Pharmacists Urge Health Canada to Set More Rigorous Standards in Light of Recalls

TORONTO, ONTARIO--(Marketwired - Sept. 11, 2013) - The recent announcement of another oral contraceptive recall has generated increased attention from patients, healthcare providers, governments, and media. It has begun to raise questions about the product integrity of some medications in Canada. Ontario pharmacists are concerned as they recognize that their patients rely on them to ensure the quality of the products they receive.

The interprofessional call for Health Canada to step up and demand increased scrutiny of brand and generic manufacturers for all aspects of drug production - including packaging of the finished product both in and outside of Canada - is appropriate and necessary. Carlo Berardi, chair of the Ontario Pharmacists Association, says the recent repackaging errors, while intolerable, is not a brand/generic issue. "Most pharmaceutical manufacturers in Canada contract the services of non-Canadian companies during preparation of the product for sale in Canada. It is up to Health Canada to set a rigorous standard for manufacturers choosing to sell their products here - a standard that looks at each and every step of the process, from product formulation right through to packaging."

The Ontario Pharmacists Association agrees with most of the elements of the four-point plan put forth by the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the College of Family Physicians of Canada (CFPC). "Pharmacists, like all healthcare providers, subscribe to the notion of immediate notification of product recalls. In many cases, providers find out about product recalls through the media or their patients and are left trying to understand the nature of the problem with little or no formal information," Berardi says.

"While recent announcements focus on yet another generic manufacturer, recalls are not limited to generic producers alone. Brand drug manufacturers are equally susceptible to such packaging problems, and should be held to the same rigorous standards being sought through Health Canada," Berardi adds.

Pharmacists concur in part with the SOGC and CFPC on steps to limit confusion by patients and providers through "look-alike/sound-alike" products. However, the Association contends that this issue is broader than, and entirely unrelated to, drug recalls. It is much more about any drug from any manufacturer - branded or generic - looking and/or sounding like another drug. "In a world where patients are often struggling with complex chemical names of products to manage complex health conditions, the last thing they need is confusion between similar looking or similar sounding trade names of their medications," Dennis Darby, Ontario Pharmacists Association's CEO, says. The Association calls for greater attention by all manufacturers, with oversight by Health Canada, in the naming of their products.

The Association disagrees, however, with calling for mandatory disclosure by pharmacists to prescribers of instances of generic substitution. Prescribers are or ought to be aware of the presence of a generic version of a particular drug product. Prescribers always have the right to stipulate the dispensing of a particular brand of product with no generic substitution. These types of requests are intended to respect the prescribers' preference based on clinical reasons specific to that particular product, but are not intended to impose his/her personal preferences against generics in principle.

Notwithstanding the recent announcements, generic pharmaceuticals are of very high quality and play an integral role in helping to sustain our health system costs. Pharmacists are required to inform their patients of generic interchangeability and are prepared to dispense the patient's brand of choice if specified, acknowledging that such a choice may carry an increased cost. As well, for beneficiaries of the Ontario Public Drug Program, pharmacists are required by law to dispense generic medications when they are available.

With respect to the recent recalls of oral contraceptive products, the Association is pleased to hear that many pharmacists are opting to go the extra step with their patients by opening the birth control packages in front of them when they come in to pick up their prescriptions. The intent is to ensure patients leave the pharmacy confident in the quality of the product they receive. "While this adds one more step for the pharmacist in an often busy dispensary, it's an important one to take as it provides women with the reassurance that they are getting what they're supposed to," says Darby. "Given our reliance on pharmacists as medication experts, this added step should help reassure patients."

ABOUT OPA

The Ontario Pharmacists Association represents the views and interests of more than 14,500 pharmacists and pharmacists-in-training across the province. We work to inspire excellence in the profession and practice of pharmacy, and to promote wellness for patients.

Our members work in community pharmacies, family health teams, long-term care facilities, hospitals, universities, business and government, and practice in more than 3,000 clinical settings.