Cataracts. Glaucoma. Macular degeneration. These are just a few of the many diseases and conditions that ophthalmologists battle every day. But they’re not the only foes. Rising drug prices, complex health insurance rules and patient compliance issues make their fight all the more challenging.

Fortunately, compounded medications are gaining a reputation as effective weapons against all of these opponents.

“There has been a lot more conversion to using compounded medications, especially during the perioperative and postoperative periods around cataract surgery,” says Jennifer Loh, MD, of Loh Ophthalmology in Miami. “As I’ve talked with colleagues across the country and in other practices, it seems that a lot of practices are switching to this option.”

Like Dr. Loh, Damien F. Goldberg, MD, of Wolstan and Goldberg Eye Associates in Torrance, Calif., agrees that more practices are adopting compounded medications as another option.

“I do think compounded medication use is growing,” says Dr. Goldberg, MD. “New barriers and new challenges have formed that have made the traditional [patient management] more difficult than it’s ever been and more confusing than it’s ever been.”

REASONS TO COMPOUND

There are many circumstances under which it is appropriate to consider using compounded medications. For instance, the patient may require a limited dosage strength or one not available in a commercially available drug. They may need a replacement for their regular drug due to a supply shortage, or they may need a different form, such as a liquid instead of a pill. They may even have allergies to dyes or other ingredients in the drug.

To be clear, unlike preformulated and branded drugs, compounded medications are neither regulated nor approved by the FDA specifically for ophthalmic conditions. However, the individual ingredients that compose them are approved by the FDA, and compounding pharmacies may be regulated by the FDA (see below).

Using compounded medications to treat patients, says Dr. Loh, is analogous to treating them with an off-label drug. She cites as an example the use of preparations containing moxifloxacin topical drops to help prevent endophthalmitis in the perioperative period.

“There’s actually no FDA-approved antibiotic for use in cataract surgery,” she says. “If you look at any antibiotic ophthalmic drop, it’s typically indicated for conjunctivitis, so we’re already using things off label. If I prescribe moxifloxacin for cataract surgery, which is an FDA-approved product sitting on a pharmacy shelf, it’s not approved for the way I’m using it, but it’s still effective for that use.”

Dr. Goldberg, who uses Pred-Moxi-Brom primarily for perioperative patient care, indicates he even uses the medication in complicated cataract cases, such as in diabetic patients who might have a high rate of developing cystoid macular edema.

GETTING PRACTICAL

There are other practical benefits to using compounded drugs. For example, conditions and procedures such as glaucoma or cataract surgery require treatment with multiple drop-based medications. This can be difficult for older patients who may live alone and/or have conditions such as Parkinson’s disease that make it challenging to take care of themselves, much less adhere to complicated medication regimens.

“When we don’t use compounded medications, the patients are often faced with using two or three different bottles of eyedrops, each with their own schedule,” says Dr. Loh. “Even when we write down the instructions, it still leads to confusion. I’ve had patients come in with the bottle in the wrong box, and they’re using the wrong bottle for the wrong dosing regimen. It’s just adding an overall burden to the patients and their caretakers.”

“Some patients may be using as many as nine to 12 eyedrops a day,” adds Dr. Goldberg, noting that compounding enables all three drugs in Pred-Moxi-Brom, for example, to be combined in one bottle and taken just two or three times a day.

Dr. Goldberg says that some of the administrative burden associated with obtaining health insurance prior authorizations, callbacks and other time-consuming tasks can be relieved by using compounded medications. In addition, payers are increasingly imposing stiff requirements on branded medication use or stopped covering them altogether.

“It’s a no-brainer,” Dr. Goldberg says. “When you’re using three or more medications, you have to worry about things like surface toxicity, issues of compliance, prior authorization and the costs of each one.”

AN INEXPENSIVE OPTION

Lower cost is indeed another important benefit to using compounded medications. For example, to treat wet AMD, diabetic macular edema (DME) and other serious eye diseases, Avastin is an inexpensive alternative at less than $100 per dose compared to some other branded medications.¹ Avastin was actually approved by the FDA in 2004 to treat colon cancer but often is used off label to treat wet AMD, DME and neovascular glaucoma. Avastin is among the most commonly used compounded medications in ophthalmology.

“Oftentimes now with insurance coverage, many of these eyedrops may not be covered or they may have a significant copay,” says Dr. Loh. “When you multiply that by multiple drops, the price can really increase for patients, so providing them with a compounded formulation can really help them with costs.”

CONSIDER THE SOURCE

Accreditation

Aside from the considerable benefits to using compounded drugs, another important factor to consider is their source: the pharmacy that makes and supplies them. Among the choices for ophthalmologists are 503A- and 503B-accredited facilities.

Pharmacies with 503A accreditation are permitted to compound drugs only for specific patient cases. These facilities are regulated by state pharmacy boards; subject to U.S. Pharmacopeia (USP) standards such as 795 and 797; and are required to undergo state inspections and environmental monitoring based on USP standards.

Those with 503B accreditation, on the other hand, are permitted to compound drugs for either individual cases or in batches for use over time. These facilities are regulated by the FDA; required to meet Current Good Manufacturing Practices and some USP standards; report adverse events to the FDA; and undergo both FDA and state inspections. They must also perform environmental monitoring at every production shift change in primary compounding areas and weekly in secondary compounding areas.²

Selection criteria

Beyond meeting basic regulatory requirements, other characteristics such as customer service, price and specific patient needs should be considered when selecting a compounding pharmacy (See “Choosing a compounding pharmacy”). Dr. Goldberg says he puts a high value on customer service.

Dr. Loh also values convenience, variety and speed of delivery. In her view, it’s helpful when a pharmacy can deliver medications directly to patients, as sometimes they are not independent and may have to rely on caretakers to pick up medications for them. The availability of delivery reduces this burden.

“With many compounding pharmacies, you can prescribe for the patient directly and get it shipped to them or the office,” Dr. Loh says.

In addition, she notes that she uses a local compounding pharmacy to supply “very specific” topical compounded chemotherapeutic agents for cancers such as ocular surface squamous neoplasia. “I use them for things like that and fortified topical antibiotic drops.”

COMPOUNDING HELPS FIGHT THE BATTLES

Until they are cured, the pathologic eye conditions that ophthalmologists battle every day — and the costs and administrative burdens that go along with them — are here to stay. Taking advantage of compounded medications can go far in helping to fight both battles.

“If you want to make your life easier, create less hassle for yourself and help your patients, it really is a good idea to adopt compounding,” concludes Dr. Goldberg. OM

REFERENCES

1. Schena LB. Expensive Drugs. American Academy of Ophthalmology. 2017. https://www.aao.org/eyenet/article/expensive-drugs . Accessed Aug. 30, 2022.
2. U.S. Food and Drug Administration. FD&C Act provisions that apply to human drug compounding. www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding . Published August 13, 2021. Accessed Sept. 8, 2022.