Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals
| Autor: | van Hunsel, Florence, Peters, Laura, Gardarsdottir, Helga, Kant, Agnes, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions Pharmacology toxicology MEDLINE Toxicology 030226 pharmacology & pharmacy 03 medical and health sciences Pharmacovigilance 0302 clinical medicine Taverne medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) 030212 general & internal medicine Thrombotic risk Pharmacology business.industry Public health medicine.disease Open data Medical emergency Public Health business Pergolide |
| Zdroj: | Drug Safety, 44, 589. Springer International Publishing Switzerland |
| ISSN: | 1179-1942 0114-5916 |
| Popis: | INTRODUCTION: The impact of pharmacovigilance activities on public health remains under-investigated, and measuring the impact on health of pharmacovigilance activities for a specific safety signal is challenging. OBJECTIVE: To gain more insight into the methodological challenges and the data required, we assessed the impact of pharmacovigilance on public health for four identified product-specific safety signals using publicly available data in the Netherlands. The assessment was on the impact of the intertwined and complementary steps of the pharmacovigilance pathways. METHODS: The impact of pharmacovigilance on public health was assessed using the assessment support tool and 'open data' from the Netherlands for four different types of pharmacovigilance safety signals: (1) off-label use of cyproterone acetate/ethinyloestradiol (CPA/EE) and thrombotic risk after pharmacovigilance measures after 2014; (2) pergolide and the risk of cardiac valvulopathy after pharmacovigilance activities in 2003; (3) proton pump inhibitors and the risk of hypomagnesaemia after pharmacovigilance activities in 2011; (4) rosiglitazone withdrawal from the market because of cardiovascular effects in 2010. RESULTS: For the signals on CPA/EE and pergolide, a crude estimation of the impact could be made with varying degrees of assumptions based on the risk described in the literature and utilisation data. CONCLUSION: This article highlights the methodological challenges and the data required to assess the impact of product-specific safety signals. A structured assessment support tool can be used as a guide for the necessary data elements and steps needed for the measurement or estimation of impact of pharmacovigilance activities on public health, provided that the appropriate data are available. |
| Databáze: | OpenAIRE |
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