PHARMACY

‘Doughnut hole’ gap’s impact on adherence spells opportunity for community pharmacy

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT — The study’s findings that the Part D coverage gap — or “doughnut hole” — led to a significant gap in the adherence of cardiovascular medications may not come as a complete surprise; however, it undoubtedly underscores the important role that pharmacy can play in helping patients navigate plan strategies that promote the use of lower-cost medications.

(THE NEWS: Study unveils drop in adherence to cardiovascular meds during ‘doughnut hole’ gap. For the full story, click here.)

As the article states, Medicare Part D beneficiaries with cardiovascular conditions who had no financial assistance during the "doughnut hole" coverage gap were 57% more likely to discontinue their cardiovascular medications than those beneficiaries who had consistent drug coverage.

That is a significant drop, and it is especially alarming when you look at some of the stats. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both men and women. In 2008, more than 616,000 people died of heart disease; it caused almost 25% of deaths — almost 1-in-4 — in the United States. Furthermore, the agency stated that, in 2010, coronary heart disease alone was projected to cost the United States $108.9 billion. This total includes the cost of healthcare services, medications and lost productivity.

The study’s research team noted that cardiovascular drugs accounted for the largest proportion of spending (25%) and prescription volume (36%) in the Part D program.

While the study found no increase in short-term negative health issues during the coverage gap, the long-term health impact of nonadherence to cardiovascular drugs during the coverage gap is unclear, according to researchers. OK, the long-term health impact may not be clear — at this point — but it is hard to imagine that a lack of adherence would lead to a positive outcome. After all, it is well-known that annual excess healthcare costs, because of medication nonadherence, in the United States are estimated to be as much as $300 billion annually.

Clearly, helping patients with plan strategies that promote the use of lower-cost medications is critical and is yet one more way in which community pharmacy can help patients live healthier lives.

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PHARMACY

Watson seeks approval for generic Type 2 diabetes drug

BY Alaric DeArment

PARSIPPANY, N.J. — Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

Watson said Thursday that it had filed with the Food and Drug Administration for approval of a generic version of Depomed’s Glumetza (metformin hydrochloride extended-release tablets) in the 1,000-mg strength.

In response, Depomed and a division of Valeant International filed suit against Watson Wednesday in the U.S. District Court for the District of Delaware, alleging that Watson’s application infringes two patents covering Glumetza. Under the Hatch-Waxman Act, the suit puts a stay of FDA approval on Watson’s drug for 30 months, or until Watson and the companies suing it settle the case.

 


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GPhA signs on with IMS Health to address drug shortages

BY Alaric DeArment

WASHINGTON — A trade organization representing generic drug manufacturers announced Thursday its latest solution to the problem of drug shortages.

The Generic Pharmaceutical Association announced a partnership with IMS Health, whereby IMS will serve as the independent third party in the Accelerated Recovery Initiative, a program the GPhA announced in December 2011 that is designed to use real-time supply and distribution information to help manufacturers, wholesalers, distributors, the Food and Drug Administration and group purchasing organizations understand current conditions and expand the supply of critical medications to patients who need them. At the time of the announcement of the ARI, the GPhA said it would involve an "independent third party," but didn’t specify which company that would be.

IMS, which provides data-mining and analysis services to drug manufacturers, will collect and process information from generic drug companies in order to identify where shortages are and where they are likely to develop, and then send the information to the FDA.

Manufacturers will provide funding for the project, with costs "somewhere in the several hundred-thousand range," GPhA president and CEO Ralph Neas said.

"As an established industry leader with decades of experience, IMS is ideally suited to fill this critical role," Neas said. "IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process and communicate the complex manufacturing data the ARI requires will be essential to the initiative’s success and will strengthen the entire healthcare industry’s collective ability to increase communication and supply patients with the medicines they need."

The Obama administration announced in October 2011 that it would seek to address the problem of drug shortages. As of that time, the FDA and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to IMS, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain, and more than 80% are injectables and generics.

Since then, the FDA has taken various actions to address shortages. In February, the agency sought to address shortages of the chemotherapy drug Doxil (doxorubicin hydrochloride liposome) by temporarily allowing India-based Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Labs, to import an identical drug, Lipodox, after a shortage of Doxil resulting from the closing of drug maker Ben Venue’s manufacturing plant in Bedford, Ohio.

The FDA also gave expedited review to APP Pharmaceuticals’ preservative-free methotrexate, used to treat leukemia in children and osteosarcoma, as well as autoimmune disorders, while Hospira released a month’s supply of 31,000 vials of the drug, and the agency said it would work with Mylan, Sandoz and other companies to increase production.

The GPhA also is hoping for passage of the Generic Drug User Fee Act, which will provide the FDA with $1.5 billion of additional funding and reduce the amount of time it takes to review generic drug and supplement applications by nearly two years.

 


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