Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

  • Maša Amrain Boehringer Ingelheim BH d.o.o., Regulatory Affairs department, Sarajevo
  • Fahir Bečić 2 Department of Pharmacology, University of Sarajevo Faculty of Pharmacy, Sarajevo
Keywords: Knowledge, attitude, perception, barriers, health care professionals, adverse drug reaction (ADR), pharmacovigilance, Bosnia and Herzegovina

Abstract

Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR) reporting was performed.

Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.

Results: Of the 1000 respondents, 870 (87%) completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH). Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4%) of surveyed health care professionals reported adverse drug reaction.

Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

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References

Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:15-20. http://dx.doi.org/10.1186/1472-6904-9-14

Baniasadi S, Fahimi F, Shalviri G. Developing an adverse drug reaction reporting system at a teaching hospital. Basic Clin Pharmacol Toxicol. 2008;102:408–11. http://dx.doi.org/10.1111/j.1742-7843.2008.00217.x

Millar JS. Consultations owing to adverse drug reactions in a single practice. Br J Gen Pract. 2001;51(463):130‐1.

The Safety of Medicines in Public Health Programmes: pharmacovigilance an Essential Tool. Geneva: WHO;2006

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96. http://dx.doi.org/10.2165/00002018-200629050-00003

Belton KJ. 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): 423–7. http://dx.doi.org/10.1007/s002280050314

Bäckström M, Mjorndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting ADR in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729–32. http://dx.doi.org/10.1007/s002280000202

Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623-7. http://dx.doi.org/10.1046/j.1365-2125.1999.00060.x

Hasford J, Goettler M, Munter KH, Muller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55: 945-50 http://dx.doi.org/10.1016/S0895-4356(02)00450-X

Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci 1999;168:257-61 http://dx.doi.org/10.1007/BF02944353

Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration: your report can make a difference. J Gen Intern Med 2003; 18:57-60. http://dx.doi.org/10.1046/j.1525-1497.2003.20130.x

Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165:1363-69. http://dx.doi.org/10.1001/archinte.165.12.1363

Medicinal products and medical devices act. Official Gazette of BiH 58/08

Book of rules on the manner of reporting, collecting and following adverse effects of the medicinal products . Official Gazette of BiH 58/12

McGettigan P, Feely J. ADR reporting: opinions and attitudes of medical practitioners in Ireland. Pharmacoepidemiol Drug Saf 1995;4:355-8 http://dx.doi.org/10.1002/pds.2630040607

Cosentino M, Leoni O, Oria C, et al. Hospital-based survey of doctors’ attitudes to adverse drug reactions and perception of drug-related risk for adverse reaction occurrence. Pharmacoepidemiol Drug Saf 1999;8:S27-35 http://dx.doi.org/10.1002/(SICI)1099-1557(199904)8:1+3.3.CO;2-H

Figueiras A, Tato F, Fontainas J, et al. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 2001;7:347-54 http://dx.doi.org/10.1046/j.1365-2753.2001.00295.x

Vallano A, Cereza G, Pedro´ s C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-8 http://dx.doi.org/10.1111/j.1365-2125.2005.02504.x

Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Physicians’ attitudes and adverse drug reaction reporting: a casecontrol study in Portugal. Drug Saf 2005;28:825-33 http://dx.doi.org/10.2165/00002018-200528090-00007

Chatterjee S, Lyle N, Ghosh S. A survey of the knowledge, attitude and practice of adverse drug reaction reporting by clinicians in Eastern India. Drug Saf 2006;29(7):641-2 http://dx.doi.org/10.2165/00002018-200629070-00009

Toklu HZ, Uysal M.K. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci. 2008;30(5):556–62.

http://dx.doi.org/10.1007/s11096-008-9209-4

Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA. 1990;263:1785–8. http://dx.doi.org/10.1001/jama.1990.03440130073028

Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34:421-6.

Eland I.A, Belton KJ, Van Grootheest AC, Meiners AP, Rawlins MD, Stricker B.H. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999;48:623-7 http://dx.doi.org/10.1046/j.1365-2125.1999.00060.x

Serrano Cozar G, Esteban Calvo C, Gijon Porta JA, Vaquero Turiño I, Vázquez Burgos MI, Ibáñez Ruiz C, Frías Iniesta J. Adverse drug reactions and a program of voluntary notification: an opinion survey of primary care physicians. Aten Primaria 1997; 19:307-12.

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 2004;117:856-61.

Mes K, deJong-van den Berg LTW, van Grootheest AC. Attitudes of community pharmacists in the Netherlands towards adverse drug reaction reporting. Int J Pharm Pract 2002;10:267-72 http://dx.doi.org/10.1211/096176702776868460

Houghton J, Wood F, Davis S, Coulson R, Routledge P. Community pharmacist reporting of suspected ADRs: (2) Attitude of community pharmacists and general practitioners in Wales. Pharm J 1999; 263:788-91.

Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions among resident doctors. J Pharm Sci Res 2011;3:1064-9.

Ramesh M, Parthasarathi G. Adverse drug reactions reporting: attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res 2009;2:10-4

Ghosh S, Ali S, Chhabra L, Prasad C, Gupta A. Investigation of attitudes and perception of medical practitioners on adverse drug reaction reporting - a pilot study. T Ph Res 2010;3:1-9

Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Phamracol 2001;51:81-6 http://dx.doi.org/10.1046/j.1365-2125.2001.01306.x

Green CF, Mottram DR, Raval D, Proudlove C, Randall C. Community pharmacists' attitude to adverse drug reaction reporting. Int J Pharm Pract 1999;7:92-9. http://dx.doi.org/10.1111/j.2042-7174.1999.tb00955.x

Rawlins MD. Spontaneous reporting of adverse drug reactions I: the data. Br J Clin Pharmac 1988;26:1–5. http://dx.doi.org/10.1111/j.1365-2125.1988.tb03356.x

Published
2014-09-27
How to Cite
Amrain, M. and Bečić, F. (2014) “Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance”, Journal of Health Sciences, 4(2), pp. 120-125. doi: 10.17532/jhsci.2014.183.
Section
Research articles