Pharmacy Compounding of Non-SterilE Preparations Standards of Practice
The following Standards of Practice describe the minimum requirements to be applied in compounding non-sterile preparations and are intended to promote consistency in the provision of the service to the people of the province. The Standards apply to all non-sterile compounding by pharmacy personnel; however, not every standard will apply in every practice setting.
These standards and companion guidance document are adopted from the National Association of Pharmacy Regulatory Authorities Model Standards for Pharmacy Compounding of Non-Sterile Preparations,
FAQ
Compounding Personnel
What is the relationship between the compounding supervisor and pharmacist-in-charge?
The pharmacist-in-charge (PIC) is responsible for developing, organizing, and supervising all activities related to pharmacy compounding. The PIC may share or assign these responsibilities to a pharmacist or pharmacy technician, who will be designated as a “compounding supervisor.” Otherwise, the PIC is the compounding supervisor by default. If they have designated another person, this person works with the PIC, pharmacy management, and compounding personnel to develop, organize, and oversee all activities related to the given area of compounding. The PIC must still ensure that the compounding supervisor adequately fulfills their role as the PIC is ultimately responsible for the operation of the pharmacy. For these reasons, the PIC must be qualified to perform and oversee the different types of compounding activities of the pharmacy. If the compounding supervisor does not carry out their responsibilities for any reason, the PIC must assume the responsibilities of the compounding supervisor.
Can a pharmacist or pharmacy technician be a compounding supervisor at multiple sites?
Whether a pharmacy professional can be responsible for more than one side depends on the scope of compounding services at each site and whether the compounding supervisor can fully meet the responsibilities outlined in section 5.1.1.2 of the compounding standards at each site. The person designated as the compounding supervisor is responsible for developing, organizing, and supervising all pharmacy compounding-related activities. This does not necessarily mean that the compounding supervisor role is a person’s sole responsibility or that a person cannot be a compounding supervisor at multiple sites.
Can a pharmacy have more than one compounding supervisor (i.e. can multiple staff share this role)?
If the scope of compounding activities requires more than one qualified individual to meet the responsibilities of a compounding supervisor, the pharmacist-in-charge may designate more than one individual to this role. However, the individuals must be specifically designated as compounding supervisors (i.e. it cannot just be whatever pharmacist/pharmacy technician is on duty) and there must be a clear delineation of compounding supervisor duties to ensure all responsibilities are fully met. Each type of compounding practice (sterile hazardous/non-hazardous, non-sterile non-hazardous/hazardous) may have a different compounding supervisor.
Our non-regulated pharmacy team members need more training, where can we access this?
Some pharmacists and pharmacy technicians have already participated in in-house training and have proactively performed reviews of the compounding techniques of non-regulated pharmacy staff members. Registered pharmacy professionals are cautioned to only use this method of remediation if they are current in their knowledge and experience base. Some companies supplying compounding ingredients offer training opportunities for pharmacists and pharmacy technicians who are new to compounding, or to those seeking to improve their skills. Pharmacists-in-charge and compounding supervisors are encouraged to research those options and, if appropriate, have at least one staff member take the training, and train and assess others at the practice site.
Compounding Area & Facility
Does the College approve facility design?
The College does not approve the design of compounding facilities. The design and construction of compounding facilities requires specific engineering expertise to ensure the necessary ventilation, airflow, and pressure differential, and certain equipment (such as containment primary engineers controls [C-PECs]) require maintenance and certification by qualified individuals. Pharmacy personnel must collaborate with engineers and contractors in the design of their compounding space. While the design of a space requires expertise beyond that of a pharmacist, input from pharmacy personnel is still important so that workflow and efficiency are taken into account. Pharmacists-in-charge (PICs) and compounding supervisors are responsible for ensuring that their compounding space is appropriately designed per the applicable standards and they must be able to demonstrate this is the case to the College’s assessors.
When a renovation is necessary, PICs are required to submit an Application for Renovation of an Existing Pharmacy/Dispensary to the College at least 15 days in advance of any planned renovations and receive approval of the application before starting the renovation. It is recommended to submit renovation applications at the earliest opportunity, especially for complex facility designs, so that College staff can review, ask questions, and provide feedback.
Do you need separate areas for compounding hazardous and non-hazardous non-sterile preparations?
It is preferable to have separate areas for performing hazardous and non-hazardous non-sterile compounding. If the same area is being used for hazardous and non-hazardous non-sterile compounding, compounding personnel must ensure proper deactivation and decontamination processes are in place to prevent cross-contamination. This includes having dedicated equipment to perform compounding activities in a separate room. Disposable or clean equipment for compounding (such as mortars and pestles, spatulas) must be dedicated for use with hazardous drugs. Additionally, if hazardous materials are used in the same space during compounding as non-hazardous materials, then non-hazardous compounded preparations must be packaged to identify that they may have been exposed to hazardous materials.
My pharmacy will be making Level A compounds only, do I need to renovate my pharmacy?
There are specific physical requirements that must be met in order to perform any level of compounding; therefore, depending on the current state of the pharmacy, renovations or modifications may be necessary. These include:
The scope of compounding activities that pharmacies need to carry out to support their patients will vary from pharmacy to pharmacy. As such, pharmacy professionals need to apply the principles in the standard to their own practice site.
For Level A compounding, doe a “designated compounding area” mean a separate room?
No, a separate room is not required. While “separate” and “designated for the preparation of compounds” ideally means the space is only used for that purpose, the College recognizes the challenges that would create for some pharmacies. If the compounding area needs to be used for other functions, it must be maintained such that it can be cleaned quickly and made appropriate for safe compounding when needed. However, other activities cannot be performed in this area while compounding is occurring.
What is the minimum size for a designated Level A compounding area?
There is no minimum size requirement. The compounding area must be large enough for compounding personnel to work comfortably and safely, with room to store equipment and products in an orderly manner in clean and secure surroundings. Also, the area should be designed and arranged to prevent cross-contamination between products, and it should be located away from parts of the pharmacy where there is a considerable amount of traffic (e.g., aisles, entrance, exits).
What are the physical requirements for Level B compounding?
Section 8.2 of the Non-Sterile Compounding Standards states that, in addition to the Level A requirements, Level B compounding requires:
Examples of the latter include allergenic products or products that could have unintended effects, such as hormones, but that may not require the extensive precautions of Level C requirements if prepared in small quantities and risk can be mitigated (see section 4.2 of the guidance document for risk assessment). If a ventilated containment device is used, the pharmacy should follow the same requirements as outlined in section 9.2.3 of the Non-Sterile Compounding Standards.
What are the differences between the Level B and C facility requirements?
The facility requirements for Level A, B, and C build upon each other in accordance with risk to both patients and compounders. Level C requires a separate, well-ventilated room with:
Section 9 of the Non-Sterile Compounding Standards and guidance document provides additional specific details on facility requirements for hazardous preparations. The notable differences from Level B are the specific air exchange and pressure requirements, the requirement for a C-PEC, and external ventilation. A Level B room is not required to be under negative pressure, and it may or may not have a C-PEC based on the risk of the APIs used for compounding and the amount/frequency they are used.
Level C facility requirements must be met when compounding any amount and any dosage form of hazardous drugs that are classified by NIOSH as Group 1 or hazardous materials that are classified by WHMIS to present health hazards such as very irritating to the respiratory tract, skin, or mucous membranes. Level C facility requirements also apply to NIOSH Group 2 and 3 drugs involving routine use of large quantities of APIs, according to the risk assessment.
How do I determine whether external ventilation is needed for non-sterile compounding?
Pharmacists-in-charge and compounding supervisors must determine whether external ventilation is required for both the compounding room, as well as for the containment primary engineering control (C-PEC) through their risk assessment. All risk assessments must be made available to staff involved in compounding.
Examples of C-PECs used in a Level B or C compounding room include containment ventilated enclosures, Class I or Class II Biological Safety Cabinets, compounding aseptic containment isolators (CACIs), etc. If the C-PEC is being used to handle hazardous products, it should be externally vented (preferred option) or have redundant HEPA filters in a series.
Risk Assessment
How do I decide what I should and should not be compounding?
Consider the following questions:
Risk assessment is an important part of this decision. Refer to section 4 of the standards and guidance document for the expectations and guidance on risk assessments. The guidance document provides an algorithm to assist with the risk assessment process as well as a list of factors to consider that help with putting information into context.
The decision to not compound should not be taken lightly. It is also important to consider the College’s Code of Ethics. Pharmacy professionals are expected to hold the health and well-being of their patients as their primary consideration and do what they can to meet patients’ health needs. The default should be to aim to provide services to the extent that is possible, and when it is not possible to compound a specific product, refer the patient to a colleague who can. Pharmacy professionals need to be able to explain to patients why they can or cannot provide a compounded preparation.
What is a small quantity?
A “small quantity” depends on the risk assessment for each API which should include an assessment of the frequency of compounding with these ingredients. As per section 4.1 of the guidance document, some factors to consider in the risk assessment include the:
The risk assessment must be reviewed on a continuum to identify and mitigate risk thereby providing quality assurance. A decision algorithm to assist in determining requirements for non-sterile compounding can be found in section 4.2 of the guidance document.
Note: Occasional small quantities of materials must not be considered in isolation. If several different high-risk or low-risk preparations are being compounded, the cumulative risk must be considered even if they are compounded on different days. This must be documented in the risk assessment.
What is the difference between the “NIOSH list of dangerous drugs” and “health hazard(s) under the Hazardous Products Act”?
In Canada, legislation (the Hazardous Products Act and related Regulations) requires that hazardous products used in the workplace are labeled to identify the associated hazards. Schedule 2 under the Hazardous Products Act provides a listing of health hazard classes. The Government of Canada, Canadian Centre for Occupational Health and Safety defines the WHMIS (Workplace Hazardous Materials Information System) as a “comprehensive plan for providing information on the safe use of hazardous materials used in Canadian workplaces. Information is provided by means of product labels, material safety data sheets (MSDS) and worker education programs.” Pharmacy professionals can assess whether an active pharmaceutical ingredient (API) is a health hazard under the Hazardous Products Act by referring to the API label and the SDS sheet for the API.
The NIOSH list is an American reference from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), and includes ingredients more specific to health care materials: NIOSH List of Antineoplastic and Other Hazardous Drugs in Health care Settings 2016.
Both the NIOSH list and WHIMIS should be considered as part of a risk assessment, as each provides information regarding potential health hazards associated with compounding ingredients. It is important to note an SDS may indicate that an API represents a health hazard even if the drug is not included on the NIOSH list of hazardous drugs.
What are some examples of Level A, B, and C Compounding?
As a self-regulated health professional, you are expected to use your knowledge, skills, and judgment to perform a risk assessment of each preparation compounded in your pharmacy. Consider all the factors outlined in the standards and guidelines, utilize all necessary resources and references, then assign the risk level, and document your decision with rationale in the master formulation record. Examples of how a risk assessment may be conducted have been provided by other regulatory bodies in Canada (available in the Additional Resources section below); however, the individual factors in your practice setting may result in a different risk assessment for the same formulation than these examples or another practice site. If there is uncertainty regarding the risk level to assign, the compounding supervisor, in collaboration with the manager, may choose to adhere to the standard for the higher risk level in the interest of safety.
What is Level B compounding?
Level B compounding includes:
As per the USP 795 definition that is included in the guidance document, complex compounding means making a preparation that requires special training, environment, facilities, equipment, and procedure to ensure appropriate therapeutic outcomes. Examples of possible complex preparation types include transdermal [delivery system] dosage forms, modified-release preparations, and some inserts and suppositories for systemic effects.
How do I determine if a product is listed as a health hazard under the Hazardous Products AcT and how do I use the product safety data sheet (SDS) to determine the hazards identified with that product?
Pharmacy professionals are expected to refer to Safety Data Sheets (SDSs) for active pharmaceutical ingredients (APIs) to determine any associated health hazard classes. SDS sheets should be accessible from the manufacturer of the API – therefore, a pharmacy professional should be able to access an SDS directly from the manufacturer or from the distributor from which the API was purchased. On each SDS, refer to Section 2 for the Hazards Identification. In addition, refer to Section 8 of an SDS for information regarding the recommended exposure limits, engineering controls, and personnel protective equipment. This fact sheet on Safety Data Sheets may be helpful. Compounding supervisors must ensure that SDS sheets for APIs are used to conduct risk assessments of compounds, and that risk assessments for compounded preparations are available to all staff involved in compounding to make sure that they are aware of all possible risks.
Can pharmacies that meet level A compounding requirements compound with any powders or ingredients that are designated as health hazards?
As per the guidance document, many non-sterile preparations can be compounded within a Level A space. These preparations could include simple and moderate compounds that contain hazardous drugs in NIOSH Group 2 or 3, or materials designated as health hazards by the Hazardous Products Act but are deemed to pose little or no risk for compounding personnel when compounded in occasional small quantities (i.e. quantities determined to represent low risk to compounders in a particular instance at the pharmacy if appropriate precautions are taken).It is important to remember that not all Level A spaces are the same. The scope of activities that may be performed in a specific pharmacy depends on the unique characteristics of that site. The pharmacist-in-charge and compounding supervisor of each pharmacy must carry out a site-specific assessment of what compounding activities are appropriate and these may differ from other Level A pharmacies.
What should I do if I am uncertain about the risk level of a compound?
If, after conducting a risk assessment to the best of your ability, you are still uncertain as to the level of risk, then always defer to the higher standard.