title: Postmarketing surveillance based on electronic patient records: the IPCI project.
abstract: Researchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information (IPCI) was to assess whether the electronic patient records of Dutch general practitioners contain sufficient data to perform studies in the area of postmarketing surveillance studies. We determined the data requirements for postmarketing surveillance studies, implemented additional software in the electronic patient records of the general practitioner, developed an organization to monitor the use of data, and performed validation studies to test the quality of the data. Analysis of the data requirements showed that additional software had to be installed to collect data that is not recorded in routine practice. To avoid having to obtain informed consent from each enrolled patient, we developed IPCI as a semianonymous system: both patients and participating general practitioners are anonymous for the researchers. Under specific circumstances, the researcher can contact indirectly (through a trusted third party) the physician that made the data available. Only the treating general practitioner is able to decode the identity of his patients. A Board of Supervisors predominantly consisting of participating general practitioners monitors the use of data. Validation studies show the data can be used for postmarketing surveillance. With additional software to collect data not normally recorded in routine practice, data from electronic patient record of general practitioners can be used for postmarketing surveillance.
authors.affiliation: Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands. vlug@mi.fgg.eur.nl
authors.forename: A E
authors.initials: AE
authors.lastname: Vlug
authors.forename: J
authors.initials: J
authors.lastname: van der Lei
authors.forename: B M
authors.initials: BM
authors.lastname: Mosseveld
authors.forename: M A
authors.initials: MA
authors.lastname: van Wijk
authors.forename: P D
authors.initials: PD
authors.lastname: van der Linden
authors.forename: M C
authors.initials: MC
authors.lastname: Sturkenboom
authors.forename: J H
authors.initials: JH
authors.lastname: van Bemmel
mesh_terms: D005194:Family Practice; D006801:Humans; D016347:Medical Records Systems, Computerized; D009426:Netherlands; D011358:Product Surveillance, Postmarketing