Memorandum on the use of information technology to improve medication safety.

BACKGROUND: Information technology in health care has a clear potential to improve the quality and efficiency of health care, especially in the area of medication processes. On the other hand, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. OBJECTIVES: To summarize definitions and observations on IT usage in pharmacotherapy and to derive recommendations and future research priorities for decision makers and domain experts. METHODS: This memorandum was developed in a consensus-based iterative process that included workshops and e-mail discussions among 21 experts coordinated by the Drug Information Systems Working Group of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). RESULTS: The recommendations address, among other things, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions, and the need for their continuous evaluation. CONCLUSION: Information technology can help to improve medication safety. However, challenges remain regarding access to information, quality of information, and measurable benefits.

[Prerequisites for electronic systems evaluating safe and effective drug therapy. A contribution to the Action Plan of the Federal Health Ministry]. / Voraussetzungen für elektronische Systeme zur Prüfung auf Arzneimitteltherapiesicherheit (AMTS). Ein Beitrag zum Aktionsplan des Bundesministeriums für Gesundheit.

Evaluation of effective and safe drug therapy assisted by electronic systems is based on certain prerequisites, including structured data of drugs and from patients. These prerequisites were identified in a workshop within the scope of the National Action Plan and have been reported in a 7+1-point plan: medicinal product data must be correct and up-to-date based on the summary of product characteristics approved by the responsible authorities. Product data must be available in an agreed textual structure and must use defined semantic elements within this structure. Identifiers must be allocated to all drugs and substances in order to enable unique identification and exchange across systems. Semantic structures of the product data, on the one hand, and of patient data, on the other, must be defined across system boundaries and for the whole German national health care system, and be available to every stakeholder, up-to-date, and preferably freely accessible. This consensus regarding content and structural conventions is a prerequisite for other scenarios in the health care system, such as transmitting individual case safety reports without system and media discontinuity, and is currently of great importance with respect to the European legislation on pharmacovigilance, which will be implemented nationally.

Telemetry as a new concept in long term monitoring of SIDS-risk infant.

Sudden Infant Death Syndrome (SIDS) is the most frequent cause of infant death within the period of 2 to 12 months in western countries. It has been found that a suit similar to that worn by the astronauts during the execution of experiments on the Spacelab Mission D-2 is a very simple and useful means to carry the sensors required to monitor vital signs of babies at risk. A small baby-suit has been developed with the same technology used for the Spacelab Mission. The baby s suit is equipped with similar sensors to record thoracic and abdominal respiratory movements as its big -space travel brother-. This is a typical example of a successful technology transfer from medical aerospace activities into fields of daily clinical routine. In addition to the above described sensors, ECG-electrodes were integrated, as well as sensors to record vascular oxygen saturation and the corresponding pulse curve, and the baby s movements. All these vital signs are registered by a medical monitor, and permanently stored and automatically analysed online. In case of a life-threatening situation the system alerts simultaneously the personal at hospital and the parents at home. The requisite software algorithms have been developed by DLR in Cooperation with the pediatricians of the Pediatric Hospital in Köln-Porz, Cologne. When the system registers an alteration of the parameters above described -as a signal of a change in the baby s health condition- all vital signs are transfered in real-time to the supervising hospital via radio data transmission devices, mobile phone or a fixed network phone. The parents are also alerted by the device, and they can carry out the necessary reanimation procedures in case of an emergency. Parents will be trained in such actions when newborns must to be monitored. But nevertheless, they are guided and tele-assisted by an expert via telephone during the action. A clinical field trial, that will start in December 1999 at the Pediatric Hospital in Köln-Porz, Cologne, will evaluate the benefits of teleprotection by home monitoring of SIDS risk-babies.