News

Posted On: 09/14/2006

Researchers Call for Adoption of Drug Surveillance System

PharmaManufacturing.com

Leading international experts in brain and behavior research on Sept. 13 asserted the need for a new drug surveillance system in the U.S. The group, convened in Washington, D.C. by the American College of Neuropsychopharmacology (ACNP), concluded that to improve patient safety and reduce adverse events due to prescription drug use, the U.S. needs to create a system that tracks prescriptions linked to adverse events.

"The current U.S. health care system only accidentally detects rare but serious harmful effects of prescription medications, including legal off-label use of drugs prescribed for illnesses that were not studied in pre-marketing trials, as well as toxic drug interactions," said Charles P. O’Brien, M.D., Ph.D., vice chair, Department of Psychiatry at the University of Pennsylvania and chair of ACNP’s Human Research Committee. "Systematic prospective data collected through a computerized monitoring system could detect possible adverse events, serve as an early warning system, and better protect the public."

The group outlined three specific areas to explore. First, the researchers urged implementation of "provisional approval" from FDA to allow drugs to come to market sooner while restricting the level of marketing that accompanies them. "This type of program will enable the people who need the drugs the most to get them while encouraging industry to continue to collect data and monitor side effects," said O’Brien.

Second, researchers said, the computerized surveillance system needs to integrate medical records and pharmacy records to adequately research side effects. "A computerized database linked to a person’s medical records will reduce medical errors and help physicians identify side effects that weren’t detected during clinical trials," said Donald F. Klein, M.D., Professor of Psychiatry at Columbia University and ACNP member.

Finally, the researchers said ACNP should consider establishing fellowships in pharmacoepidemiology to promote the field and facilitate training. The group agreed that individuals with solid methodological expertise will be essential to collecting data and using it wisely.

The potential adaptation of a computerized cross-linked surveillance system similar to one used in the Netherlands known as PHARMO and the one used at the Department of Veterans Affairs were reviewed during the meeting.

A system of computerized cross-linked surveillance currently exists in the Netherlands. Known as the PHARMO Institute, the key components of this system include practitioner, hospital, pharmacy, and laboratory records. Whether such a system is feasible in the United States was critically discussed. Possibilities include large health management organizations (HMOs) and federally-financed systems such as the Veterans Administration, Medicare and Armed Services.

Recent high profile cases stirred public concern about drug safety and the effectiveness of the current monitoring system. Clinical trials conducted before the FDA approval of a pharmaceutical drug for a particular illness do identify many potential adverse reactions or complications for the medication. However, these clinical trials:

• Select patients who may be healthier than real-life patients and who may also receive better than average care.



• Usually last only a few months and include 500 to 3,000 individuals – these trials are too small and too short to identify rare or late events. However, larger or longer studies would delay useful drugs from coming to market.

In addition, concern about adverse effects detected after marketing is realistic since, even under the present system:

• 51% of drugs have label changes because of major safety issues discovered after marketing.



• 20% of drugs receive new black box warnings after marketing.



• 3% to 4% of drugs are ultimately withdrawn for safety reasons.



• There is common mismanagement of prescription drugs or the use of prescription drugs for purposes other than the FDA-approved indication, posing serious challenges in patient safety since there is little relevant trial data.

These abrupt or seemingly late warnings about prescription drug use create uncertainty and fear among health care consumers trying to choose a correct course of treatment for themselves or their loved ones.

"Early recognition of possible harmful effects of prescription drug use is critical to improving patient health and safety in the U.S.," added Klein. "It is our hope that this meeting will call attention to making more effective our system of monitoring the effects of marketed drugs."