Taking Drug Safety To the Next Level
Taking Drug Safety To the Next Level
Single-use guidelines and flawed compounded drugs are bringing new vigilance to ASCs.
BY Virginia Pickles
Maintaining a safe environment for patients in ASCs requires constant vigilance, particularly when managing medications — as the fungal meningitis outbreak in the fall of 2012 made frighteningly clear. Although infection rates in ASCs are lower than 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. Several administrators in ophthalmic ASCs shared the challenges they’re facing and the procedures and protocols they’re instituting to minimize the chance for infection and ensure their patients’ safety.
Single-use Standards Clarified
CMS in June issued a memorandum restating and clarifying its regulations for the repackaging of single-dose vials. For 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,” Ms. Benze says. “Generally, compounded sterile preparations must be prepared by a licensed compounding pharmacy and must adhere to rigorous standards.”
Yet not even that is a guarantee. That fungal meningitis outbreak last fall was traced back to the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Mass. According to the Centers for Disease Control and Prevention (CDC), NECC was responsible for packaging and marketing the three lots of contaminated medication used for epidural steroid injections. Doses from these three lots had been distributed to 75 medical facilities in 23 states. At press time, the CDC reported 590 cases of infection and 37 deaths resulting from the contaminated steroid, preservative-free methylprednisolone acetate.
Pharmacopeia 797 Standards
Whatever the fallout may be from the NECC’s lapse, according to current CMS rules, any entity that wishes to combine and repackage single-dose or single-use medications into smaller doses must comply with US 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 Ms. Benze, few, if any, ophthalmic ASCs are equipped to do this.
“Only immediate-use compounding (retrobulbar blocks) can be performed in a surgery center,” Ms. 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 one 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, 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 one hour of the opening of a vial, the needle puncture into a stopper or, if the drug is in a glass vial, within one hour of being drawn up into a syringe,” she says.
Relying on Pharmacy
However, as Ms. 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 the staff had been dividing for single use. It now contracts with a supplier that packages single-dose pouches of the antiseptic in surgical packs.
According to Ms. 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,” Ms. Pecora says. “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 Cost of Compliance
With patient safety and infection control at the core of medication management, no one disputes the value of stringent controls. However, compliance often comes with a price. Ms. Pecora, administrator at Oregon Eye Center in Salem, notes that pharmacy costs there have increased significantly since the practice began instituting new protocols to ensure compliance with the CMS multi-dose/multi-use guidelines.
“In just one month, our pharmacy costs rose by more than 50%,” she says. “Some of that was because we did more surgeries, but some of it is because of the changes we’ve made.” Negotiating favorable contracts with compounding pharmacies will be a priority as ophthalmic ASCs take steps to come into compliance.
|Criteria for Immediate-use Compounding
According to Chapter 797 of the US Pharmacopeia, compounded sterile preparations for immediate use must meet the following criteria:
► The compounding process must be simple and involve the transfer of no more than three commercially available sterile, nonhazardous products or diagnostic radiopharmaceutical products from the manufacturer’s original container, and no more than two entries into any single container, package or administration device.
►The compounding procedure must be continuous and accomplished within one hour.
► Aseptic technique must be followed.
► If the compound is not administered immediately, it must be under the continuous supervision of the person who prepared it.
► Administration must begin within one hour of preparation.
► Unless immediately and completely administered, the compound must be labeled with the patient’s identification, ingredient names and amounts, the preparer’s initials, and the precise one-hour-beyond use date and time.
► If administration has not begun within one hour after the start of preparation, the compound must be appropriately discarded.
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.” (The FDA list of current drug shortages is available at www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm.)
Last year, a major supplier of nonpreserved, bisulfate-free epinephrine shut down, 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. Ms. Jones notes, however, that other drugs, such as Versed (midazolam) 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,” she says. “All we can do is order as much as we can in advance to make sure we have sufficient supplies in case of backorders.”
Last year, Ms. Pecora found out about how a drug shortage carries the potential for serious repercussions, not only in patient care, but in an ASC’s financial situation. Another surgery center in the state could not get the medications it needed 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, Ms. 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, Ms. Benze says, 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. Ms. Benze also notes that although the physician is primarily responsible for ordering a drug, the nurse is responsible to verify the drug before administration.
► Ensure drug administration by licensed personnel. Many ophthalmic ASCs are physician-owned and located next to a general ophthalmology practice. They share some personnel. In the general practice, technicians may instill eye drops, but 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,” Ms. Benze says.
The 7 Rights of Medication Management
Nursing has long held that the basis for safe medication administration is to ensure 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 health-care team can identify and avoid potential medication errors.
Safe Medication Practices
1. Right patient.
2. Right medication.
3. Right dose.
4. Right time.
5. Right route.
6. Right indication.
7. Right documentation.
Adhering to the seven rights is the professional responsibility of the licensed perioperative team member.
► 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 the Association of Perioperative Registered Nurses issue. The organization recently increased the number of “rights” from five to seven, adding indication and documentation to the list. (“The Seven Rights of Medication Management.”)
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. OM
, Volume: , Issue: , page(s):