Quality Problems Lead to Shortages

Ask any hospital pharmacist in America about current drug shortages and you are likely to hear a tale of woe and intrigue. Most have never seen anything like this crisis during their professional careers.
The latest disaster was triggered by an FDA inspection of a generic manufacturing plant in Ohio. The Ben Venue Laboratories flunked because there was mold on the walls, rust from aging equipment falling into the medication and other violations of good manufacturing practice.
The two essential cancer drugs this plant was making, methotrexate and doxorubicin, have been in short supply for weeks. The FDA scrambled to find replacement supplies from Germany and India.
Over the last couple of years the agency has found quality problems with both brand name and generic production facilities in the U.S. Even though manufacturers in this country expect FDA inspections every two years, many have allowed their facilities to deteriorate. Erin Fox, PharmD, an expert in drug shortages at the University of Utah, told NPR reporter Richard Knox that most people don’t realize how decrepit many U.S. drug plants are, especially those that make generic drugs.
We suspect that cutthroat competition has contributed to this situation. People who purchase medications usually have no way of judging the quality of a generic drug, and in any event, they have long been assured by the FDA that generic medicines are identical to their brand name counterparts. As a result, buying decisions by pharmacies and mail-order suppliers are based in large measure on price.
Foreign manufacturing has intensified the competition. The FDA estimates that 80 percent of the raw ingredients in our medications comes from other countries such as China, India, Brazil or Romania. Inspecting plants in such far-flung locations is logistically difficult and the FDA does not have the resources to monitor drug quality.
Visitors to the website www.PeoplesPharmacy.com have shared their frightening generic drug experiences. One person has epilepsy: “I was controlled for five years on Keppra (brand name) until my insurance switched me to the generic. I started seizing again. My doctor said he has found the generic to be less effective and switched me back to the brand.”
Another reported difficulties with a blood pressure medication: “I have been on Catapres patches for several years to control high blood pressure. My insurance company switched me to generic clonidine patches without my knowledge or consent. Within 36 hours of switching to the generic my blood pressure was out of control, over 200/100. My doctor switched me back to the name brand, and within 24 hours my blood pressure was back to normal.”
Patients need not reject all generic drugs. They can be helpful in many cases. But people should be informed about the potential for problems.
To learn more about the generic drug controversy, we suggest our new book, Top Screwups Doctors Make and How to Avoid Them, available in libraries, bookstores and online. It should come as little surprise that if companies right here in the U.S. are having quality control problems despite FDA inspections, manufacturing plants abroad may sometimes fall short of good manufacturing practices.