Background During rounds a clinical pharmacist identified and corrected subtherapeutic doses of danaparoid. This error was caused by misleading information in the German Summary of Product Characteristics (SPC).
Purpose To improve medication safety an in-house standard operation procedure for the use of danaparoid sodium was implemented and changes in the SPC were requested.
Materials and Methods The error frequency when using danaparoid was determined over a period of 4 months. The medicines information centre intensified the routine cheque of prescriptions for danaparoid as well as the counselling on dose adjustment. Medication errors were reported to the manufacturer and the Federal Institute for Drugs and Medical Devices (BfArM). At the same time an interdisciplinary working group developed in-house dosing recommendations. Suggestions for modifications of the SPC were submitted to the BfArM.
Results From April to July 2011 subtherapeutic doses were detected in 7 of 21 patients treated with danaparoid at the university hospital Klinikum rechts der Isar: because of misleading information in the SPC, prophylactic doses were administered despite indications for therapeutic anticoagulation. In July 2011 the results of the working group were communicated in the hospital’s formulary committee meeting, an in-house journal published by the pharmacy and the intranet-based quality management system. The BfArM initiated steps to effect a change of the German SPC at the European level in November 2011.
Conclusions As a result of collaboration between a clinical pharmacist, the medicines information centre, the quality management system and external experts an in-house guideline was developed. At the European level the BfArM intends to bring about a change in the German SPC.
No conflict of interest.
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