www.ijbcp.com International Journal of Basic & Clinical Pharmacology | June 2017 | Vol 6 | Issue 6 Page 1367 IJBCP International Journal of Basic & Clinical Pharmacology Print ISSN: 2319-2003 | Online ISSN: 2279-0780 Original Research Article Effect of pharmacovigilance training programme on quantitative and qualitative adverse drug reaction reporting Sangita D. Jogdand 1 *, Mugdha R. Padhye 1 , Shailesh Nagpure 1 , Raju K. Shinde 2 INTRODUCTION Vast numbers of the drugs are available in markets which are widely prescribed by physician that leads to increased number of adverse drug reactions (ADR). Newer drug molecules are being constantly entering in the market that needs to be monitored for its ADR. Monitoring of ADRs related old as well as newer drug is essential because all the drugs are usually tested in controlled conditions with strict inclusion and exclusion criterion usually in developed western countries that have different genetics and environmental condition than that of Asian countries. In real life situations after marketing, the drug is being prescribed to all indicated patients in all age groups either alone or with other drugs. Drug may be prescribed in pregnancy unless contraindicated. Obscured ADRs or unexpected therapeutic benefits may be discovered in Pharmacovigilance studies. Mortality and high morbidity due to ADR impose substantial financial burden nearly 100 million dollars in US per year. 1 Periodic evaluation of ADR helps to identify pattern of ADR to improve the safety of the drugs. National and International data helps in revision of labelling of product and patients education program. Banning or withdrawal of the drug after marketing is possible due to ADR monitoring. Ideal Pharmacovigilance program should have Monitoring, Detection, Evaluation, Documentation and reporting of ADRs. 2 International adverse drug reaction monitoring centre is managed by Uppsala Monitoring Centre at Sweden, ABSTRACT Background: Adverse Drug Reactions(ADRs) are required to monitored in post marketing phase for unstudied ADR or beneficial effect which were not evident in controlled study design, but ADRs are usually under reported due to misbelieves or ignorance of health care worker. There is increasing numbers of adverse drug reaction monitoring centers in India affiliated to governing council but are in primitive phase. Also, there is lack of knowledge and attitude towards necessity for proper reporting of ADR, understanding of terminologies. Hence present study was undertaken to assess out of educational intervention in the form of simulated ADR workshop. Methods: Hundred nursing staff of JNMC were trained through Simulation Workshop i.e. initial knowledge as assessed before intervention, followed by explanations of every terminology essential for quality reporting of ADR. Ideal ADR reports were provided for study and ADR scenario was given for reporting of ADR. Deficiencies in reported ADR explained to participants. Post intervention knowledge and reporting was assessed. Deficiencies in actual ADR were pursued for three months. Results: There was statistically significant improvement observed in knowledge (p <0.01) and corresponding, proportionate quality parameters of ADRs as suggested by Z test. Conclusions: Educational intervention through simulated ADR and understanding about significance of ADR reporting’s and related terminologies improves quality as well as numbers of ADR reporting. Keywords: Adverse drug reaction, Pharmacovigilance, Quality report DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20172225 1 Department of Pharmacology, 2 Department of Surgery, Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha, Maharashtra, India Received: 16 March 2017 Accepted: 22 April 2017 *Correspondence to: Dr. Sangita D. Jogdand, Email: drsangitaraj@gamil.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open- access article distributed under the terms of the Creative Commons Attribution Non- Commercial License, which permits unrestricted non- commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.