Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap

Abstract

Various initiatives and guidelines exist to support patient engagement (PE) throughout the lifecycle of a medicinal product. While the recent European Medicines Agency guideline on good pharmacovigilance practices (Module XVI; Revision 3) reinforces the importance of involving patients to create effective risk minimization strategies, frameworks supporting the systematic adoption of PE by Marketing Authorization Holders (MAHs) across pharmacovigilance, including the risk management system, are lacking. Furthermore, little is presented on the impact of patient review of additional risk minimization measures materials. We present a tested Pharmacovigilance Patient Centricity Framework describing key focus areas that can create the necessary infrastructure for systematic PE in effective risk minimization materials. Implementation of this framework highlighted the importance of collaboration to drive PE across the company at both local and global level, and externally, as relationships are established with patient organizations and best practices are shared with other MAHs. Therefore, this framework can be considered by other companies as a basis for developing a patient-centric approach to integrate the patient's voice into pharmacovigilance deliverables.

Keywords: Framework; Patient centricity; Patient engagement; Pharmacovigilance; Risk minimization.

Fig. 1

Drug development timeline with key areas of PE and the main guidances, frameworks and initiatives (non-exhaustive) integrating PE across the product lifecycle. CIOMS, Council for International Organizations of Medical Sciences; CDER, Center for Drug Evaluation and Research; CTTI, Clinical Trials Transformation Initiative; EFPIA, European Federation of Pharmaceutical Industries and Associations; EMA, European Medicines Agency; EPF, European Patient Forum; EUnetHTA, European network for Health Technology Assessment; EUPATI, European Patients’ Academy on Therapeutic Innovation; FDA, Food and Drug Administration; GVP, good pharmacovigilance practices; HTA, Health Technology Assessment; ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; IHI, Innovative Health Initiative; PARADIGM, Patients Active in Research and Dialogues for an Improved Generation of Medicines; PE, patient engagement; PEM, Patient Engagement Management; PEOF, Patient Engagement Open Forum; PFMD, Patient-Focused Medicines Development; PREFER, Patient Preferences in benefit risk assessments during the drug life cycle; RA, Regulatory Affairs; R&D, Research and Development; WHO, World Health Organization

Fig. 2

Plain language summary

Fig. 3

Framework for patient-centric initiatives in pharmacovigilance