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Abstract: No medicine is 100% safe for everyone
in all circumstances. A drug, which is pharmacologically
effective, can always have some hazards with it.
Pharmacovigilance helps to identify and respond to the
risk-benefit profiles of marketed medicines. Various
drug tragedies occurred during the 20th century in
different parts of the world contributed significantly
for the genesis and development of the concept of
pharmacovigilance. The drug regulatory authorities of
many countries and the WHO play significant roles in the
promotion of the concept of pharmacovigilance at
national and global levels. An inherent issue of
pharmacovigilance is that most of the case reports are
concerned not with confirmed, but with suspected cases
of ADR. Till 1980s the practice was to consider an event
as ‘possible’ if linked with a number of similar
reports. Today various methods are available to attend
the problem of determining causality of ADR, though they
are not able to prove the same with conformity.
Introduction
The discovery and development of modern medicines have
changed the way in which diseases are managed and
controlled. However, evidence continues to mount that
adverse reactions are common to many medicines, old and
new. The selection and use of the best, safest and low
cost medicines for a given patient, or patients, out of
the many choices available, requires considerable skill
and awareness of the situation.
No medicine is 100% safe for all the people under every
circumstance. A drug, which is pharmacologically
effective, can always have some hazard. The hazard may
be sometimes insignificant or may be acceptable in
relation to the drug’s therapeutic action. Prior to
marketing approval, drugs are subjected to various types
of studies focusing on their pharmacokinetics and
pharmacodynamics. Such studies usually involve a small
population of subjects. Though intensive studies are
made to know about absorption, distribution, metabolism
and elimination (ADME) of drugs, such studies tell us
only very little about certain characteristics of drugs
after their marketing. In a country like India, where
drug consumption is very high, there is tremendous scope
and need for research in the area of adverse drug
reactions.
Pharmacovigilance
Pharmacovigilance is the study of drug-related injuries
for the purpose of making warning or withdrawal
recommendations for medicines. It is a professionally
governed process of identifying and responding to the
risk- benefit issues related to the marketed medicines.
Pharmacovigilance needs input from various health
specialties including pharmacy, medicine and nursing.
Pharmacovigilance targets the monitoring of safety of
drugs. It deals with the study of drug-related injuries
for the purpose of warning, cautioning or alerting those
concerned, about a particular drug used. According to
WHO, ‘Pharmacovigilance is the science and its
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any
other medicine-related problem’. Most of the techniques
and study designs applied in pharmacovigilance are those
employed in epidemiological studies.
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