Back to Search Start Over

Prescription sequence symmetry analysis: assessing risk, temporality, and consistency for adverse drug reactions across datasets in five countries

Authors :
Ju-Young Shin
Kiyoshi Kubota
Byung Joo Park
Michio Kimura
Kenneth K.C. Man
Esther W. Chan
Nobuhiro Ooba
Edward Chia Cheng Lai
Yea Huei Kao Yang
Elizabeth E. Roughead
Nam Kyong Choi
Tomomi Kimura
Tsugumichi Sato
Nicole L. Pratt
Ian C. K. Wong
Pratt, Nicole
Chan, Esther W
Choi, Nam-Kyong
Kimura, Michio
Kimura, Tomomi
Kubota, Kiyoshi
Lai, Edward Chia-Cheng
Man, Kenneth KC
Ooba, Nobuhiro
Park, Byung-Joo
Sato, Tsugumichi
Shin, Ju-Young
Wong, Ian CK
Kao, Yang Yea-Huei
Roughead, Elizabeth E
Source :
Pharmacoepidemiology and Drug Safety
Publication Year :
2015
Publisher :
Wiley, 2015.

Abstract

Background Prescription sequence symmetry analysis (PSSA) is a signal detection method for adverse drug events. Its capacity to consistently detect adverse drug events across different settings has not been tested. We aimed to determine the consistency of PSSA results for detecting positive and negative control adverse drug events across different settings. Methods Using a distributed network model, we analyzed prescription dispensing data using PSSA in Australia, Hong Kong, Japan, Korea, and Taiwan. Positive control was amiodarone and thyroxine, as a marker of amiodarone-induced hypothyroidism, a known adverse event with a clear temporal relationship to amiodarone initiation. Negative controls were amiodarone and allopurinol, as a marker of amiodarone-induced gout and thyroxine and allopurinol, as a marker of thyroxine-induced gout. Gout is not recorded as an adverse event in product information for either medicine. Adjusted sequence ratios (ASR) were calculated for each country. Pooled estimates were obtained by using the generic inverse variance method. Results A positive association was identified between amiodarone and thyroxine in all settings with a pooled ASR 2.63 (95% confidence interval (CI) 1.47–4.72). Temporal analysis showed the effect occurred within the first few weeks of treatment. No significant associations were found for the negative controls in any setting; pooled ASR were 0.76 (95%CI 0.62–0.93) and 0.98 (95%CI 0.85–1.12) for amiodaroneallopurinol and thyroxine-allopurinol, respectively. Conclusion Despite different health settings, different populations, and different patterns of medicine utilization, PSSA gave consistent estimates across countries for a well-known positive association and two negative control adverse events. © 2015 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. key words—prescription symmetry analysis; pharmacovigilance; amiodarone; hyperthyroidism; pharmacoepidemiology

Details

ISSN :
10991557 and 10538569
Volume :
24
Database :
OpenAIRE
Journal :
Pharmacoepidemiology and Drug Safety
Accession number :
edsair.doi.dedup.....a9be9db57782094a6bbc2714fc7e98e0