PHARMO Database Network

Bakker, Michael den; Herings, Ron M. C.

doi:10.1007/978-3-030-51455-6_7

Cited by 1 publication

(2 citation statements)

References 18 publications

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“…Misclassification of outcome, especially in case of pregnancy records, was another limitation. To minimise any issues with this, we used an adapted version of a previously validated algorithm [ 12 ]. Also, lack of data on over-the-counter contraceptives, which are not captured in any of the databases, might have resulted in an underestimation of the proportion of compliant valproate use with a contraceptive coverage.…”

Section: Discussionmentioning

confidence: 99%

“…The Agenzia regionale di sanità della Toscana (ARS Tuscany) is a regional administrative claims database in Italy, with information on outpatient prescriptions, hospital admissions, diagnostic tests and exemptions from co-payment, linked to a birth registry, with a coverage of 3.6 million inhabitants. The PHARMO Data Network is an electronic medical record (EMR) database with data linked from different primary and secondary health care settings in the Netherlands (such as general practitioner [GP] visits, in- and out-patient pharmacies, hospitals, and perinatal registry), with a coverage of 4.2 million active patients [ 12 , 13 ]. The Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria (BIFAP) is an EMR database from multiple regions in Spain, with information on GP visits, prescriptions/dispensations, diagnostic procedures, laboratory tests and specialist referrals, with a coverage of 9.4 million active patients [ 14 ].…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

et al. 2023

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Introduction Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018. Objectives To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions. Methods A multi-database, times series study of females of childbearing potential (12–55 years) was conducted using electronic medical records from five countries/regions (01.01.2010–31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of contraception coverage during valproate use, and occurrence of pregnancies during valproate exposure were estimated per month. Interrupted time series analyses were conducted to estimate the level or trend change in the outcome measures. Results We included 69,533 valproate users from 9,699,371 females of childbearing potential from the five participating centres. A significant decline in prevalent use of valproates was observed in Tuscany, Italy (mean difference post-intervention −7.7%), Spain (−11.3%), and UK (−5.9%) and a non-significant decline in the Netherlands (−3.3%), but no decline in incident use after the 2018 RMMs compared to the period before. The monthly proportion of compliant valproate prescriptions/dispensings with a contraceptive coverage was low (<25%), with an increase after the 2018 RMMs only in the Netherlands (mean difference post-intervention 12%). There was no significant increase in switching rates from valproates to alternative medicine after the 2018 intervention in any of the countries/regions. We observed a substantial number of concurrent pregnancies during valproate exposure, but with a declining rate after the 2018 RMMs in Tuscany, Italy (0.70 per 1000 valproate users pre- and 0.27 post-intervention), Spain (0.48 and 0.13), the Netherlands (0.34 and 0.00), and an increasing rate in UK (1.13 and 5.07). Conclusion There was a small impact of the 2018 RMMs on valproate use in the studied European countries/regions. The substantial number of concurrent pregnancies with valproate exposure warrants a careful monitoring of implementation of the existing PPP for valproate in clinical practice in Europe, to see if there is any need for additional measures in the future. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01314-3.

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Section: Discussionmentioning

confidence: 99%