Clearer drug-safety information coming, researchers say
New drug data leaflet is to be modeled on nutrition fact boxes
Patients and doctors aren't getting the information they need to decide whether a prescription drug is likely to help, say U.S. researchers who've developed a shorter leaflet that describes how well a drug is likely to work.
Prescription drugs come with a handout that says what the drug is for, instructions on how to take it, possible side-effects and various cautions.
However, Steve Woloshin and Lisa Schwartz, professors of medicine at Dartmouth Medical School in Hanover, N.H. think the pamphlets come with too much information in fine print, while failing to address address what people really need.
"There's no way for patients or even doctors even to get good information on how well drugs work," Woloshin says.
The pair, who are also internists with the U.S. Veterans Affairs Outcomes Group in White River Junction, Vt., have developed a new, easy-to-read handout that clearly shows the number of patients helped and harmed in clinics trials used to get regulatory approval for new drugs.
A box on the leaflet also prioritizes side-effects, based on how common and serious they are.
In the U.S., an FDA advisory committee has recommended that the agency adopt the drug facts box, but Schwartz said there's no sign the agency has chosen to follow the advice.
Instead, the pair are starting a new enterprise to produce drug fact boxes reviewed by experts for the 1,000 prescribed drugs, which they said would also be useful to Canadians.
"If a drug is bad, if it doesn't work, or if it has a lot of problems, the drug box makes that crystal clear. But if the drug is good, it also makes that crystal clear. So we think it's in the interest of the government, of payers, doctors and patients to see this information so they can make wise decisions."
Woloshin said most people assume if a doctor prescribes a drug, it will work. When he and Schwartz did a survey, 40 per cent of Americans believed only extremely effective and extremely safe drugs are approved.
Medications with only a marginal effect or even dangerous side-effects sometimes get approved by Health Canada or the U.S. Food and Drug Administration.
"Some of the reviewers actually may have voted against drug approval, but in fact the drug is being approved anyway," Schwartz said. "Or the FDA had important concerns about safety and had recommended studies after marketing to monitor for those harms and those things are not routinely highlighted in the label."
David Gardner, a pharmacy professor at Dalhousie University in Halifax, said he was impressed with how simple and informative the new drug facts box are.
"This drug facts box is moving things in a giant leap in the right direction for giving things balance to support people in making informed treatment decisions around their medications," Gardner said.
With files from CBC's Pauline Dakin