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An Ounce of Prevention: Controlling Hazards in Extemporaneous Compounding Practices

Author(s):  Kastango Eric S, Trissel Lawrence A, Bradshaw Brian D

Issue:  Sep/Oct 2003 - After the Women's Health Initiative Trial
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Abstract:  This article focuses on hazard analysis critical control points, a system developed to ensure quality, and covers its historical development, basic principles, preliminary steps, conduct of a hazard analysis, actions to take in the event of failure, and documentation and verification. Tables provide a sample product description for morphine sulfate 10-mg/mL preservative-free injection and steps in the intrathecal pain medication preparation flow chart and questions related to each step. A figure provides a sample intrathecal pain medication preparation flow chart. The authors conclude that the example provided in this article can be used as a template to model other compounding procedures used in pharmacy practices. By carefully considering each of the hazards, critical control points, critical limits and monitoring plans, it is not too difficult to develop a corrective action plan; and a hazard analysis critical control point quality system will become self monitoring and self perpetuating once it is established. Everyone in the organization must know about the processes, critical control points and supporting critical limits and the monitoring and documentation procedures for each process.

Related Keywords: Extemporaneous compounding, controlling hazards during, Hazards, control of during extemporaneous compounding


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