The relatively recent evolution of pharmacy operations in the perioperative setting has led to the creation of an engaging practice that encompasses distributive functions, as well as clinical oversight of anesthesia, surgical, and nursing medication use. To enable this, operating room (OR) pharmacies are designed to provide medication security, improve charge capture, reduce costs, manage controlled substances, and ensure compliance with regulatory standards.¹ As we continue to work toward meeting the overarching goals of the Pharmacy Practice Model Initiative, pharmacy’s involvement with clinical services in the perioperative environment is becoming increasingly vital. However, developing and maintaining a significant presence in this environment comes with its own unique challenges.

Duke University Hospital, a tertiary and quaternary care hospital, is licensed for more than 1100 beds and operates over 50 ORs, comprising the major surgery suite, an ambulatory surgery center, and an eye center. Four on-campus OR satellite pharmacies manage the medication-use process in each of these platforms. The main hospital opened its first OR pharmacy satellite in 1980; it was not until many years later that the other satellite pharmacies—those serving the ambulatory surgery center, eye center, and extension to the main surgery suite—opened in 2000, 2009, and 2013, respectively. 

Providing robust pharmacy services to ORs that manage an average of more than 100 cases per day requires extensive collaboration with perioperative teams, and in turn, ensures patient safety, improves regulatory compliance, and increases revenue management outcomes.

Perioperative Drug Management
Medication management in the perioperative setting is unique and challenging given the variety of providers utilizing medications. Typically, these can include pre- and post-anesthesia care unit (PACU) nurses; OR nurses; anesthesiologists and surgeons (residents, fellows, and attendings); and certified, registered nurse anesthetists (CRNAs). In addition, depending on an institution’s practice, medication transporters, such as anesthesia technicians, also may assist with distribution functions. Therefore, a thorough understanding of the types of providers working in your ORs and their varying scopes of practice is necessary in order to develop effective medication management strategies. 

Furthermore, common pharmacy challenges in this practice area include timely medication preparation and delivery, prospective order verification, efficient inventory control and waste reduction, and strict controlled substance management. Thus, establishing a satellite pharmacy in the vicinity of the ORs can improve the safety and efficiency of product ordering and dispensing, as well as enhance the relationship between perioperative services and pharmacy, which helps foster a culture of open collaboration and partnership between mutually dependent care providers. 

Timely Drug Preparation and Delivery
Surgical cases in the OR frequently require emergent-need medications, such as vasoactive drips, heparin irrigations, and other medications that may not be commercially available. Thus, standardization is key to ensuring the safe and efficient preparation of compounded sterile preparations (CSPs) for use in the OR. At Duke, we worked with perioperative team members to identify commonly ordered CSPs, such as dexmedetomidine bolus syringes, cardioplegia solutions, and tranexamic acid infusions, and developed standardized concentrations. These products are batch-prepared daily and a pre-determined, minimum quantity is kept in the OR pharmacy at all times so that when needed, these medications can be quickly dispensed to the ORs. We also developed standardized formulations for many of the less commonly used preparations in the ORs, such as tumescent solutions and intraocular foscarnet, to ensure timely preparation and provision when needed. 

To reduce the risk of push back from providers based on the creation of standardized CSPs, our pharmacy team met with key physician leaders, with whom we developed strong relationships, to help devise a plan for standardization. We used this time to gather evidence-based recommendations and prepare data regarding the positive safety and cost impact of enabling pharmacy to prepare CSPs in a standardized form. In our experience, this approach affords minimum resistance, given its collaborative nature in the effort to improve safety and reduce costs. 

Prospective Order Verification
In the PACU and OR, a process for prospective verification of every medication order can be quite challenging to implement and maintain. In our case, the use of technology and automation, including computerized prescriber order entry (CPOE) and automated dispensing cabinets (ADCs), has been the most helpful tool in enabling us to reach our order verification goal of 100% in the PACU. However, we continue to work toward a goal of 100% prospective order verification in this area.

With more than 100 surgical cases daily, managing first-start case order verification in a timely manner in the pre-operative unit has been difficult. Our standard surgery scheduling makes it common for 30 or more patients’ orders to be activated within 30 to 60 minutes of one another. During this time, OR pharmacists manage drug dispensing and CSP checking, and respond to drug information requests while simultaneously attempting to verify orders in the medication work queue. Hence, it is virtually impossible to manage these tasks while ensuring 100% prospective order verification. To improve this process, we utilize CPOE with clinical decision support for the ordering provider. In addition, we implemented an auto-verification support process for medications located in the pre-operative unit ADCs. A committee of pharmacy and nursing leaders reviewed all requests for additions to this ADC prior to implementation of the auto-verify system. This team determined which medications would not be acceptable to stock in the ADC, such as antibiotics, to reduce medication safety risks. Under this system, if the pharmacist is busy with another task, the nurse is able to continue the process by prepping the patient and pulling the required medications; auto-verified orders still appear in the pharmacist work queue for final review, and pharmacy intervention remains viable. In the PACU, we have disabled the auto-verification function and instead utilize fully profiled ADCs.

In the OR, many of the medications required for surgical operations, such as ondansetron, neuromuscular blocking agents, and local anesthetics, are restocked by the satellite OR pharmacy in standardized kits and trays, which are stationed in the OR suites or picked up daily from the OR pharmacy. Other medications and CSPs are provided via verbal or CPOE order. This was another area where we collaborated with the perioperative team to identify specific medications or classes of therapy that should always require a CPOE order, and these CPOE orders receive 100% prospective order verification. For example, chemotherapy or immunosuppressant medications all require a physician order to be placed in CPOE prior to pharmacy preparation and dispensing. 

Inventory Control and Waste Reduction
Clearly, pharmacy oversight in the perioperative environment can help streamline medication distribution and storage functions for OR operations.^2,3 Prior to pharmacy’s direct involvement, the perioperative team was responsible for ordering their own medication inventory and ensuring secure drug storage in the OR. However, given its expertise, pharmacy’s ownership of these processes has helped reduce inventory costs and product waste, and has improved compliance with regulatory standards for medication storage. 

The pharmacy department conducts inventory counts of the OR pharmacy satellite twice each year, which identifies the total cost of medications in stock. We then use the data to determine the inventory turnover ratio, which provides insight into how well pharmacy is controlling inventory. Generally, higher inventory turns mean that product is moving faster off the shelf, which has a positive impact on net income. ADCs also allow us to review reports on par level versus usage, which show the total par per item, as well as how often inventory turnover in the ADC occurs for each item. These reports aid in fine-tuning inventory in the ADC, and thus, reduce medication expenditures.

Multiple strategies are utilized to reduce waste in the OR, including modification of CSP batch pars, implementation of practice guidelines to reduce prophylactic preparation of medications, and implementation of premixed syringes and bags that split large medication doses into unit-of-use products. One specific waste reduction strategy that has been successful at Duke involves pharmacy oversight of the preparation of dexmedetomidine syringes for intraoperative anesthesia use. Pharmacy staff identified that a large quantity of these syringes were wasted daily, which triggered a review of the preparation and dispensing process. We discovered we had been preparing 40-mcg bolus and 200-mcg premixed infusion syringes, and the unused quantity equated to 13 full vials (200 mcg/vial) of drug (valued at approximately $800) being wasted every day. Upon EHR review, we identified that the average dose administered to patients was less than 20 mcg, given as a bolus. This prompted us to decrease the total number of syringes prepared daily, in addition to reducing the dose of the bolus syringe to 20 mcg. 

After implementation of this change, the average cost of dexmedetomidine for the OR was reduced by $120,000 annually. The next step will be to conduct stability and sterility testing of the product to assess the feasibility of beyond-use date extension to further reduce overall wastage of this product.

Controlled Substance Management 
Managing controlled substances in the perioperative environment, specifically anesthesia use in the OR, is of vital importance for hospitals. It is worth noting that anesthesia providers are at an increased risk for abuse of, and dependency on, opioids and other potent anesthetics;4 therefore, a tight control system for these medications is necessary to prevent diversion. 

The two primary processes for tracking controlled substance utilization are via manual log or through automated tracking. At Duke, we use a hybrid process depending on the unit we are servicing and the medication required. ADCs are used for dispensing, wasting, and returning controlled substances in all of the ORs, and each ADC requires a witness to waste or return a controlled substance. However, certain infrequently used medications are not stocked in ADCs and must be obtained from the satellite pharmacy. For these situations, the satellite utilizes a manual tracking process with a dispense log, which is housed in the pharmacy, and a record-of-use log, which stays with the provider. At the conclusion of each case, the provider returns the completed record-of-use form and all unused product to the pharmacy. The pharmacy team then serves as the witness to wasting or returning the unused product. 

In addition to auditing the dispensing, wasting, and returning practices, a full reconciliation is needed that matches dispensing and waste/return with medication administration, which can be a time-consuming process. To enable this, an institution must identify a portion of cases, or all cases if staffing allows, that should be reconciled for auditing purposes. For example, at Duke we complete a full reconciliation of 5%-10% of cases daily. We also are developing an electronic report that will directly reconcile controlled substances dispensed from or wasted/returned to the ADC with the eMAR. Ideally, this report will be designed to track 100% of surgical cases and allow us to trend utilization by user and by surgeries performed. 

Pharmacy Staffing Levels
Determining the ideal number of pharmacy FTEs required to service the OR is key to ensuring adequate coverage and effective workflow. At Duke, we have a total of 6.4 pharmacist and 7.5 pharmacy technician FTEs that staff the morning and evening shifts in our two main satellite OR pharmacies. (See FIGURE 1 for shift assignments.) Furthermore, information is widely available in the literature that discusses how to justify implementation of an OR satellite pharmacy and OR pharmacy services through evaluation of potential revenue enhancement in the unit. In the Duke ORs, we utilize doses dispensed as the productivity metric to help identify the number of FTEs needed to service the area. In addition to looking at doses dispensed, we also review revenue enhancement and cost reduction strategies for the current and upcoming fiscal year to justify the addition of new staff. Currently, we have plans to implement a new metric, volume of surgical cases, to identify FTE needs. Our end goal is to utilize the volume of cases adjusted by patient acuity, with the addition of other productivity metrics, such as doses dispensed, to assist in developing the FTE budget.



Medication Safety Risks
As is common in many hospitals, our intraoperative anesthesia and surgery providers are solely responsible for prescribing, dispensing, and administering intraoperative medications—many times without pharmacist involvement—thereby creating a significant point of risk. The double checks that are standard on the units may not always be viable in the OR environment given the often emergent nature of medication administration. Likewise, due to the powerful narcotic nature of many surgical agents, a lack of pharmacy oversight can enhance diversion opportunities. For these reasons, standardization is extremely important when managing medication therapy in the perioperative setting. For example, at Duke we standardized our anesthesia medication tray layouts, which helps providers quickly identify emergent medications regardless of the OR they are in. Another example is through the standardization of acceptable concentrations for drug administration. Frequently, providers cover for their colleagues during breaks, lunches, etc, and medications are often already prepared and are left sitting on the medication cart until they are ready for use. In these cases, where the medications will likely be used by the covering provider, it is especially important that the preparations be made available in standard concentrations to reduce the risk of human error and prevent the potential for over- or under-dosing a patient, as providers may assume the product is in the same concentration as they would normally prepare themselves. 

Another point of risk involves medication labeling. We place considerable emphasis on educating surgery and anesthesia providers on the required elements of a medication label. In addition, we conduct random audits of anesthesia providers to ensure compliance with labeling, and we also implemented printing technology that allows us to prepare ASTM International-compliant, color-coded labels for anesthesia-specific products. Finally, to simplify the process, we purchased pre-printed medication labels that include all of the necessary elements, including drug name and concentration, to reduce the amount of information the provider needs to fill in. 



Drug Shortages in the Perioperative Environment 
Over the past five years, drug shortages have had a large impact on intraoperative medication therapy. Many of the common surgery and anesthetic agents—including succinylcholine, neostigmine, glycopyrrolate, remifentanil, vecuronium, cisatracurium, papaverine, and lidocaine—have been on shortage, and some of these shortages are ongoing. When critical medications—such as those that have become the gold standard of care—are on shortage, our clinicians are left with difficult decisions on how to deliver the same level of patient care while using alternative agents and/or practices.

Approximately four years ago, Duke implemented a policy and procedure to aid with shortage identification, collaborative plan development, and communication of shortages, which has aided in streamlining the process. At the first sign of a critical shortage that is specific to the perioperative setting, the Duke multidisciplinary drug shortage response team convenes a meeting. This team comprises service-specific clinicians, including anesthesiologists, surgeons, OR nurses, CRNAs, and clinical pharmacists. The team is charged with determining the level of change needed to provide excellent patient care, despite the shortage. Examples of shortage management actions performed in the past include:

• Utilizing alternative products
• Implementing restrictions (eg, eliminating use of succinylcholine for elective cases; using rocuronium for rapid sequence intubation) 
• Compounding premixed syringes/bags into unit-of-use products, which helps to split commercially available doses into two or three doses that can be used for multiple patients
• Centralizing medication supply at the OR satellite pharmacy to reduce inventory in ADCs that may go unusedFor more information, see PP&P’s January 2013 article, Management of Drug Shortages in the Perioperative Setting.

Conclusion
Medication management in the perioperative environment is challenging; however, with the implementation of pharmacy services, revenue enhancement, improved medication safety and oversight, and improved inventory control are achievable. The financial and safety impact also justifies the addition of pharmacy services in the OR and increases the collaborative culture between the perioperative team and pharmacy.

References

1. Fiala D, Grady KP, Smigla R. Continued cost justification of an operating room satellite pharmacy. Am J Hosp Pharm. 1993;50(3):467-469.
2. Stroup JW, Iglar AM. Implementation and financial analysis of an operating room satellite pharmacy. Am J Hosp Pharm. 1992;49(9):2198-2202.
3. Brakebill JI, Schoeneman PF, Buchanan B. Effective management strategy for establishing an operating room satellite pharmacy. Hosp Pharm. 1988;23(11):961-968.
4. Wright EL, McGuiness T, Moneyham LD, et al. Opioid abuse among nurse anesthetists and anesthesiologists. AANA J. 2012;80(2):120-128.

Christopher Murray, PharmD, MS, is the manager of perioperative pharmacy services at Duke University Hospital. He received his PharmD from Hampton University in 2008, along with a minor in leadership studies. At Duke, Christopher’s staff operates 24 hours a day, seven days a week to provide comprehensive clinical and operational pharmacy support to over 50 operating rooms and more than 80 adult PACU and pre-op beds in the main hospital and the Duke Eye Center. His professional interests include pharmacy leadership, mentorship, and medication safety.