Doctors urged to report adverse reactions to drugs, medical devices

MANILA, Philippines–Don’t fear litigation, report adverse reactions to medications and other medical devices, the Food and Drug Administration (FDA) has urged doctors and paramedical practitioners.

PHOTO from fda.gov.ph

The FDA was moved to give this advice after noting that the Philippines was among the lowest-performing countries in terms of “pharmacovigilance” because practitioners feared becoming targets of lawsuits.

The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

“Pharmacovigilance relies on, among other methods, reports submitted by clinical practitioners to generate early warning signals by which [the] FDA can pursue early investigations and actions so that the loss of lives can be averted,” said the FDA acting director general, Dr. Kenneth Go in an advisory.

Go has stressed the importance of regulating drug products as no drug product in the market is 100 percent safe.

“Post-marketing surveillance is an important aspect of the FDA’s legally constituted mandate to monitor product defects arising from post-approval manufacture and distribution,” he said.

To encourage medical practitioners to observe pharmacovigilance, Go noted a recent “landmark decision” by the Department of Justice (DOJ) upholding a group of physicians who reported a potentially harmful product to authorities.

The FDA official said the ruling was on a libel case that a pharmaceutical company had filed against members of the Philippine Society of Anesthesiology, who submitted a report to the agency about a potentially harmful precipitation in the delivery device of a gas anesthetic agent distributed by the pharmaceutical company.

Go, however, did not disclose the name of the pharmaceutical company.

“The recent DOJ [ruling] affirms the commitment of government to support the protection of the Filipino patient against potentially harmful drug products and should be a clarion call to all medical and paramedical practitioners to report adverse events that may be associated with any medical product,” he said.