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Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies

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Abstract

Additional risk minimization strategies may be required to assure a positive benefit–risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (HCPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnancy prevention. Current approaches to additional risk minimization strategy development rely heavily on information provision, without full consideration of the contextual factors and multi-level influences on patient and HCP behaviors that impact adoption and long-term adherence to these interventions. Application of evidence-based behavioral science methods are urgently needed to improve the quality and effectiveness of these strategies. Evidence from the fields of adherence, health promotion, and drug utilization research underscores the value and necessity for using established behavioral science frameworks and methods if we are to achieve clinical safety goals for patients. The current paper aims to enhance additional risk minimization strategy development and effectiveness by considering how a behavioral science approach can be applied, drawing from evidence in understanding of engagement with pharmaceutical medicines as well as wider public health interventions for patients and HCPs.

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Fig. 1

Adapted from Horne et al., 2005 [18]. This diagram shows how the behavior of an HCP or patient cannot be considered in isolation, as there are influences from a variety of interconnected sources. The individual who an intervention is designed to reach is placed at the center as the target, but a truly effective intervention would need to address all layers. HCP healthcare professional

Fig. 2

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Acknowledgements

The authors wish to acknowledge the involvement of the following contributors to this publication: Jennifer Hamilton and Linda Birnbaum.

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Authors and Affiliations

  1. Bristol Myers Squibb, Lawrenceville, NJ, USA

    Joanne Treacy, Sibel Guerler & Jeremy Jokinen

  2. Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Chicago, IL, USA

    Elaine H. Morrato

  3. Spoonful of Sugar Ltd, University College London Business Company, Brighton and Hove, UK

    Robert Horne

  4. Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Michael S. Wolf

  5. The Royal Free and University College Medical School, London, UK

    Ameet Bakhai

  6. Axian Consulting, Ltd., Cambridge, UK

    Marie-Claire Wilson

  7. Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, King’s College London, London, UK

    Mark Lightowler

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Axian Consulting has received consulting fees for supporting the work relating to this publication. No other funds, grants, or other type of support was received.

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At the time of writing, JT was an independent contractor with Bristol Myers Squib. JT received speaker engagements and honoraria with the Drug Safety Research Unit. The content is solely the responsibility of the author. EHM has received funding for consulting services on issues of drug safety from Eli Lilly, Health Care Service Corporation, Inc., i2o, Humana Inc., Ipsen, Molina Healthcare, Inc., Reata Pharmaceuticals, Syneos Health, and United Healthcare Services. The terms of this arrangement have been reviewed and approved by Loyola University Chicago in accordance with its policy on objectivity in research. EHM receives funding support from the National Center for Advancing Translational Science in the National Institutes of Health under award number 2UL1TR002389. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health. RH is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC), North Thames at Bart's Health NHS Trust, and Asthma UK (AUKCAR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. Over the last decade, there have been speaker engagements and honoraria with the following companies: AbbVie, Abbott, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, BMS, Biogen, Biomerieux Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp Dohme, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi, Shire Pharmaceuticals, TEVA, and UCB. RH is Founding Director of a UCL-Business company (Spoonful of Sugar Ltd), providing consultancy on treatment engagement and patient support programs to healthcare policy makers, providers, and the pharmaceutical industry. MSW consults/has provided consultation for BMS, Pfizer, Lundbeck, GlaxoSmithKline, and Sanofi Pharmaceuticals, and also Luto, UK on medication safety-related issues; he has also received grant support through his institution from Pfizer, Lundbeck, Merck, and Eli Lilly. These engagements have been reviewed and approved by Northwester University. AB is the founder of Amore Health Ltd and has equity in Salutare, receives honorarium from Amarin, Amgen, Astra Zeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi Sankyo, Lilly, Napp, Novartis, Pfizer, and Roche for lecturing and scientific advice. M-CW is a full-time employee of Axian Consulting Ltd. Axian Consulting has received consulting fees for supporting the work relating to this publication. SG is a full-time employee of Bristol Myers Squibb. JJ is a full-time employee of Bristol Myers Squibb. ML is the founder of Phorix Limited and has received payments from Roche, Novartis, Vaderis, Merck, and Takeda for scientific and strategic advice.

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Treacy, J., Morrato, E.H., Horne, R. et al. Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies. Drug Saf (2024). https://doi.org/10.1007/s40264-024-01420-w

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