After new regulations made a prior strategy for preventing endophthalmitis impractical, one center adopted the practice of prescribing topical azithromycin drops before intraocular surgery.
Many ophthalmologists operate in freestanding ambulatory surgical centers otherwise known as ASCs. For the purposes of this article and current legislation, ASCs include any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. The Centers for Medicare and Medicaid Services made changes to the conditions for coverage at ASCs more than a year ago. However, most ophthalmic practices are still learning how to adopt them. New guidelines cover a variety of areas such as quality assurance, patients’ rights, and anesthetic risk and evaluation. Two areas we found that affected our office the most were the addition of infection control guidelines and the revision of the administration of drugs as conditions for coverage.
New infection control guidelines instruct that the ASC must designate, in writing, a qualified licensed health care professional who will lead the facility’s infection control program. The ASC must determine that the individual has had training in the principles and methods of infection control. This individual must maintain his/her qualifications through ongoing education and training. This has resulted in numerous educational courses being developed to better explain the guidelines and train these infection control officers.
This designated leader for the ASCs infection control program is charged with a number of responsibilities including but not limited to monitoring hand-washing habits, exposed hair and jewelry in the operating room, as well as administering and mixing medications and other infusions. New guidelines also dictate anything labeled for single patient use must be used on only one patient. This includes medications, bags of fluid, syringes, needles, etc.
Several additions were made to the guidelines for mixing and administering drugs that resulted in significant changes in our practice. Most important are provisions that single-use vials of medication are used for only one patient and that compounding of medications can only take place in a designated compounding pharmacy. Previously, we would premix our anterior chamber injection each morning, giving all of our patients a mixture of BSS Plus (Alcon), amikacin and vancomycin. This is against the new regulations because the original bottles were labeled as single-use and because we are not a compounding facility. Since the compounding pharmacy labels this mixture as good for only 4 hours, we were going to have to make at least two trips to the compounding pharmacy each day. This would be inconvenient and significantly more expensive. We decided to try a different approach that would still ensure that our patients were at minimal risk for developing endophthalmitis.
We decided to prescribe topical azithromycin drops (AzaSite, Inspire Pharmaceuticals) 1 week before intraocular surgery. There were several reasons for making this decision. AzaSite sterilizes the tear film and lashes preoperatively by eradicating up to 90% of the most common pathogens on the ocular surface. Because of azithromycin’s unique ability to penetrate the tissues, it maintains therapeutic concentrations for at least 5 days after the last dose. It has also proven to be of benefit in patients with blepharitis and meibomian gland dysfunction. Many patients undergoing intraocular surgery have one or more types of ocular surface disease, so using an agent that helps these conditions is definitely a benefit. Using this approach, I have frequently found that the tear film and the cornea are clearer intraoperatively, and many patients have less postop keratitis.
This allows us to comply with the guidelines prohibiting making preoperative mixtures or using single-use medications for more than one patient, and this is now our procedure with almost all of our patients. Since azithromycin is concentrated in the tissues and does not penetrate the anterior chamber, on the day of surgery we use a fluoroquinolone drop every two hours and decrease it to three times daily on the first postop day. We continue it for 13 days, which covers the peak time periods for the development of postoperative endophthalmitis. Many patients are able to use one bottle of azithromycin and one to one-and-a-half bottles of fluoroquinolone for two eye surgeries. Of course, if they are uncomfortable using the same bottle for both eyes, we prescribe new bottles.
Another side benefit of our new approach is financial. It has saved the patients and the ASC money. Guidelines also specify that a survey team will come to the ASC at least once per year and follow at least one procedure from start to finish to ensure compliance with all regulations. It is very important to fulfill all guidelines and be prepared. One violation of using a single-dose labeled medication for more than one patient could shut you down. Many facilities have found these new inspections to be much more difficult to pass than previous inspections. While the changes have been plentiful for physicians and staff, most patients will only notice a small increase in paperwork. We are doing everything possible to keep their experience comfortable and safe with an excellent outcome.