[xtypo_dropcap]T[/xtypo_dropcap]here are too many gaps in how pharmaceuticals are monitored after they enter the market in Canada, according to a new report.
Commissioned by the Health Council of Canada, the report says the current system needs to be changed to avoid potential harm to Canadians.
“Health Canada, as the federal regulator, needs to pay more attention to how we improve our system of monitoring the drugs after they are approved for use,” says John Abbot, CEO of the Health Council of Canada.
The number of people at risk of exposure to unsafe drugs has gone up in the past 25 years, the report says, although the percentage of the drugs that have been withdrawn in the same time period has remained the same.
Two of the five drugs that were the most prominently promoted and widely prescribed in 2000, Baycol and Vioxx, were withdrawn from the market because of safety issues.
Currently there are not many regulatory obligations for pharmaceutical companies to monitor and provide reports of their drugs, the report says, and Health Canada cannot compel companies to study the effects of their products after they enter the market unless major safety issues are discovered.
But even then, although Health Canada has the power to require a company to withdraw a drug from the market, it rarely uses this power.
“It is clear ... that a passive system of monitoring drug safety—one that relies on voluntary reporting of adverse drug reactions—is not adequate to identify most emerging drug safety issues,” says the report.
Most Canadians aren’t aware of the limited scope of the pre-market test of pharmaceuticals, the report says, and don’t realize “that there is no systematic scrutiny of people’s experiences after [drugs] have been approved and are available for sale.”
Abbot says that during pre-market tests, drug manufacturers look at “ideal patients”—those who have very specific health conditions that the drug is intended to address. They administer the drug, record the reactions, and if it it’s deemed safe and effective in addressing the intended health issue, they request approval from Health Canada.
The problem is that a very small number of patients are actually tested, Abbot says, and when the drug is introduced into the wider population, people with different health issues or conditions could have different reactions to the drug.
“Sometimes these adverse effects don’t become known until several years after the drug has been in the market, because the event that’s causing health issues is not understood by the physician, it’s not recorded appropriately, or definitely not reported until it becomes more evident,” he says.
Health Canada spokesperson Gary Holub explains in an email that government experts take a number of measures to “identify public health and safety risks as quickly as possible.”
These include encouraging the report of adverse drug reactions by consumers and health professionals, getting domestic and adverse reaction reports from drug manufacturers on a mandatory basis, and looking out for new safety risks using automated and scientific review methods.
“Health Canada experts also collaborate with foreign drug regulatory agencies,” Holub says.
Abbot says the Health Council of Canada study was motivated by the recent creation of the Drug Safety and Effectiveness Network (DSEN), the federally funded program that connects researchers throughout Canada to conduct post-market research on pharmaceuticals.
“We wanted to examine what Canada was doing and the relation to other countries, and see if there were other, better, newer, brighter ways of addressing this issue,” he says.
The Health Council of Canada, an independent body funded by Health Canada, provides reports on health care reform with emphasis on accountability and transparency.
The experts commissioned to conduct the study looked into existing systems in the European Union, the U.S., U.K., New Zealand, and France and came up with recommendations for Canada.
Their recommendations include the following:
-There needs to be ongoing funding for safety and effectiveness research free of conflict of interest.
-Health Canada should have legislative authority to impose penalties if a company doesn’t complete post-market safety studies for its products.
-Health Canada needs to adopt a protocol for developing drug safety messages to be sent to different government agencies and health care practitioners and consumers.
-There should be a broader stakeholder involvement in decision-making of publicly commissioned post-market research.
-All post-market commitments should be made publicly available.
Commissioned by the Health Council of Canada, the report says the current system needs to be changed to avoid potential harm to Canadians.
“Health Canada, as the federal regulator, needs to pay more attention to how we improve our system of monitoring the drugs after they are approved for use,” says John Abbot, CEO of the Health Council of Canada.
The number of people at risk of exposure to unsafe drugs has gone up in the past 25 years, the report says, although the percentage of the drugs that have been withdrawn in the same time period has remained the same.
Two of the five drugs that were the most prominently promoted and widely prescribed in 2000, Baycol and Vioxx, were withdrawn from the market because of safety issues.
Currently there are not many regulatory obligations for pharmaceutical companies to monitor and provide reports of their drugs, the report says, and Health Canada cannot compel companies to study the effects of their products after they enter the market unless major safety issues are discovered.
But even then, although Health Canada has the power to require a company to withdraw a drug from the market, it rarely uses this power.
“It is clear ... that a passive system of monitoring drug safety—one that relies on voluntary reporting of adverse drug reactions—is not adequate to identify most emerging drug safety issues,” says the report.
Most Canadians aren’t aware of the limited scope of the pre-market test of pharmaceuticals, the report says, and don’t realize “that there is no systematic scrutiny of people’s experiences after [drugs] have been approved and are available for sale.”
Abbot says that during pre-market tests, drug manufacturers look at “ideal patients”—those who have very specific health conditions that the drug is intended to address. They administer the drug, record the reactions, and if it it’s deemed safe and effective in addressing the intended health issue, they request approval from Health Canada.
The problem is that a very small number of patients are actually tested, Abbot says, and when the drug is introduced into the wider population, people with different health issues or conditions could have different reactions to the drug.
“Sometimes these adverse effects don’t become known until several years after the drug has been in the market, because the event that’s causing health issues is not understood by the physician, it’s not recorded appropriately, or definitely not reported until it becomes more evident,” he says.
Health Canada spokesperson Gary Holub explains in an email that government experts take a number of measures to “identify public health and safety risks as quickly as possible.”
These include encouraging the report of adverse drug reactions by consumers and health professionals, getting domestic and adverse reaction reports from drug manufacturers on a mandatory basis, and looking out for new safety risks using automated and scientific review methods.
“Health Canada experts also collaborate with foreign drug regulatory agencies,” Holub says.
Abbot says the Health Council of Canada study was motivated by the recent creation of the Drug Safety and Effectiveness Network (DSEN), the federally funded program that connects researchers throughout Canada to conduct post-market research on pharmaceuticals.
“We wanted to examine what Canada was doing and the relation to other countries, and see if there were other, better, newer, brighter ways of addressing this issue,” he says.
The Health Council of Canada, an independent body funded by Health Canada, provides reports on health care reform with emphasis on accountability and transparency.
The experts commissioned to conduct the study looked into existing systems in the European Union, the U.S., U.K., New Zealand, and France and came up with recommendations for Canada.
Their recommendations include the following:
-There needs to be ongoing funding for safety and effectiveness research free of conflict of interest.
-Health Canada should have legislative authority to impose penalties if a company doesn’t complete post-market safety studies for its products.
-Health Canada needs to adopt a protocol for developing drug safety messages to be sent to different government agencies and health care practitioners and consumers.
-There should be a broader stakeholder involvement in decision-making of publicly commissioned post-market research.
-All post-market commitments should be made publicly available.
