Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20171090Keywords:
Awareness, Cross-Sectional Studies, India, Pharmacovigilance, Surveys and QuestionnairesAbstract
Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.
Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.
Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.
Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.
References
World Health Organization. International drug monitoring: The role of National Centers. Report No: 498. Geneva, Switzerland: World Health Organization;1972.
Safety of medicines - a guide to detecting and reporting adverse drug reactions - why health professionals need to take action; 2002:16. Available from: http://apps.who.int/medicinedocs/en/d/Jh2992e/
Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre; 2000:28. Available from: http://apps.who.int/medicinedocs/en/d/Jh2934e/
Ramot Y, Nyska A. Drug-induced thrombosis-experimental, clinical, and mechanistic considerations. Toxicol Pathol. 2007;35(2):208-25.
FDA Drug Safety Communication: updated risk evaluation and mitigation strategy (REMS) to restrict access to rosiglitazone-containing medicines including avandia, avandamet, and avandaryl. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. Issued on 25-11-2013.
Onakpoya IJ, Heneghan C, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC Medicine. 2016;14:10.
Lihite RJ, Lahkar M. An update on the pharmacovigilance programme of India. Front Pharmacol. 2015;6:194.
Agrawal M, Hishikar R, Joshi U, Halwai A, Toddar TL, Khubchandani V et al. Adverse drug reaction scenario at adr monitoring centre of tertiary teaching hospital at Raipur. Indian J Pharmacol. 2015;2(3):169-75.
Kamtane RA, Jayawardhani V. Knowledge, attitude and perception of clinicians towards adverse drug reaction (ADR) reporting: a pharmacoepidemiological study. Asian J Pharm Clinc Res. 2012;5(3):210-4.
Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med. 2013;4(1):191-6.
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol. 2009;9:14.
Kharkar M, Bowalekar S. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting. Perspect Clin Res. 2012;3(3):90-4.
Ramesh M, Parthasarathi G. Adverse drug reaction reporting: Attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res. 2009;2:10-4.
Awodele O, Akinyede A, Adeyemi OA, Awodele DF. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med. 2011;23(4):217-26.
Sanghavi DR, Dhande PP, Pandit VA. Perception of pharmacovigilance among doctors in a tertiary care hospital: Influence of an interventional lecture. Int J Risk Saf Med. 2013;25(4):197-204.
Kiran LJ, Shivashankaramurthy KG, Bhooma S, Dinakar Kr. Adverse drug reaction reporting among clinicians in a teaching hospital in South Karnataka. SJAMS. 2014;2(1D):399-403.
Adedeji WA, Ibrahem WA, Fehintola FA. Attitude and practice of doctors toward adverse drug reactions (adrs) reporting in a Nigerian tertiary health facility. Ann Ib Postgrad Med. 2013;11(2):77-80.
Aithal S, Hooli TV, Varun HV. Knowledge and attitude about adverse drug reaction reporting among doctors at a tertiary care hospital. Int J Pharma Biol Sci. 2014;5(1):108-13.
Ray D, Venugopal A. An evaluation of knowledge, attitude and practice of pharmacovigilance amongst the prescribers of a medical college hospital in North Eastern State of India: a cross sectional study. Indian J Pharm Pharmacol. 2015;2(4):183-90.
Pimpalkhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad A. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian J Med Sci. 2012;66:55-61.
Hardeep, Bajaj JK, Kumar R. A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in northern India. J Clin Diagn Res. 2013;7(1):97-9.
Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: knowledge, attitude and practices of medical students and prescribers. Natl Med J India. 2002;15:24-6.
Pushkin R, Frassetto L, Tsourounis C, Segal ES, Kim S. Improving the reporting of adverse drug reactions in hospital setting. Postgrad Med. 2010;122:154-64.
Madan R, Parthasarathi G. Adverse drug reaction reporting: Attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res. 2009;2:10-4.
Thomas TM, Udaykumar P, Scandashree K. Knowledge, attitude and practice of adverse drug reaction reporting among doctors in a tertiary health care centre in South India. Int J Pharmacol Clin Sci 2013;2:82-8.
