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A dizzying array of new products was highlighted at the National Association of Chain Drug Stores Marketplace 2005 conference, held in New Orleans last month. At this largest front-end trade show in the industry, the buzzword was natural, with the majority of new products containing natural ingredients to satisfy customer demand for safer solutions to healthcare problems. Here's a look at the new entries in personal care, dietary supplementation, and home health care.

An Institute of Medicine panel began a year-long investigation last month with hope of recommending fixes to the nation's foundering drug safety system. The panel was commissioned by Food & Drug Administration officials, who pledged to seek improvements to safety monitoring in the wake of highly publicized problems with COX-2 drugs, selective serotonin reupake inhibitor (SSR) antidepressants, and other products.

Just because pharmacists or pharmacies don't know that certain actions are prohibited by the Healthcare Insurance Portability & Accountability Act doesn't mean they can't be brought up on criminal charges for violations, according to a ruling issued by the U.S. Department of Justice (DOJ).

As California and Florida gear up to implement new pedigree laws—legislation that requires a paper trail on prescription drugs to thwart counterfeiting—there are growing signs of resistance and complaints that it will be very costly to install a uniform tracking system.

The FDA and the pharmaceutical industry step up their anticounterfeiting initiatives.

Communications between caregivers and medication use safety dominate the Joint Commission on Accreditation of Healthcare Organizations' 2006 National Patient Safety Goals for hospitals. Among the major additions to the 2006 goals are new requirements that "hand-offs" of patients between caregivers be standardized and that all medication containers, including syringes, medicine cups, basins, and other solutions used in perioperative areas, be labeled.

On Jan. 1, 2006, Medicare Part D will begin. MMA provides for access to the prescription drug benefit through one of four options: a stand-alone prescription drug plan (PDP); a component of a Medicare Advantage (MA) managed care plan; an employer-sponsored qualifying plan; or a government-supported fallback plan in areas with only one private option. There are a number of key dates along the path to implementation.

An electronic tool is being developed to help pharmacists assist seniors on Medicaid who may be confused about having to choose a Medicare prescription drug plan by year's end.

The Food & Drug Administration has approved Revatio (sildenafil citrate, Pfizer) for pulmonary arterial hypertension (PAH). If the drug sounds familiar, that's because Viagra, Pfizer's famed erectile dysfunction medication, contains the same active ingredient.

Do pharmacists get enough respect? Not when you consider that they still conspicuously lack provider status under Medicare Part B.

CMS proposes marketing guidelines for Medicare Part D CMS has developed draft guidelines on what pharmacists can and cannot do with regard to marketing Medicare Part D prescription drug plans in their pharmacies.

Drug products used to treat cardiovascular diseases (e.g., hypertension, congestive heart failure, ischemia, and arrhythmias) have been associated with a significant number of adverse drug events. Cardiovascular drug products are among the most widely used in both hospital and ambulatory care settings, and previous studies that have examined cardiovascular patients suggest that a significant degree of morbidity and mortality may be preventable.

Pharmacists, along with physicians and politicians, top the list of barriers keeping emergency contraception out of easy reach. That's the news from the annual meeting of the American College of Obstetricians and Gynecologists (ACOG). "Emergency contraception [EC] is almost trivial in medical terms," said Eve Espy, M.D., MPH, associate professor of obstetrics and gynecology at the University of New Mexico. "It is relatively simple, safe, and highly effective."

The American Society of Hypertension's call for a new, broader definition of hypertension could sharply increase the use of drug therapy. Current practice defines hypertension using blood pressure cut points. BP should be reduced below 140/90 for the general population and below 130/80 for patients with diabetes or chronic renal disease.

Illinois R.Ph. sues over dispensing rule

State and federal regulators are beginning to question discounts greater than 90% on drugs used in hospitals. The practice, called nominal pricing, could affect drug prices paid by Medicaid.

Terminally ill with cancer, David Pruiett decided to end his life under Oregon's Death with Dignity Act. He went through the legal process, got the lethal prescription in late January, swallowed the liquid laced with powder from 100 barbiturate pills, and fell asleep. Three days later, he woke up and asked his wife why he wasn't dead.

Pharmacists are not pleased with the first Part D contracts they have been receiving from pharmacy benefit managers and prescription drug plans (PDPs). They offer some of the lowest reimbursement rates in memory. Contracts reviewed by Drug Topics call for reimbursement at average wholesale price minus as much as 45% plus dispensing fees as low as $1.

Numerous market obstacles hinder the quest for patient loyalty and compliance. But those manufacturers and pharmacies that manage to win their patients' loyalty stand to gain considerably from their efforts.

The next time you walk into a chain or mass-merchandiser pharmacy, don't be surprised if you find a clinic. Two separate entities, MinuteClinic and WellnessExpress Clinic, are forging partnerships with pharmacy chains, mass merchants, and corporations.

Quad/Graphics, West Allis, Wis., one of the largest printing companies in the United States, spent approximately $6,000 per employee on medical costs last year. This is 30% less than that spent by the average employer in the state. Do these stellar stats have anything to do with the fact that the company provides most of this health care itself?

Companies are, for the most part, in favor of the U.S. government allowing American citizens to purchase prescription drugs from Canada, judging from the results of the 2005 Arxcel Prescription Benefit Research Survey.

T o counter the rise in drug counterfeiting, three states now have prescription drug pedigree laws on their books, another 15 have similar legislation in the pipeline, and the Food & Drug Administration is threatening to enforce its long- dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees by the end of 2006.

Neutropenia—the lowering of the white blood cells that fight infections—is a major dose-limiting side effect of systemic cancer chemotherapy. Neutropenia with fever, or febrile neutropenia, often requires hospitalization for further evaluation and the administration of broad-spectrum antibiotics. In addition to negatively impacting the patient's quality of life, such complications can result in chemotherapy delays or dose reductions, which may compromise clinical outcomes.

Although 65 million Americans have hypertension, nearly 70% of U.S. patients do not have their blood pressure (BP) controlled to goal. "We need to do a better job getting patients to understand that uncontrolled BP is associated with an increased risk of cardiovascular events, vascular disorders and endothelial dysfunction, metabolic syndrome and Type 2 diabetes, target organ damage, and dementia," said Thomas Giles, M.D., a professor of medicine at Louisiana State University School of Medicine in New Orleans. Giles addressed a media briefing on hypertension guidelines that was held recently in New York City. The event was sponsored by Novartis.

The Food & Drug Administration recently approved exenatide (Byetta, Eli Lilly/Amylin Pharmaceuticals) as adjunctive therapy to improve glycemic control in those with Type 2 diabetes who are taking metformin, a sulfonylurea, or a combination of both. Exenatide is a synthetic analog of a peptide found in the saliva of the Gila monster, a poisonous lizard. The drug is currently available in pharmacies.

To help pharmacies meet the legislatively mandated goal of providing useful written consumer medication information (CMI) to patients by 2006, the FDA has issued a draft guidance. The guidance gives recommendations not only on what drug information should be provided to consumers, but also in what sequence, type size, etc. If pharmacies' voluntary CMI efforts fail to meet FDA standards by next year, the agency could resort to a mandatory approach. For more information, refer to the May 26 Federal Register or click on www.fda.gov/cder/guidance/index.htm.

Distributors of diverted drugs indicted

Consultant pharmacists can find plenty to like about Medicare Part D. The new prescription benefit that debuts next Jan. 1 is still provoking questions, but the overall impact on long-term care (LTC) pharmacy seems to be positive. "There are several very positive aspects in medication management and prescription drug plans [PDPs] for both long-term care pharmacy and long-term care pharmacists," said Tom Clark, director of policy and advocacy for the American Society of Consultant Pharmacists.