The Asian Pharmacoepidemiology Network (AsPEN): promoting multi‐national collaboration for pharmacoepidemiologic research in Asia

Andersen, Morten; Bergman, Ulf; Choi, Nam-Kyong; Gerhard, Tobias; Huang, Cecilia; Jalbert, Jessica J.; Kimura, Michio; Kimura, Tomomi; Kubota, Kiyoshi; Lai, Edward Chia Cheng; Ooba, Nobuhiro; Park, Byung Joo; Pratt, Nicole; Roughead, Elizabeth E.; Sato, Tsugumichi; Setoguchi, Soko; Shin, Ju Young; Sundström, Anders; Yang, Yea Huei Kao

doi:10.1002/pds.3439

Cited by 64 publications

(22 citation statements)

References 9 publications

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“…This research was undertaken utilizing the network of databases established as part of the Asian Pharmacoepidemiology network (AsPEN) . AsPEN enables studies to be undertaken in datasets within different countries, with different ethnic groupings and different health systems and regulations.…”

Section: Introductionmentioning

confidence: 99%

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

Pratt

Chan

Choi

et al. 2015

Pharmacoepidemiol Drug Saf

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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.

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Section: Introductionmentioning

confidence: 99%

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

Pratt

Chan

Choi

et al. 2015

Pharmacoepidemiol Drug Saf

Self Cite

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“…They formed a voluntary research network, the Asian Pharmacoepidemiology Network (AsPEN) [10]. Recently, the USA, Sweden, Hong Kong, China, and Singapore have become collaborators with AsPEN.…”

Section: Resultsmentioning

confidence: 99%

“…Then, the scientific advisory committee evaluates and sets up a research agenda, and a project team is formed to answer the question. In the AsPEN, participating researchers achieve census on the pressing study questions regarding drug safety [10], and then teleconferences are held to develop protocols and to decide on the study execution details.…”

Section: Resultsmentioning

confidence: 99%

A Comparison of Active Adverse Event Surveillance Systems Worldwide

2014

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Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems’ structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based—the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian–the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European–the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK—the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-014-0194-3) contains supplementary material, which is available to authorized users.

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“…[27][28][29] The larger sample size afforded by multidatabases studies facilitates the application of robust study designs and, by using a common protocol, such studies enable investigators to leverage differences in the healthcare systems in the assessment of unmeasured confounding, treatment effect heterogeneity and generalisability across diverse populations, while holding constant the design and analytic approach. In the present study, we used multiple databases from three countries to: (1) address important shortcomings of prior studies by comparing the effectiveness and safety of BBs in patients with acute coronary syndromes (ACS) and COPD using a propensity score (PS)-matched, active comparator, new user cohort design; and (2) assess for potential remaining unmeasured confounding by examining a short-term COPD hospitalisation outcome.…”

Section: -6 CV Risk Reduction Ismentioning

confidence: 99%

Evidence of potential bias in a comparison of β blockers and calcium channel blockers in patients with chronic obstructive pulmonary disease and acute coronary syndrome: results of a multinational study

et al. 2017

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ObjectivesA number of observational studies have reported that, in patients with chronic obstructive pulmonary disease (COPD), β blockers (BBs) decrease risk of mortality and COPD exacerbations. To address important methodological concerns of these studies, we compared the effectiveness and safety of cardioselective BBs versus non-dihydropyridine calcium channel blockers (non-DHP CCBs) in patients with COPD and acute coronary syndromes (ACS) using a propensity score (PS)-matched, active comparator, new user design. We also assessed for potential unmeasured confounding by examining a short-term COPD hospitalisation outcome.Setting and participantsWe identified 22 985 patients with COPD and ACS starting cardioselective BBs or non-DHP CCBs across 5 claims databases from the USA, Italy and Taiwan.Primary and secondary outcome measuresStratified Cox regression models were used to estimate HRs for mortality, cardiovascular (CV) hospitalisations and COPD hospitalisations in each database after variable-ratio PS matching. Results were combined with random-effects meta-analyses.ResultsCardioselective BBs were not associated with reduced risk of mortality (HR, 0.90; 95% CI 0.78 to 1.02) or CV hospitalisations (HR, 1.06; 95% CI 0.91 to 1.23), although statistical heterogeneity was observed across databases. In contrast, a consistent, inverse association for COPD hospitalisations was identified across databases (HR, 0.54; 95% CI 0.47 to 0.61), which persisted even within the first 30 days of follow-up (HR, 0.55; 95% CI 0.37 to 0.82). Results were similar across a variety of sensitivity analyses, including PS trimming, high dimensional-PS matching and restricting to high-risk patients.ConclusionsThis multinational study found a large inverse association between cardioselective BBs and short-term COPD hospitalisations. The persistence of this bias despite state-of-the-art pharmacoepidemiologic methods calls into question the ability of claims data to address confounding in studies of BBs in patients with COPD.

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The Asian Pharmacoepidemiology Network (AsPEN): promoting multi‐national collaboration for pharmacoepidemiologic research in Asia

Cited by 64 publications

References 9 publications

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

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

A Comparison of Active Adverse Event Surveillance Systems Worldwide

Evidence of potential bias in a comparison of β blockers and calcium channel blockers in patients with chronic obstructive pulmonary disease and acute coronary syndrome: results of a multinational study

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