PostScript A Newsletter from UniCare, Inc.

January 2005

Surveys and Pharmacy – You Can Benefit From What We Hear

Surveyors are looking at Pharmacy more closely now than in the past. We would like to share with you some of the issues surveyors have raised regarding pharmacy. Sometimes they are tagged—sometimes not, but you don’t want to take the chance.

1. Storage and dating of Insulin-Insulin should be stored in the refrigerator until it is opened. Once opened, date vial and it is good for 28 days. If it’s past 28 days, it is considered out of date, regardless of the expiration date on the bottle.

2. Storage and dating of Miacalcin-Miacalcin should be stored in refrigerator until opened. Once activated, date vial and place in medication cart upright. We provide cardholders for this purpose. Whether you use the cardholders or store it in some other location on the cart, it should be stored upright. Once activated, it is good for 35 days.

3. T.B. skin tests should be kept in the refrigerator. Each multidose vial should be dated when opened and it is good for 30 days.

4. Xalatan Eye Drops – By this time, we should have changed Xalaton to Travatan. However, if you still have some residents on Xalatan, this eye drop must be refrigerated until it is opened. Once opened and placed on the cart, it should be dated and is good for 42 days.

NOTE: IF ANY OF THE ABOVE COMES FROM ANOTHER PHARMACY, THE BOTTLE IS USUALLY NOT LABELED. IF THE PRESCRIPTION LABEL IS ON THE BOX, YOU MUST WRITE THE DATE ON THE BOX AND KEEP THE MEDICATION IN IT.

5. Promod and other powdered supplements that must be scooped- You have two choices: you can keep the scoop in the container with the powder, but you must have on gloves when you scoop it, or you have to keep the scoop in a plastic bag separate from the powder.

6. Suppositories – Do not refrigerate acetaminophen and Dulcolax suppositories. Only refrigerate suppositories that say, “Store in refrigerator.” Typically that will be only Phenergan suppositories. If you purchase acetaminophen suppositories from a source other than us and the manufacturer is Goldline, you need to check with your supplier about changing to a different brand. The storage directions for these suppositories are not consistent with the required refrigerator temperature or the temperature of your facility. In other words, if you store them in the refrigerator you are out of compliance and if you store them on the cart, you are out of compliance.

7. Reconciliation of liquid controlled medication – When counting controlled liquids regular reconciliation of the count is necessary to assure the amount on the inventory corresponds to the amount on hand. Reconciliation is necessary due to the inherent inaccuracies associated with measuring liquids. The amount dispensed nor the amount measured per dose will be exact; discrepancies will occur. For example, if Phenobarbital liquid 480ml is dispensed; the dose is 5ml;and if only half the doses administered are mismeasured by 1ml, the count may be off as much as 45ml by the time the bottle is empty. If the doses were under measured, the inventory count would be 45ml when the bottle is actually empty. If the doses were over measured, the opposite would occur.

To avoid discrepancies, medication nurses should periodically reconcile the count on the inventory sheet to the amount on hand. The reconciliation must be reasonable or concerns about accountability will occur. More than a 10% discrepancy of the total prescription amount would be cause for investigation related to the measurement techniques used by the nurses and the security of the controlled medication. Upon reconciliation, TWO licensed nurses must initial the corrected amount on hand.

Some of the issues outlined above have been raised by, not only State surveyors, but also Federal surveyors. We hope this information is helpful to you and that you will understand why frequent monitoring of the above is very important.

Hospital Transfer Orders

When using hospital transfer orders for new admits and re-admits to obtain medication from UniCare, please make sure the orders are legible and the individual medication orders are complete before faxing to us. This will prevent us from having to fax back to your facility or call and it will enable us to process the orders without delay.

Hope you enjoy the rest of the newsletter.

NEW DRUGS/FORMULARY INFO

Aripiprazole (Abilify) for Acute Bipolar Mania

The Food and Drug Administration recently approved Abilify for treatment of patients with acute bipolar mania. Abilify is an atypical antipsychotic shown to be effective in the treatment of acute mania in two placebo-controlled trials of hospitalized patients, in doses of 30 mg/day. Doses may be decreased to 15 mg/day based on individual patient tolerability. Furthermore, the dose should be reduced to 15 mg/day when administered with interacting drugs such as CYP3A4 inhibitors (Biaxin, Erythromycin, Cyclosporine) or CYP2D6 inhibitors (Perphenazine, SSRI antidepressants such as Zoloft). In the elderly, aripiprazole doses should not exceed 15 mg/day.

Formulary 2004;39:51920.

New Generic Approvals

The FDA has recently approved generic availability of several medications whose patents have expired. Generic versions of medications may offer the patient and facility a cost savings.

Generic	Equivalent to Brand	Dosage Strengths	Generic Manufacturer(s)
Citalopram	Celexa	10mg, 20mg, 40mg	Aurobindo Pharma, Corepharma, Eon, Dr Reddy’s, Purepac
Gabapentin	Neurontin	100mg, 300mg, 400mg, 600mg, 800mg	IVAX, Purepac, AlPharma
Metformin Extended Release	Glucophage XR	500mg, 750mg	Barr

Arimidex for Postmenopausal, Localized, Hormone-Receptor-Positive Breast Cancer

A recent study found the aromatase inhibitor Arimidex (anastrozole) to be superior to tamoxifen for the treatment of postmenopausal women with localized, hormone-receptor-positive breast cancer. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial investigators randomly assigned 9,366 patients to receive Arimidex, tamoxifen or a combination of the two for five years. The study authors noted that five years of tamoxifen therapy is currently considered the standard adjuvant endocrine treatment for postmenopausal women with localized, hormone-receptor-positive breast cancer.

At 68 months--8 months beyond the conclusion of the planned five-year treatment period--data showed Arimidex-treated patients had significantly better disease-free survival than tamoxifen-treated subjects. Time to recurrence was also significantly improved with Arimidex.

Additionally, treatment with Arimidex was associated with significantly fewer incidences of endometrial cancer, thromboembolic events, ischemic cerebrovascular events, vaginal bleeding, hot flushes and vaginal discharge. Tamoxifen-treated patients were less likely to experience fractures and arthralgia.

ATAC Trialists’ Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. The Lancet 2004;364(9450) Available at: http://www.thelancet.com/journal/vol364/iss9450/early_online_publication  

DRUG INDICATIONS / WARNINGS

FDA Alert on Sound-Alike Drugs: Reminyl and Amaryl

Medication error reports to MedWatch, the FDA error reporting system, included instances where physicians prescribed Reminyl – an Alzheimer’s drug – but the patient received the diabetes medicine, Amaryl. The errors were reported to cause severe hypoglycemia and death, according to the FDA. Both products are in tablet form and available in a 4 mg strength. In addition, the generic names both begin with “g” which could lead to the products being placed next to each other in stock bottles or shelves.

CAUTION!

Brand Name	Generic Name	Tablet Strengths	Indications for Use
Amaryl	Glimepiride	1mg, 2mg, 4mg	Oral hypoglycemic for diabetes
Reminyl	Galantamine	4mg, 8mg, 12mg	Acetylcholinesterase inhibitor for Alzheimer’s Disease

Data Do Not Support Long-Term Use of NSAIDs Among People With Knee Osteoarthritis

A new analysis suggests that nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 selective inhibitors such as Celebrex, can reduce short-term pain in patients with osteoarthritis of the knee, although long-term use of such drugs does not seem warranted. The researchers conducted a systematic review of 23 trials involving 10,845 patients who received “adequate” doses of NSAIDs or placebo for knee osteoarthritis. When the results were pooled, treatment with NSAIDs was associated with an improvement in the visual analog pain scores of 15.6% over placebo at 2 – 13 weeks of treatment (short-term therapy). However, there was no difference between NSAIDs and placebo after 4 years of treatment (long-term). Although current treatment guidelines support the use of NSAIDs for knee osteoarthritis, the evidence of long-term benefit is lacking.

In addition, NSAIDs have been added to the list of medications with relative contraindications in the elderly (Beers List) due to the adverse effect profile, which can include gastrointestinal bleeding and ulceration, renal failure, fluid overload, increased blood pressure and worsening of congestive heart failure. Alternatives for management of mild to moderate pain can include non-acetylated salicylates (Trilisate, Disalcid) or acetaminophen for knee osteoarthritis.

Bjordal JM et al. Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase inhibitors, in osteoarthritic knee pain: meta-analysis of randomized placebo controlled trials. Brit Med J 2004;329:1317 Available at: http://bmj.bmjjournals.com/cgi/content/abstract/329/7478/1317

PATIENT CARE INFORMATION

Addressing Cardiovascular Risk in the Elderly: Focus on Lipids

Cardiovascular disease is the most common cause of death in older persons in a nursing home. There is a great deal of emerging evidence that appropriate lipid management reduces cardiovascular risk in older persons. Low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C) cholesterol serum concentrationslevels correlate towith the likelihood of having coronary artery disease (coronary artery diseaseCAD).. A study in nursing home residents showed that with an increase of 10 mg/dL increase in of serum low-density lipoprotein (LDL-C ) cholesterol significantly increased the probability of having CAD increased by 1.28 times. The same study also showed that aA 10 mg/dL decrease in of 10 mg/dL of serum high-density lipoprotein (HDL-C) cholesterol significantly increased the probability of having CAD by 2.56 times. LDL-C and HDL-C levelsvalues also correlate towith the risk of new coronary events. A study in nursing home residents showed that a 10 mg/dLn increase in of 10 mg/dL of serum total cholesterol significantly increased the relative risk of new coronary events by 1.12 times in men and by 1.12 times in women. The same study also showed that aA 10 mg/dL decrease of 10 mg/dL of serum HDL-C cholesterol significantly increased the relative risk of new coronary events by 1.70 times in men and by 1.95 times in women.

The following is a brief summary of some of the important recent literature that concludes we should be treating eligible older persons.

-Based Data for These Studies Include:

PROSPER showed that administering pravastatin for 3 years reduced the risk of coronary disease in elderly individuals and therefore extends to elderly individuals the treatment strategy currently used in middle- aged people. A randomized controlled trial in which 5804 men (n=2804) and women (n=3000) aged 70-82 years with a history of, or risk factors for, vascular disease were assigned to pravastatin (40 mg per day; n=2891) or placebo (n=2913). Findings showed that Ppravastatin lowered LDL cholesterol-C concentrations by 34% and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo. CHDoronary heart disease death and non-fatal myocardial infarction risk was also reduced. Mortality from coronary disease fell by 24% (p=0.043) in the pravastatin-treated group.

Shepherd J, Blauw GJ, Murphy MB et.al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomized controlled trial. Lancet. 2002 Nov 23; 360 (9346): 1623-30.

In the Heart Protection Study (HPS): 20,536 adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetes were randomly allocated to receive 40 mg simvastatin daily or placebo. All-cause mortality was significantly reduced (1328 [12.9%] among 10,269 persons allocated to simvastatin versus 1507 [14.7%] among 10,267 allocated to placebo; p=0.0003). Adding simvastatin to existing treatments safely producesd substantial additional benefits for a wide range of high-risk patients, irrespective of their initial cholesterol concentrations. Allocation to 40 mg simvastatin daily reduced the rates of myocardial infarction, of stroke, and of revascularizsation by about 25%one-quarter. After making allowance for non-compliance, actual use of this regimen would probably reduce these rates by about one-third. Hence, among the many types of high-risk individuals studied, 5 years of simvastatin would prevent about 70-100 people per 1000 from suffering at least one of these major vascular events. (and longer treatment should produce further benefit). Similar event reductions on simvastatin therapy occurred for men and women and for participants either under or over 70 years of age at entry.

Heart Protection Study Collaborate Group, MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6; 360 (9326): 7-22.

In the pPrimary prevention of cardiovascular disease with atorvastatin in patients with tType 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicenter randomised placebo-controlled trial,: 2838 patients aged 40 – 75 years in 132 centers in the UK and Ireland were randomized to placebo or atorvastatin 10mg daily. Study entrants had tType 2 diabetes, no documented previous history of cardiovascular disease, an LDL-C of <160 mg/dL, and at least one of the following: retinopathy, albuminuria, current smoking, or hypertension. The primary endpoint was time to first occurrence of acute coronary heart disease events, coronary revascularization, or stroke. This was the only primary prevention study stopped 2 years earlier than expected due to positive results. The study showed a 37% reduction in major cardiovascular events, a 48% reduction in stroke, and a 27% reduction in all-cause mortality.

Colhoun HM, Betteridge DJ, Durrington PN et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicenter randomised placebo-controlled trial. Lancet. 2004; 364:685-96.

The .Cholesterol and Recurrent Events (CARE) Trial at 5.0-year median follow-up in patients’ aged 65 to 75 years of age pravastatin significantly decreased:

- Coronary Artery Disease (CAD) death by 45%

- CAD death or nonfatal MI by 39%

- Major coronary events by 32%

- Coronary revascularization by 32%

- Stroke by 40%

Lewis SJ, Sacks FM, Mitchell JS, et al. Effect of pravastatin on cardiovascular events in women after myocardial infarction: The Cholesterol and Recurrent Events (CARE) Trial. J Am Coll Cardiol 1998; 32: 140–146.

Lewis SJ, Moye LA, Sacks FM, et al. Effect of pravastatin on cardiovascular events in older patients with myocardial infarction and cholesterol levels in the average range. Results of the Cholesterol and Recurrent Events (CARE) Trial. Ann Intern Med 1998; 129: 681–689. 

Plehn JF, Davis BR, Sacks FM, et al. Reduction of stroke incidence after myocardial infarction with pravastatin. The Cholesterol and Recurrent Events (CARE) Study. Circulation 1999; 99: 216–223.

Indications for Treatment of Lipids in Vascular Disease

Ø The statin drug trials have documented a decrease in all-cause mortality, coronary events, stroke, intermittent claudication, coronary revascularization, and congestive heart failure in older persons with CAD.. Statins can also be given to older persons with CAD if needed to reduce the serum LDL-C cholesterol to <100 mg/dL. Despite these data, lipid-lowering drug therapy is underutilized in older persons.

Ø Older men and women living in a nursing home with prior stroke,, PAD,, and ECADextracranial carotid artery disease are at high risk for developing new coronary events and should also be treated with statins, if necessary, to lower the serum LDL cholesterol to <100 mg/dL.

Ø Newer recommendations state that LDL-C goals of <70 mg/dl may be warrants in high risk patients, such as those with diabetes.

Ø The Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP III) recommends lowering the serum LDL cholesterol to <100 mg/dL in persons with CAD, other clinical forms of atherosclerotic disease, diabetes mellitus, and in persons with 2+ risk factors that confer a 10-year risk for CAD of >20%. The report recommends no age restriction for treatment of older persons with lipid-lowering drug therapy if they have CAD or are at higher risk for CAD.

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA. 2001; 285:2486-2497.

Grundy SM, Cleeman JI, Merz CNB et al. Implications of recent clinical trails for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004: 110: 227-239.

Aronow WS, Ahn C, Schoenfeld MR, Mercando AD, Epstein S. Prognostic significance of silent myocardial ischemia in patients >61 years of age with extracranial internal or common carotid arterial disease with and without previous myocardial infarction. Am J Cardiol 1993; 71: 115–1177.

Aronow WS, Ahn C. Prevalence of coexistence of coronary artery disease, peripheral arterial disease, and atherothrombotic brain infarction in men and women over 62 years of age. Am J Cardiol 1994; 74: 64–65.

Aronow WS, Ahn C, Mercando AD, Epstein S. Prognostic significance of silent ischemia in elderly patients with peripheral arterial disease with and without previous myocardial infarction. Am J Cardiol 1992; 69: 137–139.

Aronow WS, Schoenfeld MR. Forty-five-month follow-up of extracranial carotid arterial disease for new coronary events in elderly patients. Coronary Artery Dis 1992; 3: 249–251.

Elderly ThosePersons Who May Not be Candidates for Lipid Therapy:

Ø Terminally ill patients at the end stages of life, who may or may not be under hHospice care.

Ø Residents at the end stages of Alzheimer’s disease (CPS score 5-6, MMSE <11).

Ø Residents in a vegetative state or coma.

Ø Residents or family members/power of attorney who choose not to undergo treatment.EFERENCES: