Home Fitness Product News Adverse reactions, medical device incidents and health product recalls in Canada: 2019...

Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report – Canada.ca

28
0

Each year, Health Canada receives thousands of reports of suspected adverse reactions (side effects) about drugs and natural health products and of suspected medical device incidents. These reports, captured through the Canada Vigilance Program, contribute to Health Canada’s post-market monitoring of health product safety.

Manufacturers, importers, hospitals and other mandatory reporters are required to report to Health Canada on adverse reactions and incidents related to marketed health products. Health Canada also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse reactions or incidents concerning drugs, natural health products or medical devices. Data from both the Canada Vigilance Program and other sources, like recalls that are reported to Health Canada, provide critical information that helps improve patient safety.

Building the Canada Vigilance Program

Since the Canada Vigilance Program began, the number of reports submitted to Health Canada has increased every year. This increase is due to a number of factors, such as:

While the number of reports is increasing, we know that adverse drug reactions and medical device incidents continue to be under-reported in Canada and worldwide.

Improving the Canada Vigilance Program

Health Canada continues to improve the quantity and quality of all incoming Canada Vigilance Program data by:

About the 2019 data

This page summarizes data on adverse reaction reports received by Health Canada during 2019 and key trends over the past 10 years. We present data on:

Data on adverse drug reactions and medical device incidents are based on reports sent to Health Canada through the Canada Vigilance Program. Recall data are based on the work of the Regulatory Operations and Enforcement Branch. The statistics on this page are based only on Canadian reports and do not include data from other countries (foreign reports).

Adverse reactions to drugs and natural health products

Total number of reports

In 2019, Health Canada received 96,559 domestic reports.

Over the last 10 years:

Source of reports

In 2019:

Over the last 10 years:

Types of reported products

One or more drugs or natural health products may be mentioned in a report because the reporter suspects they played a role in the adverse reaction.

In 2019:

Over the last 10 years:

Adverse reactions

A report may mention more than one adverse reaction.

In 2019:

Over the last 10 years:

In 2019:

Over the last 10 years:

We make it a priority to review the most serious product safety issues affecting Canadians. However, all reports are important. Together, they help to flag potential product safety issues .

In 2019:

Outcomes are complex and may be the result of multiple factors, including existing medical conditions or the progression of an illness. A reported outcome may not be directly caused by the use of a drug or natural health product. Increasing the quantity and quality of reports submitted to Health Canada can provide more robust evidence and help to determine if there is a link to specific products. This in turn can keep Canadians safer from the harmful effects of certain health products.

Medical device incidents

Total number of incidents

In 2019, Health Canada received information about 25,235 domestic incidents.

Over the last 10 years:

Source of reports

In 2019:

Over the last 10 years:

With the introduction of mandatory reporting for all hospitals in December 2019, we anticipate receiving a larger volume of incident reports from hospitals in the future.

Types of reported products

A medical device incident may involve more than one medical device. This means that multiple devices may be described in the reports sent to Health Canada.

In 2019:

Over the last 10 years prior to 2019:

In 2019:

Over the last 10 years:

Device issues

More than one issue or problem with a device may be mentioned in a medical device incident.

In 2019:

Over the last 10 years:

Health effects

More than one health effect may be mentioned in a medical device incident.

In 2019:

Over the last 10 years:

In 2019:

Over the last 10 years:

While priority is given to reports that are flagged as serious, all reports are important. Taken together, reports of medical device incidents may indicate a potential public health issue.

In 2019:

Marketed health product recalls

A drug or natural health product recall results in the correction of a distributed product or its removal from further sale or use.

A medical device recall may result in:

In 2019, Health Canada received reports of:

For each report, the Department evaluates the recall strategy to ensure the appropriate corrective actions are taken and that the actions are effective.

Identified health risks

There are 3 types of health hazards:

Of the 162 recalls of pharmaceutical drugs (prescription, non-prescription, radiopharmaceutical and active pharmaceutical ingredient):

Of the 32 natural health product recalls:

Of the 822 medical device recalls:

This content was originally published here.

LEAVE A REPLY

Please enter your comment!
Please enter your name here