Background: The aim of this project was to identify international patient safety indicators used for medication safety (AMTS-PSI), to evaluate the validity by a panel of experts, and to examine the transfer of the international AMTS-PSI to the pharmacotherapy care of the German Health Care System. It was part of the "Agenda for the Improvement of Medication Safety 2008/2009 in Germany" of the German Ministry of Health.
Method: National and international AMTS-PSI were identified by a systematic review (Set 1). To define patient safety indicators as a subdivision of quality indicators, the indicators were categorised by patient's risk of adverse drug events and the degree of prevention (Set 2). Duplicates of AMTS-PSI were excluded (Set 3). The content validity was determined by the "qualify-instrument" on categories "relevance", "evidence" and "feasibility". This process was based on a double-stage Delphi method. The transferability to the pharmacotherapy care of the German Health Care System of the AMTS-PSI was evaluated (Set 4).
Results: 385 AMTS-indicators were identified. The categorisation resulted in a set of 40 AMTS-PSI, 20 AMTS-PSI were excluded. The evaluation of the validity by the "qualify-instrument" and the transferability resulted in a set of 14 for the stationary, ambulant sector. They also were valid for both sectors.
Conclusion: An AMTS-PSI-set was identified by a systematic review and recognised as valid for transferring it to the pharmacotherapy care of the German Health Care System by the "qualify-instrument". These 14 AMTS-PSI are mainly characterised by their relevance. Before using these indicators in practice, their further operationalisation seems necessary.
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