COVID-19 Update From Guaranteed Returns (GRx)

Preparing for USP <800>

This document is a brief overview of USP<800> Management of NIOSH Hazardous Drugs and is not intended for training use. You must check with your state regulatory agency to ensure you remain compliant at a state, federal and facility level.

What is NIOSH?

NIOSH is the National Institute for Occupational Safety and Health. NIOSH is responsible for conducting research and making recommendations for the prevention of work-related injury and illness.

What is USP General Chapter <800>?

USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise encounter hazardous drugs and all the environments in which they are handled.

NIOSH HD (Hazardous Drugs) USP General Chapter <800> Groups

Group 1

Antineoplastic drugs

Medications used to treat cancer. Antineoplastic drugs are also called anticancer, chemotherapy, chemo, cytotoxic, or hazardous drugs. Note that many of these drugs may also pose a reproductive risk for susceptible populations.

Group 2

Non-antineoplastic drugs

Medications that meet one or more of the NIOSH criteria for a hazardous drug. Note that some of these drugs may also pose a reproductive risk for susceptible populations.

Group 3

Non-antineoplastic drugs that are reproductive hazards

Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, because some of these drugs may be present in breast milk.

Compliance Requirements

Designated Personnel

Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The designated person must thoroughly understand the rationale for risk-prevention policies, risks to themselves and others, risks of noncompliance that may compromise safety, and the responsibility to report potentially hazardous situations to the management team.

Storage and Handling

All personnel who handle HDs are responsible for understanding the fundamental practices and precautions to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.

HDs must be handled under conditions that promote patient safety, worker safety, and environmental protection. Signs designating hazards must be prominently displayed before the entrance to the HD handling areas. Access to areas where HDs are handled, must be restricted to authorized personnel to protect persons not involved in HD handling. HD handling areas must be located away from breakrooms and refreshment areas for personnel, patients, or visitors to reduce risk of exposure.

HDs must be stored in a manner that prevents spillage or breakage if the container falls. Do not store HDs on the floor.

Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.

Sterile and nonsterile HDs may be stored together, but HDs used for nonsterile compounding should not be stored in areas designated for sterile compounding to minimize traffic into the sterile compounding area.

Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [e.g., storage room, buffer room, or containment segregated compounding area (C-SCA)]. If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered.

When to use Personal Protective Equipment (PPE)

Group 1

Personal Protective Equipment (PPE) is required to prevent exposure when managing any quantity of these drugs.

Group 2 & 3

Do not have same degree of hazard as Group 1 but still need to be identified. PPE (gloves/ eye wear and mask) is required if residue is observed. Residue involves any powder or wet items of unknown liquid or gels.

Notes

  1. Disposable PPE must not be re-used. Reusable PPE must be decontaminated and cleaned after use.
  2. In instances of cross contamination of surface areas in any group 1, 2 or 3 wearing gloves is mandatory.

Examples of Personal Protective Equipment (PPE)

  • Gloves
  • Eye/Face Protection
  • Respiratory Protection
  • Gowns
  • Head and hair covers
  • Shoe Covers
  • Chemotherapy waste bags
  • Chemotherapy spill kits
  • Contaminated surface cleaning kit

How will Guaranteed Returns (GRx) handle your USP <800> Products?

As per USP800 guidelines, the facility is responsible for identifying, separating, packaging, and labeling all USP800 products. However, in the event the customer has not provided the packaging or labels, our on-site representative is equipped to bag and label these products for you.

All GRx Representatives are required to follow the same handling instructions outlined at the facility level. All representatives will wear the proper PPE when handling USP800 products.

When shipping USP800 products, the representative will be equipped with clear bags to safely separate your products by specific group, ensuring safe handling and safe transport. In addition, the representative will have on hand, labels to identify the contents of each bag. These labels will be placed on the outside of the clear bags and on the outside of the package prior to shipping.

As handlers of pharmaceutical products, it is the responsibility of the GRx to ensure that our representatives and internal personnel are equipped with the necessary tools to ensure their safety.

For additional information, please refer to the website: USP General Chapter Hazardous Drugs - Handling in Healthcare Settings and also: USP <800> 2017

Disclaimer

This document is a brief overview of USP<800> Management of NIOSH Hazardous Drugs and is not intended for training use. You must check with your state regulatory agency to ensure you remain compliant at a state, federal and facility level.

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