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

Author

Listed:
  • Joanne Treacy

    (Bristol Myers Squibb)

  • Elaine H. Morrato

    (Loyola University Chicago)

  • Robert Horne

    (Spoonful of Sugar Ltd, University College London Business Company)

  • Michael S. Wolf

    (Northwestern University)

  • Ameet Bakhai

    (The Royal Free and University College Medical School)

  • Marie-Claire Wilson

    (Axian Consulting, Ltd.)

  • Mark Lightowler

    (King’s College London)

  • Sibel Guerler

    (Bristol Myers Squibb)

  • Jeremy Jokinen

    (Bristol Myers Squibb)

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.

Suggested Citation

  • Joanne Treacy & Elaine H. Morrato & Robert Horne & Michael S. Wolf & Ameet Bakhai & Marie-Claire Wilson & Mark Lightowler & Sibel Guerler & Jeremy Jokinen, 2024. "Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies," Drug Safety, Springer, vol. 47(8), pages 733-743, August.
  • Handle: RePEc:spr:drugsa:v:47:y:2024:i:8:d:10.1007_s40264-024-01420-w
    DOI: 10.1007/s40264-024-01420-w
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    References listed on IDEAS

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    1. Piette, John D. & Heisler, Michele & Horne, Robert & Caleb Alexander, G., 2006. "A conceptually based approach to understanding chronically ill patients' responses to medication cost pressures," Social Science & Medicine, Elsevier, vol. 62(4), pages 846-857, February.
    2. Jamie Murphy & Frédérique Vallières & Richard P. Bentall & Mark Shevlin & Orla McBride & Todd K. Hartman & Ryan McKay & Kate Bennett & Liam Mason & Jilly Gibson-Miller & Liat Levita & Anton P. Martine, 2021. "Psychological characteristics associated with COVID-19 vaccine hesitancy and resistance in Ireland and the United Kingdom," Nature Communications, Nature, vol. 12(1), pages 1-15, December.
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