Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures

Francisca, Reynold D. C.; Zomerdijk, Inge M.; Sturkenboom, Miriam; Straus, Sabine M. J. M.

doi:10.1080/14740338.2018.1512579

Cited by 7 publications

(12 citation statements)

References 17 publications

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“…The EU‐RMP is updated throughout the product life cycle as studies are completed or new information becomes available that may change the benefit‐risk balance . Significant variation exists in the requirements and execution of postauthorization safety studies (PASS) and additional risk minimization measures . This is partly because the EU‐RMP is product‐specific and strategies are tailored to be risk‐proportionate (i.e.…”

Section: Pms System For Medicinal Products and Medical Devices In The Eusupporting

confidence: 82%

“…This guidance was implemented in EU regulation in 2005 in the form of the EU risk management plan (EU‐RMP), which is a mandatory template document for the authorization dossier of innovative drugs licensed in the EU . The EU‐RMP describes the important risks and areas of missing information, the activities intended to further characterize the safety profile, and the measures to minimize the risks . The EU‐RMP is updated throughout the product life cycle as studies are completed or new information becomes available that may change the benefit‐risk balance .…”

Section: Pms System For Medicinal Products and Medical Devices In The Eumentioning

confidence: 99%

“…[10][11][12] The EU-RMP describes the important risks and areas of missing information, the activities intended to further characterize the safety profile, and the measures to minimize the risks. 13,14 The EU-RMP is updated throughout the product life cycle as studies are completed or new information becomes available that may change the benefit-risk balance. 15 Significant variation exists in the requirements and execution of postauthorization safety studies…”

Section: Medicinal Productsmentioning

confidence: 99%

“…(PASS) and additional risk minimization measures. [16][17][18][19] This is partly because the EU-RMP is product-specific and strategies are tailored to be risk-proportionate (i.e. taking into account variables such as seriousness and severity of the risk, target population, and healthcare setting of use of the product).…”

Section: Key Pointsmentioning

confidence: 99%

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EU postmarket surveillance plans for medical devices

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Francisca

Verhamme

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. Methods This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow‐up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Results The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. Conclusions The PMS plan may serve as a thorough tool for the benefit‐risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.

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Section: Pms System For Medicinal Products and Medical Devices In The Eusupporting

confidence: 82%

Section: Pms System For Medicinal Products and Medical Devices In The Eumentioning

confidence: 99%

Section: Medicinal Productsmentioning

confidence: 99%

Section: Key Pointsmentioning

confidence: 99%

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EU postmarket surveillance plans for medical devices

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Francisca

Verhamme

et al. 2019

Pharmacoepidemiology and Drug

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“…A discussion on the risk of MEs is a mandatory part of the EU RMP [10] and, if appropriate, MEs can be included as an important risk in the RMP. In addition, pharmacovigilance activities and aRMMs to prevent MEs can be proposed [11,12].…”

Section: Introductionmentioning

confidence: 99%

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

et al. 2019

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Introduction Medication errors can have serious consequences for patients. To prevent the occurrence of medication errors in clinical practice, safety concerns may be included in the risk management plan and subsequently be addressed with routine and/or additional risk minimisation measures. Objective This study aims to describe safety concerns around medication errors and the risk minimisation measures for centrally authorised products in the European Union. Methods All safety concerns included in the risk management plans of originator centrally authorised products, authorised between 1 January, 2010 and 31 December, 2017, were collected from the European Public Assessment Report registry. Medication error safety concerns were categorised by Anatomical Therapeutic Classification code, year of authorisation, type of medication error and type of risk minimisation measure. Results During the study period, 311 centrally authorised products were approved, of which 84 had at least one medication error safety concern. The proportion of centrally authorised products with medication error safety concerns showed variation between 2010 and 2017 ranging from 15.2% to 36.4%. In total, 95 medication error safety concerns were identified. The type of medication error was highly variable, drug administration error was listed most frequently (n = 17). For 27 out of 95 medication error safety concerns, corresponding to 23 centrally authorised products, additional risk minimisation measures were required. All additional risk minimisation measures consisted of educational material targeted at healthcare professionals (85.2%) and/or patients (51.9%). For 78.3% of centrally authorised products with additional risk minimisation measures for medication errors, studies to evaluate the effectiveness of the additional risk minimisation measures were agreed upon. Conclusions Medication error safety concerns were listed for almost a quarter of centrally authorised products approved during the study period. Further research is needed to evaluate the effectiveness and continued need for additional risk minimisation measures for medication errors. Key PointsOver a quarter of medicines authorised in the European Union have medication errors as an important risk included in the risk management plan.Medication errors frequently require additional risk minimisation measures.Studies are needed to confirm the effectiveness of measures implemented to minimise the risk of medication errors.Electronic supplementary material The online version of this article (https ://doi.org/10.1007/s4026 4-019-00874 -7) contains supplementary material, which is available to authorized users.

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The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report

Pasmooij,

Mol,

Bot

et al. 2024

Clin Pharma and Therapeutics

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In the Netherlands, drug regulatory science is a vibrant national and internationally oriented community. In this review, we present the factors that have contributed to this successful collaboration between relevant stakeholders and that led to a surge of activities around how regulatory science became embedded in the ecosystem of medicines research, clinical pharmacology, policymaking and regulation. We distinguished three pivotal episodes: (i) TI Pharma Escher‐project, (ii) Dutch Medicines Evaluation Board as catalyst of the big jump, and (iii) Regulatory Science Network Netherlands and multistakeholder engagement. The research agenda has been influenced by the dynamic evolution of legal frameworks in Europe, such as the EU orphan medicines legislation of 2001 and the EU pharmacovigilance legislation of 2012. All these developments have inspired and have raised pertinent regulatory sciences questions. Furthermore, clinical pharmacology as a discipline has been very influential in shaping regulatory science, contributing to discussions on the level of clinical evidence that is necessary to justify marketing approval of a new medicine. With a growing interest of multiple parties such as academics, European Medicines Agency, national agencies, patient organizations and EFPIA, connecting regulatory science activities is key.

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Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures

Abstract: During the study period, no significant differences in the proportion or trend of products with aRMMs at the time of licensing before and after the pharmacovigilance legislation were identified.

Cited by 7 publications

References 17 publications

EU postmarket surveillance plans for medical devices

EU postmarket surveillance plans for medical devices

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report

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