Pharmacists in Ontario are urging Health Canada to pay closer attention to the product integrity of some medications following a series of recalls of oral contraceptives.

Ontario Pharmacists Association, recalls of oral contraceptives, Canada, Health Canada, OPA, branded drug, generic drug, generic drug manufacturers, birth control pill, Alysena-28, Freya-28, Esme-28, Mylan, Apotex, Carlo Berardi, Dennis Darby, packaging errors, Society of Obstetricians and Gynaecologists of Canada, College of Family Physicians of Canada

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Drug recalls have Ontario pharmacists concerned

September 12th, 2013

TORONTO – Pharmacists in Ontario are urging Health Canada to pay closer attention to the product integrity of some medications following a series of recalls of oral contraceptives.

The Ontario Pharmacists Association (OPA) said Wednesday that the call by pharmacists and physicians for increased scrutiny of production for branded drug and generic drug manufacturers — including packaging of the finished product inside and outside of Canada — is "appropriate and necessary."

In early April, Apotex Inc. recalled lots of birth control pill Alysena-28 in Canada because packaging may have contained too many placebos in place of active ingredient tablets. Then in late August and early September, respectively, Mylan Pharmaceuticals recalled lots of its oral contraceptives Freya-28 and Esme-28 in the Canadian market because packages were found to have a placebo pill in place of an active pill.

Published reports said the Apotex product is made in Spain, and the Mylan products are made in India.

OPA chairman Carlo Berardi noted that the the recent packaging errors aren't a brand-name versus 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," Berardi said in a statement.

OPA said it agrees with most of the elements of a four-point plan by the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the College of Family Physicians of Canada (CFPC).

"Pharmacists, like all health care 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 explained.

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

Pharmacists agree with the SOGC and CFPC on steps to limit patient and health provider confusion resulting from "look-alike/sound-alike" products, yet OPA said the issue involves more than a 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," stated Dennis Darby, chief executive officer of OPA.

OPA said it seeks greater attention by all manufacturers, with oversight by Health Canada, in the naming of their products but disagrees with mandatory disclosure by pharmacists to prescribers in instances of generic substitution.

Prescribers should be aware of the availability of a generic version of a particular branded medication, OPA explained, and they have the right to stipulate the dispensing of a certain brand of product with no generic substitution. The association noted that pharmacists are required to inform patients of generic interchangeability and will dispense the patient's brand of choice if specified, acknowledging that such a choice may carry an increased cost. For beneficiaries of the Ontario Public Drug Program, pharmacists are required by law to dispense generics if available.

In the wake of the oral contraceptive recalls, many pharmacists are opening the birth control pill packages in front of patients when they come in to pick up their prescriptions so they leave the pharmacy confident in the quality of the product they receive, according to OPA.

"While this adds one more step for the pharmacist in an often busy dispensary," Darby stated, "it's an important one to take as it provides women with the reassurance that they are getting what they're supposed to. Given our reliance on pharmacists as medication experts, this added step should help reassure patients."