Abstract
Background Hospital pharmacists can make a considerable contribution to the spontaneous reporting system of adverse drug reactions. The factors that influence adverse drug reaction reporting among hospital pharmacists remain largely unknown in China. Objective This study aims to identify factors that affect hospital pharmacist-led adverse drug reaction reporting in Xi’an, and to obtain suggestions from pharmacists about how to improve the current adverse drug reaction reporting system. Setting Hospital settings throughout Xi’an, a region of Western China. Method A matched case–control study was conducted on a population of 2,814 hospital pharmacists in Xi’an during 2011. Cases included all pharmacists who had reported at least one adverse drug reaction between 2008 and 2010 and agreed to participate in the study (186/204; 91.2 %); controls (n = 372) were pharmacists who had not reported any adverse drug reaction during the same period. A self-administered questionnaire was distributed to the participants. Logistic regression was performed to evaluate the association between indicator variables and the outcome of having reported at least one adverse drug reaction. Main outcome measure Pharmacists’ knowledge, attitude and practice towards adverse drug reaction reporting and factors affecting reporting. Results Higher professional title (adjusted OR 1.44; 95 % CI 1.07–1.94; p = 0.018), having received training about adverse drug reaction reporting (1.64; 1.04–2.57; p = 0.032), better knowledge about reporting (1.53; 1.12–2.08; p = 0.007), “lack of access to adverse drug reaction reporting form” (0.29; 0.12–0.72; p = 0.008) was independently associated with adverse drug reaction reporting. Clinical pharmacists were more likely to report an adverse drug reaction than dispensary pharmacists (1/adjusted OR 5.26; p < 0.001), pharmacy administrators (5.00; p = 0.003), and other technicians (5.56; p = 0.001). Conclusions Higher professional title, having received training, mastering knowledge about reporting, and being a clinical pharmacist were positive predictors of pharmacist-led adverse drug reaction reporting. Lack of access to reporting forms was a negative predictor. Continuous training and establishing incentive mechanisms are needed to promote adverse drug reaction reporting among hospital pharmacists.
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References
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA. 1998;279(15):1200–5.
Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. JAMA. 1997;277(4):301–6.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ. 2004;329(7456):15–9.
Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov. 2009;8(10):779–82.
Scott HD, Thacher-Renshaw A, Rosenbaum SE, Waters WJ, Green M, Andrews LG, et al. Physician reporting of adverse drug reactions. JAMA. 1990;263(13):1785–8.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.
The Ministry of Health. Provisions for reporting and monitoring of adverse drug reactions. 2011. http://china-pharm.com.cn/News_View.asp?Newsid=183&Page=1 Cited 24 Dec 2014.
Du W, Guo JJ, Jing Y, Li X, Kelton CM. Drug safety surveillance in China and other countries: a review and comparison. Value Health. 2008;11(Suppl 1):S130–6.
China Food and Drug Administration. Annual report for National Adverse Drug Reaction Monitoring. 2012. http://www.sda.gov.cn/WS01/CL0051/79058.html Cited 25 July 2014.
Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol. 2009;65(1):43–6.
Aagaard L, Stenver D, Hansen E. Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark. Pharm World Sci. 2008;30(5):563–70.
Van Grootheest AC, van Puijenbroek EP, de Jong-van den Berg LT. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(3):205–10.
Ahmad SR, Freiman JP, Graham DJ, Nelson RC. Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA. Pharmacoepidemiol Drug Saf. 1996;5(1):1–7.
Lee A, Bateman DN, Edwards C, Smith JM, Rawlins MD. Reporting of adverse drug reactions by hospital pharmacists: pilot scheme. BMJ. 1997;315(7107):519.
Wang HC, Chen LY, Lau AH. Pharmacy practice and education in the People’s Republic of China. Ann Pharmacother. 1993;27(10):1278–82.
Ryan M, Shao H, Yang L, Nie X, Zhai S, Shi L, et al. Clinical pharmacy education in China. Am J Pharm Educ. 2008;72(6):129.
China Ministry of Health and State Administration of Traditional Chinese Medicine. Temporary regulation for pharmacy administration in medical organizations. 2002. http://www.moh.gov.cn/zhuzhan/wsbmgz/201304/c94ba546e18e488b9a1831d04c28d511.shtml Cited 18 July 2014.
Van Grootheest K, Olsson S, Couper M, de Jong-van den Berg LT. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 2004;13(7):457–64.
Belton KJ, The EPRG. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J of Clin Pharmacol. 1997;52(6):423–7.
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):623–7.
Qing L, Sumin Z, Huating C, Shiping F, Xin Y, Dong L, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J. 2004;117(6):856–61.
Figueiras A, Tato F, Fontaiñas J, Gestal-Otero JJ. Influence of physicians’ attitudes on reporting adverse drug events: a case–control study. Med Care. 1999;37(8):809–14.
Rogers AS, Israel E, Smith CR, Levine D, McBean AM, Valente C, et al. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med. 1988;148(7):1596–600.
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):825–33.
Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55(9):945–50.
Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 2007;16(2):223–8.
Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168(4):257–61.
Sweis D, Wong IC. A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf. 2000;23(2):165–72.
Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81–6.
Green CF, Mottram DR, Raval D, Proudlove C, Randall C. Community pharmacists’ attitudes to adverse drug reaction reporting. Int J Pharm Pract. 1999;7:92–9.
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.
Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case–control study in Portugal. Drug Saf. 2006;29(4):331–40.
Su C, Ji H, Su Y. Hospital pharmacists’ knowledge and opinions regarding adverse drug reaction reporting in Northern China. Pharmacoepidemiol Drug Saf. 2010;19(3):217–22.
Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract. 2004;10(4):483–9.
Tanzania Food and Drugs Authority. Guidelines for monitoring and reporting adverse drug reactions. 2006. http://apps.who.int/medicinedocs/documents/s18571en/s18571en.pdf Cited 10 Nov 2013.
Calvert RT. Clinical pharmacy—a hospital perspective. Br J Clin Pharmacol. 1999;47(3):231–8.
Schlienger RG, Lüscher TF, Haefeli WE, Schoenenberger RA. Academic detailing improves identification and reporting of adverse drug events. Pharm World Sci. 1999;21(3):110–5.
Figueiras A, Tato F, Fontaiñas J, Takkouche B, Jesus Gestal-Otero J. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract. 2001;7(4):347–54.
Van Grootheest AC, Mes K, de Jong-van den Berg Berg LT. Attitudes of community pharmacists in the Netherlands towards adverse drug reaction reporting. Int J Pharm Pract. 2002;10:267–72.
Toklu H, Uysal M. 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.
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol. 2009;9:14.
Zolezzi M, Parsotam N. Adverse drug reaction reporting in New Zealand: implications for pharmacists. Ther Clin Risk Manag. 2005;1(3):181–8.
Green CF, Mottram DR, Rowe P, Brown AM. An investigation into adverse drug reaction monitoring by United Kingdom hospital pharmacy departments. Int J Pharm Pract. 1997;5:202–8.
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The authors thank all the hospital pharmacists who participated in this study.
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Zhongliang Zhou is co-first author.
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Liu, J., Zhou, Z., Yang, S. et al. Factors that affect adverse drug reaction reporting among hospital pharmacists in Western China. Int J Clin Pharm 37, 457–464 (2015). https://doi.org/10.1007/s11096-015-0065-8
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DOI: https://doi.org/10.1007/s11096-015-0065-8