Conference raises safety issues

An international conference on drug safety at Wake Forest University, Winston-Salem, NC, found many drug safety problems facing patients, physicians, pharmacists, regulators and researchers. The conference encompassed three broad issues: detection of adverse effects of drugs already on the market, reporting of medication errors by hospitals and doctors and finding effective ways to communicate drug safety information to physicians and the public.

Dr. Murray Lumpkin of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration also highlighted four different perspectives on risk, from the standpoints of patients, physicians, pharmaceutical manufacturers and regulatory agencies.

As Lumpkin noted, patients often indicate that they are willing to take risks for drugs that might be beneficial to them. And practitioners, looking from the perspective of these individual patients, are willing to accept the risk for some, but not for others. According to Lumpkin, the central question is "How do you quantitate the benefit side as you do the risk side?"

"Individual needs and those of minorities are often overlooked" in regulatory decisions, said I. Ralph Edwards of the World Health Organization's Collaborating Centre for International Drug Monitoring in Uppsala, Sweden. He described the case of a 90-year-old woman who was being successfully treated for incontinence by a drug that was abruptly taken off the market in Sweden. "We must let patients have access to the drugs that help them."

One key issue discussed at the conference was detection of adverse reactions to drugs already on the market. Currently, no comprehensive, proactive system is in place to monitor how drugs work on large numbers of people or how they are used in day-to-day medical practice. Lumpkin acknowledged that European countries have broader regulatory tools than the FDA to determine risks of currently marketed drugs.

Future conferences will look toward developing recommendations. PR