Health Canada should at least be applauded for admitting the obvious: Last spring’s recall of Alysena 28 birth-control pills wasn’t properly communicated to the public.
Hundreds of thousands of potentially faulty birth-control packages were dispensed to Canadian women. Dozens apparently became pregnant after unwittingly popping placebos instead of the pill, and are now part of two class-action lawsuits filed against Apotex, the manufacturer.
But the problem here isn’t just one of poor communication. Nor is it something to be left to the the courts, after the fact. Three birth-control pill recalls this year point to a pattern that the Health Minister, Rona Ambrose, needs to answer for.
For one thing, pharmacists can substitute generic versions of drugs for their brand-name counterparts without alerting the patient or her physician. If a recall happens, alarm bells might not sound for patients, who may not know that their medication was swapped out. Pharmacists should be required to disclose any substitution beforehand.
Another problem: Generics aren’t held to the same clinical standards as brand-name counterparts. While the chemical composition of two products may be identical, their packaging may not be. This matters when it comes to the pill, with studies suggesting that everything from pill colour to layout influences whether women use them effectively.
There are also serious questions around quality control of generic drugs manufactured overseas. Alysena 28 was made in Spain. Esme-28 and Freya-28, the other recalled contraceptives, were manufactured in India. And third parties, not Health Canada, inspected the plants.
In a letter to the Prime Minister last spring, the Society of Obstetricians and Gynaecologists of Canada described the first of those recalls as a “debacle.” Six months and two more recalls later, it still is.