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On this page IntroductionEach year, Health Canada receives thousands of lasix online 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, lasix online 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 lasix online and medical device incidents continue to be under-reported in Canada and worldwide.Improving the Canada Vigilance ProgramHealth 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 dataThis 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 lasix online products incidents related to the use of medical devices recalls that occurred after products were approved for sale in CanadaData 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 productsTotal number of reportsIn 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 lasix online per month in 2019 Source of reportsIn 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 industryTypes of reported productsOne 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 lasix online 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 lasix online 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 reactionsA 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 lasix online 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 OutcomesIn 2019. 7 out of 10 (67,754, or 70.2%) adverse reactions reported to Health Canada were of a serious natureOver the last 10 years. The majority lasix online 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 lasix online 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 outcomeOutcomes 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 lasix online there is a link to specific products.

This in turn can keep Canadians safer from the harmful effects of certain health products. Medical device incidentsTotal number of incidentsIn 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 lasix online of 2,000 Canadian incidents were reported each month in 2019Source of reportsIn 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 lasix online incidents were reported by industryWith 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 productsA 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 lasix online 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 lasix online 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 issuesMore than one issue or problem with a device may be mentioned in a lasix online 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 lasix online 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 dataHealth effectsMore 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 lasix online 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 CanadaOutcomesIn 2019. 7,949 (34.5%) medical device incidents reported to Health Canada were of a serious natureOver the last 10 years. The proportion of medical device incidents that lasix online 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 lasix online. 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 recallsRecallsA 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 manualsIn 2019, Health Canada received reports of. 162 pharmaceutical drug recalls 32 natural health product recalls 822 medical device recallsFor each report, the Department evaluates lasix online the recall strategy to ensure the appropriate corrective actions are taken and that the actions are effective. Identified health risksThere are 3 types of health hazards.

Type I. Using or being exposed to a product will probably cause lasix online serious adverse health effects or death 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 Type III. Using or being exposed to a product is not likely to cause any adverse health effectsOf 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 IIIOf the 32 natural health product recalls.

16 were classified as type I 8 were classified as type II 8 were classified as type IIIOf the 822 medical device recalls. 37 were classified as type I 493 were classified as type II 292 were classified as type IIIRelated links.

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The rate fell from 7.3 to 4.7 per lasix online 1000 live births. This decrease was primarily due to a notable decrease in post-neonatal deaths. Over the same time period, the fetal death rate was between 6.0 and 8.5 per 1000 total births. Births trend Between 2008 and 2017, the total number of births decreased by around lasix online 7%.

The total number of births each year can influence the rate of fetal and infant deaths. Ethnic group There was no significant difference in fetal death rates between ethnic groups in 2017, consistent with the lasix online previous five-year period. Fetal death rates by ethnicity were similar between 2012 to 2017. Infant death rates in 2017 were highest for the Pacific peoples and Māori ethnic groups lasix online (8.7 and 5.9 per 1000 live births, respectively).

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In the lasix online previous five-year period (2012–2016), the infant death rate for babies of women aged less than 20 years was significantly higher than for babies of women in all other age groups. Socioeconomic deprivation In 2017, there were no significant differences in fetal death rates between levels of deprivation. The highest infant death rates in 2017 were for the lasix online most deprived areas (quintile 5). In the most deprived areas, the infant death rate was more than twice the rate of the least deprived areas (quintile 5, 6.6 per 1000 live births and quintile 1, 2.7 per 1000 live births).

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Sudden unexpected death in infancy (SUDI) There were 48 sudden unexpected death in infancy (SUDI) deaths in 2017, including 28 sudden infant death syndrome (SIDS) deaths. The SUDI deaths included 28 males and 20 lasix online females. The SUDI rate in 2017 was 0.8 per 1000 live births. In each year in the period 2013–2017, the SUDI rate was either lasix online 0.7 or 0.8 per 1000 live births.

In the five-year period 2013–2017, SUDI rates for babies in the Māori and Pacific peoples ethnic groups were significantly higher than the rates for babies in the Asian and European or Other ethnic groups. SUDI rates for babies of mothers aged less than 25 years were significantly higher than for those mothers in all other age groups. The SUDI rate lasix online for babies born in the most deprived areas (quintile 5) was significantly higher than the rate for all other deprivation quintiles. Note.

The number lasix online of fetal and infant deaths in New Zealand is small and may cause rates to fluctuate markedly from year to year. Rates derived from small numbers should be interpreted with caution. About the data used in this edition This dataset is a continuation of the Fetal and Infant Deaths series. At the lasix online time the data was extracted there were 11 infant deaths awaiting coroners' findings.

These deaths may be assigned a provisional code based on limited information available at the time, while deaths with no known cause awaiting coroners’ findings are coded to R99, ‘Other ill-defined and unspecified causes of mortality’, or X59, ‘Exposure to unspecified factor’. Deaths for which a cause is still to be determined or confirmed will be updated in the next edition of Fetal and Infant Deaths as lasix online the coroners complete their findings. Disclaimer In this edition, deaths data was extracted and recalculated for the years 2008–2017 to reflect ongoing updates to data in the New Zealand Mortality Collection (for example, following the release of coroners’ findings). For this reason, there may be small changes to some numbers and rates from those lasix online presented in previous publications and tables.

We have quality checked the collection, extraction, and reporting of the data presented here. However, errors can occur. Contact the Ministry of Health if you have any concerns regarding any of the data or analyses presented here, at [email protected].This release lasix online covers the most important statistics (Tier 1) from the 2019/20 New Zealand Health Survey. The statistics included are.

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