The Food and Drug Administration’s black box warning is the strongest advisory that prescription drugs can contain without being pulled from the market in the U.S. If improperly prescribed, drugs with a black box warning can lead to serious adverse events. How can prescribers reduce the legal risks of prescribing drugs with black box warnings?
Barbara D. Knothe, JDThe Food and Drug Administration’s black box warning is the strongest advisory that prescription drugs can contain without being pulled from the market in the United States. If improperly prescribed, drugs with a black box warning can lead to serious adverse events. How can prescribers reduce the legal risks of prescribing drugs with black box warnings?
Prescribers risk malpractice claims based on negligence or lack of informed consent for not providing the patient or patient’s representative with information to make an informed decision about whether to use the drug.
Since the number of drugs with black box warnings has increased, prescribers must keep up to date. Prescribers should consider using electronic prescribing software that warns the clinician if a potential problem is identified, or subscribing to email notices or other applications that alert the prescriber to new warnings as they are issued.
The warnings can be vague and difficult to interpret. In those cases, we recommend seeking clarification from a specialist or the manufacturer.
Consider alternatives first
The clinician should consider whether equally effective and safer alternatives exist, whether the potential benefits of the drug outweigh the safety concerns, and whether the patient is an appropriate candidate for the drug.
This analysis should be clearly documented in the patient’s medical record. Any patient selection criteria or recommended monitoring should be closely followed.
Get patient consent
The risk-benefit analysis must involve the patient or the patient’s legal representative. The patient must be informed about the black box warning, and the risks and benefits of and alternatives to treatment, including no treatment, and their informed consent obtained for the treatment. Ideally, informed consent should be in writing, with an acknowledgment of the warning and the discussion the patient has had with the clinician prior to consenting to the treatment as well as their understating of any necessary monitoring.
If written informed consent is not feasible, the medical record must reflect that the patient was informed of the warning, that the risks, benefits and alternatives were explained to the patient or the patient’s representative, and that they consented to the treatment following the discussion. Clear documentation of appropriate patient selection and informed consent is critical to the defense of any malpractice action arising out of the prescribing of a drug with a black box warning.
Use with caution
Clinicians should not permit patient pressure to influence selection of a drug that is not appropriate for the patient.
Despite the publicized warnings about these drugs, studies have shown that patients still receive prescriptions for these drugs in violation of black box warnings with some regularity, and that adverse events occur. Some states are considering subjecting the prescribing of drugs with black box warnings to regulation. Drugs with black box warnings can be viable treatment options so long as the proper steps are followed and the matter is thoroughly documented.
Barbara D. Knothe is a partner in Garfunkel Wild, P.C.’s Health Care Practice Group, in Great Neck, New York. Send your practice management questions to firstname.lastname@example.org.