How to File the Medical Marijuana Adverse Drug Reaction Report

How to File the Medical Marijuana Adverse Drug Reaction Report

May 2, 2018 By

To comply with Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR) Good Production Practices (GPP), it is mandatory to report details of all adverse reactions. An adverse drug reaction, according to ACMPR, is a noxious and unintended response to fresh or dried marihuana (marijuana) or cannabis oil. It is mandatory for a licenced producer (LP) to report all data associated with the use of fresh or dried marihuana or cannabis oil by a person.

Serious Adverse Reaction “means an adverse reaction that requires in-patient hospitalization or a prolongation of existing hospitalization that causes congenital malformation that results in persistent or significant disability or incapacity that is life threatening or that results in death”.

Some of the adverse effects of cannabis are:

1. Paranoia and anxiety
2. Dry mouth
3. Dry, red eyes
4. Hunger and “munchies”
5. Sleepiness and lethargy
6. Impaired memory

So what does Health Canada require?

Health Canada requires every licenced producer who sells or provides fresh or dried marihuana to provide the Minister with a case report for each serious adverse reaction to the substance within 15 days after the day on which the producer becomes aware of the reaction. It is also essential to prepare and maintain an annual summary report containing a concise and critical analysis of all adverse reaction that occurred during the previous 12 months. However, the Minister may request an interim summary report containing a concise and critical analysis of all adverse reactions of the substance that have occurred since the date of the most recent summary report. Why an interim report? An interim report is requested by the Minister if the Minister has reason to believe that there has been non-compliance to Good Production Practices under ACMPR.

Health Canada is Serious

Compliance and enforcement of all regulations is critical for Health Canada, specifically when it comes to commercial medical marihuana production. Health Canada is strongly committed to providing patients with safe and quality marihuana for medical purposes, and has set forth regulations, enforcing them through stringent LP application reviews and strict on-site inspections.

Their commitment is apparent in these recalls:

1. Labelling Error:

January 25, 2018. Aphria, a licenced producer of cannabis for medical purposes, located in Ontario, voluntarily recalled products under a Type III recall. The reason for voluntary recall was that two lots of dried marihuana sold in 10g bottles had a labelling error, and the labels missed the percent (%) sign next to the numerical values of cannabinoid content.

2. Non- Permissible Pesticide Additive:

May 18, 2017. Peace Naturals Project Inc., a licenced producer of cannabis for medical purposes, voluntarily recalled (Type III recall) 74 lots of dried marihuana and cannabis oil. This was a result of a random Health Canada Inspection which found that two samples of leaves tested positive for piperonyl butoxide at low levels (0.78 ppm). Piperonyl is a synergist that is combined with pesticides to increase effectiveness but is not permitted to be used in cannabis production under the Pest Control Act.

3. Non Permissible Pesticide:

August 24, 2017. Broken Coast Cannabis Ltd., a licenced producer of cannabis for medical purposes located in British Columbia, has begun a voluntary Type III recall of three lots of dried marihuana that were produced between June to July 2016. A random sampling of cannabis oil testing indicated the presence of myclobutanil. Myclobutanil and spinosad are not in the 17 pesticides authorized for use on cannabis under the Pest Control Act.

These recalls indicate that when it comes to Good Production Practices, Health Canada does not mess around and does not ignore any error, big or small.

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