In a stunning move, the Ontario College of Pharmacists has prohibited Ontario pharmacies from selling health products that are not approved for safety and efficacy by Health Canada. This directive, which takes effect immediately, banishes some of the most questionable “alternative” health products from pharmacy shelves. This message was sent to all pharmacies and pharmacists on January 20, 2010:

ADVISORY NOTICE To All Pharmacists and Pharmacies OCP Position re: Sale of Non-Approved Marketed Health Products Dear Colleague: At its meeting on December 10, 2009 the Council of the Ontario College of Pharmacists approved the adoption of the following national position statement approved by the Board of the National Association of Pharmacy Regulatory Authorities (NAPRA) at its November meeting: “Pharmacists should not sell a marketed health product without a Drug Identification Number (DIN), Natural Health Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM).” Accordingly, pharmacists are advised not to purchase or accept for sale any marketed health products, including natural health products, that do not possess a DIN, NPN, or DIN-HM. A copy of the position statement can be found on the NAPRA website www.napra.ca. Your cooperation is much appreciated. Yours truly,

Original signed by:

Deanna L. Williams, R.Ph., B.Sc.Phm., C.Dir., CAE

Registrar



This is a bold, decisive decision by a pharmacy regulator, and a tremendous victory for advocates of science-based pharmacy. As I’ve pointed out, the Canadian framework for regulating supplements, vitamins, and alternative health products (the Natural Health Products Regulations) were enacted in 2004, but the implementation has been slow. With the regulations, Health Canada mandated basic manufacturing quality standards, but significantly relaxed the standard for efficacy claims (compared to drugs). Manufacturers are permitted to make efficacy claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations apply to nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

Over 10,000 natural health products have been approved for sale by Health Canada, but thousands of products are unapproved, and openly sold on pharmacy shelves. Why? Health Canada permits the sale of unapproved products, as long as an application for review has been filed. But this left pharmacists in a difficult position when dealing with unapproved products: Had an application for review been filed? There was no easy way to determine this. Did an unapproved product meet basic manufacturing & quality standards? There was no regulator assurance. But with this order, the Ontario College of Pharmacists has eliminated the issue: If it isn’t approved, it cannot be sold in an Ontario pharmacy.

I was particularly pleased to see this statement from the National Association of Pharmacy Regulatory Authorities:

Pharmacists are obliged to hold the health and safety of the public or patient as their first and foremost consideration. As such, they must follow very specific standards of practice to fulfill this role. When presented with a product that does not bear a number issued by Health Canada, it leaves the pharmacist and their patient with no confirmation that the product was properly assessed for its safety, efficacy and quality nor granted approval for sale.

and

Even though an argument can be made that an NHP or homeopathic product without a product license is not necessarily unsafe, the reverse is also true. There is no guarantee that the required criteria for product safety were met. Pharmacists should not be placed in situations where they may be in a position to sell products that have not received approval for sale in Canada.

Fantastic. Professionalism and patient safety first.

Is a particular product licensed by Health Canada? You can look it up here, in Health Canada’s Licensed Natural Health Products Database. Or you can look on the package. If the product does not have a DIN (drug identification number) NPN (natural health product number) or DIN-HM (homeopathic remedy number), then the product is not approved. It may not be sold in an Ontario pharmacy.

Does this take all the pseudoscience out of Ontario pharmacies? No. The fact that “approved” homeopathic remedies are permitted for sale in pharmacies is an embarrassment to the profession of pharmacy (and a lesson that British pharmacies are learning the hard way). Checking through the database, there are some dubious “cleanse” and “detox” products that have actually been approved for sale and given NPNs. (Happily, no oil of oregano products appear to have been approved, so they should be disappearing from pharmacy shelves). But at a minimum, licensure signals to pharmacists and consumers that what is on the label should actually be what’s in the bottle.

Will this directive restrict patient access to natural health products? No. Over 10,000 products have been approved for sale in Canada. This is enough to fill a warehouse-sized pharmacy. If consumers really want unlicensed products, they can buy them elsewhere. Pharmacies in Ontario are raising the quality standard for consumers – only approved products may be sold.

While there are still a lot of unproven and questionable products that remain on pharmacy shelves, today we’ll celebrate this massive WIN in Ontario. Kudos to the Ontario College of Pharmacists for this move to enhance pharmacy practice and patient safety.