Doctors often ignore 'black box' warnings on drugs
The "black box" warning on medications is the health care system's strongest way to say, "Danger! Take extreme caution with this drug!" But a recent report suggests that your physicians might not be fazed by the warning.
In a study of approximately 930,000 ambulatory care patients, researchers from the department of ambulatory care and prevention at Harvard Medical School and Harvard Pilgrim Health Care in Boston found that 42% received prescriptions for drugs with black box warnings, and physicians' compliance with the recommendations of the warnings was highly variable.
The findings suggest that better methods are needed for ensuring the safe use of medications that carry serious risks, says Anita Wagner, PharmD, MPH, DPH, assistant professor in the department. In the categories studied, doctors' noncompliance with the black box warnings ranged from 0.3% to 49.6%. These results are reported on-line in the Nov. 18, 2005, issue of Pharmacoepidemiology and Drug Safety. (Editor's note: See the study at www3.interscience.wiley.com/cgi-bin/abstract/112141666/ABSTRACT.)
Wagner notes that in ambulatory care settings, approximately 1.4 billion prescriptions are written per year and until now, there has been no information about how frequently doctors prescribe black box warning drugs, nor whether prescribing is consistent with the warnings. "This study tells us that these drugs are prescribed often and that in some categories, prescribing is inconsistent with the warnings," she says.
To examine prescribing compliance, Wagner and her colleagues examined approximately 217,000 enrollees who had received at least one of 19 black box warning drugs. From this group, most noncompliance with warnings occurred when patients should have received lab tests as they began a medication; 49.6% of all prescriptions that should have been accompanied by a lab test at the onset of a prescription were not. Recommendations for pregnancy tests were most frequently not observed (for example, when women of childbearing age were given prescriptions for acitretin, which treats severe psoriasis).
On the other hand, warnings that indicated a medication was unsafe to take while pregnant had excellent compliance. Women of childbearing age received almost 79,000 prescriptions for black box warning drugs that should be avoided during pregnancy. Only 95, or 0.3%, may have occurred during pregnancy.
Wagner says the findings suggest that risk managers should review compliance with black box warnings and consider ways to improve it. Automated systems that warn the physician of a potential conflict with a black box warning can help, she says, as can any other method that prompts the physician on a case-by-case basis instead of trusting that he or she will realize the warning applies to that patient.
The "black box" warning on medications is the health care system's strongest way to say, "Danger! Take extreme caution with this drug!" But a recent report suggests that your physicians might not be fazed by the warning.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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