Dataset Information

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

ABSTRACT:

Purpose

This study evaluated the effectiveness of risk minimisation measures (RMMs) implemented following the 2014 referral for valproate in Europe.

Methods

Cross-sectional survey was conducted over 2-month period in 2016 among physicians who prescribed valproate in France, Germany, the United Kingdom, Spain and Sweden. The web-based questionnaire included five endpoints to evaluate physicians' knowledge on (a) prescribing valproate only for epilepsy and bipolar disorder in women if other treatments were ineffective or not tolerated; (b) ensuring supervision by experienced physicians while treating these conditions; (c) considering alternative treatments for women planning pregnancy, regular review of treatment needs and re-assessing the benefit-risk balance in women and girls reaching puberty; (d) informing patients about the risks of taking valproate during pregnancy and (e) advising women on effective contraception during their treatment.

Results

Among 1153 physicians, 95.5% responded prescribing valproate for epilepsy and bipolar disorder in women only if other treatments are ineffective/not tolerated; 66.5% supervised while treatment; 76.6% considered alternative treatments for women planning pregnancy; 92.1% informed patients about the risks of taking valproate during pregnancy and 94.4% advised patients on the use of effective contraception during its treatment. Overall, 25.8% physicians recalled receiving both educational material (EM) and Dear Healthcare Professional Communication (DHPC). All endpoint rates were higher for physicians who acknowledged receipt of both DHPC and EM compared to physicians who did not receive them.

Conclusions

Although results varied across geography and physician speciality, majority of physicians had good knowledge about the indication and safety aspects of prescribing and using valproate.

SUBMITTER: Toussi M

PROVIDER: S-EPMC7894483 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

Toussi Massoud M Isabelle Bardoulat B Tcherny-Lessenot Stephanie S de Voogd Hanka H Dimos Vasilis V Kaplan Sigal S

Pharmacoepidemiology and drug safety 20201120 3

<h4>Purpose</h4>This study evaluated the effectiveness of risk minimisation measures (RMMs) implemented following the 2014 referral for valproate in Europe.<h4>Methods</h4>Cross-sectional survey was conducted over 2-month period in 2016 among physicians who prescribed valproate in France, Germany, the United Kingdom, Spain and Sweden. The web-based questionnaire included five endpoints to evaluate physicians' knowledge on (a) prescribing valproate only for epilepsy and bipolar disorder in women ...[more]

PMID: 33216434

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Project description:BackgroundApixaban (ELIQUIS®) is a direct oral anticoagulant authorised for multiple indications in the European Economic Area (EEA). Additional risk minimisation measures (aRMMs) to address the risk of bleeding include educational materials comprising a Prescriber Guide and Patient Alert Card.ObjectivesThis study evaluated effectiveness of the apixaban Prescriber Guide and Patient Alert Card in terms of healthcare professional (HCP) and patient knowledge of associated bleeding risk, as well as material distribution, utilisation and behaviour.MethodsThis non-interventional, cross-sectional study included online surveys in ten countries that represented a high proportion of apixaban usage in the EEA. The HCP source population was based on HCP lists used for communications about and distribution of the risk minimisation materials. Patient recruitment took place via HCPs. Study participants included HCPs involved in apixaban treatment and patients treated with apixaban (or their caregivers) for multiple indications. Data collection took place over an 18-month period between August 2015 and February 2017.ResultsSurvey responses from 385 HCPs and 125 patients/caregivers were analysed. HCP knowledge of bleeding risk included early recognition of symptoms requiring immediate contact with an HCP (96.1%), appropriate dosing (83.6%), contraindications (76.1%) and subpopulations at increased risk of bleeding complications (ranging from 63.5 to 85.9%). Patient knowledge included abnormal bleeding as an important side effect (71.2%), communicating risk factors to HCPs (76.8%) and recognition of potential bleeding symptoms ('high' knowledge levels 22.4%, 'moderate' knowledge levels 49.6%). Of 226 (58.7%) HCPs who recalled receiving/obtaining the Prescriber Guide, 97.8% read at least part of it and 74.8% had used it to assist patient discussions. Of 74 (59.2%) patients who were aware of the Patient Alert Card, 89.2% recalled receiving/obtaining a copy. When received, 90.9% of patients read the card at least once and 93.9% kept it with them at least some of the time.ConclusionsHCP and patient respondent knowledge of bleeding risk was satisfactory. Although not optimal, reach of the aRMMs was consistent with other studies. No modifications to aRMM content were required. To increase reach, the Prescriber Guide has been provided in an additional format as a web-based platform whilst the Patient Alert Card was included within product packaging.

Project description:BackgroundA relevant safety concern for the use of valproate (VPA) in women of reproductive age is its teratogenicity. In 2014 European Medicines Agency (EMA) introduced risk minimisation measures (RMMs) to reduce the VPA use by women of reproductive age, where the impact on VPA use was not as large as expected. In 2018, the EMA introduced additional RMMs, and it is essential to assess impact of these interventions.ObjectiveThe objective of this study was to evaluate the impact of the EMA-published RMMs in 2014 and 2018 on the prevalence of VPA use and to describe trends in the prevalence rate and incidence proportion of VPA use in epilepsy, bipolar disorder and off-label indications in Latvia.MethodsThis was a nationwide population-based study using a primary care prescription database. The study included women in age groups < 15, 15-49 and > 49 years and men in age group 15-49 years who have received VPA. This study assessed the prevalence rate and the incidence proportion of VPA use. The impact of RMMs on the two study intervention periods [fourth quarter (Q4) 2014 and Q4 2018] in men and women was evaluated using causal impact analysis.ResultsIn the study cohort, VPA use in women in the age group 15-49 years decreased after the first and second intervention periods, where after the first intervention period the relative reduction in prevalence of VPA consumption was -7.7 [95% confidence interval (CI) -10%, -5.1%] and after both study periods -6.4% (95% CI -11%, -1.5%). In girls < 15 years of age, valproate use decreased after both intervention periods, while in women > 49 years old VPA use increased. In men aged 15-49 years, an increase after the first period and a non-significant decrease after both intervention periods was observed. The prevalence of valproate use in girls < 15 years and women 15-49 years of age with bipolar disorder, epilepsy and off-label indications decreased per 1000 people during the study period. The incidence proportion of VPA use in women aged 15-49 years decreased each year since the beginning of the study period.ConclusionsA statistically significant decrease in the prevalence of VPA use was identified among girls < 15 years and women 15-49 years of age. In Latvia, an overall good reaction to the EMA RMMs was observed. The effects go beyond the target population and affect the use of VPA in young girls as well.

Project description:IntroductionDue to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.ObjectivesTo investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions.MethodsA 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.ResultsWe 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).ConclusionThere 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.

Dataset Information

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

Purpose

Methods

Results

Conclusions

Publications

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

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