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?