In light of the worldwide shortage of Ozempic, many compounding pharmacies began compounding Ozempic. While they may be practicing well within guidelines, the Therapeutics Goods of Australia (TGA) has released statements on their concerns of the safety and quality of compounded Semaglutide.
What is Ozempic?
Ozempic contains the active ingredient semaglutide which belongs to the class of glucagon-like peptide-1 (GLP1) receptor agonists. It is a weekly injectable medication and is prescribed to improve blood sugar in adults with type 2 diabetes. Ozempic helps control sugar levels by increasing insulin release, suppressing glucagon, and slowing stomach emptying. While not specifically a weight loss drug, its actions have proven to contribute to weight reduction in individuals.
What is the need to compound ozempic?
Ozempic, an approved drug for diabetes, has been used off label as a weight loss medication. The demands of it skyrocketed in 2022-2023, resulting in the manufacturer facing difficulties to keep up with the demand. Novo Nordisk, the pharmaceutical company, had earlier advised the TGA that issues with Ozempic shortage will be expected to last throughout 2024.
The TGA had advised prescribers to not initiate new patients unless there was no suitable alternative. They also said those who were already on Ozempic to consider another medication due to short supply issues. This has been an international issue and has resulted in compounded versions of the drug. It has been labeled as the wonder drug.
Is it safe and effective to compound Ozempic?
Compounding of a medicine by a practitioner or pharmacist is permissible when the medicine is required to meet individuals’ clinical needs. Compounding pharmacies are licensed to create the medicine themselves when a commercially manufactured product is not suitable or available.
However, compounded medicines are not evaluated by the TGA for quality, safety and efficacy. Hence the pharmacists compounding the medicine must follow the guidelines to ensure safety and quality.
In the US, the food and drugs administration, has warned consumers of the safety risk of the compounded products. They have been believed to contain a salt formulation of Semaglutide, including sodium and Semaglutide acetate. This warning was issued following an increase in adverse event reports after patients have administered the compounded product.
Is it legal in Australia to compound Ozempic?
It is not illegal to compound the medication. However it is unlawful for pharmacists to supply medicines that have been compounded prior to receiving a prescription for an individual patient (in mass production). However compounding a medication in dire need, is part of a pharmacist’s job.
What does the TGA say about compounded Ozempic?
After hundreds of patients had ordered the compounded version, the TGA decided to release statements in December 2023. This was to remind telehealth providers and compounding pharmacies about the advertising of prescription medications being illegal in Australia. They have highlighted that Novo Nordisk is the only company with TGA approved Semaglutide and any other may be considered as a scam or counterfeit product.
TGA had issued this safety alert as Novo Nordisk began legal actions against the two US Ozempic compounding pharmacies. They have claimed the end product is less potent and would contain impurities and possible side effects.
Furthermore, in January 2024, the TGA met with the regulatory boards of Pharmacy to make changes to the Therapeutic goods Regulation. They proposed to remove all GLP-1 medicines from the pharmacist compounding exemptions. This has risen due to the public health and safety concerns following the expansion of compounding of Semaglutide.
The TGA’s consultation was due to the unknown nature of the active ingredient and the absence of evaluation of these medicines for quality and safety. A formal decision will be made in June 2024.
What are the benefits of compounding Ozempic?
Semgalutide has provided access to a life changing medicine for both diabetics and those who have struggled with weight loss for decades. While pharmaceutical companies and authorities consider how to manage the short supply, patients are very happy to have an option. Compounding Ozempic could be deemed essential while a world-wide shortage is occurring.
Considering compounded Semgalutide may not be an option past June this year, Individuals wanting to take the step should have a thorough discussion with their GP.
What are the risks of compounding Ozempic?
As the FDA has suggested that compounded Semaglutide may contain the salt formation. This has been highlighted as the manufacturer has said they do not sell their Semaglutide ingredient to pharmacies. There could be concerns of the source of the ingredient.
Novo Nordisk made Ozempic with certain ingredients that may have suited people. However there is no guarantee that compounded Ozempic will contain the same ingredients. It may contain additional ingredients and though it may be marketed to be cheaper than Ozempic, there are risks to consider.
Other alternatives to weight loss
An effective alternative to Ozempic is Wegovy. Which is yet to be released in Australia and Ozempic is facing massive delays making both options not so viable.
Although compounding Semaglutide seems to be a popular option right now, there are other weight loss options to consider. They include tablets or injections which are accessible and registered as medicines for weight loss.
Consulting a doctor for weight loss
Individuals should discuss with their regular doctor before resulting in purchasing un approved compounded medications from a telehealth service. Your usual health care team are best to recommend an alternative medicine. They may also be able to arrange a replacement product from a special access scheme.
To initiate a weight loss journey or to move to an alternative medications, it is vital to have a thorough discussion with your doctor.
Consult a doctor
Resources
Compounding safety information: semaglutide-like products | Therapeutic Goods Administration (TGA)
