Veracuity Blog

A New Approach at Conducting Post-Market Drug Safety Surveillance

The early foundation of Veracuity’s platform eVERA tracks back to a series of works by Dr Veronika Valdova in collaboration with Dr Jonathan Fishbein. The works describe the shortcomings of the current post-market drug safety surveillance and outline ways the process can be optimized. The material was ultimately organized in the form of a working paper.

A New Approach at Conducting Post-MarketDrug Safety Surveillance describes the production of real-world evidence at the hospital level to provide accurate and timely insight into the safety and efficacy of marketed drugs. The paper analyzes the current situation in post-market surveillance efforts and suggests how an integrated solution could be designed and implemented to produce medical evidence utilizing real-world data. Such a solution would address the information needs of stakeholders in the healthcare ecosystem in a more accurate, comprehensive and timely manner. A service that utilizes a variety of data analyses and integration platforms could be designed to process real-world data at a hospital level. It would utilize master study protocols to produce standardized and layered medical evidence that would, in turn, provide valuable insight into the safety and efficacy of marketed drugs.

A related presentation, Redesigning post-market safety surveillance, defines the shortcoming of pharmacovigilance as the inability to quantitatively evaluate evidence due to the absence of exposure data, lack of real-time feedback demonstrated on the OODA loop, and a lag in follow-up following to patient injury. The design and development of an integrated post-market surveillance platform can provide valuable insight into the safety and efficacy of marketed drugs by analyzing a stream of real-world data from prescribing information, patient outcomes, and adverse events in a consistent and systematic manner using standardized pre-approved Master Study Protocols.

A third presentation, Pharmacovigilance as an integral part of hospital Quality Management Systems relates the individual components of the OODA loop to specific parts of the pharmacovigilance system, defines data gaps, barriers to timely and accurate orientation, and the communication of findings. The presentation makes a case for integrating post-market drug safety surveillance directly into hospital quality management systems and utilizing real-world data in standard post-market surveillance.