Summary of Annual Trends of Adverse Reaction Case Reports submitted to Health Canada
Posted: Tuesday February 5th, 2019
Author: Pinky Mazumder
With the purpose of protecting the health of Canadians and monitoring the safety of products on the market, Health Canada collects reports of health product adverse events from manufacturers/importers as well as from healthcare professionals (1). Adverse drug reactions are noxious and unintended responses to drugs caused by the administration of any dose of the drug (2). In late 2018, Health Canada published a report consolidating the yearly trends of adverse reaction reports received during 2008 to 2017. The following article will recap key findings from the Health Canada report for adverse drug reactions and medical device incidents.
According to the Food and Drug Regulations in Canada, adverse reactions (ARs) and incident reports for medical devices are required to be submitted to Health Canada. The reports are reviewed and compiled into the Canada Vigilance database and Medical Device System database to monitor the safety of the reported health products. Upon scientific evaluation of the adverse reactions, Health Canada may even take regulatory action by requiring the addition of warnings and precautions on the drug product labels, communicating safety information to the public, or even having the product removed from the market based on safety data findings (1).
Mandatory and Voluntary AR Case Reports
From 2008 to 2017, there has been a significant increase in the volume of mandated AR case reports filed to Health Canada from 10,124 cases to 56,983 cases. However when it came to voluntary reporting of AR cases, there is little or moderate increase in the volume of cases reported voluntarily over the years (1). However, with an overall increase in the number of cases filed over the years, there is also an increase in the volume of both serious and non-serious cases filed to Health Canada. Serious ARs are defined as a noxious and unintended response requiring in-patient hospitalization or prolongation of existing hospitalization, resulting in congenital malformation, resulting in persistent or significant disability or incapacity, or is life threatening or results in death.
AR by Drug Product Type
Domestic AR reports were received for various drug products including pharmaceuticals, radiopharmaceuticals, biologics, and natural health products, of which pharmaceuticals and biologics comprised the greater portions of AR case reports at 60% and 39% respectively in 2017 (1). Moreover, of all the domestic AR cases reported in 2017, the following Anatomical Therapeutic Chemical (ATC) groups of suspected products were the most common:
· Immunosuppressants, 39.2% of reported suspected products
· Antineoplastic agents, 15.6% of reported suspected products
· Drugs for obstructive airway disease, 2.8% of reported suspected products
· Psycholeptics, 2.7% of reported suspected products
Trends of reported AR cases were similar in 2013 where majority of the reports were for pharmaceuticals and biologic drug products, and immunosuppressants and antineoplastic agents served as the most common ATC groups among the reported suspected products (1).
Mandatory Problem Reporting for Medical Devices
When an incident occurs with a medical device (e.g. failure of the device, lack of effectiveness, inadequate labelling, death or serious deterioration of the health of a patient), the manufacturer is required to file a mandatory problem report. From 2008 to 2017, there has been an increase in domestic medical device incident reports from 4,008 to 11, 307 (1). Moreover in 2017, majority of the reported medical device incidents involved Class III medical devices (47%) and Class II medical devices (30%). In addition, of the reported incidents, the following International Medical Device Regulators Forum (IMDRF) problem codes were the most common among reports:
· Material integrity problem, 15.1% of incidents
· Mechanical problem, 13.8% of incidents
· Output problem, 11.2% of incidents
Trends were fairly similar in 2013, where Class III medical devices were the most common among medical device incidents and material integrity, mechanical, and output problems were also the most commonly reported IMDRF problem codes (1).
For more information on the Health Canada issued report on annual trends for adverse reaction case reports, please refer to the References section below.
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1. Annual Trends for the Adverse Reaction Case Reports of Health Products and Medical Device Problem Incidents to Health Canada (2008-2017)
2. Food and Drug Regulations, Part C