Usefulness of black box warnings is questioned
System could do more to alert pharmacists
Black box warnings may be the strongest type of labeling. That doesn’t mean they are well-publicized to the health care community, pharmacists say.
Black box warnings have been created to alert and inform health professionals of potentially severe, life-threatening adverse events associated with a particular medication. In addition, black box warnings convey important safety information as well as revised prescribing instructions.
When a black box warning is issued, the Food and Drug Administration (FDA) often posts information about it on the FDA web site. The media often report it, too, depending on the severity of the warning. The FDA and drug manufacturer also send out "Dear Doctor" letters to health care providers that address the warning.
Not everyone is impressed with the letters. "The Dear Doctor’ system that the FDA and the manufacturers use doesn’t seem that effective to me," says Barry A. Browne, PharmD, Coordin-ator of Drug Information Services, Scott & White Hospital, Temple, TX. "Often it comes in the same type of envelope as other drug company propaganda, and sometimes it doesn’t get opened."
Once the manufacturer and/or the FDA send out the initial warning or recall information, it is added to the package insert, too. Unless pharmacists have information systems that continue to notify them of the warning when they dispense the drug, however, some lesser-publicized warnings may lose their priority — especially since some black box warnings pertain to small segments of the population.
Access to patient information can give hospital and health care system pharmacists a better handle on black box warnings than their retail counterparts. "Hospital pharmacists can check the progress notes the physician wrote. They can look at lab results. They can look at the patient’s history," says Carla B. Frye, PharmD, professional practice associate, professional practice and scientific affairs, American Society of Health-System Pharmacists, Bethesda, MD. "Medication order review is a part of every new order."
One pharmacist is angry that black box warnings are needed at all. "Sometimes I get the feeling that the black box warnings are more like a last-ditch effort on the part of the manufacturer to try and keep its product on the market before it gets pulled," says Dennis Bryan, RPh, pharmacy manager at Albertson’s in Chicago. Bryan also spent 20 years working in a hospital pharmacy setting.
"The FDA says it has issues with the product; you need to do something about it. The manufacturer creates a black box warning and hopes that it plugs the hole in the dam, so to speak. If the problem continues, then the drug is going to get pulled."
He faults a clinical research system that allows Phase III trials to involve only small populations. "When the drug hits the general population where the numbers exponentially increase, some of these problems start popping up."
If black box warnings are needed, why was the drug prescribed in the first place, Bryan asks. "If there is indeed that level of a problem, why isn’t something more stringent done instead of passing it down the ladder and putting someone else at risk — not only the patient, but the pharmacist, too?" This indicates the influence of drug manufacturers, he says.
He uses clozapine (Clozaril) as an example of what manufacturers can do to further reduce risk. Clozapine is used in psychiatric patients, but it can adversely affect white blood cell counts.
"That particular product has to come with a screening tool that says health care providers have done a blood work-up within so many days of the issue of that prescription," Bryan says. "In this case, that brings ultimate protection because the tool jumps out at us. The manufacturers don’t like that level of warning because it diminishes the amount of prescriptions being written."
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