As ASC physicians, nurses, or administrators, have you observed that medications topically applied during ophthalmic surgery, some of which could be used for postoperative care, were discarded at the conclusion of the case? Like many of us, including myself in Illinois, the answer is probably, “Yes.” But the remaining question is, “Why?”

This article, prompted by these experiences, will provide several reasons and remedies at the local, state, and national levels—whether at a hospital outpatient department (HOPD) ASC or a standalone ASC.

The Illinois Pharmacy Practice Act regulations (IPPA), like those in many other states, stipulate how medications should be distributed, tracked, counseled, and stored. A label meeting specific criteria is affixed to the topically applied, facility-provided medication by the dispensing pharmacist before the agent can be taken home. In other cases, medications are brought from an outside retail pharmacy for use in the OR with an expected return to the patient if allowed.

To determine how often these protocols are followed and to seek opinions of ophthalmologists, a statewide survey was distributed in 2019 to 700 ophthalmologists by the Illinois Society of Eye Physicians and Surgeons (ISEPS).¹ In settings where medications were either brought from an outside pharmacy or were ordered onsite, only 30% and 40%, respectively, indicated that their patients could take these agents home after surgery. Reasons cited included: lack of pharmacist time or logistical problems to counsel patients, medications are discarded, state or facility regulations, pharmacy not equipped to print labels, hospital and ASC protocols, and insufficient pharmacy staffing. Forty percent of the respondents noted potential adverse events for patients who were not able to receive medications directly from the operating room. Potential patient obstacles included: finances preventing patients from repurchasing and acquiring the same or similar agents, and transportation and support issues.

Importantly—and most disturbingly among this group of surgeons—was that quality of care issues were negatively impacted if postoperative acquisition of medications were not possible, such as increased postoperative infection and inflammation.

In a national survey of more than 1,300 cataract surgeons and nurses conducted by the American Society of Cataract and Refractive Surgery (ASCRS), findings mirrored the ISEPS survey, but also indicated an overwhelming support for using bottles of perioperative topical medications on multiple patients.² Most thought that OR medication waste was excessive and should be reduced.

Local and State Medical Society Resolutions

To help our patients and curb HOPD ASC waste, I authored a resolution to the Chicago Medical Society pertaining to pharmacy-dispensing facilities (“Topical Operating Room or Emergency Room Medications for Post-Discharge Patient Use”) that required the Chicago Medical Society and the Illinois State Medical Society (ISMS) to pursue legislation that would allow patients to take home unused topical medications for postsurgery healing. The resolution was adopted, thereby becoming policy for both societies.

In preparing the resolution, I contacted other subspecialties and found widespread agreement that the practice of discarding unused topical medications was a problematic issue in hospitals, often duplicating costs for patients when they need to repurchase the same medication postdischarge.

In February 2021, the resolution was introduced into the 102nd Illinois General Assembly as SB579 “Facility Provided Medications,” where it passed both chambers unanimously and is awaiting the governor’s signature.

Ultimately, the ISMS sent a resolution to the American Medical Association (AMA), “Permitting the Dispensing of Stock Medications for Post-Discharge Patient Use and the Safe Use of Multidose Medications for Multiple Patients,” intended for introduction at the AMA House of Delegates meeting in November 2021. The resolution is endorsed by the American Academy of Ophthalmology (AAO), the ASCRS, the American Glaucoma Society, the American College of Physicians, the American Academy of Pediatrics, and the Multispecialty Consortium on Climate and Health (31 specialties, including the AAO and ASCRS) to name a few.

Legislative Bill for ASCs With a Dispensing Pharmacy

Briefly, SB579 amends the Illinois Hospital Act, the Ambulatory Surgical Treatment Center Act, the Hospital Licensing Act, and the Pharmacy Practice Act. The Act—a collaboration of the ISMS, the Illinois Hospital Association, and the Illinois Council of Hospital Pharmacists—requires hospitals, facilities, and pharmacies to offer a patient any unused portion of a facility-provided medication upon discharge when it is administered to a patient at the HOPD ASC facility and is required for continuing treatment. The medications would be ordered at least 24 hours in advance of surgery, would be properly labeled and tracked, and the surgeons would provide the medication counseling.

The IPPA, in addition to surgical facility policies, may cause impediments to this practice. Hospitals and their pharmacies are often not staffed to implement the PPA as written.

For example, many hospital pharmacies are not equipped to label medications per the requirements of the PPA, or to counsel patients on medication usage. Changing the Acts was preferable to altering multiple existing facility policies.

Topical Medications After Discharge: Nondispensing ASCs

Whether you are an administrator, nurse, or physician, you are probably aware that medication labeling, counseling, order tracking, and storage concerns are complex and require a different approach compared with dispensing ASCs. In addition to familiarity with state regulations, including the possible need for a dispensing license (www.drugsupply.com ), it’s important to be aware of White and Brown Bag rules, the distinction between 503A and 503B compounded pharmaceuticals, product expiration dates, accreditation agency survey protocols, litigation protections, and the use of a Medicare Deemed facility.

“Brown Bagging” describes the practice of patients acquiring medications through their pharmacy benefit and bringing the drugs to the ASC to have them administered. Though potentially more affordable—and it relieves practices of the pressure to acquire and store the drugs—the physician ultimately responsible for administering these medications must determine that the patient (or their agent) is fully capable of safely handling and transporting the medication.³ Because reimbursement provided from Centers for Medicare and Medicaid Services covers all ASC-ordered medications bundled except pass-through drugs, and due to uncertainties of the product’s storage temperature and efficacy, Medicare Deemed facilities cannot accept brown bagged medications (per AAAHC and personal communication, Nikki Hurley, clinical director and OOSS board member). According to AAAHC, an exception could be made in backorder situations.

“White Bagging” refers to the distribution of patient-specific medication typically from a specialty pharmacy directly to the ASC. These often-compounded agents are provided from both a 503A patient-specific pharmacy and 503B bulk purchase from an FDA-registered outsourcing facility.

Stability studies for 503B (but not 503A) multidose and single-dose medications are required to establish an expiration date (per personal communication, John Saharek, president, ImprimisRx). Some compounding pharmacies, such as ImprimisRx, voluntarily perform 503A stability studies. If 503A medications are ordered, preplaced labels in accordance with state regulations are affixed to the patient’s single-use medication. If 503B medications are ordered, the facility divides the products into patient-specific quantities and then labels, records, and tracks the agent.

A potential source of waste occurs when surgeries are canceled and the products cannot be used. A dispensing license may be required in some states if physician-acquired products are sold to patients for post-discharge use, other-wise medications are purchased by patients from a retail pharmacy.

An example using 503A single-use medications acquired by the standalone ASC is as follows:

1. Order a mixture containing dilating, antibiotic, and anti-inflammatory drops from a compounding pharmacy to apply preoperatively.
2. Implant intracanalicular steroids and/or inject various single-use compounded combinations of intracameral antibiotic, steroids, ketorolac, and phenylephrine solutions with/without a subtenons steroid injection.

Multidose Medications

Of particular interest is the issue of allowing perioperative, multidose topical medications, such as dilating eye drops, antibiotics, and anti-inflammatories to be used on multiple patients. At the state level, creating an exception to single bottle per patient PPA requirements would be a first step if it’s not already in place. The next step, at the HOPD ASC or standalone ASC level, would be to receive authorization from risk management to minimize litigation potential. Acceptance by the Pharmacy and Therapeutics Committee or governing board would follow.

If approved, ASC administrators, creating a reference manual, would need to appropriately train the designated OR staff on what conditions mandate single-use eye drop bottles (conjunctivitis, immune-compromised patients, single-use-only drops, contamination), and supervise the proper instillation, care, tracking, billing, and expiration date monitoring of the eye drops. The nursing staff would have discretion to discard the bottle for any suspected contamination, and retraining is performed annually.

An example of a published, Joint Commission (TJC)-approved 28-day bottle expiration date protocol is provided by Jensen et al., indicating no infection rate increase with a per-procedure cost saving to both the facility ($331) and patient ($283).⁴

For systems with multiple ASC facilities, the situation becomes more administratively complex if compliance with the same protocol is required across the entire hospital network. Unfortunately, facility policy barriers may prevent multidosing.

A recent study conducted at the Aravind Eye Care System (ACES) in southern India in conjunction with the University of Michigan looked at potential bottle-tip contamination of in multi-use situations.⁵ The primary objective of the study was to evaluate for contamination between the bottle tip and the ocular surface or adnexa when trained assistants administer eye drops to patients. The assistants used multidose containers of eye drops in the perioperative setting. A total of 1,839 patients were videographically studied. The authors concluded that when ancillary staff is trained in the proper eye drop instillation technique, there was no contact with the patients’ ocular adnexa or microbial contamination of the dropper tip.

Additionally, no increased endophthalmitis rates were noted when converting from single to multidose eye drops in both another study at the ACES in more than 600,000 patients,⁶ and in personal communications with my colleagues at the Johns Hopkins Hospital (Oliver Schein, MD) and the Northern California Kaiser Permanente Health systems (Neal Shorstein, MD).

A study published by Tauber et al., investigated the financial cost of unused medications in cataract surgery.⁷ The study included four surgical sites in the northeastern United States. It found that unused quantities of surveyed drugs, mostly topical mydriatics and antibiotic drops and ointments, collectively averaged 45% by volume, with a mean of $148 per case.

Performing a cost analysis, the study found that the private ambulatory care center (the unit with the greatest volume) had the highest unused drug cost per case followed, sequentially, by the tertiary care center, federally run medical center, and HOPD center.

Considering that about 3.8 million cataract procedures are performed in the United States annually, the total cost of discarded medications potentially runs into the hundreds of millions of dollars. As most of you know, many medications come in 10 ml bottles holding about 200 drops of solution. On a typical day, we may only use three drops per bottle perioperatively and discard the rest. The waste is tremendous.

Nationally, the ASCRS OR Waste Task Force Surgical Pharmaceutical Waste subcommittee, which I co-chair with Alan Robin, MD, is looking further into the universal acceptance of a multidose eye drop protocol. An FDA position statement to our committee from Wiley Chambers, MD, director, Ophthalmology Division, endorsed the use and safety of preserved multidose eye drops up to the bottle’s expiration date if consistent with the product’s labeling and package insert.

Robert Campbell, PharmD, BCSP, director of Clinical Standards Inter-pretation Group and Medication Management at TJC, emailed our committee confirming that the 28-day expiration dating used for multidose injectable medications does not apply to topical agents, such as ophthalmic drops/ointments. The manufacturer’s package insert provides expiration dates for the particular product. CDC guidelines are similar.⁸

AAAHC emailed us that its Standards allow multidose eye drops, provided that the medication is labeled, handled per CDC guidelines, and administered and stored according to policies, manufacturer instructions, and best practice recommendations.

ASC staff must understand safe practice and apply infection-control techniques with rigor. Facilities are encouraged to consider mandatory training, competency, and monitoring programs to teach and validate safe eye drop handling.

As a precedent, the Surgical Eye Center of Morgantown, WV, successfully won an appeal to the Federal HHS allowing the facility to use multidose eye drops in agreement with position statements from the ASCRS, TJC, and the American Society of Ophthalmic Registered Nurses.⁹

Conclusion

Understanding facility policies and state/federal regulations—and educating staff accordingly—are the keys to strategically reducing ASC patient cost and waste while improving quality of care. Staying connected with other ASC managers, consultants, and professional organizations, such as OOSS, while abiding by accepted accreditation protocols will assure continued success.

In the future, the general adoption of intracameral and intracanalicular medications, the development of technologies such as multi-use medication sprays¹⁰ and medication-impregnated lens implants,¹¹ may obviate the need for complex labeling processes and simplify multidosing protocols. ■

REFERENCES

1. Palmer, D, Volpe, N, Hackett, N. Improving quality of care and reducing topical medication operating room waste. J Cataract Refract Surg. 2020;46:1200-1201.
2. Chang, D, Thiel, C. Survey of cataract surgeon’s and nurse’s attitudes toward operating room waste. J Cataract Refract Surg. 2020;46:933-940.
3. Hertzka RE; Reference Committee G. Report of the council on medical service: Medication “Brown Bagging.” Available at: https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/about-ama/councils/Council%20Reports/council-on-medical-service/a16-cms-report10.pdf . Last accessed July 8, 2021.
4. Jensen, M, Nahoopii, R, Johnson, B. Using multidose eyedrops in a health care setting. JAMA Ophthalmol. 2014:132:1476-1479.
5. Wu, A, Kumar, P, Stein, J, et al. A videographic evaluation of eye drop administration by ophthalmic technicians. Ophthalmology. 2021;128:796-797.
6. Haripriya, A, Chang, D, Ravindran, R. Endophthalmitis reduction with intracameral moxifloxacin prophylaxis: Analysis of 600,000 surgeries. Ophthalmology. 2017;124:768-775.
7. Tauber, J, Chinwuba, I, Kleyn, D, et al. Quantification of the cost and potential environmental effects of unused pharmaceutical products in cataract surgery. JAMA Ophthalmol. 2019;137:1156-1163.
8. CDC Guide to Infection Prevention. Available at https://www.cdc.gov/infectioncontrol/pdf/outpatient/guide.pdf . Last accessed June 9, 2021.
9. Powell, S, Corcoran, K. Multi-use eyedrops in the ASC—A review of dissenting opinions and prevailing practices. The Ophthalmic ASC. February, 2017;21-22,24.
10. Pasquale, L, Lin, S, Weinreb, R, et al. Latanoprost with high precision, piezo-print microdose delivery for IOP lowering: Clinical results of the PG21 study of 0.4 microgram daily microdose. Clin Ophthalmol. 2018;12:2451-2457.
11. Filipe, H, Bozukova, D, Pimenta, A, et al. Moxofloxacin-loaded acrylic intraocular lenses: In vitro and in vivo performance. J Cataract Refract Surg. 2019;45:1808-1817.