Methods Inf Med 1999; 38(04/05): 339-344
DOI: 10.1055/s-0038-1634402
Original Article
Schattauer GmbH

Postmarketing Surveillance Based on Electronic Patient Records: The IPCI Project

A. E. Vlug
1   Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands
,
J. van der Lei
1   Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands
,
B. M. Th. Mosseveld
1   Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands
,
M. A. M. van Wijk
1   Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands
,
P. D. van der Linden
2   Section on Pharmaco-epidemiology, Dept of Epidemiology, Erasmus University Rotterdam, The Netherlands
,
M. C. J. M. Sturkenboom
2   Section on Pharmaco-epidemiology, Dept of Epidemiology, Erasmus University Rotterdam, The Netherlands
,
J. H. van Bemmel
1   Dept. of Medical Informatics, Erasmus University Rotterdam, The Netherlands
› Author Affiliations
Further Information

Publication History

Publication Date:
07 February 2018 (online)

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.

 
  • REFERENCES

  • 1 Van der Lei J, Duisterhout JS, Westerhof HP. et al. The introduction of computer-based patient records in the Netherlands. Ann Int Med 1993; 119: 1036-41.
  • 2 Van Bemmel JH, Van Ginneken AM, Van der Lei J. A progress report on computer-based patient records in Europe. In: Detmer D, Steen EB. editors. The computer-based patient record. Washington DC: National Academy Press; 1997: 21-43.
  • 3 De Smet PAGM. The Dutch approach to computerized drug information: Conceptual basis and realization. Journal of Social and Administrative Pharmacy 1988; 5: 49-58.
  • 4 Lamberts H, Wood M. editors. International Classification of Primary Care. Oxford, England: Oxford University Press; 1987
  • 5 Branger PJ, Van’t Hooft A, Duisterhout JS, Van der Lei J. A standardized message for supporting shared care. In: Ozbolt JG. editor. Proceedings of the 18th annual Symposium on Computer Applications in Medical Care; 1994:. Philadelphia: Hanley and Belfus Inc; 1994. p. 473-7.
  • 6 Gezondheidsraad. Privacy bij Postmarketing Surveillance. (Health Council. Privacy and Postmarketing Surveillance. Health Council, ‘s Gravenhage; The Netherlands: 1993. In Dutch.); 1993.
  • 7 Visser LE, Stricker BHC, Vlug AE, Van der Lei J. Coughing to ACE-inhibitors: a case-control study with automated general practice data. Eur J Clin Pharm 1996; 49: 439-44.
  • 8 Van der Linden PD, Van der Lei J, Vlug AE, Stricker BHC. Skin reactions to antibacterial agents in general practice. J Clin Epidem 1998; 51 (Suppl. 08) 703-8.
  • 9 Van der Linden PD, Van der Lei J, Nab HW, Knol A, Stricker BHC. Achilles tendinitis associated with fluoroquinolones. British: Journal of Clinical Pharmacology 1999 (in press).;
  • 10 Van der Lei J, Musen MA, Van der Does E, Man in’t Veld AJ, Van Bemmel JH. Comparison of computer-aided and human review of general practitioners’ management of hypertension. Lancet 1991; 338: 1505-8.
  • 11 Van der Lei J. Use and abuse of computer-stored medical records. Method Inform Med 1991; 30: 79-80.
  • 12 Koran LM. The reliability of clinical methods, data and judgments. New Engl J Med 1975; 293: 642-6 and 695-701.
  • 13 Komaroff AL. The variability and inaccuracy of medical data. Proceedings of the IEEE 1979; 28: 1196-207.
  • 14 McMahon LF, Smits HL. Can Medicare prospective payment survive the ICD-9-CM disease classification system. Ann Intern Med 1986; 104: 562-6.
  • 15 Hsia DC, Krushat WM, Fagan AB, Tebbutt JA, Kusserow RP. Accuracy of diagnostic coding for Medicare patients under the prospective-payment system. New Engl J Med 1988; 318: 352-5.
  • 16 Burnum JF. The misinformation era: The fall of the medical record. Ann Intern Med 1989; 110: 482-4.