Feedback for Seeking Feedback on Non-Sterile Compounding Standards

CHIRON Compounding Pharmacy  ·  Nov. 17, 2016

We appreciate the College allowing pharmacists to provide feedback on the proposed Non-Sterile Compounding Standards.

We have one general comment regarding the standard and a few specific comments.

Although comprehensive, the narrative text makes the document extremely cumbersome and difficult to follow. The Good Manufacturing Practice guidelines for pharmaceutical manufacturing published by Health Canada are not as difficult to follow. Many of the requirements could be listed in point form to allow for an easier read.

We feel that section 7.11 will cause harm to veterinary patients. Currently veterinarians prescribe and dispense commercial and compounded medications from their clinic. We trust that this document has been circulated to the College of Veterinarians of Ontario to get their input on the affect this document will have on veterinary care.

The requirement for veterinarian/client/patient/pharmacist relationships will affect/delay patient care by referring the client to a compounding pharmacy which may not be well versed in veterinary compounding. This will result in delayed patient care and may cause harm (e.g. dispensing human gabapentin suspension containing xylitol to a dog. Xylitol is toxic to dogs). We suggest this section be modified to allow for compounding veterinary medications for office use. There are many medications that are required for immediate use in a veterinary clinic that must be compounded since they are not commercially available. Treatment delay may cause harm to the veterinary patient. For example:

• Apomorphine to induce vomiting in dogs after poisoning • Potassium bromide, levetiracetam for seizures • Antibiotic/antifungal/steroid ear medications that needs to be instilled at the clinic • Medications for pain management while the animal is in the clinic and/or being sent home

For office use compounded medications should be allowed for practitioners as well – most physicians use medications in their office practice (e.g. local anesthetics for dentists). When these medications go on back order or are discontinued, they may require compounding to ensure continuity of care. Currently, commercial products may be dispensed for office use, why is there a restriction on compounded medications? Medications used in practice are not re-sold, the cost is absorbed by the practitioner as overhead cost.

Under section 5.1, suggest adding BP (Vet) as a recognized pharmacopoeia.

In section 10.3.1 – we recommend adding the option to allow for an internally vented double HEPA filtered powder hood along with the option of an externally vented HEPA.

What is the College’s timeline on completion of this document and what would an anticipated implementation date be? The hazardous and non-hazardous sterile compounding guidelines are slated for implementation on January 2019.

We trust that you will consider the access to patient care when considering an implementation date.

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