The drug safety process doesn't end when a drug makes it into your medication bottle. Instead, programs are in place to monitor the medication's safety even after it is already being sold in Canada. These programs provide valuable data to help keep you safe.
Pre-clinical and clinical trials are designed to give a good picture of the safety and effectiveness of the medication, and the Health Canada review uses these trials to make a decision about whether to approve it. Medications must meet high standards for safety and must have been tested by thousands of patients before they can be sold in Canada.
But some medication side effects occur very rarely. Some happen only once in a million people. Because they are so rare, these side effects may not have been discovered in pre-clinical and clinical trials and may only become apparent when the medication is being used by a very large number of people. This is not common, but it can happen with any medication.
That's why Health Canada works together with pharmaceutical companies, doctors, and people taking the medications to keep track of side effects that occur after a medication has become available to the public. This is called post-marketing surveillance, and provides a database of information on side effects that can then be used to make future decisions about the medication. Sometimes, this stage of research is called Phase IV.
Some medications may require new restrictions or warnings, and others may be removed from the market (which means they can no longer be sold in Canada). Because of the extensive safety testing that is done before a medication becomes available to the public, this situation is rare.
Health Canada has developed a Canada-wide program called MedEffect to keep track of side effects. It encourages people taking medications and their healthcare providers to report any unexpected side effects (i.e., ones not listed in the medication leaflet) that occurred while they were taking the medications. Pharmaceutical companies are required to inform Health Canada of any new reports of side effects.
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