Feedback for Seeking Feedback on Non-Sterile Compounding StandardsTrutina Pharmacy · Nov. 17, 2016
Overall, the draft meets its goal of providing the standards required for compounding non-sterile preparations with hazardous and non-hazardous drugs.
I would suggest some minor additions/revisions:
• Consider adding a training requirement for the compounding supervisor such that training through a third-party with expertise in compounding, such as LP3 Network, must be completed biennially (every 2 years). The Model Standards for Pharmacy Compounding of Hazardous Sterile Products requires third-party training required every 3 years and I believe that training is equally important for non-sterile compounding since incorrectly prepared non-sterile compounds can have severe and even fatal consequences. Additionally, it is particularly important for hazardous drug compounding that the supervisor is appropriately trained in safe handling techniques as well as knowledgeable on the risks associated with non-compliance with personal protective equipment. Supervisor perception greatly influences employee compliance and therefore, implementing a stricter training requirement would promote a safer environment for pharmacists and technicians compounding with hazardous drugs.
• Consider adding a clarification/expanded section on the PPE requirements for level A and B compounding. A detailed outline of PPE requirements is provided for level C (section 10.3.7.4) and I believe that a similar outline for level A and B would provide additional clarity for compounders.
• Consider including a Corrective Actions section to the Appendix 6 Procedure Template. High quality SOPs such as those offered by Medisca Network include corrective measures which is important to maintain conformity, compliance, and quality assurance for compounding procedures and policies.
• Consider adding a requirement that equipment used in hazardous compounding should be disposable or dedicated for use with hazardous drugs. Example of such equipment includes mortars and pestles, spatulas, ointment mills, etc. This would add an additional level of safety in regards to preventing cross-contamination and promoting patient safety.
• spatulas) must be dedicated for use with HDs
• Appendix 11 states that Controlled Room Temperature should be 15-20°C and refers to USP <797> however, Controlled Room Temperature in USP <797> (current and proposed draft) is 20-25°C. This requires clarification and the draft needs to be more specific as to when they are referring to Controlled Room Temperature versus simply “controlling temperature”.
• Consider a revision on the requirements for temperature control for compounding areas under level A and B compounding.
Required for level A-C compounding under section 6.3.2 Physical Layout: “Appropriate temperature and humidity monitoring should be maintained as required for certain components and compounded dosage forms.”
Required for level C compounding under section 10.3.2 Heating, ventilation and air conditioning system for controlled rooms: “An air conditioning system must be included in the HVAC system to help ensure the comfort of personnel wearing personal protective equipment (PPE). The temperature of the room must be less than or equal to 20°C, taking into account employees’ comfort once all garb (including PPE) has been donned.”
I suggest that the temperature of the room where level A-B compounding occurs, should not exceed 25°C (highest limit based on USP Controlled Room Temperature definition) and should take into consideration the employee’s comfort once all the garb is donned.
• Consider adding a requirement for a hazardous drug communication program similar to what is required in USP <800>. • Consider adding an exemption for the storage of final dosage forms of compounded hazardous drug preparations including antineoplastics (NIOSH group 1) not requiring manipulation other than counting or repackaging of final dosage forms. This type of exemption is found under USP <800>. • Consider adding a requirement that tablet and capsule forms of antineoplastic hazardous drugs should not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants. This type of exemption is found under USP <800>. • Replace references throughout the draft and within the Appendix 7 References from the “National Institute for Occupational Safety and Health (NIOSH), NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” To the “National Institute for Occupational Safety and Health (NIOSH), NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016” since it supersedes the 2014 version.