Following various alerts issued by the TGA, the Australian government has decided to take the step to protect the public from the risks involved with injecting compounded Ozempic and Mounajro. They have issued a ban on compounded weight loss drugs from October this year.
At Simple Online Doctor, we only supply approved pharmaceutical products registered by the Therapeutic Goods Administration (TGA) and thus have no association with compounded GLP-1s.
What is a compounded medicine?
A compounded medication is a personalised medicine made by pharmacists in a controlled, sterile room or specialised location. It is made for individual patients with specific clinical needs where a commercially approved medicine is not suitable or available.
Compounding allows for tailored strengths, different administration route options, and allows access during times of medicine shortages.
Compounded weight loss drug concerns
In the past 12 months, compounded glucagon-like peptide-1 receptor agonist products have been in high demand worldwide. This is due to the massive shortage of brand-name Ozempic and Saxenda from manufacturer Novo Nordisk and Mounjaro from Eli Lilly.
The Regulatory concerns are due to the mass production of compounded Ozempic or Mounjaro replicas. These are not identical to the Food and Drug Administration (FDA) or TGA-approved products. Hence, they have not been evaluated for safety, quality, and efficacy.
It is unlawful for pharmacists to compound medicines before receiving a prescription for a patient. Therefore, compounded medicines should not be mass-produced. This is a regulatory requirement that has not been followed by some providers.
There has been an increasing number of reports from patients about side effects and harm from compounded weight loss drugs. Some of which included serious injury and hospitalisation.
Therapeutic Goods Administration’s decision on compounding weight loss drugs
The TGA has announced that from 1st October 2024, all GLP-1 compounding will be removed from the pharmacy compounding exemption list.
The ban has been placed in collaboration with health sector bodies such as the Royal Australian College of General Practitioners, the Medical Board of Australia, the Pharmacy Board of Australia, Diabetes Australia, and all state and territory health departments.
This means from now till the 1st of October, patients and their health care team have been given the time to find a safer and regulated alternative for continued treatment.
The TGA has said it will work with all key medical, pharmacy, and consumer groups to support the patients and their doctors. This is to ensure they navigate the change and provide guidance in finding safe and alternative medicine. This ban will not affect any other compounded medicine on that list, and only remove GLP-1s.
Is this a sudden decision by the TGA?
Compounded weight loss drugs like Ozempic and Mounjaro have been under the microscope for a while. The first official statement was issued by the TGA in December 2023. At that time, they had reminded all telehealth providers and compounding pharmacists not to initiate patients on semaglutide. They also said to find alternatives for those who are currently reliant on semaglutide. The TGA also reminded them that advertising for these medicines was not legal.
The TGA also assured that Novo Nordisk is the only company with TGA-approved semaglutide. They issued this statement after Novo took legal action against two USA Ozempic compounding pharmacies. They cited concerns about impurities and reduced potency of the salt formulation of Ozempic.
Furthermore, in January 2024, the TGA met the Pharmacy regulatory board and indicated a change to the exemption list of compounding medicines. They highlighted this due to the public health and public safety concerns. The final decision on the ban was released on the 22nd of May 2024.
Why were pharmacies compounding Ozempic and GLP-1s?
There is no doubt that semaglutide provides life-changing medicines for those with type 2 diabetes and those who have struggled with losing weight. Currently, a minimum of 20,000 Australian patients are believed to be injecting the compounded replica, with the majority using it for weight loss management.
In Australia, practitioners and pharmacists are allowed to compound a medication when the medicine is required for clinical need and otherwise not accessible. However, the compounding team needs to ensure they follow guidelines to ensure the safety and quality of the medicine. Thus, when the manufacturer Novo Nordisk faced difficulties with demand, it created a void in the supply, which resulted in compounded versions of the drug.
What are the risks of compounding injectables?
The Food and Drug Administration has suggested that the compounded semaglutide may contain salt formulation. This was based on the manufacturer’s information of not selling their semaglutide to pharmacies, hence pointing concern to the source of the active ingredient. Since the active ingredient is questionable, the possible side effects faced by patients can be serious.
Though Ozempic may have suited people, no guarantee compounded versions will contain the same ingredients. It may contain additional ingredients or be made in unsuitable conditions. This is for all GLP-1 receptors.
All compounded medicine needs to follow certain compounding requirements. GLP-1 injections must be made in a sterile environment to prevent contamination. Only certain pharmacies have the license to provide those services. If the pharmacy is not equipped with the appropriate equipment or facilities and trained staff, compounding semaglutide could be a safety risk.
What are the regulated weight loss alternatives?
Individuals who are using Ozempic and other GLP-1 receptor agonists for weight loss purposes should explore other alternatives. A promising medication is Wegovy, which has shown exceptional weight loss results worldwide however, it is yet to be released in Australia. Saxenda is an available option for weight loss, used by many individuals who experiencing effective weight loss results.
Mounjaro has been registered for weight loss in other countries. It could be a viable option in Australia once it overcomes its supply issues. Individuals using Ozempic/Mounjaro for Type 2 Diabetes can explore other effective alternatives to help manage their blood glucose.
Consulting a doctor
Though the change is effective from October 1st, it has only been given that time so people can safely switch. The aim is to have patients on safer, regulated, name-brand medications for better health results.
Patients who have been using the compounded version of GLP-1s should discuss with their health professional about the safe and regulated alternative options best suited for them.
Resources:
Consultation remove GLP1 pharmacist extemporaneous compounding exemption
