Senate Special Committee on Aging Ranking Member Sen. Susan Collins (R-Maine) participated in a hearing on Thursday that analyzed how information about prescription drugs is disseminated to customers and seniors.
The FDA does not currently regulate information that is included in leaflets about prescription drugs that pharmacists provide to consumers.
Ninety-four percent of new prescriptions come with informational leaflets, but 75 percent of those leaflets narrowly meet minimal requirements for usefulness, according to the FDA.
“In an ideal world, all patients would receive extensive counseling about the risks, benefits and safe administration of their prescription drugs from their physicians and pharmacists,” Collins said. “In the real world, however, these conversations are often limited and sometimes non-existent.”
At least 1.5 million individuals are injured each year by inadequate medication labels, according to the Institute of Medicine.
“Ensuring that patients have access to accurate, up-to-date and consumer-friendly information about their prescription medications is therefore an important component of drug safety,” Collins said.
Collins expressed concern over a proposal from the FDA to switch entirely to electronic labels rather than paper. Collins noted that there are times when electronic information is not available, like during power outages.
The hearing also explored an FDA proposal that would consolidate written information to make it more concise and consistent.