Additional risk minimisation measures in the EU– are they eligible for assessment?

Zomerdijk, Inge M.; Trifirò, Gianluca; Sayed‐Tabatabaei, Fakhredin A.; Sturkenboom, Miriam; Straus, Sabine M. J. M.

doi:10.1002/pds.3494

Cited by 21 publications

(17 citation statements)

References 11 publications

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“…The effectiveness of educational materials is debated and the materials may not always have the intended effect [23]. Effectiveness studies are important to decide whether RMMs are adequate or should be amended, although the execution often remains a challenge [24][25][26]. As the aRMMs discussed in this study are implemented at the time of the product approval, a comparison between before and after implementation of the aRMM is not feasible in these cases.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…Also, although the number of major bleeding was low, the outcome data displayed in Figure are unadjusted and do not take confounders into consideration. Last, some limitations of electronic health care databases when used for post‐approval drug safety monitoring have recently been discussed …”

Section: Discussionmentioning

confidence: 99%

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

Nyeland

Laursen

Callréus

2017

Pharmacoepidemiol Drug Saf

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“…For some drugs and for specific important safety issues, additional risk minimisation measures (ARMMs) are required to maximise the risk-benefit balance. 4,5 Examples of such measures include restrictions on access to the medicine and programmes to prevent pregnancies for drugs with a significant risk of causing fetal malformation, as well as the provision of educational material for healthcare professionals and patients, information cards and patient diaries. Despite the importance of ARMMs, making them readily available to those who need them is not straightforward and currently piecemeal.…”

Section: Flagging Riskmentioning

confidence: 99%

“…5,6 However, these assessments need to distinguish between surrogate outcomes (e.g. uptake of information) and patient-oriented objectives (e.g.…”

Section: Flagging Riskmentioning

confidence: 99%

Flagging risk

2017

DTB

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Additional risk minimisation measures in the EU– are they eligible for assessment?

Cited by 21 publications

References 11 publications

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

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

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

Flagging risk

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