Important guidance to pharmacists during the current Ozempic® shortage: Expectations when compounding semaglutide preparations to ensure quality and safe patient care

Updated January 5, 2024, for clarification under item #3.

The College is aware of Ontario pharmacies offering (advertising, promoting) and/or dispensing compounded semaglutide preparations to patients due to an ongoing shortage of the Health Canada approved manufactured product, semaglutide (Ozempic®). The following guidance focuses on the pharmacist’s obligations to keep patient care and safety at the forefront when dealing with current Ozempic® shortages.

1. Compounding is a high-risk activity to be considered after other options

Pharmacy compounding of sterile preparations is a high-risk activity and should only be considered when other options have been exhausted.  The pharmacist’s efforts to obtain the commercial product(s) and efforts to recommend alternate therapy (or reasons why alternatives are not appropriate) must be documented prior to initiating compounding.

2. Compliance with compounding standards

Compounding must be done in accordance with the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations to ensure overall quality and patient safety.  These include establishing evidence-based beyond-use dates (BUD) based on stability and sterility (storage time related to the risk of microbial contamination) and establishing a robust quality assurance program to assess facilities, equipment, personnel, and procedures.

3. Communication with prescribers

Compounded preparations may be dispensed pursuant to a patient-specific prescription. In the case of semaglutide, a prescription issued for the brand name product is not interchangeable with a compounded version, nor can a pharmacist adapt the prescribed drug.

Given that the manufactured product contains semaglutide base, and these preparations might have been compounded from a semaglutide salt (e.g., sodium or acetate), pharmacists are reminded that even if a prescription is issued using the chemical name, before dispensing a compounded alternative to Ozempic®, the pharmacist must contact the prescribing physician/primary care provider to confirm that compounded alternatives are appropriate for the individual patient. Doing so is essential as differences may exist in the pharmacokinetics or pharmacodynamics of the compounded preparation, especially using a salt of the drug, which could affect its efficacy.  The prescriber’s agreement to using a compounded preparation must be confirmed verbally or in writing.  If the confirmation is verbal, facts regarding the verbal confirmation must be documented (e.g., name of prescriber, date, and time of confirmation).

4. Informed consent is essential for quality patient care

It is also essential that express, informed consent be obtained from the patient, ensuring they understand the difference between, and potential incremental risks of, using a compounded preparation in place of the manufactured product.  This includes, but is not limited to, carefully explaining that the compounded drug cannot be referred to as Ozempic®, and is instead a compounded alternative (see, Advertising requirements below) and that the product’s efficacy may be affected compared to the manufactured drug. Pharmacists are encouraged to follow up with their patients to ensure their treatment outcomes are being achieved.  For additional guidance, please refer to the Pharmacist Prescribing: Initiating, Adapting & Renewing Prescriptions Guideline.

5. Follow Health Canada’s compounding policy

Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) states that when there is a shortage or no supply of a commercially available product and the healthcare professional has determined a medical need for this product,  it may be compounded during the period of shortage or no supply only. The preparation should be compounded from an Active Pharmaceutical Ingredient (API) used in an authorized Canadian drug or listed in a recognized Pharmacopoeia.  Even in the absence of a manufacturer’s shortage, pharmacists are reminded that compounding must provide a customized therapeutic solution for an individual patient.

6. Important reminder when using central fill services for compounding

Health Canada’s Policy 0051 permits pharmacists that do not provide specific compounding services to contract this activity to another pharmacist who does. In Ontario, this is permitted in accordance with the College’s Centralized Prescription Processing (Central Fill) Policy.  A pharmacy providing central fill services may dispense a patient-specific prescription at the request of the patient’s originating pharmacy.  Compounding a preparation and providing it to another pharmacy outside of a central fill agreement and/or without a patient-specific prescription is considered manufacturing. For more information please read the Pharmacy Connection article 5 Things to Know about Centralized Prescription Processing (Central Fill).

7. Be aware of your obligations related to advertising compounded preparations

The College’s Advertising Fact Sheet summarizes the relevant provincial legislation governing advertising and pharmacy professionals engaged in compounding must also comply with all relevant sections of the Food and Drugs Act  (Section 3 – Prohibited advertising, 9 – Deception regarding drugs, etc.) It is misleading to refer to a compounded semaglutide preparation as Ozempic®.

Please refer to the relevant links included in this guidance when making decisions in the best interest of the patient.