USP 800 and Hazardous Drugs

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Questions and Answers

What does USP 800 refer to?

Handling hazardous drugs in healthcare settings for safety and environmental protection.

What are hazardous drugs?

Carcinogenic, teratogenic, reproductive toxicity, organ toxicity, geotaxis.

What does NIOSH stand for?

National Institute for Occupational Safety and Health.

What is the full name of NIOSH list of antineoplastic and other hazardous drugs in healthcare settings?

NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. Signup and view all the answers

How are NIOSH drugs divided?

Antineoplastic drugs, non-antineoplastic drugs, drugs that pose reproductive risk. Signup and view all the answers

Name some common drugs on the NIOSH list.

Estrogens, clonazepam, phenytoin, raloxifine, topiramate, dutasteride, voriconazole, risperidone, carbamazepine, fluconazole, colchicine, paroxetine, valproic acid, spironolactone. Signup and view all the answers

Most pharmacies do not stock at least one of the medications on the NIOSH list.

False Signup and view all the answers

The NIOSH list is continuously updated.

False Signup and view all the answers

What are two ways to evaluate hazardous potential?

Check SDSs (Safety Data Sheets) from the manufacturer and review product labeling. Signup and view all the answers

Which of the following is NOT a route of unintentional entry of hazardous drugs into the body?

Telepathic contact Signup and view all the answers

What does 'receipt' refer to in hazardous drug handling?

Contact has drug residues on the container, work surface, and floors. Signup and view all the answers

What does 'dispensing' mean in the context of hazardous drugs?

Contact with hazardous drugs when counting or repacking tablets or capsules. Signup and view all the answers

What does 'compounding/manipulation' involve?

Manipulating drugs, coming into contact with hazardous drugs. Signup and view all the answers

What are some patient care activities that involve hazardous drugs?

Handling body fluids or body fluid contaminated materials. Signup and view all the answers

What are the potential hazards associated with hazardous drugs?

All of the above Signup and view all the answers

What should facilities do regarding hazardous medications?

Each facility needs to identify hazardous drugs to ensure procedures for safe handling. Signup and view all the answers

What is considered low risk when dispensing hazardous drugs?

Dispensing a single unopened intact tablet or capsule Signup and view all the answers

What is the risk level associated with repeatedly counting, cutting, or crushing tablets?

Higher risk Signup and view all the answers

Which of the following is true about compounding IV products of hazardous drugs?

It is very high risk. Signup and view all the answers

What types of drugs must follow USP 800 regulations?

HD active pharmaceutical ingredients (powder/substances in compounding) and antineoplastic that need manipulating. Signup and view all the answers

What types of drugs do not have to follow USP 800 regulations?

Final dosage forms that do not require further manipulation other than counting or repackaging. Signup and view all the answers

What are engineering controls in hazardous drug handling?

Containment Primary (Secondary) Engineering Controls. Signup and view all the answers

What does CPEC stand for?

Containment Primary Engineering Controls. Signup and view all the answers

What is the purpose of HEPA filtration?

Removes 99.97% of particles greater than 0.3 microns. Signup and view all the answers

Which of the following is an example of sterile CPEC?

Class II Biological Safety Cabinets Signup and view all the answers

What is an example of non-sterile CPEC?

Containment Ventilated Enclosures Signup and view all the answers

What does CSEC refer to?

Room in which CPEC is placed. Signup and view all the answers

Study Notes

USP 800 Overview

USP 800 regulates the safe handling of hazardous drugs (HD) in healthcare to ensure safety and environmental protection.

Hazardous Drugs

Drugs classified as hazardous due to potential carcinogenic, teratogenic, reproductive, organ toxicity, or other harmful effects.

NIOSH List

The National Institute for Occupational Safety and Health maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.

NIOSH Drug Categories

Drugs are divided into three groups:
- Antineoplastic drugs
- Non-antineoplastic drugs
- Drugs that pose reproductive risks

Common Hazardous Drugs

Frequently found drugs on the NIOSH list include estrogens, clonazepam, phenytoin, and valproic acid, among others.

Pharmacy Practices

Most pharmacies stock at least one medication from the NIOSH list, highlighting the prevalence of these drugs.

NIOSH List Updates

The NIOSH list is not continuously updated, so facilities must routinely assess new hazardous drugs and their risks.

Evaluating Hazardous Potential

Evaluate hazardous drugs by checking Safety Data Sheets (SDSs) and reviewing product labeling.

Routes of Unintentional Exposure

Hazardous drugs can enter the body through:
- Dermal/mucosal absorption
- Inhalation
- Injection
- Ingestion

Contact Points for Hazardous Drugs

Receipt of hazardous drugs may leave residues on containers, work surfaces, and floors.
Dispensing activities can result in contact during tablet processing.
Compounding or manipulation involves direct contact with hazardous drugs.
Administration may involve IV setups or specialized aerosol procedures.
Patient care activities include handling contaminated body fluids.

Spill Management

Spills require effective management and disposal strategies to minimize exposure risks.

Drug Transport

Healthcare settings must manage the transport of hazardous drugs carefully to prevent exposure.

Waste Disposal

Safe collection and disposal of hazardous drug waste is critical for environmental safety.

Facility Responsibilities

Each healthcare facility must identify hazardous medications and establish procedures for safe handling.

Risk Levels by Activity

Dispensing a single, intact tablet or capsule is low risk (gloves recommended).
Repeatedly counting, cutting, or crushing tablets increases risk, necessitating double gloves, gowns, and respiratory protection.
Compounding IV hazardous drugs is very high risk and requires rigorous controls including double gloves and containment devices.

USP 800 Compliance

Only hazardous drugs that are active ingredients in compounding or require manipulation are subject to USP 800.
Final dosage forms that only require counting or repackaging do not need to follow USP 800.

Engineering Controls

Containment Primary (CPEC) and Secondary (CSEC) Engineering Controls are essential to protect staff from hazardous exposure.

CPEC Definition and Function

CPECs are ventilated devices designed to minimize worker and environmental exposure to hazardous drugs.

CSEC Definition

CSEC is the designated room where CPECs are located, ensuring controlled environments for hazardous drug handling.

Supplemental Engineering Controls

These provide additional protection, such as closed-system drug transfer devices, which minimize exposure during drug transfer.

HEPA Filtration

High-Efficiency Particulate Air (HEPA) filters are crucial, capturing 99.97% of particles larger than 0.3 microns, creating sterile environments.

Sterile Compounding CPECs

BSCs and CACIs are examples of CPECs for sterile compounding, ensuring protection against contamination.

Non-Sterile Compounding CPECs

Examples include Containment Ventilated Enclosures (CVE) and Class I and II BSCs, providing protection for the compounder.

Importance of CSEC

CSECs are necessary for containing CPECs and ensuring both sterile and non-sterile compounding safety.

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Description

Explore key concepts related to USP 800 and the safe handling of hazardous drugs in healthcare settings. This quiz covers definitions and important organizations like NIOSH relevant to hazardous drug management. Enhance your knowledge and ensure safety in healthcare environments.