New Challenges in Medication Management

Compounding restrictions and drug shortages are top of mind in ophthalmic ASCs.

By Virginia Pickles, Contributing Editor

Maintaining a safe environment for patients in ASCs requires constant vigilance, particularly when managing medications. Although infection rates in ASCs are lower than in hospitals, increased surveillance of ASCs has uncovered some lax infection control practices, according to Crissy Benze, RN, BSN, a consultant with Progressive Surgical Solutions LLC. “It has become apparent that people aren’t necessarily using best practices,” she says.

We spoke with several administrators in ophthalmic ASCs to find out what challenges they’re facing and the procedures and protocols they’re instituting to minimize the chance for infection and to ensure their patients’ safety.

Single–use Standards Clarified

The Centers for Medicare & Medicaid Services (CMS) in June issued a memorandum restating and clarifying its regulations for the repackaging of singledose vials. For many ophthalmic ASCs, this means they must re-examine how — and where — their drug combinations, such as retrobulbar blocks and dilating drops, are prepared.

“Compounding is a hot topic because many ophthalmic ASCs have been drug compounding in the surgery center,” Benze says. “Generally, compounded sterile preparations must be prepared by a licensed compounding pharmacy and must adhere to rigorous standards.”

According to CMS, any entity that wishes to combine and repackage single-dose or single-use medications into smaller doses must comply with U.S. Pharmacopeia 797 standards. Basically, this means medications can be repackaged only by a licensed pharmacist in a dedicated area that meets International Organization for Standardization air quality conditions. The compound must then be assigned and labeled with a “beyond use” or expiration date based on the contamination risk level. According to Benze, few, if any, ophthalmic ASCs are equipped to do this.

“Only immediate-use compounding (retrobulbar blocks) can be performed in a surgery center,” Benze says, “but even with immediate-use compounding, there are specific guidelines that must be followed. Only licensed personnel, such as registered nurses, are permitted to mix medications in a syringe. The compound labeling must meet specific criteria, and the preparation must be used within 1 hour.”

The CMS memorandum was high on the agenda at a recent meeting of the Quality Assurance Performance Improvement Committee of Oregon Eye Surgery Center in Eugene, Ore. According to administrator Ginny Pecora, RN, the committee approved revisions to the ASC’s policies to reflect the CMS language. “For example,” she says, “our policy now states that all single-dose vials or single-dose medications will be used for one patient only and must be used within 1 hour of the opening of a vial, the needle puncture into a stopper or, if the drug is in a glass vial, within 1 hour of being drawn up into a syringe.” However, as Pecora notes, changing the policy is only the first step in ensuring compliance.

Like many ophthalmic ASCs, Oregon Eye Surgery Center had been preparing its own “cocktails,” combining dilation drops, an anesthetic agent and antibiotic drops in one bottle, thus eliminating the need for a nurse to handle several different bottles for each patient whose eye needed to be dilated prior to cataract surgery. Because of the stringent requirements for in-house compounding, however, Oregon Eye Surgery Center will contract with a compounding pharmacy to repackage its dilation drops for single use. This ASC took a similar route several months ago for povidone-iodine, which they had been dividing for single use. They now contract with a supplier that includes single-dose pouches of the antiseptic in surgical packs.

According to Pecora, the directive to contract with compounding pharmacies to mix specific drug combinations is creating a need to standardize some of these “recipes,” which often were mixed to each surgeon’s specifications. With 12 surgeons operating at Oregon Eye Surgery Center, keeping customized medication packets on hand will likely become cost-prohibitive. In addition, not being able to mix “cocktails” as needed means pharmacy orders must accurately reflect the surgery schedule, particularly when medications have a short “beyond use” date. “Clearly, we’ll need to anticipate our needs accurately,” says Pecora. “We won’t keep the ingredients for the compound here any more, so we will depend on the pharmacy to fulfill our orders in a timely manner.”

The 7 Rights of Medication Management

The nursing profession has long held that the basis for safe medication administration is to ensure that the right patient receives the right dose of the right medication at the right time by the right route. Recently, the Association of Perioperative Registered Nurses expanded these five “rights” to include two more: the right indication and the right documentation. Using this checklist, the healthcare team can identify and avoid potential medication errors. Safe Medication Practices •Five Rights are now Seven Rights • Right Patient • Right Medication • Right Dose • Right Time • Right Route • Right Indication • Right Documentation • Adhering to the seven rights is the professional responsibility of the licensed perioperative team member (AORN 2012)

Anticipating the Unknown

Another challenge for ophthalmology practices, especially ASCs, involves recent shortages of certain drugs. “Trying to manage all of our back-orders has been a real challenge,” says Gynetta Jones, RN, surgery administrator at Murphy, Watson, Burr Surgery Center in St. Joseph, Mo. “The most difficult situation for us occurred during a shortage of preservative-free epinephrine, which is a key ingredient for intracameral epi-Shugarcaine.” Last year, a major supplier of nonpreserved, bisulfate-free epinephrine stopped operations, creating a shortage. During that time, some ophthalmologists reportedly diluted preserved, bisulfate-containing epinephrine before mixing it with the other ingredients for epi-Shugarcaine.

The strategy at Murphy, Watson, Burr Surgery Center was to increase the ACS’s supply of Malyugin rings as a backup for difficult dilations. Jones notes, however, that other drugs, such as Versed and Propofol, have also been on back-order in the past year, and she would not be surprised if this happened again. “I’m sure other facilities are facing the same problems with drug shortages,” Jones says. “All we can do is order as much as we can in advance to make sure we have sufficient supplies in case of back-orders.”

Earlier this year, Pecora was made aware of a situation that underscores the potential for serious repercussions, not only in patient care, but in an ASC’s financial situation, during a drug shortage. She learned a surgery center in another area of the state was unable to obtain needed drugs from its compounding pharmacy and had to cancel a full day of surgery. “That was a costly situation for that ASC, and we are keenly aware that we could face a similar situation if we don’t have sufficient drugs on hand ready to use,” she says.

Do’s and Don’ts Worth Repeating

Although preprinted forms and checklists can contribute to efficiency, Benze cautions that the routine nature of the perioperative activities that take place in an ophthalmic ASC can lead to complacency. “Because of the narrow scope of care, nurses, technicians and other staff members are doing the same things over and over again,” she says, “so it’s important that everyone receives appropriate in-service education to stay current on best practices for medication administration.” Some examples include:

• Identify and document drug allergies. Fully documenting a patient’s medication allergies is a critical safety measure, says Benze, noting that some ASCs place a wristband on the patient or a note on the bed, alerting all personnel to a patient’s allergy.

• Confirm that medication orders are signed. Orders for routine procedures may be preprinted, but they aren’t authorized until the physician signs them for each patient for each procedure, including laser treatments. Benze also notes that although the primary responsibility for ordering a drug falls to the physician, it’s the nurse’s responsibility to verify the drug before it is administered.

• Ensure drug administration by licensed personnel. Many ophthalmic ASCs are physician-owned and located adjacent to a general ophthalmology practice, with some shared personnel. In the general practice setting, technicians are permitted to instill eye drops, while in the ASC, only licensed personnel may administer medications, including eye drops. “Since it’s common practice to bring staff from the office to the surgery center, some facilities have been cited on recent audits because unlicensed personnel administered medications,” Benze notes.

• Label and relabel all medications. This includes all open medication containers, syringes, balanced salt solution and medications on the sterile field. Once opened, multidose medications should be relabeled with the date opened, the initials of the person who opened it and the revised expiration date.

For a succinct list of general guidelines, nurses and other personnel involved in administering medications need to look no further than the “rights” of medication management issued by the Association of Perioperative Registered Nurses. The organization recently increased the number of “rights” from five to seven, adding indication and documentation to the list. (For further information, see “The 7 Rights of Medication Management, on page 13.)

Safety is Paramount

Clearly, creating and maintaining a safe environment for patients while ensuring optimal outcomes is paramount in an ophthalmic ASC. A team approach toward incorporating best practices in medication management and keeping abreast of the latest regulations will go a long way toward achieving these goals. ◊