Consumers’ adverse drug event reporting via community pharmacists: three stakeholder perception

Informa UK Limited - Tập 15 - Trang 1-10 - 2022
Tanattha Kitisopee1, Jirunya Assanee1, Bernard A. Sorofman2, Suntaree Watcharadmrongkun1
1Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand
2College of Pharmacy, The University of Iowa, Iowa City, USA

Tóm tắt

Adverse drug event (ADE) reporting is a significant process to increase consumer care and consumer safety associated with the use of medicines. An in-depth investigation into low ADE reporting by consumers and community pharmacists was undertaken to uncover interventions to improve reporting. In-depth interviewing of the three parties; consumers, pharmacists and employees of the Pharmacovigilance Center in Thailand, was used to collect the data. They were interviewed about ADE reporting experiences and contributing factors and problems of ADE reporting. Thematic analysis was used to interpret the results. The HPVC received few ADE reports from consumers. Most community pharmacists received ADE reports from consumers; however, the Pharmacovigilance Center received few ADE reports from community pharmacists. ADE reporting of community pharmacists and consumers were influenced by many factors which were categorized into four themes which were (1) “Cognition” (awareness, attitude and responsibility); (2) “Reporting process” (complication, competency, information deficiency, feedback, and resource); (3) “Inducer” (service orientation, acquaintanceship, motivation, severity level, regulatory and reward); and (4) “Obstacle” (doubt, belief and prosecution). Health professionals should motivate consumers to report ADEs. Building social responsibility and benefits and increasing knowledge of reporting process, channels, and system to both community pharmacists and consumers were recommended. Providing rewards and making community pharmacists feel comfortable to report ADEs by simplifying the ADE form and providing training, guidelines, and an ADR assessment tool can drive them to report ADEs. Feedback to consumers by confirming whether it was ADE and feedback to pharmacists that the Pharmacovigilance Center received their reports and their reports were utilized were also important.

Tài liệu tham khảo

Schatz S, Weber R. Adverse drug reactions. Pharm Practice. 2015;1:1. Härmark L, Van Grootheest A. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743–52. World Health Organization, The importance of pharmacovigilance. Vol. 2018. 2002: World Health Organization. World Health Organization, WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems. WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems. 2015: World Health Organization. Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An overview. Online J Public Health Inform. 2015;7:2. Heath product vigilance system in Thailand. 2016. http://203.157.72.106/fulltext2/book/17993/1.pdf. Accessed 12 Jan 2018. Hughes ML, Weiss M. Adverse drug reaction reporting by community pharmacists—the barriers and facilitators. Pharmacoepidemiol Drug Saf. 2019;28(12):1552–9. Li R, et al. Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey. Int J Clin Pharm. 2018;40(4):878–89. Yu YM, et al. Patterns of adverse drug reactions in different age groups: analysis of spontaneous reports by community pharmacists. PLoS ONE. 2015;10(7):e0132916. Elkalmi R, et al. Adverse drug reactions reporting: Knowledge and opinion of general public in Penang, Malaysia. J Pharm Bioallied Sci. 2013;5(3):224. Heath Product Vigilance Center, Report: Problems of health products vigilance in drug stores. 2003. Thai FDA-Health Product Vigilance Center. Statistic of Adverse Events during 1984 - 2019. 2019; http://thaihpvc.fda.moph.go.th/thaihvc/Public/News/uploads/hpvc_5_13_0_100805.pdf. Accessed 1 Oct 2020. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82. Mahmoud MA, et al. Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia. Saudi Pharm J. 2014;22(5):411–8. Obara T, et al. Prevalence, determinants, and reasons for the non-reporting of adverse drug reactions by pharmacists in the Miyagi and Hokkaido regions of Japan. Adv Pharmacoepidemiol Drug Saf. 2015;4(191):2167–1052. Qassim S, et al. Reporting adverse drug reactions: evaluation of knowledge, attitude and practice among community pharmacists in UAE. IOSR J Pharm. 2014;22(30):31–40. Duarte M, et al. Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study. Drugs Ther Persp. 2015;31(9):316–22. Khan TM. Community pharmacists’ knowledge and perceptions about adverse drug reactions and barriers towards their reporting in Eastern region, Alahsa, Saudi Arabia. Ther Adv Drug Safety. 2013;4(2):45–51. Irujo M, et al. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30(11):1073–82. Matos C, van Hunsel F, Joaquim J. Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting. Eur J Clin Pharmacol. 2015;71(7):883–90. Härmark L, et al. Patients’ motives for participating in active post-marketing surveillance. Pharmacoepidemiol Drug Saf. 2013;22(1):70–6. Al Dweik R, et al. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017;83(4):875–83. World Health Organization. Good Pharmacy Practice Joint FIP/WHO guidelines on GPP: Standards for quality of pharmacy service 2012. https://www.fip.org/file/1476. Accessed 1 Oct 2020. Herdeiro MT, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting. Drug Saf. 2006;29(4):331–40.