Достижения в области фармакоэпидемиологии и безопасности лекарственных средств

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Prevalence, Determinants, and Reasons for the Non-Reporting of Adverse Drug Reactions by Pharmacists in the Miyagi and Hokkaido Regions of Japan

Obara T, Yamaguchi H, Satoh M, Iida Y, Sakai T, Aoki Y, Murai Y, Matsuura M, Sato M, Ohkubo T, Iseki K and Mano N

Little is known about the potential of adverse drug reaction (ADR) non-reporting by Japanese pharmacists. The aim of the present study was to clarify the prevalence, determinants, and reasons for ADR non-reporting by pharmacists in the Miyagi and Hokkaido regions of Japan. In this cross-sectional, self-administered questionnaire-based study, we contacted 3,164 pharmacists who belonged to the Miyagi Prefecture Hospital Pharmacists Association or the Hokkaido Society of Hospital Pharmacists during the 3-month period between January to March 2013. Of the 1,795 respondents 22.4% were <30 years of age, 25.6% were ≥ 50 years of age, and 42.1% were female. A total of 77.6% of the respondents did not have a personal history of ADR reporting. The multivariate logistic regression analysis showed that female sex (odds ratio, 1.52; 95% confidence interval, 1.17-1.97), having <10 years of practical experience (2.59, 1.39-4.82 for 5-9 years; 7.03, 2.94-16.83 for <5 years), working at a community pharmacy or drugstore (1.90, 1.16-3.12), having <5 pharmacists in the workplace (2.01, 1.48-2.75), and not understanding the ADR reporting system (5.93, 4.23-8.33) were significantly and independently associated with not having a personal history of ADR reporting. The most common reason for ADR non-reporting was “It was a well-known adverse drug reaction” (43.0%) followed by “Association between the drug and adverse reaction was not clear” (38.0%), “It was a minor adverse drug reaction” (29.0%), “Did not know how to make a report” (17.4%), and “Never been consulted about ADRs” (17.2%). As an understanding the ADR reporting system was strongly associated with ADR reporting, a more aggressive promotion of the ADR reporting system among pharmacists is warranted.