Magazine article Drug Topics

Psychiatrists Look to E-Records for Drug Safety

Magazine article Drug Topics

Psychiatrists Look to E-Records for Drug Safety

Article excerpt

Several dozen neuropsychiatrists and others, at a recent meeting in Washington, D.C., emphasized the need for a national postmarketing surveillance system for drugs. But how will the country move to such a system?

"Right now the whole country is moving toward an electronic medical record," said Charles O'Brien, M.D., Ph.D., vice chair of psychiatry at the University of Pennsylvania and moderator of the meeting, convened by the American College of Neuropsychopharmacology (ACNP). He is hopeful that if medical records are linked with pharmacy records, side effects that occur perhaps only in every 10,000 patients can be detected relatively early.

The current system, which relies on premarketing testing, is intrinsically limited, he said. Drugs are tested on perhaps a few thousand patients. Such a small sample size will not detect a problem that is relatively rare but possibly severe, said O'Brien. The challenge is to ensure that newly developed EHR systems can be integrated into databases to track medications after they are on the market.

The meeting spotlighted Ron Herings, Pharm.D., Ph.D., a developer of the national database in the Netherlands' PHARMO Institute, linking pharmacy records with medical records and used to study drug effects. O'Brien noted that the database is possible because the Netherlands is a small country in which no one is uninsured, so records are available.

But Herings told the meeting that his country's system had hardly been a panacea. Problems range from changes in government regulations to charges that studies produced from it have favored pharmaceutical or other interests. The quality of the data entered into the system by physicians and pharmacists, said Herings, is supported by Netherlands laws requiring strict recording of dispensed drugs. The system is now being tested in Germany and Poland, but it will be some years before the results of that expansion are known.

On the other hand, speaker Brian Strom, M.D., MPH, epidemiology professor at the University of Pennsylvania Health System, contended, "The fact that you are seeking data probably isn't right. There are lots of data sources out there. The real lack is in brains of people to use data."

Strom agreed that the current system is inadequate, pointing to reports that 51% of drugs that make it to market eventually have label changes because of major safety issues discovered after marketing. …

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