Preparing for Phase 2 of the Non-Sterile Compounding Standards

THE STANDARDS APPLY TO YOUR PRACTICE FOR PATIENT AND PERSONNEL SAFETY

The NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations apply to every pharmacy and pharmacy professional engaged in compounding. If you are unclear whether you are engaged in compounding, read the Pharmacy Connection article Compounding: Are You Doing It?. Even if your pharmacy is engaged in very simple compounds, such as 50:50 creams, the standards will still apply.

The standards are accompanied by a Guidance Document for Pharmacy Compounding of Non-Sterile Preparations which provides pharmacists and technicians who compound non-sterile preparations with the details necessary to evaluate their practice, develop service-related procedures, and implement appropriate quality controls for the protection of both patients and compounding personnel.

The standards have been developed to support the safety and quality of pharmacy care in the province. Meeting and adhering to these standards is an important way of protecting patients and preventing harmful incidents. The standards are also an important way to protect pharmacists, pharmacy technicians and others involved in compounding from the potential harmful effects of these drugs and substances.

PHASE 1: ASSESSING RISKS AND GAPS – COMPLETION DATE OF JANUARY 1, 2020

The expectation of the College is that by January 1, 2020 all pharmacies engaged in non-sterile compounding will have completed a risk assessment for ALL preparations compounded by the pharmacy.

Phase 1 requires a risk assessment to be completed for each preparation compounded by the pharmacy. The Designated Manager (DM), pharmacy department head and/or the non-sterile compounding supervisor (the pharmacy professional assigned to oversee all compounding-related activities) is responsible for ensuring risk assessments are performed.

For examples of how community and hospital pharmacies undertook this task, read the Pharmacy Connection articles Implementing the Non-Sterile Compounding Standards: The Community Pharmacy Experience and Consider These Steps While Preparing for the First Phase of Non-Sterile Compounding Compliance: The Hamilton Health Sciences Experience. College Operations Advisors will be reviewing your risk assessment activities during operational assessments in 2020 (do not send the risk assessment to the College).

After completing risk assessments and determining the level of requirements for each preparation the pharmacy compounds (or intends to compound), a gap analysis can be performed. This involves evaluating the pharmacy’s current practices in comparison to the minimum standards in each area. The College has produced a Non-Sterile Compounding Self Assessment Criteria document that can be used for this process. This document is intended to support your self-assessment process and should not be submitted to the College. College Operations Advisors will review your self-assessment documentation with you during operational assessments.

The knowledge and skills of compounding personnel must be assessed for gaps. The potential need for training is not limited to the compounding processes or technique; personnel must also be educated on policies and procedures related to attire, personal protective equipment, cleaning, maintenance, conduct and behaviour.

The nature and extent of the gaps identified will be a good indicator of the magnitude of changes the pharmacy needs to make in order to fully achieve and maintain the standards.

Where change is needed, it is important to be cognizant that pharmacy personnel will require sufficient time and training to modify their usual routines and adapt to the Standards.

The Designated Manager, pharmacy department head and/or compounding supervisor should develop a plan of action to address gaps with this in mind. As you move towards full compliance, it may be appropriate to put into place an intermediary risk mitigation strategy that addresses safety, while providing continuity of care for patients.

For more details on Phase 1, read the Pharmacy Connection articles Timelines Announced for Non-Sterile Compounding Standards and Non-Sterile Compounding FAQs. The deadline for completing Phase 1 is January 1, 2020.

PHASE 2: TRAINING AND QUALITY ASSURANCE – COMPLETION DATE OF JULY 1, 2021

Phase 2 must focus on addressing the gaps identified in Phase 1 between current practice and the standards, specifically training and policies and procedures that need to be in place. The College has highlighted some of the key considerations to start with, including their corresponding references to the Guidance Document for Pharmacy Compounding of Non-Sterile Preparations (GPCNP), when preparing for full implementation.

Training and skills

Refer to the checklist regarding responsibilities for pharmacy personnel (regulated and non- regulated) and delineate these responsibilities. Note the responsibilities for non-hazardous and hazardous non-sterile compounding (GPCNP 5.2.1 and 5.2.1.1).
Complete the skills assessment checklist (Checklist 1) and determine the skills training program required to address gaps and maintain quality practice. Appropriately train all personnel involved in non-sterile compounding and document completion.
Assess the skills required for cleaning personnel and provide appropriate training (GPCNP 5.2.2).

Policies and procedures

Review policies and procedures and identify gaps based on the findings from Phase 1. Develop and update policies and procedures as necessary.
Ensure your policies and procedures address proper hygiene for personnel (GPCNP Template 1, 6.5).
Complete policies and procedures for Standards 9.3, 9.4, and 9.5 (if compounding hazardous preparations).
Complete master formulation records, including all necessary information to compound a non-sterile preparation (GPCNP 6.2, Template 2).

Quality assurance

Develop policies and procedures for components of quality assurance program (GPCNP 7.6).
Implement quality assurance processes for personnel (GPCNP 7.3), and adherence to policies and procedures. (GPCNP 7.4).
Quality assurance components related to facilities, equipment, personnel metrics, final compounded non-sterile preparations and documentation (GPCNP 7.2, 7.5) can be finalized in Phase 3.

PHASE 3: EQUIPMENT AND FACILITIES – COMPLETION DATE OF JANUARY 1, 2022

Work for Phase 3 should happen in tandem with Phase 2, as the improvements needed may require additional time and resources. Note that SPCNP is a reference to the Model Standards for Pharmacy Compounding of Non-Sterile Preparations and GPCNP is a reference to the Guidance Document for Pharmacy Compounding of Non-Sterile Preparations document.

Ensure that hoods are certified every six months, hazardous material is stored appropriately, and cleaning and decontamination equipment and supplies are in place for hazardous compounding (SPCNP 9.2, GPCNP 9.3, 9.6.1).
Ensure that your facility and equipment meet the requirements for lighting, heating, ventilation and air conditioning systems, water supply, work surfaces, furniture, walls, and flooring (SPCNP 9.1).
Establish protocols and schedules for cleaning facilities and equipment to maintain the quality and integrity of the final preparations (GPCNP 5.4.1.6).
Ensure routine maintenance of the facility and all equipment including the cleaning of specialized equipment. This must be documented in the general maintenance log (GPCNP 5.4.2.1).
Finalize your quality assurance program and ensure that it addresses: facility, equipment, personnel metrics, final compounded non-sterile preparations, and documentation (GPCNP 7).
For facilities that compound hazardous preparations, ensure that proper deactivation, decontamination, and cleaning procedures are addressed (GPCNP 9.3).
Ensure that an environmental monitoring plan is in place (GPCNP 9.6.3).

KEY RESOURCES TO ASSIST IN IMPLEMENTING THE STANDARDS