13
Sterile and
Hazardous
Compounding
Learning Objectives
1 Explain why an intravenous (IV) medication must have compatible characteristics to blood plasma in terms of pH value, osmotic pressure, and tonicity and have chemical compatibility with other medications. (Section 13.1)
2 Describe the sterile compounding process, which follows USP Chapter <797>. (Section 13.2)
3 Identify parts of a CSP medication order and label and the types of IV solutions. (Section 13.2)
4 State the functions of the Master Formulation Record and the Compounding Record. (Section 13.2)
5 Describe handle overfill concerns and calculate the infusion rates and 24-hour supply quantities for IV solutions. (Section 13.3)
6 Explain general principles in sterile and hazardous compounding with vials, ampules, and automated sterile compounding equipment. (Section 13.4)
7 Paraphrase the handling of premade parenteral products, including vial-and-bag systems and frozen intravenous sterile solutions. (Sections 13.5, 13.6, 13.7)
8 Define a hazardous drug and the categories of risks of exposure and the different levels of primary engineering controls for compounding them, according to USP Chapter <800>. (Section 13.8)
9 Describe the importance of a medical surveillance program for those preparing hazardous compounded sterile and nonsterile products. (Section 13.8)
10 Discuss the key techniques for receiving, storing, handling, delivering, and disposing of hazardous drugs and ingredients, and the function and the contents of a spill kit. (Section 13.8)
11 Define personal protective equipment and primary engineering controls for preparing hazardous drugs. (Section 13.8)
12 Understand the role of the USP’s evolving standards in nuclear pharmaceutical compounding. (Section 13.9)
ASHP/ACPE Accreditation Standards
To view the ASHP/ACPE Accreditation Standards addressed in this chapter, refer to Appendix B.
In the hospital pharmacy, sterile and hazardous compounded drug products are used on a regular basis. Therefore, having an overview of the nature of the compounded sterile preparations (i) and the compounding processes entailed in their preparation is useful.
This chapter describes the required chemical properties of CSPs and the most common parenteral solutions. Some of the processes that will be explored include calculations of overfill and infusion rates, adding medications into solutions with vials and ampules, and operating automated compounding devices. The advantages of commercially available vial-and-bag systems and frozen IV solutions for specific drugs and situations will also be considered.
Hazardous drug compounding shares many aspects of sterile drug compounding because many hazardous preparations must be sterile. Hazardous compounding, however, requires additional training, equipment, supplies, procedures, medical surveillance, and cleanup regulations, which are covered in the newly released USP Chapter <800>. These guidelines for hazardous drugs stress the importance not only of protecting the patients but of protecting yourself as a compounding technician from the toxicity of hazardous drugs. The compounding of nuclear drug products falls under the extremely hazardous category and requires even more training and protection. With the overview in this chapter, you will have a better understanding of some of the fields of specialization that you could choose from within the institutional setting.