PHARMACY

Drug store pharmacists want in on vaccine game

BY Allison Cerra

CHICAGO Prompted by fear of a severe outbreak of H1N1, Illinois health officials, along with other states, temporarily allowed pharmacists to administer vaccine shots to children ages 9 years old. Now, drug stores are looking to get rid of the age restrictions altogether.

According to a recent report by the Chicago Tribune, Walgreens and CVS are lobbying for the restrictions — which prohibit pharmacists from administering seasonal and H1N1 flu vaccinations to children under the age of 14 — to be lifted, so that pharmacists can aid the government prepare against future pandemics, but also provide consumers easy access to thousands of sites at an affordable cost, the retail chains said.

 

"We proved last year with our seasonal flu and H1N1 shots that a pharmacy can be a critical access point for Americans to get their vaccines at a low cost and (with) more convenience," said Kermit Crawford, Walgreens’ EVP pharmacy. "How many doctor’s offices are open on Christmas Eve, Christmas Day and New Year’s Day? We are re-engineering the existing model."

 

Retail health clinics, like Take Care and MinuteClinic, also offer inoculation for flu and H1N1, in addition to other services at a reasonable price.

 

"MinuteClinic is able to offer vaccines to both children and adults in the retail pharmacy setting because of the scope of practice of our nurse practitioners," Andrew Sussman, president of CVS Caremark’s MinuteClinic subsidiary, was quoted as saying. "This includes vaccines for flu, hepatitis, measles and pneumonia, among others. In most states, this is beyond what pharmacists can administer, so we believe that the combination of MinuteClinic nurse practitioners and CVS pharmacists provides our customers with the most convenient access."

 

The physician community, however, sees the situation differently. Many believe that state health officials should make it a requirement for pharmacists to collaboratively work with doctors, since pharmacists may be unaware of a patient’s medical history.

 

"The practice of medicine benefits from a team-based approach, and pharmacists are valuable and necessary members of the healthcare delivery team," said Dr. Edward Langston, a member of the American Medical Association board of trustees, to the Chicago Tribune. "When working in collaboration with physicians, pharmacists can play an important role in helping to improve community health."

 

 

Added Patrick Tranmer, president of the Illinois Academy of Family Physicians, "[A healthcare provider] needs to take into account the patient’s whole life, the whole medical history. Their role is to understand possible drug interactions. Their role isn’t in the decision-making on what medication is appropriate in the context of the patient’s entire medical history."

 

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Report: Lawmakers seek to revise patent system

BY Alaric DeArment

NEW YORK Lawmakers in Washington have taken steps to reform the U.S. patent system, according to published reports.

Reuters reported Thursday that Senate Judiciary Committee chairman Sen. Patrick Leahy, D-Vt., and other members Congress had reached an agreement on patent reform, introducing a bill that would allow the patent office to set its own fees and allow judges decide the importance of an infringed patent as part of a product.

Drug companies, which depend on small numbers of patents, have opposed the effort, while large computer and hardware companies have supported it, Reuters reported.

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KV’s Ethex to plead guilty to criminal charges

BY Alaric DeArment

ST. LOUIS The generic drug marketing and distribution division of KV Pharmaceuticals will plead guilty to criminal charges and close shop under a deal between KV and the Department of Justice, KV announced Thursday.

The generic drug maker said Ethex will plead guilty to two felony counts and pay $27.6 million to resolve a criminal investigation of the company that began amid allegations that it failed to file field alerts to inform regulators of manufacturing problems with the drugs dextroamphetamine and propafenone in 2008. The payment includes a fine, $2.3 million in restitution to the federal government and an administrative forfeiture of $1.8 million.

“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward,” KV interim CEO David Van Vliet said in a statement. “Management and the board have been working diligently to address this issue, and we are looking forward to having this matter resolved.”

Ethex recalled a large number of generic drugs in late 2008 and early 2009 due to problems such as possibly oversized tablets and manufacturing deficiencies. In March 2009, the Food and Drug Administration filed an injunction against KV to prevent it from making or distributing adulterated and unapproved drugs and forced it to destroy all the drugs it had recalled, forbidding it from resuming manufacturing until the FDA was satisfied that it had been brought back into compliance with regulations. KV said the current settlement would allow it to continue manufacturing once it had regained compliance with the FDA’s current good manufacturing practices regulations, also known as cGMP.

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