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

Posted:Dec 21st, 2023
Read Time: 3 Min Read
Category:News

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) PolicyA 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.

 

Frequently Asked Questions

Drug shortages are an ongoing concern within the Canadian health-care system, affecting patients and pharmacies across the country. Health Canada works closely with many partners to prevent shortages, mitigate their impacts, and help resolve them when they occur. The Drug Shortages Canada website for mandatory reporting of anticipated and actual drug shortages has a flag to indicate a Tier 3 shortage that could potentially have the highest impact on Canada’s drug supply and health care system.

The Ozempic® shortage is a Tier 3 shortage which has also led to supply chain issues with a number of alternative GLP-1 agonists. Health Canada has published a Notice: Recommendations while Ozempic and other GLP-1 agonists are in shortage with recommendations for both prescribers and patients.

Other resources for pharmacy professionals related to drug shortages:

Dispensing Quantity:

Novo Nordisk Canada Inc. and Eli Lilly Canada Inc. are asking pharmacists to limit refill prescriptions for patients to a 30-day supply. The Canadian Pharmacists Association (CPhA) continues to advocate on behalf of pharmacists and encourage insurers to enable 30-day supply. Patients are encouraged to contact their pharmacy well in advance of running out of their current supply.

Supply chain issues:

Registrants who are experiencing supply chain disruptions of semaglutide (Ozempic®) in their pharmacy are encouraged to collaborate with their pharmacy peers to identify alternative sources if possible (i.e., another pharmacy with the medication in stock) and, in the interest of patient care, provide that referral to parents or caregivers.

Therapeutic Alternatives:

Pharmacists should use their knowledge, skills and judgment to advise on appropriate alternatives based on the individual circumstances. This may include:

  • switching to different strengths of pre-filled pens
  • switching from subcutaneous semaglutide to oral semaglutide
  • switching to alternative glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or glucose-dependent insulinotropic polypeptide and glucagon-like petide-1 agonists (GIP-GLP-1RA)

CPhA has collaborated with medSask to provide guidance for managing this shortage, which includes information about alternative therapies for patients being treated for diabetes or obesity. A list of alternatives can be found on the CPhA website.

Compounding

Compounding semaglutide preparations, in accordance with the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, should only be considered when all other treatment options, such as those presented above, have been exhausted. Evidence of the actual shortage is important, along with documentation of the alternatives explored by the pharmacist before considering use of a compounded preparation.

No, not that the College is aware of. However, in the United States, the Food and Drug Administration has received evidence of adverse events. Extra diligence is warranted due to the potential risk to patient safety when switching therapies, especially to a compounded sterile preparation. The College will continue to monitor the situation and collaborate with its system partners to keep registrants informed of any new developments.