Perform an AOR to Comply With USP

United States Pharmacopeia (usp) chapter <800> hazardous drugs—handling in health care settings describes standards for the safe handling of hazardous drugs which include the use of engineering controls, personal protective equipment (PPE), and safe work practices.

Hazardous drugs are defined as those on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs used in Healthcare Settings, although some of these drugs and dosage forms pose less of a hazard than others. In some circumstances, an assessment of risk (AOR) may be performed and implemented to determine alternative containment strategies and/or work practices.

It is important to understand that if an AOR is not performed and implemented on a specific hazardous drug or dosage form, it must be handled according to USP <800>. There are 2 instances when an AOR is not permitted.

An AOR is not permitted when handling hazardous drug active pharmaceutical ingredients (APIs). APIs are defined in USP <800> as “any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.”

An AOR is also not permitted when handling antineoplastic drugs that require manipulation, other than counting or repackaging. Instead, an AOR may be used to identify alternative containment strategies when handling final dosage forms of hazardous compounded preparations and when handling conventionally manufactured hazardous drug products, including antineoplastic dosage forms that do not require any further manipulation other than repackaging, unless required by the manufacturer. For other hazardous drugs, an AOR may be used to determine alternative containment strategies and/or work practices.

When performing an AOR, consideration must be given to the type of hazardous drug. The current NIOSH list is divided into 3 groups. Group 1 includes antineoplastic drugs, group 2 includes nonantineoplastic drugs that meet 1 or more of the NIOSH criteria for a hazardous drug, and group 3 includes drugs that primarily pose a reproductive risk. Consideration must also be given to the dosage form, risk of exposure, packaging, and any manipulation that might be required. The AOR needs to document what alternative containment strategies and/or work practices will be used for each applicable aspect of the hazardous drug handling process, including receipt, storage, compounding, dispensing, administration, transport and disposal. AORs must be reviewed at least every 12 months, and the review must be documented.

Let’s walk through a couple of scenarios:

Scenario 1.

A technician compounds a NIOSH group 2 topical hormone cream from APIs in a containment ventilated enclosure (CVE) located in a corner of the pharmacy designated for compounding. Is this permissible per USP <800>?

No. Hazardous-drug APIs must be handled per the containment requirements of USP <800>. The CVE must be located within a containment secondary engineering control that is externally vented, has a pressure of —0.01 to –0.03 inches of water column relative to adjacent areas, and has at least 12 air changes per hour. In addition, the CVE used in this example must itself either be externally vented or have redundant high-efficiency particulate air filters in series. An AOR may be used only when a compounded preparation made from a hazardous drug API is in its final dosage form.

Scenario 2.

A technician compounds a NIOSH group 2 topical hormone cream from APIs following the containment requirements of USP <800>. When the compounding is complete, the compounded preparation is checked by a pharmacist and then taken to the retail area, where it will be stored until dispensing. Is this permissible per USP <800>?

Yes. An AOR may be used to identify alternative containment strategies when handling final dosage forms of hazardous compounded preparations. The AOR will need to address storage, packaging, labeling, dispensing, and, if applicable, transport and disposal.

Keep in mind that the scenarios above discuss containment. USP <800> has additional requirements that include creating standard operating procedures for each aspect of the hazardous drug handling process, designating a person to oversee compliance, identifying hazardous drugs in use, and ensuring personnel are competent and trained, employ safe work practices, and use proper PPE.

Brenda Jensen, CPhT, CNMT,MBA, is a consultant to sterile and nonsterile compounding pharmacies and an owner of Compounding Consultants LLC in Sioux Falls, South Dakota.

Reference

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeial Convention website. usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed February 19, 2019.

The views and opinions expressed are those of the author and are not endorsed by or affliated with United States Pharmacopeia. In some circumstances, an assessment of risk may be performed and implemented to determine alternative containment strategies and/or work practices.