More pitfalls appear in Part D contracts
August 8th 2005The 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.
Top docs stump for Medicare Rx benefit
August 8th 2005CDC 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.
First race-specific drug approved for heart failure
August 8th 2005In 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.
GPhA's Jaeger envisions strong 2006 for generic market
August 8th 2005The 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.
Medicare Part D to require disclosure of generic options
August 8th 2005As 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.
Generic drug names: Fertile groud for errors?
August 8th 2005Confusion 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.
PBMs are driving up generic utilization
August 8th 2005A 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."
Biogenerics at the gate waiting for the FDA to act
August 8th 2005Generic 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.
Generic manufacturers riding a wave of market consolidation
August 8th 2005Like 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."
Cerner/Bridge merger dominates news at ASHP
July 25th 2005Acquisitions, 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.
Walgreens, R.Ph. union still wide apart on contract terms
July 25th 2005About 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
CPT code for MTM reflects new reimbursement arena
July 25th 2005In 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.
Is there a new role for R.Ph.s in postmarket surveillance?
July 25th 2005A 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.
The latest word on penicillin allergy
July 25th 2005Editor'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 treat or not to treat: Managing chronic insomnia
July 25th 2005To 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?
This HIV drug offers option when other therapeutics fail
July 25th 2005Based 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.
R.Ph. involvement improves A1c levels in Type 2 diabetes
July 11th 2005Involving 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.
NACDS show offers treasure trove of new products
July 11th 2005A 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.
IOM panel begins review of Rx drug safety
July 11th 2005An 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.
Ignorance no defense in HIPAA criminal violations, say feds
July 11th 2005Just 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).
State pedigree laws running into some barriers
July 11th 2005As 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.
Hospital R.Ph.s weigh in on new JCAHO patient safety goals
July 11th 2005Communications 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.