Saturday, July 13, 2024

Medicines Shortages and EMA-HMA’s Strategic Plan to Address GLP-1 Receptor Agonist Supply Issues

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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued recommendations through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address the shortages of GLP-1 receptor agonist medicines, including Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide), and Victoza (liraglutide). These medications are essential for diabetes treatment and weight management under specific conditions.

Since 2022, there has been a surge in demand for these medicines, coupled with manufacturing constraints, leading to widespread shortages across the EU. The misuse of these drugs for cosmetic weight loss by individuals without obesity or related health issues has exacerbated the situation. This high demand has also attracted criminal activities, increasing the risk of falsified products entering the market and posing serious public health risks.

The EMA and the EU regulatory network have been monitoring and taking action to manage these shortages since 2022. The recommendations by the MSSG represent a coordinated response to the ongoing issues. “We need to step up actions now – industry, regulators, healthcare professionals, patients, and the public all have a role to play,” said Emer Cooke, EMA’s Executive Director.

Optimizing Medicines Distribution and Addressing GLP-1 Receptor Agonist Shortages in the EU

Member States are advised to collaborate with marketing authorization holders to optimize the distribution of these medicines. Continuous cooperation through the Medicine Shortages Single Point of Contact Working Party (SPOC WP) will allow the MSSG to monitor the situation comprehensively and assess the impact of measures. Additionally, Member States are encouraged to develop guidelines to prioritize patients with the greatest need for these medications.

To understand the real-life usage of these medicines, the MSSG plans to conduct a study using real-world data via DARWIN EU. Marketing authorization holders are urged to increase manufacturing capacity and engage with regulatory authorities to ensure coordination. They must ensure that promotional messages align with rational medicine use and public health goals. A multistakeholder workshop scheduled for July 1, 2024, will bring together key actors, including international regulators, to discuss additional measures to improve the supply of GLP-1 receptor agonists in the EU/EEA. “Bringing everyone to the table is the most effective way to solve these complex shortages,” said Professor Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM) and chair of the HMA.

Healthcare professionals are reminded to prescribe GLP-1 receptor agonists only for their approved uses. These medications are not intended for cosmetic weight loss. They should be used under medical supervision to prevent exacerbating shortages and to avoid serious health risks associated with off-label use. The MSSG emphasizes that GLP-1 receptor agonists are prescription medicines and should only be used under medical supervision. The most common side effects include digestive issues such as diarrhea and nausea. Due to high demand, there is a risk of substandard or falsified medicines being offered online. Individuals should only purchase these medicines from registered pharmacies to avoid this risk.

Medicines

EMA and EU Efforts to Monitor and Mitigate GLP-1 Receptor Agonist Shortages

For the past two years, EMA and the EU regulatory network have been closely monitoring these shortages through the Medicine Shortages SPOC WP and the MSSG. The redistribution of stocks among EU Member States has been facilitated to avoid stocks running out and ensure patients receive the medications they need. EMA and the European medicines regulatory network hold regular meetings with marketing authorization holders to gain full oversight of the market situation, including current and anticipated shortages, and closely monitor the effects of any mitigation actions.

Some EU Member States have also implemented tailored measures to control the supply of these medicines within their national healthcare systems. The MSSG, under the EMA’s new mandate, ensures a robust response to medicine supply issues caused by major events or public health emergencies. The MSSG includes representatives from EU Member States, the European Commission, EMA, and observers from EMA’s Patients’ and Consumers’ Working Party and Healthcare Professionals’ Working Party.

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GLP-1 receptor agonists mimic the natural hormone GLP-1, increasing insulin release from the pancreas in response to food, which helps control blood glucose levels. They also help regulate appetite by increasing feelings of fullness and reducing food intake, hunger, and cravings.

 

Resource: The European Medicines Agency, June 26, 2024

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