Establishing Patient Safety Monitoring in the Benefit-Risk Paradigm for Off-Label and Emergency Use of Medications for COVID-19: A Pharmacovigilance Perspective: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: With the massive widespread impact of COVID-19 [1, 2], before the accelerated development timelines for vaccines, one of the options to help mitigate disease impact was in repurposing already approved drugs [3-6]. In the race to discover/implement an already approved agent, which may also be effective in treating COVID-19, we have learned lessons to form a pharmacovigilance perspective that is central to the conscientious approach one is required to employ to ensure patient safety and continued assessment. This work was written under the umbrella of NASoP and represents learnings/recommendations for safety monitoring relating to off-label use in future pandemics or other emergency scenarios after an appropriate benefitrisk assessment, it does not represent an official view of our respective companies/institutions. Objective: Within the lens of optimizing pharmacovigilance through both the planning and the implementation phases of drug repurposing, we outline a strategy and provide suggestions to ensure optimal drug rollout and patient safety. Methods: An international, multi-institutional expert panel provides a review of lessons learned through a descriptive narrative. Results: All drug repurposing should be pursued through a systems approach insuring institutional/regional collaboration, innovation, and data-driven decision making. The roll-out of any repurposed drug should occur in two phases the planning and implementation. Institutional responses in drug repurposing requires identification of key stakeholders, establishment of local expert working groups tasked with continuous assessment and critical review of emerging literature. The off-label use is at the discretion of the healthcare provider, in collaboration with institutional/regional authorities after an appropriate benefit-risk assessment, and we are not recommending or promoting off-label use. A shared decision making strategy is central to ensure patient involvement and understanding of not just the available evidence, but the rationale and acceptance of the repurposed drug. Pharmacovigilance plays a crucial role in the expedient evaluation of new uses for existing therapies and can rely on already established institutional monitoring modalities. A close institutional partnership with regional/national drug regulatory agencies, healthcare professionals, and pharmaceutical companies allows for a wider breadth of information and experience dissemination for the purposes of patient safety and continuation of a drug's repurposed indication.