Drug Warnings Too Often Ignored

Doctors are way too busy these days. Full waiting rooms and crammed schedules mean physicians rush from one patient to another with barely enough time to do scribble a prescription.
Because of this frenetic pace, many doctors don’t take much time to read drug labels. Surveys suggest that only one physician in ten actually reviews the official prescribing information that accompanies every medication.
Even more alarming, many doctors ignore the warning associated with some high-risk drugs or fail to follow the precautions.
A black box warning (BBW) is reserved for a small number of prescription medications. The FDA devised this BBW system to alert doctors to certain extraordinary dangers that require careful medical attention.
One example of such a warning is found with the anti-seizure drug Tegretol (carbamazepine). Doctors are informed that this medicine can cause very serious blood disorders and are encouraged to order pre-treatment blood tests and then monitor patients periodically.
A BBW that accompanies the diuretic triamterene (Dyazide, Maxzide) urges physicians to measure potassium levels frequently, especially during the early months of a patient’s treatment.
A study by Harvard researchers found that physicians order such lab tests only about half the time (Pharmacoepidemiology and Drug Safety, Nov. 18, 2005). This means many patients were taking high-risk drugs without the kind of supervision the FDA sought.
Another weak link in the drug safety chain is the possibility of drug interactions. Many BBWs specify incompatible medications that should never be prescribed together. The Harvard investigators discovered that nearly one out of ten patients received two medicines on the same day that should not be taken simultaneously.
Deadly drug interactions are a serious problem. The FDA has taken the extreme step of removing some valuable medications from the market because warnings about lethal interactions were ignored. The antihistamines Seldane and Hismanal and the heartburn medicine Propulsid disappeared due to interaction issues.
Because hundreds of thousands of people are injured by prescription drugs each year, the FDA has proposed major modifications for drug labels. The hope is that by reorganizing the prescribing information, physicians will pay more attention to black box warnings and other key guidelines.
Even with a more streamlined system, doctors still have to take time out of their busy schedules to read this critical information. The FDA cannot force them to do this homework.
That’s why patients must be proactive and learn about any special tests, drug interactions or food restrictions that apply to their medicine. After all, the patient has the most at stake.
To help you and your health care providers communicate about these crucial matters, we have prepared a drug safety check list. It can be downloaded for free from our Web site, www.peoplespharmacy.com, so that you can give it to your physician and pharmacist.
When it is filled in, the key information regarding dose, timing, interactions, side effects and special precautions will be available at a glance. Ensuring drug safety requires everyone’s collaboration.