The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting
Introduction: Adverse drug reactions (ADRs) are threat to the patient’s safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina.
Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014.
Results: The response rate was 73% (44 of 60) and 93% (148 of 160) among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate.
Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field.
World Health Organization [Internet]. [cited 2014 Sep 07]. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
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; 277:301–306. http://dx.doi.org/10.1001/jama.1997.03540280039031
Lazarou J, Pomeranz BH, Corey PN. The incidence of adverse drug reactions in hospitalized patients - a meta-analysis of prospective studies. JAMA 1998;279:1200–1205.
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.
Millar JS. Consultations owing to adverse drug reactions in a single practice. Br J Gen Pract 2001;51(463):130-1.
Agency for Medicines and Medical Devices in Bosnia and Herzegovina [Internet]. [cited 2014 Sept 07]. Available from: http://www.almbih.gov.ba/farmakovigilansa [in Bosnian]
Rulebook on the manner of reporting, collecting and following adverse effects of the medicinal products. Official Gazette of BiH 58/12. [in Bosnian]
The Importance of Pharmacovigilance - Safety monitoring of medicinal products. WHO; 2002.
Karelia BN, Piparava KG. Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city. Int J Basic Clin Pharmacol 2014;3:50-3.
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.
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
Belton KG, Lawis SC, Payne S, Rawlins MD. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995;39:223-26. http://dx.doi.org/10.1111/j.1365-2125.1995.tb04440.x
Grootheest K van, Olsson S, Couper M, de Jong-van den Berg, L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004;13:457-64. http://dx.doi.org/10.1002/pds.897
Morrison-Griffiths S, Walley TJ, Park BK, Breckenridge AM, Pirmohamed M. Reporting of adverse drug reactions by nurses. Lancet 2003;361:1347-48.
Grootheest AC van, Passier JL, van Puijenbroek EP. Direct reporting of side effects by the patient: favourable experience in the first year. Ned Tijdschr Geneeskd 2005;149:529-33.
Belton KJ, the European Pharmacovigilance Research Group. Attitude survey of adverse drug reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol 1997;52:423-27. http://dx.doi.org/10.1007/s002280050314
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker HCh. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999;48:623-27. http://dx.doi.org/10.1046/j.1365-2125.1999.00060.x
Backstrom M, Mjorndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000;56:729-32.
Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34:421-6.
van Puijenbroek, Conemans J, van Grootheest K. Spontaneous ADR reports as a trigger for pharmacogenetic research: a prospective observational study in the Netherlands. Drug Saf 2009;32(3):255-64. DOI: 10.2165/00002018-200932030-00008
Serrano Cozar G, Esteban Calvo C, Gijon Porta JA, Vaquero Turi-o I, Vázquez Burgos MI, Ibá-ez Ruiz C, et al. Adverse drug reactions and a program of voluntary notification: an opinion survey of primary care physicians [Article in Spanish]. Aten Primaria 1997;9:307-12.
Kozamernik B. Spontaneous adverse drug reaction reporting: attitudes and practice of health care professionals and distributors in South East European region. Farm Vestn 2010; 61:271-281.
Jovic Z, Djordjevic V, Milena M, Vasic K. Spontaneous reporting of adverse drug reactions at a department of Internal Medicine. Cent Eur J Med 2010;5(3):338-346.
Frontini R, Miharija-Gala T, Sykora J. EAHP survey 2010 on hospital pharmacy in Europe: parts 4 and 5. Clinical services and patient safety. Eur J Hosp Pharm 2013;20:69–73.
Mirosevic Skvrce N, Macolic Sarinic V, Mucalo I, Krnic D, Bozina N, Tomic S. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study. Croat Med J 2011;52(5):604-14. http://dx.doi.org/10.3325/cmj.2011.52.604
Wilbur K, Beniles A, Hammuda A. Physician perceptions of pharmacist roles in a primary care setting in Qatar. Globalization and Health 2012; 8:12.
Harriman McGrath S, Snyder M.E, Garcia Due-as G, Pringle JL, Smith RB, Somma McGivney M. Physician perceptions of pharmacist-provided medication therapy management: Qualitative analysis. J Am Pharm Assoc (2003) 2010;50:67-71
Amrain M, Bečić F. Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting Journal of Health Sciences 2014;4(2):120-125. http://dx.doi.org/10.17532/jhsci.2014.183
Toklu HZ, Soyalan M, Gültekin O, Özpolat M, Aydın MD at al. The knowledge and attitude of the healthcare professionals towards pharmacovigilance and adverse drug reaction reporting in Northern Cyprus. Pharmacovigilance 2016;4:1.
Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008; 30:556–562. http://dx.doi.org/10.1007/s11096-008-9209-4
Kalari S, Dormarunno M, Zvenigorodsky O, Mohan A. Pharmacy student perceptions of adverse event reporting. Am J Pharm Educ 2011; 75(7):1-5.
Toklu HZ. Promoting evidence-based practice in pharmacies. Integr Pharm Res Pract 2015:4 127–131. http://dx.doi.org/10.2147/IPRP.S70406
Toklu HZ. Pharmaceutical education vs. pharmacy practice: Do we really teach what they need for practicing? J Pharma Care Health Sys 2015 S3:e001.