The Indian Practitioner

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Pharmacovigilance - A Global System of Monitoring ADRs


Affiliations
1 Department of Pharmacology, Government Medical College, Azamgarh, India
     

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No drug is safe. Every drug has the potential to develop minor to life threatening adverse effects. Adverse Drug Reactions (ADRs) are one of the major causes of morbidity&mortality worldwide. It adds economic burden to healthcare. Pharmacovigilance is the science dealing with activities related to detection, assessment, understanding and prevention of adverse reactions or any other possible medicine related problem.

Pharmacovigilance has an important role in rational use of medicine, as it provides the basis for assessing safety of medicine in the community. Its International Center is situated in Uppsala, Sweden. Pharmacovigilance Program of India (PvPI) started since 2011. India is major contributor participating in WHO international drug monitoring. PvPI is now expanded and incorporated with RNTCP&NACO. Haemovigilance, Materiovigilance, AEFI&Biovigilance are additional programmes.


Keywords

Haemovigilance, Materiovigilance, Biovigilance, Teratogenicity, Vigiflow.
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  • Guidance document for spontaneous adverse drug reaction reporting: Published by Indian Pharmacopoeia Commission; Ministry of Health & Family Welfare, Government of India; 2014.

  • Classification of ADRs: P.V Rataboli; Clinical Pharmacology & Rational Therapeutics;459 -460;2007.

  • News Letters: Published by NCC-PvPI, Indian Pharmacopoeia Commission; Ministry of Health & Family Welfare , Government of India ; Vol 5, Issue 12, 2015.


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  • Pharmacovigilance - A Global System of Monitoring ADRs

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Authors

R. C. Chaurasia
Department of Pharmacology, Government Medical College, Azamgarh, India

Abstract


No drug is safe. Every drug has the potential to develop minor to life threatening adverse effects. Adverse Drug Reactions (ADRs) are one of the major causes of morbidity&mortality worldwide. It adds economic burden to healthcare. Pharmacovigilance is the science dealing with activities related to detection, assessment, understanding and prevention of adverse reactions or any other possible medicine related problem.

Pharmacovigilance has an important role in rational use of medicine, as it provides the basis for assessing safety of medicine in the community. Its International Center is situated in Uppsala, Sweden. Pharmacovigilance Program of India (PvPI) started since 2011. India is major contributor participating in WHO international drug monitoring. PvPI is now expanded and incorporated with RNTCP&NACO. Haemovigilance, Materiovigilance, AEFI&Biovigilance are additional programmes.


Keywords


Haemovigilance, Materiovigilance, Biovigilance, Teratogenicity, Vigiflow.

References