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When Things Aren’t Done Right

Wednesday, June 16th, 2010

I recently read an article in USA Today with the headline “The FDA Warned At Least 43 Drug Plants In Recent Months Over Manufacturing Practices.” The story reported the following: “At least 43 drug factories supplying medications to thousands of U.S. consumers have received government warnings in recent months for failing to correct shoddy manufacturing practices that may have exposed patients to health risks.”

The violations “include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.” From 2002 to 2006, “more than half of inspections at domestic drug plants and 62% at foreign plants supplying the US had violations that didn’t prompt warning letters, but were classified as requiring correction, FDA data published by the Government Accountability Office show. The FDA declined to provide more recent numbers.”

As I read this disturbing news item—and thought about who is responsible for the recent Gulf oil spill—I asked myself, how important is external oversight to assuring that any activity is done appropriately?
 
For example, do we need an accreditation program of community pharmacies, as now being debated in our profession? It is easy at one level to say, “I know what I am doing and I always do it correctly.” But as you think about the examples where things were not done right, it makes this type of discussion worth having. 
 
Do you think a voluntary accreditation program is needed for community pharmacy?

Fred Eckel
Editor-in-Chief
Pharmacy Times

Blog Info
Fred Eckel, RPh, MS, Editor-in-Chief of Pharmacy Times
Blog Description
This blog focuses on what our Editor-in-Chief sees as the future of pharmacy.
Author Bio
Fred Eckel, RPh, MS, is the Editor-in-Chief of Pharmacy Times, a position he has held since 2002. Mr. Eckel is a professor at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He serves as executive director of the North Carolina Association of Pharmacists.

In this blog, Eckel will provide commentary on relevant issues impacting pharmacists and pharmacy professionals, including the merging of pharmacy benefit managers, the implications of health care reform, the conversion of major drugs from prescription to over-the-counter, trends in pharmacy careers, and opioid abuse. He will also discuss legislative issues that impact pharmacists, and comment on the evolving role of the pharmacist.
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