Despite Black Box Warnings (BBW) issued for high-risk medication by the FDA, doctors have been found to prescribe such medicines to ambulatory care patients. The percentage of patients found to receive such drugs was nearly 42% according to a survey conducted by Harvard Medical School and Harvard Pilgrim Health Care.
The response of the doctors to comply with recommendations of the BBWs was highly variable, with noncompliance rates soaring from 0.3 % to 49.6%. In view of the fact that more than 1.4 million prescriptions are written per year in ambulatory settings, appropriate methods are needed for ensuring patient safety and maximizing benefits of drug therapy.
BBWs are warnings printed in a black frame in the package insert of a drug. It contains details regarding the drug safety, precautions and adverse effects. It is intended to alert prescribers to the serious risks that may be associated with certain drugs.
The present study assessed 217,000 participants who were prescribed the medication. The duration of prescription, other medications and possible drug interactions, and pregnancy status were taken into consideration during the evaluation process.
Noncompliance was noted in each of these categories, with a majority of the prescriptions were given away without a lab test that was mandatory. Recommendations for pregnancy tests were most frequently not observed. There was no sustained lab monitoring while taking the medication. Furthermore, nearly 9% of medications were given with a drug combination regarded unsafe (methotrexate with non-steroidal anti-inflammatory drugs). An excellent compliance was noted with respect to taking the medication during pregnancy as it was avoided in most of the cases.
An effective strategy to communicate the risks associated with such medicines is the need of the hour. It has to be targeted at both patients and physicians. For example, in the opinion of the authors, patient specific alerts automated alerts can be issued to serve as a warning against consumption of BBW drugs.
However, designing such an exhaustive system requires careful and consistent efforts with a critical evaluation of morbidity and mortality. "This will require new information about risks, about the way drugs are used in everyday practice, about effective methods of influencing clinicians' prescribing, and about ensuring that patients understand how to use their drug as safely as possible," said the senior researcher involved in the study.
The development of such a patient friendly system would be worth the investment in view of the potential health benefits.