Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee
| Autor: | Robert W. V. Flynn, Puja R. Myles, Xavier Kurz, Tarita Murray-Thomas, Peter Arlett, Alexandra Pacurariu, Hilary Shepherd, Karin Hedenmalm |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Databases
Factual MEDLINE Primary care computer.software_genre Risk Assessment Article Orphan drug Pharmacovigilance media_common.cataloged_instance Medicine Electronic Health Records Humans Pharmacology (medical) European Union European union Duration (project management) media_common Pharmacology Database Primary Health Care business.industry Research Articles Medical research Legislation Drug Pharmaceutical Preparations Risk assessment business computer |
| Zdroj: | Clinical Pharmacology and Therapeutics |
| ISSN: | 1532-6535 0009-9236 |
| Popis: | This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data-UK, IQVIA Medical Research Data-France, IQVIA Medical Research Data-Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing. |
| Databáze: | OpenAIRE |
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