Article Published by LECOM Pharmacy Faculty stirs up FDA reporting issues.
Study on the effectiveness of US Food and Drug Administration medication reporting policies has generated a new debate on the effectiveness of the FDA policies.
A study on the effectiveness of US Food and Drug Administration medication reporting policies has generated a new debate on the effectiveness of the FDA policies.
The prestigious Archives of Internal Medicine just published an article written by Abby Powers, Pharm. D. and Elliott Cook, Pharm. D. of the Lake Erie College of Osteopathic Medicine School of Pharmacy.
Since the article was released Monday on the Archives web site, the story has been picked up by the New York Times and other publications. http://prescriptions.blogs.nytimes.com/2011/11/15/f-d-a-is-urged-to-issue-more-alerts-about-drug-risks/
Since 2007, federal law requires the FDA to review adverse drug reports bi-weekly and issue a quarterly report on any new safety information or potential signal of a serious risk. Dr. Powers and Cook studied the quarterly reports between 2008 and 2010. They determined that half of the reported risks resulted in label changes, which meant the drug manufacturer had to report the risk on the medication, and in at least one case, the drug was removed from the market.
They noted that concern exists because the FDA does not recommend physicians take action on the potential signal of risk in these quarterly reports. According to the authors, this leads to confusion among health care providers. “It is time we better recognize the importance these signals for the safety of the publiceven if it they are just a “potential” signal,” the authors concluded.
Contact Dr. Elliott Cook (814) 860-5113 at LECOM campus
Dr. Abbey Powers (814) 868-7743 (Millcreek Community Hospital Pharmacy)
Contact: Pierre Bellicini, Lake Erie College of Osteopathic Medicine, Media Relations, (814) 868-8121, (814) 866-8408 Fax, pbellicini@lecom.edu
The Lake Erie College of Osteopathic Medicine and LECOM School of Pharmacy offer innovative and affordable education in osteopathic medicine and pharmacy. From campuses in Erie, Pennsylvania, Greensburg, Pennsylvania and Bradenton, Florida, LECOM provides student-centered pathways to prepare the next generation of healthcare professionals. Prepare yourself for medicine as your life’s profession.
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