How should beyond-use-dates for compounded preparations be determined?
Introduction
In light of drug shortages, concerns about outsourcing pharmacy services, and unique patient needs, Hospital Pharmacy Services is often required to compound pharmaceutical preparations. 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 () guidance and best practices.
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. When compounding sterile preparations stability, sterility, compatibility, and risk level need to be considered.1 Compounding of sterile preparations is guided by <797>, whereas compounding of nonsterile preparations is guided by <795>.1,2 USP provides guidance on appropriate compounding practices and assignment of BUDs. Extended-dating or use of a preparation later than the USP recommended BUD should be supported by the literature or by sterility testing.
Steps to determine BUDs
When determining appropriate compounding practices and assignment of a BUD, the manufacturer(s) of the pharmaceutical ingredients should provide the most accurate information.1-3 In the absence of manufacturer information, published literature can be reviewed. However, if there are any deviations between the literature and the institution’s practices, then USP guidance should be used to assign a BUD. Deviations include differences in brands, concentrations, or formulations of products used; types of containers or devices; risk level; environmental variables; and storage conditions. Additionally, deviations may render the ingredients incompatible and these factors should be carefully considered before proceeding. For CSPs, the literature should address both stability and sterility of the final preparation.1,3 If the dates are different for stability and sterility, then the shorter of the 2 dates should be used to assign a BUD. If the literature addresses only one of these factors, then USP guidance should be followed when assigning a BUD. Critical interpretation of sources is necessary to determine a conservative and safe BUD.
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 <795> BUDs for nonsterile preparations are summarized in Table 1 below.2
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Introduction
In light of drug shortages, concerns about outsourcing pharmacy services, and unique patient needs, Hospital Pharmacy Services is often required to compound pharmaceutical preparations. 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 () guidance and best practices.
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. When compounding sterile preparations stability, sterility, compatibility, and risk level need to be considered.1 Compounding of sterile preparations is guided by <797>, whereas compounding of nonsterile preparations is guided by <795>.1,2 USP provides guidance on appropriate compounding practices and assignment of BUDs. Extended-dating or use of a preparation later than the USP recommended BUD should be supported by the literature or by sterility testing.
Steps to determine BUDs
When determining appropriate compounding practices and assignment of a BUD, the manufacturer(s) of the pharmaceutical ingredients should provide the most accurate information.1-3 In the absence of manufacturer information, published literature can be reviewed. However, if there are any deviations between the literature and the institution’s practices, then USP guidance should be used to assign a BUD. Deviations include differences in brands, concentrations, or formulations of products used; types of containers or devices; risk level; environmental variables; and storage conditions. Additionally, deviations may render the ingredients incompatible and these factors should be carefully considered before proceeding. For CSPs, the literature should address both stability and sterility of the final preparation.1,3 If the dates are different for stability and sterility, then the shorter of the 2 dates should be used to assign a BUD. If the literature addresses only one of these factors, then USP guidance should be followed when assigning a BUD. Critical interpretation of sources is necessary to determine a conservative and safe BUD.
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 <795> BUDs for nonsterile preparations are summarized in Table 1 below.2
continue to read here
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