DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20172225

Effect of pharmacovigilance training programme on quantitative and qualitative adverse drug reaction reporting

Sangita D. Jogdand, Mugdha R. Padhye, Shailesh Nagpure, Raju K. Shinde

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

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References


Dhikav V, Singh S, Anand KS. Adverse drug reaction monitoring in India. J Indian Acad Clin Med. 2004;5(1):27-33.

Allu PH, Nambari H, Majjaru C. Adverse drug reaction monitoring and reporting at H.S.K Hospital and Research Center Bagalkot. Research and Reviews: Journal of Hospital and Clinical Pharmacy. 2016;2(2):54-62.

Lihite RJ, Lahkar M. An update on the Pharmacovigilance programme of India. Front Pharmacol. 2015;6:194.

Pharmacovigilance program of India (PvPI) National coordination centre, Indian Pharmacopoeia commission Ghaziabad. Available from: http://www.ipc.gov.in/PvPI1/pv_amcs.html

European medicines agency. Guideline for good clinical practice. Available from: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf. Accessed January20, 2006.

Yadav S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J Pharmacol. 2008;40(1):S4-9.

Introduction- Indian Pharmacopoeia commission. Available from: http://ipc.nic.in/writereaddata/linkimages/introduction%20to%20pv-4112657251.pdf

Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.

Nazario M, Feliu JF, Rivera GC. Adverse drug reactions: The San Juan Department of Veterans Affairs Medical Centre experience. Hosp Pharma. 1994;244-6:249-50.

Scott HD, Thacher-Renshaw A, Rosenbaum SE, Waters WJ, Green M, Andrews LG, et al. Physician reporting of adverse drug reactions: results of the Rhode Island adverse drug reaction reporting project. Jama. 1990 Apr 4;263(13):1785-8.

Fincham J. A statewide program to simulate reporting of adverse drug reactions. J Pharm Pract. 1989;2:239-44.

McGettigan P, Golden J, Conroy RM, Arthur N. reporting of adverse drug reactions by hospital doctors and response to intervention. Br J Clin Pharmacol. 1997;44:98-100.

Hanafi S, Torkamandi H, Hayatshahi A, Gholami K. An educational intervention to improve nurses’ knowledge, attitude, and practice towards reporting of adverse drug reactions. Iran J Nurs Midwifery res. 2014;19(1):101-6.

Fugueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: A cluster-randomized controlled trial. JAMA. 2006;296(9):1086-93.

Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Improving the reporting of adverse drug reaction: a cluster randomized trial among pharmacists in Portugal. Drug Saf. 2008;31(4):335-44.