Arkansas Pharmacy Law Update

John Clay Kirtley, Pharm.D.

Assistant Director

Arkansas State Board of Pharmacy

Objectives

• Analyze recent changes in Pharmacy

regulations in Arkansas

• Discuss the reasoning behind changes to

pharmacy regulations

• Have participants demonstrate

understanding of recent pharmacy

regulatory changes and challenges

About the Board of Pharmacy

• The Board licenses:

– Individuals

– Businesses

• The Board tracks over 21 different license

configurations / types

• We have a 3 member administrative team

• We are always busy

• Please remember to be patient and polite…

• Employment change notifications are required

Permits

0

1000

2000

3000

4000

5000

6000

7000

0 4 8 9 1011

RPh

Techs

Bus

• Technician Permits Expire at the end of even years

• Does not include Charity Clinics or NH permits

• Does not include: Preceptor, Immunization, Consultant or Intern permits

State Board of Pharmacy

www.arkansas.gov/asbp

• Board News & Events

• Pharmacist Information - Newsletters

• Forms & Instructions

• Pharmacy Lawbook – Regulation Changes

• Complete – Up-to-Date Lawbook

Board Issues

• Violations of Controlled Substance Laws

– Diversion for Personal Use

– Diversion for Distribution

– Chemical Addictions

• Arkansas Pharmacy Support Group

– The Arkansas Pharmacy Support Group helps

pharmacy professionals who are fighting addiction.

We know how to help, because we've been there. If

you or someone you know has a problem, call:

– The Arkansas Pharmacy Support Group HELP LINE

(870) 636-0923 or http://www.arpsg.org/

Regulation Changes Oct 2010

• Regulation 02 – Pharmacists

• Regulation 04 – Pharmacy

• Regulation 7—Drug Products/

Prescriptions

Regulation 02 – Pharmacists • Allow for consideration of a pharmacist’s practice

history outside a permitted pharmacy when

applying for reciprocity.

• Update language regarding the North American

Pharmacist Licensure Examination to reflect

changes made by NAPLEX and to reflect the period

of validity for a score transfer.

• Update requirements for Board of Pharmacy

accreditation of pharmacist continuing education to

explain requirements for anyone requesting CE so

that the Board can verify participation by

pharmacists.

Regulation 04 – Pharmacy • Clarify that both the pharmacist in charge and the

pharmacy permit holder are responsible for the

security and accountability of controlled

substances. These changes will describe the

different roles of the permit holder and pharmacist

in charge and give examples of appropriate steps

and procedures that pharmacies and pharmacists

may take in order to maintain security over

controlled substances.

Regulation 04 – Pharmacy • Add a section providing guidance on how a

pharmacy may provide prescription medications to

animals as part of a contractual agreement with the

veterinarian.

• Update requirements for the handling of paper

prescription orders by a pharmacy when processed

which will decrease the burdens of maintaining

paper files of these prescriptions.

• Add language requiring hospitals to develop and

routinely evaluate Medication Error Reduction

Plans to identify medication related errors to

increase safety in hospitals.

Regulation 7—Drug Products/Prescriptions • Delete the prohibition on pharmacy compounding

for veterinarian office stock. This will allow

pharmacies to prepare customized medications to

be administered by veterinarians in their practice

which will give veterinarians additional choices to

best treat animals.

• Compounding for office stock for veterinarians is

prohibited, except for compounds to be used in life-

threatening situations where lack of immediate

availability of the product could result in patient harm

and no FDA-approved product is commercially

available.

Proposed Regulation Changes

PUBLIC NOTICE

On June 28, 2011 at 9:30 AM, the Arkansas

State Board of Pharmacy will hold a public

hearing at the Arkansas State Board of

Pharmacy, 101 E. Capitol Suite 218, Little

Rock, AR 72201. The following regulation

changes will be considered

Proposed Regulation Changes

• Regulation 1 – General Operations:

• Regulation 2 – Pharmacists

• Regulation 5 – Long-Term-Care Facilities

• Regulation 7 – Drug Products/

Prescriptions

• Regulation 9 - Pharmaceutical

Care/Patient Counseling

Regulation 1 – General Operations • Change the expiration dates for nursing

home consultant pharmacist permits and

pharmacist preceptor permits to December

31 of odd numbered years. These

changes will cause endorsements on a

pharmacist’s license to expire at the same

time as the pharmacist license in

accordance with Act 597 of 2011.

Regulation 2 – Pharmacists

• Simplify the requirements for pharmacist

interns to work in pharmacies and will also

allow consideration of graduation from a

nationally accredited college of pharmacy

as fully meeting the experiential

requirements to apply for pharmacist

licensure in Arkansas.

Regulation 5 – Long-Term-Care Facilities • Specify that any emergency kits provided

in Arkansas by an out of state pharmacy

must be approved by the Arkansas State

Board of Pharmacy and may be subject to

the same restrictions imposed by their

home state when supplying emergency

kits from Arkansas. This rule is being

adopted in accordance with Act 1019 of

2011.

Regulation 7 – Drug Products/ Prescriptions • Update language regarding the sale of

Schedule V Exempt Products and adding

language specifically related to the selling

of Pharmacist Authorized Drugs such as

pseudoephedrine, ephedrine and

phenylpropanolamine in accordance with

Act 588 of 2011..

Regulation 9 - Pharmaceutical Care/Patient Counseling • Update the age restrictions for

pharmacists to provide pharmaceutical

care to patients seven (7) years of age

and older in accordance with Act 147 of

2011.

CPE Monitor

• The new National Association of Boards of

Pharmacy® (NABP®) CPE Monitor service, a

collaborative effort between NABP, the

Accreditation Council for Pharmacy

Education (ACPE)‚ and their providers, will

allow pharmacists and technicians to

easily track their ACPE-accredited

continuing pharmacy education (CPE)

credits beginning in the latter part of 2011.

CPE Monitor Cont.

• Pharmacists can obtain their ID by

creating an NABP e-Profile using the

portal in the Pharmacists section of the

NABP Web site at

www.nabp.net/pharmacists .

• Visit www.MyCPEmonitor.net for more

information.

Monitor, Secure and Dispose

• Patients should know what they are

taking and how much they have

• Secure their prescription medications

• Properly dispose of prescription drugs.

– www.smarxtdisposal.net

– www.ioit2me.com

Questions?

Arkansas State Board of

Pharmacy

www.arkansas.gov/asbp

(501) 682 - 0190

Post Test Questions

1. When will nursing home consultant

pharmacist permits and pharmacist

preceptor permits expire according to

proposed regulations?

A. May 31 of any odd year

B. May 31 of any even year

C. December 31 of any odd year

D. They never expire

Post Test Questions

2. Under proposed regulation changes for

pharmacy interns, when will the Pharmacist

in Charge need to file affidavits of experience

for students in a college of pharmacy?

A. Prior to May 31 each year

B. Prior to December 31 each year

C. Prior to the student’s graduation

D. Never

Post Test Questions

3. Which OTC medications are included in

regulation changes for Pharmacist

Authorized Medications?

A. Pseudoephedrine products

B. Exempt Schedule V Narcotics

C. Ephedrine products

D. All of the above

Post Test Questions

4. What will the lower age limit be for

patients receiving influenza

immunizations from pharmacists

according to protocols this winter?

A. 18

B. 15

C. 7

D. Any age