DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20181626

Knowledge and perception towards pharmacovigilance and adverse drug reactions reporting among medical students at a teaching hospital in South India

Akshay J. K., Hemanth Kumar K. H.

Abstract


Background: Pharmacovigilance and adverse drug reactions monitoring has become an integral part to ensure patient safety. Targeting the younger doctors for sensitization towards pharmacovigilance is the key to ensure practice of ADR reporting in clinical practice. The objective of the study is to understand and assess the knowledge and perception of students towards pharmacovigilance and adverse drug reactions reporting.

Methods: The study included undergraduate medical students of second, pre-final and final years of Mysore Medical College. A validated and standardized KAP based questionnaire was distributed to all students. Willingness to answer and complete the questionnaire was considered as consent.

Results: The questions were statistically analysed individually and compared. Q1-Q10 compared knowledge towards pharmacovigilance, Q11-Q20 on the attitude and Q21-Q23 on the practice of ADR reporting. 325 questionnaires were distributed of which only 280 consented (second year - 114, pre-final - 98, final - 68). 112(49.1%), 137(69.9%) and 79(58.1%) of the three groups respectively knew what pharmacovigilance and ADR is. 79.8%, 76.5% and 75% knew who can report ADRs while 18.4%, 32.7% and 33.8% did not know what ADRs to report. 73(64.1%); 93(81.6%), 18(18.4%); 69(70.4%), 13(19.1%); 37(54.4%) knew the existence of AMC in the institute and the PvPI respectively. More than 92% agreed that ADR reporting is necessary. Majority (>90%) agreed that PV and ADR reporting should be taught to all health care students while 28%, 30% and 54% said that it was not well covered in their curriculum.73(64%), 51(52%) and 63(93%) were not familiar with the ADR reporting form.

Conclusions: Pharmacovigilance and ADR reporting needs to be made compulsory, have better, interesting ways to learn and understand it, so that the students can practice it with confidence in their clinical practice.


Keywords


Adverse Drug Reactions, Attitude and Practice (KAP), Knowledge, Pharmacovigilance, PvPI

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References


Lee A, Thomas SHL. Adverse drug reactions. In: Walker R and Edward C. Clinical Pharmacy and Therapeutics, 3rd Edition. US; Churchill Livingstone; 2003:33-46.

World Health Organization. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions. Geneva: WHO/EDM/QSM/2002.2;2002.

Lacoste-Roussillon C, Pouyanne P, Haramburu F, Miremont G, Begaud B. Incidence of serious adverse drug reactions in general practice: A prospective study. Clin Pharmacol Ther. 2001;69:458-62.

Classen DC, Pestonik SL, Evans RS, Lioyd JF, Burke JP. Adverse drug events in hospitalized patient- excess length of stay, extra cost and attributable mortality. JAMA. 1997;277:301-6.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse reactions in hospitalized patients. A metaanalysis of prospective studies. JAMA. 1998;279:1200-5.

Pirmohamed M, James S, Meakin S, Green C, Scott AK. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. Br Med J. 2004;329:15-9.

Geer MI, Koul PA, Tanki SA, Shah MY. Frequency, types, severity, preventability and costs of Adverse Drug Reactions at a tertiary care hospital. J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:323-34.

ASHP guidelines an adverse drug reaction monitoring and reporting. Am J Health Syst Pharm. 1995;52:140-2.

Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 2007;16:223-8.

Conforti A, Costantini D, Zanetti F, Moretti U, Grezzana M, Leone R. Adverse drug reactions in older patients: an Italian observational prospective hospital study. Drug Healthc. Patient Saf. 2012;4:75-80.

Posthumus AA, Alingh CC, Zwaan CC. Adverse drug reaction-related admissions in paediatrics, a prospective singlecentre study. BMJ Open. 2012.

Protocol of National Pharmacovigilance Programme, November 2004. CDSCO, Ministry of Health and Family Welfare, Government of India. November, 2004. Available at: http://www.cdsco.nic.in/html/Pharmacovigilance%20protocol%20.pdf

Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reaction by using a fee. Br Med J. 1990;300:22-3.

Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJM, Aronson JK, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol. 1996;42:423-9.

Tandon VR, Mahajan V, Khajuria V, Gullani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian J Pharmacol. 2015;47(1):65-71.

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.

Ratan JL, Mangala L. An update on the Pharmacovigilance Programme of India. Front Pharmacol. 2015;6:194. Available at: https://www.researchgate.net/publication/282513881

Sivadasan S, Chyi NW, Ching AL, Ali AN, Veerasamy R, Marimuthub K, et al. Knowledge and perception towards pharmacovigilance and adverse drug reaction reporting among medicine and pharmacy students. World J Pharm Pharm Sci. 2014 Jan 8;3(3):1652-76.

Komaran and Dhar, A study on assessment of Knowledge, attitude and practice regarding pharmacovigilance among healthcare professionals in a tertiary care hospital, Andra Pradesh Int J Pharm Sci Res. 2016;7(12):5082-87.

Dhananjay K, Himasri E. A study of assessing knowledge, attitude, and practice pharmacovigilance among medical students of a South Indian teaching hospital. Int J Basic Clin Pharmacol. 2017;6(1):43-7.

Arjun TN, Sudhir H, GourahaA JS, Chavan K, Dayma A. Assessment of knowledge, attitude and practice related to pharmacovigilance among the healthcare professionals in a teaching hospital in central india: a questionnaire study. WJPPS. 2015 Jan 17;4(4):785-99.