The Society of Obstetricians and Gynaecologists of Canada (SOGC) and the College of Family Physicians of Canada (CFPC) have joined to urge the Minister of Health to take swift action to ensure that the Apotex Alysena 28 faulty birth control debacle never happens again in Canada.
“What happened at the beginning of April represents a breach of immense proportions which has seriously eroded our confidence in what is typically viewed as a very reliable contraceptive,” said Dr. Jennifer Blake, CEO of the SOGC. “Women were not informed as soon as the defective packs were discovered. In fact it wasn’t until six days later that a Class 1 recall was issued by Health Canada.”
“The Members of the SOGC and the CFPC have come together to endorse key recommendations that will go a long way towards ensuring this situation is not repeated,” said Dr. Francine Lemire, Executive Director and CEO of the CFPC. “It is imperative that Health Canada put in place an open, transparent system that will restore the confidence of the Canadian public in their contraceptive options.”
The SOGC and the CFPC together represent over 35,000 health care professionals who provide 95% of all contraceptive counseling to Canadians. In a letter to Minister of Health, Leona Aglukkaq, they put forward four recommendations for immediate implementation.
1. Immediate Product Recall Notification
Apotex was aware of this product deficiency from as early as April 3. Health Canada did not send out a Class 2 recall notice until three days later; the Class 1 recall was not issued until three days after that, April 9. Had women been notified immediately on April 3, there were appropriate actions they could have taken, in particular, the use of a back-up method of contraception, or the use of an emergency contraceptive. Either of these measures could have prevented unplanned and/or unwanted pregnancies. The CFPC and the SOGC urgently requests that Health Canada mandate immediate public notification if and when flaws are brought to light that impair effectiveness of any licensed contraceptive product. This requirement must be binding on the manufacturers and Health Canada and/or any of its agencies.
2. All Pharmaceuticals Must Adhere to Same High Standard – Brand Name or Generic
Health Canada must hold all pharmaceuticals to the same high standard, whether they are brand name or generic medications. While we respect the economic benefit to the Canadian health care system of generic medications, this economic benefit cannot be achieved at the expense of quality. It is unacceptable that any birth control pills could be manufactured for the Canadian marketplace without adequate quality control. Canadian women and their partners have a right to expect proven levels of quality and effectiveness through the use of accepted tests.
3. Disclosure of a Generic Substitution
The SOGC and the CFPC ask Health Canada to mandate disclosure of generic substitution be mandatory – that is, disclosure to both the patient and her health care provider, should a substitution be made by a pharmacist.
4. Regulation Against Look-Alike/Sound Alike Branding of Generic Medications
The SOGC and the CFPC ask that Health Canada institute measures that ensure that generic medications are subject to a similar rigorous review of their packaging to ensure that they neither look nor sound like any existing medications. It is unacceptable that many women did not realize that they were on Alysena because the packaging and branding looks and sounds like the tablet their physician had discussed with them in the office. To guard against this confusion, the SOGC and the CFPC strongly recommend that generic drugs be prohibited by regulation from adopting look-alike, sound-alike ‘brand’ names, but be identified by their generic medical ingredients.
The SOGC and CFPC endorse these four recommendations as a means to ensure that this situation is not repeated, and that a more timely response will happen should there be any shortfall in quality in years to come. It is imperative that Health Canada put in place an open, transparent system that will restore the confidence of the Canadian public in their contraception options.