Main Article Content
Pharmacovigilance can be helpful in protecting consumers from harmful effects of medicines. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In Nepal, pharmacovigilance activities were initiated in 2004.
Objectives: The present study evaluated the knowledge, attitude and practices (KAP) of the healthcare professionals towards ADRs and pharmacovigilance in Manipal Teaching Hospital (MTH), a tertiary care teaching hospital attached to the regional pharmacovigilance center in western Nepal.
Methods: A cross-sectional study was carried out in 2007 using a pretested (Cronbach alpha=0.72) questionnaire having 25 questions (15 questions on knowledge, 5 on attitude and 5 on practice). The correct/positive responses were given a score of ‘2’ and the wrong/negative responses ‘1’, maximum possible score of ‘50’.
Results: A total of 131 responses were obtained among which 42 were incomplete and remaining 89 [females 49 (55.1%)] were analyzed. Of the 89 professionals, 29 (32.6%) were doctors, 46 (51.8) nurses and 14 (15.7%) pharmacists. The mean age was 28.32 (SD=8.46) years and the median (interquartile range) of duration of the service 14.5 (6-36) months. The total KAP scores was 40.06 (SD=3.51) for doctors, 38.92 (SD=4.83) for pharmacists, and 35.82 (SD=3.75) for nurses. Among the 89 professionals, 59 (62.3%) had not reported even a single ADR to the pharmacovigilance center.
Conclusion: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals.
Keywords: Adverse Drug Reaction Reporting Systems. Attitude of Health Personnel. Nepal.
2. Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm. 1993;28(12):1199-204,1240.
3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-1205.
4. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997;277(4):301-306.
5. Anonymous. Safety monitoring of medicinal products. The importance of pharmacovigilance. World Health Organization, Geneva, 2002.
6. Li,Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, Shi LY, Zeng FD. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J (Engl). 2004;117:856-861.
7. Meyboom R, Olsson S, Thorogood M. Teaching pharmacovigilance, In: Pharmacovigilance R.D. Mann, E.B. Andrews, (ed)., John Wiley and Sons, 2002, p.505-508.
8. Anonymous. Safety of Medicines. A guide to detecting and reporting adverse drug reactions, WHO, Geneva, 2002.
9. Hartigan-Go K. Pharmacovigilance and the pursuit of rational drug use: The Philippines experience. Uppsala Reports. 2001;(14 S):1-4.
10. Lee A, Thomas SHL. Adverse drug reactions In: Walker R and Edward C. Clinical pharmacy and Therapeutics. 3rd edition Churchill Livingstone, 2003, p.33-46.
11. Hughes ML, Whittlesea CM, Luscombe DK. Review of national spontaneous reporting schemes. Strengths and weaknesses. Adverse Drug React Toxicol Rev. 2002;21(4):231-241.
12. Anonymous. Validating vigibase online. Uppsala Reports. 2006;(32):10-11.
13. Faich GA. Adverse-drug-reaction monitoring. N Engl J Med. 1986;314(24):1589-1592.
14. Eisenhauer LA. Adverse drug reactions: a concern for clinicians and patients. Clin Excell Nurse Pract. 2002;6:3-7.
15. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health Syst Pharm. 1995;52(4):417-419.
16. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-396.
17. Lee KK, Chan TY, Raymond K, Critchley JA. Pharmacists' attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother. 1994;28(12):1400-1403.
18. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 2007;16(2):223-228.
19. Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians' attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf. 2005;28(9):825-833.
20. Okezie E O, Olufunmilayo F. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiol Drug Saf. 2008;17(5):517-522.
21. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.
22. Subish P, Mohamed Izham MI, Mishra P. Evaluation of the knowledge, attitude and practices on adverse drug reactions and pharmacovigilance among healthcare professionals in a Nepalese hospital-a preliminary study. Internet Journal of Pharmacology 2008;6:1.
23. Olsson S. The need for pharmacovigilance In: Gupta SK. Pharmacology and therapeutics in the new millennium. Narosa publishing house, New Delhi, 2001, p.502-508.
24. Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007; 30(11):1073-82.
25. Belton K J, Lewis SC, Payne S, Rawlins MD, Wood SM.Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol. 1995;39(3):223-326.
26. 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(1):24-26.
27. Graille V, Lapeyre-Mestre M, Montastruc JL. Drug vigilance: opinion survey among residents of a university hospital. Therapie. 1994;49(5):451-454.
28. Cosentino M, Leoni O, Banfi, F, Leechini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res. 1997;35(2):85-8.
29. Bharathan B, Raju, N. A survey about the knowledge, attitude and practice of adverse drug reaction reporting among doctors in Bangalore city. Sixth annual conference of the Society of Pharmacovigilance (India), Kurupanidhi College of Pharmacy, Bangalore, India, 2006.
30. Subish P, Izham M, Mishra P. Pharmacovigilance in Nepal. A guide for healthcare professionals. Regional Pharmacovigilance Centre, Pokhara, Nepal, 2007.
31. Belton K J. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol. 1997;52(6):423-427.
32. Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999;48(4):623-627.
33. Holland EG, Degruy FV. Drug-Induced Disorders. Am Fam Physician. 1997;56(7):1781-1792.
34. Shankar PR, Mishra P, Subish,P, Upadhyay DK. The drug information center at the Manipal teaching hospital- going beyond drug information. Drug Inform J. 2007;41:61-68.
35. Subish P, Mishra P, Shankar PR, Bista D, Purwar B. Contribution of the regional drug information center towards drug safety. JNMA J Nepal Med Assoc. 2006;45(161):216-218.
36. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-245.
37. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-2232.
38. Shankar PR, Subish P, Mishra P, Dubey, AK. Teaching pharmacovigilance to medical students and doctors. Ind J Pharmacol. 2006;38:316-319.