USP Chapter 800: Handling Hazardous Drugs

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

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.