Safety of Anesthetic and Perioperative Medication Practices

Introduction

A 2016 study from researchers at Johns Hopkins analyzed medical death rate data over an eight-year period. The study found more than 250,000 deaths per year are due to medical errors. This number would place medical errors as the third leading cause of death in the U.S. after heart disease and cancer if medical errors were classified in the disease ranking.¹

Medication errors are some of the most common causes of medical errors.² In a 2019 systematic review and meta-analysis, Panagioti et al reviewed 337,025 cases in a pooled sample of patients and found that one in 20 patients are exposed to preventable harm in medical care. Drug management accounted for the highest category at 25% of preventable patient harm causes.³

The World Health Organization (WHO) describes unsafe medication practices and medication errors as a leading cause of injury and avoidable harm in healthcare systems worldwide. The estimated global cost associated with medication errors is $42 billion each year. Errors can occur at different stages of the medication-use process, and in any area that orders, stores, prepares, prescribes, transcribes, verifies, administers or monitors medications. These errors result when weakened medication systems or processes and/or human factors such as fatigue, inadequate environmental conditions or staff shortages occur. The patient outcome can result in harm, permanent injury or death. The WHO’s initiative, “Medication Safety Without Harm,” was launched March 29, 2017, which aimed to reduce severe avoidable medication-related harm by 50% globally in the following five years.⁴

Unfortunately, risks to patients may not have declined but may have risen even higher over the past 2.5 years. Almost three years after the beginning of the COVID-19 pandemic, hospitals and healthcare entities are faced with greater employee shortages, turnover and use of relief/traveler staffing. In addition, healthcare workers are suffering from stress, fatigue, burnout and turnover, and this can prompt individuals to resign, seek early retirement or pursue a change of employer for higher paying temporary traveling positions. The problem may have intensified as COVID-19 persists and new strains or variants continue to spread, with employees expressing feelings of exhaustion.⁵

To add to the challenges, some hospital staff are acquiring the virus for a second time, developing long COVID, or working longer hours due to staffing shortages and experiencing the strain of constantly training and orienting new staff. The concern is that this has become the new normal. Some leaders predict patients could face higher risks for medical errors because of the burdens placed on healthcare personnel. It will be interesting to see whether the WHO’s five-year review will show an increase in medication errors after the launch of “Medication Safety Without Harm” and following our experience with the pandemic rather than the hoped-for decrease.⁵

Focus on Medication Errors

Considerable attention on medication safety initiatives had focused on medication errors that occurred on patient care floors. Although such errors warrant efforts and ongoing evaluation, another setting carries a significant risk for patient harm when safe medication practices are not followed: the perioperative area. With an estimated 234.2 million major surgical procedures undertaken annually worldwide, the stakes are high for medication mishaps.⁶

Regardless of the care setting, a patient’s exposure to potentially and actually harmful medication events is an unfortunate but common reality in healthcare. Medication administration has always been an exceedingly complex process, and even more so now with the frequency of new medications that enter the market, unique delivery systems, complex dosing regimens, drug shortages, look-alike medications (vials, IV solutions, syringes, oral medications) and confusing and similar medication names.

A “medication error” is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer.⁷ An error occurs when someone is attempting to do the right thing but does the wrong thing.⁸ An example would be misreading a label or administering a wrong drug due to a look-alike drug vial. A “violation” occurs when there is an intentional, but not reprehensible, deviation from established practices known by the individual to be required by regulations intended to improve patient safety.⁹ An example would be failure to label a syringe followed by accidental administration of the wrong medication.

Medication errors frequently do not involve culpability or blameworthy elements; however, when a violation known to increase the risk for error occurs, blameworthy elements most likely exist.

A recent event may have changed how medical errors are perceived and handled. The event, reported on the national news, was of a nurse who administered an unknown quantity of IV vecuronium to the patient, believing it was midazolam. The nurse was convicted of criminally negligent homicide and gross neglect of an impaired adult.¹⁰

Harmful effects from medications given in hospitals are not only caused by medication errors, but also can occur from adverse drug reactions (ADRs). An ADR is an unintended or excessive response to a drug that occurs at doses normally used. Although the drug reactions are considered nonpreventable, they also can cause, as in the case of medication errors, untoward harmful effects.¹¹

Prevalence of Medication Errors in the OR

The perioperative setting is potentially a much higher area of risk than other areas of the hospital. Information about medication error rates occurring in surgical patients is somewhat limited, and medication errors may be underreported. This factor illustrates the potential dangers of high-risk medications used in the perioperative area, as well as the unique vulnerability of the patients in the perioperative setting.

In 2007, the U.S. Pharmacopeial Convention reviewed 11,000 medication errors occurring in the outpatient surgery, preoperative holding, intraoperative and postoperative settings over a seven-year period.¹² This was the largest known national analysis of perioperative medication errors at that time, and revealed that 5% of the errors resulted in harm, including four deaths. The report concluded that surgical patients are three times more likely to experience a harmful medication error than patients in other settings within the healthcare system. The authors also found that children are at heightened risk for harm throughout the perioperative continuum, with approximately 12% of pediatric medication errors resulting in harm. Patients who experienced ADRs had significantly longer hospital stays.

In other studies, the medication error rate has been estimated to be as high as one in 203 cases, with serious morbidity occurring in about 4.7% of those cases and death in about 0.3%.¹³ The APSF Newsletter, from the Anesthesia Patient Safety Foundation, reports one error for every 133 anesthetics administered.¹⁴ The most prevalent categories were incorrect doses and drug substitutions.¹⁵ These incident numbers rely on self-reporting and are likely grossly underreported.

In a 2013 review, an observational multicenter cohort study of eight surgical wards from three Dutch hospitals found 27.5 adverse drug events (ADEs) and 4.2 preventable ADEs per 100 admissions. An ADE refers to harm caused by either appropriate or inappropriate use of a medication. All wards were using computerized prescriber order entry systems with clinical decision support. The study included 567 surgical participants. One-fourth of the preventable ADEs were severe or life-threatening. The medications most associated with ADEs and preventable ADEs were opioids and anticoagulants. The risk factors associated with ADEs were patients who were classified as ASA physical status III (severe systemic disease) or higher, were older than 65 years of age, had cardiovascular comorbidity or were undergoing vascular surgery.¹⁵

Medication errors in the perioperative arena can cause significant harm and death to surgical patients, and many of these errors recur. The Institute for Safe Medication Practices (ISMP) has identified medication mishaps in the OR that have resulted in negative outcomes for surgical patients. An example is the incorrect use of topical thrombin, used to stop oozing blood and minor bleeding. This topical medication, when accidently injected systemically, can cause intravascular clotting and death.¹⁶

Other studies highlight medication errors in the perioperative area and provide a better understanding of the risks in current practice. Neily et al conducted a review of 292 root cause analysis reports involving anesthesia providers, with 36 root cause analysis reports specifically involving anesthesia care at the Veterans Health Administration from 2012 to 2015. The most common reported events were medication errors, which involved high-risk medications (e.g., heparin and epinephrine), syringe swaps, IV pump line confusion related to labeling and medication dilution errors.¹⁷

Fasting et al actively recorded anesthesia-related information for 36 months. Intraoperative problems, which included medication errors, were also noted. They found 63 cases that included medication errors. The errors were due to syringe swaps, erroneously administered neuromuscular blocking agents and ampule swaps. Although the overall rate was low when compared with the volume of surgical procedures, approximately 47% of the medication errors were ranked as moderately serious to serious.¹⁸

A 2016 prospective observational study by Nanji et al, using trained anesthesia staff as observers, found a 5.3% rate of errors or ADEs for medication administrations during surgery. The properly trained observers (four anesthesiologists and one nurse anesthetist) began the observation when the anesthesia care provider assumed care of the patient and ended the observation when the patient entered the PACU or ICU. Data collection also was abstracted from the anesthesia information system. One-third of the errors/ADEs were observed to cause harm to the patient, and the remaining two-thirds had the potential risk for harm. Surgeries lasting longer than six hours had more errors, and surgeries with greater than 12 medication administrations were also noted to have higher rates. Of the errors/ADEs, 79.3% were found to be preventable.¹⁹

In 2017, Wahr et al published a rigorous review of the literature of medication errors and medication strategies that occur during anesthesia and in the OR.²⁰ Although the focus was to identify recommendations, they found articles that used voluntary error reporting that indicated errors occurring in the range of one in every 130 to 300 surgeries. The researchers noted the scarcity of publications of randomized controlled trials of interventions to improve medication safety.²⁰

The Process of Medication Use in the OR

The process for medication administration in the OR may vary widely. Not only are medications used by anesthesia providers, but they are also used by the surgical team, and each group may employ dissimilar methods, processes and medications. The anesthesia care provider will typically use a tray or will access medications from automated dispensing cabinets (ADCs) either in each OR suite or via a central location. These are typically restocked by the pharmacy. Controlled substances, such as opioids and IV induction agents, are most likely retrieved from an ADC. Large-volume IV drips may be prepared by the main pharmacy or OR satellite pharmacy, or, in some circumstances, by the anesthesia providers.

Medications given intraoperatively are typically prescribed, prepared, administered and recorded by one person without any system or other health professional to check the process.²¹ Pharmacy verification of the order, with extra checks from nursing prior to administration, can be absent. Barcoding of each drug administration, which is common on the medical/surgical units, is not consistently done in the OR.

The OR is a high-stress area, and medication administration can be time critical. The anesthesia care provider has multiple functions to perform, including manually calculating doses, administering doses, monitoring of patients and equipment, dealing with distractions, documenting, and performing other tasks. Thus, the medication-use process is significantly different from other areas of the hospital, where the physician will prescribe, the pharmacist will dispense and the nurse will administer and monitor medication effects with expected checks at each step.

Factors That Increase Risk

Many factors can increase the risk for medication errors and/or ADEs in the perioperative setting. An inexperienced staff member placed in an unfamiliar setting with unfamiliar equipment and medications is a recipe for error. In addition, the fast pace, quick turnover and production demands can cause a distraction leading to errors. For the same reasons, emergency cases or unstable patients can create a high-risk situation. Often, a patient giving verbal feedback is an additional safety net to prevent harm due to medications. This obviously is impaired in the anesthetized or sedated patient.

Finally, the types of medications typically used in the perioperative setting often leave little room for error due to their normal effects. Because of the types of drugs readily available in a surgical setting (e.g., muscle relaxants, IV induction agents, anticoagulants and potent vasoactive agents), a syringe swap error can be particularly harmful. Nanji et al found that propofol, phenylephrine and fentanyl are most frequently associated with errors in the OR.¹⁹

Certain patient populations can be more susceptible to ADEs, for many reasons. Accuracy is particularly important in the OR because more than half of all surgical procedures are performed on patients aged over 65 years.²² For example, older patients can be more susceptible to adverse events related to medications that have sedating properties due to the physiologic changes that occur with aging and common coexisting diseases. Although ADEs can occur at any age, risk increases with age-related changes in pharmacokinetics and pharmacodynamics, comorbidities, and polypharmacy.²³ Aging patients will have progressive impairments in the functional reserve of multiple organs that will affect drug absorption, distribution, metabolism and excretion, which can further complicate anesthetic management.^23,24

To help clinicians and patients avoid potentially inappropriate medications, the Beers Criteria were developed and are updated by an expert panel convened by the American Geriatrics Society.²⁵ This is a list of medications for older adults best avoided in most circumstances or in specific situations, because of an unfavorable balance of benefits and harms.

Also, pediatric patients, especially neonates, require weight-based calculations to dose medications. Calculation errors can lead to errors in medication dosing, especially in cases where the provider only rarely cares for small children. Not all medications are FDA approved for use in children, which sometimes reduces available options and can add complexity and risk of error when the medication needs to be given to a pediatric patient. Even if the drug has been studied and is used off-label, the available dosage forms may be for adult dosing, necessitating careful calculation of the pediatric dose by body weight, and accurate drawing up of the appropriate aliquot.

The therapeutic index for a drug also may be narrower in children, with greater individual variation. Children of a similar age may differ markedly in weight, body surface area and organ system development. To minimize risk, careful attention must be given to the health condition, status and physiology of the individual child. Off-label use of medications in pediatrics is common and published data supporting this may often be lacking in dosing, efficacy and safety details and may relate only to a specific age range.²⁶ These factors contribute to a higher safety risk in children, especially in a busy recovery unit.²⁶

The ISMP Gathers Consensus

The ISMP released safety enhancements every hospital must consider: Neuromuscular blocking agents should be segregated, sequestered and differentiated from other medications, wherever they are stored in the organization. The ISMP suggests using interactive warnings during medication removal and have a distraction-free zone (avoid distractions and talking) during medication removal from ADCs.²⁷ The recent and tragic event at Vanderbilt University Medical Center highlights the need for the use of best practices. Although this event occurred in the radiology department, these agents are available in other areas of the hospital, such as the emergency department, and are in plentiful supply in the OR.

As previously noted, not all errors are equal in their ability to cause harm.¹⁰ The perioperative setting, with many high-alert drugs, likely poses even more threat for adverse drug errors than other areas of the hospital.

The ISMP was awarded a grant from the FDA to develop a self-assessment tool intended to evaluate medication safety in perioperative settings across U.S. hospitals and freestanding ambulatory surgery centers (ASCs). The ISMP gathered a group of multidisciplinary perioperative providers and clinicians to further develop the tool. The ISMP stated the purpose of the project was to provide a standard way to assess perioperative and procedural medication use and to create a baseline for national practice.

The key elements of the survey were focused on patient information, drug information, and communication of the information, drug labeling, standardization, device acquisition, environmental factors, competency, patient education and quality processes. The items in the survey were weighted on their impact on safety for the scoring of the assessment. Data were obtained from 362 hospitals and 60 ASCs.

The ISMP then invited expert faculty to a summit, titled “The Future of Perioperative Medication Safety: Charting Our Path Forward,” to discuss three priorities: labeling, workflow and barcode scanning. The ISMP used results from the assessment, literature reviews, observations from ISMP clinical consultants and feedback from the summit attendees to determine practices with the biggest opportunity for safety improvement. Seventy-one statements were prioritized. The ISMP has the statements available on its website and recommends these be used in concert with other resources, including information from the APSF, American Society of Health-System Pharmacists (ASHP), Association of periOperative Registered Nurses and other professional sources, and after careful review of applicable regulatory standards.²⁸

The Risk Inherent in Drug Shortages

Drug shortages can be another source of medication errors. Medications used frequently in the perioperative period have been off and on in short supply, forcing providers to choose different products. The substituted medication may be unfamiliar to the provider ordering the medication or to the provider administering it. These different products can lead to dosing errors when ordering or administering the medications. If the regular, stocked medications are unavailable, even for a short period of time, there is risk that their replacements can have a significant impact on patient care.

Drug shortages have caused turmoil to anesthesia practice. The ASHP tracks active drug shortages. The most recent data show that in the second quarter of 2022, there were 264 active drug shortages.²⁹

Improper medication administration techniques are an additional source of patient harm. This is illustrated by high-profile examples of inappropriate reuse of syringes and needles or improper use of multidose vials, leading to morbidity from infectious diseases—most notably, hepatitis C virus.³⁰ In addition to patient harm, the cost of treating even one infection resulting from improper technique could quickly dwarf any cost savings that may have been the goal of using multidose vials or reused syringes or needles. Contamination risks also can occur at the manufacturing, in-house pharmacy preparation level, or in cases where drugs are provided by compounding pharmacies. An outbreak of fungal meningitis due to tainted epidural steroid injections was traced back to a single compounding pharmacy that had prepared the steroids.³¹

Risk Reduction

Writing new policies or providing more education may or may not always prevent medication errors. Conscientious efforts to practice safety certainly play an important role in reducing medication errors, but will not, in and of themselves, guarantee the avoidance of errors.21

ASHP received funding from the FDA to develop and implement national standardized concentrations. The program is called Standardize 4 Safety and is the first national, interprofessional project to standardize medication concentrations to reduce errors. Pharmacist, nurse and physician experts were invited to take part in sessions for standardizing concentrations.

The ASHP has created and posted several standardized concentration lists. Hospitals, health systems, clinicians and healthcare leaders are requested to view and implement these standardized concentration lists to improve patient and medication safety. Additional lists will be added to the ASHP website soon. The lists available are for standardized concentrations for IV and oral liquid medications.³²

In 2019, the ASHP published “Guidelines on Perioperative Pharmacy Services” to provide direction on the role and pharmacy services that can be provided in the perioperative setting. Like pharmacists dedicated to an oncology service or an ICU, many hospitals have a dedicated pharmacist in areas of medication safety: in the education of clinicians/providers, ensuring proper medication preparation using safe and sterile techniques, working on alternatives for drug shortages, identifying and avoiding look-alike/sound-alike medications, oversight of high-risk medications, and audits and reviews for diversion prevention.³³

The APSF published the 2022 Perioperative Patient Safety Priorities. Medication safety is one of its 10 priorities. The APSF webpage lists the priorities and related specific actions, and includes advisory groups associated with each priority. The Medication Safety Advisory Group developed its own list of five recommendations³⁴:

1. The APSF should optimize the use of pre-filled syringes and pre-prepared infusions to reduce chance for dilution/labeling errors and potentially minimize waste.
2. The APSF should implement point-of-care electronic medication scanning for medication checks and clinical decision support prior to medication administration, with auditory (spoken) and displayed medication name, alerts, and other critical information.
3. The APSF should work with regulatory bodies and manufacturers to standardize medication vials and distinguish medications by class with color-coded labels to reduce errors.
4. The APSF should recommend the use of standard concentrations of medications across patient care areas (e.g., emergency department, ICU, perioperative environments).
5. The APSF should develop online resources highlighting best medication safety practices (toolbox, checklists, whitepapers, etc.) tailored for anesthesia professionals who practice in facilities with fewer resources than large health systems or academic institutions, such as ASCs, office-based settings and community hospitals

Strategies

As this article notes, there are now multiple sources of recommendations for medication safety in the intraoperative and perioperative setting. Safety organizations, professional societies and well-respected thought leaders/authors/clinicians on perioperative medication safety provide detailed and comprehensive tactics to guide an organization on specific practices that can be adopted. Below is a partial list of recommendations from the sources discussed in this review (the majority from the ISMP). Please refer to the organizations’ websites and view the references for citations on perioperative medication safety.^20,28,33,34

1. Reconcile medications taken at home (or administered in the facility) before the medical procedure with the list of medications prescribed in the perioperative/procedural setting: before arrival or no later than time of admission, upon transfer and at discharge.
2. Obtain a patient’s weight on the day of surgery; use metric units and avoid stated, estimated or historical weight (except in emergent situations).
3. Use a process to determine opioid-naive or tolerant status, and those at high risk for respiratory depression. Document findings in a designated and shared electronic health record.
4. Use continuous electronic monitoring of adequacy of ventilation and oxygenation, for moderate and deep sedation, monitored anesthesia care, general anesthesia, and continuous or intermittent IV/neuraxial opioids, including patient-controlled analgesia or patient-controlled epidural analgesia, and regional anesthesia with both local anesthetic and an opioid.
5. Establish safe dosage ranges; consider age, opioid status, organ function for perioperative IV push doses and/or infusions of high-alert medications, and local anesthetics for peripheral nerve blocks, and neuraxial anesthesia and/or epidural injections/infusions.
6. Read and verify every medication label before administration.
7. Standardize drug trays across all locations.
8. Create a process to assess for and hold current medications and create a process to restart, retime or discontinue (e.g., antithrombotic medications, insulin) after the procedure.
9. Establish protocols/policies/guidelines/order sets to identify, treat and monitor for signs of hyponatremia, water intoxication and syndrome of inappropriate antidiuretic hormone.
10. Establish protocol and maintain appropriate vials of medications for malignant hyperthermia, using recommendations from the Malignant Hyperthermia Association of the United States (MHAUS). Have the protocol, MHAUS resources and phone number available in all areas where general anesthesia is administered.
11. Configure medication vial storage in medication trays, kits, carts and ADCs, with labels faceup instead of cap up.
12. Segregate and sequester all neuromuscular blocking agents from other medications and label storage bins, ADCs, pockets, drawers, kits or trays with neuromuscular blocking agents to communicate that respiratory paralysis will occur with use of the drug and ventilation is required. An auxiliary label may be affixed.
13. Require labeling even if only one medication is in the sterile field and label containers (syringes, bowls, cups, basins) with medications and solutions inn the sterile field immediately after filling.
14. Do not label empty syringes, basins, cups or other containers for expected use.
15. Create a limited number of adult, pediatric and neonatal standard drug and solution concentrations.
16. Expand use of pre-filled syringes.
17. Secure and segregate medications and solutions for injection or irrigation one patient case at a time immediately before the procedure.
18. Use smart infusion pump technology with an engaged dose error reduction system in all perioperative/procedural settings for continuous, intermittent, secondary, and regional anesthesia infusions and patient-controlled anesthesia.
19. Establish a dedicated pharmacist for management of the medication-use process.
20. Educate staff on a quarterly basis on medication risks and errors with strategies to minimize risks. Educate staff on new formulary medications and alternative products based on drug shortages.
21. Reevaluate the perioperative medication use process every two years.
22. Review use of rescue, reversal agents and antidotes to identify risks with specific medications.
23. At discharge after surgery or a procedure, a patient’s home medications must be identified, and discrepancies (e.g., omissions, duplications, contraindications, unclear information) should be resolved as soon as possible.

Conclusion

Medication administration in the OR is a complex process that can lead to safety errors. Hospital perioperative services and ASCs have struggled with determining which high-leverage risk reduction programs will produce the optimal surgical patient safety environment. An organization’s perioperative medication safety initiative should start with an assessment of the center’s current state.

• The lists of recommendations can be used to measure if the perioperative safety recommendations are implemented and being followed or if the recommendations are not.
• This analysis can be presented to a multidisciplinary perioperative team to determine the recommendations with the highest medication safety need.
• Develop a plan to improve medication safety and present it to leadership for approval.
• Implement the recommendations and document the progress.

References

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Safety of Anesthetic and Perioperative Medication Practices

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