Clinical News

Of the 1,100 public hospitals that treat a disproportionately large share of indigent patients and that are eligible to participate in the federal government's 340B drug discount program, about 700 are not enrolled. This means that up to 63% of disproportionate share hospitals (DSHs) are not taking advantage of potential discounts.

Patients requiring immune globulin (IG) are finding the therapy difficult to acquire because of tightening supplies of the plasma-derived biologic and new, lower Medicare reimbursements, according to patient groups and industry analysts.

New guidelines for the management of heart transplant patients are coming from the International Society for Heart & Lung Transplantation (ISHLT). "The last version of the currently advocated guidelines was approved in consensus form in 1992," said Mandeep Mehra, M.D., an ISHLT board member and the head of the division of cardiology at the University of Maryland School of Medicine in Baltimore. "Since that time, the management of congestive heart failure [CHF] has changed dramatically," he said.

A 75-year-old woman, G.D., is in the ER for chest pain that has now been diagnosed as heartburn. She is given lansoprazole (Prevacid, TAP) samples. Five months ago she had an acute myocardial infarction (MI) with stent placement. She was discharged on a daily regimen of clopidogrel (Plavix, Sanofi-Aventis) 75 mg, aspirin 80 mg, ezetimibe (Zetia, Merck/Schering-Plough) 10 mg, atorvastatin (Lipitor, Pfizer) 20 mg, sublingual nitroglycerin, metoprolol timed-release 50 mg, and valsartan (Diovan, Novartis) 160 mg.

This year's American Academy of Neurology (AAN) meeting featured key drug trials for diseases ranging from epilepsy to Alzheimer's disease (AD) to multiple sclerosis (MS). About 1% of all children up to the age of 16 are affected by epilepsy. Despite broadened and improved pharmacologic options, about 25% of these are refractory to standard therapy. Oxcarbazepine (Trileptal, Novartis), a newer antiepileptic drug (AED), has been assessed and found to be safe and effective both as monotherapy and adjunctive therapy in children.

Donald Goldmann, M.D., who has studied antibiotic resistance for 20 years, said community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is infiltrating hospitals and "it is a pandemic that will not be controlled. It is going to fundamentally alter how we use antibiotics and how we attempt to control them."

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.

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."

Pharmacists play a critical role in ensuring patient safety. They detect and report medication errors, counsel patients, and educate other healthcare personnel. But two common communication problems?lack of a shared definition of error and of agreement as to the role and scope of the pharmacist's work?coupled with inadequate access to resources for managing the pharmacy workload prevent R.Ph.s from fulfilling their key role.

A 30-year-old African-American, B.H., is scheduled for hernia repair surgery at your hospital. In his admitting medical history, he acknowledges to your student that he is a heavy drinker and uses marijuana recreationally. Your student is suspicious that his recreational drug use may extend beyond marijuana. Will you recommend any modifications to your standard premedication/ anesthesia/postsurgery protocol?

At the recent annual meeting of the American Society of Clinical Oncology (ASCO), some 25,000 cancer specialists from around the world came to Orlando, Fla., to consider the latest advances in cancer care, treatment, and prevention. Novel targeted therapies for major cancers abounded, as did improvements in quality of life for patients suffering adverse effects from conventional therapy. Here are some highlights

A 40-year-old HIV-positive man, V.L., is hospitalized with Pneumocystis carinii pneumonia (PCP). His current viral RNA load > 50,000 copies/ ml, CD4 = 40 cells/mcl.

Scios Inc., a Johnson & Johnson company, has changed its package labeling to add data about deaths associated with its heart failure drug nesiritide (Natrecor) after studies in prominent medical journals raised questions about an increased risk of fatal renal problems. The Food & Drug Administration-approved label change, which stops short of an outright warning, indicated that in clinical trials 5.3% of the patients treated with nesiritide died, compared with 4.3% who took other agents, including diuretics and intravenous nitroglycerin. However, the new label states that the data might not be statistically significant because of the small number of patients involved.

Are hospitalized heart failure patients getting adequate discharge instructions, such as counseling on diet, exercise, medication management, and smoking cessation? Not according to the results of a new study released by the world's largest heart failure registry-ADHERE (Acute Decompensated Heart Failure National Registry).

A: Findings from the Womens Health Initiative (WHD) and other studies offered important information about the risks and benefits of long-term menopausal therapy. As a result, it is currently recommended that HRT be used only for the treatment of moderate to severe menopausal symptoms (vasomotor symptoms, symptoms of vulvar and vaginal atrophy) at the lowest effective dose and for the shortest duration of time consistent with a woman's individual treatment goals and risks. Results from these trials have prompted many women to seek alternatives to conventional HRT. One such alternative is bioidentical hormone replacement therapy (BHRT).

Sensing that the time has come for the profession to take responsibility for policing what many view as a pharmacist"s cherished prerogative—compounding—Kenneth Baker has accepted the job of implementing a way for compounding pharmacies to earn a stamp of approval from the Pharmacy Compounding Accreditation Board (PCAB).

The always high-interest Late Breaking Clinical Trials at the Annual Scientific Session of the American College of Cardiology, held in Orlando, Fla., were particularly notable this year. First, they included an unprecedented three individual sessions on the antiplatelet agent Plavix (clopidogrel, Sanofi-Aventis). Second, justifying the plunge to lower and lower LDL-cholesterol (LDL-C) targets, they included strong results for a trial of 80 mg of atorvastatin (Lipitor, Pfizer), and, finally, they featured a session with conflicting messages on the risks of COX-2 inhibitors.

How do you increase the dispensing rate of generic prescription drugs in a state that's in the backyard of some of the largest name-brand pharmaceutical companies? That was the dilemma facing Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare Services Inc., New Jersey's largest health insurer.

Compounding pharmacies were put on the defensive recently after a group of health organizations asked federal regulators to crack down on how the pharmacies market their products.

Everyone knows market competition isn't pretty, but the battle between Big Pharma and generic manufacturers is often downright nasty. That's especially true as some generic companies fight Big Pharma—and one another—to stop a practice they find particularly abhorrent: authorized generics. The only thing everyone agrees about is that no one knows where the issue goes from here—to Congress or the Supreme Court.

Everyone knows market competition isn't pretty, but the battle between Big Pharma and generic manufacturers is often downright nasty. That's especially true as some generic companies fight Big Pharma—and one another—to stop a practice they find particularly abhorrent: authorized generics. The only thing everyone agrees about is that no one knows where the issue goes from here—to Congress or the Supreme Court.

The Rx Outreach program, from Express Scripts Specialty Distribution Services Inc. (ESSDS), is the first prescription drug assistance program for generic drugs. Through the program, begun in November 2004, more than 108 million lower-income adults and children can purchase more affordable medications.

Employers like pharmacy benefit programs that encourage members to use generic equivalents—or do they? Two industry-sponsored studies show that the generic prescriptions are continuing to grow as a percentage of total prescriptions filled. However, another study of employer trends, by a nonprofit research firm, showed a decrease in the percentage of workers in the United States who belong to managed care plans that require the use of generic products when they are available.

Generic drug use varies widely by state, according to an Express Scripts study that measured per-capita generic drug utilization in 2003 using a random sample of approximately three million pharmacy benefit plan members.