A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana

Aitha Swetha Rani; Chakradhar T.; Swarupa Rani Kasukurthi; E. Bhuvaneshwari; Sravani Marpaka

doi:10.18203/2319-2003.ijbcp20221039

Authors

Aitha Swetha Rani Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
Chakradhar T. Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
Swarupa Rani Kasukurthi Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E. Bhuvaneshwari Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
Sravani Marpaka Senior PV associate, AMC, Osmania Medical College, Hyderabad, Telangana, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20221039

Keywords:

Pharmacovigilance, Knowledge, Attitude, Practice, Post-graduates, Under-reporting

Abstract

Background: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.

Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.

Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.

Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.

ng.

Metrics

Metrics Loading ...

References

WHO Pharmacovigilance Indicators: A Practical Manual for the Assessment of Pharmacovigilance Systems. 2015.

Verma S, Gulati Y. Fundamentals of Pharmacovigilance, Need for Pharmacovigilance. 1st edition. 2017;9-12.

WHO. Safety of medicines in Public Health Programmes: Pharmacovigilance an essential tool. WHO. 2006.

Sarkar S, Srivastava V, Mohanty M. Textbook of Post-Graduate Pharmacology, Pharmacovigilance. 1st edition. 2020;84-9.

PvPI official website. Available at: https://www.ipc.gov.in/PvPI/pv_home.html. Accessed on 20 February 2021.

Giardina C, Paola M, Cutroneo, Mocciaro E, Giuseppina T et al. Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study, Pharmaceutical Medicine and Outcomes Research. 2018;9(350):1-12.

Srinivasan V, Sheela D, Mridula D. Knowledge, Attitude, and Practice of Pharmacovigilance among the Healthcare Professionals in a Tertiary Care Hospital – A Questionnaire Study, Biomedical and Pharmacology Journal. 2017;10(3):1441-7.

Pharmacovigilance Programme of India. Available at: https://www.ipc.gov.in/PvPI/faq.html. Accessed on 27 February 2021.

Rehan HS, Sah RK, Chopra D. Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital, Indian Journal of Pharmacology. 2012;44(6):699-703.

Kumar D, Muthu MS, Pandey BL. Pharmacovigilance program in India: Current status and its perspectives, Journal of Pharmacology and Toxicological Studies. 2015;3(4):20-4.

Dhananjay K, Himasri E. A study of assessing knowledge, attitude, and practice of pharmacovigilance among medical students of a South Indian teaching hospital. IJBCP. 2017;6(1):43-47.

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.

Smita S, Prasad SD, Prabin S, Pragati P. Knowledge, Attitude, and Practices of Pharmacovigilance among Doctors at a Tertiary Care Teaching Hospital Birgunj, Nepal. JNMC. 2021;6(1):14-8.

Gupta D, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. 2015;6(1):45-52.

Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC et al. Evaluation of patient reporting of adverse drug reactions to the UK, Yellow Card Scheme: Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1-234.

Nichols V, Thériault-Dubé I, Touzin J, Delisle JF, Lebel D, Bussières JF et al. Risk perception and reasons for noncompliance in pharmacovigilance: a qualitative study conducted in Canadá. Drug Saf. 2009;32(7):579-90.

Gavaza P, Brown CM, Khoza S. Texas pharmacists‟ opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study. Pharm World Sci. 2010;32(5):651-7.

Ganeshan S, Sandhiya S, Reddy KC, Adithan C. The impact of educational intervention on knowledge, attitudes, and practice of pharmacovigilance towards adverse drug reaction reporting among health care professionals in a tertiary care hospital in South India. Journal of natural science, biology and Medicine. 2017;8(2):203-9.

Alsbou M, Abdeen G Batereh A, Bawaresh N, Jaber J, Qawasmi G. Analysis of National Pharmacovigilance database in Jordan. Biomedical and Pharmacology Journal. 2017;10(1):319-28.

Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reaction reporting culture in Pharmacovigilance program of India. Indian Journal of Medical Research. 2014;140(4):563-4.

Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of Adverse Drug Reactions: A challenge for Pharmacovigilance in India. Indian Journal of Pharmacology. 2015;47(1):65-71.