If you are a cancer patient, caregiver, or survivor, your life or the life of your loved one depends on drugs, medical devices, and other health products. You need to have assurance that these products are both safe and effective, and that you know about any potential risks. Below is an overview of safety issues that can occur with drugs, and a list of organizations that take responsibility for preventing them.
Kinds of drug safety issues
There are two main kinds of safety issues that can occur with drugs.
Reactions or side effects
This is when you have an unexpected and unwanted reaction or effect caused by a medication (when it is used as directed). For example, a rash, nausea, dizziness; more serious ones can also occur. These may also be called adverse drug reactions (ADRs). Unexpected side effects typically cannot be prevented, since they are not caused by an error.
If you encounter a side effect from medication, you should talk to a doctor. You can also report it to Health Canada, or to mederror.ca, which is a website created by the Institute for Safe Medication Practices.
Medication incidents or errors
This is any kind of preventable error with medication. For instance, if you are given the wrong dose, the wrong medication altogether, or if it was administered incorrectly, that would be a medication error. About 1 in 10 Canadians who have health problems report receiving the wrong dose or wrong medication within the past two years.1
If you think there has been a mistake with your medication, you should talk to a doctor. You can also report it to mederror.ca. The reports go to the Canadian Medication Incident Reporting and Prevention System (CMIRPS), which works in collaboration with Health Canada, the ISMP, and the CPSI.
In Canada, there are several organizations that promote drug safety. Health Canada is the federal regulator; others, like the CPSI, are non-profits that work together with patients and other organizations; still others, like the DSEN, are research networks.
Health Canada regulates drugs and health products to ensure that they are safe, effective, and of good quality. They have the power to create and enforce regulations about drugs and health products through the Food and Drugs Act.
Here are some of the ways Health Canada helps ensure patient safety:
- Reviews new drugs to make sure they are safe and effective. These reviews rely on high-quality evidence from clinical trials. Read about how drug products are regulated here.
- Monitors side effects of drugs and health products. You can report a side effect here.
- Reports on safety issues and adverse side effects. They may recall a drug or health product if it is discovered to have serious risks. Find drug advisories and recalls here.
- Regulates how drugs are labelled, so that drugs can easily be distinguished and clearly display their purpose, risks, and benefits.
- Monitors medication incidents, for example, when someone receives the wrong medication, or the wrong dosage, by mistake. Read about preventing medication incidents here.
The CPSI was established by Health Canada in 2003 as a result of a 2002 report by the National Steering Committee on Patient Safety. They run a variety of programs aimed at improving patient safety. Their work falls into several areas, including:
- Developing policy frameworks that governments can refer to when they seek to advance patient safety
- Educating and providing resources for healthcare providers to help them ensure the safety of their patients
- Empowering patients to ask their healthcare providers the right questions and advocate for their own safety
The Institute for Safe Medication Practices Canada (ISMP) is an independent national organization dedicated to promoting safe medication practices. They collaborate with Health Canada, local healthcare partners, drug manufacturers, and patient safety organizations. They pursue their goal of zero preventable harm from medication by:
- identifying medication-related risks
- analyzing medication incidents
- recommending ways to avoid future incidents and mitigate risks
- promulgating information and educational materials about medication safety
ISMP Canada receives reports on medication incidents through the Canadian Medication Incident Reporting and Prevention System (CMIRPS), which is a collaborative initiative of ISMP Canada, the Canadian Institute for Health Information (CIHI) and Health Canada, in conjunction with the Canadian Patient Safety Institute (CPSI).
The Drug Safety and Effectiveness Network (DSEN) is a network of researchers whose aim is to research the safety and effectiveness of drugs outside of clinical trials, once they are being sold and prescribed. This is called ‘real-world’ evidence, in contrast to the clinical evidence that is provided by clinical trials. There is a great unmet need for real-world evidence of drug efficacy and safety.
Clinical trials are relied upon extensively for evidence when approving a drug, but they can’t tell you everything, because it is a controlled environment. The participants in a clinical trial can never be truly representative of the population of Canada that may ever receive the drug, so there is always the possibility of unforeseen safety issues and side effects. The DSEN’s job is to conduct research in response to queries from government health agencies or government-mandated health organizations. The DSEN is a project of the Canadian Institutes of Health Research, funded by Health Canada.
The Canadian Pharmacogenomics Network for Drug Safety (CPNDS) is a national research network that aims to understand and prevent adverse drug reactions (side effects) in children. Some adverse drug reactions can be so severe that they result in long-term disability or even death. The CPNDS aims to reduce the incidence of such severe reactions by investigating genetic variations as a potential cause.
The CPNDS monitors adverse drug reactions in children across Canada, in collaboration with local healthcare professionals, and collects DNA samples. They also collect DNA samples from children who got the same medication but did not experience an adverse reaction. They analyze these samples and use the information to develop genetic tests that predict, based on their DNA, whether someone will react adversely to a drug.
The CPNDS is a research partner with the DSEN.