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State legislators have emerged as key players in pharmacy. Faced with shrinking margins from Medicare Part D and the specter of bankruptcy from proposed Medicaid reimbursement rates, many pharmacists are pushing their state legislatures to shift the balance.

Like it or not, health-system pharmacies are under tremendous pressure to perform at a high level. Addressing patient safety concerns, improving outcomes, implementing state-of-the-art technology, and keeping drug costs down requires a juggling act that pharmacists must perform on a daily basis.

NIOSH, the National Institute for Occupational Safety and Health, is updating its list of hazardous pharmaceutical products. The new list will become part of the organization's 2004 alert, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

When Michelle Rutledge, Pharm.D., heard about the fatal shooting of a hospital pharmacist at Shands Jacksonville hospital in Florida last November, it really hit home. The victim, 37-year-old Shannon McCants, was a fellow graduate of the Florida A&M College of Pharmacy. McCants was shot by a customer who was waiting for a prescription to be filled in the outpatient pharmacy. Rutledge, an associate investigator at the James A. Haley VA Hospital in Tampa, said that e-mails from former student-colleagues began pouring in.

It seems to me that doctors are pretty much taking off the better-than-you crowns and the are-you-looking-at-me cloaks these days. They seem to be much more egalitarian than ever before. They often appear to be more democratic than they were just 10 years ago. I can even call them by their first names without getting attitude. When I question them on restricted refills on something like Freestyle strips, they are likely to back off and change to p.r.n. Doctors are getting human on us.

Medicare Part D has gone a long way toward closing an important gap in healthcare coverage by providing a prescription drug benefit to enrollees. Now several government agencies are aiming to close the gap between the availability and use of covered preventive services among persons with Medicare. The goal is to do more to help beneficiaries manage their medical care rather than just paying the bills.

Now Type 2 diabetics will have another option for controlling blood glucose. Exenatide (Byetta, Amylin Pharmaceuticals) injection can now be used as add-on therapy in patients who have not achieved adequate blood glucose control on a thiazolidinedione (TZD). The drug was approved by the Food & Drug Administration for expanded combination use in December.

Pharmacists can now refer to a new treatment algorithm for the metabolic management of Type 2 diabetes when caring for patients. This is one new addition to the Standards of Medical Care in Diabetes-2007 from the American Diabetes Association (ADA). The clinical practice guidelines have been updated to include new information about treatment and prevention that reflects the latest research.

As many as one in five Americans, or 55 million people, suffer with the abdominal discomfort associated with irritable bowel syndrome (IBS), according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Symptoms vary from patient to patient but typically include abdominal pain and discomfort with changes in bowel function-either predominantly diarrhea (IBS-d) or constipation (IBS-c). Some patients, however, experience a mixed form (IBS-m), with alternating diarrhea and constipation. Currently there exist few therapies for treating the condition; however, several entities in development look promising.

Two commonly prescribed antihypertensive medications have now been combined into one tablet. With an anticipated availability this September, valsartan (Diovan, Novartis) and amlodipine (Norvasc, Pfizer) will be sold as a combination product under the trade name Exforge (Novartis). The Food & Drug Administration approval is tentative, pending expiration of market exclusivity and patent protection for amlodipine in September.

According to the FDA Web site (www.fda.gov), 18 new molecular entities (NMEs) were approved in 2006, the lowest number to be given the nod by the agency since 2002 when only 17 drugs were approved.

The Centers for Medicare & Medicaid Services' proposal to share claims information data with researchers and other government agencies has met with widespread support as well as hope that the agency will take it even further. Pharmaceutical companies, some pharmacy organizations, and even Democratic Party leaders all welcomed the change, and many urged CMS to broaden the data sharing to include state Medicaid officials. The proposed rule change can be found in the Oct. 18, 2006, Federal Register

Pharmacists at one of the nation's largest military medical centers found that elderly patients are likelier to comply with drug regimens following a program of patient education, pharmacy counseling, and specially packaged drug blisterpacks. Jeannie Lee, Pharm.D., and Karen Grace, Pharm.D., clinical pharmacists at the Walter Reed Army Medical Center, led the research. "The Federal Study of Adherence to Medications in the Elderly" (FAME) was published in the Dec. 6 issue of the Journal of the American Medical Association.

At the ASHP Midyear Clinical Meeting in December, technology vendors from the largest system integrators to mom-and-pop software startups hawked their products and services. Bedside bar-coding, medication management tools, and smart pumps were among the dominant product categories displayed.

Last month, the House Ways and Means Committee held a hearing on patient safety and quality issues regarding end-stage renal disease (ESRD) treatment. In his opening remarks, outgoing committee chairman Rep. Bill Thomas (R, Calif.) acknowledged that Medicare payments for the treatment of ESRD increased by almost 50% between 1998 and 2003. In fact, epoetin alfa (Epogen, Amgen) has been identified as the single largest drug expenditure in Medicare Part B each year.

Sometimes in medication safety the simplest solution is the best.

With what may turn out to be a nationwide model, hospitals in San Diego have joined forces in an effort to reduce the number of adverse drug events (ADEs) associated with intravenous medication administration.

Final rules on hospital participation in Medicare and Medicaid may help pharmacists crack down on patients who try to provide their own drugs for hospital use. The practice is called "brown bagging," from the brown paper bags patients get from retail pharmacies.

Following months of anticipation and concern, in late December the Centers for Medicare & Medicaid Services issued a proposed rule governing Medicaid reimbursement that would cut more than $8 billion in Medicaid generic drug reimbursements over a five-year period. The ruling, which implements provisions of the Deficit Reduction Act of 2005 (DRA), drew sharp reactions from pharmacy industry organizations, which worried that it would have a profound and negative impact on patients and community pharmacy.

As Medicare Part D moves into its second year, the program has undergone modest yet important changes. Still, despite sometimes significant premium increases and lack of coverage in the donut hole, most seniors seem to be sticking with the prescription drug plans (PDPs) they picked last year.

A survey commissioned by pharmacist groups indicates once again that patients are often not adhering to directions for prescription medications.

The Centers for Medicare & Medicaid Services' proposal to share claims information data with researchers and other government agencies has met with widespread support as well as hope that the agency will take it even further. Pharmaceutical companies, some pharmacy organizations, and even Democratic Party leaders all welcomed the change, and many urged CMS to broaden the data sharing to include state Medicaid officials. The proposed rule change can be found in the Oct. 18, 2006, Federal Register

Multiple myeloma (MM) is not curable, according to the Multiple Myeloma Research Foundation (MMRF), but it is treatable. The MM panel of the National Comprehensive Cancer Network (NCCN) has added several drugs and drug combinations to the MM guidelines. Bortezomib (Velcade, Millennium Pharmaceuticals and Johnson & Johnson), lenalidomide (Revlimid, Celgene), and melphalan (Alkeran, GlaxoSmithKline) are all included in several combinations with cortico-steroids and other chemotherapy drugs. Lenalidomide is also recommended as single-agent treatment for salvage therapy.

The American Thoracic Society (ATS) recently issued a statement on the hepatotoxicity of antituberculosis medications. The statement, which appeared in the Oct. 15 issue of the American Journal of Respiratory and Critical Care Medicine, addresses the growing incidence of drug-induced liver injury (DILI) by tuberculosis medications.

Many agents are in development to fight resistance to Gleevec (imatinib, Novartis) in patients with chronic myeloid leukemia (CML). That was one of the issues highlighted at the recent meeting of the American Society of Hematology (ASH), held in Orlando, Fla. The meeting drew 20,000 attendees seeking news of improved treatments for blood cancer.

Last fall, the Infectious Diseases Society of America (IDSA) released updated guidelines for the diagnosis and treatment of Lyme disease. (See Drug Topics, Nov. 20, 2006, "Updated Lyme disease guide clarifies confusion".) Approximately one month later, Connecticut attorney general Richard Blumenthal issued a Civil Investigative Demand (CID) to look into possible antitrust violations by IDSA in connection with exclusionary conduct and monopolization in the development of its Lyme disease guidelines.

The Food & Drug Administration recently approved paliperidone (Invega, Janssen, L.P.), an atypical antipsychotic, for the treatment of schizophrenia, a disease that affects more than two million Americans. It is the first new treatment for schizophrenia to be approved since 2003.

House Democrats to push for Medicare drug negotiation