Commonly asked questions regarding the implementation of the NAPRA Standards for Pharmacy Compounding of Non-Sterile Preparations. For more information, please visit the Non-Sterile Compounding Key Initiative.
Note: OCP would like to thank the Alberta College of Pharmacists and the New Brunswick College of Pharmacists for allowing us to adapt their Frequently Asked Questions (FAQs).
STANDARDS, TIMELINES AND RESOURCES
Compounding is within the scope of practice and authorized acts for pharmacy professionals defined in the Pharmacy Act, and compounding non-sterile preparations according to recognized guidelines and standards is an entry-to-practice competency for both pharmacists and pharmacy technicians. It is reasonable that the public and other health practitioners expect any pharmacy to provide some compounding services. The requirements for “all levels of compounding” (Section 5 in the NAPRA standards), corresponding to Level A, should be attainable for all pharmacies already engaged in compounding. Moreover, the Code of Ethics expects that “members make every reasonable effort to provide quality cost-effective pharmacy care and services to patients and society.”
As explained in the standards, “given that pharmacists and pharmacy technicians are expected to maintain competency in basic compounding skills, they are also expected to provide compounded preparations within their level of expertise and within the limitations of available and appropriate facilities and equipment.” The Designated Manager/department head must ensure, with the best interest of the patient in mind, that the pharmacy has the resources necessary to compound a preparation in a safe and appropriate manner. When this is not possible, they have an ethical obligation to “assume responsibility for making reasonable efforts to ensure continuity of patient care when they are unable to provide requested pharmacy services.” Patient care should not be jeopardized by abrupt cessation of compounding services due to the transition to the new standards.
Council approved a three-phased approach for implementation. In recognition of the evolving COVID-19 pandemic situation and the need for pharmacy professionals to focus on continuity of care and minimizing public risk, on March 23, 2020, Council approved an extension of the deadlines for pharmacies to meet the standards. The updated timelines for completion of each phase are:
Learn more about each phase on the Non-Sterile Compounding Standards and Implementation page of the OCP website.
The standards are now the minimum requirements for all registrants involved in non-sterile compounding. Standards establish requirements, using the language of “must.” It is mandatory that the people and places involved in non-sterile compounding be compliant with the standards.
The Guidance Document for Pharmacy Compounding of Non-Sterile Preparations was developed by NAPRA as a supplemental resource and provides direction on and assistance with implementing the new standards. The guidance uses the language of “should” and establishes the professionally-accepted means by which pharmacies can achieve compliance with the standards. Pharmacies and pharmacy professionals may choose to meet the required standard using another process than one suggested in the guidance document; this is acceptable as long as the process meets or exceeds the requirements in the standard.
The College has prepared a checklist to provide guidance to pharmacy professionals and pharmacies as they work to implement the requirements but it is not intended to replace the standards. It is the responsibility of the pharmacy professional/pharmacy to review and ensure compliance with the standards.
The College has produced a Non Sterile Preparations Assessment Criteria document. This document is intended to be used by pharmacy professionals to assess the gaps between current processes/practices at the pharmacy and the requirements of the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations.
The document lays out each standard and the accompanying section in the NAPRA Guidance Document for Pharmacy Compounding of Non-Sterile Preparations to illustrate specific insights or activities required to ensure adherence to the standard. Pharmacy professionals can “check off” each standard as it is met and track their progress at meeting the standards. However, this document is not meant to replace the standards. Pharmacies should not send this document to the College.
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 and exit).
RISK ASSESSMENT AND MITIGATION
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, utilizing 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, however, the individual factors in your practice setting may result in a different risk assessment for the same formulation than 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 higher standard in the interest of safety.
Refer to Sections 4.3 and 8.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
The National Institute for Occupational Safety and Health (NIOSH) is an occupational health and safety agency, part of the Centers for Disease Control and Prevention in the U.S. The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings places hazardous drugs into one of 3 groups based on specific criteria. The actual risk to personnel depends on how the drug is handled and what risk mitigation measures are in place.
In Canada, Workplace Hazardous Materials Information System (WHMIS) is implemented through federal and provincial occupational health and safety legislation. Health Canada administers the Hazardous Products Act (HPA) and regulations which establish hazard classifications, cautionary labelling requirements, and the provision of Safety Data Sheets (SDS). WHMIS includes products used in various workplaces — a far wider group of chemicals than NIOSH — that are categorized as either physical or health hazards (See Schedule 2 of the HPA).
The Model Standards for Pharmacy Compounding of Non-sterile Preparations require both references to be consulted in the risk assessment process, such as described in Section 4 of the Guidance Document and illustrated in the Decision Algorithm. Risk assessments for compounded preparations should be available to all compounding personnel.
Refer to Section 4.3, 6.4.3, 8.3 and Glossary of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
To determine if an active pharmaceutical ingredient (API) is a health hazard under the Hazardous Products Act (HPA), check Section 2 – Hazards Identification of the Safety Data Sheets (SDS): health hazard classes can be identified by a pictogram (see below) which also appear on the API’s label.
Section 8 of an SDS includes information on engineering controls and personnel protective equipment that may be helpful in determining appropriate risk mitigation measures when applied in the context of the pharmacy’s compounding practice and cumulative risk assessment.
When manufactured drugs (i.e., those with a DIN, approved by Health Canada) are used to compound a preparation, active and inactive ingredients must be considered. In addition to consulting the SDS of the ingredients, the drug’s Product Monograph includes information on Storage, Stability and Disposal and Special Handling Instructions to consider. SDS should be available to all compounding personnel.
Small quantity depends on the risk assessment for each API which should include an assessment of frequency of compounding with these ingredients. As per the guidance document Section 4.1, 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.
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. Registrants must make available an environment and equipment that ensures the safety of pharmacy personnel when evaluating level of risk. If there is uncertainty as to the level of risk, then the registrant shall defer to the higher standard.
The table on page 5 of the standards document contains an outline regarding what to look for when seeking to mitigate risk, particularly to compounding personnel. Key points to consider in your decision making are:
If there is uncertainty as to the level of risk, then personnel shall defer to the higher standard.
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