studies due to treatment emergent adverse events (6.9% and 7.8% respectively). There were no adverse reactions in which more than 1% of subjects withdrew from any treatment group. The long-term safety of VIMOVO was evaluated in an open label clinical trial of 239 patients, of which 135 patients received 500/20 mg of VIMOVO for 12 months. There were no differences in frequency or types of adverse reactions seen in the long-term safety study compared to shorter-term treatment in the randomized controlled studies above. In the pooled data from all VIMOVO clinical trials in patients (n=2317), there were 4 reports of atrial fibrillation/flutter. All 4 events occurred in patients assigned to VIMOVO but all were assessed as unrelated or unlikely to be related to study drug.Other Adverse Events: Post-Market Adverse Drug Reactions: Because post-marketing events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to the product. The following post-marketing adverse events have been reported with NSAIDS including naproxen and naproxen sodium, taken alone. Gastrointestinal: Peptic ulcers, perforation, or GI bleeding, sometimes fatal, particularly in the elderly. Heartburn, nausea, esophagitis, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, nonpeptic gastrointestinal ulceration, melena, hematemesis, stomatitis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn’s disease, pancreatitis, gastritis. Infections: Aseptic meningitis. Blood and Lymphatic System Disorders: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leucopenia, thrombocytopenia. Immune System Disorders: Anaphylactoid reactions. Metabolic and Nutrition Disorders: Hyperkalemia. Psychiatric Disorders: depression, dream abnormalities, insomnia. Nervous System Disorders: Dizziness, drowsiness, headache, lightheadedness, retrobulbar optic neuritis convulsions, cognitive dysfunction, inability to concentrate. Eye Disorders: Visual disturbances, corneal opacity, papillitis, papilledema. Ear and Labyrinth Disorders: Hearing impairment, hearing disturbances, tinnitus, vertigo. Cardiac Disorders: Palpitations, cardiac failure has been reported in association with NSAID treatment, congestive heart failure. Vascular Disorders: Hypertension, vasculitis. Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pulmonary edema, asthma, eosinophilic pneumonitis. Hepatobiliary Disorders: Hepatitis (some cases of hepatitis have been fatal), jaundice. Skin and Subcutaneous Tissue Disorders: ecchymoses, itching (pruritus), purpura, skin eruptions, sweating, alopecia, epidermal necrolysis, very rarely toxic epidermal necrolysis, erythema multiforme, bullous reactions, including Stevens-Johnson syndrome, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, skin rashes, SLE, urticaria, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (“pseudoporphyria”) or epidermolysis bullosa and angioneurotic edema. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored. Musculoskeletal and Connective Tissue Disorders: myalgia, muscle weakness. Renal and Urinary Disorders: hematuria, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis. Reproductive System and Breast Disorders: Female infertility. General Disorders and Administration Site Conditions: Edema, thirst, pyrexia (chills and fever), malaise. Investigations: Abnormal liver function tests, raised serum creatinine. From esomeprazole post-marketing experience there have been uncommon reports (<1%) of peripheral edema, insomnia, paresthesia, somnolence, vertigo and increased liver enzymes. There have also been rare reports (<0.1%) of blurred vision, hypersensitivity reactions (e.g. angioedema, anaphylactic reaction/shock), myalgia, leukopenia, thrombocytopenia, depression, alopecia, hepatitis with or without jaundice, hyponatremia, agitation, confusion, taste disturbance, bronchospasm, stomatitis, GI candidiasis, rash, dermatitis, photosensitivity, arthralgia, malaise, and hyperhidrosis. Very rarely (<0.01%) agranulocytosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pancytopenia, aggression, hallucination, hepatic failure, hepatic encephalopathy, interstitial nephritis, muscular weakness, gynecomastia, and hypomagnesaemia have been reported.DRUG INTERACTIONS:Drug-Drug Interactions: Overview: Studies conducted with VIMOVO have shown no interactions between its two components, naproxen and esomeprazole. Interaction studies have not been conducted with VIMOVO and other drugs. Interactions for VIMOVO would be expected to reflect those of the monocomponents, taken separately, which are detailed below. NSAID related drug-drug interactions: Acetylsalicylic acid (ASA) or other NSAIDs: The use of VIMOVO in addition to an NSAID, including over-the-counter ones (such as ASA and ibuprofen) for analgesic and/or anti-inflammatory effects is NOT recommended because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. The exception is the use of low-dose ASA for cardiovascular protection, when another NSAID containing product, such as VIMOVO is being used for its analgesic/anti-inflammatory effect, keeping in mind that combination NSAID therapy is associated with additive adverse reactions. However, in clinical trials, patients taking VIMOVO in combination with low-dose ASA did not have an increased occurrence of gastric ulcers compared to patients taking VIMOVO alone. Ulcer complications such as bleeding, perforation and obstruction were not studied in VIMOVO trials. Some NSAIDs (e.g. ibuprofen) may interfere with the anti-platelet effects of low-dose ASA, possibly by competing with ASA for access to the active site of cyclooxygenase-1. Albumin Bound Drugs: The naproxen anion may displace from their binding sites other drugs which are also albumin-bound and may lead to drug interactions. For example, in patients receiving bishydroxycoumarin or warfarin, the addition of VIMOVO, which contains naproxen, could prolong the prothrombin time. These patients should, therefore, be under careful observation. Similarly, patients receiving VIMOVO and a hydantoin, sulfonamide or sulfonylurea should be observed for adjustment of dose if required. Antacids: The rate of absorption of naproxen is altered by concomitant administration of antacids but is not adversely influenced by the presence of food. Anti-coagulants: See WARNINGS AND PRECAUTIONS; Hematologic, Anti-coagulants. Anti-hypertensives: NSAIDs may diminish the anti-hypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. Combinations of ACE inhibitors, angiotensin-II antagonists, or diuretics with NSAIDs might have an increased risk for acute renal failure and hyperkalemia. Blood pressure and renal function (including electrolytes) should be monitored more closely in this situation, as occasionally there can be a substantial increase in blood pressure. Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta blockers as well as other antihypertensive agents. Anti-platelet Agents (including ASA): There is an increased risk of bleeding, via inhibition of platelet function, when anti-platelet agents are combined with NSAIDs, such as naproxen, a component of VIMOVO (see WARNINGS AND PRECAUTIONS; Hematologic, Anti-platelet Effects). Cyclosporin: Inhibition of renal prostaglandin activity by NSAIDs may increase the plasma concentration of cyclosporine and/or the risk of cyclosporine induced nephrotoxicity. Patients should be carefully monitored during concurrent use. Cholestyramine: Concomitant administration of cholestyramine can delay the absorption of naproxen, but does not affect its extent. Digoxin: Concomitant administration of an NSAID with digoxin can result in an increase in digoxin concentrations which may result in digitalis toxicity. Increased monitoring and dosage adjustments of digitalis glycosides may be necessary during and following concurrent NSAID therapy. Diuretics: Clinical studies as well as post-marketing observations have shown that NSAIDs can reduce the effect of diuretics. Glucocorticoids: Some studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of GI adverse events such as ulceration and bleeding. This is especially the case in older (>65 years of age) individuals. Lithium: Monitoring of plasma lithium concentrations is advised when stopping or starting a NSAID, as increased lithium concentrations can occur. Methotrexate: Caution is advised in the concomitant administration of naproxen and methotrexate since naproxen and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, thereby possibly enhancing its toxicity. Probenecid:


Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. Caution is advised when probenecid is administered concurrently. Selective Serotonin Reuptake Inhibitors (SSRIs): Concomitant administration of NSAIDs and SSRIs may increase the risk of gastrointestinal ulceration and bleeding (see WARNINGS AND PRECAUTIONS; Gastrointestinal). Tacrolimus: As with all NSAIDs caution is advised when tacrolimus is co-administered because of the increased risk of nephrotoxicity. Esomeprazole related drug-drug interactions: Esomeprazole magnesium is metabolized by the cytochrome P-450 system (CYP), mainly in the liver, through CYP 2C19 and CYP 3A4. There are no clinically significant interactions between esomeprazole and diazepam, phenytoin, quinidine or cisapride (cisapride not marketed in Canada). Drugs known to inhibit CYP 2C19 or CYP 3A4 or both (such as clarythromycin and voriconazole) may lead to increased esomeprazole serum levels by decreasing the rate of esomeprazole’s metabolism. Drugs known to induce CYP 2C19 or CYP 3A4 or both (such as rifampin and St. John’s Wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism (see DRUG-HERB INTERACTIONS). Diazepam: Concomitant administration of EC-esomeprazole (30 mg once daily for 5 days) resulted in a 45% decrease in the clearance of diazepam in healthy male volunteers. Studies in females have not been conducted. Increased levels of diazepam were seen some 12 hours after dosing and later when the plasma levels of diazepam were below its therapeutic range. Therefore, this interaction is unlikely to be of clinical significance. Warfarin: Concomitant administration of 40 mg EC-esomeprazole (once daily for 3 weeks) to male and female patients on stable anticoagulation therapy with warfarin, resulted in a 13% increase in trough plasma levels of R-warfarin (the less potent enantiomer) while that of S-warfarin was unchanged. Coagulation times were stable throughout the entire study period. No clinically significant interaction was observed. However, from post marketed use, cases of elevated international normalized ratio (INR) of clinical significance have been reported during concomitant treatment with warfarin. Close monitoring is recommended when initiating and ending treatment with warfarin or other coumarin derivatives (refer to approved Product Monograph for warfarin or relevant coumarin derivative). Cilostazol (not marketed in Canada): Omeprazole as well as esomeprazole act as inhibitors of CYP 2C19. Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased C

max and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites,

3,4-dihydrocilostazol, by 29% and 69% respectively. Phenytoin: Concomitant administration of 40 mg EC-esomeprazole (once daily for 2 weeks) to male and female epileptic patients stabilized on phenytoin, resulted in a 13% increase in trough plasma levels of phenytoin. This minor interaction is unlikely to be of clinical relevance as dose reduction was not required in any patient nor was the profile and frequency of adverse events affected. Results from a range of interaction studies with EC-esomeprazole versus other drugs indicate that daily doses of 40 mg EC-esomeprazole, given for 5 to 21 days in male and/or female subjects, has no clinically relevant interactions with CYP 1A2 (caffeine), CYP 2C9 (S-warfarin), and CYP 3A (quinidine, estradiol and cisapride [cisapride not marketed in Canada]). Antiretroviral Drugs: Omeprazole, the racemate of esomeprazole, like other acid-reducing agents, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. A change in gastric pH may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP 2C19. Reports indicate that omeprazole has a significant impact on atazanavir exposure, decreasing AUC, C

max and C

min. This interaction is only partially overcome by

the addition of ritonavir to the atazanavir treatment regimen. Similarly, decreased serum levels of nelfinavir have also been reported when given together with omeprazole. Concomitant administration of omeprazole with atazanavir and nelfinavir is not recommended. For other antiretroviral drugs, such as saquinavir, increased serum levels have been reported. There are also some antiretroviral drugs where unchanged serum levels have been reported when given with omeprazole. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration of EC-esomeprazole and antiretroviral drugs such as atazanavir and nelfinavir is not recommended (see WARNINGS AND PRECAUTIONS). Voriconazole: Concomitant administration of EC-esomeprazole with a combined inhibitor of CYP 2C19 and CYP 3A4 may result in more than double the levels of esomeprazole exposure. As with all drugs that reduce gastric acidity, changes in plasma levels of other drugs whose absorption is pH dependent (e.g. ketoconazole or itraconazole) must be taken into account when they are co-administered with esomeprazole. Digoxin: The absorption of digoxin can increase during treatment with esomeprazole and other drugs that reduce gastric acidity. Concomitant treatment with omeprazole (20 mg daily) and digoxin in ten healthy subjects increased the bioavailability of digoxin by an average of 10% (up to 30% in two out of ten subjects). Other interactions: As demonstrated with other PPIs, prolonged use may impair the absorption of protein-bound Vitamin B

12 and may contribute to the development of Vitamin B

12 deficiency. Drug-Food Interactions: Concomitant

administration of food can delay the absorption of the naproxen component of VIMOVO, but does not affect its extent of absorption. Concomitant administration of food however, does not delay the absorption of the esomeprazole component of VIMOVO, but significantly reduces its extent of absorption (see DOSAGE AND ADMINISTRATION; Dosing Considerations and Product Monograph ACTIONS AND

CLINICAL PHARMACOLOGY; Pharmacokinetics, Absorption, Food Effect). Drug-Herb Interactions: Use of St. John’s Wort may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism (see DRUG INTERACTIONS, Esomeprazole related Drug-Drug Interactions). Drug-Laboratory Interactions: During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference esomeprazole treatment should be temporarily stopped five days before CgA measurements. (See also WARNINGS AND PRECAUTIONS; Special Populations, Monitoring and Laboratory Tests). Drug-Lifestyle Interactions: There are no specific studies about effects on the ability to drive vehicles and to use machinery. It should be taken into account that some of the adverse effects (e.g. dizziness) reported following the use of VIMOVO may reduce the ability to react. Patients who experience visual disturbances or other central nervous system disturbances should refrain from these activities. Concurrent use of alcohol with an NSAID may increase the risk of gastrointestinal side effects, including ulceration and hemorrhage.DOSAGE AND ADMINISTRATION:Missed Dose: The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of VIMOVO should not be taken at the same time. Special Populations: Hepatic Insufficiency: VIMOVO is not recommended for use in patients with severe hepatic impairment (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS; Hepatic/Biliary/Pancreatic and WARNINGS AND PRECAUTIONS; Special Populations). Renal Insufficiency: VIMOVO is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS; Renal and WARNINGS AND PRECAUTIONS; Special Populations). Poor Metabolizers: Dosage adjustment based on CYP 2C19 status is not necessary (see WARNINGS AND PRECAUTIONS; Special Populations and Product Monograph ACTION AND CLINICAL PHARMACOLOGY; Pharmacokinetics, Special Populations).OVERDOSAGE:

For management of suspected drug overdose, contact your regional Poison Control Centre.

There is no clinical data on overdosage with VIMOVO. Any effects of an overdose with VIMOVO would be expected to reflect those of the monocomponents of naproxen and esomeprazole, taken separately. Naproxen: Significant overdosage may be characterized by drowsiness, dizziness, disorientation, heartburn, indigestion, epigastric pain, abdominal discomfort, nausea, vomiting, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis and apnea. A few patients have experienced convulsions, but it is not clear whether or not these were naproxen related. Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare. Anaphylactoid reactions have been repeated with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes. Prevention of further absorption (e.g. activated charcoal) may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. Esomeprazole: Limited information is available on the effects of higher doses in man, and specific recommendations for treatment cannot be given. Experience from a patient who deliberately ingested an overdose of EC-esomeprazole (280 mg), demonstrated symptoms that were transient, and included weakness, loose stools and nausea. Single doses of 80 mg EC-esomeprazole have been shown to be uneventful. No specific antidote is known. Esomeprazole is extensively protein-bound and is therefore not readily dialyzable. Treatment should be symptomatic and general supportive measures should be utilized.Product Monograph is available upon request from AstraZeneca Canada Inc.Revision date: January 13, 2011.

VIMOVO® and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies. © AstraZeneca 2011

AstraZeneca Canada Inc.1004 Middlegate Road, Mississauga, Ontario L4Y 1M4

www.astrazeneca.ca T 1-800-668-6000 F 1-800-250-1909VIM105E


PRESCRIBING SUMMARY


THERAPEUTIC CLASSIFICATION: Anxiolytic-Sedative

INDICATIONS AND CLINICAL USE PrATIVAN® (lorazepam) is useful for the short-term relief of manifestations of excessive anxiety in patients with anxiety neurosis. It is also useful as an adjunct for the relief of excessive anxiety that might be present prior to surgical interventions. Anxiety and tension associated with the stresses of everyday life usually do not require treatment with anxiolytic drugs.

CONTRAINDICATIONSATIVAN is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma, and in those with known hypersensitivity to benzodiazepines.

SPECIAL POPULATIONSUse in Pregnancy: ATIVAN should not be used during pregnancy. Several studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines chlordiazepoxide and diazepam, and meprobamate, during the first trimester of pregnancy. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery.

Use in Women of Child-Bearing Potential: Since lorazepam is also a benzodiazepine derivative, its administration is rarely justified in women of child-bearing potential. If the drug is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuation of the drug if she intends to become or suspects that she is pregnant.

Use in Nursing Mothers: Lorazepam has been detected in human breast milk; therefore, it should not be administered to breast-feeding women, unless the expected benefit to the mother outweighs the potential risk to the infant. Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines. Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).

Use in the Elderly: Elderly and debilitated patients, or those with organic brain syndrome, have been found to be prone to CNS depression after even low doses of benzodiazepines. Therefore, medication should be initiated with very low initial doses in these patients, depending on the response of the patient, in order to avoid oversedation or neurological impairment. For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated.

Use in Children: Because of the lack of sufficient clinical experience, ATIVAN is not recommended for use in patients less than 18 years of age.

Safety Information

WARNINGS

Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis, or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a benzodiazepine should not be rechallenged with the drug.

ATIVAN is not recommended for the use in depressive neurosis or in psychotic reactions. Since ATIVAN has a central nervous system depressant effect, patients should be advised against the simultaneous use of other CNS depressant drugs. Patients should also be cautioned not to take alcohol during the administration of lorazepam because of the potentiation of effects that may occur.

Excessive sedation has been observed with lorazepam at standard therapeutic doses. Therefore, patients on ATIVAN should be warned against engaging in hazardous activities requiring mental alertness and motor coordination, such as operating dangerous machinery or driving motor vehicles.

Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.

PRECAUTIONSLorazepam should be used with caution in patients with compromised respiratory function (e.g., COPD, sleep apnea syndrome).

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. The use of benzodiazepines may unmask suicidal tendencies in depressed patients and should not be used without adequate antidepressant therapy.

Paradoxical reactions have been occasionally reported during benzodiazepine use (see ADVERSE REACTIONS). Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

Dependence Liability: ATIVAN should not be administered to individuals prone to drug abuse. Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse. Caution should be observed in patients who are considered to have potential for psychological dependence. It is suggested that the drug should be withdrawn gradually if it has been used in high dosage.

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer-term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when lorazepam is used at the appropriate dose for short-term treatment. In general, benzodiazepines should be prescribed for short periods only (e.g., 2 to 4 weeks). Continuous long-term use of lorazepam is not recommended.

Use in Mental and Emotional Disorders: ATIVAN is not recommended for the treatment of psychotic or depressed patients. Since excitement and other paradoxical reactions can result from the use of these drugs in psychotic patients, they should not be used in ambulatory patients suspected of having psychotic tendencies. As with other anxiolytic-sedative drugs, lorazepam should not be used in patients with nonpathological anxiety. These drugs are also not effective in patients with characterological and personality disorders or those with obsessive-compulsive neurosis. When using ATIVAN, it should be recognized that suicidal tendencies may be present and that protective measures may be required.

Use in Patients with Impaired Renal or Hepatic Function: Since the liver is the most likely site of conjugation of lorazepam and since excretion of conjugated lorazepam (glucuronide) is a renal function, the usual precaution of carefully titrating the dose should be taken, should ATIVAN be used in patients with mild to moderate hepatic or renal disease. In patients for whom prolonged therapy with ATIVAN is indicated, periodic blood counts and liver function tests should be carried out. Dosage for patients with severe hepatic insufficiency should be adjusted carefully according to patient response. Lower doses may be sufficient in such patients. As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy; therefore, lorazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy.

ADVERSE REACTIONSThe adverse reaction most frequently reported was drowsiness.

Reported adverse reactions (by system) are:

Body as a Whole: angioedema, asthenia, muscle weakness, anaphylactic reactions, change in weight, hypersensitivity reactions, hyponatremia, hypothermia, SIADH.

Cardiovascular: hypotension, lowering in blood pressure.

Digestive: nausea, constipation, change in appetite, increase in bilirubin, jaundice, increase in liver transaminases, increase in alkaline phosphatase.

Hematological/Lymphatic: agranulocytosis, pancytopenia, thrombocytopenia.

Nervous System and Special Senses (benzodiazepine effects on the CNS are dose-dependent, with more severe CNS depression with higher doses):

Quick dissolving


anterograde amnesia, drowsiness, fatigue, sedation, ataxia, confusion, depression, unmasking of depression, dizziness, change in libido, impotence, decreased orgasm, extrapyramidal symptoms, tremor, vertigo, visual disturbances (including diplopia, and blurred vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, disinhibition, euphoria, coma, suicidal ideation/attempt, impaired attention/concentration, balance disorder, paradoxical reactions (including anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, hallucinations), psychomotor agitation.

Respiratory: respiratory depression, apnea, worsening of sleep apnea (the extent of respiratory depression with benzodiazepines is dose-dependent – more severe depression at higher doses), worsening of obstructive pulmonary disease, and ear, nose and throat disturbances.

Skin: allergic skin reactions, alopecia.

There is evidence that tolerance develops to the sedative effects of benzodiazepines.

Release of hostility and other paradoxical effects such as irritability and excitability, are known to occur with the use of benzodiazepines. Paradoxical reactions may be more likely to occur in children or the elderly. Should paradoxical reactions occur, use of the drug should be discontinued. In addition, hypotension, mental confusion, slurred speech, oversedation, abnormal liver and kidney function tests and hematocrit values have been reported with these drugs.

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect a patient has had a serious or unexpected reaction to this drug, you may notify Health Canada by telephone: 1-866-234-2345.

Administration

DOSAGE: The dosage and duration of therapy of ATIVAN must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment. As with other anxiolytic sedatives, short courses of treatment should usually be the rule for the symptomatic relief of disabling anxiety in psychoneurotic patients and the initial course of treatment should not last longer than one week without reassessment of the need for a limited extension. Initially, not more than one week’s supply of the drug should be provided and automatic prescription renewals should not be allowed. Subsequent prescriptions, when required, should be limited to short courses of therapy.

The lowest effective dose of ATIVAN should be prescribed for the shortest duration possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of lorazepam should be avoided and a gradual, dose-tapering schedule followed after extended therapy. Symptoms reported following discontinuation of benzodiazepines include: headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold, such as antidepressants.

Generalized Anxiety Disorder: The recommended initial adult daily oral dosage is 2 mg in divided doses of 0.5, 0.5 and 1 mg, or of 1 mg and 1 mg. The daily dosage should be carefully increased or decreased by 0.5 mg depending upon tolerance and response. The usual daily dosage is 2 to 3 mg. However, the optimal dosage may range from 1 to 4 mg daily in individual patients. Usually, a daily dosage of 6 mg should not be exceeded.

In elderly and debilitated patients, the initial daily dose should not exceed 0.5 mg and should be very carefully and gradually adjusted, depending upon tolerance and response.

Excessive Anxiety Prior to Surgical Procedures: Usually 0.05 mg/kg to a maximum of 4 mg total, given by the sublingual route (1 to 2 hours before surgery). As with all premedicant drugs, the dose should be individualized. Doses of other central nervous system depressant drugs should be ordinarily reduced.

ADMINISTRATION: The sublingual tablet, when placed under the tongue, will dissolve in approximately 20 seconds. The patients should not swallow for at least 2 minutes to allow sufficient time for absorption.

SUPPLEMENTAL PRODUCT INFORMATION

DRUG INTERACTIONS

If lorazepam is to be used together with other drugs acting on the CNS, careful consideration should be given to the pharmacology of the agents to be employed because of the possible potentiation of drug effects. The benzodiazepines, including ATIVAN (lorazepam), produce additive CNS depressant effects when administered with other CNS depressants such as barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, anesthetics, and alcohol.

There have been reports of apnea, coma, bradycardia, heart arrest, and death with the concomitant use of lorazepam injection and haloperidol.

Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, and ataxia.

Concurrent administration of lorazepam with valproate may result in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when co-administered with valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when co-administered with probenecid.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

In post-marketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs.

Symptoms: With benzodiazepines, including lorazepam, symptoms of mild overdosage include drowsiness, mental confusion and lethargy. In more serious overdoses, symptoms may include ataxia, hypotonia, hypotension, hypnosis, Stages I to III coma, and, very rarely, death. Symptoms can range in severity and include, in addition to the above, dysarthria, paradoxical reactions, CNS depression, respiratory depression, and cardiovascular depression.

Treatment: In the case of an oral overdose, if vomiting has not occurred spontaneously and the patient is fully awake, emesis may be induced with syrup of ipecac 20 to 30 mL (where there is risk of aspiration, induction of emesis is not recommended). Gastric lavage should be instituted as soon as possible and 50 to 100 g of activated charcoal should be introduced to and left in the stomach.

Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.

General supportive therapy should be instituted as indicated. Vital signs and fluid balance should be carefully monitored. An adequate airway should be maintained and assisted respiration used as needed. With normally functioning kidneys, forced diuresis with intravenous fluids and electrolytes may accelerate elimination of benzodiazepines from the body. In addition, osmotic diuretics such as mannitol may be effective as adjunctive measures. In more critical situations, renal dialysis and exchange blood transfusions may be indicated. Published reports indicate that intravenous infusion of 0.5 to 4 mg of physostigmine at the rate of 1 mg/minute may reverse symptoms and signs suggestive of central anticholinergic overdose (confusion, memory disturbance, visual disturbances, hallucinations, delirium); however, hazards associated with the use of physostigmine (i.e., induction of seizures) should be weighed against its possible clinical benefit.

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The physician should be aware of the risk of a seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

For a copy of the Product Monograph or full Prescribing Information, please contact: Pfizer Canada Medical Information at 1-800-463-6001 or visit www.pfizer.ca.

©2010Pfizer Canada Inc.Kirkland, Quebec H9J 2M5

TMPfizer Inc, used under licenseATIVAN® Wyeth LLC, ownerPfizer Canada Inc., Licensee


Dabigatran Etexilate 110mg and 150mg Capsules

Prescribing Summary

This is a condensed version of the Product Monograph. For complete information please refer to the Product Monograph available at www.boehringer-ingelheim.ca or by contacting Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario, L7L 5H4.


THERAPEUTIC CLASSIFICATION: AnticoagulantINDICATIONS AND CLINICAL USE Prevention of stroke and systemic embolism in patients with atrial fi brillation, in whom anticoagulation is appropriate.

Geriatrics (>65 years of age): Clinical studies have been conducted in patients with a mean age >65 years. Safety and effi cacy data are available (see CLINICAL TRIALS in the Product Monograph). Pharmacokinetic studies in older subjects demonstrate an increase in exposure to dabigatran in most of those patients, usually in association with age-related decline of renal function (see WARNINGS AND PRECAUTIONS, Renal, and DOSAGE AND ADMINISTRATION, Renal Impairment).Pediatrics (<18 years of age): The safety and effi cacy of PRADAX have not been established in children less than 18 years of age. Therefore, PRADAX is not recommended in this patient population.

CONTRAINDICATIONSSevere renal impairment (CrCl <30mL/min)Hemorrhagic manifestations, bleeding diathesis, or patients with spontaneous or pharmacological impairment of hemostasisLesions at risk of clinically signifi cant bleeding, e.g., extensive cerebral infarction (hemorrhagic or ischemic) within the last 6 months, or active peptic ulcer disease with recent bleedingConcomitant treatment with strong P-glycoprotein (P-gp) inhibitors, i.e., oral ketoconazole (see DRUG INTERACTIONS) Known hypersensitivity to dabigatran or dabigatran etexilate or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.

Safety Information

WARNINGS AND PRECAUTIONSThe following Warnings and Precautions are listed in alphabetical order.BleedingAs with all anticoagulants, PRADAX should be used with caution in circumstances associated with an increased risk of bleeding. Bleeding can occur at any site during therapy with PRADAX. An unexplained fall in hemoglobin and/or hematocrit or blood pressure should lead to a search for a bleeding site. Patients at high risk of bleeding should not be prescribed PRADAX (see CONTRAINDICATIONS).Close clinical surveillance (looking for signs of bleeding or anemia) is recommended throughout the treatment period, especially if risk factors are combined.Table 1: Factors which increase hemorrhagic risk, as identifi ed in clinical studies

Factors increasing dabigatran plasma levels

Moderate renal impairment (30-50 mL/min CrCl)

P-glycoprotein-inhibitor comedication

Pharmacodynamic interactions

Acetylsalicylic acid

NSAID

Clopidogrel

Diseases/procedures with special hemorrhagic risks

Congenital or acquired coagulation disorders

Thrombocytopenia or functional platelet defects

Active ulcerative gastrointestinal disease

Recent gastro-intestinal bleeding

Recent biopsy or major trauma

Recent intracranial hemorrhage

Brain, spinal or ophthalmic surgery

Bacterial endocarditis

Others Age 75 years

The measurement of dabigatran-related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional risk factors.In patients who are bleeding, an aPTT test may be useful to assist in determining an excess of anticoagulant activity, despite its limited sensitivity. An aPTT >80 sec at trough, i.e., when the next dose is due, is associated with a higher risk of bleeding (see Monitoring and Laboratory Tests).Should severe bleeding occur, treatment with PRADAX must be discontinued and the source of bleeding investigated promptly.Agents that may enhance the risk of hemorrhage should not be administered concomitantly with PRADAX, or, if necessary, should only be administered with caution (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetic Interactions in the Product Monograph).Treatments that should NOT be administered concomitantly with PRADAX due to increase in bleeding risk include: unfractionated heparin and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux, bivalirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, sulfi npyrazone, and vitamin K antagonists

such as warfarin. The concomitant use of PRADAX with the following treatments has not been studied and may increase the risk of bleeding: rivaroxaban, prasugrel, and the strong P-gp inhibitors itraconazole, tacrolimus, cyclosporine, ritonavir, tipranavir, nelfi navir and saquinavir. Unfractionated heparin may be administered at doses necessary to maintain a patent central venous or arterial catheter. In patients with atrial fi brillation treated for the prevention of stroke and systemic embolism, the co-administration of oral anti-platelet (including aspirin and clopidogrel) and NSAID therapies increases the risk of bleeding by about two-fold (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph). If necessary, co-administration of low-dose ASA, i.e.,

100 mg daily with PRADAX may be considered for other indications than stroke prevention in atrial fi brillation. Note that in the RELY trial, there is no evidence that the addition of ASA or clopidogrel to dabigatran, or its comparator warfarin, improved outcomes in respect to stroke (see CLINICAL TRIALS, Stroke Prevention in Atrial Fibrillation in the Product Monograph).Treatment initiation with verapamil should be avoided in patients following orthopedic surgery who are already treated with PRADAX. Simultaneous initiation of treatment with PRADAX and verapamil should also be avoided at any time (see DRUG INTERACTIONS, P-glycoprotein inhibitors).

Interaction with P-gp inducersThe concomitant use of PRADAX with the strong P-gp inducer, rifampicin, reduces dabigatran plasma concentrations. Other P-gp inducers such as St. John’s Wort or carbamazepine are also expected to reduce dabigatran plasma concentrations, and should be co-administered with caution (see DRUG INTERACTIONS and Special Populations).

Surgery/Procedural InterventionsPatients on PRADAX who undergo surgery or invasive procedures are at increased risk for bleeding. In these circumstances, temporary discontinuation of PRADAX may be required.

Pre-operative PhaseIn advance of invasive or surgical procedures PRADAX should be stopped temporarily due to an increased risk of bleeding. If possible, PRADAX should be discontinued at least 24 hours before invasive or surgical procedures. In patients at higher risk of bleeding (see DOSAGE AND ADMINISTRATION) or in major surgery where


complete hemostasis may be required, consider stopping PRADAX 2-4 days before surgery. Clearance of dabigatran in patients with renal insuffi ciency may take longer (see DOSAGE AND ADMINISTRATION, Renal). This should be considered in advance of any procedures.PRADAX is contraindicated in patients with severe renal dysfunction (CrCl <30 mL/min). Should acute renal failure occur before surgery is required, PRADAX should generally be stopped at least 5 days before major surgery.If acute intervention is required, PRADAX should be temporarily discontinued, due to increased risk of bleeding. Surgery or procedural interventions should be delayed if possible until at least 12 hours after the last dose of PRADAX, with risk of bleeding weighed against the urgency of the needed intervention. Peri-Operative Spinal/Epidural Anesthesia, Lumbar PunctureProcedures such as spinal anesthesia may require complete hemostatic function.In patients treated with PRADAX for VTE prevention following major orthopedic surgery and who undergo spinal or epidural anesthesia, or in whom lumbar puncture is performed in follow-up to surgery, the formation of spinal or epidural hematomas that may result in long-term or permanent paralysis cannot be excluded. In the case of these peri-spinal procedures, administration of the fi rst dose of PRADAX should occur after hemostasis has been obtained and no sooner than 2 hours following puncture or removal of catheters related to these procedures.The risk of these rare events may be higher with post-operative use of indwelling epidural catheters or the concomitant use of other products affecting hemostasis. Accordingly, the use of PRADAX is not recommended in patients undergoing anesthesia with post-operative indwelling epidural catheters.Post-Procedural PeriodResume treatment with PRADAX as soon as complete hemostasis is achieved.RenalPRADAX is contraindicated in cases of severe renal impairment (CrCl <30 mL/min). Patients who develop acute renal failure while on PRADAX should discontinue such treatment. Patients with atrial fi brillation treated for prevention of stroke and systemic embolism: Since no dose adjustment is necessary for most atrial fi brillation patients with moderate renal impairment (CrCl 30-50 mL /min), a standard daily dose of 300 mg, taken orally as one 150 mg capsule twice daily i s r e c o m m e n d e d ( s e e D O S A G E

AND ADMINISTRATION, Renal Impairment). Special PopulationsPregnant Women: Since there are no studies of PRADAX in pregnant women, the potential risk in these patients is unknown. Animal reproductive studies did not show any adverse effects on fertility or postnatal development of the neonate.Women of child-bearing potential should avoid pregnancy during treatment with PRADAX and when pregnant, women should not be treated with PRADAX unless the expected benefi t is greater than the risk.Nursing Women: Breast-feeding during treatment with PRADAX is not recommended. There are no clinical data available on the excretion of dabigatran into breast milk.Geriatrics (>65 years of age): Pharmacokinetic studies in older subjects demonstrate an increase in drug exposure; especially in those patients with age-related decline of renal function (see WARNINGS AND PRECAUTIONS, Renal, and DOSAGE AND ADMINISTRATION, Renal Impairment). Patients with atrial fi brillation treated for prevention of stroke and systemic embolism: Patients aged 80 years and above should be treated with a daily dose of 220 mg taken orally as one 110 mg capsule twice daily. This alternate dosing may also be considered for other geriatric patients (see DOSAGE AND ADMINISTRATION, Elderly). Use with caution.

Pediatrics (<18 years of age): The safety and effi cacy of PRADAX have not been established in children less than 18 years of age. Therefore, PRADAX is not recommended in this patient population.Patients of low body weight (<50 kg): Since limited data are available in these patients, PRADAX should be used with caution.Monitoring and Laboratory Tests At recommended doses of PRADAX, dabigatran prolongs coagulation time as measured by the activated partial thromboplastin time (aPTT), thrombin time (TT) and ecarin clotting time (ECT). In patients who are bleeding due to excess activity of dabigatran, these coagulation tests would be expected to be elevated and may be helpful in assessing anticoagulant activity of dabigatran, if necessary (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics in the Product Monograph). The aPTT is generally less sensitive to anticoagulant activity than either TT or ECT (see DRUG INTERACTIONS, Drug-Laboratory Interactions). However, the aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran. In patients who are bleeding, the aPTT test may be useful to assist in

determining an excess of anticoagulant activity, despite its limited sensitivity. An aPTT greater than 80 sec at trough (when the next dose is due) is associated with a higher risk of bleeding. In circumstances where there is no excess of anticoagulant activity, the utility of aPTT is limited in monitoring anticoagulant status of patients taking PRADAX.ADVERSE REACTIONSThe safety of PRADAX has been evaluated overall in 22,126 patients.A total of 10,084 patients were exposed to at least one dose of dabigatran as study medication in four active-controlled clinical trials conducted to evaluate the safety and effectiveness of dabigatran etexilate in the prevention of venous thromboembolic events (VTE) following major elective orthopedic surgery. Of these, 5,419 were treated with 150 mg or 220 mg daily of PRADAX, while 389 received doses of less than 150 mg daily, and 1,168 received doses in excess of 220 mg daily. In the RELY trial investigating the prevention of stroke and systemic embolism in patients with atrial fi brillation, a total of 12,042 patients were exposed to PRADAX. Of these, 6,059 were treated with 150 mg twice daily of dabigatran etexilate, while 5,983 received doses of 110 mg twice daily. About 21% of patients with atrial fi brillation treated with dabigatran and about 16% of patients treated with warfarin for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years) experienced adverse events considered related to treatment.BleedingBleeding is the most relevant side effect of PRADAX. Bleeding of any type or severity occurred in approximately 14% of patients treated short-term for elective hip or knee replacement surgery and in long-term treatment in 16.5% of patients with atrial fi brillation treated for the prevention of stroke and systemic embolism. Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. A summary description of major and total bleeding is provided in Table 2.Table 2 shows the number of patients experiencing major and total bleeding event rates during the treatment period in the RELY study, conducted in patients with atrial fi brillation. In Table 2, the category of major bleeds includes both life-threatening and non-life threatening bleeds. Within life-threatening, intracranial bleeds is a subcategory of life-threatening bleeds.


Intracranial bleeds include intracerebral (hemorrhagic stroke), subarachnoid and subdural bleeds. For this reason, these events may be counted in multiple categories. Table 2: Frequency and annualized event rate (%) of bleeding events from the RELY trial

Dabigatran etexilate 110 mg bid

N (%)

Dabigatran etexilate 150 mg bid

N (%)

Warfarin**N (%)

Patients randomized 6,015 6,076 6,022

Patient-years 11,899 12,033 11,794

Major bleeding event (MBE)* 342 (2.9) 399 (3.3) 421 (3.6)

Hazard ratio vs. warfarin (95% CI)

0.80 (0.70, 0.93) 0.93 (0.81, 1.07)

p-value 0.0026 0.3146

Life threatening MBE 147 (1.2) 179 (1.5) 218 (1.9)


0.67 (0.54, 0.82) 0.80 (0.66, 0.98)

p-value 0.0001 0.0305

Intra-cranial hemorrhage (ICH)+ 27 (0.2) 38 (0.3) 90 (0.8)


0.30 (0.19, 0.45) 0.41 (0.28, 0.60)

p-value < 0.0001 < 0.0001

Any bleeding eventa 1,754 (14.7) 1,993 (16.6) 2,166 (18.4)


0.78 (0.73, 0.83) 0.91 (0.85, 0.96)

p-value < 0.0001 0.0016

*Adjudicated bleeds**Dose-adjusted warfarin to an INR of 2.0 – 3.0 + ICH consists of adjudicated hemorrhagic stroke and subdural and/or subarachnoid hemorrhage.

aInvestigator-reported bleeding events

Major bleeding fulfi lled one or more of the following criteria: Bleeding associated with a reduction in hemoglobin of at least 20 grams per litre or leading to a transfusion of at least 2 units of blood or packed cells;

Symptomatic bleeding in a critical area or organ: intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding.

Major bleeds were classifi ed as life-threatening if they fulfi lled one or more of the following criteria: Fatal bleed; symptomatic intracranial bleed; reduction in hemoglobin of at least 50 grams per litre; transfusion of at least 4 units of blood or packed cells; a bleed associated with hypotension requiring the use of intravenous inotropic agents; a bleed that necessitated surgical intervention.

Clinical Trial Adverse Drug Reactions:Because clinical trials are conducted under very specifi c conditions, the adverse reaction rates observed in the clinical trials may not refl ect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Table 3: Common Adverse Reactions observed in 1% of dabigatran-treated patients with atrial fi brillation in the active- controlled trial, RELY

Dabigatran etexilate 110 mg N (%)

Dabigatran etexilate 150 mg N (%)

Warfarin N (%)

5,983 (100) 6,059 (100) 5,998 (100)

Bleeding and anemia* 599 (10.0) 747 (12.3) 825 (13.8)

Anemia 73 (1.2) 97 (1.6) 74 (1.2)

Epistaxis 66 (1.1) 67 (1.1) 107 (1.8)

Gastrointestinal hemorrhage

196 (3.3) 277 (4.6) 155 (2.6)

Urogenital hemorrhage 66 (1.1) 84 (1.4) 96 (1.6)

Gastrointestinal disorders* 735 (12.3) 772 (12.7) 220 (3.7)

Abdominal pain 135 (2.3) 134 (2.2) 15 (0.3)

Diarrhea 75 (1.3) 71 (1.2) 11 (0.2)

Dyspepsia 250 (4.2) 234 (3.9) 13 (0.2)

Nausea 58 (1.0) 73 (1.2) 12 (0.2)

* Aggregate incidence presented for all adverse reactions within the body system, including those reactions occurring <1% and not listed in the Table above.Gastrointestinal adverse reactions occurred more often with dabigatran etexilate than warfarin. These were related to dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort), or gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, gastrointestinal ulcer). Gastrointestinal (GI) hemorrhage occurred at a higher frequency with PRADAX compared to warfarin (see Table 3). GI adjudicated major bleeds were reported at 1.1%, 1.6%, and 1.1% (annualized rates) in the DE 110 mg, DE 150 mg and warfarin groups, respectively. GI life-threatening bleeds occurred with a frequency of 0.6%, 0.8% and 0.5% in the DE 110 mg, DE 150 mg and warfarin groups, respectively. Any GI bleeds occurred with a frequency of 5.4%, 6.1% and 4.0% in the DE 110 mg, DE 150 mg and warfarin groups, respectively. The underlying mechanism of the increased rate of GI bleeding has not been established (see CLINICAL TRIALS, Prevention of stroke and systemic embolism in patients with atrial fi brillation in the Product Monograph). Allergic reactions or drug hypersensitivity including urticaria, bronchospasm, rash and pruritus have been reported in patients who received dabigatran etexilate. Rare cases of anaphylactic reactions have also been reported.

Less Common Clinical Trial Adverse Drug Reactions (<1%)Observed with exposure to dabigatran 110 mg bid and 150 mg bid during the RELY trial, an active-controlled clinical trial for the prevention of stroke and systemic embolism in patients with atrial fi brillation:Blood and lymphatic system disorders: thrombocytopeniaVascular disorders: hematoma, hemorrhageGastrointestinal disorders: gastrointestinal ulcer, gastroesophagitis, gastro-esophageal refl ux disease, vomiting, dysphagiaHepatobiliary disorders: hepatic function abnormal/liver function test abnormal, hepatic enzyme increasedSkin and subcutaneous tissue disorders: skin hemorrhage, urticaria, rash, pruritusMusculoskeletal and connective tissue and bone disorders: hemarthrosisRenal and urinary disorders: hematuriaGeneral disorders and administration site conditions: injection site hemorrhage, catheter site hemorrhageInjury, poisoning and procedural complications: incision site hematoma, traumatic hematoma, incision site hemorrhageImmune system disorder: drug hypersensitivityRespiratory disorders: hemoptysis, bronchospasmNervous system disorders: intracranial hemorrhageFor abnormal liver function tests reported in the RE-LY trial, please see Table 5.To report an adverse event, contact your

Regional Adverse Reaction Monitoring Offi ce at 1-866-234-2345, or contact: Boehringer Ingelheim (Canada) Ltd., Drug Safety at 1-800-263-5103 ext. 4603.DRUG INTERACTIONSBased on in vitro evaluation, neither dabigatran etexilate nor its active moiety, dabigatran, have been shown to be metabolized by the human cytochrome P450 system, nor did they exhibit effects on human CYP P450 isozymes.Concomitant use of PRADAX with treatments that interfere with hemostasis or coagulation increases bleeding risk (see WARNINGS AND PRECAUTIONS, Bleeding). Co-administration of PRADAX with other anticoagulants has not been adequately studied and is not recommended. In the RELY trial, conducted in patients with atrial fi brillation, a two-fold increase in major bleeding was seen in both dabigatran study treatment arms, as well as that of the comparator, warfarin, when ASA was administered concomitantly (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph; CLINICAL TRIALS, Stroke Prevention in Atrial Fibrillation in the Product Monograph; and DOSAGE AND ADMINISTRATION).Drug-Drug InteractionsTransporter interactions: Dabigatran etexilate, but not dabigatran, is a substrate with moderate affi nity for the effl ux P-glycoprotein (P-gp) transporter. Therefore, potent P-glycoprotein inducers or inhibitors may be expected to impact exposure to dabigatran.P-glycoprotein inhibitors: P-gp inhibitors like verapamil, quinidine and amiodarone may be expected to increase systemic exposure to dabigatran, see Table 4 below. The strong P-glycoprotein inhibitor ketoconazole, when administered orally, is contraindicated (see CONTRAINDICATIONS). If not otherwise specifi cally described, close clinical surveillance (looking for signs of bleeding or anemia), along with a sense of caution is required when dabigatran is co-administered with strong P-glycoprotein inhibitors.P-glycoprotein inducers: The concomitant use of PRADAX with the strong P-gp inducer rifampicin, reduces dabigatran plasma concentration. Other P-gp inducers such as carbamazepine and St John’s Wort are also expected to reduce the systemic exposure of dabigatran. Less potent inducers such as tenofovir can potentially reduce systemic exposure. Caution is advised when co-administering these drug products. P-glycoprotein substrates: Dabigatran etexilate is not expected to have a clinically meaningful interaction with P-glycoprotein substrates that do not also act as inhibitors or inducers of P-gp.


Table 4: Summary of Drug-Drug InteractionsProper name Ref* Effect Clinical comment

Amiodarone CT Dabigatran exposure in healthy subjects was increased by 60% in the presence of amiodarone (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

Adjust dosing for patients treated for prevention of VTE after hip- or knee-replacement surgery to 150 mg daily PRADAX with amiodarone. Caution should be exercised.

No dose adjustment is generally recommended for AF patients. Use with caution. Occasional testing of aPTT may be considered to rule out excessive anticoagulant effect.

Antacids (aluminium compounds, sodium bicarbonate, calcium and/or magnesium compounds, or combinations of these)

CT In population PK analyses, a reduction in dabigatran exposure by 35% was seen over the fi rst 24 hours following surgery. Thereafter, (>24 hours after surgery), a reduction of about 11% was observed.

Diminished clinical effect may occur, as may be expected for any drug resulting in an increase in gastric pH during PRADAX administration. PRADAX should be administered at least 2 hours before taking an antacid. Co-administration with PRADAX should be avoided within 24 hours after orthopedic surgery.

Atorvastatin CT When dabigatran etexilate was co-administered with atorvastatin, exposure of atorvastatin, and atorvastatin metabolites were not signifi cantly changed. Dabigatran concentrations were decreased about 20%.

No dose adjustment is recommended.

Clarithromycin CT Dabigatran exposure in healthy subjects was increased by about 15% in the presence of clarithromycin (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

No dose adjustment is recommended. Caution should be exercised.

Diclofenac CT When dabigatran etexilate was co-administered with diclofenac, pharmacokinetics of both drugs appeared unchanged.

No dose adjustment is recommended.Use with caution (see WARNINGS AND PRECAUTIONS, Bleeding, Table 1.)

Digoxin CT When dabigatran etexilate was co-administered with digoxin, no PK-interaction was observed.

No dose adjustment isrecommended.

Ketoconazole CT Dabigatran exposure was increased 150% after single and multiple doses of ketoconazole (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

Co-administration with PRADAX is contraindicated.(see CONTRAINDICATIONS).

Pantoprazole CT When dabigatran etexilate was co-administered with pantoprazole, a decrease in dabigatran AUC of about 30 % was observed. In the Phase III study, RELY, PPI co-medication did not result in lower trough levels and on average only slightly reduced post-dose concentrations (-11%) (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

No dose adjustment is recommended. Diminished clinical effect may occur, as may be expected for any drug resulting in an increase in gastric pH during PRADAX administration.

Rifampicin CT After 7 days of treatment with 600 mg rifampicin qd total dabigatran AUC0- and Cmax were reduced by 67% and 66% compared to the reference treatment, respectively (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

Concomitant use of PRADAX with rifampicin should, in general, be avoided. Concomitant use would be expected to result in substantially diminished anticoagulant effect of PRADAX.

Verapamil CT When dabigatran etexilate, given at 150 mg once daily, was co-administered with moderate doses of oral verapamil, the Cmax and AUC of dabigatran were increased, but the magnitude of this change varied depending on the timing of administration and the formulation of verapamil used (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic Interactions in the Product Monograph).

Dosing should be reduced to 150 mg PRADAX daily in patients treated for prevention of VTE after hip- or knee-replacement surgery who concomitantly receive dabigatran etexilate and verapamil. To minimize potential for interaction, PRADAX should be given at least two hours before verapamil.Caution should be exercised.

Although no dose adjustment is recommended for AF patients, to minimize potential for interaction, PRADAX should be given at least two hours before verapamil.Caution should be exercised.

Quinidine CT Dabigatran exposure in healthy subjects was increased by 53 % in the presence of quinidine.

Adjust dosing for patients treated for prevention of VTE after hip- or knee-replacement surgery to 150 mg daily PRADAX.Caution should be exercised.

Although no dose adjustment is recommended for AF patients, to minimize potential for interac-tion, PRADAX should be given at least two hours before quinidine, if possible.Caution should be exercised.

*C = Case Study; CT = Clinical Trial; T = Theoretical

Drug-Food InteractionsFood does not affect the bioavailability of PRADAX but delays the time-to-peak plasma concentrations by 2 hours.Drug-Herb InteractionsDrug-herb interactions have not been investigated. Potent P-gp inducers such as St. John’s Wort (Hypericum perforatum) may be expected to affect systemic exposure of dabigatran. Co-administration of these products is not recommended.Drug-Laboratory InteractionsNo single test (aPTT, TT, ECT) is adequate to reliably assess the anticoagulant activity of dabigatran following PRADAX

administration. At therapeutic levels of dabigatran, thrombin time (TT) is the best measure of the pharmacodynamic effect of dabigatran because of its linear and sensitive relationship with dabigatran exposure (WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests; ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics, in the Product Monograph).The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran. In patients who are bleeding, the aPTT test may be useful to assist in determining an excess of anticoagulant activity, despite its limited sensitivity. An aPTT greater than 80 sec at trough (when the next dose is due) is associated with a higher risk of bleeding. Note that a PT (INR) test is not useful to assess the anticoagulant activity of PRADAX.Drug-Lifestyle InteractionsNo direct interaction between dabigatran etexilate and alcohol was demonstrated in animal models or has been hypothesized. The effect of PRADAX on the ability to drive and use machines has not been investigated. However, no such interaction is to be expected.

vAdministration

DOSAGE AND ADMINISTRATIONPRADAX should be taken orally, with the entire capsule to be swallowed whole. The capsule should not be chewed, broken, or opened.PRADAX should be taken regularly, as prescribed, to ensure optimal effectiveness. All temporary discontinuations should be avoided, unless medically indicated. Recommended Dose and Dosage Adjustment Prevention of stroke and systemic embolism in patients with atrial fi brillation: The recommended dose of PRADAX is 300 mg daily, taken orally as one 150 mg capsule twice a day.

Elderly: Prevention of stroke and systemic embol ism in pat ients wi th at r ia l fi brillation: Patients aged 80 years and above should be treated with a dose of 220 mg of PRADAX daily, taken orally as one 110 mg capsule twice a day (see WARNINGS AND PRECAUTIONS, Geriatrics, and CLINICAL TRIALS, Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation, Tables 24 and 25, in the Product Monograph).

The usual recommended dose for most geriatric patients under the age of 80 years is 300 mg daily, taken orally as one 150 mg capsule twice a day (see

CLINICAL TRIALS, Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation, Tables 24 and 25, in the Product Monograph). However, in geriatric patients, especially those over the age of 75 with at least one other risk factor for bleeding (see WARNINGS AND PRECAUTIONS, Bleeding, Table 2), the administration of a dose of 220 mg of PRADAX daily, taken orally as one 110 mg capsule twice a day, may be considered. It should be noted, however, that the effectiveness of stroke prevention may be expected to be lessened with this dosage regimen, compared to that of the usual one of 300 mg of PRADAX daily. As with any anticoagulant, caution is required when prescribing PRADAX to the elderly (see CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS, Bleeding).

Patients at risk of bleeding: Prevention of stroke and systemic embolism in patients with atrial fi brillation: Patients with an increased risk of bleeding (see WARNINGS AND PRECAUTIONS, Bleeding, Table 1), should be closely monitored clinically (looking for signs of bleeding or anemia). In such patients, a dose of 220 mg, given as 110 mg twice daily may be considered. A coagulation test, such as aPTT (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests), may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure. As for any anticoagulant, PRADAX is NOT indicated in patients at excessive risk of bleeding (see CONTRAINDICATIONS).Renal impairment: Following oral dosing with dabigatran etexilate, there is a direct correlation of systemic exposure to dabigatran with degree of renal impairment (see WARNINGS AND PRECAUTIONS, Renal). The kidneys account for 85% of dabigatran clearance.There are no data to support use in patients with severe renal impairment (CrCl <30 mL /min). Given the substantial increase in dabigatran exposure observed in this patient population, treatment with PRADAX is not recommended (see CONTRA-INDICATIONS, and ACTION AND CLINICAL PHARMACOLOGY, Renal Insuffi ciency in the Product Monograph). Patients with atrial fi brillation treated for prevention of stroke and systemic embol ism hav ing moderate renal impairment (CrCl 30-50 mL /min): No dose adjustment is recommended (see CLINICAL TRIALS, Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation, Renal Impairment in the Product Monograph). Patients with moderate renal impairment (CrCl 30-50 mL /min) should be treated with a daily


dose of PRADAX at 300 mg taken orally as one 150 mg capsule twice daily, with caution. Regular assessment of renal status is required in these patients (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Renal). A coagulation test, such as aPTT (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests), may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure.

Creatinine clearance can be estimated using the Cockroft-Gault formula as follows:Creatinine clearance (mL/min) = Males: (140-age (years)) x weight (kg) 72 x serum creatinine (mg/100mL)

Females: 0.85 x (140-age (years)) x weight (kg) 72 x serum creatinine (mg/100mL)P-glycoprotein inhibitors: P-gp inhibitors like verapamil, quinidine, and amiodarone may be expected to increase systemic exposure to dabigatran. Combination use with oral ketoconazole is contraindicated (see CONTRAINDICATIONS). Patients with atrial fi brillation treated for prevention of stroke and systemic embol ism: No dose adjustment is recommended in patients concomitantly receiving amiodarone, quinidine or verapamil (see DRUG INTERACTIONS, Ta b l e 4 , S u m m a r y o f D r u g - D r u g Interactions; and ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic interactions in the Product Monograph). Patients should be treated with a daily dose of 300 mg PRADAX taken orally as one 150 mg capsule twice daily. To minimize potential for interaction, PRADAX should be given at least two hours before verapamil (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Pharmacokinetic interactions in the Product Monograph). Caution should be exercised. Close clinical surveillance is recommended.

Drugs that increase gastric pH, such as antacids, protein pump inhibitors (PPI): Diminished clinical effect for antacids may occur (see DRUG INTERACTIONS, Table 4, Summary of Drug-Drug Interactions). Although no dosage adjustment is generally necessary, administer PRADAX at least two hours before antacids, if possible, to minimize interaction potential. No dose adjustment is required for pantoprazole or other PPIs.Concomitant antithrombotic use:Concomitant use of ASA or clopidogrel with PRADAX in patients with atrial fi brillation approximately doubled the risk of major bleed, irrespective of dose of PRADAX used. A similar increase was noted with such concomitant use with the study comparator, warfarin. These observations contrasted

with little apparent additional improvement in stroke and systemic embolic events with combined antithrombotic use and PRADAX (or warfarin). Concomitant use of PRADAX with an antithrombotic is not recommended for prevention of cardiogenic thromboembolic stroke in patients with atrial fi brillation. Concomitant use of ASA or other antiplatelet agents based on medical need to prevent myocardial infarction should be undertaken with caution. Close clinical surveillance is recommended.Acute myocardial infarction (AMI):Consideration should be given to discontinuing PRADAX in the setting of acute myocardial infarction should the treatment of myocardial infarction involve invasive procedures, such as percutaneous coronary revascularization, or coronary artery bypass surgery. Similar consideration should be given if thrombolytic therapy is to be initiated, because bleeding risk may increase. Patients with AMI should be treated according to current clinical guidelines for that disorder. In this setting, PRADAX may be resumed for the prevention of stroke and systemic embolism upon completion of these revascularization procedures.Children: Since PRADAX has not been investigated in patients <18 years of age, treatment is not recommended.Patient Body Weight: Population PK modelling shows that patients with a body weight of about 120 kg have about 20% lower drug exposure. Patients with a body weight of about 48 kg have about 25% higher drug exposure compared to patients with average weight. No dose adjustment deemed necessary.Switching from PRADAX treatment to parenteral anticoagulant: In patients with atrial fi brillation treated for prevention of stroke and systemic embolism: wait 12 hours after the last dose of PRADAX before switching to a parenteral anticoagulant.

Switching from parenteral anticoagulants treatment to PRADAX: If deemed medically appropriate, treatment with PRADAX should be initiated 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g., intravenous unfractionated heparin, [UFH]).Switching from Vitamin K antagonists to PRADAX: If deemed medically appropriate, PRADAX should only be started after Vitamin K antagonists have been discontinued, and the patient’s INR is found to be below 2.0.Cardioversion: Patients can be maintained on PRADAX while being cardioverted. Missed Dose: Prevention of stroke and systemic embolism in patients with atrial

fi brillation: If the prescribed dose of PRADAX is not taken at the scheduled time, the dose should be taken as soon as possible on the same day. A forgotten PRADAX dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted. Patients should not take a double dose to make up for missed individual doses. For optimal effect and safety, it is important to take PRADAX regularly twice a day, at approximately 12-hour intervals.AdministrationPRADAX may be taken with food, or on an empty stomach with water.The capsule should be swallowed intact. It should not be opened, broken, or chewed (see ACTION AND CLINICAL PHARMACOLOGY in the full Product Monograph, Pharmacokinetics in the Product Monograph).SUPPLEMENTAL PRODUCT INFORMATIONAdverse Reactions:Liver Function Tests: In the long-term RELY study, observed abnormalities of liver function tests (LFT) are presented below in Table 5.

Table 5: Liver Function Tests in the RELY trial

Dabigatran etexilate 110 mg twice daily

N (%)

Dabigatran etexilate 150 mg twice daily

N (%)

Warfarin N (%)

Total treated 5,983 (100.0) 6,059 (100.0) 5,999 (100.0)

ALT or AST >3xULN 118 (2.0) 106 (1.7) 125 (2.1)

ALT or AST >5xULN 36 (0.7) 45 (0.7) 50 (0.8)

ALT or AST >3xULN + Bilirubin >2xULN

11 (0.2) 14 (0.2) 21 (0.4)

OVERDOSAGEThere is no antidote to dabigatran etexilate or dabigatran. Doses of PRADAX beyond those recommended expose the patient to increased risk of bleeding. Excessive anticoagulation may require discontinuation of PRADAX. In the event of hemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. Since dabigatran is excreted predominantly by the renal route, adequate diuresis must be maintained. Appropriate standard treatment, e.g., surgical hemostasis as indicated and blood volume replacement, should be undertaken. In addition, consideration may be given to the use of fresh whole blood or the transfusion of fresh frozen plasma.As protein binding is low, dabigatran can be dialysed, although there is limited clinical experience in using dialysis in this setting.Activated prothrombin complex concentrates (e.g., FEIBA) or recombinant Factor VIIa or concentrates of coagulation factors II, IX or X, may be considered. There is some experimental evidence to support the role of these agents in reversing the anticoagulant effect of dabigatran but their usefulness in clinical settings has not yet been clearly demonstrated. Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long-acting antiplatelet drugs have been used. All symptomatic treatment should be given according to the physician’s judgement.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Product Monograph is available upon request or at www.boehringer-ingelheim.ca

Boehringer Ingelheim (Canada) Ltd.5180 South Service RoadBurlington, ON L7L 5H4

PRADAX™ is a trademark of Boehringer Ingelheim Pharma GmnH & Co. KG, used under license by Boehringer Ingelheim (Canada) Ltd.

November 8, 2010


PRESCRIBING SUMMARY

PATIENT SELECTION CRITERIA

THERAPEUTIC CLASSIFICATION Analgesic Agent

INDICATIONS AND CLINICAL USE LYRICA (pregabalin) is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury. LYRICA is indicated for the management of pain associated with fibromyalgia. The efficacy of LYRICA in the management of pain associated with fibromyalgia for up to 6 months was demonstrated in a placebo-controlled trial in patients who had initially responded to LYRICA during a 6-week open-label phase.

Use in Special PopulationsGeriatrics (>65 years of age): Pregabalin oral clearance tended to decrease with increasing age. This decrease in pregabalin oral clearance is consistent with age-related decreases in creatinine clearance. Reduction of pregabalin dose may be required in patients who have age-related compromised renal function (see WARNINGS AND PRECAUTIONS, Geriatrics [>65 years of age ]).Pediatrics (<18 years of age): The safety and efficacy of pregabalin in pediatric patients (<18 years of age) have not been established. Renal: There have been reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other medications. Discontinuation of pregabalin showed reversibility of this event in some cases (see Product Monograph, WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS, Post-Marketing Adverse Drug Reactions; and DOSAGE AND ADMINISTRATION ). Because pregabalin is eliminated primarily by renal excretion, the dose of pregabalin should be adjusted as noted for elderly patients or those with renal impairment (see Product Monograph, ACTION AND CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). Pregnant Women: There are no adequate and well-controlled studies in pregnant women. Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Labour and Delivery: The effects of pregabalin on labour and delivery in pregnant women are unknown. Nursing Women: It is not known if pregabalin is excreted in human breast milk; however, it is present in the milk of rats. Because of the potential for adverse reactions in nursing infants from pregabalin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.CONTRAINDICATIONSPatients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.

SAFETY INFORMATION

WARNINGS AND PRECAUTIONSAngioedema: There have been post-marketing reports of angioedema in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), neck, throat, and larynx/upper airway. There have been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Some of these patients did not have reported previous history/episode(s) of angioedema. LYRICA should be immediately discontinued in patients with these symptoms. During the pre-marketing assessment of pregabalin in clinical trials, angioedema was reported as a rare reaction (see Product Monograph, ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions and Post-Marketing Adverse Drug Reactions).

Caution should be exercised when prescribing LYRICA to patients with previous history/episode(s) of angioedema and related events. In addition, patients who are taking other drugs associated with angioedema (eg, ACE-inhibitors) may be at increased risk of developing this condition.Hypersensitivity: There have been post-marketing reports of hypersensitivity reactions (e.g. skin redness, blisters, hives, rash, dyspnea, and wheezing). Pregabalin should be discontinued immediately if such symptoms occur (see Product Monograph, Post-Marketing Adverse Drug Reactions).Renal Failure: In both clinical trials of various indications and post-marketing database, there are reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other medications. Discontinuation of pregabalin should be considered as it has shown reversibility of this event in some cases. Caution is advised when prescribing pregabalin to the elderly or those with any degree of renal impairment (see Product Monograph, Special Populations, Renal; Abrupt or Rapid Discontinuation; ADVERSE REACTIONS, Post-Marketing Adverse Drug Reactions; and DOSAGE AND ADMINISTRATION ).Tumorigenic Potential: In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, a high incidence of hemangiosarcoma was identified in two different strains of mice. The clinical significance of this finding is uncertain. Clinical experience during pregabalin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans. Ophthalmological Effects: In controlled studies, pregabalin treatment was associated with vision-related adverse events such as blurred vision (amblyopia) (6% pregabalin and 2% placebo) and diplopia (2% pregabalin and 0.5% placebo). Approximately 1% of pregabalin-treated patients discontinued treatment due to vision-related adverse events (primarily blurred vision). Of the patients who did not withdraw, the blurred vision resolved with continued dosing in approximately half of the cases (see Product Monograph, Post-Marketing Adverse Drug Reactions).Patients should be informed that if changes in vision occur, they should notify their physician. Peripheral Edema: LYRICA may cause peripheral edema. In controlled peripheral neuropathic pain and fibromyalgia clinical trials, pregabalin treatment caused peripheral edema in 9% of patients compared with 3% of patients in the placebo group. In these studies, 0.7% of pregabalin patients and 0.3% of placebo patients withdrew due to peripheral edema (see Product Monograph, ADVERSE REACTIONS, Peripheral Edema ).In controlled clinical trials of up to 13 weeks in duration of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. In the same trials, peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function.Higher frequencies of weight gain and peripheral edema were observed in patients taking both LYRICA and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering LYRICA and these agents. Congestive Heart Failure: In controlled clinical studies, events of congestive heart failure were reported at an infrequent rate (between 0.1% and 1%; see Product Monograph, ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions). There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin (see Product Monograph, ADVERSE REACTIONS, Post-marketing Adverse Drug Reactions). Although this adverse reaction has mostly been observed in elderly cardiovascular-compromised patients during pregabalin treatment for a neuropathic pain indication, some cases have occurred in patients without reported edema or previous history of cardiovascular disease. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.Gastrointestinal: There have been post-marketing reports of events related to reduced lower gastrointestinal tract function (eg. intestinal obstruction, paralytic ileus, and constipation) in patients, some without reported previous history/episode(s), during initial/acute and chronic

treatment with LYRICA, primarily in combination with other medications that have the potential to produce constipation. Some of these events were considered serious and required hospitalization. In a number of instances, patients were taking opioid analgesics including tramadol.Caution should be exercised when LYRICA and opioid analgesics are used in combination, and measures to prevent constipation may be considered, especially in female patients and elderly as they may be at increased risk of experiencing lower gastrointestinal-related events (see Product Monograph, ADVERSE REACTIONS, Post-Marketing Adverse Drug Reactions).Weight Gain: LYRICA may cause weight gain. In pregabalin-controlled peripheral neuropathic pain and fibromyalgia clinical trials with durations of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 8% of pregabalin-treated patients and 3% of placebo-treated patients. Few patients treated with pregabalin (0.6%) withdrew from controlled trials due to weight gain (see Product Monograph, ADVERSE REACTIONS, Weight Gain). Pregabalin-associated weight gain was related to dose and duration of exposure. Pregabalin-associated weight gain did not appear to be associated with baseline BMI, gender, or age. Weight gain was not limited to patients with edema and was not necessarily due to edema-related events (see Product Monograph, WARNINGS AND PRECAUTIONS, Peripheral Edema).Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of pregabalin-associated weight gain are unknown. While the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed, in controlled and longer-term open-label clinical trials with diabetic patients, pregabalin treatment did not appear to be associated with loss of glycemic control (as measured by HbA1c).Dizziness and Somnolence: LYRICA may cause dizziness and somnolence. In controlled studies, pregabalin caused dizziness in 32% of patients compared to 8% in placebo. Somnolence was experienced by 17% and 4% of the patients treated with pregabalin and placebo, respectively. These events begin shortly after the initiation of therapy and generally occur more frequently at higher doses. In these studies, dizziness and somnolence led to withdrawal of 5% (placebo: 0.5%) and 3% (placebo: 0.1%) of the pregabalin-treated patients, respectively. For the remaining patients who experienced these events, dizziness and somnolence persisted until the last dose of pregabalin in 35% and 49% of the patients, respectively (see Product Monograph, ADVERSE REACTIONS, Tables 2, 4, and 11, and Post-Marketing Adverse Drug Reactions). Abrupt or Rapid Discontinuation: Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis and diarrhea. Pregabalin should be tapered gradually over a minimum of one week rather than discontinued abruptly (see Product Monograph, ADVERSE REACTIONS, Adverse Events Following Abrupt or Rapid Discontinuation ).

ADVERSE REACTIONSBecause clinical trials are conducted under very specific conditions, the adverse reaction rates observed in clinical trials may not reflect the rates observed in practice and should not be compared to the rates in clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Clinical Trial Adverse Drug ReactionsMost Common Adverse Events in All Pre-marketing Controlled Clinical Studies of Neuropathic Pain: The most commonly observed adverse events ( 5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: dizziness, somnolence, peripheral edema, and dry mouth. Adverse events were usually mild to moderate in intensity. Adverse Events from a Controlled Clinical Study in Neuropathic Pain Associated with Spinal Cord Injury: The most commonly observed treatment-related adverse events ( 5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: somnolence, dizziness, asthenia, dry mouth, edema, myasthenia, constipation, thinking abnormal, amblyopia, and amnesia. Adverse events were usually mild to moderate in intensity.


Most Common Adverse Events in Controlled Clinical Studies in Fibromyalgia: The most commonly observed treatment-related adverse events ( 5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: dizziness (37.5%), somnolence (18.6%), weight gain (10.6%), dry mouth (7.9%), blurred vision (6.7%), peripheral edema (6.1%), constipation (5.8%), and distur-bance in attention (5.3%). Adverse events were usually mild to moderate in intensity.To monitor drug safety, Health Canada collects infor-mation on serious and unexpected effects of drugs. If you suspect a patient has had a serious or unexpected reaction to this drug, you may notify Health Canada by telephone: 1-866-234-2345.

ADMINISTRATION

DOSING CONSIDERATIONSPatients with Impaired Renal FunctionPregabalin is primarily eliminated from the systemic circulation by renal excretion as unchanged drug. In some elderly patients and those with a medical history of significant renal insufficiency, daily dosages should be reduced accordingly (see Table in Supplemental Product Information).

AdultsNeuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia: The recom men-ded starting dose for LYRICA is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Efficacy of LYRICA has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week.For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used. However, in clinical trials, LYRICA 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced markedly higher rates of adverse events and discontinued the trial more frequently (see Product Monograph, ADVERSE REACTIONS, Tables 1 and 5). Doses above 600 mg/day have not been studied and are not recommended.Neuropathic pain associated with spinal cord injury:The recommended starting dose for LYRICA is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Efficacy of LYRICA has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week.For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, a maximum daily dose of 600 mg (300 mg twice a day, BID) may be considered. Doses above 600 mg/day have not been studied and are not recommended. Pain associated with fibromyalgia: The recommended dosage is 300 to 450 mg/day, given in two divided doses. The recommended starting dose for LYRICA is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Based on individual response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. Patients who do not experience sufficient bene-fit with 300 mg/day may be further increased to 225 mg BID (450 mg/day). In some patients, efficacy of LYRICA has been demonstrated within the first week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used. However, in clinical trials of fibromyalgia, LYRICA 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced significantly higher rates of adverse events and discontinued the trial more frequently (see Product Monograph, ADVERSE REACTIONS, Tables 7 and 10). In view of the dose-related adverse events, the decision to treat patients with doses above 450 mg/day should be based on clinical judgment of the treating physician. Doses above 600 mg/day have not been studied and are not recommended.

ADMINISTRATIONLYRICA is given orally with or without food.

STUDY REFERENCES

References:1. LYRICA Product Monograph, Pfizer Canada Inc., June 21, 2010.2. Moulin DE et al. Pharmacological management of chronic neuropathic

pain – consensus statement and guidelines from the Canadian Pain Society. Pain Res Manage 2007;12:13-21.

3. Arnold LM et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008;9:792-805.14-week, randomized, double-blind, multiple-dose, placebo-controlled, multicentre study. 745 patients who had moderate-to-severe pain, i.e. mean baseline score (mean of the last 7 daily diary pain scores prior to study medication) of 4, and a diagnosis of fibromyalgia based on the ACR criteria. This study used an enriched population as placebo responders ( 30% reduction in mean pain scores) during the one-week run-in phase were discontinued and did not enter the double-blind phase. 1.6% of patients screened (n=19/1,195) were reported to be placebo responders. Patients were randomized to LYRICA 300 mg/day (n=183), 450 mg/day (n=190), 600 mg/day (n=188), or placebo (n=184). Patients were allowed to take acetaminophen up to 4 g/day as needed for pain relief. The number of completers was: LYRICA 300 mg/day (n=123), 450 mg/day (n=125), 600 mg/day (n=113), or placebo (n=125). The primary endpoint was the reduction in endpoint mean pain scores. Pain scores rated on 11-point numerical scale from 0 (no pain) to 10 (worst possible pain) during the past 24 hours. Mean baseline pain scores were 6.7 for LYRICA 300 mg/day, 6.7 for 450 mg/day, 6.8 for 600 mg/day, and 6.6 for placebo.

4. Crofford LJ et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain 2008;136:419-31.26-week, long-term relapse observation study. Patients who met the ACR criteria for fibromyalgia and who had a score of 40 on the pain Visual Analog Scale (VAS) were eligible to enter a 6-week, open-label, dose-optimization phase. During this phase, patients were titrated up to a total daily dose of 300 mg, 450 mg, or 600 mg. 566 LYRICA responders were randomized in the double-blind phase to either their optimized LYRICA dose (n=279) or to placebo (n=287). 38% of LYRICA responders completed 26 weeks of treatment vs 19% on placebo. The primary endpoint was time to loss of therapeutic response. Loss of therapeutic response was defined as having either a <30% reduction in pain VAS score, or worsening of symptoms necessitating alternate treatment. Responders were defined as having a 50% reduction in pain on the VAS and self-rating on the Patient Global Impression of Change scale of “much improved” or “very much improved”.

5. Freynhagen R et al. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain 2005;115:254-63.In a 12-week, multicentre, randomized, double-blind, placebo-controlled study, 338 patients with either DPN (n=249) or PHN (n=89) were randomized to receive BID flexible-dose pregabalin (150-600 mg/day), fixed-dose pregabalin (600 mg/day) or placebo. In the flexible-dose arm, dose could be adjusted up or down over the first four weeks based on patients’ individual response and tolerability. The primary efficacy measurement was mean pain score at endpoint, derived from ratings recorded by patients in a daily diary on an 11-point numerical pain rating scale (0=no pain, 10=worst possible pain). A significant difference in pain scores versus placebo was seen in the flexible dose range 150-600 mg/day (p 0.05, weeks 2-3 and p 0.01, weeks 4-12), and the fixed dose of 600 mg/day (p 0.05, week 1 and p 0.01, weeks 2-12).

6. Mease PJ et al. A randomized, double-blind, placebo- controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502-14.Multicentre, double-blind, 13-week, randomized trial. 748 patients who met the ACR criteria for fibromyalgia and who had an average mean pain score of 4 on an 11-point numeric rating scale (NRS) during the baseline assessment were randomized to LYRICA 300 mg/day (n=185), 450 mg/day (n=183), 600 mg/day (n=190), or placebo (n=190). Patients were allowed to take acetaminophen up to 4 g/day as needed for pain relief. The number of completers was: LYRICA 300 mg/day (n=123), 450 mg/day (n=121), 600 mg/day (n=111), or placebo (n=130). The primary endpoint was the reduction in endpoint mean pain scores (mean of the last 7 daily pain scores while on study medication). Pain-related sleep difficulties were assessed using the Medical Outcomes Study-Sleep Scale (MOS-SS), a scale that runs from 0-100. Mean baseline MOS-SS score for overall sleep problem index was 65.0.

SUPPLEMENTAL PRODUCT INFORMATIONWarnings and PrecautionSee the Product Monograph for further information on the following: tumorigenic potential, ophthalmological effects, peripheral edema, congestive heart failure, weight gain, dizziness and somnolence, sexual function/reproduction, and special populations.Drug InteractionsOverview: Since pregabalin is predominately excreted unchanged in the urine, undergoes negligible metabolism in humans ( 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, LYRICA (pregabalin) is unlikely to produce, or be subject to, pharmacokinetic interactions.Drug Abuse and Dependence/Liability: Pregabalin is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, physicians should carefully evaluate patients for history of drug abuse and observe them for signs of LYRICA misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behaviour).ADMINISTRATIONDosage Adjustment Based on Renal Function: Dosing adjustment should be based on creatinine clearance (Clcr), as indicated in Table 1.Pregabalin is effectively removed from plasma by hemodialysis. Over a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%. For patients receiving hemodialysis, pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose adjustment, a supplemental dose should be given immediately following every 4-hour hemodialysis treatment (see Table below).

Table 1. Pregabalin Dosage Adjustment Based on Renal Function

Creatinine Clearance

(CLcr)(mL/min)

Total Pregabalin Daily Dose (mg/day)a

Recommended Dose Escalation*Dose

Regimen

Starting dose up to

Maximum daily dose

≥60 150 300 450 600 BID or TID30-60 75 150 225 300 BID or TID15-30 25-50 75 100-150 150 QD or BID<15 25 25-50 50-75 75 QD

Supplementary dosage following hemodialysis (mg)b

Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mgPatients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mgPatients on the 50-75 mg QD regimen: take one supplemental dose of 75 mg or 100 mgPatients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg

TID = Three divided doses; BID = Two divided doses; QD = Single daily dose.* Based on individual patient response and tolerability. a Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.

b Supplementary dose is a single additional dose.Overdosage For management of a suspected drug overdose, contact your regional Poison Control Centre.Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans: The highest known dose of pregabalin received in the clinical development program in which there was no fatal outcome was 15,000 mg in 1 patient. The types of adverse events experienced by patients who received an overdose were not clinically different from other patients receiving recommended doses of pregabalin. In post-marketing experience, fatal outcomes in cases in which pregabalin has been taken in combination with other medications have been reported with a pregabalin overdose as low as 800 mg in a day. In none of these cases has pregabalin been established as the cause of death or in pregabalin monotherapy. The lowest fatal dose with pregabalin alone has not yet been identifi ed.The most commonly reported adverse events observed when pregabalin was taken in overdose (dose range from 800 mg/day up to 11,500 mg as a single dose) included affective disorder, somnolence, confusional state, depression, agitation, and restlessness. Treatment or Management of Overdose: There is no specifi c antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. A Certifi ed Poison Control Center should be contacted for up-to-date information on the management of overdose with pregabalin.Hemodialysis: Standard hemodialysis procedures result in signifi cant clearance of pregabalin (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient’s clinical state or in patients with signifi cant renal impairment.Availability of Dosage Forms LYRICA is available in dosage strengths of 25 mg, 50 mg, 75 mg, 100 mg*, 150 mg, 200 mg*, 225 mg, and 300 mg capsules.* Not commercially available in CanadaFor a copy of the Product Monograph or full Prescribing Information, please contact: Pfi zer Canada Medical Information at 1-800-463-6001 or visit www.pfi zer.ca.


OFFICE SPACE AVAILABLE

Ajax — Harwood & Taunton: Profes-sionally renovated medical office space for lease or sublease. 1,600 sq. ft. Seven exam rooms, two private offices, two bathrooms, reception and waiting room. Beside dentist and pharmacy. 100 pa-tients on waiting list.Contact: Renu AnandappaTel. 416.732.6220

Bayview and Elgin Mills: New medi-cal space available with Shoppers Drug Mart within property. Leasehold im-provements and rent subsidy available.Contact: LorraineTel. 905.882.2320

Boxgrove Medical Centre — now open: Four-storey, 60,000 sq. ft. medi-cal building located at the 9th Line and Highway 407. Prime medical space available for lease. X-ray, lab, rehab and urgent care on-site. Contact: HowardTel. 416.357.7509

Dufferin/Clark: A turnkey medical office up to 2,500 sq. ft. Great location, four exam rooms and a reception, free parking. Beside dentist, physiothera-pist, dietician, and a pharmacy. Dense

residential and commercial area. Contact: HanyTel. 647.501.4269

Exci t ing opportuni ty avai lable for young energetic group of fam-ily MDs to practise near downtown Toronto. Close access to TTC. Bloor and Islington — ideal for a walk-in/family practice set-up. Street access, very v is ib le on major intersect ion inside a fully furnished medical build-ing wi th MD spec ia l t ies , lab and X-ray. Call for serious inquiries.Contact: JohnTel. 416.818.8373E-mail: [email protected]

Free rent: Family physicians in Toronto needed! Furnished office. Eight exam rooms. Medical building at busy inter-section.Contact: JoeTel. 416.564.7585

Mississauga — excellent medical office for family physician: Fully fur-nished recently renovated suites with private underground free parking. Great location in a medical centre, close to Credit Valley and Trillium Hospitals in a densely populated residential and com-mercial area. Lab services, physiother-

apist, and pharmacy on-site. Low rent and relocation incentives.Tel. 416.587.9430

Office space in North York: Part-time family doctor looking for another part-time family doctor or specialist to cost-share office space. Located in modern medical building with free parking and easy subway access at Yonge/Finch.Contact: Dr. Todd LevyTel. 416.573.8339E-mail: [email protected]

PAR-Med Realty Ltd.: Specializing in medical office building leasing, prop-erty management, and building sales. We have over 70 medical office build-ings in our portfolio throughout On-tario. For leasing inquiries:Contact: Brad StoneburghTel. 416.364.5959, ext. 403E-mail: [email protected]: www.par-med.com

Two rooms to rent within 3,500 sq. ft. medical clinic in Bayview/Richmond Hill. Ideal for medical specialist, psychiatrist, internist, and surgeon.Contact: Dr. Lorne KlimanTel. 647.284.3759E-mail: [email protected]

66 March 2011

Classifieds

Following are the classified

advertising deadline dates

for the next six issues.

I S S U E D E A D L I N E

May 2011 April 11

June 2011 May 10

July/August 2011 June 10

September 2011 August 10

October 2011 September 9

November 2011 October 10

GENERAL INFORMATIONAdvertisements are accepted by mail, e-mail

or fax. Copy deadline, notice of cancellation

and/or changes to existing advertisements

must be submitted in writing no later than the

10th of the month prior to the month of publi-

cation. A proof copy of your classified ad will

be faxed to your attention for approval prior to

publication.

Payment: Payment is accepted by VISA, Mas-

tercard or American Express. Please provide

credit card information by phone only to Marga-

ret Lam at 416.340.2263 or 1.800.268.7215,

ext. 2263, at time of booking.

Rates: $50 for first 4 lines (minimum), each line

approximately 35 characters; $5 per line there-

after; $5 for each line of contact information.

Spot colour billed at $20 per issue.

Send advertisements to:Margaret Lam

Ontario Medical Association

150 Bloor Street West, Suite 900


Tel. 1.800.268.7215, ext. 2263 or

416.340.2263

Fax: 416.340.2232


The Ontario Medical Review is required to com-

ply with the provisions of the Ontario Human

Rights Code 1990 in its editorial and advertis-

ing policies, and assumes no responsibility or

endorses any claims or representation offered

or expressed by advertisers.

Added Value Classified ads are posted online https://www.oma.org/Pages/OntarioMedicalReview.aspx and accessible to OMA members and the

general public.

A Classified Advertisement Insertion Order Form is posted online: www.oma.org/Resources/Documents/AdOrder.pdf


Yonge and Major Mackenzie: Opposite to York Central Hospital medical offices for sale/rent. Newly decorated six to 11 exam rooms with reception and waiting room. Busy location with free parking. Ideal for physician, specialist, and dentist.Contact: Sam HuiTel. 647.833.8266

Yorkville (Holt Renfrew Centre) — Möcelle OfficeMD™ provides luxury furnished small medical offices/rooms and virtual clinics at a prestigious ad-dress. Möcel le Off iceMD™ means instant prestige for your practice and access to some of Canada’s most af-fluent individuals. Rent the number of rooms you need, only on the days you need, with shared waiting room and restrooms. Enjoy the benefits of a full-service office without the capital outlay, hassles and overhead. Featuring on-demand nursing/admin. support staff, appointment booking, file storage, mail/fax handling, printing and photocopy-ing. Rooms available from $150/day and virtual clinics from $395/month. To schedule a viewing:Tel. 416.964.6150 E-mail: [email protected]

REAL ESTATE

Disney/Orlando real estate: Un believ- able buying opportunit ies, former Ontario resident. Contact: Kathy JaworskiCozy Homes Real Estate, Inc.Tel. 352.223.3389E-mail: [email protected]

Limited Partnership opportunity: Tri-Star Living Inc. is eastern Ontario’s leading provider of retirement home real estate developments. ROI 10% plus. Limited Partnership. Minimum invest-ment $150,000.00. Closing March 31, 2011.Contact: J.C. GodardTel. 613.534.8400 or 1.877.524.6327Website: www.riverdaleterrace.ca

Mississauga office/home/property for sale: Large 1,500 sq. ft. profes-sional office attached to a 2,000 sq. ft. private residence with pool. On-site parking for 10+ cars. Excellent invest-ment potential. Contact: Karen Moore or John Howse via websiteWebsite: www.3197DixieRoad.com

New hospital. New lifestyle. New price: Fabulous country executive home. See it. Love it. Buy it. Website: www.Egroup2.com

FOR RENT

Attention Florida snowbirds/families/golfers! MD-owned three bedroom, 1,250 sq. ft. luxurious townhome in gated resort, five miles to Disney. Peace-ful, five-year new resort. All amenities, including private spa pool backing onto a large pond with walking path. Includes clubhouse facilities and free long dis-tance calls to Canada/USA. Owner direct rates: US $750 one week, $1,400 two weeks (tax included). E-mail: [email protected]: www.privatevacationhomes.com/slideshow_yl3133.html

LOCUM TENENS

Locum for solo practice: June 6-24, or any part of. Lovely office, excellent secretary. Islington and Bloor, Toronto.E-mail: [email protected]

POSITIONS WANTED

Rehabilitation on-site: Looking to pro-vide on-site rehab in a walk-in or medical clinic to give physical rehabilitation and generate additional revenue for clinic.E-mail: [email protected]

POSITIONS VACANT

70:30 split or better: South Ottawa. Fam-ily medicine or specialists. Flexible sched-ule, full EMR, excellent nursing and resi-dent support, full time, part time or locum, and opportunity of joining FHO. Enjoy life, earn a phenomenal wage, get home for a hot meal and stop fretting about stuff! Let us do all the administrative work. Contact: FaizaTel. 613.692.5433E-mail: [email protected]

$200/hour: GP required immediately at Mississauga outpatient clinic. Hours: 8 a.m. to 11 p.m. seven days a week.Contact: AngelaTel. 905.272.5200

$250 per hour minimum: Pediatrician, internist, surgeon, subspecialist in busy outpatient clinic in Mississauga.Contact: Dr. SteinTel. 416.464.0238

Atikokan, Ontario: The canoeing capi-tal of Canada is recruiting family physi-cians to join our present group of five. Situated in northwest Ontario, we are an entry point for Ontario’s wilderness Quetico Park. Come and enjoy Atiko-kan’s community spirit, recreational opportunities, and numerous lakes for fishing and swimming. Atikokan is a rural family practice, working collaboratively with the Atikokan Family Health Team. We use an electronic medical record and our practice includes inpatient hos-pital care and emergency department work. Atikokan’s accredited hospital has PACS, video-conference technology and Meditech access. Family physicians are funded by the RPNGA. We are also seeking locum physicians, funded by HealthForceOntario’s locum program.Contact: Dr. John Fotheringham, Chief of StaffTel. 807.597.4215, 807.597.2721 (clinic)E-mail: [email protected]: www.aghospital.on.ca

67 March 2011

Classifieds

Added Value for

Classified

Advertisers

Classified advertisements

published in the


are also posted online

at no additional charge.

For more information,

please contact:

Margaret Lam

Classifieds Co-ordinator

Tel. 416.340.2263 or

1.800.268.7215,

ext. 2263

E-mail:

[email protected]


Bayview/Richmond: Busy clinic seeks part-time or full-time MD. FHG. Bonus available.Contact: Dr. Lorne KlimanTel. 647.284.3759E-mail: [email protected]

Brampton, Ontario: Full-time/part-time family physicians and GP psy cho thera-pist required for busy family practice/walk-in clinic. Attractive modern office. Option to join FHG. High fee-for-service split or flat monthly rate. Best EMR.Tel. 416.949.3830Fax: 647.340.2586E-mail: [email protected]

Brampton/south Etobicoke medical centres seeking GPs and specialists. Walk-in shifts and family practice. F/T or P/T. Relocate or start a new prac-tice. EMR or paper. Turnkey. Tel. 647.403.1810 E-mail: [email protected]

Brockville: Full-time general radiolo-gist position available immediately. You will be one of four (three FTE). New, fully digital department (2003). CT, fluoros-copy, U/S and bone densitometry. FFD mammography performing general and OBSP screening. VR frontend and back-end reporting (Dictaphone Powerscribe). 70,000 exams (2008/09), (www.bgh-on.ca). Brockville is a community of 22,000 located on the St. Lawrence River, in the beautiful Thousand Islands region; 45 minutes east of Kingston, and one hour south of Ottawa. Contact: Dr. Jonathan Lasich Medical DirectorTel. 613.345.5645, ext. 1256E-mail: [email protected]: Carlene MacDonald Physician RecruiterE-mail: [email protected]: www.brockville.com

Busy walk-in clinic: Weston Road at Hwy. 401 – 10 to 12 patients/hour. Very competitive split. P/T or F/T. Contact: Dr. Howard GoldmanTel. 647.458.2541Fax: 416.240.8870E-mail: [email protected]

Doctors needed: New office/retail plaza in New Hamburg/Baden. Established location. Units sized to suit. Completion May 2011.Tel. 905.881.0994E-mail: [email protected]

Downsview, Ontario: Paperless com-puterized new clinic in a medical build-ing with pharmacy, lab and X-ray. No set-up cost. Part time or full time. Move existing practice or build up from walk-in clinic. Support staff for EKGs, PFTs, venipuncture for income supplement. Contact: Mr. SamuelTel. 647.400.0401

Downtown Toronto medical centres seeking family physicians, pediatricians, and specialists. Two beautiful and spa-cious clinics within “in-demand” down-town neighbourhoods, full EMR with wonderful facilities. One clinic is located steps from downtown teaching hospitals with potential for large referral base. Re-locate or start a new practice. Attractive split, first three months of overhead nego-tiable. Come join a brand new innovative form of health-care delivery with our team.Tel. 416.591.3900E-mail: [email protected]

East York, Toronto: Just starting your medical practice? Returning to practice in Ontario? Upgrading your offices? We need family health practitioners plus re-lated specialists in the East York/TEGH area, for our 40,000 sq. ft., one-storey renovated building. Occupancy Janu-ary 2011 – 220 free parking spaces – national pharmacy and labs in place. Contact: Trevor Jones Tel. 416.750.4645, ext. 27E-mail: [email protected]

Etobicoke, Ont. — recruiting family and walk-in physicians for extremely busy clinic for regular shifts. Competitive split. EMR, no administrative worries. Very pleasant and easy to manage patient population.Contact: Clinic DirectorTel. 416.742.9449E-mail: [email protected]

Exciting opportunity available for young energetic group of family MDs to practise near downtown Toronto. Close access to TTC. Bloor and Islington —ideal for a walk-in/family practice setup. Street access, very visible on major inter- section inside a fully furnished medical building with MD specialties, lab and X-ray. Serious inquiries, please call.Contact: JohnTel. 416.818.8373E-mail: [email protected]

Family and walk-in doctor: Locum/ part time/full time. Instant full practice. Extremely busy! Congenial colleagues and low overhead (20%). EMR, FHG, partnership option, >700K billing for a five-day work week. Contact: Thomas VanTel. 647.227.5088E-mail: [email protected]

Family physician looking to take over existing practice or replace retiring physicians in west GTA (Mississauga/Brampton/Oakville).Tel. 416.837.3323

Full-time or part-time medical doctors required for a busy walk-in located in downtown Mississauga. Contact: AdelTel. 416.904.2929 or 905.897.6160 (office)

GP needed for Spanish and Portu-guese speaking patients in two locations in the GTA. Terms negotiable. Tel. 416.749.2084 or 905.270.2713Fax: 905.270.3626

Internal medicine and/or subspecial-ties required immediately for outpatient coverage in Mississauga. FT/PT/locum. No on-call. Top take-home pay.Contact: Dr. SekelyTel. 416.464.0238

Kitchener — new walk-in clinic, mod-ern with full EMR and RN support. High volume with a variety of shifts available.E-mail: [email protected]

Loblaws Superstore: North York walk-in clinic/family practice located inside Loblaws requires family physician/ pediatrician. Flexible hours and very attractive split.Tel. 416.546.3393

68 March 2011

Classifieds

OMR Ads Hit Home!

Reach 29,000+

physicians, residents

and medical students

every issue.


Magna International Inc. is seeking full-time and part-time family doctors to join its new community clinic. Located on the Magna International campus in Aurora, Ontario, this brand new 1,800 square foot facility is state-of-the-art and can accommodate three full-time health practitioners. This practice-man-aged facility will be open to the general public and Magna employees for ser-vices. The facility is equipped to provide primary care services, occupational health services, and sports and injury management. We welcome established physician practices to relocate or new physicians to start their practice with us. Relocation and practice subsidies will be available for the right candidates. Call for a viewing of the facility or to obtain more information about the practice model, hours of operation, or scope of services.Contact: Arif BhimjiTel. 905.726.7240E-mail: [email protected]

MedVisit Doctors Housecall Service: Greater Toronto or Ottawa. PT or FT. New higher OHIP fees and housecall bonuses now in effect. Flexible shifts. Drivers available. Contact: Dr. BurkoTel. 416.631.0298E-mail: [email protected]: www.medvisit.ca/doctors

Mississauga central location: Family physician (F/T, P/T). Immediate require-ment for very busy established family practice/walk-in clinic, EMR, lab, FHG. Ideal for a doctor wanting to move exist-ing practice or develop a new practice.Contact: RafayTel. 416.821.2300

Mississauga — Malton/Brampton: Two locations seeking GPs, special-ists, walk-in shifts or family practice. F/T or P/T. EMR or paper. Turnkey op-eration.Tel. 647.278.5358 or 905.565.5866E-mail: [email protected]

North Etobicoke — walk-in clinic: Flexible hours. Work as much or as little as you wish.Tel. 416.834.2807E-mail: [email protected]

Obstetrician/gynecologist — full time/part time: Instant full practice in a group of 14 GPs and 20 plus spe-cialists. Extremely busy. Congenial colleagues and low overhead. EMR, PACS.Contact: Thomas VanTel. 647.227.5088E-mail: [email protected]

Opportunity for doctors FT/PT: Build your practice in brand new medical clinic, 2,000 sq. ft. located in a busy residential area in Mississauga/Oakville. Pharmacy next door. Split or lease. Tel. 416.219.3191

Opportunity in Richmond Hill & mid-town Toronto, Ontario: Well-estab-lished family practice seeking physician full time or part time. Walk-in shifts also available. No financial commitments, clinics are fully EMR integrated (EMR training included). On-site lab. Above-average compensation package. Tel. 905.884.1017 (direct office line)E-mail: [email protected], [email protected]

Ottawa Centre East: Sunshine Medical Clinic is looking for physicians. Join us. Low overhead. EMR.Tel. 613.695.9001E-mail: [email protected]

Ottawa — family medicine: Full-time or part-time positions available in an attractive building in a beautiful new community. Free parking. Contact: Dr. AshikianTel. 613.822.0171 (9 a.m. to noon, or 1 p.m. to 3 p.m., Monday to Friday)Fax: 613.822.1838E-mail: [email protected]

Physician needed — enjoy medicine more: Enjoy medicine again! If you have an interest in this important clinical area, we would like you to join our busy clinic. We need family doctors, GPs, GP psychotherapists, psychiatrists, semi- retired, part time or full time. We are open weekends and weeknights. We provide comfortable offices, profes-sional staff, excellent financial arrange-ments, professional supervision, and CME programs are available.Contact: Dr. Michael ParéTel. 416.229.2399 or 1.888.229.8088Website: www.medicalpsychclinic.org

Psychiatrists, medical psychothera-pists are needed at a busy private men-tal health clinic. Contact: Sue Tel. 416.778.1496

Richmond Hill, Ontario: Richmond Hill After-Hours Clinic requires phy sicians for daytime shifts 9 a.m. to 5 p.m., as well as evenings and weekends. Guaranteed minimum 70:30 split. Con tact: Dr. Ian ZatzmanTel. 905.884.7711Fax: 905.553.5360E-mail: [email protected]

Scarborough, Ontario: F/T, P/T family physicians required for medical clinic serving mainly Cantonese and Man-darin speaking seniors. Open to public. Pharmacy on-site.Contact: Martin ChaiTel. 416.299.0555, ext. 12E-mail: [email protected]

Specialists — Brampton, Ontario: Dermatologist, pediatrician, internist, and psychiatrist required for medical centre with several GPs and large pa-tient base. Attractive modern office with seven days/week reception service. Fee-for-service split or low flat monthly rate. Tel. 416.949.3830Fax: 647.340.2586E-mail: [email protected]

Toronto — St. Clair/Dufferin: Physician needed one to two days per month for se-niors’ independent living apartments. Time negotiable. Office space free of charge.Contact: Marilyn GitsidisTel. 416.654.2265Fax: 416.654.0943E-mail: [email protected]: www.hellenichome.org

Toronto — Yonge and Davisville: Fam-ily physician needed – FT/PT. Medical building central location, on subway line. EMR, FHO model.Tel. 416.486.8444E-mail: [email protected]

Vaughan — specialist: Full-time or part-time opportunity for a consultant physician in a pediatric office. Brand new medical building with ancillary services on-site. Turnkey operation. Staff and EMR provided. Available March 1, 2011.Contact: AdrianaTel. 905.303.3448E-mail: [email protected]

69 March 2011

Classifieds


PRACTICES

Bathurst and Bloor: Family practice with 6,000 active patient files, in a busy medical centre, in front of subway, bus, and streetcar stations. Available from June 2011. Call for further information. Contact: Mrs. Hoang Tel. 416.533.5882 or 416.205.9991 or 416.879.5881Fax: 416.205.9991

Family physician wanted to take over a busy downtown practice: Located in a medical building with lab, X-ray/ultra-sound, and several specialists avail-able. Present physicians will be retiring from this practice end of June 2011, but if interested, space could be available earlier on a part-time basis. For further details if interested, please call. Contact: Dr. Michael Soboloff Tel. 416.537.2527Fax: 416.537.1280E-mail: [email protected]

Keele and Lawrence: Busy obstetrics and gynecology practice for sale with hospital privileges.Tel. 416.967.0761

SERVICES AVAILABLE

Arya & Sher, health lawyers: Prac-tice focused on representing medical practitioners, clinics, hospitals, and health-care companies. Business and regulatory issues, including professional incorporations, business registrations, contracts, partnership/shareholder issues, tax and estate planning, employ-ment, leasing, medical real estate, and regulatory matters. Contact: Kashif Sher, LLB, MBATel. 416.218.8373E-mail: [email protected]: www.aryasher.com

Bil l ing agent — electronic data transfer to MOHLTC for all practices, specialties and locums. Medical Bill-ing and Secretarial Services.Contact: Edith ErdelyiTel. 416.576.6788

Experienced insurance broker spe-cializing in disability income, critical ill-ness, long-term care and life insurance programs, as well as financial, tax and planned giving consultations. We are proud of the ongoing service we have provided to our clients for over 25 years.

Contact: James CorriganTel. 1.866.235.1754, ext. 23Website: www.thelivingbenefitsgroup.com

Free record storage for closing prac-tices: RSRS is Canada’s leading paper and digital storage provider. No prohibi-tive fees to patients. Physician managed since 1997. Tel. 1.888.563.3732, ext. 221 Website: www.RSRS.com

Going EMR? Need to scan your pa-tient records? We can find you an af-fordable solution that fits your budget. For more information and many refer-ences:Contact: Sid Soil, DOCUdavit SolutionsTel. 1.888.781.9083, ext. 105E-mail: [email protected]

How would your practice run…if your computer(s) crashed? Got your patient database and computer(s) backed up? We’ll come right to your office and do it! You get an external hard drive and a complete backup of all your data for only $599! Many computer services of-fered! Don’t wait until disaster strikes! Serving York Region and area. Profes-sional references available + 25 years of computer experience.Contact: BarryTel. 416.400.4000Website: www.siteclick.ca

Jonathan Ruben Prof. Corp. — GTA: Chartered accountant firm offering high level accounting and tax services for sole practitioners and professional corps.Contact: Jonathan Ruben CA, CPA (MI, NY, IL), CFPTel. 416.487.3000, ext. 225E-mail: [email protected]: www.jruben.com

Medical Transcription Services: Tele-phone dictation and digital recorder files. PIPEDA compliant; excellent qual-ity, next business day service. All spe-cialties, patient notes, letters, reports, including medical-legal and IME reports.Tel. 416.503.4003 or 1.866.503.4003Website: www.2ascribe.com

Moving or moved to EMR? Still have lots of paper? RSRS scans your records and offers full electronic access to your active patient records. It’s easier than you think. PHIPA compliant. Contact: RSRS

Tel. 1.888.563.3732, ext. 221 Website: www.RSRS.com

Retiring, moving or closing your practice? Physician’s estate? DOCU-davit Medical Solu tions provides free paper or electronic patient record stor-age with no hidden costs. Contact: Sid Soil, DOCUdavit SolutionsTel. 1.888.781.9083, ext. 105E-mail: [email protected]

UPCOMING EVENTS

Alaska CME cruise: August 19-26 Cardiology & occupational medicine. 15 hours CME. Companion cruises free. Contact: Sea Courses CruisesTel. 1.888.647.7327E-mail: [email protected]: www.seacourses.com

Alaska CME cruise: July 10 -17 Endo-crinology & sports medicine. 15 hours CME. Companion cruises free. Contact: Sea Courses CruisesTel. 1.888.647.7327E-mail: [email protected]: www.seacourses.com

Blue Mounta in CME f rom Ju l y 11-14, 2011. Fantastic family holiday. Get a rock-solid foundation in medical CBT (cognitive behaviour therapy), and provide more effective psychological care within your standard-length appoint-ments. Earn 12.0 Mainpro-C credits. Contact: CBT Canada Tel. 1.877.466.8228E-mail: [email protected]: www.cbt.ca Doctors Against Racism & Antisemi-tism (DARA) annual medical confer-ence. Topic: Disaster Medicine and Hu-manitarian Missions. Lessons learned from international experience. Sunday, April 3, 2011, 1 p.m. to 4:30 p.m. Health Sciences Building, University of Toronto, 155 College Street, 6th Floor. Special guest speakers: Dr. Ofer Merin, Dr. Ber-nie Goldman, Dr. Peter Chu, Dr. Sandy Buchman, a representative of DART, Canada’s Military Disaster Assistance Response Team. CME accreditation pending. Physicians/dentists $25, gen-eral admission $20, students free. DARA AGM to follow 4:30 p.m. to 5:15 p.m.Register by phone or via website. Tel. 416.966.0722Website: www.daradocs.org

70 March 2011

Classifieds


Classifieds

Disney World CME at the Grand Floridian Resort & Spa from December 19-22, 2011. Located in the heart of Disney World. Get a rock-solid founda-tion in medical CBT (cognitive behav-iour therapy), and provide more effective psychological care within your stan-dard-length appointments. Earn 12.0 Mainpro-C credits. Contact: CBT Canada Tel. 1.877.466.8228E-mail: [email protected]: www.cbt.ca Europe CME cruise aboard the top- rated Disney Magic from August 20 -27, 2011. Companion cruises free. Quality Disney childcare from 3 months up. Get a rock-solid foundation in medical CBT (cognitive behaviour therapy), and pro-vide more effective psychological care within your standard-length appoint-ments. Earn 12.0 Mainpro-C credits. Contact: CBT Canada Tel. 1.877.466.8228E-mail: [email protected]: www.cbt.ca

Las Vegas CME at the spectacular Palazzo from September 22-24, 2011. World’s largest five-diamond resort, in-cluding a 134,000 sq. ft. Canyon Ranch Spa. Get a rock-solid foundation in medi-cal CBT (cognitive behaviour therapy), and provide more effective psychological care within your standard-length appoint-ments. Earn 12.0 Mainpro-C credits. Contact: CBT Canada Tel. 1.877.466.8228E-mail: [email protected]: www.cbt.ca

Mediterranean CME cruise: Sep-tember 5-17 Spain, France, I ta ly, Croat ia, Montenegro. Cardiology, geriatric psychiatry, physician health, practice management. Accredited for 22 hours CME. Companion cruises free. Contact: Sea Courses CruisesTel. 1.888.647.7327E-mail: [email protected]: www.seacourses.com Niagara-on-the-Lake CME f rom September 8-10, 2011. Shaw Fes-tival, wine tasting, gourmet dining. Get a rock-solid foundation in medi-cal CBT (cognitive behaviour therapy), and provide more effective psycholog-ical care within your standard-length appointments. Earn 12.0 Mainpro-C credits.

Contact: CBT Canada Tel. 1.877.466.8228E-mail: [email protected]: www.cbt.ca

North York General Hospital’s 24th Annual Emergency Medicine Update 2011: May 5-7, 2011 at the Royal York Hotel in Toronto. Canada’s leading EM educators giving practical updates to clinicians. Extended hands-on work-shops (central lines, ultrasound, oph-thalmology, advanced suturing, cast-ing, etc), “How the Experts Think” and “5 Things You Need to Know” lecture series...over 60 great sessions to choose from. Plus special pre-conference courses (EDE, EDE2, HIC, CASTED, ACLS, and more). Priority seminar

selection plus early bird discount if you sign-up now. E-mail: [email protected]: www.emupdate.ca (for further details and registration)

FOR SALE

Office furnishings: Oshawa solo ortho-pedic practice has closed. Top quality excellent condition furnishings for sale: reception area, two examining rooms, secretary area, doctor’s desk and cre-denza; filing cabinets. All for $2,500 or buy individual items. Cash and carry. See pictures by e-mail. Contact: Leon Tel. 905.263.2212 E-mail: [email protected]

Publisher’s Notes (continued from page 5)

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Current display advertising rate card, effective January 1, 2011, available on request.

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1599 Hurontario Street, Unit 301, Mississauga, Ontario L5G 4S1

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“Is there a file compression program that will help me squeeze 12 hours of work into an 8 hour schedule?”

Advertisers’ Index

A&L Computers ................................. 11

Arya & Sher Health Lawyers ............... 27

AstraZeneca .................................36-37

Boehringer Ingelheim ......................OBC

EPC Medical Billing Seminar .............. 42

Grant Thorton LLP ............................. 35

Klinix Software ................................. IFC

Merck Frosst Canada ....................... 2,6

Novartis .............................................. 4

OMA Advantage Partner Discount

Program .......................................... IBC

OMA CME Locating Service .............. 29

OMA Corporate Hotel

Directory .................................12,34-35

OMA Insurance Services ................... 40

OMA Legal Services ............................ 9

OMA Physician Health Program ......... 43

OMA Physician’s Guide to Third Party

and Other Uninsured Services ........... 27

OMA Pregnancy and Parental Leave

Benefit Program ................................ 48

OMA Response Centre...................... 32

OMA Women’s Health and

International Medicine ........................ 33

OMR Added Value .............................. 67

OMR Classifieds ................................. 11

OMSBF 7th Annual Fundraising

Golf Tournament ................................. 46

OntarioMD .......................................... 31

Ontario Psychiatric Association ........... 27

Optimed Software ............................... 51

Pfizer Canada .......... 3,9,12-13,18-19,41

Record Storage & Retrieval Services .... 25

Safe Stor Records Management ........ 49

Section on General & Family Practice ....9

Torkin Manes LLP ............................. 11

Prescribing Information:

Ativan.............................................56-57

Caduet ................................................ 63

Lyrica .............................................64-65

Pradax ...........................................58-62

Vimovo ..........................................52-55

72 March 2011ONTARIO MEDICAL REVIEW

Take Advantage of the OMA’s growing team of affinity partners.

OMA Advantages is the OMA affinity partner program providing special offers and services. It is designed exclusively for all OMA members.

Visit www.oma.org/Advantages to learn more about this new program and how it can benefit your personal and professional life.

www.oma.org/Advantages


WITH PRADAXPREVENT STROKE HELP

AND SYSTEMIC EMBOLISM

NOW INDICATED FOR THE PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH ATRIAL FIBRILLATION, IN WHOM ANTICOAGULATION IS APPROPRIATE.1

NEW PrPRADAX™ 150 mg BID

PRADAX (dabigatran etexilate) is indicated for the prevention of stroke and systemic embolism in patients with atrial fi brillation, in whom anticoagulation is appropriate. PRADAX is contraindicated in patients with: severe renal impairment (CrCL <30 mL/min); hemorrhagic manifestations, bleeding diathesis, or patients with spontaneous or pharmacological impairment of hemostasis; lesions at risk of clinically signifi cant bleeding, e.g. extensive cerebral infarction (hemorrhagic or ischemic) within the last 6 months, active peptic ulcer disease with recent bleeding; concomitant treatment with the strong P-glycoprotein (P-gp) inhibitors, i.e. oral ketoconazole, and with known hypersensitivity to dabigatran, dabigatran etexilate or to any ingredient in the formulation or component of the container. Bleeding is the most relevant side effect of PRADAX; bleeding of any type or severity occurred in long-term treatment in 16.5% of patients with atrial fi brillation treated for the prevention of stroke and systemic embolism. As with all anticoagulants, PRADAX should be used with caution in circumstances associated with an increased risk of bleeding. Bleeding can occur at any site during therapy with PRADAX. An unexplained fall in hemoglobin and/or hematocrit or blood pressure should lead to a search for a bleeding site. Patients at high risk of bleeding should not be prescribed PRADAX. Close clinical surveillance (looking for signs of bleeding or anemia) is recommended throughout the treatment period, especially if risk factors are combined. Should severe bleeding occur, treatment with PRADAX must be discontinued and the source of bleeding investigated promptly. Patients who develop acute renal failure must discontinue PRADAX. In patients who are bleeding, an aPTT test may be useful to assist in determining an excess of anticoagulant activity, despite its limited sensitivity. An aPTT >80 sec at trough, i.e. when the next dose is due, is associated with a higher risk of bleeding. Agents that may enhance the risk of hemorrhage should not be administered concomitantly with PRADAX, or, if necessary, should only be administered with caution. Treatments that should NOT be administered concomitantly with PRADAX due to increase in bleeding risk include: unfractionated heparin and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux, bivalirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, sulfinpyrazone and vitamin K antagonists such as warfarin. The concomitant use of PRADAX with the following treatments has not been studied and may increase the risk of bleeding: rivaroxaban, prasugrel and the strong P-gp inhibitors itraconazole, tacrolimus, cyclosporine, ritonavir, tipranavir, nelfi navir and saquinavir. Unfractionated heparin may be administered at doses necessary to maintain a patent central venous or arterial catheter. In patients with atrial fi brillation treated for the prevention of stroke and systemic embolism, the co-administration of oral anti-platelet (including ASA and clopidogrel) and NSAID therapies increases the risk of bleeding by about two-fold (see ACTION and CLINICAL PHARMACOLOGY,

Special Populations, Pharmacokinetic Interactions). If necessary, co-administration of low-dose ASA, i.e. 100 mg daily with PRADAX may be considered for other indications than stroke prevention in atrial fi brillation. The concomitant use of PRADAX with the strong P-gp inducer, rifampicin, reduces dabigatran plasma concentrations. Other P-gp inducers such as St. John’s Wort or carbamazepine are also expected to reduce dabigatran plasma concentrations and should be co-administered with caution. The most common adverse events observed in 1% of PRADAX 150 mg BID patients and 110 mg BID patients was anemia (1.6%, 1.2%), epistaxis (1.1%, 1.1%), gastrointestinal hemorrhage (4.6%, 3.3%), urogenital hemorrhage (1.4%, 1.1%), abdominal pain (2.2%, 2.3%), diarrhea (1.2%, 1.3%), dyspepsia (3.9%, 4.2%) and nausea (1.2%, 1.0%), respectively. Gastrointestinal adverse reactions occurred more often with dabigatran etexilate than warfarin. These were related to dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort) or gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis and gastrointestinal ulcer). Gastrointestinal hemorrhage occurred at a higher frequency with PRADAX 150 mg BID and 110 mg BID (4.6%, 3.3%, respectively) compared to warfarin (2.6%). The underlying mechanism of the increased rate of GI bleeding has not been established.Allergic reactions or drug hypersensitivity including urticaria, bronchospasm, rash and pruritus have been reported in patients who received dabigatran etexilate. Rare cases of anaphylactic reactions have also been reported.Patients at an increased risk of bleeding should be closely monitored clinically. A coagulation test, such as aPTT may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure. For complete prescribing information, please refer to the Product Monograph.* A randomized non-inferiority trial of 18,113 AF patients at risk of stroke. Patients received dabigatran 110 mg BID or 150 mg BID (blinded arm) and adjusted doses of warfarin (unblinded arm).

† Stroke or systemic embolism: dabigatran 150 mg BID (n=6076, no. of events=134) vs. warfarin (n=6022, no. of events=202).

‡ Intracranial bleeding includes adjudicated hemorrhagic stroke, subarachnoid, and/or subdural bleeding.§ Intracranial bleeding: dabigatran 150 mg BID (no. of events=38) vs. warfarin (no. of events=90). References: 1. Pradax Product Monograph. Boehringer Ingelheim (Canada) Ltd., 11/08/10. 2. Connolly SJ et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361:1139–1151. 3. Connolly SJ et al. Newly Identifi ed Events in the RE-LY Trial. N Engl J Med. 2010;363:1875-1876 supp appendix.

Pradax™ is a trademark used under license by Boehringer Ingelheim (Canada) Ltd.

35% reduced risk of stroke or systemic embolism

vs. warfarin1-3*†

Dabigatran 150 mg BID (1.1%/yr) vs. warfarin (1.7%/yr), p=0.0001.

59% reduced risk of intracranial bleeding‡

vs. warfarin1-3*§

Dabigatran 150 mg BID (0.3%/yr) vs. warfarin (0.8%/yr), p<0.0001.

No INR monitoring

or dose titration1

For patients with atrial fi brillation, PRADAX demonstrated:

See prescribing summary on page

BOE9815_01AA_FP_JRNL.indd 1BOE9815_01AA_FP_JRNL.indd 1 2/23/11 10:47:32 AM2/23/11 10:47:32 AM

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