Are risk minimization measures for approved drugs in Europe effective? A systematic review

Artime, Esther; Qizilbash, Nawab; Garrido‐Estepa, Macarena; Vora, Pareen; Soriano‐Gabarró, Montse; Asiimwe, Alex; Pocock, Stuart J.

doi:10.1080/14740338.2019.1612875

Cited by 25 publications

(45 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A recent systematic review of studies evaluating the effectiveness of RMMs highlighted common challenges in designing and conducting these studies, including low response rates, limited generalisability of results and inconsistencies in reporting [7]. More specifically, the challenges of conducting studies to evaluate RMMs around potential hepatic risk are recognised in the literature, and these studies have generally found suboptimal compliance with livermonitoring requirements [8][9][10].…”

Section: Discussionmentioning

confidence: 99%

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

et al. 2019

View full text Add to dashboard Cite

Background Hepatotoxic reactions are an important identified risk listed in the agomelatine risk management plan. This postauthorisation safety study evaluated the effectiveness of additional risk-minimisation measures (aRMMs) for agomelatine. Objective The objective of this study was to evaluate, among physicians prescribing agomelatine and their patients, liver function monitoring adherence, compliance with contraindications and patients' reasons for non-compliance with liver monitoring. Methods A non-interventional cohort study was conducted among adults initiating agomelatine in routine clinical practice in Denmark, France, Germany and Spain through a retrospective medical record abstraction (MRA) before and after implementation of aRMMs and a cross-sectional patient survey. Results Fifty-four sites contributed data on 437 and 404 patients in the before-and after-RMM periods, and 237 patients completed the survey. No patient had cirrhosis in either study period; 98.2% of patients in the before-and 98.0% in the after-RMM period had no active liver disease reported at initiation or during treatment. Compliance to contraindicated medications was > 99% in both periods. The adherence to the liver-monitoring regimen was similar in both periods (15.1% before RMM and 16.3% after RMM). In the after-RMM period, 25.2% of patients had a liver test before or at treatment initiation; 61.5% had a liver test during treatment. Among patients surveyed who did not have a blood test before treatment initiation or during treatment, the most frequently cited reason was a test ordered but not yet performed. Conclusions The overall adherence to liver-monitoring recommendations remained weakly influenced by aRMMs. However, patients treated with agomelatine are in compliance with relevant contraindications.

show abstract

Section: Discussionmentioning

confidence: 99%

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

et al. 2019

View full text Add to dashboard Cite

show abstract

“…While the concept of risk management is now firmly embedded in pharmacovigilance, recent reviews have highlighted significant shortcomings in its actual practice to date [21][22][23]. The EMA's landmark 2017 Public Hearing on the risk management of valproate, a teratogenic medicine, revealed numerous problems with both the design and implementation of the valproate RMMs [24].…”

Section: Bridging the Gap: Current Reality Versus Envisioned Statementioning

confidence: 99%

Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

View full text Add to dashboard Cite

Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidencebased approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

show abstract

“…Pre‐post designs are generally unfeasible because of the lack of baseline assessments before the implementation of educational interventions. A recent meta‐analysis of survey RM studies identified three with multiple waves of assessment; however, no study aimed to evaluate the impact of an updated educational material with a pre‐post design . Same findings were observed in other review articles .…”

Section: Discussionmentioning

confidence: 80%

Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet

Artime¹,

Shui

Méndez

et al. 2019

Pharmacoepidemiology and Drug

Self Cite

View full text Add to dashboard Cite

Background: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs.Methods: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP.Changes between the waves were analysed.Results: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2.Conclusions: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.

show abstract

Are risk minimization measures for approved drugs in Europe effective? A systematic review

Cited by 25 publications

References 19 publications

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Risk Management for the 21st Century: Current Status and Future Needs

Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet

Contact Info

Product

Resources

About