ArticleTherapeutics and clinical risk management2018
Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China.
Article in Therapeutics and clinical risk management, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024Pooled it
- Pharmacy practice and policy research in Türkiye: a systematic review of literature.Journal of pharmaceutical policy and practice · 2024Review
- Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.Pharmaceutical medicine · 2019Article
- Article
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Abstract
backgroundSpontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU).
objectiveIn order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU's clinical pharmacists established a pharmacist-led ADE management model. The aim of this paper is to introduce this management model and explore the advantages and disadvantages of the model.
methodsPharmacist-led ADE management model was gradually formed from 2015 to 2017 in the SAHZU. This "pharmacist-led" model is reflected not only in the fact that clinical pharmacists are the main reporters of SAHZU's ADEs but also in that they are the main groups to analyze and manage ADE and drug errors. The sources of ADEs reported by clinical pharmacists mainly include pharmacy rounds, ADE-related pharmacist consultations, centralized monitoring, ADE warning signal analysis, newly introduced drug evaluations, and drug safety research.
resultsA total of 533 ADEs were reported by SAHZU to China's spontaneous reporting system (SRS) in 2017, while the data in 2012 was 177, with an increase by 201%. In 2012, the proportion of "new" and "serious" reports was 16.4%. The proportions during the period from 2015 to 2017 were 41.4%, 60.8%, and 52.2%, respectively, which were statistically significant compared with the proportion in 2012. The proportion of ADEs reported by clinical pharmacists during the period from 2014 to 2017 were 51.5%, 57.3%, 68.8%, and 90.8%, respectively, which were statistically significant compared with the proportion in 2013 (
conclusionThe pharmacist-led pharmacovigilance working model significantly increased the quantity and quality of ADE reporting in SAHZU and promoted pharmacovigilance. This model is worth developing in Chinese tertiary hospitals and the following hospitals, where the physicians working there spend little time and energy on ADE reporting or the cost of physicians is high, while the clinical pharmacist team has strong professional skills.
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