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

On this page

• Introduction
  • Building the Canada Vigilance Program
  • Improving the Canada Vigilance Program
  • About the 2019 data
• Adverse reactions to drugs and natural health products
  • Total number of reports
  • Source of reports
  • Types of reported products
  • Adverse reactions
  • Outcomes
• Medical device incidents
  • Total number of incidents
  • Source of reports
  • Types of reported products
  • Device issues
  • Health effects
  • Outcomes
• Marketed health product recalls
  • Recalls
  • Identified health risks
• Related links

Introduction

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:

• the rise in the overall number of marketed health products
• the implementation of mandatory reporting for all hospitals in Canada
• the expansion of the Canadian Medical Devices Sentinel Network (CMDSNet), Health Canada’s proactive surveillance program that encourages program participants to report medical device incidents
• the implementation of voluntary consumer reporting
• Health Canada’s efforts to promote simpler and easier ways to report
• a changing and aging Canadian population with changing health needs
• an increase in patient safety programs by industry, which leads to an increase in targeted detection and reporting
• proactive information gathering efforts by Health Canada, which lead to the discovery of unreported adverse drug reactions and medical device incidents

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:

• providing feedback to stakeholders on the quality of reports
• identifying and flagging duplicate reports in the Canada Vigilance database
• cleaning the data so it can be analyzed
• using automated data entry to reduce human error
• implementing mandatory reporting by hospitals of serious adverse drug reactions and medical device incidents (as of December 2019)

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:

• adverse reactions to drugs and natural health products
• incidents related to the use of medical devices
• recalls that occurred after products were approved for sale in Canada

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:

• the number of Canadian reports has increased over 4-fold (from 22,211 reports in 2010 to 96,559 reports in 2019)
• Health Canada received an average of 8,000 Canadian reports per month in 2019

Source of reports

In 2019:

• 90,350 (93.6%) of reports came from mandatory reporters
  • Canada has a strong reporting system in place to ensure that industry is responsible for their products and that they submit reports in a timely manner
• 3,849 (4.0%) were voluntary reports from health professionals working outside of hospitals
• 956 (1.0%) were voluntary reports from the general population
• 1,248 (1.3%) were from hospitals, which, until December 16, 2019, submitted reports to Health Canada on a voluntary basis
  • Going forward, Health Canada anticipates receiving a larger volume of reports from hospitals because of the new mandatory reporting regulations

Over the last 10 years:

• 9 out of 10 reports received at Health Canada were submitted by industry

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:

• a total of 208,383 drugs or natural health products were mentioned in the 96,559 reports sent to Health Canada
• pharmaceutical drug products were most often reported, at 68.1%
• biotechnological products were the second most frequently reported, at 28.1%
• within these product categories, the specific products most often reported were:
  • immunosuppressants (drugs that aim to reduce the activity of the body’s immune system) at 32.5% of all reported suspected products
  • anti-neoplastic agents (drugs used to treat cancer) at 16.4% of all reported suspected products

Over the last 10 years:

• the most common products reported each year in adverse drug reactions have been immunosuppressants and anti-neoplastic agents
• these numbers reflect the:
  • large number of anti-neoplastic agents approved for use in Canada
  • known risks associated with these products
  • large number of patient reporting programs in place for these products
  • severity of the underlying disease in the population being treated 
• each year, more drugs and natural health products are included in the adverse reactions reported to Health Canada
  • from 25,668 reported products in 2010 to 208,383 reported products in 2019, an 8-fold increase
  • this may be due to improved reporting mechanisms and increased general awareness of the risks involved in using multiple products
  • with the reporting of more drugs and natural health products, we can look at product interactions seen in real-world situations involving Canadians with complex medical needs

Adverse reactions

A report may mention more than one adverse reaction.

In 2019:

• 420,120 adverse reactions were mentioned in the reports sent to Health Canada
• the top 4 reported adverse reactions included:
  • general disorders and administration site conditions, such as pain or weakness (96,640, or 23.0%)
  • gastrointestinal disorders, such as vomiting or diarrhea (37,892, or 9.0%)
  • investigations that include performing tests and physical examinations (33,651, or 8.0%)
  • musculoskeletal and connective tissue disorders resulting in swelling or joint pain (33,531, or 8.0%)

Over the last 10 years:

• each year, more adverse reactions are included in the reports sent to Health Canada
  • from 79,249 adverse reactions in 2010 to 420,120 reported reactions in 2019, a 5-fold increase
  • this may be due to improved reporting mechanisms
  • if more reporters report similar details about adverse reactions, this will help to reinforce ongoing issues seen with certain products
  • this may signal a potential public health issue for further review

Outcomes

In 2019:

• 7 out of 10 (67,754, or 70.2%) adverse reactions reported to Health Canada were of a serious nature

Over the last 10 years:

• the majority of adverse reaction reports were serious because:
  • regulated parties are legally obligated to report all serious reactions to Health Canada
  • health professionals and consumers are more likely to report serious reactions that result in harm

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:

• 6,119 (6.3%) reports mentioned a suspected link between a death that had occurred and the use of a drug or natural health product
• 18,852 (19.5%) reports mentioned hospitalization
• 2,483 (2.6%) reports mentioned the occurrence of a potentially life-threatening condition
• 193 (0.2%) reports mentioned a congenital anomaly (birth defect)
• 52,119 (54.0%) reports indicated that, without intervention, the reported adverse reaction could have resulted in a serious outcome

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:

• the number of Canadian incidents has increased almost 4-fold (from 6,326 incidents in 2010 to 24,726 incidents in 2019)
• an average of 2,000 Canadian incidents were reported each month in 2019

Source of reports

In 2019:

• 22,809 (92.2%) incidents were reported by industry
  • Canada has a strong reporting system in place where industry is held accountable for their products and must report incidents in a timely manner to Health Canada as per the Medical Devices Regulations
• 1,018 (4.1%) incidents were based on voluntary reports from the community
  • Voluntary reports from consumers, health care professionals and others add to the quality and quantity of incoming data and help provide a comprehensive picture of medical device problems or issues
• 554 (2.2%) incidents were reported by health care institutions participating in CMDSNet
  • CMDSNet is a proactive surveillance program that encourages the reporting of medical device problem reports from participating institutions
  • CMDSNet provides a complementary data source for post-market safety evaluations

Over the last 10 years:

• 9 out of 10 incidents were reported by industry

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:

• a total of 25,519 suspected medical devices were mentioned in the incidents reported to Health Canada
• the most frequently reported devices were used in:
  • general and plastic surgery (8,926, or 35.8%)
  • general hospital settings (5,977, or 24.0%)
  • cardiovascular care, like pacemakers, defibrillators and stents (2,478, or 10.0%)

Over the last 10 years prior to 2019:

• devices for general hospital use (such as needles, catheters and syringes) were most often reported
• these incidents do not mean that these devices have more risk or cause more harm; rather, they were:
  • reported more frequently to Health Canada
  • used more often
  • more readily available when compared to other medical devices in more specialized categories

In 2019:

• the category of general and plastic surgery (with devices such as electrodes, implants and surgical staplers) was the most reported
• this was due to the submission of a large number of reports related to breast implants
  • this prompted Health Canada and its partners to:
    • investigate the risks associated with some types of breast implants
    • take some unsafe breast implant products off the market
    • educate Canadians about breast implants

Over the last 10 years:

• each year, more suspected products are being reported in the medical device incidents sent to Health Canada
  • from 6,544 devices in 2010 to 25,519 devices in 2019, a 4-fold increase
  • this may be due to improved reporting mechanisms and increased general awareness of the importance of reporting
  • increased reporting gives us the ability to better understand what happens when people use more than one device at a time

Device issues

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

In 2019:

• 28,124 issues related to the use of medical devices were experienced     
• material integrity problems (for example, material rupture, a burst container or vessel, or breaking) were mentioned 28.1% of the time
• mechanical problems (especially fluid leaks) were mentioned 21.1% of the time

Over the last 10 years:

• the types of reported issues may vary from year to year
• more issues with medical devices are being included in the reports sent to Health Canada
  • from 374 issues in 2010 to 28,124 issues in 2019
• this is likely due to improved reporting practices, which are capturing more detail, and the increase in the number of incoming reports
• we are working on improving standardized reporting and categorization of information, which will increase the quality and usability of the data

Health effects

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

In 2019:

• 22,518 health effects were mentioned in incidents reported to Health Canada
• the top reported health effect was hyperglycemia (high blood sugar), which was reported in 1,896 (8.4%) incidents
• other reported health effects included:
  • capsular contracture (when the capsule surrounding an implanted device distorts) (1,671, or 7.4%)
  • injury (1,338, or 5.9%)
  • pain (761, or 3.4%)

Over the last 10 years:

• hyperglycemia has remained a top reported health effect
• this is not unexpected; devices that measure blood sugar, such as glucose meters and glucose monitoring systems, are some of the most frequently used medical devices in Canada

Outcomes

In 2019:

• 7,949 (34.5%) medical device incidents reported to Health Canada were of a serious nature

Over the last 10 years:

• the proportion of medical device incidents that were serious:
  • varied between 10.3% and 19.6% from 2010 to 2018
  • jumped to over one-third of all incidents in 2019
  • this was due to the submission of a large number of reports related to breast implants

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:

• 85 (0.4%) of all medical device incidents mentioned a possible link between a death that occurred and the use of a medical device
  • however, the reported death may not have been directly caused by the suspected medical device incident
• surgery was the most common outcome reported in medical device incidents, with 3,365 incidents involving some form of surgery
  • 1,659 (49.3%) were revision surgeries (to fix an issue)
  • 1,291 (38.4%) were explantations (removal of device)
  • 1,274 (76.8%) of the reported revision surgeries and 1,079 (83.6%) of the explantations involved breast implants
• 3,791 (19.7%) incidents indicated that there was no reported patient involvement or consequences to a patient
  • these incidents did not cause harm, but were reported to Health Canada because they were near misses
  • under different circumstances or without intervention, serious harm may have occurred
  • this information helps us work with industry to take action before an actual harm occurs

Marketed health product recalls

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:

• removal of a product from further sale or use
• an on-site correction of the device
• an advisement to consumers of problems or potential problems with their device
• alternative labelling, which may include updates to instructions or manuals

In 2019, Health Canada received reports of:

• 162 pharmaceutical drug recalls
• 32 natural health product recalls
• 822 medical device recalls

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:

1. Type I: using or being exposed to a product will probably cause serious adverse health effects or death
2. Type II: using or being exposed to a product may cause temporary adverse health consequences or the possibility of serious adverse health effects is remote
3. Type III: using or being exposed to a product is not likely to cause any adverse health effects

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

• 52 were classified as type I
• 59 were classified as type II
• 51 were classified as type III

Of the 32 natural health product recalls:

• 16 were classified as type I
• 8 were classified as type II
• 8 were classified as type III

Of the 822 medical device recalls:

• 37 were classified as type I
• 493 were classified as type II
• 292 were classified as type III

Related links

• Why you should report
• Report a side effect
• Canadian Medical Devices Sentinel Network (CMDSNet)
• Search the Canada Vigilance Adverse Reaction Online Database
• Interpretation of suspected adverse reaction data
• Search the medical device incidents database
• Search recalls and safety alerts
• Reports and publications - MedEffect Canada