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With the increase in counterfeit GLP-1 and GLP/GIP medications available online, education may be needed for patients around the dangers of unregulated medications.
Over the past decade, pharmacies have expanded their services into the digital market to make themselves more accessible to patients. However, with the expansion of social media, and the internet in general, access to counterfeit medications have threatened the health of patients worldwide.
The Pharmaceutical Security Institute was established in 2002 with security directors from 14 major pharmaceutical companies to identify and assess counterfeit medication operations worldwide.1 In 2022, there were 6615 pharmaceutical crime incidents (a 10% increase from 2021) impacting 141 countries.1 North America was responsible for 3029 of those incidents.1 Pfizer, as well as other pharmaceutical manufacturers, have aggressive campaigns to combat fake medications. Pfizer has confirmed at least 103 counterfeit versions of Pfizer medications in 116 countries.2
The FDA recently warned consumers that the compounded forms of injectable semaglutide (Ozempic; Novo Nordisk and Wegovy; Novo Nordisk) may not contain the correct ingredients or the necessary potency and purity. The FDA has received reports of salt forms of semaglutide being used (both semaglutide sodium and semaglutide acetate) in the compounding process, thus making the medication different from what is FDA-approved.3 The FDA wants patients to know that products sold online as semaglutide without proper licensing and regulation by the FDA have not been shown to be safe and effective.3 Counterfeit medications can have zero, some, or too much active ingredient. Therefore, unregulated products can be subtherapeutic or supratherapeutic causing patient harm or even death.2 This advice is applicable to all medications that are in shortage, tempting patients to look to online sellers. Through the FDA’s adverse event medication reporting system, at least 3 Americans have been hospitalized from using suspected counterfeit semaglutide medications.4
The Risks of GLP-1 and GLP/GIP Weight Loss Medications
Like all prescribed medications, the use GLP-1 and GLP/GIP medications should be monitored under the care of a licensed medical professional. Additionally, pharmacists also have a duty to monitor the safety of the medications being dispensed by engaging in patient counseling, reviewing the dosing, adverse effects (AEs), drug interactions, and contraindications. Not taking the medication as prescribed can increase the risk of AEs. With this class of medications gaining popularity, there has been an increase in demand, even from individuals not actively under the care of a provider. These patients have been able to access the counterfeit versions of the medications through a variety of mechanisms, including online suppliers and Medspa locations. When individuals take prescription medications that are not prescribed by a licensed medical provider, they are at a greater risk of complications and AEs because of the lack of follow up and monitoring.
While the weight loss benefits of this class of medications is significant, as health care professionals, we have the responsibility of sharing information about safety and AEs. In September 2023, 5 years following the initial approval date, the FDA added a warning label of intestinal blockages to Ozempic. This warning was already in place for Mounjaro and Wegovy. Medical professionals need to monitor patients for AEs from these medications, such as vomiting, nausea, and diarrhea, which can lead to intestinal blockages. Pharmacists can counsel patients on how these medications can make them feel fuller which can cause an increase in gastrointestinal symptoms. Pharmacist can also advise patients on ways to manage the symptoms, such as by decreasing meal sizes and eating smaller portions throughout the day. Additionally, patients’ should understand when to seek medical attention based on symptoms. In Australia, a woman who was prescribed Ozempic and liraglutide (Saxenda;Novo Nordisk) died from complications of intestinal blockages from the injectable weight loss medications.5 Her husband spoke to 60 Minutes Australia, and explained that she was prescribed these medications for weight loss before her daughter’s wedding.5 She became very ill with nausea and diarrhea but continued to take the medications. Her death highlights potential significant complications that can occur with these medications.
Online Pharmacy Safety
How can patients determine if they are using an online pharmacy safely? The FDA launched its BeSafeRx campaign to ensure patients are using a valid prescription to buy from licensed pharmacies located in the US that are being overseen by a state board of pharmacy.6 If patients are unsure which online pharmacies are safe, they can visit www.FDA.gov/BeSafeRx to browse safe pharmacies. Health care professionals can advise patients to only take prescription medication as directed, and to remain mindful of safety when exploring online pharmacies. Pharmacists can provide patients education about the risks of counterfeit medications and how to identify them.
When browsing for pharmacies online or receiving their orders, some red flags to look for include:
Reporting
Health care professionals, patients, and compounders should report AEs or quality problems to the FDA MedWatch Adverse Event Reporting Program online.3 Everyone is urged to report websites that they suspect are illegally selling medicine using the FDA MedWatch site.
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