April 30, 2009 – In Quebec, St. John’s Wort supplements may no longer be available over the counter in pharmacies or health food stores.
Citing that this medicinal plant can cause undesirable interactions with certain drugs, the Order of Pharmacists of Quebec (OPQ) wants only pharmacists to be authorized to provide St. John’s Wort to consumers who request it. However, a doctor’s prescription would not be required.
Last January, the OPQ asked the Office des professions du Québec to modify the classification of St. John’s Wort to include it in Schedule II of the Regulation respecting the terms and conditions for the sale of drugs in Quebec. Concretely, if this request receives the approval of the Office des professions du Québec, St. John’s Wort in all its forms would be placed behind the pharmacist’s counter.
It could take several months, or even a year or two, before products are removed from drugstore and health food store shelves. The Office des professions must first appoint a committee of experts who will analyze the OPQ’s request and then issue an opinion.
For the Order of Pharmacists, “subjecting access to St. John’s Wort to pharmacist control will make it possible to offer better supervision in order to ensure patient safety”, underlines Michel Caron, pharmacist and professional assistant to the general management of the OPQ.
Known interactions, but poorly indicated
St. John’s Wort is a medicinal plant whose flowers can be made into herbal tea, mother tincture, and capsules or supplements. Many studies have shown that these supplements are effective in treating mild to moderate clinical depression. It is also used to counter anxiety and nervous agitation.
Studies have already shown that the main active ingredient in St. John’s Wort – hyperforin – can cause dangerous interactions with certain drugs. Among other things, St. John’s Wort decreases the effectiveness of drugs used to treat AIDS as well as certain cardiovascular disorders (statins, warfarin, digoxin). This side effect also occurs with birth control pills (birth control pills).
Under Canadian Natural Health Product Regulations1, the label of St. John’s Wort products must warn of these possible interactions. However, the lack of uniformity in the warnings and the nature of the information indicated is a major problem, according to the OPQ.
“St. John’s Wort has a significant potential for side effects and it is not because the label states that we can ensure that it will be used properly,” says Michel Caron.
Mixed reactions
Already aware of the request for the reclassification of St. John’s Wort made by the OPQ, the Guilde des herboristes du Québec is preparing a counter-proposal aimed at maintaining the free sale of the product while better informing the public.
“Public safety does not go through restriction, but through the implementation of more effective measures to better inform consumers,” says Natacha Imbeault, spokesperson for the Guild.
According to her, patients who want an alternative to antidepressants can find St. John’s Wort in nature, in the wild. “This is why the OPQ’s request does not solve the problem,” she maintains.
At the Canadian Natural Products Association (ACPN), we are wondering about the implications of the OPQ’s approach to St. John’s Wort.
“If the OPQ’s request is approved, there will be two different levels of risk in Canada for the same product, which risks confusing the public with regard to St. John’s Wort,” warns Pierre Morin. According to him, the change in classification of St. John’s Wort in Quebec should, if necessary, be followed by harmonization across the country.
The case of CoQ10 The OPQ’s request to change the classification of a natural product is not a first. A few years ago, at the request of the Order of Pharmacists, coenzyme Q10, a product used in several countries to treat heart failure or to control hypertension, was now available behind the pharmacist’s counter. However, it is possible to find products containing less than 10 mg of CoQ10 over the counter. |
The freedom to care
For her part, herbalist Marie Provost is sorry that St. John’s Wort can become a product sold only through the pharmacist.
“In France, St. John’s Wort was withdrawn from the shelves a few years ago, which led to an increase in the cost of the product sold in pharmacies,” she says. And the experience has not been conclusive, so they are reverting to the old regulations to put St. John’s Wort back over the counter. “
A specialist in natural products, pharmacist Jean-Yves Dionne specifies that “used alone, St. John’s Wort poses no risk to health. The problem is, you can’t make specific claims on the label of St. John’s Wort regarding its effect on depression. However, St. John’s Wort is a very effective antidepressant. “
The OPQ’s approach also calls into question the notion of the freedom to take care of oneself after being diagnosed, deplore Jean-Yves Dionne and Marie Provost. “We have the right not to want to go through the pharmacist, just as no one is forced to go to the hospital,” says Jean-Yves Dionne.
But Michel Caron sees it differently. “St. John’s Wort will remain accessible to anyone who requests it, but we will ensure that the product will be used under the conditions for which it should be used and consumers will make a more informed choice,” said the spokesperson for the OPQ.
Martin LaSalle – PasseportSanté.net
1. For more information on the Natural Health Products Regulations: www.hc-sc.gc.ca [consulté le 29 avril 2009].