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

Pharmacist  ·  June 30, 2016

I find a number of the postings very...confusing...to say the least, especially with some coming from major organizations and associations of pharmacy.

Speaking only of the Sterile Non-Hazardous Preparations, it has always been expected that any pharmacist undertaking to make such preparations does so in compliance with existing standards/guidelines for sterile preparations. The OCP even has its own "Guidelines for Compounding" that include a section related to Sterile Compounding. The consultation has made it clear that if a pharmacy can't meet the standards, then it will have to discontinue the service in a way to not compromise patient care (i.e., referral to someone who does comply).

It is beyond comprehension that the OCP would even buy into suggestions to allow any such operation to continue with this specialty compounding, under OCP jurisdiction.

It is shocking to hear such suggestion from the OPA, as well. These standards could be applied across Canada -- not just in Ontario. They are "national" in scope.

Are we now to understand that some have been doing these tasks, have NOT complied with such guidelines/standards, and now want a "do over" to be able to put the same safeguards in place but be allowed to continue while installing the requirements? How would that sit with those who ensured their premises were complaint BEFORE they even undertook to practise in this area?

What will happen in the 2, 3, 4, 5, or more years should these non-compliant pharmacies be allowed to continue while they "come into compliance"? We're not talking here about slapping some menthol/phenol/camphor into Dermabase...we're talking about a requirement for sterility/endotoxin testing to be performed on a specific class of preparations that should only be allowed to be dispensed from fully-compliant premises.

I fail to see how certain chains of pharmacies that currently do not have such facilities (but have lots of room for grocery products) will be able to modify the premises to become compliant with what not only these standards require, but which have always been the requirement of USP standards.

It's one thing to say that having to revise the premises might result in "unintended negative patient consequences;" but this could certainly also occur if a non-compliant preparation is released to the patient while the years go by during "modifications."

It only takes one. Just ask New England Compounding Centre and the victims of that disaster. And recall the Thiessen Report findings (specifically the victims in that one), which are likely hugely mitigating in why these standards are even being created.

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