Adverse Reaction Reporting to Health Canada for pharmaceuticals (drugs), natural health products (NHPs), medical marijuana / marihuana (cannabis) and its extracts / derivatives (under the ACMPR). But can also be used address adverse reaction reports for foods & cosmetic products.
Why are there never any good side effects? Just once i’d like to read a medication bottle that says “may cause extreme sexiness”. [FYI, Health Canada no longer uses the term “side effect“, but calls them adverse events, and then classifies them according to the degree of seriousness”
Within this page, one will note that the phrase “Adverse Reaction Reporting” is interchanged with “Adverse Event Reporting” (AER). This is because different departments of Health Canada sometimes use one term over the other. Generally speaking, one can think of an Adverse Event as something that can be somewhat exected when using the product (i.e.: gastoinstestinal (GI) upset when not taken with food). Whereas, Adverse Reaction reporting is often for events that might be unexpected & more severe. This can also occur if it’s discussed in a Regulation vs. a Guidance document or Policy. Therefore, both terms are used, since people may be coming to this site after reading a specific document on Health Canada’s web site.
As part of a company’s quality assurance (QA) program / Quality Management System (QMS) – whether it be GMP, GCP, GPP, HACCP / ISO 22000 – one must have a process for documenting, investigating & reporting any suspected adverse reactions to Health Canada. If there are no adverse reaction reports submitted to Health Canada, they will most likely think you are hiding them, which could trigger an audit / inspection by them.
For drugs, this would also be part of Health Canada’s program for Good Pharmacovigilance Practices (GVP) (previously known as Post-Market Reporting Compliance). The GVP inspection program is intended to verify that the manufacturer / importer meets the requirements of pertaining to ADR reporting.
We can create the Standard Operating Procedures (SOPs) for Adverse Reaction reporting, along with their associated quality records (forms / checklists) for this process. In this way, if/when a customer or health care practitioner does inform you of such a possible situation, you can be proactive vs. reactive. We also have somewhat of a formal background in health / medicine, complimented with many years of medical research on behalf of numerous companies. As a matter of fact, the president of ICS Inc. gave a 45-minute presentation on Adverse reaction Reporting for medical marijuana & its extracts (derivatives) in Vancouver on Oct. 1, 2015 at the International Pharmaceutical Academy (IPA) Summit.
Why do we have to perform Adverse Reaction Reporting? Some adverse reactions may become evident only after a product is in use by the general population for some time. Secondly, you contribute to the ongoing collection of info that occurs once products are on the market. It then helps authorities like Health Canada better evaluate risks vs. benefits of consumer products. One is therefor expected to provide Health Canada with an annual summary report of such adverse reactions. They might then want to see a summary of your investigation.
These notifications of suspected adverse reactions often occur through a product quality related complaint. One should therefore have an SOP (and associated form) for Complaint Handling, as the starting point. As a consultant, on your behalf, we can gather more information from the patient or their health care practitioner (HCP) to gather further background information on the situation and investigate the underlying possible root cause. We have done this in the past for various clients of ours, who don’t have the in-house expertise. In addition, we have already read the various Health Canada regulations & associated guidance documents, then created our own internal SOPs & associated forms.
For example, our investigation form has separate sections for Patient Background (age, sex, etc); Description of the suspected reaction (diagnosis, lab tests, medical history, etc); Outcome, Follow-Up, and other investigation sections. We then have a second SOP / template on how to notify Health Canada and the effected customers. i.e.: do you have to notify all your customers? Or just the ones that have a specific medical condition or taking a specific prescription drug at the same time?
Since there are many things to consider, we strongly recommending using a consulting firm such as ICS Inc. for the development of the application SOPs and their associated forms. This could save you a lot of time & frustration, and lower the probability of accidentally overlooking something critical in the process. Our documents are based on real world situations and are continually being improved upon. Who is/are your designated person(s) responsible for complaint handling and adverse reaction investigation & reporting? Do you have template notification letters already developed for both Health Canada and the clients / patients?
Why use a consultant?
Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Please see our web page “Why Use a Consultant” as part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.