Pharmacovigilance has been defined by the WHO as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.’
PHARMACOVIGILANCE
Pharmacovigilance has been
defined by the WHO as the ‘science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other drug
related problems.’ The information generated by pharmacovigilance is useful in
educating doctors about ADRs and in the official regulation of drug use. It has
an important role in rational use of medicines, as it provides the basis for
assessing safety of medicines.
The activities
involved in pharmacovigilance are:
a. Postmarketing surveillance and other methods
of ADR monitoring such as voluntary reporting by doctors (e.g. yellow card
system of UK), prescription event monitoring, computerized medical record
linkage and other cohort/case control studies as well as anecdotal case reports
by doctors.
Voluntary reporting
depends on the initiative and willingness of the health professionals. It is
minimal in India, while even in the developed countries only ~10% ADRs are reported
voluntarily. Generally, immediately occurring reactions and those that are
dramatic are reported. Though even rare reactions can be detected by this
method, it does not provide incidence of the reaction.
b. Dissemination of ADR data through ‘drug alerts’,
‘medical letters,’ advisories sent to doctors by pharmaceuticals and regulatory
agencies (such as FDA in USA, committee on safety of medicines in UK).
c.
Changes in the labelling of medicines indicating restrictions in use or statuary warnings, precautions, or
even withdrawal of the drug.
Pharmacovigilance
centres have been set up in most countries. The Uppsala Monitoring Centre (Sweden)
is the international collaborating centre. In India, the national coordinating
centre is located in the All India Institute of Medical Sciences. Regional
centres are expected to collect, communicate and disseminate ADR data by
linking with medical institutions and practitioners. The pharmacovigilance
centres are also expected to provide expertise for assessing causality and severity
of ADRs by using standard algorithms and rating scales.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.