PMID- 24661251
OWN - NLM
STAT- MEDLINE
DCOM- 20150330
LR  - 20181202
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 39
IP  - 4
DP  - 2014 Aug
TI  - 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.
PG  - 361-7
LID - 10.1111/jcpt.12153 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVE: The implementation of appropriate epidemiological 
      methodology using medical information databases (MIDs) to evaluate the effects of 
      regulatory actions has been highly anticipated. To assess scientific methods for 
      active pharmacovigilance using MIDs, 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.
CI  - (c) 2014 John Wiley & Sons Ltd.
FAU - Hanatani, T
AU  - Hanatani T
AD  - Division of Medicinal Safety Science, National Institute of Health Sciences, 
      Tokyo, Japan; Department of Regulatory Science, Graduate School of Pharmaceutical 
      Sciences, Nagoya City University, Aichi, Japan.
FAU - Sai, K
AU  - Sai K
FAU - Tohkin, M
AU  - Tohkin M
FAU - Segawa, K
AU  - Segawa K
FAU - Antoku, Y
AU  - Antoku Y
FAU - Nakashima, N
AU  - Nakashima N
FAU - Yokoi, H
AU  - Yokoi H
FAU - Ohe, K
AU  - Ohe K
FAU - Kimura, M
AU  - Kimura M
FAU - Hori, K
AU  - Hori K
FAU - Kawakami, J
AU  - Kawakami J
FAU - Saito, Y
AU  - Saito Y
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140324
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0 (Antiviral Agents)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Proton Pump Inhibitors)
RN  - 20O93L6F9H (Oseltamivir)
RN  - A74586SNO7 (Clopidogrel)
RN  - KG60484QX9 (Omeprazole)
RN  - OM90ZUW7M1 (Ticlopidine)
SB  - IM
MH  - Adolescent
MH  - Age Factors
MH  - Antiviral Agents/administration & dosage/therapeutic use
MH  - Child
MH  - Clopidogrel
MH  - Databases, Factual/statistics & numerical data
MH  - Drug Interactions
MH  - *Drug and Narcotic Control
MH  - Humans
MH  - Interrupted Time Series Analysis
MH  - Japan
MH  - Omeprazole/administration & dosage/*therapeutic use
MH  - Oseltamivir/administration & dosage/*therapeutic use
MH  - Pharmacovigilance
MH  - Platelet Aggregation Inhibitors/administration & dosage/therapeutic use
MH  - Practice Patterns, Physicians'/statistics & numerical data
MH  - Proton Pump Inhibitors/administration & dosage/therapeutic use
MH  - Regression Analysis
MH  - Ticlopidine/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - clopidogrel
OT  - medical information database
OT  - omeprazole
OT  - oseltamivir
OT  - pharmacovigilance
OT  - regulatory action
EDAT- 2014/03/26 06:00
MHDA- 2015/03/31 06:00
CRDT- 2014/03/26 06:00
PHST- 2013/09/19 00:00 [received]
PHST- 2014/02/20 00:00 [accepted]
PHST- 2014/03/26 06:00 [entrez]
PHST- 2014/03/26 06:00 [pubmed]
PHST- 2015/03/31 06:00 [medline]
AID - 10.1111/jcpt.12153 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2014 Aug;39(4):361-7. doi: 10.1111/jcpt.12153. Epub 2014 Mar 
      24.