Six Changes in AORN’s New Medication Safety Guideline

Find out how updated recommendations will impact your practice.

Big changes to rules on sterile compounding, labeling meds and safer use of medication administration technology are a few key practice updates that will be published electronically this month in AORN’s Guideline for Medication Safety on eGuidelines+.

eGuidelines+ is where AORN publishes mid-year guideline updates from the Guidelines for Perioperative Practice.

Insider info

Big picture, these updates reflect new recommendations and new studies to improve medication safety — changes that accreditation organizations are likely to look for. Get ahead by reviewing and adopting these recommendations early, suggests this guideline’s lead author Julie Cahn, DNP, RN, CNOR, RN-BC, ACNS-BC, CNS-CP, AORN’s senior perioperative practice specialist.

Dr. Cahn shares the highlights from six of the major updates in the revised guideline that outpatient professionals in all roles will need to understand and implement as a team.

1. Rethink compounded medication procurement practices

Because of quality issues surrounding compounded medications, the FDA suggests changes in procurement practices. If you compound your own heparinized saline or tumescent solution in the OR, it’s time to change that.

“ASC facilities may need to update strategies for procuring compounded medications,” says Dr. Cahn. Primary strategies for procurement are to get a sterile compounded medication directly from the manufacturer, an FDA-registered outsourcing facility, or a compounding pharmacy that meets USP General Chapter 797 standards. If procurement from one of these sources isn’t possible, second tier strategies are to have the facility pharmacy make the medication, and if that’s not an option, facilities can still compound medications in the OR — but this is now the very last option that should be used. “It is important to remember that compounded medications are not approved by the FDA. Two main issues with compounded medications are contamination and inconsistent amounts of ingredients in the medication. Serious adverse events from these quality issues in compounded medications have been reported to the FDA,” says Dr. Cahn.

HANDLE WITH CARE One of the practice updates in AORN’s Guideline for Medication Safety includes how meds are handled in the OR, including how they should be transferred to a new container in the OR.

2. Reconsider pharmacy oversight

ASC leaders will want to review pharmacy oversight procedures. ASCs must comply with all regulations, and specifically state regulations, that require pharmacist oversight. Evidence suggests that 24-hour pharmacy oversight is beneficial and may be achieved by contracting with a licensed pharmacist for consultive services on-site or via telepharmacy. See recommendations 1.5 and 1.5.1 in the updated guideline for details.

“The big takeaway for ASCs is that the evidence shows how consistent access to a licensed pharmacist overseeing pharmaceutical services supports the regulatory requirement to provide medications in a safe and effective manner,” says Dr. Cahn.

3. Revamp processes for transferring medications to the sterile field & medication labeling

Practice updates on how medications are handled in the OR include how meds are transferred to a new container. For example, make sure to disinfect medication vial stoppers, including at the initial entry after removal of the cap or cover with alcohol and allow to dry. When withdrawing medication from a vial, make sure to use a new sterile access device such as a vial spike, filter straw, or plastic catheter each time. (Note: a needleless method or blunt needle is preferred.)

Dr. Cahn also reinforces existing recommendations that are still critical to patient safety, including careful inspection of expiration date and contents for discoloration or particulates that signal that the medication could be compromised and concurrent verification of medication label information between the RN and receiving individual when transferring the medication on the sterile field.

A big change is that medication labeling no longer includes the date and time accepted on the sterile field. The expiration date and time or the beyond-use date and time are only added to the label if the medication will expire during the procedure. All medications, solutions, liquids or compounds removed from the original container should be labeled with the full name, concentration, dilution and diluent if used, using no abbreviations (or only approved abbreviations), with no unnecessary information. Also, teams should switch to using sterile, preprinted labels on the sterile field, when available.

KEY RESOURCES

Tips for Navigating New Medication Safety Guidance

Medication safety has never been more of an interdisciplinary endeavor, and ASC leaders need to navigate several medication safety resources to share new practices with their teams. Here’s a quick guide to finding what you need:

AORN’s Revised Guideline for Medication Safety
The updated guideline and collection of updated guideline implementation tools, including more on key takeaways and competency verification tools, can all be found on AORN’s electronic platform for guidelines at eGuidelines+ at aornguidelines.org. Note that AORN’s previous medication safety guideline included a separate section for ASCs, which has been incorporated into the updated guideline.

Learn more on the AORN guideline updates from Dr. Cahn’s March online webinar and find a thorough rundown of the updates in the Guideline First Look for medication safety published in the March issue of AORN Journal.

Revised USP General Chapter 797
The USP moved from print to online subscription for the November 2022 updates to General Chapter 797: Pharmaceutical Compounding – Sterile Preparations in its Compounding Compendium. The updates officially take effect November 2023.

Learn more at usp.org/compounding/general-chapter-797. It’s also beneficial to review USP General Chapter 800, which outlines safety practices associated with managing hazardous drugs.

New ISMP Guidelines for Safe Medication Use in Perioperative and Procedural Settings
The Institute for Safe Medication Practices released a new guideline on medication use in perioperative settings in August 2022. This guideline is designed to help teams identify and address gaps in medication safety practices.

Learn more at osmag.net/ISMP-RESOURCES

— Carina Stanton

 

4. Plan ahead for spiking IV bags and adjusting to medication and solution shortages

Teams should establish in policy and procedure the length of time between when an IV solution container is spiked and when administration should begin. “Evidence does not support a one-hour rule between spiking an IV bag and the beginning of administration. A study on spiked IV bags containing lactated Ringer’s solution did not find contamination for up to eight hours,” Dr. Cahn notes.

Medication and solution shortages are common. The guideline suggests establishing a plan for proactively managing medication shortages with all stakeholders, including those on the front line, Dr. Cahn says. “Perioperative personnel should be consulted during the decision-making process for managing medication shortages that will affect surgical patients,” she adds. “Have a standard process and communication plan to clarify changes in what medications and processes will be used during a shortage. Clear processes during a medication shortage can decrease the risk for development of workarounds, medication errors, or other issues such as increases in sharps injuries due to the use of alternative medication access devices.”

5. Use technological devices in medication management and administration as intended

Recognizing that technological devices such as automatic dispensing cabinets, barcode scanning and smart infusion pumps are integral to perioperative medication use processes, new recommendations in the guideline emphasize correct use of these technologies in accordance with manufacturer instructions for use.

If team members develop workarounds and don’t use the technology as intended, these technologies designed to increase safety can instead pose safety risks for medication errors.
Julie Cahn, DNP, RN, CNOR, RN-BC, ACNS-BC, CNS-CP

Dr. Cahn cautions, “If team members develop workarounds and don’t use the technology as intended, these technologies designed to increase safety can instead pose safety risks for medication errors.” Therefore, new and updated recommendations in the guideline address standardization, use of technology as intended and competency verification for all users. “ASC leaders can directly observe staff using medication technology to take a proactive role in identifying barriers to correct use, workarounds or overrides and correcting these risks,” she says. “Don’t just rely on incident reports to tell you what is going on with technology used with medication procurement and administration.”

6. Be a good antibiotic steward

Current evidence shows that prophylactic use of antibiotics in the OR is commonly used in topical applications and as an IV medication administered before incision. This is occurring while antimicrobial resistance is increasing, Dr. Cahn explains. Additionally, evidence shows there are high rates of errors reported with use of these medications and limited standardization or adherence to accepted guidelines. Therefore, all prophylactic antibiotic use in the OR should be overseen by the facility’s antimicrobial stewardship committee. This helps ensure that prophylactic use of antibiotics in surgery is based on accepted standards to promote maximum effectiveness.

To target these safety risks, the updated guideline includes new guidance that emphasizes oversight of antibiotic agents used “routinely” (or for prophylactic use), including antibiotics given to all patients during a specific procedure. This is different from therapeutic use to treat a patient’s active infection with a medication shown to be effective for the specific infection. OSM