New guidance for pharmacists compounding semaglutide preparations amid Ozempic shortage

Thanks to the ongoing shortage of Ozempic, pharmacies are compounding semaglutide preparations for patients, and also advertising that they’re offering these services. The Ontario College of Pharmacists (OCP) has recently released guidance for pharmacies in this position that shares the rules around compounding and promoting semaglutide preparations amid the shortage. It points out that compounding is “a high-risk activity.” While there haven’t been any cases of patient harm from compounded semaglutide in Canada that the OCP is aware of, adverse events around it have happened in the U.S. and have been reported to the FDA. Read: Ozempic: ‘We created a monster’The OCP’s guidance reminds pharmacies only to consider compounding if no other options are available. Pharmacists need to both try and find Ozempic and consider if alternate therapy is appropriate before compounding, and they must document this process. Alternatives might include patients using a different strength of pre-filled pen, switching from subcutaneous semaglutide to oral semaglutide, or switching to alternative glucagon-like peptide-1 receptor agonists or glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 agonists. (A list of alternatives is available on the CPhA’s website.) Pharmacists must work to NAPRA’s Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations when compounding. As part of that, they must create evidence-based beyond-use dates and have a robust quality assurance program that assesses facilities, equipment, personnel and procedures. Read: Opportunities in compounding for community pharmacistsThe OCP also reminds pharmacists that prescriptions for Ozempic aren’t interchangeable with its compounded version, and a pharmacist also cannot adapt the prescribed drug.The manufactured product contains semaglutide base, and pharmacists may create a compounded preparation from a semaglutide salt. As a result, even if a prescription is given using the chemical name, the pharmacist has to contact the prescriber to confirm that compounded alternatives are appropriate for that patient. The confirmation may be in writing or verbal. If it’s verbal, the pharmacist should document the facts around the confirmation. Read: Ozempic and similar drugs linked to gastrointestinal conditions: Canadian researchersThe patient must also give their express, informed consent. Pharmacists should explain the differences between the drugs and that there are potential incremental risks to using a compounded preparation. That includes the fact that the compounded drug cannot be referred to as Ozempic, its efficacy may differ from Ozempic, and other differences between the drugs. More guidance around this is available in this guideline. Pharmacists should also follow up with patients to ensure their treatment outcomes are achieved. They must follow Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada. That says products may be compounded during a period of shortage or no supply of a commercially available product, when a healthcare professional has stated that there’s a medical need for it. Read: Watch those units of measurement: Mistakes with compounded clonidine products send children to hospital: ISMP CanadaThe preparation should be compounded from an Active Pharmaceutical Ingredient that’s used in an authorized Canadian drug or listed in a recognized Pharmacopoeia. Pharmacists who do not provide specific compounding services can contract out compounding to another pharmacist who does. Compounding a preparation and providing it to another pharmacy outside of a central fill agreement, or without a patient-specific prescription, is considered manufacturing. More information about the college's central fill policy can be found here and here. Finally, pharmacies should know that advertising or referring to compounded semaglutide preparation as Ozempic is misleading, and not allowed. Read: POLL: Have patients been pushing to be prescribed Ozempic for weight loss?This story has been updated to clarify information about central fill prescribing and what is considered manufacturing.

New guidance for pharmacists compounding semaglutide preparations amid Ozempic shortage

Register for free access or login.

Related Topics