By Francesca Lunzer Kritz
While medical and pharmacy groups and others slug it out over how to improve patient information leaflets, consumers don’t have to settle for out-of-date or incomplete drug data.
The Food and Drug Administration (FDA) makes about 1,000 changes to drug labels each year, some of them of vital importance to patients.
When your doctor prescribes a drug, you can ask which version of the PDR (the Physicians’ Desk Reference, which contains the FDA-approved prescribing information for most drugs) he or she subscribes to: the online edition (updated monthly) or Personal Digital Assistant version (updated daily). The printed version, which is what most doctors have, is updated only three times each year and may be out-of-date when your drug is prescribed. Ask your doctor to check for the latest information.
Most pharmacies have a book called Facts and Comparisons, which lists more drugs than does the PDR and is updated monthly. You can ask the pharmacist to check the book or its software program to see if there have been any label changes to the drug you’re picking up.
For the most complete information, ask your pharmacist for a copy of the “prescribing information” (PI) for the drug you’re getting. That’s the information regulated by the FDA that’s intended for doctors. It may be hard to navigate — and a little scary since it lists virtually all potential side effects, regardless of how rare. Ask your doctor or pharmacist for help deciphering what you need to know. You can find the most up-to-date version of the PI online by going to your drug maker’s Web site and searching for the name of your drug. Drug makers are required to post this information and update it whenever changes are required by the FDA.
Consumers can also check the FDA Web site for some label changes. Important changes are listed at www.fda.gov/medwatch. For the most recent changes, click on “What’s new in the past two weeks.” Older information, arranged by year, can be found by clicking on “Safety Information.” If you don’t mind lots of extraneous information, the FDA will send you a periodic newsletter, dispatched when there are significant changes to report. Sign up at www.fda.gov/medwatch/elist.htm.
FDA-mandated label changes come after weeks or months of negotiation with the drug companies. You can sometimes get some earlier information about new risks — or benefits — of a drug at medlineplus.gov. Click on “More News” and then “Health News by Topic.” From there, “About Your Medicines” links you to news articles about medications, which often include information on early research, label changes and newly identified concerns about a drug.
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