By Frank Goldman, PharmD.
Some of the prescription medications we take may have traveled thousands of miles to reach our prescription bottles. As many as one in every five generic drugs sold in the United States and more than 40% of the active ingredients in medications made here now originate from India or China.
Unfortunately, measures to ensure that these products are safe have not gone the extra mile. In 2008, 81 people died and hundreds were sickened in the United States from tainted heparin, a widely used blood thinner, which was manufactured in China.
The drug contained a cheap additive that wasn’t recognized through normal testing, and the U.S. Food and Drug Administration (FDA) didn’t inspect the facility that produced it until after the crisis.
The United States has imported drugs and ingredients from Europe and Japan for many years and has a track record with regulators there. But in countries where regulations are weaker--- and officials are often corrupt---the FDA can’t rely as much on its foreign counterparts to ensure safety.
While the FDA conducts surprise inspections of all U.S. drug makers every two years, limited resources and other obstacles have meant such inspections are only rarely conducted in foreign manufacturing facilities. What’s more, these foreign inspections are done after giving companies advance notice.
Frank Goldman is the McCready Memorial Hospital Pharmacist.
|