Compounding pharmacies have been within the information quite a bit currently, due to reviews of a few of them advertising and marketing and promoting in-demand weight reduction medicine resembling semaglutide (Wegovy). However whereas there are some conditions in which you’ll want to show to a compounding pharmacy, you must do some cautious analysis earlier than you employ one, advises Dr. Robert Shmerling, Senior School Editor at Harvard Well being Publishing. Here is what it’s essential know.
What’s a compounding pharmacy?
The definition of a compounding pharmacy is broad. “Any pharmacy that gives medicines that aren’t commercially out there and prepares them onsite to fulfill your particular wants is a compounding pharmacy,” explains Dr. Shmerling. It is estimated that compounded medicines symbolize as much as 3% of all pharmaceutical prescriptions.
In accordance with the American Pharmacists Affiliation, there are about 56,000 community-based or retail pharmacies in the USA. Of those, about 7,500 are compounding pharmacies.
When may you want a compounding pharmacy?
There are just a few totally different explanation why somebody might have a compounding pharmacy. Among the most typical embody:
- a person requires a sure power or dosage that’s not commercially out there
- a person requires a special type of the treatment (for instance, an individual who can not swallow a tablet could require a pharmacy to supply the drug as a liquid)
- the necessity to take away allergens resembling lactose or gluten
- to supply a flavored treatment for a kid.
One other time you might require a compounding pharmacy is when there are drug shortages, notes Dr. Shmerling. Lately, for instance, shortages of in style weight reduction medicine resembling tirzepatide (Zepbound) and semaglutide led individuals to compounding pharmacies. Compounding pharmacies can get entry to chemical compounds immediately from the drug producer and blend the treatment themselves.
What are the dangers of utilizing a compounding pharmacy?
Whereas compounded medicine are at all times presupposed to include FDA-approved components, the formulations as ready at compounding pharmacies aren’t reviewed by the FDA for purity, security, or effectiveness. Because of this, there’s an opportunity that you could be not be getting the drug that you simply assume you might be, stresses Dr. Shmerling.
In 2023, for instance, the FDA acquired reviews that some compounders had been utilizing salt types of the diabetes and weight reduction drug semaglutide, resembling semaglutide sodium and semaglutide acetate. However these components aren’t FDA-approved, and there is not any proof that they’re secure or efficient.
Dosing will also be much less dependable with compounded medicine. FDA-approved injectable semaglutide merchandise, for instance, are solely out there in pre-filled pens, so it is more durable for well being care suppliers or sufferers themselves to make errors. However compounding pharmacies could load the pens with treatment themselves, or count on sufferers to take action. The FDA has acquired reviews of well being suppliers calculating an incorrect dose, or sufferers giving themselves an incorrect dose. This may result in doubtlessly critical unintended effects like nausea, vomiting, headache, or acute pancreatitis. Some individuals have even wanted to be hospitalized.
“The compounding pharmacy could not give sufferers sufficient instruction. There are reviews of sufferers mistakenly giving themselves 20 occasions the suitable dose,” says Dr. Shmerling.
Since compounding pharmacies themselves aren’t FDA-regulated, there’s additionally a better danger of drug contamination. That is what occurred in 2012, when sufferers developed fungal meningitis after receiving contaminated spinal injections of a compounded product. Virtually 800 individuals acquired sick, and 64 died.
For all of those causes, says Dr. Shmerling, it is best to make use of a compounding pharmacy solely when actually essential — that’s, whenever you want a medicine that’s not commercially out there by an everyday pharmacy.
Is it potential to know if compounded medicine are secure and potent?
Not at all times. “There’s loads of purchaser beware on the subject of compounded pharmacies,” says Dr. Shmerling. In contrast to the medicine you buy at a neighborhood pharmacy, compounded medicine aren’t FDA-approved. This implies there is not any simple option to know for positive how secure and efficient they’re.
You do, nonetheless, have some safety. All compounded pharmacies have to be licensed and controlled by their state’s pharmacy board. And the Drug Enforcement Administration (DEA) oversees any managed substances, resembling hydrocodone and amphetamines, which are put into compounded medicine.
Compounding pharmacies should additionally comply with guidelines set out by US Pharmacopeia (USP). That is an impartial nonprofit group that works with the FDA to set high quality requirements for medicines.
Figuring out a authentic compounding pharmacy
It may be tough to determine a authentic compounding pharmacy, says Dr. Shmerling. Your physician could already use a compounding pharmacy with different sufferers and might be able to refer you to at least one they know is dependable. However different occasions, they could not know.
Yow will discover compounding pharmacies close to you on the Alliance for Pharmacy Compounding web site. When evaluating a compounding pharmacy, listed below are some inquiries to ask:
- Are you licensed to dispense or ship to my state?
- What coaching do your pharmacists have? (Ideally, you desire a pharmacy the place the pharmacists are board-certified sterile compounding pharmacists, or BCSCPs.)
- Does a third-party lab take a look at your compounded medicines?
- What different accreditation does your pharmacy have? (Ideally, your pharmacy will probably be accredited by the Pharmacy Compounding Accreditation Board (PCAB), which is taken into account the gold normal for compounding pharmacies.)
You also needs to be cautious of shopping for compounded medicine on-line, whether or not it is by an internet pharmacy or a telehealth platform. This has change into a very in style possibility for weight reduction medicine. In accordance with the FDA, when shopping for medicine on-line, you might not know whether or not the drug was produced by a compounder whose medicine meet applicable high quality requirements, or whether or not the compounder is appropriately licensced and controlled.
