Community Practice

The Food & Drug Administration recently issued letters to three pharmacies warning them to "stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nationwide." The three named companies, RoTech Healthcare, CCS Medical, and Reliant Pharmacy Services, were all warned that if they did not comply, they risked injunctions and the possible seizure of their products in question.

Genetic testing and custom-tailored drug treatments promise a sea change in pharmacy practice

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recently created a consensus statement on the management of hyperglycemia in patients with Type 2 diabetes. "This is a consensus document that is supported by evidence from clinical trials. Some of the recommendations are based on expert opinion, but this is true for any guideline. These guidelines will likely be useful to pharmacists and nurses because many times their practice is driven by guidelines," stated Stuart Haines, Pharm.D., FCCP, FASHP, professor and vice chair for education at the University of Maryland school of pharmacy.

Managing patients with valvular heart conditions can be a real challenge. They often require lifelong monitoring, with replacement surgery and subsequent anticoagulation. Recently, in a joint effort, the American College of Cardiology (ACC) and the American Heart Association (AHA) revised their 1998 recommendations to create the ACC/ AHA 2006 Practice Guidelines for the Management of Patients with Valvular Heart Disease. The executive summary and recommendations were published in the Aug. 1, 2006, issues of the Journal of the American College of Cardiology and Circulation.

In an effort to improve the care of patients with sexually transmitted diseases (STDs), the Centers for Disease Control & Prevention recently updated its STD guidelines. The update is an evidence-based document, the result of experts' evaluation of the medical literature since the previous publication of Sexually Transmitted Diseases Treatment Guidelines in 2002.

The pharmacy community seems to be solidly behind the Food & Drug Administration's move to switch Duramed Pharmaceuticals' Plan B (levonorgestrel) emergency contraception to over-the-counter status. In giving the green light, the FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for girls 17 and younger.

As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.

As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.

As in years past, this year's American Diabetes Association annual meeting offered attendees the latest scoop on the treatment of this growing disease. Marking this year's presentations were those dealing with investigational oral agents and a simplified algorithm for dosing mealtime insulin. Other sessions highlighted unexpected findings: glucose-lowering properties of a lipid-lowering agent and protection from nephropathy with oral contraceptives.

ASHP's revised guidelines on the handling of hazardous pharmaceuticals could not have come at a more opportune time. As chemotherapy agents become more powerful and chemotherapy administration shifts from the inpatient setting to physician offices and infusion centers, controlling occupational exposure to hazardous drugs has taken on a new urgency.

With some programs enjoying a resurgence and others on the wane, here's a look at what's out there

How much written drug information is enough for consumers? Is there such a thing as too much information?

It's been a year since ABC news anchor Peter Jennings died of lung cancer. And the disease remains as lethal as ever. In the past year alone, 170,000 Americans have received a diagnosis of lung cancer. Lung cancer deaths among women have increased almost 200% over the past 20 years, while those among men have actually decreased 5%.

The American Association for Geriatric Psychiatry (AAGP) recently released a position paper to affirm that a minimal set of care principles now exists for those with Alzheimer's disease (AD) and their caregivers, and to articulate these principles. "Principles of care for patients with dementia resulting from Alzheimer disease" was published in the July 2006 issue of the American Journal of Geriatric Psychiatry and on the AAGP Web site at http://www.aagponline.org/prof/position_caredmnalz.asp.

A subdermal implantation of a single etonogestrel-containing rod can prevent pregnancy for up to three years. Does this sound too simple to be true? The manufacturer of Implanon, Organon Inc., is hoping women will be intrigued. The Food & Drug Administration approved the new 68-mg implant just last month. It contains the same component that's in the company's vaginal contraceptive, NuvaRing.

With the Food & Drug Administration's approval of Atripla (efavirenz/emtricitabine/tenofovir, Bristol-Myers Squibb and Gilead Sciences), HIV patients will have access to a once-daily single-tablet regimen. The new product combines three agents from two classes of antiretrovirals: Efavirenz (600 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and emtricitabine (200 mg) and tenofovir (300 mg) are nucleoside reverse transcriptase inhibitors (NRTIs). All three work by blocking reverse transcriptase, an enzyme required for HIV replication.

Pharmacists will continue to assume a gatekeeper role in individualized oncologic therapy, according to experts participating in an American Medical Association-sponsored media briefing, "Revolutionary Cancer Treatments," held in New York City recently. The event addressed the issue of unmet needs in cancer therapy. Carolyn D. Runowicz, president of the American Cancer Society, was the moderator for the meeting.

The exhibit floor at the ASHP summer meeting in Orlando was sizzling with the latest wares on display for hospital pharmacy in categories ranging from automation solutions to dispensing equipment, computer hardware and software, drug administration devices, packaging equipment, and pharmacy management services.

In time for back to school, manufacturers have introduced many lice busters, from products that contain natural ingredients to mechanical combs to remove nits and eggs. Here's a preview of this season's lice exterminators

Pharmacists are still divided over whether the mandate to drop the B.S. degree was a bad call

Hospitals with large indigent patient populations have a new financial ally: the Medicare Part D outpatient pharmacy benefit.

Thanks in large part to vaccination of children and adolescents, the number of new cases of hepatitis B in the United States has declined over the past decade or so. However, the hepatitis B virus (HBV) is still a problem. The Centers for Disease Control & Prevention estimates that about 1.25 million people have been infected with HBV, and about 5,000 Americans die each year from complications of the disease.

A 55-year-old male, P.N., is being followed in your cardiovascular risk reduction clinic. He has been titrated up on Avalide (irbesartan/hydrochloro-thiazide, Bristol-Myers Squibb/Sanofi-Aventis) and today his blood pressure is 130/80. He also takes Vytorin 10/80 (ezetimibe/simvastatin, Merck/Schering- Plough) daily. His current lipid panel is HDL 42, LDL 79, TC 145, triglycerides 120, but he is complaining of severe muscle pain of recent onset. Four days ago, his physician prescribed Ketek (telithromycin, Sanofi-Aventis) 800 mg daily for acute sinusitis. His sinusitis is now asymptomatic. What do you recommend?

The Institute of Medicine (IOM) recently released Preventing Medication Errors, a 544-page report that is the fourth in its Quality Chasm series. The authors concluded that medication errors harm at least 1.5 million people per year in the United States. In addition, the cost of treating drug-related injuries that occur in hospitals alone conservatively amounts to $3.5 billion per year, according to the Committee on Identifying and Preventing Medication Errors, which wrote the report. The report was funded by the Department of Health & Human Services and the Centers for Medicare & Medicaid Services.

Washington State pharmacists are wondering if they are expected to be the penmanship police since a new law decrees that prescriptions in cursive handwriting are no longer considered to be legible.

Make no mistake about it. Community pharmacies are in peril, thanks largely to low and slow reimbursement from Medicare Part D and aggressive efforts by pharmacy benefit managers to pressure beneficiaries to switch to mail order. What are pharmacy associations doing to rescue pharmacies from the plight they are in?

Reams of articles have been written on when drug treatments should be initiated, but far less literature is available on when they should be discontinued. A recent analysis of Medicare records found that, rather than stopping pharmacotherapy and resorting to hospice care, almost 12% of cancer patients in 1999 received chemotherapy in the last two weeks of life, up 2% from 1983.

The Food & Drug Administration recently granted marketing approval to oxymorphone immediate-release and oxymorphone extended-release tablets (Opana/Opana ER, Endo Pharmaceuticals).

The Food & Drug Administration recently granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy-including imatinib (Gleevec, Novartis). The FDA also granted full approval to dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib, considered an orphan drug for each of these indications, is currently available in retail pharmacies.

Retailers who fail to comply with a new federal law on methamphetamine can be fined up to $25,000 and jailed for up to two years. Furthermore, if a state or local requirement conflicts with the federal requirement, retailers must comply with the most stringent version. So warned Kevin N. Nicholson, R.Ph., J.D., VP-pharmacy regulatory affairs, National Association of Chain Drug Stores, at the association's Marketplace Conference, held in San Diego recently.