ABSTRACT
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.
Subject(s)
Medical Errors/prevention & control , Medical Informatics , Medication Therapy Management/standards , Patient Safety , Quality Improvement , HumansABSTRACT
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.
Subject(s)
Drug Therapy, Computer-Assisted/methods , Electronic Prescribing , Medical Order Entry Systems/organization & administration , National Health Programs , Drug Information Services/organization & administration , Drug Labeling , Drug-Related Side Effects and Adverse Reactions , Education , Germany , Humans , Medication Reconciliation/organization & administration , Patient Safety , SoftwareABSTRACT
The paper summarizes the concept of somatoform disorders, which was first introduced in the Diagnostic and Statistical Manual of Mental Disorders in its third edition in 1980. The relevant clinical trials related to this concept are reviewed. On the basis of this experience, the present study discusses methodological requirements for clinical trials, including inclusion and exclusion criteria, measurements of efficacy and safety, and statistical considerations, in the hope that this will stimulate the use of this diagnostic entity in the future.
Subject(s)
Somatoform Disorders/diagnosis , Somatoform Disorders/therapy , Clinical Trials as Topic , Humans , Terminology as TopicABSTRACT
Non-opioide analgesics have different pharmacological effects and different profiles of their risks. The life-threatening side effects i.e. agranulocytosis after administration of Dipyrone (Metamizol) are rare, but the must be known and cautions must be considered. On the other hand information must be given about the severe side effects following the not-recommended use i.e. end-stage renal disease after misuse of non-opioid analgesics, because these diseases are preventable.
