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 surveil-lance 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.

Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions

“…The Our analysis confirms that skin reactions are the most frequent clinical manifestations reported in the context increased consumption of drugs with age may at least partially account for age-related variations [19,[24][25][26]] of a spontaneous surveillance system, accounting for more than 30% of all the reported adverse events. The but there are analyses suggesting that, depending on the drug involved, age per se may or may not be an proportion is higher than in other countries, where skin reactions usually represent 10% to 20% of all reported independent risk factor for the development of adverse drug reactions [24][25][26].…”

“…An interaction between infection and drug exposure has been proposed as a Few data are available for dipyrone: the overall incidence of skin rash during dipyrone therapy was 2.4% in an possible mechanism for the development of drug-related exanthematic reactions in the course of some viral epidemiologic study [39]. Further, our data do not support the assumption that phenamates have fewer sideinfections [19,[29][30][31], the prototype of such an interaction being ampicillin-associated exanthema in effects than other NSAIDs as niflumic acid appeared to cause even more cutaneous reactions; these included patients with infectious mononucleosis [29].…”

“…Urticaria was the most frequently reported reaction; the most frequently reported patients [18]. It has been suggested that the rate of skin reactions in inpatients may be higher compared with serious reactions were angioedema (60 reports) and erythema multiforme (21), followed by photosensitivity outpatients [19]. Hospitalized patients may have more concurrent diseases (e.g.…”

“…It cannot be excluded that bullous manifestations associated with piroxicam were part of a antimicrobial agents based on computerized data from Dutch general practitioners [19], which showed higher more specific and undiagnosed reaction pattern such as Stevens-Johnson syndrome or photosensitivity, but an adjusted incidence density rates for sulphonamides, followed by aminopenicillins and fluoroquinolones. No excess of not otherwise specified bullous reactions to piroxicam has previously been reported in a specialistreaction to cephalosporins was observed in the Dutch study, but the population base was relatively small and it based surveillance program [40], which found that they frequently occurred in sun-exposed areas.…”

Non-alcoholic fatty liver disease and risk of incident acute myocardial infarction and stroke: findings from matched cohort study of 18 million European adults

“…We included patient data from four primary care databases available through the EMIF network: The Health Improvement Network (THIN, UK), Health Search Database (HSD, Italy), Information System for Research in Primary Care (SIDIAP, Spain), and Integrated Primary Care Information (IPCI, Netherlands) 1314151617. The databases are compliant with local data protection laws.…”