Some doctors are embracing compounded versions of popular weight loss drugs

Some health care providers report that they are slowly gaining confidence in the prescription of compounded versions of the highly popular obesity medicines, Wegovy and Zepbound though there are still doubts regarding the ingredients used in compounding them. 
 
It has been common knowledge that, even with a prescription, the weight loss drugs can sometimes be rather difficult to obtain. They are expensive – a month’s supply can easily set you back over $1000 – and many of them are hard to find. 
 
While compounded formulations of Semaglutide (the active ingredient of Wegovy) and Tirzepatide (The active ingredient of Zepbound), are much cheaper and easily available most of the time. 
 
“Not only are physicians more OK with prescribing compounded GLP-1 medications, but they are also advocating for them,” said Dr. Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans referring the class of drug which encompasses Wegovy and Zepbound. 
 
The brand-name formulations of these drugs are currently in shortage but at the Duke Health’s Hillsborough Primary Care Center in North Carolina, the remaining providers have been issuing compounded forms. 
 
Leanne Owens, a physician assistant at the practice said she had compounded versions of the weight loss drugs for 10 of her patients after the state ceased to provide the brand-name versions for the state employees in April this year. 
 
At first, she claimed that she had never prescribed compounded weight loss medications and this made her fearful. But when she talked to a compounding pharmacist at Duke, she was comforted. 
 
“Is this truly the medication? And is the recipe the same recipe that’s being used by the commercial drug manufacturers?” Owens said to himself. “In terms of any new concept that may be under consideration for a patient, what we want is to make sure that we have investigated. ” 
 
Far from being on his own, Owens has had company: other members of the medical practice have also resorted to using compounded versions of weight loss drugs. 
 
What is compounding? 
 
It is taken for various reasons Compounded versions of drugs are used. A compounding pharmacy can turn a drug that is available in the tablet form into a liquid form for a patient who cannot swallow a pill, or it can prepare a form of a drug which does not include a specific colouring, for instance, if a patient has an allergy to it. 
 
Compounding also comes into play during drug shortages: The Food and Drug Administration permits compounded versions that are ‘‘worth saying are a copy of a CBE drug’’ under such circumstances as those. 
 
As of writing this report / conducting a search in the FDA drug shortage database semaglutide for weight loss has been in shortage since 2022. Tirzepatide, that was approved for weight loss in the U. S. only in November, began to be in shortage in April and is still in shortage according to the agency. 
 
At present, both drugs are still patented and Novo Nordisk and Lilly do not distribute their ingredients to other organizations leaving doubts as to what is being marketed to the public. 
 
A compounding pharmacist though usually sources his raw materials from other FDA registered facilities which in turn cannot directly source the ingredients from the manufacturers of drugs. 
 
These facilities can, in effect, recreate or make exact duplicates of the active ingredients on people’s demand, as the FDA says. However, as with generic drugs, the agency doesn’t assay or check the ingredients, but it is the role of the pharmacists. Doctors agree that it has to be prescribed from those compounding pharmacists whom the latter can rely on. They should visit doctors and obtain prescriptions and then go to state licensed pharmacies and get the medications. Patients should also desist from ordering drugs online or purchasing them from the med spas. 
 
Providers should also educate the patients on on how to measure doses accurately. In May this year, the FDA revealed that it had received information of patients overdosing on compounded semaglutide for which some were hospitalized. The dosing errors, the agency said, stemmed from patients’ ability to measure and administer to themselves the wrong amount of drugs and from healthcare organizations and healthcare providers who got it wrong in their calculations. 
 
Matthew Brown, the pharmacy manager at the Duke Compounding Facility speaking on behalf of the center acknowledged that the Duke University is compounding medication from state licensed pharmacies that have been given a clearance to compound medication. This facility gives compounding pharmacy services to the entire health system of the university and the Hillsborough Primary Care Center. 
 
Brown said that Duke only uses compounded versions of the weight loss medications in cases of scarcity. If the shortages are over, he will become prescriptive of the brand-name drugs once more, he said. 
 
Owens, the physician assistant said she believes that the compounded versions are the some, as patients are achieving weight loss. As for side effects, she said she hasn’t perceived a rise. 
 
Indications that a product is in short supply were that Elizabeth Kenly, 58, of Graham, North Carolina, had difficulty obtaining Wegovy and was instead prescribed tirzepatide by a doctor at the Hillsborough practice in March. As for the compounded drug regimen, she has shed 25 pounds since its commencement and wishes to shed another 25. 
 
“I was a bit apprehensive,” Kenly said smiling, “I asked, ‘What is a compounded medication?’” “After having spoken to my doctor, I felt very comfortable indeed. ” 
 
As for some others, there are just too many open questions 
 
Even as more doctors are now comfortable with the practice of prescribing the compounded weight loss drugs, Novo Nordisk and Eli Lilly are diametrically opposed to it. 
 
All have initiated several legal proceedings against compounding pharmacies, weight loss clinics and medical spas. The drugmakers that responded to the NBC News rightly pointed out that the drugs aren’t regulated like FDA-approved medicines because they are a risk to patients. 
 
A representative of Novo Nordisk referred to the compounding system as “not functioning as it was designed. ” 
 
“It is for passing that same message that Novo Nordisk will persevere in filing legal actions against compounding pharmacies and any other organizations who engage in ILLEGAL marketing and selling of unauthorized compounded ‘semaglutide’ drugs,” the spokesperson stated. 
 
Lilly’s spokeswoman, Antoinette Forbes said in a statement “Poison control centers, regulators and patient advocacy groups across the nation are sounding alarms over the use of compounded anti-obesity products. ” 
 
And many more doctors are still in doubt, too. 
 
“In theory, if you can do it perfectly, it can be a fairly reasonable product,” said Dr. Scott Isaacs, president-elect of the American Association of Clinical Endocrinology. “Yeah, perhaps there are more and more doctors prescribing it, but from an organisational & professional angle, there are more and more warning signals. ”

“It is maybe not everyone is doing it as well as Duke,” Isaacs said. 
 
Dr. Christopher McGowan, a Cary-based gastroenterologists who runs a clinic that specializes in weight loss, has also received countless reports from his patients about the use of compounded weight loss drugs. However, he said, he would be “very hesitant” to prescribe them himself. 
 
“Looking at some of the compounded versions of semaglutide and tirzepatide, there are still many uncertainties about the compounded versions of these drugs,” said McGowan. That means in an accredited pharmacy the actual compound is not monitored or regulated by the FDA and is not tested in any way.
Patients, therefore, have no way of knowing what they are get in terms of an equivalent to a brand-name drug. 
 
Dr Daniela Hurtado Andrade an endocrinologist at the Mayo clinic in Jacksonville Florida has also noted that she has been attending to patient who were already on compounded versions of the drugs. But when she does, she recommends different generic brand weight loss drugs like that of the phentermine and topiramate marketed under the brand name Qsymia, or the naltrexone and bupropion commercial named Contrave. 
 
“I noticed that people tend to be preoccupied with the idea that there are no other treatments for overweight and obesity, but the new injectable medications,” Andrade said. “There are other anti obesity medicines that are as equally effective and are not as costly. ”