Surgeons consider compounded vs. branded drops after cataract surgery
Click Here to Manage Email Alerts
Welcome to another edition of CEDARS/ASPENS Debates. CEDARS/ASPENS is a society of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.
This month, William F. Wiley, MD, discusses the merits of using compounded drops after cataract surgery, while Ehsan Sadri, MD, tells us why he uses branded drops. We hope you enjoy the discussion.
Kenneth A. Beckman, MD, FACS
OSN CEDARS/ASPENS Debates Editor
Compounded drops
When I first started doing cataract surgery 20 years ago, patients had more options when it came to branded drops.
In those cases, prescribers regularly used two drops that were manufactured by the same company. That gave providers the option of prescribing one drop while offering the other as a “free sample” from the manufacturer. Patients who underwent cataract surgery would have to buy only one drop, and that drop was covered by insurance. Coverage was much better back then, and out-of-pocket costs were often less than $20 per patient.
Fast forward over the years, and prescription drugs have gotten more complicated and more expensive, as we have added a third drop into the mix, an NSAID. There is also much less sampling available, while insurance coverage has become much less broad. Prescription costs for patients have gone from $20 to potentially more than $600, which surpasses Medicare reimbursement for the actual surgery, which is less than $600. In the last 2 decades, pricing has become unsustainable, and many patients cannot afford medications, thus preventing them from undergoing safe cataract surgery.
With that in mind, compounding pharmacies saw an opportunity to put the steroid, antibiotic and NSAID all in one bottle. This dramatically simplified the postoperative drop regimen by reducing the frequency of drops. Furthermore, it has reduced the postop regimen cost for patients to between $40 and $70. It is simpler to administer and makes compliance more reliable.
Compounding medications should not be confused with generic medications as compounding medications are made from known sources in known facilities as opposed to generics, which many are made outside the country.
By working with a certified compounding pharmacy, known as a 503B pharmacy, compounded drops can be ordered in bulk and thus readily available to new patients on short notice, which makes the process easier for staff who will not have to worry about pharmacy callbacks, substitutions and or other challenges seen with branded distribution.
There are currently no branded antibiotics labeled for cataract surgery and no branded anti-inflammatories FDA approved for the prevention of cystoid macular edema. Thus, physicians must make an educated choice based on our collective clinical experience when choosing drops around the time of cataract surgery. The medications used in compounded drops have a proven track record and are well known to physicians. Compounded drops have been used in more than 1 million cataract surgeries over the past few years. I am happy to say that many of my friends and family members are among those millions of users who have benefited from the value compounded drops deliver.
When choosing compounding pharmacies, there are differences, and make sure you are choosing reputable sources with 503B designations as these pharmacies are regularly audited and inspected by the FDA.
- For more information:
- William F. Wiley, MD, can be reached at Cleveland Eye Clinic, 2740 Carnegie Ave., Cleveland, Ohio 44115; email: wiley@cle2020.com.
Branded drops
As ophthalmologists in premium channel surgery, we want the best outcomes. We spend a lot of time on the science and the process. We make lens calculations and conduct intraoperative aberrometry. It does not make sense to me to use a drop that we are not confident in. The trouble with compounded drops is that we do not know what kind of efficacy we are going to get with them.
These generic drops are produced outside of the United States, and there are no FDA regulations on them. They can use the moiety of our FDA-approved products. For those in biochemistry, we know that it is more than the active molecule that goes into the bottle. There are incipient medications or other substrates of medication in the bottle that affect the total efficacy and bioavailability of the drug inside the eye.
At the end of the day, the patient is our boss, and their outcomes are the most important thing. Why leave it to chance? I recommend branded drops for all of my patients. Cost can be a factor, but the cost of not getting the best results is also an issue. I am not saying all compounded medications are bad and should never be used. I am sure they work well in a subset of patients, but we do not have any data on that. I know that if my mother were the patient, I would not use a generic drug.
- For more information:
- Ehsan Sadri, MD, FACS, can be reached at Visionary Eye Institute, 361 Hospital Road, Suite 324, Newport Beach, CA 92663; email: esadrii@gmail.com.
Collapse
Click Here to Manage Email Alerts