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Safety monitoring of local anaesthetic drugs from the perspective of Pharmacovigilance Programme of India
Author(s) -
Pramod Kumar,
Ishwinder Kaur,
Vivekanandan Kalaiselvan,
Abhishank Singh
Publication year - 2017
Publication title -
indian journal of anaesthesia/indian journal of anaesthesia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.645
H-Index - 30
eISSN - 0976-2817
pISSN - 0019-5049
DOI - 10.4103/ija.ija_418_17
Subject(s) - pharmacovigilance , medicine , christian ministry , adverse drug reaction , excellence , drug reaction , medical emergency , adverse effect , drug , pharmacology , philosophy , theology , political science , law
Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs) to the database and can draw signals for regulatory decisions. To foster the culture of spontaneous reporting, India has launched paperless and simple modes of reporting ADRs such as Helpline and an Android application. This will help to create a national centre of excellence at par with global drug safety monitoring standards. With the increasing popularity of regional anaesthesia, adverse events may occur due to local anaesthetic drugs, techniques and adjuvants. Uncommon but clinically significant ADRs can be identified in a nationwide pharmacovigilance programme. Anaesthesiologists in India are encouraged to report local anaesthesia-related ADRs to the national pharmacovigilance database.

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