Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

The Association of Compounding Pharmacists of Canada  ·  June 30, 2016

The ACPC welcomes the opportunity to respond and comment on the implementation timeline for NAPRA’S Standards for Pharmacy Compounding of Hazardous (and Non-Hazardous) Sterile Preparations.

It is recognized that the implementation of compounding standards for sterile preparations is necessary to ensure the safe compounding of quality sterile products. Further, it is recognized that proper handling of hazardous drugs in the sterile room setting, as well as in any environment, is crucial not only for the protection of pharmacy staff but also to prevent cross-contamination and limit exposure of our patients and the environment.

CONFLICTING GUIDELINES: Pharmacy compounding is already held to a high standard for patient safety reasons, as well as for consistency of preparations, through pharmacists adhering to the requirements set out in the United States Pharmacopeia (USP 39-NF34). In particular, chapters <795> (non-sterile compounding) and <797> (sterile compounding) address compounding. A recent USP call for comments on proposed amendments to USP<797> resulted in a revamping of that chapter, which will be published on November 1, 2016 and go into force on May 1, 2017 (assuming no further amendments are made). Similarly, a newly-proposed chapter to the USP has received substantial scrutiny (USP<800>, Hazardous Drugs -- Handling in Healthcare Settings). This chapter will be relevant to all healthcare personnel who "handle HD preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices)”.

In many instances, the NAPRA guidelines are either in conflict, incomplete or outdated when compared to USP standards. This will create confusion amongst compounders, many of whom are already in compliance with the universally-accepted USP standards and are therefore compounding sterile preparations in a safe, professional manner. The NAPRA guidelines may not be implemented by all provinces and territories. This will also add a bevy of issues around entrenching a national standard of practice for compounding sterile preparations. USP is already in place and could easily be adopted nationally.

OFFICE-USE: Dispensing for office-use is a vital pharmacy practice in which a pharmacist receives an order from a licensed prescriber for a specified medication, and then dispenses that medication to that prescriber for use in treating their patients. The key component of this practice is the prescriber-pharmacist relationship that exists at the time the order is being placed. Under no circumstances is the pharmacist dispensing medication without that relationship with the prescriber who is directly involved in treating patients.

Dispensing for office-use is critical to effective patient care in many settings. While emergency-use preparations are most widely recognized, prescribers in many specialties rely on office-use to effectively treat their patients. These environments include:
• Maternal Fetal Medicine • Urology • Ophthalmologists and retina specialists • Addiction medicine • Dermatology • Dentistry • Autism • General practice and pediatrics • Ear, nose and throat specialists • Pain management • Veterinary medicine

Currently, office-use is allowed in Canada and by the provincial regulatory authorities. Significantly, the very terms "patient-specific" and “office-use” are not defined in the NAPRA documents. These critical terms are incorporated into both documents, which pharmacy PRAs are now considering adopting without further modifications. The terms must be defined in the documents in which they are used, as is done with other important terms found within the documents. One such definition suggested is: "patient-specific" shall include "office-use" prescription orders of a practitioner entitled to prescribe in a province/territory of Canada.

TIMELINE: Any pharmacy performing sterile compounding should already have SOPs in place ( as required by the licensing body, along with an internal quality assurance program and follow USP<797>.

Until pharmacists are able to evaluate and resolve any conflicts between the NAPRA documents and current recognized standards, a timeline for implementation is impossible to calculate. As such, any comment on “timeline” must make reference to what is required to be put into place within that timeline (ie, contents of proposed standards).
It is the opinion of the ACPC that changes need to be made to the NAPRA documents to address the issues above and to bring them into compliance with current USP standards. The ACPC also believes that further stakeholder/public feedback is warranted on the content of the documents, given the discrepancies already identified between those documents and the reference documents to which they reference. It is premature at this time to simply look for a timeline to implement the proposed NAPRA standards and the ACPC suggests that input from the broad cross-section of practicing pharmacists with expertise in these areas regarding the content of the documents can only serve to better protect patient and employee safety.

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