Although glucagon-like peptide-1 (GLP-1) agonists for diabetes and weight loss remain in short supply, some doctors have turned to compounding pharmacies to fill prescriptions. Still, news reports and social media posts have referred to the combination products as “knockoffs” and “fakes” and linked them to illegal products.
Meanwhile, Novo Nordisk and Eli Lilly, the makers of semaglutide and tircepatide, have filed multiple lawsuits against compounding pharmacies alleging variousviostiveaaaclaimsÂ¡¦claimsÂ¡¨claimsÂ¨claimsÂ¨claims-claims-of-marketing-for-produce-lawsuits-lawsuits-lawsuits against Novo Nordisk and Eli Lilly, the makers of semaglutide.
Compounding pharmacies are pushing back. According to the industry, it is mixed with unregulated companies that sell the so-called semaglutide and tircepatide, active ingredients in diabetes and weight-loss drugs.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), said misunderstandings about the field can make doctors reluctant to prescribe compounding even when a patient could benefit from an adjusted dose or when an essential drug is in short supply. In the case of GLP-1 agonists.
“These websites are selling directly to the patient without a prescription, and they’re telling the patient, ‘Hey, this is semaglutide.’ the buyer cannot be sure what he is buying. “It is absolutely natural stuff. But it’s not a pharmacy, and it’s not messed up.”
The US Food and Drug Administration allows compounding pharmacies, which are typically tasked with making custom formulations, to produce “substantially a copy of a commercially available drug” when the drug is in short supply.
The APC, which represents about 130 facilities, issued a statement in October to correct “mistakes and errors” it says have appeared in media stories and communications from state pharmacy boards.
APC also said scammers posing as legitimate compounding pharmacies can contribute to perceptions that compounds are unsafe. It recently alerted FDA regulators to a flyer promoting “GLP-1 mimickers” by a company falsely claiming to be an authorized manufacturer of the compound.
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The APC’s concern is not unfounded: some doctors said they would not prescribe combined GLP-1 drugs because they were unsure about the ingredients and safety.
Fatima Cody Stanford, MD, MPH, MPA, an obesity expert at Massachusetts General Hospital and Harvard Medical School, said. Medscape Medical Newshe “doesn’t consider compounding,” even though some of his patients wait months to receive their first doses of branded GLP-1 drugs.
“I don’t have data to support a combination medication,” Stanford said. Without the ability to show his patients the data from clinical trials that go up for FDA approval, he said, “I don’t use it.”
Stanford said he often prescribes older drugs that are commercially available, such as phentermine-topiramate or naltrexone-bupropion combinations, while a patient waits for a GLP-1 product. That way, he said, his patients “aren’t just sitting there, not on top of anything.”
According to the FDA, compounded drugs pose a greater risk of contamination and dosing errors than commercially available drugs because compounded versions do not undergo premarket safety, efficacy or quality review. Compounding pharmacies order the same active ingredients found in an FDA-approved drug and manufacture them on-site, usually in much smaller batches to order.
Advocates of the combination acknowledge that prescribers should choose a commercially available drug if possible, but resist the idea that combination drugs are inherently dangerous. According to Brunner, compounding pharmacies operate within a strict compliance framework.
For semaglutide, data from the manufacturer’s clinical trials provide “reasonable confidence support [active ingredient] in the combined preparation,” Brunner said.
The extent of safety problems with compounded GLP-1 drugs is unclear, according to the FDA. In May, the FDA warned that it had received reports of adverse reactions related to the use of the combined semaglutide. It also cited reports of compounds that used a different active ingredient than the commercially available drug.
Agency spokesman Charles Kohler told Medscape that as of Oct. 27, the agency had received more than 95 reports of adverse events related to compounded semaglutide.
“Although many of the events appear to be consistent with certain adverse events included in the labeling of FDA-approved semaglutide products, the FDA is unable to determine how or if other factors, such as differences in ingredients and composition between the FDA-approved and compounded semaglutide products, may have makes an impact,” Kohler said.
Compounding pharmacies that dispense bulk orders to facilities such as hospitals must report “serious and unexpected” adverse events to the FDA, but community pharmacies that fill prescriptions for individual patients do not have the same rule.
Kohler said the FDA’s “ability to draw conclusions about safety concerns” is limited by the variable quality and low volume of reports.
Ultimately, individual clinicians must decide whether they want to prescribe a compounded drug, said Rita Jew, PharmD, MBA, president of the nonprofit Institute for Safe Medication Practices. Medscape Medical News. Compounding pharmacies tend to use less automation, which can increase the potential for potency or contamination errors, including sterilization failures, according to Jew. In addition, he noted that states have varying degrees of regulatory oversight.
As with any procedure, “the doctor has to balance the risk and the benefit” when prescribing drug combinations, Jew said.
A blessing for patients
Despite widespread reluctance to use combination drugs, some doctors say these versions are a boon for patients, who pay about a third of what they would for brand-name products, which cost $900 to $1,350 for a four-week supply. Insurance companies often do not pay for medicines.
The compound allows doctors to precisely tailor doses to minimize side effects and control the rate of weight loss, said David Wertheimer, MD, a cardiologist and internist at the Wertheimer Center for Functional Medicine in Franklin Lakes, New Jersey. Medscape.
Wertheimer said he has prescribed the blended weight-loss pills to more than 50 of his patients, many of whom have found the versions “incredibly effective.” He said he trusts his local pharmacy, which he has worked with for years.
“The one I use is accredited. It’s a state-regulated facility, and they’re very particular about what they do,” including sending a sample of each batch of semaglutide to an independent lab to ensure purity and accuracy of the formula, he said. .
Wertheimer said he dreads the day the shortage ends.
“You just hope that if the compound manufacturers are stopped from doing this, there will be a cost-effective alternative for people,” he said.
Manufacturers are already trying to curb alloying to some extent. Last month, Novo Nordisk sued two compounding pharmacies in Florida, alleging the facilities sold products with impurities and false potency.
For doctors who want to prescribe combination drugs, experts suggested several steps to check the pharmacy and its products:
- For a community pharmacy that dispenses individual prescriptions, check the state board of pharmacy website to verify that it is licensed in the state where the patient lives and has a clean disciplinary record.
- For an outsourcing facility that distributes bulk products, check its FDA registration and inspection records.
- Request a facility tour.
- Check to see if the company is accredited by the Pharmacy Compounding Accreditation Board based on adherence to United States Pharmacopoeia (USP) quality and safety standards.
- Ask where the ingredients are sourced and if they meet USP requirements. Ask for a certificate of analysis to check the active ingredient of the medicine.
- Ask for documents that the medicine has been tested for potency and sterility.
Wertheimer recommends dialogue with compounding pharmacies, both to get clinical advice and to instill confidence in the quality of the surgery.
“As in all areas of medicine, there are ethical players and people who don’t play by the rules,” he said.
Brunner, Jew, Kohler, and Wertheimer reported no relevant financial relationships. Stanford accepted payments for consulting, travel and lodging, and food and beverage from Novo Nordisk and Eli Lilly. Open Payments.
Mary Chris Jaklevic is a healthcare reporter in the Midwest.
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