Medication Without Harm: One Step Closer with Real-time Access and Centralized Safety Data
This year, the World Health Organization (WHO) is devoting World Patient Safety Day, September 17, to establishing new goals for “Medication Without Harm.” One of the cornerstones of WHO’s effort is fostering better collaboration among the key stakeholders in drug safety: sponsors, patients, clinicians and healthcare professionals, and regulatory agencies.
Improving data access and allowing key stakeholders to collaborate seamlessly will be crucial to these efforts. Advancements in technology continue to remove system silos and create a more robust data foundation so that information can be accessed and analyzed more quickly throughout the drug development lifecycle.
But at many companies today, there is no single source of trusted data, as Pilar Carrero, VP of pharmacovigilance at LEO Pharma in Copenhagen, noted recently. Departments that must interact or collaborate to ensure patient safety — pharmacovigilance, clinical, regulatory, quality, marketing — and external partners work separately with siloed information in separate systems.
Even though drug safety is a priority at every stage of a drug’s life cycle and a shared responsibility, inefficient approaches to data and siloed systems slow the industry’s ability to assess problems and react when they emerge. Real-time information will be essential to making real-time decisions.
More pharma companies are starting to bring different functions together and figure out how to unify safety data. This work will ensure that potential safety problems are visible as early as possible during development or after commercialization, and will support timely follow on activities.
Cloud-based digital technologies and data analytics enable these efforts with easier access and seamless cross-functional connections, both internally and with CROs and CDMOs.
Safety evolves from cost center to strategic partner
Effective use of technology requires internal buy-in and process alignment. Companies working toward these goals are redefining drug safety, not only as a regulatory requirement and a duty to patients, but as a way to achieve more efficient drug development and improved patient-centricity. “Pharmacovigilance has always existed for patients, but recently we have become so focused on compliance that we need to return to our original mandate,” says Carrero, who sees pharmacovigilance becoming a strategic partner within R&D by better leveraging safety data to improve overall business decisions.
Building a strong data foundation, with a single source of truth and more thoughtful approaches to automation, safety departments would have more input during product development and when clinical protocols are being defined. Patient safety issues would be considered closely from the very beginning of drug development, avoiding surprises when safety problems show up during late development.
Benefits would also extend into post-marketing, for example, when certain groups of patients could be shown to respond better or worse to a drug, or to experience fewer side effects. Exploring the reasons for these differences would have far-reaching impacts on the overall business and help focus commercial efforts.
As more companies reconsider the way they manage safety data and reimagine the impact of proactive safety, the industry is moving closer to WHO’s goal of medication without harm. This work will also break down the divisions that still prevent drug safety from being everyone’s responsibility. Building a strong data foundation, across functions, will be essential to success.
Learn more about LEO Pharma’s vision for safety.