Introduction: The management of patients with adverse drug events (ADEs) has a significant economic impact owing to hospitalization and treatment costs. Recently, social and healthcare costs related to ADEs have become a relevant issue, and they are increasingly being included in budget estimations for health resource allocations. Aim: To evaluate the costs of ADEs and their predictability, and to estimate the impact of a pharmacovigilance facility on ADE-related cost savings within a regional healthcare system. Methods: A systematic review of English medical literature quoted in PUBMED (January 2005–March 2015) was conducted. We included all studies performed in Western Europe, USA and Canada about direct costs of ADEs in inpatient settings, for which the mean cost of serious and/or not-serious ADEs could be estimated. Studies on specific side-effects or drug-classes were excluded. The following data were extracted: mean cost of ADEs; percentage of preventable ADEs; charges for outpatient care and medications. The mean cost (into Euros) of serious and not-serious ADEs and the mean percentage of preventable ADEs were estimated. Based on spontaneous ADE reports recorded by the Tuscan Pharmacovigilance Centre in 2014, the theoretical cost of ADEs in Tuscany (3,704,152 inhabitants) was calculated. A sensitivity analysis was performed about cost (mean cost ±standard deviation ±50 %), and preventability (the maximum and minimum percentage estimated). The resulting range of ADE costs and the theoretically costs-saving that can be achieved with the implementation of pharmacovigilance activities were assessed. Results: Fourteen studies were analyzed: 13 on serious ADEs; 3 on costs of not-serious ADEs; 8 on percentage of preventability. The mean cost of an ADE was: €3526 ± 1927 for serious and €172 ± 93 for not serious. We estimated a mean preventability of 51.3 ± 21 %. In 2014, the Italian National Network of Pharmacovigilance database accounted for 1498 serious ADEs and 2997 not-serious ADEs in Tuscany (1214 ADEs/million- inhabitants). The overall costs of ADEs incurred by the Tuscan Regional Healthcare System was: €5281,948 (€1,425,953/million-inhabitants; sensitivity analysis: €3304,827–322,957/million-inhabitants) for serious ADEs; €515,484 (€139,164/million-inhabitants; sensitivity analysis: €321,094 32,117/million-inhabitants) for not-serious ADEs. Based on the estimated preventable costs in Tuscany, an effective pharmacovigilance system could allow to save €2,974,083 (€802,905/million-inhabitants; sensitivity analysis: €1,697,370–237,115/million-inhabitants) over one-year. Conclusion: Resource allocations to improve the regional pharmacovigilance systems might increase appropriateness and safety of therapies, thus reducing the costs incurred by regional healthcare systems. It could be obtained through: ADE evaluation systems; computerized prescription systems with alerts; continuing education of health professionals; multidisciplinary support to medical therapies.
Estimation of Theoretical Cost Preventability Achievable with an Effective Pharmacovigilance Activity in a Pharmacovigilance Regional Centre in Italy
Tuccori, M;Convertino, I;Mantarro, S;Blandizzi, C
2015-01-01
Abstract
Introduction: The management of patients with adverse drug events (ADEs) has a significant economic impact owing to hospitalization and treatment costs. Recently, social and healthcare costs related to ADEs have become a relevant issue, and they are increasingly being included in budget estimations for health resource allocations. Aim: To evaluate the costs of ADEs and their predictability, and to estimate the impact of a pharmacovigilance facility on ADE-related cost savings within a regional healthcare system. Methods: A systematic review of English medical literature quoted in PUBMED (January 2005–March 2015) was conducted. We included all studies performed in Western Europe, USA and Canada about direct costs of ADEs in inpatient settings, for which the mean cost of serious and/or not-serious ADEs could be estimated. Studies on specific side-effects or drug-classes were excluded. The following data were extracted: mean cost of ADEs; percentage of preventable ADEs; charges for outpatient care and medications. The mean cost (into Euros) of serious and not-serious ADEs and the mean percentage of preventable ADEs were estimated. Based on spontaneous ADE reports recorded by the Tuscan Pharmacovigilance Centre in 2014, the theoretical cost of ADEs in Tuscany (3,704,152 inhabitants) was calculated. A sensitivity analysis was performed about cost (mean cost ±standard deviation ±50 %), and preventability (the maximum and minimum percentage estimated). The resulting range of ADE costs and the theoretically costs-saving that can be achieved with the implementation of pharmacovigilance activities were assessed. Results: Fourteen studies were analyzed: 13 on serious ADEs; 3 on costs of not-serious ADEs; 8 on percentage of preventability. The mean cost of an ADE was: €3526 ± 1927 for serious and €172 ± 93 for not serious. We estimated a mean preventability of 51.3 ± 21 %. In 2014, the Italian National Network of Pharmacovigilance database accounted for 1498 serious ADEs and 2997 not-serious ADEs in Tuscany (1214 ADEs/million- inhabitants). The overall costs of ADEs incurred by the Tuscan Regional Healthcare System was: €5281,948 (€1,425,953/million-inhabitants; sensitivity analysis: €3304,827–322,957/million-inhabitants) for serious ADEs; €515,484 (€139,164/million-inhabitants; sensitivity analysis: €321,094 32,117/million-inhabitants) for not-serious ADEs. Based on the estimated preventable costs in Tuscany, an effective pharmacovigilance system could allow to save €2,974,083 (€802,905/million-inhabitants; sensitivity analysis: €1,697,370–237,115/million-inhabitants) over one-year. Conclusion: Resource allocations to improve the regional pharmacovigilance systems might increase appropriateness and safety of therapies, thus reducing the costs incurred by regional healthcare systems. It could be obtained through: ADE evaluation systems; computerized prescription systems with alerts; continuing education of health professionals; multidisciplinary support to medical therapies.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
