Within the mad rush to shed pounds, prescriptions for semaglutide drugs like Ozempic, Wegovy and Mounjaro have skyrocketed.
Manufacturers have struggled to maintain pace with the overwhelming demand — which has paved the best way for compounding pharmacies to step in.
Compounding pharmacies are drugmakers that mix, mix or alter ingredients to create medication that’s tailored to a person patient.
They could, for instance, make a drug for a baby who’s allergic to a certain dye and desires a medicine without it.
Though they perform a vital service, these pharmacies exist in a state of regulatory limbo with lax or conflicting oversight, and their history is riddled with errors — some deadly.
And now, reports are surfacing of Ozempic and other semaglutide drugs made by compounders causing severe or life-threatening overdoses in unsuspecting patients.
“We’ve gotten calls about several of those cases,” Jimmy Leonard, director of clinical services on the Maryland Poison Center on the University of Maryland School of Pharmacy, recently told WebMD. “We’ve had people give themselves tenfold overdoses right off the bat. Boy, were they sick.”
Compounding pharmacy problems
In 2012, a compounding pharmacy in Massachusetts shipped drugs contaminated with a fungus throughout the US — the drugs were injected into patients’ spines and joints.
Greater than 750 people in 20 states developed severe fungal infections consequently, and 64 people died from the injections.
Drug safety researchers from Pew found 73 compounding errors or potential errors linked to greater than 1,562 adversarial events, including at the very least 116 deaths, from 2001 to 2019.
Pew researchers also reported that only 30% of states require compounding pharmacies to report serious adversarial events, so the actual tally of deaths and adversarial effects might be much higher.
Generally, state boards of pharmacy are liable for the day-to-day oversight of state-licensed pharmacies.
Only compounding pharmacies that register with the Food and Drug Administration as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act are overseen and inspected by the FDA.
And on the occasions that the FDA inspects a compounding pharmacy, it could possibly find very disturbing conditions.
The FDA reports that it “has observed troubling conditions during a lot of its inspections of compounding facilities, including toaster ovens used for sterilization, pet beds near sterile compounding areas, and operators handling sterile drug products with exposed skin, which sheds particles and bacteria.”
Shortage of semaglutide drugs
The present shortage of semaglutide and plenty of other drugs has been a windfall for compounding pharmacies.
Earlier this 12 months, the University of Utah Drug Information Service reported greater than 300 energetic drug shortages.
Drugs comparable to Adderall, cancer drugs like carboplatin and cisplatin, anesthetics including lidocaine and ketamine, and antibiotics like amoxicillin are in desperately short supply for hospitals and other medical facilities.
But as compounding pharmacies produce drugs like semaglutide, they’re often allotting their versions in a liquid vial and an insulin syringe as an alternative of a pen, which makes calculating a correct dosage difficult for patients.
Furthermore, the FDA is warning people who the ingredient in compounding pharmacies’ so-called “semaglutide” won’t even be semaglutide, but knockoff salt forms comparable to semaglutide sodium or semaglutide acetate.
These counterfeit salt types of semaglutide have never been shown to be secure or effective, and the FDA has not tested or approved them to be used.
Just last month, the Journal of the American Pharmacists Association reported three cases of semaglutide overdoses, two from compounding pharmacies and one from an aesthetic spa.
Two patients self-administered 10 times the beneficial dose, leading to nausea, vomiting and abdominal pain that lasted for several days.
Tips on how to spot fake Ozempic
In June, Ozempic maker Novo Nordisk alerted the general public that “a counterfeit Ozempic (semaglutide injection) pen was present in the US.”
The phony product “was reportedly purchased at a retail pharmacy and the corporate is actively investigating the report and collaborating with the FDA to discover the origin and distribution of the counterfeit pen.”
The drugmaker also offered tricks to inform consumers of the differences between the actual product and fakes. Real Ozempic pens:
- Don’t extend or increase in length when setting the dose
- Can be found in three doses: 0.25/0.5-milligram pen, 1-milligram pen, or 2-milligram pen
- Are available in a box that features 4 needles that directly attach to the pen, except the 0.25/0.5-milligram dose, which comes with six needles
- Only show the intended dose when dialed up from 0
Real Wegovy pens:
- Can be found only as fixed-dose auto-injectors and should not have a push button to manage the medication
- There is no such thing as a choice to set a dose or increase the length of the pen. Somewhat, pens can be found in 0.25 milligram, 0.5 milligram, 1 milligram, 1.7 milligram and a couple of.4 milligram dosages
Counterfeit products may be identified in the next ways:
- The label on a counterfeit pen may very well be of poor quality and should not adhere well to the pen
- A counterfeit carton can have spelling mistakes or typos on the front of the box
- A counterfeit carton may not include the tamper-resistant perforation
- The batch number printed on a counterfeit box may not correspond to the product strength stated on the identical box and pen