Medication Past Its Expiry Date Could Still Work
Category: Medication
Author: Georgina Tyburski
Posted: Friday - September 4, 2015
From Huffington Post
TORONTO - The recall earlier this week of a batch of Alesse birth control pills sold past their expiry date has raised questions about whether it's safe to take over-the-counter and prescription medications beyond their best-before marker — and just how long past?
"I think it would alarm a lot of Canadians if they knew that there isn't a lot of study on this," said Phil Emberley, director of pharmacy innovation at the Canadian Pharmacists Association.
Drug manufacturers must provide evidence on the potency and safety of products related to exposure to light, heat and humidity in order to get market approval from Health Canada, using what are known as stability studies.
"The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug product, a shelf life and label storage instructions applicable to all future batches of the drug product manufactured and packaged under similar circumstances," Health Canada says.
These tests include studies in which pilot batches of medications are stored at a temperature of about 25 C, with about 60 per cent relative humidity, for a minimum of 12 months, the federal department says on its website.
The expiration date is the final date that a manufacturer will guarantee 100 per cent potency and safety of a medication, based on stability testing under Health Canada's good manufacturing practices, or GMP.
