Premium
Evaluation of two Japanese regulatory actions using medical information databases: a ‘Dear Doctor’ letter to restrict oseltamivir use in teenagers, and label change caution against co‐administration of omeprazole with clopidogrel
Author(s) -
Hanatani T.,
Sai K.,
Tohkin M.,
Segawa K.,
Antoku Y.,
Nakashima N.,
Yokoi H.,
Ohe K.,
Kimura M.,
Hori K.,
Kawakami J.,
Saito Y.
Publication year - 2014
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12153
Subject(s) - oseltamivir , medicine , clopidogrel , neuraminidase inhibitor , database , pharmacovigilance , pharmacology , omeprazole , cpg site , adverse effect , aspirin , biology , gene , biochemistry , gene expression , disease , covid-19 , computer science , infectious disease (medical specialty) , dna methylation
Summary What is known and objective The implementation of appropriate epidemiological methodology using medical information databases ( MID s) to evaluate the effects of regulatory actions has been highly anticipated. To assess scientific methods for active pharmacovigilance using MID s, we conducted a quantitative assessment of the impact of two regulatory actions by the Japanese government: (i) restriction of use of oseltamivir in teenagers in March 2007 and (ii) caution against the co‐administration of omeprazole ( OPZ ) with clopidogrel ( CPG ) in April 2010. Methods Data were obtained from four hub hospitals in Japan. We measured the seasonal proportion of patients prescribed oseltamivir to those prescribed neuraminidase inhibitors for the 2002/2003 to 2010/2011 seasons. The monthly proportion of patients co‐administered OPZ and CPG ( OPZ + CPG ) to those prescribed CPG was measured from May 2009 to April 2011. We evaluated the changes observed with implementation of the regulatory actions. To estimate the impact of the actions, we conducted segmented regression analysis using interrupted time series data. The impact was assessed by two parameter estimates of the regression model: the change in level for short‐term effects and change in trend for long‐term effects. Results and discussion The use of oseltamivir in the target 10–19 years age group showed a significant and large decline (63·16%) immediately after the intervention ( P = 0·0008). No change was observed in OPZ + CPG , although there was a relative inhibitory trend for OPZ + CPG compared with co‐administration of lansoprazole or rabeprazole with CPG as the control group. When restricted to new users of CPG , the stratified results were consistent with the overall results. What is new and conclusion The current analysis demonstrates the effectiveness of two regulatory actions. The results of the current study indicate that MID research can contribute to assessing and improving pharmacovigilance activities.