Barriers to reporting of adverse drugs reactions: a cross sectional study among community pharmacists in United Kingdom
Background: Adverse Drug Reactions (ADRs) are a major public health problem. Prompt reporting of suspected ADRs is fundamental in the post-marketing surveillance of medicines and helps in ensuring medicine safety. However, fewer ADRs are reported in general and in particular by community pharmacists. There is limited knowledge about the factors which are preventing community pharmacists in the UK from reporting an ADR.
Objectives: To identify the barriers to ADR reporting among community pharmacists practicing in the UK.
Methods: A cross sectional study using a 25-items questionnaire (both online and paper based) including 10 barriers to ADR reporting was conducted from 1st April 2012 to September 2012. Community pharmacists practicing in the West Midlands, UK, were approached for the participation in this study. Chi-Square and regression were applied to identify covariates for the barriers to ADR reporting. A significant value of 0.05 was assigned for analysis.
Results: Of the 230 invited community pharmacists, 138 pharmacists responded (response rate 60%). The median age of respondents was 31 years. All pharmacists reported that they would report both serious and mild ADRs from drugs with black triangle among children as well as adults. About 95% (n=131) of the pharmacists were familiar with the paper based ADR reporting system. Store-based pharmacists were more likely to be more confident about which ADRs to report [0.680, 95% Confidence Interval 0.43-3.59]. Lack of time 46.4% (n=64), and pharmacists perception that ADR is not serious enough to report (65.2%; n=90) were identified as barriers to ADR reporting. Majority 63.0% (n=87) of the pharmacists identified training and information about what to report and access to Information Technology (IT) (For example access to internet connection) 61.6% (n=85) as facilitators to ADR reporting process.
Conclusion: Lack of time and ADRs considered not serious enough by pharmacists to report were barriers to ADR reporting. Further training and education about the types of ADRs to be reported can help to improve the reporting of ADRs.
2. Meier F, Maas R, Sonst A, Patapovas A, Muller F, Plank-Kiegele B, Pfistermeister B, Schoffski O, Bürkle T, Dormann H. Adverse drug events in patients admitted to an emergency department: an analysis of direct costs. Pharmacoepidemiol Drug Saf. 2015;24(2):176-186. doi: 10.1002/pds.3663
3. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008;42(7):1017-1025. doi: 10.1345/aph.1L037
4. Wiffen P, Gill M, Edwards J, Moore A. Adverse drug reactions in hospital patients. A systematic review of the prospective and retrospective studies. Bandolier Extra 2002;1-16.
5. Beijer HJM, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002;24(2):46-54.
6. MHRA. Adverse Drug Reactions. http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/TheYellowCardScheme/Informationforhealthcareprofessionals/Adversedrugreactions/index.htm (accessed 18 August 2016).
7. Shenfield GM, Robb T, Duguid M. Recording previous adverse drug reactions-a gap in system. Br J Clin Pharmacol. 2001;51(6):623-626.
8. MHRA. Best practice in reporting of individual case safety reports (ICSRs). 2011. 273 http://medicines.mhra.gov.uk (accessed 18 August 2016).
9. Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36(2):75-81. doi: 10.1007/s40264-012-0014-6
10. Davis S, Coulson R. Community pharmacist reporting of suspected ADRs: (1) The first year of the yellow card demonstration scheme. Pharm J. 1999;263:786-788.
11. Major E. Yellow card scheme and the role of pharmacists as reporters. Pharm J. 2002; 269: 25-26.
12. Calvert RT. Clinical pharmacy—a hospital perspective. Br J Clin Pharmacol. 1999;47(3):231-238.
13. Elkalmi RM, Hassali MA, Ibrahim MI, Jamshed SQ, Al-Lela OQ. Community pharmacists' attitudes, perceptions, and barriers toward adverse drug reaction reporting in Malaysia: a quantitative insight. J Patient Saf. 2014;10(2):81-87. doi: 10.1097/PTS.0000000000000051
14. Rouleau B, Lavoie L, Leblanc J, Moretti S, Collin C. Reporting of adverse drug reactions by community pharmacists: a qualitative study in Quebec. Ther Innovat Regul Sci. 2011;45(5):627-639. doi: 10.1177/009286151104500613
15. Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Diaz 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):1073-1082.
16. Granas AG, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf. 2007;16(4):429-434. doi: 10.1002/pds.1298
17. Gavaza P, Brown CM, Lawson KA, Rascati KL, Wilson JP, Steinhardt M. Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol. 2011;72(1):143-152. doi: 10.1111/j.1365-2125.2011.03944.x
18. Green CF, Mottram DR, Raval D, Randall C. Community pharmacists' attitudes to adverse drug reaction reporting. Int J Pharm Pract. 1999;7(2):92-99. doi: 10.1111/j.2042-7174.1999.tb00955.x
19. Whittlesea CM, Walker R. An adverse drug reaction reporting scheme for community pharmacists. Int J Pharm Pract. 1996;4(4):228-234. doi: 10.1111/j.2042-7174.1996.tb00873.x
20. 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 Oct;48(4):623-7. doi: 10.1046/j.1365-2125.1999.00060.x
21. Sheridan JC, Lyndall GS. SPSS analysis without anguish version 100 for Windows. Singapore: John Wiley & Sons; 2001.
22. Jadeja M, McCreedy C. Positive effect of new medicine service on community yellow card reporting. Pharm J. 2012;289:159-160.
23. Cox A. Embracing ADR reporting could improve pharmacists’ standing. Pharm J. 2002;269:14.
24. Martys C. Adverse reactions to drugs in general practice. Br Med J. 1979;2(6199):1194-1197.
25. Khalili H, Mohebbi N, Hendoiee N, Keshtkar AA, Dashti-Khavidaki S. Improvement of knowledge, attitude and perception of healthcare workers about ADR, a pre- and post-clinical pharmacists' interventional study. BMJ Open. 2012;2:e000367. doi: 10.1136/bmjopen-2011-000367
26. Smith MP, Webley SD. Pharmacovigilance teaching in UK undergraduate pharmacy programmes. Pharmacoepidemiol Drug Saf. 2013;22(3):223-228. doi: 10.1002/pds.3311
27. Christensen ST, Sondergaard B, Honore PH. Pharmacy student driven detection of adverse drug reactions in the community pharmacy setting. Pharmacoepidemiol Drug Saf. 2011;20(4):399-404. doi: 10.1002/pds.2069
28. Stanhope N, Crowley-Murphy M, Vincent C, O'Connor AM, Taylor-Adams SE. An evaluation of adverse incident reporting. J Eval Clin Pract. 1999;5(1):5-12.
29. Lawton R, Parker D. Barriers to incident reporting in a healthcare system. Qual Saf Health Care. 2002;11(1):15-18. doi: 10.1136/qhc.11.1.15
30. Kingston MJ, Evans SM, Smith BJ, Berry JG. Attitudes of doctors and nurses towards incident reporting: a qualitative analysis. Med J Aust. 2004;181(1):36-39.
31. Jeffe DB, Dunagan WC, Garbutt J, Burroughs TE, Gallagher TH, Hill PR, Harris CB, Bommarito K, Fraser VJ. Using focus groups to understand physicians’ and nurses’ perspectives on error reporting in hospitals. Jt Comm J Qual Saf. 2004;30(9):471-479.
32. Ashcroft DM, Morecroft C, Parker D, Noyce PR. Likelihood of reporting adverse events in community pharmacy: an experimental study. Qual Saf Health Care. 2006;15(1):48-52. doi:10.1136/qshc.2005.01463
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