Assess your risks
April 17, 2019
How to conduct your non-sterile compounding risk assessment.
If your pharmacy offers or plans to offer non-sterile compounding services, you have until January 1, 2020, to comply with the first two priorities identified in the Standards for Pharmacy Compounding of Non-sterile Preparations. Priority One focuses on assessing the risks and gaps that currently exist in your pharmacy.
Many pharmacy teams are uncertain as to how to complete their risk assessments. ACP has developed many tools to support you in conducting your risk assessment and they are available on the Non-sterile Compounding page on the ACP website, including the following:
- Getting Started,
- Non-sterile Compounding Essentials, and
- *NEW* Non-sterile compounding FAQs (including sample risk assessments).
Also, to help you conduct your risk assessment, here are some tips to get you through the process.
Assessing risks and gaps
To provide non-sterile compounding services that meet or exceed the minimum standards, a risk assessment must be completed for each active pharmaceutical ingredient (API) that is in the preparation compounded by the pharmacy. The licensee 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.
Three levels of requirements (A, B, and C) are defined in section 8 of the Standards which correlate to the risks associated with the preparation and its complexity. Both risk of contamination to the preparation, which is essential for patient safety, and risk to personnel, which must be mitigated by adequate protection measures, are considered.
The steps for conducting a risk assessment are described in Section 4 of the standards. The complexity of the compound is categorized as simple, moderate, or complex. The level of requirements the pharmacy needs to have in place is dependent on the category of the products compounded. The decision algorithm for risk assessment (Section 4.2 of the non-sterile compounding guidance document) can be used in conjunction with workplace guidelines provided in Section 4.3 of the guidance to determine if a preparation needs Level A, B, or C requirements.
Workplace guidelines which play a role in pharmacy compounding include the Workplace Hazardous Materials Information System and the National Institute for Organizational Health and Safety.
The Workplace Hazardous Materials Information System (WHMIS) 2015 Safety Data Sheets (SDS):
- should be reviewed for each API that is used in the preparation of a non-sterile compound
- are essential to occupational health and safety and provide a summary of a product’s hazards;
- must be provided by the manufacturer or supplier per federal Hazardous Products Regulations; and
- identify measures for risk mitigation, such as Personal Protective Equipment (PPE).
For more information on how to use WHMIS when completing a risk assessment, the Canadian Centre for Occupational Health and Safety (CCOHS) offers several WHMIS 2015 Fact Sheets, including one outlining the content of an SDS.
If you plan to perform hazardous non-sterile compounding, the National Institute for Occupational Safety and Health (NIOSH) has published its List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016:
- Drugs listed in Group 1 (Table 1) are antineoplastic and pose an occupational hazard due to their cytotoxicity and/or reproductive risks.
- Preparations containing Group 1 drugs warrant Level C requirements and must be handled using the recommended engineering controls (e.g., specialized equipment and facility design).
- The PPE requirements at Level C are significantly more extensive than those encountered in Level A. These, along with other provisions specific to Level C, are explained in Section 9.
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 conducted. This involves evaluating the pharmacy’s current practices in comparison to the minimum standards in each area.
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, and conduct.
The nature and extent of the gaps identified will be good indicators of the magnitude of changes the pharmacy needs to make to fully achieve and maintain the standards. A significant factor to the success and sustainability of any program is collaboration between the people involved. Where change is needed, it’s important to be cognizant that pharmacy personnel will require sufficient time and training to modify their usual routines and adapt to the standards. The licensee and/or compounding supervisor should develop a plan of action to address gaps with this in mind.
To proactively prepare for Priority Two (Compounding and cleaning, personnel training, and quality assurance) compliance by January 1, 2020, we suggest holding a team meeting to determine how you will divide the workload in Priority One. Use the list below and corresponding guidance document references as resources to assist you:
- Identify the compounding supervisor who will develop, organize, and oversee all activities. (5.1.2.)
- Confirm all personnel who will require skills and training assessment. (5.1.3-5.2.2)
- Complete the risk assessment for each non-sterile compound that you are preparing.
- Refer to the NIOSH list, SDS and WHMIS to determine level of risk to the compounding personnel. (4.3)
- Identify the levels of requirements for the compounds you are preparing. Refer to algorithm in the guidance document. (4.1-4.3)
- Ensure master formulations are comprehensive and evidence-based with safety data sheets for each chemical used. (6.2)
Section 11 (page 58) of the guidance document provides a summary list of diagrams, tables, checklists, and templates. There are printable and fillable forms available on the Non-sterile Compounding page.The tools and resources provided above will help pharmacy professionals prepare to meet the deadlines for non-sterile compounding compliance.