FDA holds hearing to solicit ideas on risk management for drugs
For health problems minor or mortal, evaluating risks of new drugs is relatively simple: For life-threatening illnesses such as AIDS, serious side effects are tolerated; for relatively mild medical conditions, like hay fever, they are not. In between is where balancing benefit and risk becomes difficultand where Food & Drug Administration decisions please few.
Last month, responding to long-standing criticism that too many drugs (10 since 1997) were approved and then withdrawn, the FDA Center for Drug Evaluation and Research (CDER) in-vited suggestions for reducing medicine-associated risks. The hearing, a chance to "get to the issues instead of shouting at each other," as Janet Woodcock, director of CDER, put it, allowed pharmacists to offer their advice for reducing risks.
At the heart of managing drug risks is communication: The FDA must receive news of unexpectedly serious or numerous adverse events and then warn doctors and pharmacists. MedWatch, a decades-old program that lets doctors report adverse events by fax, e-mail, or toll-free telephone has always disappointed the FDA, because it is infrequently used. A major reason, said Joseph W. Cranston of the American Medical Association, is probably that doctors overwhelmed with red tape regard MedWatch as yet more paperwork, to be shunned despite its worthy intent.
Communications from the FDA are similarly disappointing. Research shows that its "Dear Health Practitioner" letters often go unread. "That's one of our biggest frustrations," said Sandra Kweder, deputy director of CDER's Office of New Drugs. "We feel like we're not being heard."
It would be easier to hear if messages were prioritized, said Thomas E. Menighan, the immediate past president of the American Pharmaceutical Association. The typical pharmacist receives more than 100 FDA communications each year, he noted, and "unfortunately, letters are not categorized to readily identify the importance or urgency." Thus, they "are very difficult to assimilate, let alone re- call, days or weeks later."
Classifying drugs by risk would also help, Menighan suggested. If high-risk drugs were classified as such, in the same way narcotics are classified as controlled substances, "health professionals would know that a drug in the high-risk category bears special or unusual risks that require close monitoring."
Outdated drug labels are another problem for pharmacists. Each year, as the FDA handles more than a thousand proposals for label changes, time lags develop between when the changes are approved and when they show up in pharmacies. "We face a conundrum," said Menighan. "We have physical access to drug information from the manufacturers and the FDA, but nothing confirming the currency of that information." But the situation will improve, he predicted, as more pharmacists gain access to electronic labeling.
Menighan is less certain of seeing improvements in a trend many pharmacists dislikerisk management programs that control which pharmacists have access to drugs. The problem is exemplified by controlled access to thalidomide, the infamous, once-banned drug now approved for treating leprosy. Proliferation of product-specific risk management programs will confuse pharmacists, he warned, and force them to focus on "red tape rather than appropriate medication use."
Adopting unit-of-use packaging is another way to reduce risks, maintained Peter Mayberry, who represents the Health Care Compliance Packaging Council and the Pharmaceutical Printed Literature Association. Drug repackaging in pharmaciesdispensing pills from large bottles into small onescauses numerous avoidable errors, he said. Mandat- ing unit-of-use packaging by manufacturers, with literature attached, would reduce many drug risks.
Officials did not announce when they may act on the plentiful advice they received. But they will do well to remember the simple comment offered by Thomas R. Clark, director of professional affairs at the American Society of Consultant Pharmacists. As drugs make their way from manufacturers to patients, he reminded attendees, "pharmacists are the last safety check."
Tom Hollon. Pharmacists advise FDA on how to manage drug risk.