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Questions and Answers
What is the primary goal of USP General Chapter?
What is the primary goal of USP General Chapter?
What type of drugs require manipulation and must follow stricter containment requirements?
What type of drugs require manipulation and must follow stricter containment requirements?
What is the purpose of performing a risk assessment?
What is the purpose of performing a risk assessment?
What are the three groups of hazardous drugs categorized by?
What are the three groups of hazardous drugs categorized by?
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What is the purpose of a C-PEC?
What is the purpose of a C-PEC?
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What type of personal protective equipment (PPE) is required for sterile compounding of hazardous drugs?
What type of personal protective equipment (PPE) is required for sterile compounding of hazardous drugs?
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When should personal protective equipment (PPE) be worn?
When should personal protective equipment (PPE) be worn?
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What is the purpose of deactivation?
What is the purpose of deactivation?
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What is the purpose of decontamination?
What is the purpose of decontamination?
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What is the order of cleaning steps?
What is the order of cleaning steps?
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Study Notes
Hazardous Drugs: USP Chapter
- Describes standards for handling hazardous drugs to ensure safety of patient, worker, and environment
- Handling includes receipt, storage, compounding, dispensing, administration, and disposal
Scope of USP General Chapter
- Applies to any hazardous drug API, antineoplastic requiring manipulation
- Excludes final dosage forms (tablets, capsules, injectable agents) that do not require further manipulation
Risk Assessment
- Performed when full requirements of USP are not met for a medication
- Working document that outlines the steps taken to reduce risk of exposure
- Must contain: type of HD, dosage form, risk of exposure, packaging, manipulation
Criteria for Hazardous Drugs (According to NIOSH)
- Carcinogenicity
- Teratogenicity or other developmental toxicity
- Reproductive toxicity
- Organ toxicity at low doses
- Genotoxicity
- Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous
Classification of Hazardous Drugs
- Three groups:
- 1- antineoplastic drugs
- 2- non-antineoplastic drugs that meet one or more NIOSH criteria for a hazardous drug
- 3- pose a risk to individuals actively trying to conceive, and/or those who are pregnant or breastfeeding
Engineering Controls for Sterile Compounding of Hazardous Drugs
- Primary engineering controls:
- Example: C-PEC (ventilated device designed to minimize worker and environmental HD exposure)
- Secondary engineering controls:
- Example: C-SEC (room in which C-PEC is placed)
- Supplemental: ex, CSTD
Personal Protective Equipment (PPE) Required
- Gowns, head/hair covering, facial hair covering, shoe covers, two pairs of chemotherapy gloves, eye face protection, mask
- When to wear: receipt, storage, transport, compounding, administration, deactivation/decontamination/cleaning/disinfecting, spill control, waste disposal
Deactivating, Decontaminating, Cleaning, and Disinfecting
- Deactivation: render compound inert or inactive
- Decontamination: remove HD residue
- Cleaning: remove organic and inorganic material
- Disinfection: destroy microorganisms
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Description
Test your knowledge of USP General Chapter 800, which outlines standards for safely handling hazardous drugs. Learn about the scope of this chapter and the requirements for receipt, storage, compounding, dispensing, administration, and disposal of hazardous drugs.
