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.
