Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data

Nyeland, Martin Erik; Laursen, Mona Vestergaard; Callréus, Torbjörn

doi:10.1002/pds.4203

Cited by 18 publications

(21 citation statements)

References 23 publications

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“…However, RM evaluation is an emerging area of regulatory science. 5,6 Currently, there is a dearth of information on how to meaningfully change prescriber or patient behavior in the context of pharmaceutical RM; as a result, the impact of label changes on physician and patient behavior is understudied with few examples, 7,8 and when assessments are done, as with US REMS, many are not publicly disclosed 9 or of sufficient scientific interest or rigor to be publishable.…”

Section: Introductionmentioning

confidence: 99%

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Sobel

Bate

Marshall

et al. 2018

Pharmacoepidemiology and Drug

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Section: Introductionmentioning

confidence: 99%

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Sobel

Bate

Marshall

et al. 2018

Pharmacoepidemiology and Drug

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“…While RMM are intended to ensure safe and effective use of medicinal products, off‐label prescriptions may still be issued and pose a safety risk to the patients . Evaluation of the effectiveness of the implemented RMM has become an integral part of pharmacovigilance in the European Union to ensure a positive benefit‐risk balance in patients treated with a medicinal product …”

Section: Introductionmentioning

confidence: 99%

Evaluation of the effectiveness of risk minimization measures for trimetazidine: A cross sectional joint PASS survey among physicians in selected European countries

Bredow

Toussi

Samad

et al. 2018

Pharmacoepidemiology and Drug

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Purpose: In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to "add-on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line therapies." TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM. It also analyzed actual prescribing pattern of TMZ. Methods: A cross sectional, web-based survey was developed and conducted among prescribing physicians of TMZ across 12 European countries. Physicians' samples were weighted to account for the actual proportion of specialties within and across countries.Results: Using weighted samples, data from 1123 physicians and 8332 prescriptions were analyzed. Most (74.0%) of the physicians assumed stable angina pectoris to be an indication for TMZ. Three quarter of (75.7%) of these physicians were aware of the approved indication. Vertigo (62.1%), tinnitus (42.5%), declined visual acuity, and visual field disturbances (45.1%) were also presumed to be approved indications for TMZ, and physicians actually prescribed for these indications. Only 29.8% of the physicians remembered receiving RMM communications regarding TMZ. Most (90.5%) of the physicians expressed their interest to know and comply with the safety communications. Of all prescriptions, 33.9% were issued for add-on therapy for patients with stable angina pectoris.Conclusions: RMM for TMZ prescription have been moderately effective. Improvement in physician's compliance with safety information of TMZ is necessary for patient's safety.

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“…Also, this update emphasised the importance of monitoring of renal function, in particular in patients over 75 years. The impact of this safety update, as well as the features of the framework previously described, is assessed in the case study described below 28 .…”

Section: Caractéristique De Plan Spécifique -Utilisation Du Médicamenmentioning

confidence: 99%

La déclaration RECORD-PE (Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement for Pharmacoepdemiology) : directives pour la communication des études realisées à partir de données de santé observationelles collectées en routine en pharmacoépidémiologie

Langan

Schmidt

Wing

et al. 2019

CMAJ

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portée, revues systématiques), la clarté du libellé du titre et du résumé facilitera la réutilisation appropriée des résultats de la recherche, réduisant ainsi le gaspillage de ressources. En décrivant la conduite d'une étude utilisant des données de santé collectées en routine, les directives RECORD recommandent de rapporter le type de données utilisé et le nom de la (ou des) base(s) de données, en indiquant notamment si les données couplées ont été utilisées ; ces spécifications sont aussi directement pertinentes pour les études pharmacoépidémiologiques 1 .

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Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data

Abstract: The application of the framework provided useful graphical displays and an opportunity for a statistical evaluation (interrupted time series analysis) of a regulatory intervention. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.

Cited by 18 publications

References 23 publications

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Evaluation of the effectiveness of risk minimization measures for trimetazidine: A cross sectional joint PASS survey among physicians in selected European countries

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