A cross sectional study of knowledge, practice and attitude of medical professionals regarding pharmacovigilance function
Keywords:Attitude, Medical professional, Practice, Pharmacovigilance, Transformation of knowledge, Underreporting
Background: Pharmacovigilance is of core importance for the prevention of adverse effect by signal generation. It developed as a science and Practice. Central database collecting international reports helpful in generating signals, improving safety profile, prevention of future adverse effects, thus provide a key data to national drug regulatory to make regulation. It is not only a science but act as a law and regulation. Underreporting of ADRs by healthcare professionals remains a major problem. Clinician’s collaboration is needed to come up with the challenges of underreporting. Spontaneous reporting plays a cardinal role in Pharmacovigilance practice.
Methods: Cross Sectional, questioner-based study, 56- postgraduates, 42- first year,60- Second year, 35- Third year students of Institute of Medical Sciences were included with prior consent and Ethical committee permission. Structured pre-test questioner on, Knowledge-10, Attitude-02, Practice-06 were asked. Seminar was conducted on the ‘Pharmacovigilance in India: current Scenario, Study material were distributed to students. Prior to seminar and one week after conduction of seminar again the questioner was distributed again, and the same study was conducted, the difference in the response and attitude after transformation of knowledge were recorded.
Results: After transformation of knowledge 77% JR responded that ADR and medication both should be reported which was earlier only 31%. 80% JR replied that ADR should be reported as early as possible which was earlier 38%. It indicates that transformation of knowledge is a pillar to bring the change in practise. 100% second year students responded that they have seen ADR reporting form which was only 30% before seminar.
Conclusions: Up gradation of Knowledge by seminar, research papers, awareness pamphlets, Apps will promote the reporting and will strengthen the signal generation systems.
World Health Organization. The importance of Pharmacovigilance. 2002.
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016 Nov;48(6):624.
Bavdekar SB, Karande S. National pharmacovigilance program. Indian Pediatr. 2006 Jan 1;43(1):2
Kalaiselvan V, Thota P, Singh A. Current status of adverse drug reactions monitoring centres under pharmacovigilance programme of India. Indian J Pharm Pract. 2014 Jul;7:19-22.
Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian J Pharmacol. 2015 Jan;47(1):65.
Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013 Feb;69(2):237-44.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions. Drug Saf. 2006 May 1;29(5):385-96.
Meyboom RH, Egberts AC, Edwards IR, Hekster YA, de Koning FH, Gribnau FW. Principles of signal detection in pharmacovigilance. Drug Saf. 1997 Jun 1;16(6):355-65.
van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002 Jan;11(1):3-10.
Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med. 1986 Nov;81(5B):49-55.
Şencan N, Altınkaynak M, Ferah I, Özyıldırım A, Ceylan E, Clark P. The knowledge and attitudes of physicians and nurses towards advers event reporting and the effect of pharmacovigilance training: a hospital experience. Hacettepe Uni J Faculty Pharma. 2010 Jan;30(1):25-40.
Pérez García M1, Figueras A. The lack of knowledge about the voluntary reporting system of adverse drug reactions as a major cause of underreporting: direct survey among health professionals. Pharmacoepidemiol Drug Saf. 2011 Dec;20(12):1295-302.
Ganesan S, Vikneswaran G, Reddy KC, Subrahmanyam DK, Adithan C. A survey on knowledge, attitude and practice of pharmacovigilance towards adverse drug reactions reporting among doctors and nurses in a tertiary care hospital in South India. J Young Pharm. 2016 Oct 1;8(4):471-6.
Fadare JO, Enwere OO, Afolabi AO, Chedi BA, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Trop J Pharmaceut Res. 2011;10(3).