Why can’t pharmacies let patients know when there is a problem with a prescription drug? In the last few years there have been an amazing number of recalls because of quality control problems. Both Ranbaxy Laboratories and Wockhardt have had import bans imposed. So have Sun Pharmaceuticals and Marck Biosciences.
Earlier this year, when Dr. Reddy’s Laboratories and Wockhardt each recalled large lots of the heart medicine metoprolol, pharmacies were required to take the bottles off their shelves but no patients were notified. That’s because the FDA considered this a Class II recall, “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.” In other words, it might make you sick but won’t kill you.
When ground glass was found in atorvastatin pills (generic for Lipitor), the manufacturer Ranbaxy had to recall millions of pills. Because this too was a Class II recall, most patients were not notified.
Even people who were paying attention had a difficult time determining if their medicine was in the affected lots. Pharmacists rarely if ever include lot numbers on the label of generic pills.
That stands in contrast to over-the-counter medications or consumer goods such as cereal, soup or peanut butter. They all have lot numbers on the label that consumers can check if there are problems.
We recently received a phone call from the supermarket chain where we shop. The automated voice told us about a nut butter recall. It was a brand we sometimes buy, and the call listed lot numbers and expiration dates so we could check our pantry. The computerized call even told us how to contact the manufacturer with any questions and what to do if we had an affected jar (take it back to the store for a refund).
Why can’t pharmacies do the same thing when there is a drug recall? Drugstores collect a lot more information about us as customers than grocery stores. To get a prescription filled, you’ll likely need to supply the name of your insurance company, along with your own name, age, address, date of birth and phone number.
Yet in the event of a Class II recall you probably will not be notified and no refund will be offered. Even though the affected pills wouldn’t kill you, if the FDA determines that the problem is serious enough to require taking medicine off pharmacy shelves, why shouldn’t we take them out of our medicine cabinet?
If you notice something wrong with your pills, you are encouraged to report the problem to the FDA through its MedWatch website. The form requires the manufacturer, lot number, expiration date and NDC (national drug code). Your drug label might have the manufacturer, but rarely, if ever, is there a lot number or an expiration date. There is a “discard date,” usually one year from the dispense date.
To have all critical information, especially lot number, on your prescription drug label will take an act of Congress. We also think country of origin information would be useful. Most of our medications are now manufactured abroad. If your pajamas and your pears have to reveal where they came from, why not your prescriptions?
