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This chapter presents an overview of medication safety hazards and mitigation strategies during the perioperative period. The goal of the chapter is to aid surgical team members to better appreciate the complexity and mitigate the risks of the medication use process. The perioperative environment is complex and marked by a high degree of safety hazards. Thankfully, this patient care setting has seen remarkable progress in patient safety and reliablity over the past few decades. Advances in perioperative care have saved countless number of lives and improved surgical patient outcomes from preventing medical gas tube misconnections to rescuing patients during crises situations. Needless to say, many of these advances are the result of painful lessons following catastrophic incidents that were linked to patient disability and/or death.
Despite advances in safety practices, the perioperative medication administration remains one of the most vulnerable for unsafe patient outcomes due to several reasons. For example, the intraoperative medication process—managed primarily by anesthesia providers—lacks key safety guardrails enjoyed by practitioners in other areas of the hospital. Medications are primarily ordered, dispensed, prepared, administered, and monitored by the same anesthesia provider, removing the potential for valuable safety checks by other clinicians such as pharmacists and nurses. Additional factors that contribute to this safety vulnerability, but are not limited to, poorly designed technology and user interfaces, uncertainty of patient information, cognitively demanding tasks and a lack of appropriate support, poor teamwork, ambiguous communication, inadequate work coordination, little performance feedback, and a poor unit culture.
Healthcare organizations have instituted several measures to improve medication safety in the perioperative setting. Key interventions include color-coding of medication labels and containers, using prefilled syringes of medications, standardization of medication concentrations, and deployment of safety enhancing technology such as smart infusion pumps. Technologies such as point-of-care barcode systems—though widely used in other areas of the hospital—are yet to be fully leveraged during anesthesia at the point of care, including in assisting with syringe labeling and automated documentation of administered medications. Even in the context of such progress and safety investments, medication errors continue to occur in the perioperative care setting and harm patients. A recent study, for example, showed that 1 in 20 medication administrations was associated with a medication error and/or adverse effect.
There is a need to reexamine existing management strategies, improve current systems that remain risky, and ensure implementation of effective and reliable strategies that have been learned from analyzing perioperative adverse events. Creating a culture of safety and continuous learning where speaking up is encouraged and deep reflection after practice is supported will be key and where data generated during routine care are consistently used to improve medication safety and overall patient outcomes. We emphasize that medication safety is produced or degraded as a result of a complex interplay among social and technical systems—collectively referred to as a sociotechnical system—situated within the perioperative care delivery setting. We believe that this reframing of the perioperative service line will help the reader embrace a new view of medication safety hazards, enabling technologies and potential solutions.
The perioperative setting is a sociotechnical system with high complexity—where social (i.e., people) and technical elements interact and work together to produce individual and shared goals. Each of the preoperative, intraoperative, and postoperative phases involves multiple clinical roles, care protocols, and medical technologies, including hardware and software (e.g., electronic health records (EHRs), computerized provider order entry (CPOE), and clinical decision support (CDS) systems, infusion pump systems, etc. Even though each surgical patient goes through the perioperative care process in the same order, care events may manifest quite differently due to the wide variation in their disease types and states, patient characteristics and comorbidities, provider preferences, resource availability and constraints, the inherent uncertainty in the process and given different unit, and organizational cultural environments. In particular, unexpected variations have amplified effects on subsequent procedures, all relevant services, and downstream hospital units.
To achieve reliable care and operational efficiency in this dynamic environment, each team member must be responsible for their specific tasks while working collaboratively and interdependently throughout the perioperative process. In this system, not only do the clinical actors and clinical technologies need to collaborate, interact, and follow protocols, they also need to be comfortable speaking when they see a problem and have the ability to respond appropriately and quickly to unanticipated events or situations. A high level of coordination in terms of resource allocation, physical and information workflows, communications, as well as a sustained culture of safety are essential in each steps of the clinical process in order to achieve reliable outcomes.
The perioperative complex sociotechnical system has inherent challenges and increased opportunities for potential errors and harm. Several aspects of the process are key. First, a variety of medications need to be correctly prepared and appropriately stocked in the operating room (OR) for a surgical case. At times, the anesthesia provider needs to quickly and accurately administer the right medications in response to an unexpected situation. This cannot be achieved without the correct medications and dosing tools readily available. Clinicians must also follow the correct sequential steps when preparing and administering these medications. Second, patient information and clinical records, such as anesthesia notes, infusion records, and nursing documentation, need to be updated quickly and truthfully to ensure patient status and conditions are the most up-to-date and available to all surgical team members. Third, communication and coordination between and among members of the surgical care team, within and between perioperative phases, is highly shaped by implicit organizational norms and needs to be accurate and effective.
While intraoperative medication use may receive the most attention and direct oversight of the anesthesia provider, the pre- and postoperative phases represent dangers to the patient and different challenges to safe medication administration. This is particularly important when care responsibility is handed off across service boundaries, such as when a patient is moved out of the OR and transferred to the postanesthesia care unit (PACU). Under these circumstances, multiple factors can contribute to unsafe conditions including, but not limited to, differences in drugs and dosings, and variable technology used across these settings (e.g., different narcotics, infusion pumps and dosing configurations), differences in medication concentrations, and professional norms and expectations unique to each particular clinical setting.
Communication gaps across care settings is a key contributor of unsafe medication practices. For example, the ability of clinicians in the PACU and ICU to easily access and view intraoperative anesthesia records not only influences therapeutic decisions but also can have a direct impact on planning and safe medication practices. Communication gaps may also be exacerbated by unanticipated external pressures, as in the case of the COVID-19 pandemic. Early in the pandemic, the sole focus on containing the infection and protecting clinical staff drove key workflow decisions across many healthcare organizations, such as in limiting clinical staff to the most essential personnel, canceling, or postponing non-urgent elective surgical procedures, and restricting family visits. For example, during the immediate postoperative period, a family member may be the only person to receive education on postoperative plans and medications that need to be continued after the patient is discharged. Limited interactions with family members meant lost opportunities for education on safe and appropriate medication use, which often is the only instruction a patient may receive before a patient is discharged, and before they see an outpatient provider or a member of their surgical team during a follow-up visit.
Fig. 11.1 depicts the perioperative sociotechnical workflow system with the opportunities for medication safety advancement. The top part of the figure depicts the patient/family journey before, during, and after the surgical experience, highlighting the longitudinal care needs of the patient across the care continuum. The alignment of the perioperative work system's resources and processes (lower part of the figure) to the patient/family needs is key to achieve safe patient outcomes. The timeline suggests this may not always be the case and gaps in care may develop when the patient transitions from one setting to another (e.g., from postoperative care to home discharge).
Technology plays a key role in risk reduction through a variety of technologies such as CPOE with CDS systems that may recognize dosing errors and reduce transcription errors. Other technologies include infusion pumps, automated dispensing cabinets (ADCs), and electronic documentation of medication administration and patient information. Technologies such as barcode medication administration (BCMA) systems are rarely used at the anesthesia point of care, with current reports of their use mostly limited to research studies. However, many frustrations still exist with the usability, interoperability, and implementation of these technological advances. Another concern is that these complex order entry systems and barcode technologies have been reported to add to the cognitive load on nurses and physicians and degrade their communication and may result in medication administration delays and errors. The following section provides a brief overview of the most common medication safety technologies in current use.
An infusion pump is a medical device that allows clinicians to deliver controlled amounts of fluids—such as intravenous (IV) medications and nutrients—into a patient's body. Although infusion pump designs can vary by vendors, most share similar core features. The ability to program volume and a rate of medication flow allows precision in medication delivery—an advantage over traditional methods of IV medication administration. While infusion pumps have been in use since the 1960s, significant improvements in their safety mechanisms were only realized in the last two decades when “smart” infusion pumps were introduced on the market. Smart infusion pumps feature a Dose Error Reduction Software/System (DERS) that helps prevent programming errors. The DERS allows incorporation of predefined drug dose limits within which a medication can safely be administered and generate alerts when these limits are violated. Smart infusion pumps help prevent programming missteps that were common sources of serious medication errors in the pre-smart infusion pump era.
In contrast to other areas of the hospital, some of the key safety features of smart infusion pumps may be challenging to implement in the OR. For example, the hard dose limits seen elsewhere (where a provider cannot proceed with pump programming unless input settings are changed) would be impractical to deploy in the urgent and changing circumstances of intraoperative care where medications need to be rapidly titrated in response to changing patient circumstances and a desired pharmacologic effect such as when the patient's blood pressure drops precipitously. For this reason, smart infusion pump may include an “Anesthesia Mode,” a pump configuration “workaround” which allows no restrictions on programming by the anesthesia provider, effectively bypassing the safety potential of the infusion pumps. This mode supersedes the pump's preprogrammed drug limits and allows the anesthesia provider to work-around the smart infusion pump's limits and potentially to cause serious adverse drug event by delivering the wrong medication dose/drug/rate of infusion.
With widespread adoption of EHR systems, the opportunity exists for greater integration and true interoperability between the pump system and other clinical technologies including BCMA and EHR. Multiple health systems in the United States are slowly undertaking this form of integration outside of the OR, and to achieve additional safety by preprogramming the infusion pump with verified medication orders directly from the EHR as well as documenting pump-delivered medications directly into the EHR. However, in 2022, only about 15% of hospitals in the United States purported to using auto-populated data in their infusion pumps. [CR] With a deeper understanding of the OR workflow and clinician's needs, these interoperability principles may be leveraged to bring an additional safety layer and add more resilience to the OR environment.
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