While glucagon-like peptide-1(GLP-1)agonists for diabetes and weight loss remain in short supply, some clinicians are turning to compounding pharmacies to fill prescriptions. However, news reports and social media posts called the composite products “knockoffs” and “fakes” and lumped them in with banned products.
Meanwhile, Novo Nordisk and Eli Lilly, makers of semaglutide and tirzepatide, respectively, have filed several lawsuits against the pharmacy combine alleging various claims, including it violates the rules of marketing and manufacturing unauthorized products.
Compounding pharmacies are pushing back. The industry says it is confused by unregulated companies selling what it claims are semaglutide and tirzepatide, the active ingredients in blockbuster diabetes and weight-loss drugs.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), says that misconceptions about the industry can make clinicians reluctant to prescribe any compounded drug, even if a patient may benefit from a custom dose or when an important drug is lacking, as usual. the case with GLP-1 agonists.
“What these online sites are doing is selling directly to a patient without a prescription, and they’re telling the patient, ‘Hey, this is semaglutide.’ In some instances, it may often be marked ‘research grade,'” Brunner said, adding that unlike a compounded drug, a consumer cannot verify what they are buying. “It’s absolutely sketchy stuff. But that’s not pharmacy, and that’s not compounding.”
The US Food and Drug Administration allows compounding pharmacies, which are typically tasked with making custom formulations, to make a “master copy of a commercially available drug” when that drug is in short supply.
The APC, which represents about 130 facilities, issued a statement in October to correct “false statements and errors” it said appeared in media stories and communications from state pharmacy boards. .
APC also said that scammers posing as legitimate compounding pharmacies can contribute to perceptions that compounded drugs are unsafe. It recently alerted FDA regulators to a flyer advertising “GLP-1 mimickers” being faxed to doctor’s offices by a company falsely claiming to be an accredited compounder.
The APC’s concern is not unfounded: some clinicians say they do not prescribe compound GLP-1 drugs, citing uncertainty about ingredients and safety.
Fatima Cody Stanford, MD, MPH, MPA, an obesity specialist at Massachusetts General Hospital and Harvard Medical School, says Medscape Medical News“he wouldn’t consider the combination,” even though some of his patients are waiting months to receive their first doses of branded GLP-1 drugs.
“I don’t have any data to support compound medicine,” Stanford said. Unable to show his patients the clinical trial data that accompanied FDA approval, he said, “I’m not going to use it.”
Stanford said he often prescribes older commercially available drugs, 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 anything.”
According to the FDA, compounded drugs pose a greater risk of contamination and dosing errors than commercially available drugs because the compounded versions do not undergo premarket testing for safety, efficacy , or quality. Compounding pharmacies bulk-order the same active ingredients found in an FDA-approved drug and prepare them on site, often in smaller, made-to-order batches.
Compounding advocates recognize that prescribers should choose a commercially available drug if possible, but resist the idea that compounded drugs are inherently dangerous. Brunner said compounding pharmacies operate under a strict compliance framework.
For semaglutide, the manufacturer’s clinical trial data offer “some reasonable level of confidence to support the use of [active ingredient] in an integrated preparation,” said Brunner.
The extent of safety issues with the compounded GLP-1 drugs is unclear, according to the FDA, which in May warned that it had received reports of adverse events linked to compounded semaglutide. It also cites accounts of compounders using different active ingredients than those in the commercially available drug.
Charles Kohler, a spokesman for the agency, told Medscape that as of October 27, the agency had received more than 95 reports of adverse events related to the semaglutide compound.
“Although many of the events appear to be consistent with some of the adverse events included in the labeling for FDA-approved semaglutide products, the FDA cannot determine how or if other factors, such as of differences in ingredients and formulation between FDA-approved and compounded semaglutide products, may have contributed,” Kohler said.
Compounding pharmacies that dispense bulk orders to facilities such as hospitals are required to report “serious and unexpected” adverse events to the FDA, but community compounding pharmacies that fill prescriptions for in individual patients there is no same rule.
Kohler said the FDA’s “ability to draw conclusions about safety concerns,” is limited by the variable quality and low number 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 Jew said can increase the chance for potency or contamination errors, including lapses in sterilization. In addition, he noted that states have varying degrees of regulatory oversight.
As with any intervention, “the doctor has to balance the risk versus the benefit,” when prescribing a combination drug, Jew said.
A Blessing for Patients
Despite widespread skepticism about compounded drugs, some clinicians say these versions are a boon for patients, paying about one-third of what they would for branded product, which runs $900 to $1350 for a four-week supply. Insurers often do not pay for drugs.
Using a compounder 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. Medicine in Franklin Lakes, New Jersey. Medscape.
Wertheimer said he has prescribed the weight-loss compounds to more than 50 of his patients, many of whom have found the versions to be “incredibly effective.” He said he has confidence in his local compounding pharmacy, which he has worked with for many years.
“The one I use is accredited. It’s a state-regulated facility, and they’re very fast in the work they do,” including sending a sample of each batch of semaglutide to an independent lab to ensure the formula’s purity and accuracy, he said.
Wertheimer said he dreads the day the shortages end.
“You just hope that if the compounders stop doing it, that there will be a cost-effective alternative for people,” he said.
To an extent, manufacturers are already trying to prevent compounding. Last month, Novo Nordisk sued two compounding pharmacies in Florida, alleging the facilities sold products with impurities and incorrect strengths.
Reviewing a Pharmacy
For clinicians who want to prescribe compounded drugs, experts suggest several steps for evaluating a pharmacy and its products:
- For a community pharmacy that dispenses individual prescriptions, verify on the state board of pharmacy website 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 tour of the facility.
- Check if the company is accredited by the Pharmacy Compounding Accreditation Board, which is based on compliance with quality and safety standards set by the United States Pharmacopeia (USP).
- Ask where the ingredients are sourced and if they meet USP requirements. Ask for a certificate of analysis to verify the active ingredient of a medicine.
- Ask for documentation that the drug has undergone potency and sterility testing.
Wertheimer recommends maintaining a dialogue with compounding pharmacists for both clinical advice and to provide confidence in the quality of the operation.
“As in any area of medicine, there are ethical players and there are people who don’t play by the rules,” he said.
Brunner, Jew, Kohler, and Wertheimer report no relevant financial relationships. Stanford has received payments for consulting, travel and lodging, and food and beverage from Novo Nordisk and Eli Lilly, according to Open Payments.
Mary Chris Jaklevic is a healthcare journalist in the Midwest.
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