Pharmacovigilance
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Pharmacovigilance is the science and activities relating
to the detection, assessment, understanding and prevention of adverse
effects or any other drug-related problems. Pharmacovigilance is
an umbrella term used to describe the processes for monitoring and
evaluating adverse drug reactions (ADRs) following the introduction
of new drugs into the marketplace, and is a key component of effective
drug regulation systems. The role of pharmacovigilance is to monitor
the effectiveness and safety of new and medically-evolving treatments
under real-life conditions post release; to gather information about
use in specific population groups notably children, pregnant women
and the elderly; and to gather information on the efficacy and safety
of chronic use of drugs in combination with other medicines. Most
countries monitor ADRs via passive pharmacovigilance. Individual
case safety reports (ICSRs) are submitted to a regulatory agency
by manufacturers, health professionals, consumers and hospitals. |
WHO’s Drug Monitoring Program consolidates data from a number
of National Centres. Each report represents a suspicion, opinion or observation
of the individual making the reports. Since not all ADRs are reported,
pharmacovigilance data cannot be generally used to estimate the incidence
of adverse reactions on a population basis.
Pharmacovigilance is particularly important in identifying potential adverse drug reactions that may have been missed in pre-market tests. Pharmacovigilance data is also important in identifying potential risks to pregnant women and children, who are not included in clinical trials conducted prior to market authorization. Pharmacovigilance data requires careful interpretation for reporting of adverse drug reactions is not mandatory (with the exception of market authorization holders), the number of ADRs occurring in the general population will be underestimated. Data is primarily collected by MAH’s into their own databases and by a spontaneous surveillance system at Health Canada in which adverse reactions to marketed health products are reported by market authorization holders and others to Health Canada on a voluntary basis.
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