Local Medical Safety, A New Capability Ensuring the Safe Use of Products at the Local Level

• Published in: Drug safety Vol. 44; no. 12; p. 1456
• Main Authors: Willems, P, Michielsens, C, Lau, A G, Corboy, Khedr, A
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.12.2021
• Subjects: Dashboards; Occupational safety; Optimization; Pharmacology; Pharmacovigilance; Product safety; Risk management; Risk reduction; Safety
• ISSN: 0114-5916

Background/Introduction: Historically, local/affiliate pharmacovigilance units of big pharmaceutical companies were rightly focusing on the performance and compliance of local pharmacovigilance systems. However, at companies like Johnson & Johnson, a vast amount of data is available on the safety profile of the products, often summarized in multiple, separate documents such as aggregate reports and risk management plans. While these reports are submitted to local health authorities and utilized by local stakeholders, there is greater opportunity for the data to be proactively translated by local safety units into safety insights and messaging for local use. Objective/Aim: Ensuring the proper use of products at the local level through proactive risk minimization activities. Methods: With a wealth of safety data across all of our products around the world, there was a need to partner at the regional level. To meet this need, Johnson & Johnson created a new capability within the local safety units, Local Medical Safety. Local Medical Safety is the liaison between the local affiliate's stakeholders and the global safety organization and ensures that global safety data and information are translated into locally applicable, practical, and relevant insights and actions. This practice closes the benefit-risk management loop, linking global to local to ensure the proper and safe use of our products free from avoidable harm. This is achieved by enhancing safety knowledge through product safety profile education, the creation of a knowledge sharing platform to ensure standardized messaging, and actively measuring the outcomes of our risk minimization activities using the data in our safety database (pilot). Through our Interaction Dashboard we're focusing on the right products and activities. Results: Through the new Local Medical Safety capability, local safety employees are now integrated in launch activities and country product strategy teams, ensuring consistent, standardized and up-todate safety messaging and providing expertise on the safety profile of our products. Through our pilot, we're monitoring the results of our risk minimization activities at the country level enabling the creation of targeted interventions on the country level in close collaboration with our Medical Affairs colleagues. Conclusion: Local Medical Safety is a new, country based, capability ensuring the safe use of products based on global insights and data.