What is Pharmacovigilance? Drug Safety Monitoring
To build and update the safety profile of a medicinal product, it is necessary to collect and evaluate reports from healthcare providers, patients and the scientific literature on all adverse events that occur in connection with the use of the medicine.
As a result of the monitoring of adverse events, over the course of time, new information about the hazards associated with a particular medicine can come to light. Any changes to the safety profile need to be reflected in the Summary of Product Characteristics and Patient Information Leaflet, the updated information ultimately helps to prevent harm to patients.
The WHO definition is: Pharmacovigilance is concerned with the detection, assessment, understanding and prevention of adverse reactions to drugs. It is also concerned with drug related problems.
Why do we need Pharmacovigilance?
No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty when taking medicines.
In the 1960’s, the thalidomide disaster led to limb deformities in the newborns of those mothers who took the drug while pregnant. This implies that pre marketing evaluation of drug safety, in animal experiments and in phase 1-3 clinical trials, provides insufficient evidence of safety.
There are four main reasons of why we need Pharmacovigilance:
1. Clinical trials concern a very small group of persons and they give insufficient evidence of safety.
2. Adverse Drug Reactions may lead to serious health issues and even death in some cases.
3. We have to protect patients from unnecessary harm as many ADRs are preventable
4. To promote the Rational use of medicines and adherence to treatment
And there are two specific reasons why we need Pharmacovigilance in Mauritius:
a. The prevalence of chronic diseases which implies lifelong drug treatment
b. The wide use of generics
The WHO international drug monitoring program started in 1968; it is located in Uppsala, Sweden.
The National Pharmacovigilance Committee in Mauritius was established in December 2011 and Mauritius became a full member of the the WHO Programme for International Drug Monitoring in 2014. It functions to manage and address any potential safety and quality issues that could arise from the use of health products marketed in Mauritius.