By Donna Itzstein, Pharmacist and Credentialled Diabetes Educator
Ozempic is the trade name for an active ingredient, Semaglutide, produced by Novo Nordisk. It comes from a class of medications called GLP-1 mimetics. When food is present in the small bowel, natural hormones called Incretins are released into the blood. These natural Incretin hormones are Glucose-dependent insulinotropic polypeptide (GIP) and Glucagon-like peptide-1(GLP-1). GIP and GLP-1, released in response to food, are broken down quickly in the body and have a short action. The hormones slow the motion of the gut, stimulate the pancreas to produce a little more insulin for meals, and make people feel full.
Researchers found these hormones in studies conducted as far back as 1964.(1) As Incretins have a useful effect in diabetes, medications were developed to harness these effects. The first set of medications developed that are still widely used today are Dipeptidyl Peptidase Inhibitors (DPPis), also called gliptins. Gliptins block the quick breakdown of natural incretin hormones. They have a modest effect on reducing post-meal blood glucose levels. This medication group includes Saxagliptin, Sitagliptin, Alogliptin, Vildagliptin and Linagliptin.
The other Incretin medications mimic the action of GLP-1 and some GIP. This class includes Exenatide (Byetta and Bydueron), Liraglutide (Saxenda, Victoza), Dulaglutide (Trulicity), Semaglutide (Ozempic, Wegovy) and Tirezpatide (Mounjaro). These medications are all injected into the subcutaneous fat. They are hormone-like medications that are not broken down as quickly as the natural Incretin hormones in your body and have an amplified action. Incretin mimics, but will not withstand, digestion and therefore, all have to be injected.
When a new medication is developed by a company a patent is placed on the medication. A patent is a legal agreement which is not necessarily international. The patent allows the company time to recoup the enormous cost of research and development of medications. During this time, the active ingredient in the medication cannot be produced and marketed by another company. After the patent expires, other companies may produce generic options with the same active ingredient. (2)
Novo Nordisk produces Ozempic and it will be under patent for at least another couple of years. The Therapeutic Goods Administration (TGA) is a government body that ensures the safety and effectiveness of our medications and medical devices. To be used in Australia, a product must be registered with the TGA.(3)
When Ozempic was introduced in Australia, prescribers were already familiar with the safety and efficacy of other medications such as Trulicity. As Ozempic has a favourable effect on weight and blood glucose levels, the demand for this medication has increased. In Australia, we have strict rules for the advertising of prescription medications. These laws are in place so that prescribers independently prescribe for best outcomes without bias. Advertising laws on prescription medication advertising differ in other countries. As Ozempic became popular for its weight effects, it became discussed on social platforms. Additionally Ozempic on private prescription is half the price of its counterpart Saxenda. These factors increased the demand for Ozempic more than Novo Nordisk could produce. At the same time, the COVID-19 pandemic impacted the supply of other medications.
The vast majority of medications are manufactured overseas. Supply issues can result from a disturbance in transportation, a shortage in active ingredients, recalls of batches of medications, companies closing down or stopping manufacture, and overdemand.
We have seen some locally compounded and imported versions of Ozempic recently. These products are ‘unapproved’ therapeutic goods and have not been evaluated by the Therapeutic Goods Administration (TGA) for safety, quality and efficacy. When a medicine is compounded, it can have a different strength and different ingredients from similar medicines approved by the TGA. The TGA has not checked these copies for safety and efficacy.
Under an agreement with doctors and pharmacists, Ozempic should only be supplied to people with type 2 diabetes. However, the TGA cannot regulate the clinical decisions of health professionals and cannot prevent doctors from using their clinical judgement to prescribe Ozempic for other health conditions.
Novo Nordisk has advised the TGA that supply of all strengths of Ozempic will be limited until December 2024.
Some patients who had been prescribed Ozempic for its registered use to treat type 2 diabetes were then prescribed alternate medicines, including Trulicity (dulaglutide). Unfortunately, this, in turn, has resulted in a shortage of Trulicity.(4)
