Medication errors in the unique environment of the operating room (OR) can have deadly consequences. For every 133 anesthetic medications administered, one error occurs; of these errors, one out of every 250 results in patient death.1,2 To prevent such errors, the Anesthesia Patient Safety Foundation (APSF) held a medication safety conference in 2010 to identify challenges and opportunities for improved anesthesia practice. The importance of integrating pharmacy services in the OR was highlighted, as well as standardizing drug concentrations and anesthesia workflows to prevent errors and patient harm.1 In 2016 the Institute for Safe Medication Practices (ISMP) recommended that To the maximum extent possible, commercially-prepared, premixed parenteral products and unit dose syringes are used versus manually compounded sterile products.3 Furthermore, CMS recommends that health care providers take advantage of available technology in efforts to promote patient safety. Aligning these guidelines and regulatory requirements, ready-to-administer (RTA) syringes and standardized drug concentrations can be utilized in the OR to improve patient safety, reduce medication errors, and reduce drug waste.
Moses H. Cone Memorial Hospital (MCMH) is a 536-bed acute-care hospital, part of the Cone Health System in Greensboro, North Carolina. MCMH has 20 ORs: four neurosurgical, four heart and vascular, and 12 general surgical suites. The ORs also service an adjacent outpatient surgical center, which comprises eight general surgical suites. Drugs are dispensed within each OR using automated anesthesia cabinets, and syringes are given customized labels generated via bar code automated labeling technology. An OR satellite pharmacy provides medication management and support for the hospital-based OR suites. As of April 2017, RTA syringes have been implemented and optimized across all ORs at the hospital, as well as in the outpatient surgical center.
Planning for Conversion
After deciding to implement RTA syringes in the OR, anesthesia and pharmacy teams collaborated to reach a consensus on the specific drugs and concentrations to convert to RTA syringes. Product and concentration availability, utilization, and safety were the considerations for conversion to RTA. To justify the cost of the RTA syringes, we performed an analysis that demonstrated potential savings via a significant reduction in drug waste; this data further clarified which syringe concentrations and volumes should be included in the conversion.
In traditional anesthesia practice, anesthesia staff prepares drug syringes prior to surgical cases in anticipation of patient and case needs. Certain medications are prepared in advance to allow for urgent administration, if necessary. To ensure appropriate sterility and stability of these prepared syringes, a maximum beyond-use date (BUD) of 1 hour is applied, per USP standards and CMS regulations.4,5 This limited BUD results in significant drug waste if the medication is ultimately not used within this time frame. RTA syringes offer an advantage, in that the anesthesia provider has timely access to drugs available in specific doses or concentrations, while minimizing waste if the syringes are not used during the procedure. Unused RTA syringes can be returned to the automated anesthesia cabinet for future use, as their BUDs range up to 90 days at room temperature. This was an important consideration in justifying the cost of RTA syringes.
Once the RTA syringe formulary was approved, it was essential to establish safe and efficient implementation for anesthesia practice. A hands-on planning session was held with both pharmacy and anesthesia staff in attendance to determine the appropriate configuration of the RTA syringes and additional drugs within the automated anesthesia cabinet drawers. Empty drawer tray liners were utilized to mock up several configurations for the team to consider. Sample syringes from the compounding pharmacy were included to demonstrate proper spacing in the trays and to assess how these syringes would streamline anesthesia workflow. In consideration of matching the included drugs and amounts to the types of surgeries performed in each operating suite, four different tray configurations were developed:
- Standard: Contains frequently used paralytics, induction agents, and reversal agents, as well as other medications universal to most surgical procedures. This tray is standard across all rooms regardless of procedure.
- General: Contains drugs more common to general surgical cases.
- Heart and Vascular: Contains drugs specific to open heart surgery and other vascular procedures, such as heparin and protamine.
- Outpatient Surgery: For drugs utilized more commonly in the outpatient surgery center.
Compartments at the front of the tray were assigned to the most commonly utilized drugs, while those in less frequent rotation were placed toward the back (see FIGURE 1). Once the final configurations were approved, PAR levels were established based on anticipated use for each RTA syringe. We noted that historical vial utilization data would not necessarily match RTA syringe utilization, due to the decrease in drug waste; thus, timely adjustments of par levels would be required during the early stages of implementation.
Because the RTA syringes are larger than the vials they replaced, an initial challenge was making room for the larger products. The automated anesthesia cabinets in the ORs are replenished once every 24 hours; therefore, par levels for each prefilled syringe must be sufficient to prevent outages prior to the next day. For the most commonly used syringes, a sufficient par level was established, which later had to be decreased because the drawers kept catching, and in some cases breaking, the syringes. We maintain the once-daily replenishment schedule and continue to evaluate stock-outs and usage trends. The OR pharmacy satellite is available to supply product in the event of a stock-out.
When we began placing syringes into trays, it quickly became apparent that the layout would need to be adjusted to reduce the potential for look-alike drug errors. Because the majority of the syringes utilized were 10 mLs (for either 5 mL or 10 mL fill volume), they looked similar at first glance. In addition, the syringe label colors were nearly identical in some cases (eg, green: glycopyrrolate, atropine; red: succinylcholine, rocuronium) (see FIGURE 2). This required immediate remediation. As a short-term solution, additional color-coded labels were applied to the syringe caps to help differentiate among the look-alike syringes. Thereafter, our RTA syringe vendor presented alternative label options for each drug.
The team also explored alternative fill volumes for certain drugs based on patient utilization to determine if a different volume would suffice in the majority of cases. This presented yet another physical differentiator, in addition to the label and color, to help prevent errors. Working closely with anesthesia providers, we reached a consensus on the appropriate labels, color, and volume for each drug with respect to its location in the tray vis-a-vis adjacent drugs. The effort to prevent look-alike errors instills peace of mind that patients are receiving the correct medication.
The Conversion Process
The pharmacy department dedicated a conversion workspace to our RTA syringe implementation project. Critical concerns included ensuring sufficient space to accommodate the equipment and inventory, as well as maintaining drug security. Pharmacy purchasing agents placed a drug order specific to the build. Upon delivery, this inventory was segregated from the hospital’s daily drug order and stored in the designated build room, which made inventory available for the conversion without disrupting the daily flow of drugs out of the pharmacy.
Because automated anesthesia cabinets were already in place in the ORs, two options for conversion were considered: we could build/modify the existing configuration of the trays directly at the machine level, or we could build a new set of trays outside of the OR setting and use a tray-exchange system during the conversion process. To optimize efficiency and to limit downtime for each OR suite, the latter was chosen.
Pharmacy acquired additional drawer liners and dividers from the automated anesthesia cabinet vendor in advance of implementation, which allowed us to construct and fill trays with drugs prior to go-live. Using the updated configurations, 56 drug trays were constructed, labeled, stocked to the pre-determined par levels, and stored according to their designated areas. Before deployment, a pharmacist verified the contents of each tray.
It was imperative to consider OR needs during the conversion process. Specific ORs needed to remain open at all times to be available for potential traumas, emergent open-heart surgeries, as well as scheduled cases. Mindful of these requirements, the implementation group developed a room conversion order by which the 20 on-campus ORs would be taken out of service and converted into the new configuration over the course of 3 days. This ensured OR staff was adequately prepared and aware of suite downtime. To be less invasive, the group elected to convert the cabinets during third-shift hours over the course of 3 nights, when the volume of surgical cases was light. Because the outpatient surgical center is closed during weekends, its eight cabinets were converted on a Saturday.
A team of pharmacists and pharmacy technicians were responsible for completing the conversion process. Each OR automated anesthesia cabinet conversion required approximately 45 to 60 minutes to complete. If a technician converted a device, a pharmacist verified their work to confirm that the device was properly mapped to the appropriate drug in each tray.
The automated anesthesia cabinets are now refilled nightly during the third shift. Bar coding technology ensures that the proper drugs are refilled to the correct pocket. The minimum par level for each pocket is set at one less than the maximum quantity to ensure each machine is refilled to capacity.
Open spaces in each drawer were added to allow for future addition of new drugs or quantities. In addition, monitoring usage data drives par level adjustments in order to minimize drug waste.
The replenishment process for each automated anesthesia cabinet in the OR is a labor-intensive process. A pharmacy technician pulls a specific quantity of drug for each OR cabinet from the main pharmacy stock based on the automated anesthesia cabinet utilization report. Often, there are discrepancies between the report and what remains in the cabinet upon refill, which can be attributed to incomplete anesthesia documentation practices, rotating drugs among rooms/devices, and utilization after the report is generated. Thus, the cabinets may not be stocked to their maximum inventory during refill. Looking ahead, we are considering changing the replenishment process from “drug pick per machine” to a tray-exchange system, which would allow for accurate, complete par quantities to be reset each evening. Using a tray-exchange system bolstered by technology, such as RFID scanning and verification, would allow for streamlined, efficient, and accurate replenishment practices.
Once our providers began to realize the benefits of using RTA syringes, requests for expansion into other areas followed. In recognition of these areas, MCMH has begun including RTA syringes in rapid sequence intubation (RSI) kits, ambulance drug bags, and other kits throughout the hospital.
RTA syringes have proven a convenient, safe, and efficient option for our ORs. Additionally, using RTA syringes presents an opportunity for reducing drug waste and increasing cost savings. Moving forward, we anticipate reaping additional benefits through analyzing utilization data, optimizing syringe volume, expanding to areas outside of the OR, and using technology-assisted standardized workflows with RFID. Collaboration between pharmacy and anesthesia staff is critical to improving medication distribution, administration, and streamlining workflows.
- Eichhorn JH. APSF Hosts Medication Safety Conference: Consensus Group Defines Challenges and Opportunities for Improved Practice. APSF Newsletter (Spring 2010). www.apsf.org/newsletters/html/2010/spring/01_conference.htm. Accessed February 20, 2018.
- Stabile M, Webster CS, Merry AF. Medication administration in anesthesia: Time for a paradigm shift. APSF Newsletter. 2007;22(3):44-46.
- ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations. Institute for Safe Medication Practices (2016). www.ismp.org/tools/guidelines/ivsummit/ivcguidelines.pdf. Accessed February 20, 2018.
- USP <797> Pharmaceutical Compounding—Sterile Preparations. In: The United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: The United States Pharmacopeial Convention, 2017.
- Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications. Center for Clinical Standard and Quality/Survey & Certification Group (October 2015). www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf. Accessed February 20, 2018.
Emily M. Howes, CPhT, is a certified pharmacy technician specialist at Moses H. Cone Memorial Hospital in Greensboro, North Carolina, where her responsibilities include pharmacy automation and technician training. Emily will graduate with an Associate’s of Applied Science in Pharmacy Technology in May 2018 from Forsyth Technical Community College in Winston-Salem, North Carolina.
Kevin N. Hansen, PharmD, MS, BCPS, the assistant director of pharmacy at Moses H. Cone Memorial Hospital, provides oversight and leadership for pharmaceutical compounding and perioperative services pharmacy. He graduated from the Lake Erie College of Osteopathic Medicine with a Doctor of Pharmacy degree and received an MS in Pharmaceutical Sciences from the University of North Carolina Eshelman School of Pharmacy. Kevin’s professional interests include sterile compounding, quality assurance, and data analytics.
Checklists for RTA Syringe Use
- Determine which drugs will be converted to RTA syringes
- Establish drug concentrations and volumes that will be provided in syringe form
- Select labeling options to prevent look-alike errors
- Finalize complete drug list including drugs not being converted to RTA syringes
- Configure trays to meet OR needs
- Interpret historical usage and waste data to determine appropriate par levels
- Ensure a dedicated build space is available
- Place drug order in advance of build phase
- Specify conversion method (tray exchange or reconfigure at device level)
- Determine the order by which the suites will be converted and the schedule of conversion
- Establish replenishment workflow following conversion
- Evaluate utilization and waste data and adjust par levels where appropriate
- Meet with anesthesia regularly to discuss concerns and adjust as appropriate
- Utilize RFID-assisted technology to enhance workflow
- Expand utilization of RTA syringes to areas outside of the OR (eg, RSI kits, ambulance bags, etc)
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
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