Pharmacists employ grassroots efforts to officially recognize pharmacists as healthcare providers
NEW YORK — A St. John’s University College of Pharmacy and Health Sciences Doctor of Pharmacy Candidate last week picked up on a petition to recognize pharmacists as healthcare providers and filed the petition on the Obama Administration’s "We the People" web site, according to a report published online by The Pharmacopedia.
The petition, filed by Steve Soman, is a replication of a similar charge started Dec. 11, 2011 on Change.org by pharmacist Sandra Leal. The movement even has its own Facebook page.
To date, the Change.org petition has garnered 21,951 signatures, 3,049 shy of a 25,000 signature goal. The "We the People" site has generated 1,052 signatures to date. That petition needs to reach 25,000 signatures by the end of January in order to qualify for an official White House response.
Both petitions are seeking to qualify pharmacists as healthcare professionals under the Social Security Act. "Despite overwhelming evidence of the positive impact pharmacists can have on patient health, pharmacists are not recognized as healthcare providers under the Social Security Act and therefore cannot be paid by Medicare for therapy management and patient consultation services," the petition reads. "The Social Security Act does recognize other healthcare professionals such as dieticians, nurse practitioners, physician assistants, nurse midwives and clinical social workers."
For the full Pharmacopedia report, click here.
FDA approves Bristol-Myers Squibb’s Eliquis to reduce risk of stroke, blood clots
PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.
Atrial fibrillation — one of the most common types of abnormal heart rhythm — is an abnormal, irregular and rapid beating of the heart in which the heart’s two upper chambers (i.e., atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.
“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.
FDA approves Mylan’s generic Maxalt MLT tablet
PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck’s Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and was awarded 180 days of marketing exclusivity.
"Mylan’s immediate launch of the first generic rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and the company’s simultaneous launch of rizatriptan benzoate tablets, 5 mg and 10 mg, further demonstrates our commitment to continue expanding access to high-quality medicines for patients who need them in the U.S. and around the world. We look forward to continue growing our portfolio of more than 1,100 generic pharmaceutical products to further support this cause," said Mylan CEO Heather Bresch.
Currently, Mylan has 183 ANDAs pending FDA approval, representing $79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ended June 30, 2012, according to IMS Health.