Recent recalls of birth control pills in Canada reveal a lack of due diligence in the production process, a provincial pharmacy group says.
Last week's voluntary recall notice of Mylan Pharmaceuticals's Esme-28 oral contraceptives as a precaution followed the company's recall last month of its Freya-28 birth control pills across Canada after a pharmacy reported a placebo pill was misplaced in one package. In April, Apotex said one lot of its Alysena 28 contained an extra week of placebo pills.
Whether the issue occurs during production of brand name or generic drugs themselves, their packaging or labelling, "somewhere in there there is a weak link in the chain," Allan Malek, a senior vice-president at the Ontario Pharmacists Association, said Wednesday.
After the Alysena 28 recall, the Society of Obstetricians and Gynaecologists of Canada and the College of Family Physicians of Canada expressed concerns to Health Canada about how the recall was handled.
"We can't have people questioning the integrity of our drug system," Malek said. "That's where Health Canada comes in. They are the ones that have assumed the responsibility for approval of medications in this country. If that's their mandate then they ought to live up to and they need to ensure that they work with the manufacturers to re-establish confidence in our system."
In April, then health minister Leona Aglukkaq said her ministry was looking into whether processes were followed and sufficient.
The obstetricians group also raised concerns that women could confuse the name of the generic birth control, Alysena, with a brand name birth control, Alesse.
Malek said look-alike and sound-alike drug names are an important but separate issue from product integrity, which Health Canada also needs to address.
Drug name examples include:
- Losec, used to inhibit acid reflux and Lasix, a diuretic. Both are brand name medications and happen to come in the same 20-milligram strength.
- Celebrex, an anti-inflammatory and Celexa, an antidepressant.
- Zantac for excess acid in the stomach versus Xanax for anxiety, which pharmacists say can sound confusing, especially over the phone.
Health Canada has guidelines on look-alike and sound-alike names but these lack the force of regulations, Malek said.