<b>Steps in Developing a Database of Drug Use-Result Surveillance: As an Example of Anti-Hyperlipidemia Drugs </b> / 薬剤疫学

ABSTRACT

The spontaneous reporting system for adverse drug reactions(ADRs), through which information is collected on patients who experience ADRs, can lead to hypotheses on causal relationships between drugs and ADRs; however, lack of information on patient characteristics or patients who have not experienced ADRs makes quantitative, relative comparison of risks difficult. From the viewpoint of adapting pharmacoepidemiology to supplement spontaneous reporting of ADRs, RAD-AR Council Japan(RCJ) has been promoting development of a database assembling drug use-results surveillance(DURS) data under the re-examination system for secondary use. RCJ received observational DURS data on antihypertensive drug users from pharmaceutical companies and integrated to develop a database of over 100,000 patients and 19 antihypertensives in 2003. RCJ maintains the database, expanding it to 143,509 patients and 21 antihypertensives in 2007, and also developed a database of antihyperlipidemics with approximately 34,000 patients in 2011. Researchers study these databases through an application and protocol review process stipulated by RCJ, and their results have been presented at conferences and published in articles. This report summarizes DURS data collection and its underpinning regulated systems in terms of data assembly and database maintenance at RCJ. The report also introduces the example for constructing the antihyperlipidemics DURS database and summarizes its patient characteristics. The database is characterized by ADR information and treatment-related laboratory values in addition to patient backgrounds and drug use information. However, it is too small to study rare ADRs and has limited longitudinal observational data. Therefore, RCJ worked to expand the antihypertensives DURS database in 2012 by adding data that include long-term surveillance results. (Jpn J Pharmacoepidemiol 2012; 17(2): 87-97)