BUILDING A STRUCTURED MONITORING AND EVALUATING SYSTEM OF POSTMARKETING DRUG USE IN SHANGHAI

Abstract

In order to understand a drug’s full profile in the post-marketing environment, information is needed regarding  utilization  patterns,  beneficial  effects,  ADRs  and  economic  value.  China,  the  most populated country in the world, has the largest number of people who are taking medications. To begin to appreciate the impact of these medications, a multifunctional evaluation and surveillance system was developed, the Shanghai Drug Monitoring and Evaluative System (SDMES). Set up by the Shanghai Center for Adverse Drug Reaction Monitoring in 2001, the SDMES contains three databases: a population health data base of middle aged and elderly persons; hospital patient medical records; and a spontaneous ADR reporting database. Each person has a unique identification and Medicare number, which permits record-linkage within and between these three databases. After more than three years in development, the population health database has comprehensive data for more than 320,000 residents. The hospital database has two years of inpatient medical records from five major hospitals, and will be increasing to 10 hospitals in 2007. The spontaneous reporting ADR database has collected   20,205   cases   since   2001   from   approximately   295   sources,   including   hospitals, pharmaceutical  companies,  drug  wholesalers  and  pharmacies.  The  SDMES  has  the  potential  to become an important national and international pharmacoepidemiology resource for drug evaluation.