AYLMER (PasseportSanté.net) February 16, 2006 – Many consumers take both drugs and natural health products. How to take into account this new reality and monitor it adequately to reduce health risks? This is a question that experts around the world tried to answer during an international symposium organized by Health Canada.1.
“Interest in interactions has been around for about ten years, especially since 2000, when it was realized that St. John’s Wort could interact dangerously with several drugs taken by people with HIV infection. or having undergone an organ transplant ”, underlined Mark Blumenthal, editor-in-chief of the American journal Herbalgram and Executive Director of the American Botanical Council2. According to him, we must keep an eye open.
Hence the importance of pharmacovigilance. This term covers the detection, evaluation and prevention of adverse reactions to drugs and natural health products (NHPs) as well as their interactions.
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What is a serious side effect? Whether it is drug-related or attributable to a natural substance, an adverse reaction (or side effect) is serious when it:
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Internationally, this surveillance is coordinated in Sweden, by the Uppsala Monitoring Center (UMC), a center of the World Health Organization (WHO)3. The UMC database currently has over 3.5 million suspected adverse reaction reports, of which just over 16,000 relate to NHPs.
It is clear that the side effects of drugs are much more numerous and dangerous than those of plants. However, more and more people are taking both drugs and natural health products that were not originally designed for them. It is therefore important to closely monitor this new phenomenon in order to prevent rather than wait for a possible serious problem, believe most specialists.
A complex problem
The solutions are not simple, according to several speakers present at the symposium. For example, the drug monitoring system, put in place in the 1960s, does not reveal all the adverse reactions associated with drugs. Indeed, these are not all declared by health professionals or consumers. In Canada, only 10% of problematic cases are reported, according to Health Canada estimates.
What about NHPs? “It is very likely that the adverse effects and interactions of plants are even less declared than those of drugs, because of the general perception of the harmlessness of natural health products,” said Pierre Haddad.4, professor at the University of Montreal, and one of the many researchers who attended this symposium.
What is Health Canada doing?
Currently in Canada, the Natural Health Products Regulations require manufacturers or distributors to report serious adverse reactions to their products to Health Canada. “For all of their products, they also have to report annually on all of these effects, serious or not,” said Jenna Griffiths, manager of the science section of the Marketed Natural Health Products Division at Health Canada.
This federal department plans to set up a pilot project based on the distribution of information in businesses that sell NHPs. “We will be inspired by the model proposed by the American Botanical Council2 », She announced. This US organization has established a web-based training program for distributors of NHPs and employees of retailers. This should improve the knowledge and awareness of Canadian consumers.
Health Canada also wants to help improve the knowledge of health professionals on how to report adverse effects from natural products to the authorities. Doctors and pharmacists are targeted, as are naturopaths. “This is a fundamental point. The implementation of this project must be carried out in such a way as to bring the two types of medicine closer together: the witch hunt carried out by classical medicine against the alleged great dangers of NHPs must end, as must the recklessness of certain alternative practitioners who are convinced that these dangers do not exist at all. These parochial disputes are detrimental to patient safety, ”commented Pierre Haddad, national researcher for the Quebec Health Research Fund.
“Physicians and naturopaths must work together, it is in the patient’s interest,” said Paul Richard Saunders, a renowned Ontario naturopath who was one of the guest speakers at the Symposium.
It is very important to report all serious side effects. However, Health Canada also wishes that any unforeseen effects be declared, as well as those concerning products (drugs or NHPs) recently placed on the market, that is to say for less than five years.
Jenna Griffiths of Health Canada promises that detailed guidelines on reporting adverse reactions will soon be available to the public: “Next summer, consumers will have access to them on our MedEffect website.5 “.
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Well report an adverse reaction and an interaction Until the guidelines for consumers are available on the Health Canada website, here are some ways to make a well-documented report. Before contacting a healthcare professional or completing the form yourself, make specific note of the following:
To report an adverse reaction, you can talk to your doctor or pharmacist or fill out the Adverse reaction reporting form yourself, which you can download at the following address (pdf document): www.hc- sc.gc.ca |
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For more news on the International Symposium on Drug, Food and Natural Health Product Interactions, see our Dossier index. |
Françoise Ruby – PasseportSanté.net
1. This event, entitled Health Canada International Symposium on Drug, Food and Natural Health Product Interactions, was held on February 9 and 10, 2006 in Aylmer, Quebec. It brought together more than 250 people from the health field, the medicinal plants industry, as well as researchers, representatives from various branches of Health Canada and some consumer groups.
2. The American Botanical Council (ABC), founded by Mr. Blumenthal in 1988, is a non-profit organization dedicated to the dissemination of accurate and reliable information on medicinal plants. HerbalGram is a quarterly review: http://herbalgram.com
3. The WHO Drug Monitoring Center was established in response to the many very serious side effects caused by thalidomide, a drug developed in 1959 and prescribed to pregnant women to relieve their nausea. Canada was one of the very first countries in 1968 to join the WHO voluntary drug monitoring program, which as of February 2006 had 79 member countries. www.who-umc.org
4. Pierre Haddad is a national researcher for the Quebec Health Research Fund and full professor in the Department of Pharmacology at the University of Montreal. He is also active with the Canadian Society for NHP Research.
5. For more information on this website launched in August 2005: www.hc-sc.gc.ca
