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Abstract: Clinical and preclinical studies cannot
guarantee absolute safety of a drug. Therefore
pharmacovigilance has been introduced to identify and
respond to drug safety issues. It is related to the
surveillance of drugs once they are released for use in
the community (post marketing surveillance) and relies
on voluntary reporting, prescription monitoring, medical
records and statistical studies in the population. It is
important that adequate Pharmacovigilance standards are
introduced to monitor adverse reactions of drugs, before
they are launched in a country like India. In this
article we have tried to give an insight view on
different aspect of pharmacovigilance.
Introduction
Modern medicines have changed the way to control and
manage diseases. Despite all these benefits adverse drug
reactions continue to be the common, often preventable,
cause of illness, disability and sometimes death also.
Clinical and preclinical studies cannot guarantee
absolute safety of a drug. Therefore pharmacovigilance
has been introduced to identify and respond to drug
safety issues. The term pharmacovigilance originates
from the Greek words Pharmacon (=Drug) and Vigilare (=
to keep watch). It is related to evaluation,
understanding and prevention of possible adverse drug
reactions related to any medication or treatment.
Pharmacovigilance has grown to a considerable extent
over the past 10-15 years. Pharmacovigilance works the
same way as regulatory agencies to protect the patients
from unnecessary drug hazards.
Pharmacovigilance is the pharmacological science
relating to the detection, assessment, understanding and
prevention of long term and short term side effects of
medicines.4 It is the science of collecting, monitoring,
researching, assessing and evaluating information from
healthcare providers and patients on the adverse effects
of medications, biological products, herbal and
traditional medicines with a view to:
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Improve patient care and safety in relation to the
use of medicines and all medical and paramedical
interventions.
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Improve public health and safety in relation to the
use of medicines.
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Contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging
their safe, rational and more effective (including
cost-effective) use.
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Promote understanding, education and clinical
training in pharmacovigilance and its effective
communication to the public.
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