Saturday, July 13, 2024

Products Warning Over Counterfeit Ozempic Found in Global Supply Chain

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Warning of counterfeit Ozempic products infiltrating Germany’s official supply chain in October 2023 was reported by Medscape Medical News. The World Health Organization (WHO) recently identified three additional counterfeit batches of Ozempic discovered in late 2023 in Brazil, the United Kingdom, and the United States, with an unknown number of unreported cases. Novo Nordisk, the manufacturer, confirmed these batches are not genuine, raising concerns about their safety and efficacy.

Ozempic (semaglutide) is approved for treating type 2 diabetes and obesity (under the brand name Wegovy) and is used off-label for obesity treatment. High demand has led to production shortages, making Ozempic a target for counterfeiters. Novo Nordisk has stated that production cannot meet the sustained high demand, particularly for Ozempic 1 mg, which is prioritized for current type 2 diabetes patients.

Consequently, the introductory dosage of Ozempic 0.25 mg will not be delivered in the second quarter of 2024, and Ozempic 0.5 mg will be delivered with restrictions, preventing new patient initiation. Typically, an initial subcutaneous dose of 0.5 mg is administered weekly and eventually increased to 1 mg weekly to mitigate side effects.

WHO Alerts on Counterfeit Ozempic Products with Key Identifiers for Pharmacists

Yukiko Nakatani, MD, PhD, WHO assistant director-general for access to medicines and health products, urges physicians and pharmacists to be vigilant. The WHO has identified specific characteristics of counterfeit packages, including nonexistent batch number LP6F832, a mismatch between batch number NAR0074 and serial number 430834149057, and a genuine batch number MP5E511 associated with counterfeit products.

Pharmacists should look for suspicious batch numbers online and be aware that counterfeit Ozempic pens may have a scale protruding when adjusting the dose, poorly adhered labels, or spelling errors on the packaging. Being attentive to these details can help prevent the distribution of counterfeit medications and protect patient safety.

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) oversees secure pharmacotherapy. Despite identifying no additional counterfeit packets beyond the known batch MP5E511, the BfArM advises pharmacists to inspect the primary packaging for authenticity before dispensing the drug. The securPharm system, developed under the EU Falsified Medicines Directive (2011/62/EU), adds another layer of security.

Product

Enhanced Security Measures Urged for Pharmaceutical Supply Chain to Combat Counterfeit Ozempic

This system assigns a unique serial number, product code, batch number, and expiration date in a Data Matrix code on each drug package, uploaded to a central database. Throughout the supply chain, employees scan and verify these codes. If discrepancies are detected, the medication cannot be dispensed. Tamper-evident seals on packaging further ensure the integrity of the product.

The discovery of counterfeit Ozempic in various countries underscores the critical need for vigilance and enhanced security in the pharmaceutical supply chain. The WHO’s warning and the actions taken by regulatory bodies like BfArM highlight the importance of ensuring the authenticity of medications to protect public health. Novo Nordisk’s efforts to manage supply shortages and the implementation of systems like securPharm are essential steps in combating the risks posed by counterfeit drugs.

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As counterfeit products can easily enter markets through drug importers or reimporters, the need for robust verification and monitoring systems is paramount. Ensuring that healthcare providers and pharmacists are well-informed and vigilant can help mitigate the risks associated with counterfeit medications, ultimately safeguarding patient health and maintaining the integrity of the pharmaceutical supply chain.

 

Resource: Med Scape, July 03, 2024

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