EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Um das mannigfaltige Bedürfnis nach Auskunft über Arzneimittel zu befriedigen und um die Überwachung von Arzneien auf dem Markt zu bewältigen, wurde ein On-line-Arzneiauskunfts-System entwickelt, welches aus zwei Datenbanken zusammengesetzt ist: der Datenbank klinischer Krankheitsfall-Aufzeichnungen und der Fachliteratur-Datenbank.

Die wichtigsten Erwägungen bei der Realisierung dieses Systems waren die Eingabe von verläßlichen Daten, die Sicherstellung, daß keine Nebenwirkungen übersehen wurden, die Sammlung der neuesten Daten, eine Einsparung von Arbeitskräften für die Verarbeitung und die Bewältigung von großen Datenmengen.

Das System wurde so konstruiert, daß mit japanischen Schriftzeichen ein- und ausgegeben werden kann.

Key-Words

Post-Marketing Surveillance - Clinical Data - Machine-Readable Literature Data Base - Adverse Reaction - Electronic Data Processing

Schlüssel-Wörter

Überwachung von Arzneimitteln auf dem Markt - klinische Daten - maschinen-lesbare Fachliteratur-Datenbank - Nebenwirkungen - Elektronische Datenverarbeitung

• References

• 1 Crawford M., Berneker G. C, Pinto O., de S.. The philosophy and practice of drug-surveillance within Ciba-Geigy. In Inman W. H. W.. (Edit.) Monitoring for Drug Safety, pp 165-188 Lancaster: MTP Press 1980;
• 2 Farina J. C, Krupp P., Tobber H. J.. Computer tools in spontaneous reporting of adverse drug reactions: A multinational company approach. Conf. Comput. Aid Drug Ther. Drug Monit., Bern 1978
• 3 Frycki S. J., Roskos P. A., Gerity C. F., Levett I. S.. Squibb science information system: Computerized selective dissemination, current awareness, and retrospective searching of pharmaceutical literature. J. Amer. Soc. Inform. Sci 1975; 26: 174-183.
• 4 Gregory W., Bell R., Jackson R. R.. An automated clinical and data analysis system. Comput. biomed. Res 1981; 14: 472-481.
• 5 Hasman A., Chang S. C.. A data storage and retrieval system for clinical research. Comput. biomed. Res 1982; 15: 145-154.
• 6 IMS Amedica Ltd. Health Care Service Research Group: An experiment in early post-marketing surveillance of drugs. Contract 223-78-3007 October 24 1978
• 7 Jackson A. R. H.. Library and technical information services: ICI Pharmaceutical Division. Aslib Proc 1977; 29: 337-347.
• 8 Jones J. K.. TARGET: Adverse drug reactions. FDA reporting system zeroes in on >Real World < drug use. Amer. Pharm. NS 19, No 1979; 9: 30-33.
• 9 Karch F. E., Lasagna L.. Toward the operational identification of adverse drug reactions. Clin. pharmacol. Ther 1977; 21: 247-254.
• 10 Kitaguchi T., Nojiri T., Suzuki S., Fukita T., Kawa-na T.. Spontaneous adverse drug reaction reporting system in the industry post-marketing surveillance of drugs. Iyakuhin Kenkyu/Japan (in press)
• 11 Kitaguchi T., Nojiri T., Suzuki S., Fukita T., Kawa-na T.. Survey of clinical experience on new drugs in the industry post-marketing surveillance of drugs. Iyakuhin Kenkyu/Japan (in press)
• 12 Kitaguchi T., Nojiri T., Suzuki S., Fukita T., Kawa-na T.. Some assessment systems of industry post-marketing adverse drug reaction information. Iyakuhin Kenkyu/Japan (in press)
• 13 Kitaguchi T., Nojiri T., Suzuki S., Fukita T., Kawa-na T.. Selection of scientific periodicals for monitoring drug safety by means of EXCERPTA MEDICA and JAPICDOC in the industry post-marketing surveillance of drugs. Inform. Proc. Mangmt (in press)
• 14 Kitaguchi T., Nojiri T., Suzuki S., Fukita T., Kawa-na T.. Comparative study of machine-readable literature data-bases in the post-marketing surveillance of drugs. Inform. Proc. Mangmt 1983; 26: 189-198.
• 15 Kramer M. S.. Assessing the causal relationships between drugs and their adverse effects. Drug Inform. J 1981; 15: 146-152.
• 16 Quast U.. Post-marketing surveillance: Computerized evaluation of side effects. Proceed. IVth Internat. Congr. Phar-maceut. Physicians, pp 291-300 Paris 1981;
• 17 Shapiro A.. The library literature retrieval system. Drug Inform. J 1981; 15: 84-86.
• 18 Streichenwein S. M., Blomer R.. Computer documentation of adverse drug reactions with a multinational pharmaceutical company. Drug Inform. J 1982; 16: 109-111.
• 19 Venulet J., Ciucci A., Berneker G. C.. Standardized assessment of drug-adverse reaction associations—rationale and experience. Int. J. clin. Pharmacol. Ther. Toxicol 1980; 18: 381-388.
• 20 World Health Organization First consultation on computer systems in drug monitoring, June. 1972 DMO/RDM/72.73