What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.

In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.

In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.

How Much Evidence?

The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:

• Australian Skeptics awarded pharmacists their Bent Spoon Award in 2006 for selling “quackery and snake oil.” They recently published an open letter to pharmacists criticizing the sale of ear candles, noting, “Pharmacies need to make a profit, but this should not be done through quack products and bad advice. To regain the status a pharmacy should have – a place to get sound advice and effective medicine, supported by scientific and clinical evidence – we implore our pharmacists to stick to worthy products sold by knowledgeable staff.”
• In New Zealand, some are asking, What are homeopathic remedies doing in New Zealand Pharmacies?
• In Canada, pharmacists have been advised not to sell natural health products that are not approved for sale by Health Canada. While this sounds promising, it does not establish a rigorous evidence standard, as Health Canada approves and regulates products such as homeopathy.
• In the United States, the FDA warned consumers in 2009 to stop using Zicam intranasal products, commonly sold in pharmacies, because of serious adverse effects.
• In the United Kingdom, as part of the Evidence Check into homeopathy, the Professional Standards Director for Boots, a British pharmacy chain, made the following admission: “There is certainly a consumer demand for these products. I have no evidence to suggest they are efficacious. It is about consumer choice for us and a large number of our customers believe they are efficacious.”

Establishing a Standard?

Is it possible to define a minimum evidence standard for products sold in pharmacies? Here are some possible thresholds:

• Copper bracelets, magnets, homeopathy, and similar implausible products without any persuasive evidence of effect
• Products with biological plausibility, but without any clinical data (positive or negative) in humans
• Plausible products, (e.g., some herbal remedies), supported by anecdotal evidence, case reports, or very weak RCT data
• Products with evidence of benefit and possible harms (e.g.,  some vitamins)
• Products that may not be helpful, but are generally regarded as safe (e.g., cough and cold products)
• Products backed with robust evidence, approaching the standard used for prescription drugs (e.g., antibiotics, analgesics)

Other Considerations

In the United Kingdom, the Evidence Check into homeopathy made the following recommendation:

Although the availability of homeopathic products in pharmacies could be interpreted by patients as an endorsement of efficacy, in our view it would be pointless to seek to remove homeopathic products from sale in pharmacies. Many pharmacies sell ranges of non-evidence-based products and homeopathic products are easily available over the internet in any case. We consider that the way to deal with the sale of homeopathic products is to remove any medical claim and any implied endorsement of efficacy by the MHRA—other than where its evidential standards used to assess conventional medicines have been met—and for the labelling to make it explicit that there is no scientific evidence that homeopathic products work beyond the placebo effect.

Is the sale of homeopathy, or any other product acceptable in a pharmacy, if there is full disclosure about the level of evidence supporting efficacy claims?

In Canada, the United States, and some other countries, pharmacies can be part of large retailers like Walmart. Should there be a different threshold in these types of pharmacy settings?

Where do you see the line being drawn between the right of a retailer to sell a product, and the responsibility of a health professional to sell credible products?

Focusing the Question

Let’s keep the discussion focused on products intended or marketed for therapeutic or health use. That is, set aside the sale of chips, tobacco, cosmetics, televisions, donuts, or propane. We’re discussing products intended for therapeutic use, that may be legally sold.

Assume for this exercise that pharmacies that restrict the sale of certain products don’t interfere with market access through other retailers, like vitamin shops.

Pharmacy practice varies by country and even by state. Describe the current standard you observe in pharmacies, and what you think the standard should be.

Let’s leave aside discussion about prescription drug access. Focus only on products available for self-selection (over-the-counter).

Conclusion

Pharmacies play an important role in the health care system by providing access to pharmacists and therapeutic products to support health. If our intent is to support self-selection of science-based products supported by good evidence, what evidence standard should be applied in pharmacies? I look forward to your comments.