PostScript A Newsletter from UniCare, Inc.

November, 2004

NEW DRUGS/FORMULARY INFO

Beta-Blocker and Thiazide Use Linked to Reduced Risk of Fracture

New results indicate that beta-blockers are associated with a significantly reduced risk of fractures when taken alone or in combination with thiazide diuretics. Users of beta-blockers had a 37% reduced risk of fracture. As compared with non-users of beta-blockers or thiazides, fracture risk was reduced by 23 percent for current users of beta-blockers, by 20 percent for current users of thiazides and by 29 percent for current users of a combination of beta-blockers and thiazides.

While further studies are needed, the study authors said, "many elderly patients with hypertension are at risk of developing osteoporosis, and they may potentially benefit from positive effects of the relatively inexpensive beta-blockers and thiazide diuretics on fracture risk."

JAMA 2004; September 15.

DRUG INDICATIONS / WARNINGS

Rofecoxib (Vioxx) Withdrawn from the U.S. Market

On Sept. 27, the data safety monitoring board for an ongoing long-term study of rofecoxib (APPROVe) recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving rofecoxib compared with placebo, particularly those who had been taking the drug for longer than 18 months. Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.

Patients who were receiving Vioxx and still require an anti-inflammatory drug can be changed to celecoxib (Celebrex), provided they do not exhibit an allergy to sulfonamides (i.e. sulfa allergy). Celecoxib has been Omnicare’s recommended COX-2 for several years. The American Geriatrics Society Pain guidelines recommend non-acetylated salicylate products, such as Trilisate or Disalcid as alternatives for inflammation. Nonsteroidal anti-inflammatory drugs, such as naproxen, are not recommended in the elderly because of gastrointestinal muscosal damage and risk of bleeding. If NSAIDs are used in elderly patients, they should receive gastrointestinal protection with a proton pump inhibitor, such as omeprazole. Lastly, the safest and least expensive analgesic in the elderly is acetaminophen. At doses of 650 mg every 6 hours, acetaminophen is an effective analgesic that is not associated with gastrointestinal side effects.

PATIENT CARE INFORMATION

Influenza Vaccine Update

In October the Centers for Disease Control (CDC) was notified by Chiron Corporation that none of its influenza vaccine would be available for distribution in the United States due to quality problems in the vaccine manufacturing process. Chiron’s announcement effectively reduced the US supply of flu vaccine to approximately one half of the expected supply.

As a result, the CDC is recommending that priority groups receive existing vaccines. Nursing home residents, patients aged 65 years and older, persons aged 2 – 64 with underlying chronic medical conditions and health care workers with direct patient contact with these groups should receive the vaccine. The CDC is working with Aventis Pasteur to reallocate existing vaccine to priority groups. More information from Omnicare will follow as details develop.

Live attenuated influenza vaccine (FluMist) is not an option for health care workers or residents in nursing facilities. Transmission of the live virus from vaccinated health care workers to immunocompromised patients may cause them to develop influenza infection. Patients at high risk of severe influenza infection following exposure to FluMist include: patients with chronic disorders of the cardiovascular and pulmonary systems, diabetes, renal dysfunction or hemoglobinopathies, and those with immunosuppression. For these reasons, FluMist is not a good alternative for health care workers or others who will come in contact with high-risk individuals in the 21 days following vaccination with FluMist.

Flu and Cold Fact Sheet
Omnicare is doing everything possible to acquire sufficient supplies of influenza vaccines for our residents. In the meantime, here is some helpful information about the flu.

Is It the Flu or a Common Cold?
Although often confused with the common cold, influenza is more severe and poses a greater health concern. Every year, an estimated 17 million to 50 million cases of influenza are reported nationwide—many of which occur in otherwise healthy people.

Similar to the common cold, the flu can produce respiratory symptoms, such as runny nose, coughing, and sore throat. However, the influenza virus typically causes more intense symptoms, such as sudden onset of fever, chills, headache, and muscle aches in children, adolescents and adults. Unlike symptoms of the common cold, the fatigue and cough caused by the flu can last more than two weeks—lingering long after other symptoms subside.

Differences in Symptoms between the Flu and Common Cold
The table below shows the difference in symptoms between the common cold and the flu.

Symptoms	Cold	Flu
Fever	rare in adults and older children, but can be as high as 102° F in infants and small children	usually 102° F, but can go up to 104° F and usually lasts 3 to 4 days Ability to mount a fever may be compromised in frail elderly persons
Headache	rare	sudden onset and can be severe
Muscle aches	mild	usual, and often severe
Tiredness and weakness	mild	can last two or more weeks
Extreme exhaustion	never	sudden onset and can be severe
Runny nose	often	sometimes
Sneezing	often	sometimes
Sore throat	often	sometimes
Cough	mild hacking cough	usual, and can become severe
Five Simple Flu Prevention Tips Tip 1: Eat a Balanced Diet and Get Proper Rest This is good general advice for keeping your body healthy and able to fight off infections. A proper diet and sleep can help your immune system stay strong so that it can fight off viral infections before they wipe you out. Tip 2: Wash Your Hands Hand washing is one of the best ways to prevent infectious diseases. You should wash your hands often to kill the germs you may pick up from touching people, surfaces, and animals. Tip 3: Keep Your Distance Generally speaking, you should avoid being closer than six feet to someone who is ill for more than a minute or two, especially if they’re coughing and sneezing. You should also avoid going to work when you are ill with the flu. Tip 4: Routinely Clean and Disinfect Surfaces Cleaning and disinfecting are not the same. While cleaning with soap and water removes visible dirt and most germs, disinfecting with a bleach solution or other disinfectant kills additional germs on surfaces, providing an added margin of safety. Tip 5: Get Vaccinated! Although the above preventative measures can help, the best way to prevent the flu is to get a flu vaccine every year. Prescription antivirals that specifically inhibit influenza virus can be taken to prevent the flu.

Illness from influenza generally strikes 1 – 3 days after exposure to the virus with a sudden onset. Diagnosis should be confirmed by a rapid diagnostic test (i.e. nasopharyngeal or throat swabs) and antiviral treatment with rimantadine or oseltamivir (Tamiflu) initiated within 24 – 48 hours of the onset of symptoms (see the table for dosing). Antibiotics are not effective against viruses such as the common cold or influenza strains. However, patients with sings and symptoms of pneumonia should undergo a complete diagnostic evaluation to rule out bacterial pneumonia, before the infection is presumed to be viral.

Chemoprophylaxis of nursing facility residents is recommended when a cluster of influenza-like illness occurs during the influenza season and at least one resident is documented to have influenza. When an institutional outbreak occurs, rimantadine or Tamiflu should be administered to all residents, regardless of whether they received influenza vaccine prior to flu season, and should continue for the duration(s) noted in the table below. Antiviral therapy should be offered to all unvaccinated facility staff as well.

Other outbreak control measures to consider include instituting droplet precautions and associated respiratory infection control procedures, identifying groups of residents with confirmed or suspected influenza, and restricting contact between ill staff or visitors and residents.

Medication	Dosage	Duration	Side Effects	Comments
Rimantadine (Flumadine)	100 mg/day tablet or syrup	Prophylaxis: Minimum of 2 weeks or until 1 week after the end of the outbreak Treatment: 5 days or 48 hours after disappearance of signs & symptoms	Lower risk of seizures and CNS effects (6%) than amantadine. GI- nausea and anorexia (1-3%)	No dosage reduction needed for renal impairment
Oseltamivir (Tamiflu)	75 mg twice daily capsule or oral suspension	Prophylaxis: Minimum of 2 weeks or until 1 week after the end of the outbreak. Treatment: 5 days.	Rare reports of seizures. Nausea & vomiting (10%)	Take with food to reduce nausea & vomiting. Reduce treatment dose to 75 mg/day for Clcr < 30 ml/min Reduce prophylaxis dose to 75 mg every other day for Clcr < 30 ml/min

Influenza Educational Materials – Free!
The Centers for Disease Control and Prevention (CDC) has announced that the 2004-05 Flu Gallery is now available online. This “gallery” provides health care professionals access to current influenza educational materials, such as posters, flyers, and brochures for a variety of audiences, including seniors. These educational tools can be viewed, downloaded, and printed for free. Visit http://www.cdc.gov/flu/gallery.

Polypharmacy in the Elderly

What is the Definition of Polypharmacy?

Polypharmacy is a growing health concern and can be defined as the administration of more medications than are warranted clinically. In other words, does the adverse drug effect outweigh its health benefits? It is important to understand that polypharmacy encompasses the overuse, underuse and misuse of medications, and is not just associated with a quota on the number of medications prescribed concurrently. Elderly are especially prone to the hazards of polypharmacy since they often have multiple medical conditions, may see more than one physician, and have a higher likelihood of a recent hospitalization.

For some residents, 1 medication may be too many and for others 15 medications may be too few. The goal is to provide the right number of medications. This comes through identifying opportunities to eliminate unnecessary of potentially harmful drugs while adding drugs needed to assure optimal therapeutic outcomes.

Why is it Important to Focus on Polypharmacy?

It is important to focus on polypharmacy in the elderly for many reasons. A study of 3000 nursing home residents found a rate of 1.89 adverse drug events per 100 residents’ months. Overall, 51% of the events were judged to be preventable, with fatal, life-threatening, or serious events more likely to be preventable than less serious events. Other studies indicate that from 30-64% of nursing home residents experience an adverse drug event. Risk factors for developing adverse drug events have been identified and some are modifiable.

Risk Factors for Polypharmacy

NONMODIFIABLE	MODIFIABLE
Age	Multiple Prescribers
Recent Hospitalization	Multiple Pharmacies
Underlying medical conditions	High-risk Medications
Gender- male	Number of Medications
New Resident to Nursing Home	Diet
	Multiple Ingredient Products
	Failure to order drugs with knowledge of drug effects, interactions, doses, and adverse effects
	Failure to monitor drug therapy appropriately

How Can Polypharmacy Be Prevented?

Several key steps to make medications safer in the elderly are communicated by Omnicare Consultant Pharmacists as part of educational programs offered to Omnicare serviced facilities.

ü Document a desired measurable outcome for each medication prescribed-Assess outcomes (e.g. improved incontinence) at each office visit. Discontinue medications that do not achieve your desired outcome.

ü Take comprehensive medication histories- Include over-the-counter drugs, vitamins, minerals, and herbal preparations.

ü Ask patients and families to bring in all medications to hospital or office visits and upon admission to the nursing home- Continuously review the need for each medication.

ü Conduct a Drug Assessment- Are there multiple prescribers? Is the person compliant or non-compliant? Are medications being administered correctly?

ü Have the patient/family keep a list of all medicines taken.

ü Determine if the drug is producing adverse effects- Do not assume symptoms are due to natural aging problems. Consider all drugs as potential causes.

ü Assess the benefit to risk ratio of drug treatment -Is a drug with potential side effects in the elderly being considered for a relatively minor complaint?

ü Avoid prescribing a drug to treat adverse effects of other drugs.

ü Consider, where appropriate, the use of combination preparations.

ü Limit the use of PRN medications.

What is Omnicare’s Answer to this issue?

Omnicare consultants have been focusing on polypharmacy for many years. This program serves as a basis for a consistent approach to preventing drug-related problems for all of our customers. Omnicare pharmacists through interdisciplinary involvement make interventions for specific chronic conditions to make drug therapy more appropriate. They also decrease misuse, and overuse by focusing on less than ideal drug combinations, drug-disease interactions and waste to improve resident outcomes. For further information regarding this program, please contact your Omnicare Consultant Pharmacist.

EDITORIAL BOARD

Karen Burton, Pharm.D., CGP, FASCP

Mark Coggins, Pharm.D., CGP, FASCP

Kelly Hollenack, Pharm.D., CGP

Philip King, Pharm.D., CGP

Susan J. Klem, B.S. Pharm., CGP, FASCP

Terry O’Shea, Pharm.D., CGP, FASCP

Elmer Schmidt, Pharm.D., CGP, FASCP

Barbara J. Zarowitz, Pharm.D., CGP, BCPS, FCCP