TO ASSESS THE KNOWLEDGE, ATTITUDE, AND PRACTICE OF PHARMACOVIGILANCE AND ADVERSE DRUG REACTION REPORTING AMONG THE UNDERGRADUATE AND POSTGRADUATE MEDICAL STUDENTS IN A TERTIARY CARE TEACHING HOSPITAL IN ASSAM: A QUESTIONNAIRE-BASED STUDY
DOI:
https://doi.org/10.22159/ajpcr.2023.v16i5.47180Keywords:
Pharmacovigilance, Adverse drug reactions reporting, Knowledge, attitude, practice, Undergraduate, Postgraduate, Competencybased medical educationAbstract
Objectives: Adverse drug reaction (ADR) is an important factor contributing to mortality and morbidity worldwide. Since undergraduate (UG) and postgraduate (PG) students are the future caregivers to the patients, they should have sound knowledge, a positive attitude, and good practice of Pharmacovigilance (PV). Hence this study was conducted to assess their knowledge, attitude, and practice (KAP) of PV and ADR reporting. Furthermore, secondarily this study tried to look into the impact of competency-based medical education (CBME) on the KAP of the students.
Methods: Questionnaire-based, observational, and cross-sectional study. The questionnaire was pre-validated and consisted of 30 questions to assess the KAP of UG and PG medical students of a tertiary care teaching hospital in Assam.
Results: A total of 419 students participated in the study. Data were analyzed using Microsoft Excel Sheet and the Student’s t-test. Both UGs and PGs have good knowledge about PV, ADR, and the types of ADRs to be reported. They also have a positive attitude but in practice, only a few have filled up the ADR form. Mean score analysis showed p-value was significant for attitude and practice among the UGs and PGs and highly significant for KAP when the CBME and Old Curriculum were compared.
Conclusion: Although students have good knowledge and attitude, they need to improve in their practice. Regular training and awareness programs might help in educating them about PV and ADR reporting. However, the introduction of the CBME curriculum has been shown to improve the knowledge and attitude of the students about PV and ADR reporting.
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References
Young LR, Wurtzbacher JD, Blankenship CS. Adverse Drug Reactions: A review for Healthcare Practitioners. Am J Manag Care 1997;3: 1884-1910.
Meher BR, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res 2015;6:217-21. doi: 10.4103/2229- 3485.167102, PMID 26623394
Ganesan S, Sandhiya S, Reddy KC, Subrahmanyam DK, Adithan C. The impact of the educational intervention on knowledge, attitude, and practice of pharmacovigilance toward adverse drug reactions reporting among health-care professionals in a tertiary care hospital in South India. J Nat Sci Biol Med 2017;8:203-9. doi: 10.4103/0976- 9668.210014, PMID 28781488
Formica D, Sultana J, Cutroneo PM, Lucchesi S, Angelica R, Crisafulli S, et al. The economic burden of preventable adverse drug reactions: A systematic review of observational studies. Expert Opin Drug Saf 2018;17:681-95. doi: 10.1080/14740338.2018.1491547, PMID 29952667
World Health Organization. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions, Why Health Professionals Need to Take Action, WHO/EDM/QSM/2002-2. Geneva: World Health Organization; 2002.
World Health Organization. Safety of medicines: The WHO collaborating centre for international drug monitoring. WHO Drug Inf 2016;30:24-34.
World Health Organization. Pharmacovigilance: Ensuring the Safe Use of Medicines, WHO Policy Perspectives on Medicines, WHO/ EDM/2004.8. Geneva: World Health Organization; 2004.
Pharmacovigilance Programme of India. Guidance Document for Spontaneous Adverse Drug Reaction Reporting. Available from: https://www.ipc.gov.in
Desai M. Pharmacovigilance and spontaneous adverse drug reaction reporting: Challenges and opportunities. Perspect Clin Res 2022;13:177-9. doi: 10.4103/picr.picr_169_22, PMID 36337368
Lopez-Gonzalez EL, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf 2009;32:19-31. doi: 10.2165/00002018-200932010-00002, PMID 19132802
Marko S. A study of knowledge, attitude, and practice of pharmacovigilance among medical students at a tertiary care teaching hospital in Madhya Pradesh, India. Natl J Physiol Pharm Pharmacol 2019;9:851-5. doi: 10.5455/njppp.2019.9.0620408062019
Kulmi M, Reddy P, Dhakre S, Shinde M, Goyal C. Knowledge, attitude and practices of pharmacovigilance among the postgraduate and undergraduate medical students in a tertiary care hospital in Central India. Int J Basic Clin Pharmacol 2017;6:1127-32. doi: 10.18203/2319- 2003.ijbcp20171663
Acharya TA, Trivedi MD, Joshi KJ, Chhaiya SB, Mehta DS. An observational study to evaluate knowledge, attitude and practice of pharmacovigilance among undergraduate medical students of a tertiary care teaching hospital. Natl J Physiol Pharm Pharmacol 2022;12:1361- 5. doi: 10.5455/njppp.2022.12.01001202213012022
Katekhaye VM, Kadhe NG, John J, Pawar SR. Knowledge, attitude and practice of pharmacovigilance among medical professionals at a tertiary care hospital in Mumbai, Maharastra, India. Int J Res Med Sci 2017;5:156-61.
Alam K, Karki B, Gupta AK, Sarraf DP, Wagle S. Assessment of knowledge, attitude and practice of pharmacovigilance and adverse drug reactions reporting among the community pharmacies in Dharan. Int J Sci Rep 2021;7:382-7. doi: 10.18203/issn.2454-2156. IntJSciRep20212833
Venkatasubbaiah M, Reddy PD, Satyanarayana SV. Knowledge, attitude, and practices (KAP) of the Pharm.D interns towards adverse drug reaction (ADR) reporting and pharmacovigilance. Pharm Educ 2021;21:186-93. doi: 10.46542/pe.2021.211.186193
Gupta R, Malhotra A, Malhotra P. A study on determinants of underreporting of adverse drug reactions among resident doctors. Int J Res Med Sci 2018;6:623-7. doi: 10.18203/2320-6012.ijrms20180310
Upadhyaya HB, Vora MB, Nagar JG, Patel PB. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat. J Adv Pharm Technol Res 2015;6:29-34. doi: 10.4103/2231-4040.150369, PMID 25709967
Kunnoor NS, Singanal S, Lohit K. Perception of doctors towards Adverse Drug Reaction (ADR) reporting: A cross sectional survey using a validated questionnaire. Int J Basic Clin Pharmacol 2017;6:2671-5. doi: 10.18203/2319-2003.ijbcp20174786
Shrestha S, Sharma S, Bhasima R, Kunwor P, Adhikari B, Sapkota B. Impact of an educational intervention on pharmacovigilance knowledge and attitudes among health professionals in a Nepal cancer hospital. BMC Med Educ 2020;20:179. doi: 10.1186/s12909-020-02084-7, PMID 32493307
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Copyright (c) 2023 S Renuka Singh, Dwipen Khanikar, Pran Pratim Saikia, Diptimayee Devi
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