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The Center for Medicare & Medicaid Services is now reviewing proposals from prescription drug plans (PDPs) interested in becoming Medicare Part D sponsors. At the same time, pharmacies are receiving contracts as competing PDPs build the pharmacy networks needed to implement their proposals.

Parmacists could begin selling generic versions of brand-name biologics between 2007 and 2012. So projected speakers at the American Association of Pharmaceutical Sciences' 2005 National Biotechnology Conference, held recently in San Francisco. But the new versions of insulin, human growth hormone, and other products, while less expensive than innovator products, won't be the 70% to 90% less that the industry has come to expect from generics.

Sometime in the next year—when details are ironed out—QLT Inc., Vancouver, Canada, plans to launch Aczone (dapsone 5% gel) for the topical treatment of acne vulgaris. The product was approved in July, but QLT is pondering how best to work with the labeling required by the Food & Drug Administration. "We might wait [to launch] until we have phase IV data," said Mohammed Azab, M.D., chief medical officer of QLT. Phase IV trials evaluating this issue are slated to begin this year.

Over the past five years, the number of counterfeit drug cases in the United States has skyrocketed. Between 2000 and 2004, the number of counterfeit drug cases initiated by the Food & Drug Administration's Office of Criminal Investigations rose by more than 900%, from just six cases in 2000, to 58 cases in 2004.

DEA has issued a final rule regarding the reporting of theft of controlled substances (CSs). DEA said pharmacists should notify DEA in writing of any theft or significant loss of CSs within one business day of discovery of the incident.

The FDA has issued a Public Health Advisory highlighting the risk of sepsis in patients undergoing medical abortion using Danco Laboratories' mifepristone (Mifeprex) and misoprostol in a manner that is not consistent with the approved labeling.

The Medicare Part D prescription drug benefit remains on track to debut next Jan. 1, but questions abound. Independents and smaller chains worry about access as pharmacy benefit managers and prescription drug plans (PDPs) pressure pharmacies to sign preferred provider network contracts.

CDC director Julie Gerberding, M.D., and Surgeon General Richard Carmona, M.D., were among the Health & Human Services officials touting the Medicare Part D benefit at the Massachusetts College of Pharmacy and Health Sciences in Worcester during a national bus tour.

In a controversial move, the Food & Drug Administration notified manufacturer NitroMed Inc., Lexington, Mass., in June, that its lead drug, BiDil (isosorbide dinitrate/ hydralazine), has been approved for the treatment of heart failure in African-Americans.

The generic pharmaceutical industry is poised for tremendous growth over the next several years. Industry observers expect several factors to drive the market, including: the Medicare Part D prescription drug plan, generic versions of innovator drugs that are coming off patent, industry consolidation, and growth in the biogeneric field. Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA), spoke with Drug Topics recently about some of the hot issues impacting the generic pharmaceutical industry.

As the countdown on different statin drugs' licenses continues, so do the plans for generic formulations. A generic formulation for simvastatin (Zocor) has received tentative approval, and others are expected to follow.

As part of Medicare Part D, prescription drug plans (PDPs) must ensure that pharmacies inform enrollees of the price differential between a brand-name drug and the lowest-priced generic version when a covered drug is involved. The program begins Jan. 1, 2006, and PDPs have been preparing for the transition for months.

Confusion over look-alike drug names continues to worsen as more and more medications reach pharmacy shelves. While much of the attention has focused on brand-name drugs, mix-ups over generic names also result in serious medication errors, posing a threat to patient safety.

A clear sign that generics are now part of the mainstream of the healthcare industry is that they are now the drugs of choice of most pharmacy benefit managers. It's a strategy that is paying off well for the PBMs. "It's a clear win-win situation," said Steve Littlejohn, VP of communications for the PBM giant Express Scripts. Its 54% generic utilization rate is the highest in the industry, he said. "Our customers want us to use generics. Studies show that for every 1% increase in generic utilization, there's a 1% drop in drug-cost trends."

Generic drug manufacturers are in a high-stakes waiting game with the Food & Drug Administration, anxious to act once the agency outlines an application process for the creation of generic equivalents to biopharmaceuticals. "We are at a similar crossroads today with respect to generic biopharmaceuticals as we were in 1984 with respect to traditional pharmaceuticals," said attorney William B. Schultz, a partner with Zuckerman Spaeder in Washington, D.C. He has testified before Congress on behalf of the Generic Pharmaceutical Association about the laws governing biologic medicine. "The generic pharmaceutical industry is convinced the savings resulting from competition can be applied to the biopharmaceutical industry," he said.

Like most maturing markets, the generic industry is experiencing a groundswell of international mergers and acquisitions. "Generic manufacturers are looking increasingly attractive for acquisition and consolidation," said attorney David Balto, a partner with Robins, Kaplan, Miller, & Ciresi in Washington, D.C., and a former policy director of the Federal Trade Commission's Bureau of Competition. "We anticipate a significant increase in consolidation events in coming years. It's part of a natural course of market growth."

Changing market conditions are catapulting pharmacists into the pivotal role of patrolling a third class of drugs.

Acquisitions, integration, and point-of-care strategies were dominant technology themes at the 2005 ASHP Summer Meeting in Boston in June. Topping the headlines was Cerner Corp.'s acquisition of Bridge Medical Inc. The $11 million deal will substantially expand Cerner's presence in the bar-code market at a time when pressure from regulatory agencies is driving hospitals to reduce medication errors.

About 20% of Chicago staff pharmacists at Walgreens have resigned from the National Pharmacists Association (NPhA) as talks between the union, Walgreens, and a federal mediator failed to produce an agreement. About 1,200 Walgreens union pharmacists in northern Illinois and northwest Indiana walked off their jobs at 10 PM on July 11

Changing market conditions are catapulting pharmacists into the pivotal role of patrolling a third class of drugs.

In the world of medical reimbursement, having a "CPT code" for a type of professional effort or procedure is much like having its existence recognized. Medication therapy management (MTM) services by pharmacists crossed that threshold on July 1, when the American Medical Association's official list of procedures added three codes for MTM?initial service, subsequent service, and additional time, each in 15-minute blocks?in its chapter on cognitive services.

A key drug safety researcher says the electronic systems that pharmacists use to talk to one another may be a powerful tool for postmarket safety surveillance. The organizations he works with are doing pilot studies to explore that possibility.

Editor's note: Our April 18 cover story, "Staving off allergies," drew so many inquiries from readers about the issue of the risk of cross-sensitivity with penicillins and cephalosporins that we invited Michael E. Pichichero, M.D., the source of our information, to explain the subject in greater detail below.

To sleep: perchance to dream: ay, there's the rub," wrote Shakespeare in Hamlet several centuries ago. And that still appears to be true: According to recent estimates, about 20% of the American population is afflicted with intermittent or chronic sleep problems. But how much of a health problem is this?

The symptoms sound innocuous?uncontrolled laughing and crying?but its effects can be seriously disabling in social and occupational settings. Pseudobulbar affect (PBA), also known as emotional lability, is believed to affect up to one million patients with neurological disorders, including amyotrophic lateral sclerosis (ALS), multiple sclerosis, Alzheimer's disease, and stroke. Currently there are no approved treatments for this condition.

Based on early data from clinical trials, the Food & Drug Administration's Antiviral Drugs Advisory Committee recommended tipranavir (Aptivus, Boehringer Ingelheim) for accelerated approval in May. The product was approved in June and is now available through wholesalers. Although not a first-line drug for HIV, tipranavir, a protease inhibitor (PI), could be an important option for a subset of patients with advanced disease.

FDA issues public health advisory on fentanyl patch The FDA has issued a public health advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued, identifying several important safety precautions for the use of fentanyl transdermal patches.

Formularies under Medicare Part D

Involving clinical pharmacists in the management of patients with diabetes results in improvements in A1c levels, blood pressure, and lipid profiles. So reported investigators at the 65th annual scientific sessions of the American Diabetes Association (ADA). Management models that incorporate pharmacists can also reduce healthcare utilization and cost of care.