21/02/2024
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When Carrie Davis found out her health insurance wouldn’t cover Ozempic, she looked for an alternative route to getting the diabetes drug, which is increasingly being used off-label for weight loss. Ms Davis, 55, did not have diabetes, but she had gained 50 pounds during menopause and developed hypothyroidism, she said, and was eager to lose weight.

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After seeing someone claiming to be a doctor on TikTok saying he could help patients get a generic version of the drug, he reached out. After a few days and a quick video consultation with someone who introduced himself as a nurse practitioner, Ms. Davis was holding a prescription. It was really quick, Ms. Davis said.

It took a week for the drug to arrive in a vial filled with a mauve-colored liquid that was semaglutide, the doctor said, the same active ingredient as Ozempic. She was told to inject it weekly, just like people who take Ozempic do. But his medicines had been shipped to his home in Galveston, Texas, from a Kentucky pharmacy.

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In the race to find Ozempic, patients are looking to telehealth platforms, medical centers and compound pharmacies for what some advertise as generic versions of the drug. But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for compounding purposes and there is no generic form of the drug approved by the Food and Drug Administration, a Novo Nordisk representative wrote in a statement.

There are approximately 7,500 pharmacies in the United States, according to the American Pharmacists Association. Compounding involves mixing and altering drugs, customizing them for patients with specific needs — for example, someone who is allergic to a drug ingredient might require a reformulated version.

Because the FDA’s drug shortage website lists Ozempic as currently in shortage, compounding pharmacies can purchase semaglutide from pharmaceutical ingredient manufacturers and combine it into an injectable drug that they dispense. They also often mix it with B vitamins or a metabolic compound called L-carnitine, which limited research has shown can contribute to weight loss. Some compounding pharmacies are dishing out an entirely different active ingredient: semaglutide sodium, the salt form of semaglutide.

In recent weeks, regulators have raised concerns about semaglutide sodium, which is sometimes sold as a research chemical. Semaglutide sodium doesn’t appear to meet standards for composition in federal law, in part because the substance isn’t part of any FDA-approved drug and officials have expressed alarm at how widespread it is.

The FDA does not control compounded drugs and has not reviewed, approved, or tested the safety or efficacy of the semaglutide drugs offered by pharmacies. The compound semaglutide poses a higher risk to patients, as any compound drug would, a representative for the agency said.

There are many large compounding pharmacies out there that take care of patients every single day, said Betty Jones, senior compliance officer of accreditation and inspection programs at the National Association of Boards of Pharmacy. But there are some of those bad actors.

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In late April, the FDA sent a letter to the National Association of Boards of Pharmacy, saying the agency was aware that compounders might use saline forms of semaglutide. We are not aware of any basis for making a drug using these semaglutide salts that meet the requirements of federal law, the letter reads.

Functionally, when semaglutide sodium is dissolved in water, the sodium ion separates from the semaglutide molecule, leaving semaglutide and an extremely small amount of sodium, said Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding. But there’s no data to show whether semaglutide sodium is safe for consumers, or even if it’s effective, said Mary-Haston Vest, director of pharmacy systems with UNC Health.

In response to growing questions about the semaglutide compound, the North Carolina Board of Pharmacy issued a statement prohibiting compound pharmacies from using salt forms of semaglutide. The West Virginia Board of Pharmacy has issued its own warning on the matter. The Mississippi Board of Pharmacy also issued a similar notice, writing that drug makers have become aware of the practice of using semaglutide salts for compounding and may choose to initiate legal proceedings to combat this practice.

A Novo Nordisk representative said the company is taking action, including but not limited to issuing cease and desist letters, against entities that are engaging in the illegal sale of the compound semaglutide, spreading false advertising, and infringing on its trademarks.

It’s a scary area, said Dr. Andrew Kraftson, a clinical associate professor in the division of metabolism, endocrinology and diabetes in Michigan Medicine at the University of Michigan. And I think it’s only going to get thornier.

Compounding pharmacies are attempting to plug a crucial hole in the market, said Tenille Davis, a compounding pharmacist in Arizona. They’re not trying to make a million dollars doing this. They are trying to meet an intense and overwhelming patient and provider demand for this product.

There are some guardrails in place. Under federal law, compounding pharmacies can only combine pharmaceuticals with active ingredients that come from FDA-registered facilities, Brunner said. And the State Boards of Pharmacy license and inspect compound pharmacies; the FDA also inspects compound pharmacies it deems to pose a safety risk. Just because it’s not FDA-approved doesn’t automatically mean it’s unsafe, Brunner said.

But it’s not clear how pharmacies mixing vitamins or other additives with semaglutide might interact, and compounding pharmacies are largely making educated guesses about how safe these combinations are, said Robin Bogner, a professor in the School of Pharmacy at the US. ‘University of Connecticut and compound expert. While there are no known interactions, Dr. Vest said, that doesn’t necessarily mean there aren’t any interactions.

Ms. Davis didn’t seem to have a bad reaction to the medications she received, but she switched to a different source to get compound semaglutide: a weight-loss clinic that gets its medications from a local pharmacy. The clinic required blood tests, in-person appointments and stricter supervision than that provided by the doctor she found on TikTok, she said, measures that made her feel more comfortable than she was as a patient; even the clinic costs less. Both compound drugs seemed to work, she said.

Some websites sell what they claim to be semaglutide directly to consumers without a prescription, without supervision, just vials of the chemical, with the statement on the label that the semaglutide is intended for research use only. There’s a key difference between those sites and compound pharmacies, Mr. Brunner said. The National Association of Boards of Pharmacy maintains a list of websites that sell fraudulent and unsafe drugs, and patients should consider cross-checking to ensure they aren’t receiving semaglutide through one of those channels, said Bill Cover, associate executive director of the state pharmacy affairs at the National Association of Boards of Pharmacy. And beware of telehealth services that offer compound semaglutide without a prescription or any input from a licensed physician, Cover added. If it’s too good to be true, it could potentially be a big red flag, he said.

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