Medication Errors
Drug safety: Monitoring must be expanded
Should pharmaceutical companies pay the tab?
There is a national need for an office of drug safety with the authority, independence, funding, and legal mandate to undertake the responsibilities of drug safety monitoring, according to a study and commentary published last May.1 An estimated 1.5 million people require hospitalization in the United States each year, the authors stated, and 100,000 die each year because of injuries linked to prescription drugs. Overall, 51% of approved drugs have serious adverse effects that are not detected prior to approval. The authors point out that the diet drug fenfluramine was approved 24 years before studies on heart valve damage prompted the Food and Drug Administration (FDA) to pull it from the market.
They highlight four specific tasks of such a program:
· Estimating the number and cause of serious injuries and deaths. The authors write, "It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a Federal Aviation Administration not knowing how many airplane crashes have occurred."
· Identifying new serious reactions. The FDA estimates only about 1% of adverse events are ever reported. They add, "A spontaneous reporting system cannot capture adverse effects that manifest themselves as a disease with high prevalence or with a long delay between exposure and clinical manifestations. Cancer is the classic example."
· Monitoring the effect of previous safety alerts. The authors write, "It is important to discover why important safety warnings are not being heeded. Are 'Dear Doctor' letters and label changes being lost in the avalanche of pharmaceutical marketing and advertising information being sent to the physicianoffice? Or do physicians disbelieve the message?"
· Operating an early-warning system. Rather than waiting passively for spontaneous reports of adverse reactions, the authors argue active surveillance is needed to check for sensitive indicators of possible problems. "In particular, regular monitoring is needed to check for drug involvement in reported cases of birth defects, agranulocytosis, and aplastic anemia," they say.
Funding, they say, should come from user fees collected from pharmaceutical companies. "The drug industry should be no less liable for the costs of its safety regulation than the nuclear power industry, which pays for the full costs of the Nuclear Regulatory Commission." Even if the pharmaceutical business (already the nation's most profitable industry as measured by return on investment) passes on the whole burden to consumers, the added cost would be small: Just one penny per prescription would yield approximately $24 million for an enhanced drug safety monitoring program. They conclude: "This investment in drug safety has the potential to save thousands of lives and prevent tens of thousands of serious injuries every year."
Reference
1. Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety (commentary). JAMA 1998; 279:1,571-1,573.
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