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Along with addressing storage and handling, USP provides measures for protecting those administering HDs.1 When the dosage form allows, a closed-system transfer devices (CSTD) should be used to administer an HD. Critical interpretation of sources is necessary to determine a conservative and safe BUD.
Nurses and anyone administering HDs should also be familiar with the Oncology Nursing Society Hazardous Drugs—Handling in Healthcare Settings. USP guidance to assign BUDs The BUD per USP guidance indicates the amount of time the preparation is expected to be stable (for sterile and nonsterile preparations) and sterile (for CSPs) from the start of preparation to the time of administration.1,2 USP API=active pharmaceutical ingredient.
Media-fill tests that duplicate the most challenging or stressful conditions encountered during compounding the given risk-level should be performed by all compounding personnel semi-annually for high-risk CSPs and annually for other risk levels. Factors in determining risk-level per USP BUD=beyond-use-dating; CPR=cardiopulmonary resuscitation; ISO=International Standards Organization; LAFW=laminar air flow hood; PEC=primary engineering controls; TPN=total parenteral nutrition.
These risk levels can then be used to determine appropriate BUDs as summarized in Table 3.
How should beyond-use-dates for compounded preparations be determined?
If an HD is in a unit dose packaging, there are no further requirements for alteration prior to dispensing to the patient.1 If non-antineoplastic drugs need to be transferred from their packaging to a prescription bottle, they should be counted with equipment (spatula, tray) dedicated for use with these drugs. If the literature addresses only one of these factors, then USP guidance should be followed when assigning a BUD.Hazardous drugs that require refrigeration will need to be placed in a refrigerator in a negative pressure room. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. To ensure appropriate compounding practices and assignment of a beyond-use-date (BUD), appropriate resources should be consulted and multiple factors including stability, sterility, compatibility, and risk level should be considered.1-3 This article summarizes steps in determining the most appropriate BUD for a compounded sterile preparation (CSP) or a compounded nonsterile preparation based on United States Pharmacopeia (USP) guidance and best practices.The rooms in which HDs are stored and compounded also require certain air changes per hour (ACPH). See the Table for required ACPH for compounding nonsterile and sterile HDs, as well as a detailed description of other engineering controls. Centers for Disease Control and Prevention website. Compounded sterile preparations include injections, aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, irrigations for wounds and body cavities, and ophthalmic drops and ointments.1 Other preparations can generally be classified as nonsterile.2 When compounding nonsterile preparations, stability and compatibility need to be considered.The chapter will be useful in addressing the following in relation to HDs: Hazardous drug definition and risks A HD is defined as any chemical that is a health hazard, including those considered to be carcinogens, teratogens, reproductive toxins, genotoxins, irritants, corrosives, sensitizers, and/or agents that produce target organ effects.2,3 While the proposed chapter does not contain a list of HDs, they refer to The National Institute for Occupational Safety and Health (NIOSH) list of HDs which is updated periodically.10 Drugs that are classified as chemotherapy, antivirals, hormones, and immunosuppressants are commonly considered hazardous.