Designing a Passive Drug Safety Surveillance System in Guangdong Province

Jodi Segal, MD, MPH

Abstract

Since 1998, China has been part of the World Health Organization International Drug Monitoring Program. There are 400 city-regional monitoring centers across China with a standardized reporting system for adverse drug reactions. This is a passive reporting system that relies on individuals to spontaneously report the occurrence of events. Active reporting systems do not rely on reporting; they allow for continual surveillance for safety signals, which are drug-event pairs that may be indicative of a safety problem. The U.S. Food and Drug Administration is in the process of establishing an active reporting system called the Sentinel Initiative. Presently more than 100 million electronic records are available for querying for safety signals. With this pilot funding, we propose an exploration of the feasibility of establishing an active surveillance system in Guangdong province or a subset of the regional hospitals. The value of a regional surveillance system is multifold: it will allow for local detection of potential adverse drug events allowing for interventions to reduce risk in the local population, and it may be a prototype for an expanded surveillance system which could be implemented in other provinces or nationally. This will allow for more enhanced evaluation of the postmarket safety of drugs and other medical products including traditional medications. We seek to collaborate with an investigator at Sun Yat-sen University with a background in pharmacoepidemiology or pharmacovigilance and who has familiarity with the electronic health records and other data resources in Guangdong province. We would welcome this investigator to work with the Johns Hopkins Center for Drug Safety and Effectiveness to gain the additional skills necessary to establish a local sentinel system. We propose this as a feasibility pilot to explore the sufficiency of the local resources to establish and maintain a sentinel system.