Assessment of Knowledge, Attitude and Practices (KAP) of Health Professionals Towards Adverse Drug Reactions (ADRs) and Pharmacovigilance in a Tertiary Hospital of North India

Abstract

Pharmacovigilance is a method of quick detection and
reporting, of adverse drug reactions and adverse drug events
after drug is in clinical use, thus preventing major drug events.
Ignorance of physicians in developing world, about reporting
adverse drug reaction is a big roadblock to pharmacovigilance.
This cascades into many problems e.g.; increased lab to clinic
interval, increased premarketing expense for newer drugs. In
quickly changing genomes scenario it leads to almost fatal
therapeutic failures. The huge population of India and lack of
appropriate post marketing surveillance contribute towards
disasters due to adverse drug reactions. With evolution of
pharmaceutical industry, the Indian doctors have gained wide
knowledge of drugs but the area of adverse drug reactions still
remains neglected. Indian Government launched National
Pharmacovigilance Programme in 2004 to inculcate the culture
of Adverse Drug Reaction reporting among Indian health
professionals. Medical Council of India has also made
Pharmacovigilance Programme mandatory in every medical
college. Still the picture is disheartening. Motivated to improve
Adverse Drug Event reporting in Chattrapati Shivaji Subharti
Hospital, the present survey was conducted to find Knowledge,
Attitude, Practices (KAP) of physicians, surgeons & nurses
regarding Adverse Drug Reaction reporting.  

India is emerging as a major hub of pharmaceutical
industry. The Indian pharmaceutical market has flourished
with the introduction of new drugs with the help of clinical
research. But, in the realm of this tremendous boom of
pharmaceuticals, the hazards due to adverse drug reactions
appear to have been ignored. Indian companies are among the
world leaders in the production of generics and vaccines –
now producing more than 20% of the world’s generics. Since
Indian firms will be marketing products globally they will
have to fulfill the regulatory requirements of respective
countries as well, post marketing surveillance of new drugs
being one. But unfortunately ADR reporting is very low in
India. This ugly situation can be improved by implementing
adequate laws such as insurance against adverse drug
reactions for general public, inclusion of pharmacovigilance
under corporate social responsibility, encouraging regulatory
authorities to take educative and publicizing role and by
identifying each and every component of a drug including the
excipients and preservatives while assessing the root cause of
particular adverse drug event.