Commonly asked questions regarding the implementation of the NAPRA Standards for Pharmacy Compounding of Non-Sterile Preparations.
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).
HOW LONG DO I HAVE TO MEET THE NEW STANDARDS AT MY PHARMACY?
Council approved a three-phased approach for implementation. Implementation priorities and timelines for completion of each phase are:
- Phase 1: January 1, 2020 - Assessing Risks and Gaps
- Phase 2: July 1, 2020 - Personnel Training and Quality Assurance
- Phase 3: January 1, 2021 - Facilities and Equipment
Learn more about each phase on the Non-Sterile Compounding Standards and Implementation page of the OCP website.
WHAT IS THE DIFFERENCE BETWEEN THE STANDARDS AND GUIDANCE DOCUMENTS?
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.
CAN YOU EXPLAIN WHAT IS REQUIRED OF ME AND MY TEAM DURING PHASE 1 OF THE IMPLEMENTATION TIMELINE?
During “Phase 1,” the College expects pharmacies involved in non-sterile compounding to evaluate their current practices and determine what areas require work to be compliant with the standards (“Assessing Risks and Gaps”). Learn more in the Winter 2019 Pharmacy Connection article Timelines Announced for Non-Sterile Compounding Standards.
Since Phases 2 and 3 of the implementation plan contain a greater workload than Phase 1, all pharmacies involved in non-sterile compounding are encouraged to commence work on those sections of the implementation timeline ahead of the required deadlines.
HOW DO I PREPARE A GAP ANALYSIS/SELF ASSESSMENT? IS THERE A FORM OR CHECKLIST I CAN USE?
The Self-Assessment Criteria for Non-Sterile Compounding Standards can be found on the OCP website. 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.
CAN YOU PROVIDE EXAMPLES OF LEVEL A, B AND C COMPOUNDS?
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.
AS PART OF OUR RISK ASSESSMENT, WHICH IS MORE IMPORTANT, THE WHMIS LIST OR THE NIOSH LIST? I DON’T UNDERSTAND THE DIFFERENCE BETWEEN THE TWO.
While both resources may be used as part of a risk assessment process in the pharmacy, each provides a different perspective to ingredient classification.
- WHMIS refers to products used in various workplaces, not just pharmacies, as outlined in Health Canada’s Workplace Hazardous Materials Information System. WHMIS encompasses a far wider group of chemicals used in workplaces than NIOSH.
- NIOSH 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 refers to a list of ingredients more specific to health care materials: NIOSH List of Antineoplastic and Other Hazardous Drugs in Health care Settings 2016
Practitioners may be familiar with the WHMIS Material Safety Data Sheets with regard to products used in the pharmacy for such things as cleaning supplies. The NIOSH list may be more useful for medications used during compounding.
Ultimately, the standards reference both documents and, as such, both should be used while performing risk assessments of various ingredients used in making compounds.
HOW DO I DETERMINE IF A PRODUCT IS LISTED AS A HEALTH HAZARD UNDER THE HAZARDOUS PRODUCTS ACT? HOW DO I USE THE PRODUCT SAFETY DATA SHEET (SDS) TO DETERMINE THE HAZARDS IDENTIFIED WITH THAT PRODUCT?
See schedule 2 under the Hazardous Products Act for a listing of health hazard classes.
Refer to the SDS for the active pharmaceutical ingredient (API) to determine any associated health hazard classes. Canada has aligned the Workplace Hazardous Materials Information System (WHMIS) with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). On each SDS, refer to Section 2 - Hazards Identification. A health hazard can be identified with a pictogram (see left). Refer to the Canadian Centre for Occupational Health and Safety to learn more.
The compounding supervisor should make risk assessments for APIs available to all staff involved in compounding to make sure that they are aware of all possible risks.
WHAT IS ARE THE MINIMUM DIMENSIONS OF A DESIGNATED 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 and exit).
WHAT IS A SMALL QUANTITY?
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:
- complexity of compounding the preparation;
- need for verification and uninterrupted workflow;
- frequency of compounding high-risk or low-risk preparations;
- risk of cross-contamination with other products (e.g., allergens);
- concentration of ingredients in the preparation;
- quantity of ingredients being handled;
- physical characteristics of ingredients (e.g., liquid vs. solid vs. powders, or water-soluble vs. lipid-soluble);
- education and competency of compounding personnel;
- availability of appropriate facilities and equipment;
- classification of ingredients if identified by WHMIS as presenting a health hazard, or a drug classified by NIOSH as hazardous (see reference to NIOSH in section 4.3);
- type of hazardous drug (e.g., anti-neoplastic, non-antineoplastic, reproductive risk only);
- exposure to compounding personnel for each preparation and accumulation of exposure over time; and
- risk of microbial contamination (liquids, creams, and ointments may be particularly susceptible to microbial and other contamination).
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.
WHAT DOES “MITIGATING RISK” MEAN EXACTLY, IN RELATION TO LEVEL B RISK COMPOUNDS?
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:
- the level of risk the ingredient(s) may present;
- the volume/frequency of that ingredient’s use; and
- the combined exposure to all higher risk ingredients.
If there is uncertainty as to the level of risk, then personnel shall defer to the higher standard.