Doctors in the dark about changes in drug safety

Doctors in the dark about changes in drug safety

Part of the problem is these letters look like a form letter that could easily be mistaken for junk mail. Unsolicited incoming mail tends to go quickly to the recycling bin.

by Mary Budinger —

When drug companies have an important new warning about their products, they tell doctors about it in what is called a “Dear Healthcare Professional” letter. These letters inform doctors about serious risks of a medication and protocols to ensure the medication’s safe use. The letters are the most commonly used communication tool between pharmaceutical companies and doctors.

The Food and Drug Administration (FDA) recently reported that as few as 13 percent of recipients of a “Dear Healthcare Professional” letter can recall receiving a letter from the drug company about risk evaluation and mitigation strategy (REMS). And of the intended recipients who recall receiving such a letter, about 28 percent report they do not read all or most of it.

Julia Ju, a social scientist at the FDA, said, “I think that is really human behavior.”

Part of the problem is these letters look like a form letter that could easily be mistaken for junk mail. Unsolicited incoming mail tends to go quickly to the recycling bin.

At a December 2013 meeting of the Drug Safety and Risk Management Advisory Committee, FDA personnel admitted that the agency does not know who actually opens the REMS-related letters addressed to health care professionals. The FDA’s Risk Communi-cation Advisory Committee is tasked with finding a better way to get doctors to pay attention to information from drug companies about warnings and other safety issues. Committee chairman, William K. Hallman, urged the FDA to think “way, way out of the box.”

Source: American Society of Health-System Pharmacists.

Mary Budinger is an Emmy award-winning journalist who writes about integrative medicine.

Reprinted from AzNetNews, Volume 33, Number 1, February/March 2014.