Managing a safe medication use program for surgical services within any health care organization is one of the most important, albeit most challenging responsibilities for the pharmacy department. As administrators of TJC’s medication management tenets, the pharmacy has an obligation to oversee all medication use processes, and this includes ensuring the availability of essential medications, timely deliveries, appropriate storage, and complete labeling, as well as targeting a reduction in the risk of medication errors, among several other critical elements.
Because the pharmacy often has a limited (if any) staff presence in the OR, an effective OR medication management program will emphasize strong collaboration with surgical services providers, nurses, and anesthesiologists. In order to meet the perioperative demand for medications, pharmacy distribution models for OR services often are facilitated by a satellite pharmacy, specialized OR/anesthesia ADCs, or a hybrid model of both. Ingraining one of these models will help establish pharmacy’s presence in the OR, but the viability of this presence will depend on active, ongoing collaboration with anesthesia leadership in ensuring the provision of vetted and clearly identifiable medications in the most ready-to-use (RTU) form possible. As demonstrated by recent survey data, many organizations achieve this by outsourcing the preparation of OR medication syringes to outside vendors.1, 2
Deciding Factors for Outsourcing
The decision to outsource OR medication syringes is predicated on a comprehensive analysis of a variety of factors including overall product cost and availability, convenience for staff, ease of standardization, potential for waste reduction due to extended beyond-use dating, the rigidity of contractual requirements, and vendor provision of product-quality data. Early on in the process, thorough due diligence should be made to collect information from the vendor that attests to product integrity such as licensure history, scope of facility operations, and extent of routine quality testing and batch testing. Batch testing should consist of sterility, stability, endotoxin, and pyrogen testing, and be documented accordingly. Ultimately, the decision to outsource involves weighing the value of compliance and improved safety from having readily available sterile products in a fast-paced environment against the costs, contractual obligations, and regulatory concerns associated with using a third party vendor.3, 4
Although a metaphorical cloud has been cast over the outsourced pharmacy compounding industry recently resulting in significant regulatory concerns, outsourcing remains a widely used practice. Some organizations have chosen to keep or bring sterile compounding in house by investing in IV-preparation robotics or other compounding automation, but many facilities do not have financial access to such resources or see little need to pursue them. While the future path of outsourced compounding is uncertain, the benefits of procuring bona fide OR medication syringes, as well as other sterile products in standardized concentrations and RTU forms, will remain appealing.
Weighing the Pros and Cons
In October 2012, WakeMed Health & Hospitals’ Raleigh Campus—a 650-bed, not-for-profit community hospital—made the decision to begin purchasing prefilled syringes for our surgical services area. The use of prefilled syringes along with standardized anesthesia trays is now being implemented using a two-phased approach: the first phase, which was completed in January, involved the integration of essential, non-controlled medications. Phase 2, slated for initiation in early March, will usher in controlled substances.
Outsourcing syringes for the OR was determined to be the most cost-effective among our patient safety-prioritized options as it offered medication error reduction while bolstering compliance with TJC standards for sterile product preparation and labeling.3 For us, the provision of RTU syringes has proven a vast improvement over the antiquated practice of having certified registered nurse anesthetists (CRNAs) draw up their own syringes in a questionably sterile environment filled with distractions. As a result of the due diligence we performed early in the process, we determined the extensive system of quality testing, automated bar code verification, and double checks used by our suppliers in preparing our prefilled syringes far surpasses the riskier method of preparing on-demand syringes in the OR.
Expanding Pharmacy Presence in the OR
Among the operational advantages of employing outsourced OR medication syringes is that it has allowed us to augment the role of the OR pharmacy satellite in the overall distribution model. Meeting the medication needs of perioperative services—which encompass 22 operating rooms, three endoscopy rooms, one room for pediatric dental procedures, and three obstetric operating rooms—has historically been a challenge. However, the implementation of an OR pharmacy satellite and the provision of prefilled syringes in standardized anesthesia trays has given the pharmacy greater oversight of medication use in this sensitive setting. Building on the functions of dispensing medication and anesthesia trays, OR pharmacy satellite staff now manage floor stock in the substerile areas, check expiration dates, and reconcile controlled substance use after each surgical case.
The OR pharmacy manages the distribution of prefilled syringes by stocking them in four unique standardized medication trays that are differentiated by specialty (see Table 1). The quantity of each type of tray maintained on hand, along with the configuration, has been determined based on historical need for each case type. After completing Phase 1, the WakeMed pharmacy now supplies 11 of the most commonly used medications as prefilled syringes (see Table 2). This constitutes 38% of the 29 standardized syringe concentrations that have been approved by WakeMed pharmacy and anesthesia leadership. After completion of Phase 2, we anticipate over 50% of the approved syringes will be provided as prefilled products.
Establishing Standards, Policies, and Procedures
Achieving an approved list of standardized syringe concentrations required collaboration between pharmacy management, the chief CRNA, the chair of anesthesiology, and several staff CRNA representatives. After a thorough review of practice standards, the group came to a consensus on 29 standardized syringe concentrations by agreeing to one standardized concentration for each medication. Preprinted labels for all 29 medications in their standardized concentrations are available in perioperative areas so that labeling is complete for any medications drawn up by CRNAs (ie, products not available as prefilled syringes). Anesthesia management conducts weekly audits on a random sampling of at least five CRNA-drawn medications in order to ensure that the standardized concentrations and preprinted labels are used consistently. While audits of syringe labeling are only performed on syringes drawn by CRNAs, OR pharmacy technicians are responsible for validating that the approved configuration of each medication tray is maintained, a process that includes verifying prefilled syringes are placed in the right tray compartment during the restocking process.
The OR pharmacy satellite is staffed 24 hours a day (with a pharmacist present from 6am to 6pm), so swapping and restocking of medication trays is done at night to avoid peak surgery times. Any medications that are needed ad hoc are retrieved and delivered by anesthesia technicians. Pharmacy is responsible for OR syringe procurement, so all ordering is done through the OR pharmacy satellite, and anesthesia is billed interdepartmentally for all inventory as it is received. Ordering is usually performed twice per week, as storage space is limited, but the goal is to keep at least four to five days estimated supply on hand, with exceptions made during shortages.
Preparing For Shortages
While WakeMed has not yet experienced the effects of any substantial shortages of outsourced OR medications, there is a departmental process in place for managing such events. All shortage situations are handled by an internal, system-wide shortage team comprised of pharmacy management, procurement specialists, and other affected disciplines (eg, anesthesia, nutrition) from all sites throughout the health system. Medications placed on allocation will typically be purchased to the maximum of that allocation and be distributed across the system according to utilization.
The final step remaining in WakeMed’s adoption of outsourced OR syringes is to complete the Phase 2 incorporation of prefilled controlled substance syringes. This process is more complex, as it will require modification to current lockboxes, as well as controlled drug administration records (CDARs) in order to accommodate the new RTU products. Because the WakeMed Raleigh Campus does not have anesthesia-specific ADCs, the CRNAs are issued a standardized lockbox for each individual case. All required controlled substance documentation (amount administered, amount wasted, witness signatures, etc) is recorded on the CDAR issued with the lockbox and returned to the OR pharmacy satellite after the case.
Outsourcing OR syringes remains a relatively new process at the WakeMed Raleigh Campus, but the comprehensive action plan prepared by the pharmacy in collaboration with anesthesia has resulted in a successful implementation thus far. Any organization considering outsourced OR medication syringes should first conduct an internal cost/benefit analysis by comparing current practices with projected gains in efficiency, safety, and regulatory compliance. If the decision is made to outsource, a project plan should be developed that includes an approved list of standardized syringe concentrations, preprinted label templates for all syringes, standardized medication tray configurations, and processes for restocking and ordering inventory. As with any project that affects multiple departments and disciplines, the effective implementation of outsourced OR syringes will only be successful when conducted in a transparent and coordinated effort with anesthesia.
Alexander T. Jenkins, PharmD, MS, is the manager for ambulatory services and medication safety officer at WakeMed Health & Hospitals in Raleigh, North Carolina. He completed a 2-year health-system pharmacy administration residency at the University of North Carolina Hospitals and graduated with a MS in health-system pharmacy from the University of North Carolina at Chapel Hill. He also earned a BS from the College of William & Mary and a PharmD from the University of North Carolina.
Abbie Williamson, PharmD, MHA, BCPS, is the pharmacy operations manager at WakeMed Health & Hospitals. After graduating from the UNC Eshelman School of Pharmacy in 2004, she completed two years of residency at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina. Abbie also received a master of healthcare administration degree from the UNC Gillings School of Global Public Health.