US Pharm. 2022;47(10):HS-14-HS-16.
In August 2022, the Institute for Safe Medication Practices (ISMP) released guidelines for safe medication use in perioperative and procedural settings (www.ismp.org/resources/guidelines-safe-medication-use-perioperative-and-procedural-settings). These guidelines were funded by the FDA and were based on the national results from the ISMP Medication Safety Self-Assessment for Perioperative Settings, a review of the literature, data from the ISMP National Medication Error Reporting Program, onsite clinical observations by ISMP, consensus feedback from a national perioperative summit, and public comments. The result was 71 best practice statements intended to enhance medication safety in the perioperative and procedural settings.
While these guidelines address recommendations in 10 domains (including patient information; drug information; communication of drug orders and other drug information; drug labeling, packaging, and nomenclature; drug standardization, storage, and distribution; environmental factors, workflow, and staffing patterns; staff competency and education; patient education; quality processes; and risk management), the focus of this article will be on medication delivery device acquisition, use, and monitoring, and the role that smart infusion pumps (SIPs) play in enhancing medication safety in perioperative and procedural settings.
Minimizing Human Error
The potential for human error is minimized through SIP technology. The guidelines call for the implementation of SIPs with an engaged dose error–reduction system (DERS). ISMP defines DERS as “the integral computer software in SIPs intended to aid in the prevention of infusion programming-related errors and (to) warn users of potential over- or under-delivery of a medication or fluid by checking programmed doses/rates against facility-configurable preset limits specific to a medication/fluid and to a clinical application and/or location.” SIPs/DERS should be utilized for the administration of continuous, intermittent, secondary, and regional anesthesia infusions as well as for patient-controlled analgesia. SIP/DERS technology should be employed for the administration of IV hydrating solutions to help reduce the risk of complications secondary to fluid overload or underhydration.
Organizations should set a goal of >95% compliance for their practitioners to utilize SIPs/DERS for the administration of all infusions. This goal should also apply to epidural and nerve-block infusions. Libraries for anesthesia-related medications and fluids should be developed and maintained along with tailored DER limits. Upper and lower hard limits should be identified for specific populations, such as adults, pediatric patients, or neonatal patients for drug doses, concentrations, infusion rates, and loading doses or bolus doses administered via the SIPs. Safe dosage ranges that consider patient-related factors such as age, opioid status, and/or organ function should be established for perioperative IV push doses and/or infusions of high-alert medications such as opioids, midazolam, heparin, insulin, vasopressors, and neuromuscular blocking agents, local anesthetics for peripheral nerve blocks, neuraxial anesthesia and/or epidural injections/infusions, and antibiotics.
Further, only a limited number of standard drug and solution concentrations of high-alert medications, hydration solutions, regional and neuraxial anesthesia, peripheral nerve blocks, parenteral medications used during eye surgery, irrigation solutions and flushes, cardioplegic solutions, and medications administered via elastomeric pumps should be available in the perioperative setting. Unlike SIPs, elastomeric pumps contain a stretchable medication reservoir ball that uses pressure from the balloon to deliver medication at a steady rate.
Electronic Health Record Interoperability
A goal should be to work towards bidirectional SIP electronic health record interoperability in all pre-, intra-, and postoperative and procedural settings such that there is autoprogramming and autodocumentation of SIP-derived data. When appropriate, loud, activated clinical alarms should be employed in the perioperative setting based on data review, but clinically nonactionable alerts should be minimized.
SIPs should also have separate hard limits for bolus or loading doses so that these doses are not able to be administered via continuous infusion if the rate of infusion is increased and/or the settings are changed to the basic infusion mode.
The Pharmacist’s Role
Pharmacists should advocate for the adoption of medication-related technology and safety resources such as SIPs and DERs in the intraoperative setting, ambulatory surgery centers, and ambulatory settings. They should also be an integral part of the interdisciplinary team driving decision-making regarding the development of DERs and drug libraries, assisting with training on the use of SIPs, developing policies about the use of SIPs, and assisting in the evaluation of medication errors or adverse events related to the use of SIPs as well as in the analysis of data from SIPs such as compliance rates, percentage of overridden alerts, and percentage of alerts resulting in reprogramming. These guidelines can assist pharmacists in these efforts.
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