Drug manufacturers’ data on side effects are of poor quality, lacking information – Report

Drug manufacturers’ data on side effects are of poor quality, lacking information – Report

Tuesday, July 07, 2015 by: Antonia

It’s common for medications to come with a slew of side effects that may even include possible death, but now, a report has shown that many times, some side effects are actually lacking. In other words, while you take a certain pain medication, it’s entirely possible that the information on the package insert or side of the bottle may not be painting a full picture.

The details of the finding were published by the Institute for Safe Medication Practices, where it was noted that approximately half of side effect reports submitted by manufacturers met basic standards for completeness. Often, a patient’s age, sex and the date an event took place was not provided. It was compared to the Food and Drug Administration (FDA), which is said to meet such standards in about 85 percent of cases.

Below average reporting found among major drug manufacturers

Thomas J. Moore, the senior scientist at the institute who is also the report’s lead author, said that while some manufacturers had high-quality reports, many were rather troubling. Generic drug manufacturer Par Pharmaceutical, along with Cubist Pharmaceuticals (recently acquired by Merck), were found to perform significantly below average.

“We know it is feasible to do reasonably complete reports,” Moore says. Therefore, he says that the poor quality reports that are because of a “…lack of due diligence by the manufacturers.”

The report, titled, “A Critique of a Key Drug Safety Reporting System,” notes that “…it seems clear that this drug safety monitoring system is in need of modernization. It suffers from a flood of low quality reports from drug manufacturers and has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers.”

Then there’s the scary fact that out-of-date practices are still in place, further fueling doubt about what is reported.

The report states:

How drug manufacturers collect and report adverse drug events is specified in legally binding FDA regulations, described in substantial detail in guidance documents, and enforced through compliance inspections. However, the major FDA guidance document has not been revised since 2001, when manufacturer reporting was standardized on a global basis. But the world has changed. Since 2001 the FDA has approved a growing number of drugs available with restricted distribution schemes that require intensive manufacturer contact with both patients and prescribing doctors, spurring large volumes of potential reports.

Reporting varies among manufacturers, some spokespeople entirely silent on matter

The inconsistencies and blatant lack of information seem to be commonplace.

A Par Pharmaceutical spokesperson explained that his company very rarely received reports directly from consumers or doctors; instead the majority of information contained in their reports were from reports and medical literature. A Merck spokesperson refused to comment on their reporting methods in regards to Cubist.

The FDA suggests that those with concerns about their medication speak to their doctor directly, in addition to reading the package insert. Experts with the administration say, “All medicines have benefits and risks. The risks of medicines are the chances that something unwanted or unexpected could happen to you when you use them. Risks could be less serious things, such as an upset stomach, or more serious things, such as liver damage.”





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