Fibromyalgia: A Review

Inside This Issue:

Fibromyalgia:

A Review

Page 2-3

Guidelines for Cou-

madin Therapy:

How Long do we Treat?

Page 4

Red Yeast Rice Ex-

tract and Cholesterol

Management

Page 5

Conclusion:

Fibromyalgia:

A Review

Pages 6-7

Pharmacist Inter-

vention Leads to

Lower Rates of

Medication Errors

Page 8

NMG

Contact

Information

July/August

2012 Neil Medical Group: The Leading

Volume 12, Issue 2

PHARM NOTES

PHARM NOTES Volume 15, Issue 4

July/August

2012 Neil Medical Group: The Leading Pharmacy Provider in the Southeast

Fibromyalgia is a chronic musculoskeletal disorder character-

ized by widespread musculoskeletal pain, stiffness, parasthe-

sias, disturbed sleep, and easy fatigability. It is more common

in women than men, with a prevalence of 3.4% of women in

the United States, and 0.5% of men, making fibromyalgia nine

times more common in women than in men. The incidence of

this disease is increased with age, and occurs in about 7.4% of

women between the ages of 70-

79 years. Original symptoms

generally appear between the

ages of 30 and 50 years. Risk

factors for fibromyalgia include

advancing age, female sex, fam-

ily history, concurrent rheumatic

disease (RA, lupus, ankylosing

spondylitis), and disturbed sleep

patterns (restless leg syndrome,

sleep apnea).

The exact cause of fibromyalgia

is unknown, but several theories

exist to explain the abnormal

pain perception. One possible

cause involves CNS abnormali-

ties and a possible deficiency of serotonin. Other proposed

causes include a deficiency of growth hormone, increased lev-

els of substance P in the CSF, or decreased cortisol response

to stress. It is also thought that autonomic dysfunction may be

a cause of fibromyalgia. Psychological abnormalities may be

to blame in up to 30% of patients.

There are a number of conditions that are commonly seen in

combination with fibromyalgia, including: IBS, chronic head-

aches, chronic fatigue syndrome, temporomandibular joint

pain, and major depressive disorder. Additionally, conditions

such as dysmenorrhea or PMS, RLS, non-cardiac chest pain,

Raynaud’s phenomenon, sleep disorders, and anxiety are also

frequently seen in patients with fibromyalgia. Certain disease

states are also common in fibromyalgia patients, including:

rheumatoid arthritis, Lupus, hepatitis C, HIV, Parovirus B19

infection, Lyme disease, and hy-

pothyroidism.

Signs and symptoms associated

with fibromyalgia include mus-

culoskeletal aches and pains,

stiffness, numbness of hands and

feet, fatigue and exhaustion, in-

somnia, cognitive impairment

with difficulty thinking and loss

of short-term memory, head-

aches or migraines, episodes of

light-headedness, dizziness,

anxiety or depression. Muscu-

loskeletal aches and pains may

occur after only mild exertion,

but there may always be some

degree of pain present, even at rest. Pain is often described as

a burning or gnawing pain, or as a soreness, stiffness or ach-

ing. Pain may begin in one region before it becomes wide-

spread. Stiffness is usually present in the morning, and im-

proves throughout the day. It is not as severe or prolonged as

stiffness associated with RA. Symptoms are often worsened

by stress or anxiety, cold temperature, damp weather, or over-

exertion. Patients may also feel colder overall than others in

the home, and some may experience Continued on page 5

Article by Colleen Summe and Sarah Kraszeski, Pharm D Candidates, UNC School of Pharmacy

Page 2

Guidelines for Coumadin Therapy: How Long Do We Treat?

Neil Medical Group—Pharmacy Services Division

Coumadin is a highly used and well studied drug for use as an anticoagulant in several disease

states. Among these are deep vein thrombo-

sis, pulmonary embolism, and atrial fibrillation.

While Coumadin has been shown to prevent

events such as CVAs and MIs, it has always

been plagued with problems such as drug-

drug interactions, drug-food interactions and

constant monitoring. With this in mind, it be-

comes important to know when to discontinue

Coumadin therapy. Recently, the American

College of CHEST Physicians (ACCP) up-

dated their antithrombotic therapy guidelines

(Feb, 2012). On the following page is a chart

outlining recommendations for duration of

therapy.

There are now several other alternatives to using Coumadin. These include Lovenox®, Pradaxa®,

and Xarelto®. Lovenox® is an injection that Inhibits factor Xa and IIa (thrombin) in the clotting cas-

cade and can be used as “bridge therapy.” Pradaxa® is an oral direct thrombin inhibitor used in

residents with atrial fibrillation to prevent stroke

and embolism. Xarelto® is a factor Xa inhibitor

used for postoperative thromboprophylaxis.

While

these

newer

medica-

tions will not require as much monitoring, they do not have as

much clinical data supporting their use as Coumadin does.

With any anticoagulant, be vigilant in looking for symptoms of

bleeding as these patients are at higher risk. Look for bruis-

ing that is unexplained or does not subside; red or dark urine;

red, black or tarry stools; nosebleeds; or bleeding around the

gums after gentle tooth brushing. With any anticoagulation

therapy, it is important to treat each resident as an individual

and assess the therapy that is most favorable.

Article by Ryan Czmiel, PharmD Candidate

Wingate University School of Pharmacy

“With any anticoagulant, be vigilant

in looking for signs and symptoms

of bleeding as these patients are at

higher risk.”

Neil Medical Group – Pharmacy Services Division Page 3

INDICATION TARGET INR DURATION OF THERAPY

Moderate Intensity Therapy 2.0—3.0

• Prophylaxis of total hip replacement, total knee replacement or hip fracture sur-

gery. New guidelines suggest closer to 35 days for major orthopaedic surgery.

10 to 35 days

• Treatment of deep vein thrombosis (blood clot) or pulmonary embolism (blood

clot in lungs)

3 months

* Due to reversible risk factors (such as obesity, smoking, immobility) 3 months or longer based on risk

factors

* Idiopathic (no clear reason for blood clot) Indefinite

* 2 unprovoked episodes of DVT Indefinite

* Cancer (any type) Indefinite after tx with LMWH

for 3—6 months

• Chronic atrial fibrillation Indefinite

• Cardioversion for atrial fibrillation ≥ 48h or of unknown duration 3 weeks pre and 4 weeks

post cardioversion

• Chronic thromboembolic pulmonary HTN Indefinite

• Antiphospholipid syndrome (a disorder in which the immune system mistak-

enly produces antibodies to normal proteins putting patients at higher risk for

DVT)

Indefinite

• Tissue mitral valve 3 Months

• Tissue aortic or mitral valve and history of or risk factors for thromboembolism 3 months or longer (+/- ASA 81mg

daily)

• Mechanical aortic valve (normal left atrial size and normal sinus rhythm) Indefinite

• Acute anterior myocardial infarction (STEMI – high risk) at least 3 months post STEMI

(with ASA 81mg daily)

High Intensity Therapy 2.5—3.5

• Mechanical mitral valve (St Jude Medical bileaflet valve, Carbomedics bileaflet

valve, Medtronic-Hall tilting disc valve)

Indefinite

• Mechanical aortic or mitral valve with additional risk factors for thromboem-

bolism (atrial fibrillation, hypercoaguable state, left atrial enlargement, low

ejection fraction; add ASA if low risk of bleeding and age ≥ 80)

Indefinite (with ASA 81mg qd)

• Antiphospholipid syndrome with recurrent thromboembolism Indefinite

Very High Intensity Therapy

• Mechanical aortic or mitral valve and systemic embolism despite therapeutic

INR 2.5-3.5

3.0—4.0 Indefinite (+/- ASA 81mg daily)

Neil Medical Group – Pharmacy Services Division Page 4

Red yeast rice is a traditional Chinese medicine that naturally contains several ingredients that may help

control cholesterol levels. These include a number of monacolins, most importantly monacolin K, sterols,

isoflavones, and monosaturated fatty acids. What is so interesting is that monacolin K is also known as

lovastatin, the active ingredient in the prescription drug Mevacor®. Red yeast rice is a substance that has

been extracted from rice that has been fermented with a type of yeast called Monascus purpureus. It is red-

dish or purplish in color and has also been used as a food coloring, additive and preservative. It is used to

color a wide variety of products such as wine, red rice vinegar, Peking Duck and Chinese pastries just to

name a few.

Red yeast rice use can be traced back to the Tang Dynasty in China in 800 AD and was taken internally to

invigorate the body, aid in digestion and revitalize the blood. Studies have shown that red yeast rice (2.4

grams per day) can significantly lower total cholesterol

by 16% and LDL cholesterol by 22% in 12 weeks.

The controversy over the years is that red yeast rice is a

traditional remedy that helps lower cholesterol. How-

ever, the pharmaceutical manufacturer of Mevacor® ar-

gues that it owns the rights to the ingredient lovastatin.

This debate and confusion means that the FDA tries to

control the sale of the supplement in the US and has

asked in the past for some red yeast rice supplements to

be withdrawn from the market because they contained

lovastatin. The FDA cited a risk of severe muscle prob-

lems that could lead to kidney disease.

Despite the controversy, some red yeast rice supple-

ments are still available in the US. The recommended

dose for cholesterol management is unclear and varies

from 1.2 to 2.4 grams per day. The most important thing

to remember is that the amount of red yeast rice extract

can vary greatly from one product to the next. Different

types of fermentation may be used and the ingredients of different brands of red yeast rice extract might

vary so much that it is hard to make firm statements about efficacy and safety.

Side effects reported are mild and include headache, heartburn, and upset stomach. People who have aller-

gies to fungus or yeast should also be cautious when taking red yeast rice extract. Patients taking the fol-

lowing medications need to avoid taking red yeast rice extract: statins, Lopid®, Tricor®, Diflucan®, eryth-

romycin, clarithromycin, protease inhibitors, and cyclosporine.

Due to potential drug interactions, any patient taking red yeast rice extract needs to make their practitioner

and/or pharmacist aware.

Red Yeast Rice Extract and Cholesterol Management

Article by Bobbie Hall, Pharm D, CGP

Consultant Pharmacist, Neil Medical Group

Neil Medical Group – Pharmacy Services Division Page 5

Fibromyalgia: A Review…………………………… …………………………………………….continued from page 1

Raynaud’s-like or true Raynaud’s phenomenon. Many patients

experience improvement during warmer weather or during va-

cation.

Diagnosis of fibromyalgia revolves around the 18 ―tender

points‖ that have been identified with this disease. The practi-

tioner will perform a digital palpation of the tender points, and

if the patient reports that the palpation is ―painful‖ and not just

―tender‖, then the point is considered positive. Subcutaneous

nodules may also be felt at sites of tenderness. Musculoskeletal

and neurologic exams are generally normal, but tenderness is

often not limited to the 18 specific points.

For a diagnosis of fibromyalgia, the patient must have both

pain on digital palpation in at least 11 of the 18 tender point

sites and widespread pain for at least three months in all of the

following areas: left and right side of the body, above and be-

low waist, and axial skeletal pain. Differential diagnosis should

include chronic fatigue syndrome, systemic lupus erythemato-

sus, polymyositis, polymyalgia rheumatica, statin-induced

myopathy, hypothyroidism, sleep apnea and RLS. There are no

laboratory abnormalities that can help diagnose fibromyalgia,

and if laboratory abnormalities are present, other sources

should be investigated. Patients with symptoms of fibromyalgia

should have a TSH level, ESR level, and CBC labs performed

to help with differential diagnosis. Antinuclear Antibodies

(ANA) may be present in people with fibromyalgia, but these

can also be present in the general population.

Treatment of fibromyalgia is a multidisciplinary approach,

which involves mental health, physical therapy, rehabilitation

and medication. The initial goal of therapy is to improve the

quality of sleep. Relief of pain and other symptoms associated

with fibromyalgia should also be attempted. If the patient ex-

periences depression and/or anxiety, these conditions should

also be treated when indicated. Treatment of these conditions

should include psychiatric counseling. Treatment of fibromyal-

gia should also involve regular aerobic exercises and stretching.

Non-pharmacological treatment is an important component in

the management of fibromyalgia. This includes patient support

groups, identification and reduction of life stressors, regular

aerobic exercise, and regular stretching. Local measures such as

heat, massage, steroid injections and acupuncture may provide

temporary relief of pain.

Pharmacologic treatment of fibromyalgia is based on the man-

agement of associated conditions and involves the use of a

number of medications including antidepressants, sleep aids,

benzodiazepines and anticonvulsants. Antidepressants such as

TCA’s (including amitriptyline, nortriptyline, and doxepin)

may help improve sleep disorders. Other medications that may

improve sleep disorders include cyclobenzaprine, trazodone,

and zolpidem. Symptoms of restless leg syndrome can be de-

creased by the use of clonazepam. SSRIs, SNRIs (i.e., duloxet-

ine, venlafaxine) and trazodone are helpful in treating depres-

sion associated with fibromyalgia, while benzodiazepines such

as alprazolam and lorazepam are helpful in treating anxiety. For

the treatment of pain associated with fibromyalgia, anticonvul-

sants such as pregabalin and gabapentin may be effective.

Acetaminophen and tramadol are also useful alternatives. Sali-

cylates (i.e., aspirin) and NSAIDs generally only provide par-

tial relief of pain. Steroids have little benefit and should not be

used due to the side effects associated with this class of medi-

cation. Opiate analgesics should also be avoided.

Ongoing monitoring of symptoms and medication side effects

is important. Complications of fibromyalgia such as sleep dis-

turbances and chronic pain may lead to an inability to perform

in the workplace. Patients may receive an evaluation by a work

evaluation specialist to determine disability in the workplace.

This is a controversial subject because all clinicians do not ac-

cept the diagnosis of fibromyalgia. There is also difficulty in

assessing the patient’s perception of inability to function, and

determination of tender points can be subjective for both pa-

tient and physician.

The prognosis for fibromyalgia is poor due to the fact that there

is currently no cure. However, symptoms may wax and wane,

providing patients with periods of symptom relief. Unfortu-

nately, pain and fatigue may persist for many patients, regard-

less of therapy. Approximately 10-25% of patients are not able

to work in any capacity, while others require modification of

work. Prognosis is especially poor for recovery for most pa-

tients in tertiary medical centers, but better for community-

treated patients.

In summary, fibromyalgia is a chronic musculoskeletal disorder

characterized by widespread pain and tenderness in the joints,

tendons, and other soft tissues. It is linked to fatigue, sleep dis-

orders, headaches, depression and anxiety. Women are affected

more often than men (9:1 ratio), and there is no known preven-

tative measure. Symptoms may persist despite pharmacologic

therapy with antidepressants, anti-seizure medications, anxio-

lytics, and sleep aids.

Neil Medical Group – Pharmacy Services Division

Page 6

Pharmacist Intervention Leads to Lower Rates of Medication Errors

In 1999, the landmark Institute of Medicine

study, “To Err is Human,” estimated that as many as

98,000 Americans die every year from preventable

medication errors. Obtaining a complete and accu-

rate medication history is a job that is vital to the

care of patients in all healthcare settings. Without

this important task performed correctly, the patient

is at risk for medication errors which may affect the

patient in the acute care setting and possibly con-

tinue to affect the patient long-term. Pharmacists

are especially suited to obtain medication histories

based on their education, counseling abilities, over-

all medication knowledge, and ability to recognize

where therapy is lacking or duplicated based on the

patient’s medical history. The majority of medica-

tion reconciliations are performed by nursing staff

that are already overworked and may not have the

ability to identify potential medication related prob-

lems such as drug-drug interactions, side effects,

medications used without an indication, and identi-

fying medications in specific classes that may cause

an allergic reaction based on patient history. Re-

cent studies have shown that pharmacist-led medi-

cation reconciliation decreases error rates while pa-

tients are hospitalized and in transition to other

healthcare facilities.

Rothchild JM, Churchill W, Erickson A, et al.

published an article in the June 2010 Annals of

Emergency Medicine which analyzed medication er-

rors that were prevented by having a pharmacist in

the emergency room to perform medication recon-

ciliations. The primary outcome was medication er-

rors recovered by pharmacists, including errors in-

tercepted before reaching the patient (near miss or

potential adverse drug event), caught after reaching

the patient but before causing harm (mitigated ad-

verse drug event), or caught after some harm but

before further or worsening harm (ameliorated ad-

Neil Medical Group – Pharmacy Services Division Page 7

verse drug events.) The most common medication

classes associated with recovered medication errors

were antimicrobial agents (32.1%), central nervous

system agents (16.2%), and anticoagulant and throm-

bolytic agents (14.1%). The most common error types

were dosing errors, drug omissions, and wrong fre-

quency errors. This study was not developed to ana-

lyze total costs in dollars that were potentially

avoided with reducing the number of medication as-

sociated errors. Another study in the ED, Hayes BD,

Donovan JL, Smith BS, et al., compared the effect a

pharmacist had on a hospital’s medication recon-

ciliation form that was usually filled out by a nurse

and found that pharmacists had significantly less

errors upon completion of the form than the nurses

(3% vs. 59%, p = 0.001). The nurses also recorded sig-

nificantly less allergy documentation than the phar-

macists (79% vs. 100%, p = 0.001).

Medication reconciliations are not only impor-

tant in the acute care setting of a hospital, but also

when patients are transitioning from acute to long

term care. Other settings that an elderly patient can

be transferred to from an acute care setting are a

nursing home, skilled nursing facility, residential

care facility, home care with a home health agency,

and hospice care. Having the most accurate docu-

mentation of medications and medical history to be

transferred with the patient is a very important fac-

tor for the care received after the care transition.

Medication errors, poor communication, and poor

coordination between providers from the inpatient to

outpatient settings, along with the rising incidence

of preventable adverse events, have drawn national

attention. “Partnership for Patients: Better Care,

Lower Costs” was launched by the Obama Admini-

stration to help improve the quality, safety, and af-

fordability of health care. One of the goals of this

partnership is to prevent complications during a

transition from one care setting to another so that all

hospital readmissions would be reduced by 20%

(compared to 2010 data) by the end of 2013. Achiev-

ing this goal requires the help of all members of the

healthcare system in the United States. Having

proper documentation of medications upon entering

a healthcare facility and when leaving is key to re-

ducing errors and preventing readmission due to

complications arising from medication errors. To

read more on this partnership you may access back-

ground information and ways you can pledge to help

by going to http://www.healthcare.gov/compare/

partnership-for-patients/index.html.

Article by Justin Rice, Pharm D Candidate

Wingate University School of Pharmacy

Mooresville Pharmacy

947 N. Main Street

Mooresville, NC 28115

Phone 800 578-6506

Fax 800 578-1672

Kinston Pharmacy

2545 Jetport Road

Kinston, NC 28504

Phone 800 735-9111

Fax 800 633-3298

Pharm Notes is a bimonthly publication by Neil Medical Group Pharmacy Services Division.

Articles from all health care disciplines pertinent to long-term care are welcome. References

for articles in Pharm Notes are available upon request. Your comments and suggestions are

appreciated. Contact:

Cathy Fuquay (cathyf@neilmedical.com)

1-800-862-4533 ext. 3489

Note: Periodically, we are asked to add a name to our distribution list. At this time, copies of

Pharm Notes newsletters are distributed in bulk to Neil Medical Group customers only.

Neil Medical

Group

Pharmacy Services

Greetings to all the PharmNotes “family”,

I am dedicating this issue of PharmNotes to my new grandson, Mason Cole Matthews, who was

born on May 22nd, 2012 at 23 weeks and 5 days gestation, weighing 1 lb and 5 oz. The last 14

days have been a blur, full of ups but also full of many downs. I have heard the NICU team

very matter-of-factly lay out statistics and they are anything but encouraging. I am all too fa-

miliar with medical statistics…..I quote them in my recommendations every day…...and for

once, I am hoping that they are wrong. I have learned a lot from a pharmaceutical standpoint.

I never knew that Indomethacin was used to close a PDA heart condition in Preemies or that

the high doses of Magnesium given to slow labor in pre-term women has been found to de-

crease the risk of Cerebral Palsy in premature infants. This knowledge….and more…...are

things that I would have blessedly gone a lifetime without ever having to know. But this is

where we are…..living and learning from day to day. I have started to view my medical knowl-

edge as a curse…...sometimes it is best to know NOTHING. We have been told that Mason is a

“real fighter”….that all the measures taken for him thus far have not

“been heroic”….that they are supporting his own systems that are as of

yet too immature to survive. This has fortunately kept my daughter and

son-in-law from having to make decisions about a new born that are

much easier made for a loved one at the end of a long and fruitful life.

The outpouring of love and prayers for Mason and family has been over-

whelming. If you would like to follow his journey you may do so at

ljmatthews.blogspot.com.

Till next time……

Cathy Fuquay

...a note from the Editor