With the strategic use of pharmacists and automation in the OR, medication errors, accountability, and diversion can be positively impacted. These same resources also can improve drug usage, and ensure compliance with accreditation standards and state and federal regulations, while also encouraging more comprehensive clinical recommendations. Investing in an OR-dedicated pharmacist and strategic deployment of automation are particularly important for centers that have extensive operating facilities or perform complex surgeries.
Advocate Christ Medical Center & Children’s Hospital (ACMC) is a 695-bed community teaching, research, and tertiary care hospital. As a level I trauma center and a level III perinatal center, ACMC’s pharmacy department comprises a 24-hour main pharmacy; an OR satellite pharmacy; a pediatric satellite pharmacy; a pediatric oncology satellite pharmacy; a pharmacy satellite in the outpatient pavilion that services an infusion center, outpatient clinics, and outpatient surgeries; and a pharmacist-run anticoagulation clinic.
The OR satellite pharmacy provides services to a full surgical suite for both inpatient and outpatient surgeries and jointly oversees surgeries performed in a newly opened outpatient pavilion. The OR pharmacy is open 12 hours per day Monday through Friday and services a 22-bed OR that performs approximately 13,000 inpatient surgeries and 10,000 outpatient surgeries annually. The pharmacy is staffed by a full-time pharmacist and a technician who offer a range of services, including aseptic compounding, medication charging, narcotic distribution and surveillance, general drug distribution, pre-surgical antibiotic review, and formulary review, and also educate providers on new medications and drug protocols.
A core function of the OR pharmacy is to oversee the narcotic surveillance program, which acts to prevent and identify drug diversion. The sheer volume of opioids and sedative agents that are administered and stored in the perioperative setting provides an ideal environment for diversion. Furthermore, the literature confirms an increased prevalence of drug diversion and opioid abuse in the surgical setting, specifically among anesthesiologists and anesthesiology residents.1 In 1987, Talbot, et al, reviewed a group of 1000 physicians who completed the Georgia impaired physicians program. The reviewers discovered that although anesthesiologists represented only 4% of the US practicing physician population at the time, they represented 12% of the participants in the program.2 Similarly, an article published in 1993 discussed 26 anesthesiology personnel who died from overdose during the previous two years and presented a review on basic concepts of addiction, legal issues, and clinical manifestations.3 In addition, in 2005, Collins, McAllister, and Jensen published the results of a survey conducted between 1991 and 2001 revealing that an astonishing 80% of US anesthesiology residency programs reported experience with impaired residents and 19% reported at least one pretreatment fatality.4 Given such statistics, a primary goal for hospital ORs should be to ensure that a robust, closed-loop narcotic surveillance program exists that is capable of identifying drug diversion and preventing or minimizing the extent to which it occurs.
The distribution of narcotics at ACMC occurs in one of two ways depending on the location of the surgery. For inpatient surgeries, anesthesiologists obtain narcotics on a case-by-case basis from the inpatient OR pharmacy, whereas anesthesiologists involved in surgeries in the new outpatient pavilion surgical suites retrieve narcotics from anesthesia workstations (AWSs).
Anesthesiologists who perform inpatient surgeries present to the OR pharmacy prior to their cases for the day and complete a form requesting the opioids and sedation agents they anticipate needing for the day’s patients. A copy of the form is given to the anesthesiologist and a copy is kept in the pharmacy. At the end of the day, the anesthesiologist returns the form, any unused, unopened medications, and any medications that need to be wasted (ie, drawn up in a syringe and labeled). The pharmacist reconciles all opioid medications that were administered intraoperatively against the anesthesia intraoperative record and performs a random quality check of the contents of the returned, opioid waste using a refractometer. The refractometer measures the refractive index of substances and can identify when the purity of a substance has been altered or when the substance has been replaced with another agent. This routine quality check occurs daily during operating hours and includes all anesthesiologists, CRNAs, and residents who administer opioids and return waste to the pharmacy. Employing this quality check has resulted in the pharmacy identifying and addressing diversion in the past. Because the OR staff is aware of the random testing of waste, the practice is also useful as a diversion prevention tool.
Pros and Cons of Case-By-Case Distribution
Under this system, the OR pharmacy ensures that all opioids and sedative agents that are dispensed to anesthesiologists, CRNAs, and residents are documented, and that hospital protocol is followed for any missing doses. Additionally, all anesthesiologists, CRNAs, and residents are aware that the medical center has a narcotic surveillance program, that narcotic transactions are reviewed daily, and that the pharmacy performs quality checks on narcotic waste. The information from the narcotic continuous quality control system is shared with the department chair of anesthesiology to aid in deterring diversion.
Conversely, the amount of time spent by the anesthesiologists, CRNAs, and residents requesting and returning the day’s narcotics; the time spent by pharmacy to sign out, record, and reconcile narcotic transactions; and the time devoted by pharmacy to charge for the medications is substantial and could be minimized with the deployment of appropriate technology and automation. On average, about one-third of the OR pharmacist’s time is spent on administrative duties surrounding narcotic surveillance and charging activities, time that could be redirected to, for example, improving pre-surgical antibiotic selection, timing, and dosing; assisting with collecting preoperative medication histories; and providing prospective and retrospective drug therapy reviews on preoperative and postoperative patients. Additionally, during the course of a day, add-on cases and modifications to the surgery schedule often necessitate that the anesthesiologist repeat the requisition process to retrieve additional opioids or sedative agents. Because this can require a significant amount of additional time, many anesthesiologists overestimate the amount of medications needed for the day, a practice that creates additional paper work and increases the amount of time spent by both the pharmacy and anesthesiology staff on reconciliation at the end of the day.
AWS Distribution System
In the outpatient OR suites, anesthesiologists, CRNAs, and residents retrieve the medications needed for each case from a room-specific AWS. The workstations provide an allotment of opioids, sedative agents, anesthetizing agents, antiemetics, anticholinergics, and supplies that are typically used during outpatient surgeries. Because of its mobility, the anesthesiologist, CRNA, or resident uses the AWS exclusively during the course of a surgical case. The workstation has an attached return bin and, depending on the model and manufacturer, a bar code scanner to verify medication selection, as well as a label maker that integrates with the workstation to provide drug-specific, ready-to-use (RTU) labels for medications that are not provided in RTU syringes.
The OR pharmacy technician restocks the medications in the AWS during off hours, retrieves any waste from the return bin, and returns the waste to the OR pharmacist. The OR pharmacist is responsible for wasting and delivering a selected amount of the returned medication to the main OR for refractometer testing, and reconciling all opioids and sedative agents that were removed from the AWS against the electronic intraoperative anesthesia report.
Value of an Automated Approach
In 2010, The Anesthesia Patient Safety Foundation (APSF) convened a national conference to develop new recommendations to improve medication safety in the OR. These recommendations, intended to reduce medication errors, are based on four principles: standardization, technology, pharmacy/prefilled/premixed, and culture (STPC).5
As a result, we have adapted several case-specific OR kits to ensure emergency medications and supplies are readily available, thereby reducing delays in care and minimizing delays in selecting or prescribing the wrong medication during an emergency. These kits include a pediatric and adult open heart kit (consisting of medications such as electrolytes and hemostatic, colloidal, and antiarrhythmic agents, etc), a hyperthermia kit (consisting of medications such as dantrolene and selected electrolytes, diuretics, antiarrhythmic agents, etc) and an obstetric epidural kit (consisting of anesthetizing agents, etc).
In addition, the deployment of AWSs and labeling technology assisted our facility in meeting the technology recommendations and should continue in helping us reduce medication errors and decrease patient harm. Our automated OR medication system has several advantages over our manual, case-by-case system. One advantage is that the labeling system attaches to the AWS and generates labels for all vials and ampules programmed into the formulary. These labels contain the drug name, diluent, expiration date and time, concentration, 2D bar code, and configurable institution-specific messages. In addition, the labels, which can be color-coded according to drug class, comply with 2011 Joint Commission standards and meet the intent of the ISO 26845 standard.
To configure the system, pharmacy reviews the formulary, compatible diluents, and organization-specific concentrations, and establishes the beyond-use dating parameters. This allows the provider to prep the medication and label the syringe accurately. The labeling system comes equipped with an audio read-back system that repeats the name and concentration of the drug upon scanning the medication, and the safety features of the printer meet key technology components of the new APSF recommendations.
Because drug-specific, dose-specific, color-coded labels are printed in the outpatient OR only when the medication or vial is scanned into the system, the potential for mix-ups is minimized compared with the case-by-case dispensing method, wherein the provider selects the label from a manual label dispenser. With multiple labels to select from, the risk of selecting the wrong label for a syringe is ever-present. The practice of hand-writing custom labels to account for unusual concentrations and drug admixtures also is minimized with our automated system, as is neglecting to place expiration dates on syringes and administering medications beyond expiration dates/times.
However, because the labeling system is not integrated with our AWSs, duplicate steps are required of the anesthesiologists. For example, both the AWS and the labeling system require a separate login, as well as a separate scan; the labeling system requires a scan for safety and accuracy, whereas the AWS requires a scan for patient charging. Ideally, the anesthesiologists would like an integrated system that can complete both steps with a single scan. Our organization is currently working to be a beta-test site for this technology once it has completed the alpha testing phase.
Creating Efficiencies in the OR
With the deployment of the AWSs in the outpatient pavilion, providers only have access to the medications necessary for a specific surgery. This minimizes the number of individuals transporting narcotics and sedative agents between the OR suites and the pharmacy, and makes better use of anesthesiologists’ time. Since billing occurs electronically at the transactional level, the need for manual charging is eliminated and the number of lost or erroneous charges is reduced. For organizations looking to maximize workflow efficiency while still maintaining a robust surveillance system, an AWS may complement an existing narcotic surveillance program. Furthermore, pharmacy can elect to maintain a 100% narcotic reconciliation system of narcotics removed from the AWS versus what was documented as administered in the medical chart, or implement a randomized audit of narcotic removals versus administrations.
An additional benefit may be realized in the future when interfaces are developed to share transactional level information between the AWS and the electronic medical record (EMR). Ideally, a highly integrated system would create an exceptions report that lists all narcotics pulled from the AWS that were not documented as administered or wasted in the EMR. Such a system would drastically reduce the amount of time pharmacy spends on narcotic reconciliation.
Data from the automated system can be leveraged to assist with making formulary decisions, managing drug shortages, and tracking usage patterns and inventory levels. For example, our system generates reports that estimate usage over a specified time period. Given that RTU dose-specific syringes have a much shorter stability period, are generally more expensive, and incur much more waste, the usage reports have provided valuable information to assist with managing the inventory level of these agents to minimize waste.
Reflections on Workflow and Future Growth
The deployment of automation in the outpatient OR has provided valuable benefits including reducing the pharmacy’s time in managing and reconciling narcotics, providing better security solutions for narcotics, allowing prescribers to easily view formulary agents and their standard concentrations, providing an accurate expiration date and time on labels for medications that are drawn up in the surgical setting, and hardwiring bar code technology into surgical workflow to further reduce patient harm. With better inventory and formulary management systems, pharmacy is able to reduce the resources necessary to dispense and oversee the narcotic system, and then redeploy staffing resources.
From a financial perspective, the addition of automation results in decreased inventory levels, waste minimization, and a much more robust reporting system. For facilities that are expanding the number of surgeries and/or procedure rooms, minimizing and better leveraging pharmacy’s time in overseeing controlled substances is beneficial to all parties.
In the future, the ACMC pharmacy would like to purchase AWSs for the inpatient OR. This will standardize our inventory and distribution systems in the outpatient and inpatient ORs, reduce the amount of time that the pharmacy spends on narcotic oversight, and allow us to provide additional clinical activities in perioperative settings consistent with the ASHP Guidelines on Surgery and Anesthesiology Pharmaceutical Services.6 Additional activities the pharmacy would like to provide within the next 18 to 24 months include preoperative collection of medication histories; review, verification, and monitoring of pre- and postoperative antibiotic use; review of drug therapy to improve postoperative nausea, vomiting, and pain; and reduction of PACU holding times. Leveraging automation will be critical to meeting these goals.
Judith Brown-Scott, RPh, is the pharmacy manager of operations and quality at Advocate Christ Medical Center & Children’s Hospital in Chicago. Judith received her BS degree from Midwestern College of Pharmacy and is in her last semester at the University of Florida’s Working Professional PharmD program. She worked at the University of Chicago for five years where she implemented several practice model enhancements, including creating a non-traditional residency program. Judith received an ASHP Best Practice Award in 2011 for her work in creative application of changing the pharmacy practice model at an academic medical center and currently oversees the inpatient and OR satellite pharmacy operations at ACMC. She led the implementation of 13 AWSs in the outpatient pavilion and currently oversees the implementation of automation for a major pharmacy redesign project.
Rolla Sweis, PharmD, MA, BCPS, is the director of the department of pharmacy at Advocate Christ Medical Center & Children’s Hospital in Chicago. Rolla received her PharmD from the University of Illinois and holds an MS in organizational leadership from Lewis University. She also is an adjunct clinical professor for the University of Illinois College of Pharmacy. Rolla established pharmacy services in the ED at ACMC and has received two ASHP Best Practice Awards relating to her work and research in the ED.
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