Objectives To develop a quality risk management process for the clinical pharmacy field by adaptation of quality risk management methods known from production and logistics.
Methods The risk management process for clinical pharmacy was initiated according to the International Conference on Harmonisation Quality Risk Management guideline (ICH-Q9) which provides principles and examples of tools that can be applied to different aspects of pharmaceutical quality. Failure modes and effects analysis was used to detect critical steps in the working process of the clinical pharmacist and to categorise them according to their potential hazard risk.
Results In clinical pharmacy workflow several critical steps could be detected by means of risk assessment methods. The major risk factors proved to be incorrect interventions, inconsistent consultation, non-reproducible results and the missing safeguard of the clinical pharmacist. Suitable measures for risk reduction referring to risk analysis include the specification of tools and work steps, compliance with predefined quality indicators and the establishment of a continuous improvement process system administered by a pharmaceutical board.
Conclusions The risk management strategies and instruments used for production and logistics such as ICH-Q9 can be successfully adapted for clinical pharmacy. Quality risk management in the clinical pharmacy field is important to avoid patient hazards. Standardisation of work steps and specification of tools are preconditions for achieving reproducibility. Quality standards need to be defined and followed. A continuous improvement process system is a significant component in risk reduction in clinical pharmacy. The embedding of decisions in a professional safety net, based on an interdisciplinary pharmaceutical board, benefits clinical pharmacists as it validates their work.
- Clinical pharmacy
- Uality managemqent
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