What is Hazardous Compounding? Do you require additional training? Does your pharmacy need specific equipment? Find out how to be compliant with NAPRA’s Model Standards for Pharmacy Compounding and how it will impact your compounding pharmacy practice. Let us help you implement the practical changes required to maintain compliance.
The “Guidelines to Pharmacy Compounding”, published by the National Association of Pharmacy Regulatory Authorities (NAPRA) in October 2006, have recently been reviewed. As such, three new guidelines relating to Hazardous Drug compounding have been published:
The implementation of the Model Standards in Canada is under the authority of the respective provincial, territorial or Canadian Forces pharmacy regulatory bodies (“Colleges”). Each College will establish their respective process for the implementation of these standards in their jurisdiction. The Model Standards will come into effect once they have been reviewed and approved by each College.
The purpose of the guidelines is to provide standards and define processes to protect personnel, patients, and the environment when handling Hazardous Drugs in a healthcare setting. The guidelines provide a comprehensive approach for handling Hazardous Drugs with the ultimate goal of preventing and/or minimizing exposure to Hazardous Drugs.
The guidelines do not list specific Hazardous Drugs, but refer to the Workplace Hazardous Materials Information System (WHMIS) hazard classification and the current National Institute for Occupational Safety and Health (NIOSH) list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Drugs identified on this NIOSH list are considered hazardous or potentially hazardous with respect to at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing Hazardous Drugs in structure or toxicity.
The requirements of The Model Standards for Pharmacy Compounding of Non-Sterile Preparations (draft 5b) separates non-sterile compounding activities into levels (i.e., Level A, B, and C) based on the complexity and risks associated with preparing the compound and handling the substances used to make the compound. Level C compounding requires a C-PEC which is either externally vented (preferred) or have redundant-HEPA filters in a series. Level B compounding may require the same precautions based on the Hazardous Drug being handled.
For sterile Hazardous Drug compounding, the C-PEC must be externally vented through HEPA filtration.
The requirements of The Model Standards for Pharmacy Compounding of Non-Sterile Preparations (draft 5b) separates non-sterile compounding activities into levels (i.e., Level A, B, and C) based on the complexity and risks associated with preparing the compound and handling the substances used to make the compound. Level B and C compounding requires a dedicated room that is separate from the rest of the pharmacy. Moreover, Level C compounding requires negative pressure with respect to adjacent rooms, at least 12 Air Changes Per Hour (ACPH), and external venting to the exterior of the building.
For sterile compounding, the containment primary engineering control (C-PEC) must be housed within a room segregated from non-hazardous compounding rooms. This room must maintain negative pressure with respect to adjacent rooms, be externally vented to the exterior of the building, and maintain the required ISO quality air as described in the guidelines.
When not properly protected through the use of personal protective equipment and engineering controls, occupational exposure has been shown to be associated with health effects such as skin rashes, decreased fertility, spontaneous abortions, congenital malformations, and possibly leukemia and other cancers.
Yes, gloves worn for Hazardous Compounding are required to meet the American Society for Testing and Materials (ASTM) standard D6978 (or its successor). Double gloving is required when working with hazardous substances.
Even if the right controls (e.g., personal protective equipment, engineering controls) are in place, occupational exposure can occur if these controls are not being used properly or if personnel are inappropriately handling Hazardous Drugs. Personnel training and verification of competency is imperative to risk minimization in the workplace, making it one of the most important aspects of a Hazardous Drug exposure control program. Pharmacy personnel must be educated and trained in all aspects of working with hazardous substances. Any personnel expected to handle or come in contact with a hazardous substance, either directly or indirectly, should complete a thorough training program on working with Hazardous Drugs as well as risk mitigation techniques.
Moreover, for sterile preparations, the compounding supervisor must be evaluated at least every 3 years by a third party.
Segregation is an important aspect of exposure control and it is strongly recommended that equipment be set aside for Hazardous Drug compounding as well as between each of the risk levels for non-sterile compounding (i.e., Level A, B, and C as defined in The Model Standards for Pharmacy Compounding of Non-Sterile Preparations (draft 5b)) as this will minimize the likelihood of cross-contamination. If possible, disposable equipment should be used to reduce the chance of cross-contamination. Hazardous Compounding equipment that should be segregated from non-hazardous compounding equipment may include balances, mortars, pestles, spatulas, stir bars, beakers, cylinders, and counting trays.
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