The World Health Organization (WHO) defines adverse drug reactions (ADRs) as unintended consequences suspected to be related to the use of medicinal products, including herbal medicines. Adverse reactions may be a result of herb-drug, herb-herb and/or herb-food interactions from herbal medicines and other natural health products (NHPs) that are available over the counter from community pharmacies, grocery outlets and health food stores, as well as online.
Despite the worldwide availability of herbal medicines and NHPs, it is suspected that ADRs are significantly underreported.
In Canada, in addition to reporting directly to the manufacturer of a product of concern, physicians, pharmacists, TCM practitioners other healthcare providers should also submit reports of product or herbal safety concerns to the Canada Vigilance Program.
“The Canada Vigilance Program is Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada.
The Canada Vigilance Program provides a variety of tools for health professionals and consumers to report suspected adverse reactions. Reporting is simple and can be done online, by phone or by submitting the Side Effect Reporting Form by fax or mail.”
Here are some excerpted definitions from Canada Vigilance Program’s Side Effect Reporting Form.
A side effect (also known as adverse reaction) is a harmful and unintended response to a health product.
A serious side effect is one that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Side effects that result in significant medical intervention to prevent one of these listed outcomes are also considered to be serious.
Health products include prescription and non-prescription medications; natural health products; biologics (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues, and organs) radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims.
Types of side effects that should be reported. All suspected side effects should be reported, especially those that are:
unexpected, regardless of their severity (i.e., not consistent with product information or labelling;
serious, whether expected or not;
reactions to recently marketed health products (on the market less than five years), regardless of their nature or severity.
This includes any undesirable patient effect suspected to be associated with health product use. An unintended effect, health product abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable side effects.
It is imperative to ensure that TCM practitioners licensed to prescribe and dispense TCM herbal medicines (R.TCM.H, Dr.TCM, R.TCM.P classes) maintain excellent herbal inventory records including TCM herbal name, herbal medicine name and/or natural product number (NPN), lot number, date of purchase, date of expiry, and service notes (if applicable). Well-maintained records will help practitioners inform and protect patients in the event of a manufacturer or distributor recall.