Are pro­grams with com­pound­ed GLP-1s safe for your pop­u­la­tion?

Pa­tients who would ben­e­fit from a GLP-1 face sig­nif­i­cant chal­lenges when it comes to ac­cess. Short­ages have made it dif­fi­cult to get a pre­scrip­tion. And even when avail­able, the cost can be pro­hib­i­tive. It leaves pa­tients look­ing for an­swers.

When com­pa­nies pro­mote that they can de­liv­er weight loss drugs to your door in a mat­ter of days at a frac­tion of the cost, it’s easy to see the ap­peal. Com­pound­ed drugs make this pos­si­ble. But is this a safe op­tion for pa­tients?

Drug com­pound­ing is the process of com­bin­ing, mix­ing or chang­ing in­gre­di­ents to cre­ate a cus­tomized med­ica­tion. It’s noth­ing new, but it’s typ­i­cal­ly done based on an in­di­vid­ual pa­tient’s needs. For ex­am­ple, drug com­pound­ing can cre­ate a drug in liq­uid form for a pa­tient un­able to swal­low a pill or cap­sule.

Be­yond serv­ing an in­di­vid­ual pa­tient’s needs, drugs may be com­pound­ed when the ap­proved drug is on the FDA’s drug short­ages list. And it’s be­cause of this sit­u­a­tion with GLP-1s that has cre­at­ed a per­fect storm for com­pound­ed GLP-1s to take off.

When GLP-1s are on the short­ages list, com­pounders hur­ry to meet a mar­ket op­por­tu­ni­ty dri­ven by high de­mand, pri­or­i­tiz­ing near-term gains over long-term safe­ty and out­comes.

While there are some guardrails for man­u­fac­tur­ing com­pound­ed drugs, they’re not FDA-ap­proved. Sim­ply, this means the FDA does not ver­i­fy their safe­ty, ef­fec­tive­ness or qual­i­ty. This is some­thing pa­tients and providers re­ly on for the in­formed use of a med­ica­tion.

Good com­pounders—man­u­fac­tur­ers that are fol­low­ing the ap­pro­pri­ate rules and reg­u­la­tions—do ex­ist. But at the scale at which GLP-1 com­pound­ing is oc­cur­ring makes it im­pos­si­ble to ful­ly trust these com­pound­ed med­ica­tions are re­li­ably equiv­a­lent to the FDA-ap­proved ver­sions.

Be­cause many pa­tients pay cash for com­pound­ed drugs, it’s dif­fi­cult to iden­ti­ty un­safe sources. De­spite these track­ing chal­lenges, the FDA has al­ready doc­u­ment­ed mul­ti­ple con­cerns on com­pound­ed GLP-1s, in­clud­ing: com­pounders us­ing semaglu­tide “salts,” which are not the same as the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent; warn­ings about ad­verse events from over­dos­es; and the rise of coun­ter­feit semaglu­tide.

Then there is the ques­tion about the long-term avail­abil­i­ty of com­pound­ed GLP-1s. As of ear­ly Oc­to­ber 2024, semaglu­tide (Ozem­pic and We­govy) re­mained on the FDA’s short­age list while tirzepatide (Moun­jaro and Zep­bound) was of­fi­cial­ly re­moved (though lat­er be­ing re­con­sid­ered by the FDA). When patent ex­cep­tions no longer al­low for com­pound­ed drugs to be man­u­fac­tured, how will pa­tients tak­ing com­pound­ed drugs be af­fect­ed? When sup­ply is not an is­sue, the FDA is re­mind­ing com­pounders of re­stric­tions “on mak­ing copies of FDA-ap­proved drugs.”

At Teladoc Health, pa­tient safe­ty is a cor­ner­stone of our ap­proach. Pa­tients in our care will on­ly be pre­scribed brand­ed, FDA-ap­proved ver­sions of obe­si­ty med­ica­tions. We stand by this know­ing their man­u­fac­tur­ing process and fa­cil­i­ties are FDA-in­spect­ed and fol­low­ing the rec­om­men­da­tions from lead­ing or­ga­ni­za­tions, like the Obe­si­ty So­ci­ety, Obe­si­ty Ac­tion Coali­tion and Obe­si­ty Med­i­cine As­so­ci­a­tion.

Still, we ac­knowl­edge that bar­ri­ers to GLP-1s for obe­si­ty are too com­mon. Our providers are ded­i­cat­ed to em­pa­thet­i­cal­ly car­ing for pa­tients in a po­ten­tial­ly frus­trat­ing sit­u­a­tion.

Our providers work with mem­bers to ed­u­cate them on safe ap­proach­es to weight loss and the po­ten­tial risks of com­pound­ed GLP-1s. Be­cause our providers aren’t tied to one spe­cif­ic ther­a­py, they take a per­son­al­ized ap­proach work­ing with mem­bers to un­der­stand their mo­ti­va­tion. When pa­tients need a safe ap­proach as a tem­po­rary bridge be­cause of sup­ply chain is­sues, our providers look for al­ter­na­tive, safe an­ti-obe­si­ty med­ica­tions.

A re­cent STAT spe­cial re­port found that some vir­tu­al obe­si­ty care com­pa­nies re­ly on “white la­bel” med­ical net­works. These net­works fre­quent­ly fo­cus on pre­scrib­ing on­ly GLP-1s (in­clud­ing com­pound­ed ver­sions) and not a broad­er set of car­diometa­bol­ic or an­ti-obe­si­ty med­ica­tions. They may not have rig­or­ous pro­to­cols for the di­ag­no­sis, eval­u­a­tion, med­ica­tion ac­cess and fol­low-up re­quired for safe­ly and ef­fec­tive­ly treat­ing peo­ple on GLP-1s.

We pri­or­i­tize the time and at­ten­tion qual­i­ty obe­si­ty care de­serves. Our providers are part of the Teladoc Health Med­ical Group and com­mit­ted to clin­i­cal qual­i­ty. Teladoc Health providers in our weight man­age­ment pro­gram are fo­cused on safe, com­pas­sion­ate, lon­gi­tu­di­nal care.

Pa­tients de­serve safe and ef­fec­tive obe­si­ty care pro­grams, which should fo­cus on sup­port­ing lifestyle change and clin­i­cal­ly ap­pro­pri­ate pre­scrib­ing of FDA-ap­proved obe­si­ty med­ica­tions. There are ways that com­pound­ed GLP-1s can in­ter­fere with this ap­proach. While they may seem like a vi­able fix giv­en the cir­cum­stances, some ben­e­fits may be fleet­ing. The role of com­pound­ed GLP-1s in a safe, long-term weight and obe­si­ty care strat­e­gy may be lim­it­ed or ques­tion­able.

Learn more about Teladoc Health here.