‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework

Brown, Patrick; Bahri, Priya

doi:10.1007/s00228-019-02705-1

Cited by 32 publications

(31 citation statements)

References 75 publications

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“…Another layer of complexity relates to stakeholder engagement. While the importance of patient and HCP engagement is increasingly recognised, its incorporation into pharmacovigilance activities remains in its infancy [75,76].…”

Section: Discussionmentioning

confidence: 99%

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

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

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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.

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Section: Discussionmentioning

confidence: 99%

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

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

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“…The depth of public engagement in drug safety decisions varies, 129 and the most effective methods have not been determined. Techniques include consumer testing of patient communications, public consultation, public hearings, and consumer representation on advisory committees.…”

Section: Considerationsmentioning

confidence: 99%

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

Bhasale

Sarpatwari

Bruin

et al. 2020

Clin Pharma and Therapeutics

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In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a "life cycle" approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements. Yet regulators differ in their use of postmarket safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about postmarket safety issues through safety advisories by assessing their governance, legislative authority, risk communication capabilities, and transparency.

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“…While an urgent need for engagement is expressed, there is a great variation in depths of engagement ranging from information, consultation to participation (Brown & Bahri 2019;Deverka et al 2013). Often there is a lack of precise conceptualization and de nition of what engagement means and entails.…”

Section: Background Developments and Implications Of Dementia Predictionmentioning

confidence: 99%

Methodological Reflection on an Initiated Expert Stakeholder Engagement Process. A Case Study of a Dementia Prediction Discourse

Perry¹

2020

Preprint

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BackgroundEngagement and participation are vital for including experiences, opinions, or expertise regarding the need for action and specifying goals of relevant stakeholders. In recent years, engagement processes have significantly gained in prominence especially in the field of healthcare; and participation has been actively demanded by public health agencies as well as by health research funding organizations. Despite numerous international work and wide agreement on the benefits of stakeholder engagement, there is still limited published empirical evidence on methodological best practices for stakeholder approaches and even less on evaluation or outcomes in the process of developing policy.MethodsOn the basis of previous research on stakeholder discourses and with the German case study at hand, I inferred normative criteria for the evaluation of discourse processes. For the methodological examination, my manuscript presents a comprehensive framework of normative criteria relevant to stakeholder engagement planning, implementation, evaluation and reporting, and to illustrate different evaluation and reporting needs for research on stakeholder engagement, namely, depth of participation, legitimate selection of stakeholders, representativeness, process management, output, role definition, and transparency. ResultsThe developed normative evaluation criteria make the evaluation of an engagement process with a large amount of material possible. My analysis indicates the key facilitating elements and also barriers of this participatory approach, demonstrating the importance of especially deploying the following evaluation criteria: output, representativeness, process management, and transparency.ConclusionThe seven developed evaluation criteria have been effective for the evaluation of the stakeholder discourse on dementia prediction. These evaluation criteria may also be conducive to the evaluation of engagement processes on other health research topics with a large corpus of material. To date and to my knowledge, a comprehensive evaluation framework for engagement processes with experts in the field of assessing biomedical issues is missing in the literature and my work aims at bridging this gap.

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‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework

Cited by 32 publications

References 75 publications

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

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

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

Methodological Reflection on an Initiated Expert Stakeholder Engagement Process. A Case Study of a Dementia Prediction Discourse

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