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Pediatric Anesthesiology: Original Clinical Research Report

Medication Errors in Pediatric Anesthesia: A Report From the Wake Up Safe Quality Improvement Initiative

Lobaugh, Lauren M. Y. MD*; Martin, Lizabeth D. MD†‡; Schleelein, Laura E. MD§‖; Tyler, Donald C. MD, MBA; Litman, Ronald S. DO§‖

Author Information
doi: 10.1213/ANE.0000000000002279
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According to the Food and Drug Administration, medication errors account for approximately 1.3 million injuries per year and 1 death every day in the United States.1 Because the data source for most studies is primarily voluntary reporting, the incidence of medication errors committed by hospital providers is difficult to know precisely.2–5 Anesthesiologists are uniquely predisposed to commit medication errors because of the necessary multistep preparation process, which entails removing the medication from the manufacturer-supplied vial, manually labeling the syringe containing the medication, and personally calculating the appropriate dose and the correct corresponding volume before administering the medication to the patient. This process is performed in isolation, without supervision or concurrence from another health care provider, and without safety checks to be sure it is the correct medication, at the correct dose, or to the correct patient, all while working in a complex, dynamic, unsterile, and sometimes chaotic environment. A Canadian study from 2001 found that 85% of anesthesiologists have experienced a drug error or a “near miss.”2 But, a 2016 study from the United States demonstrated that a medication error or adverse drug event occurred in approximately 1 in 20 perioperative medication administrations, and every second surgical procedure.6 More than one-third of these errors led to patient harm, and the remaining two-thirds had the potential for patient harm. Pediatric patients were excluded from this study but may be at an even higher risk due to weight-based dosing calculations and the complexity of diluting medications that are prepared at the point of care.7,8

In 2008, the Society for Pediatric Anesthesia created Wake Up Safe, a multicenter collaborative quality improvement initiative whose global aim is to eliminate preventable harm in children undergoing anesthesia by analyzing reports of complications from participating institutions.9 The initiative was formed with the SMART (Specific, Measurable, Achievable, Realistic and Timely) aim10 to reduce preventable anesthesia-related serious events 50% by 2017. At the time of this writing, there are 32 member institutions (since its inception, additional institutions are added on a continuous basis) that contribute deidentified data on their anesthesia-related adverse events ( Reporting criteria for participating institutions include: (1) complications that resulted in patient harm; and (2) all medication errors and all wrong-side procedure errors (including surgical procedures and regional nerve blocks), regardless of harm.

The aim of this study was to use the Wake Up Safe database to characterize the types of medication errors reported in pediatric anesthesia. We hypothesized that a pattern of medication errors exists that will be amenable to targeted interventions.


Wake Up Safe was designed to compile data on anesthetic complications submitted by participating institutions. Each institution conducts data acquisition independently and electronically submits deidentified events, as well as demographic population data of anesthetized patients on a monthly to quarterly basis to a centralized web-based data input service (Axio Research, LLC, Seattle, WA). Events are collected with a variety of methods by individual institutions such as risk management reports, incident reports, anesthesia quality improvement reports, or review of unexpected hospital or intensive care unit admissions or readmissions. Each participating institution has a team of designated Wake Up Safe representatives who analyze every reported adverse event that harms or has the potential to harm an anesthetized child. Event analysis, a simplified form of root cause analysis, is performed by a minimum of 3 pediatric anesthesiologists at each institution to arrive at a consensus. Educational sessions to reinforce this process occur on a biannual basis at national meetings of the Society for Pediatric Anesthesia. Reportable events are then submitted to the central data center for Wake Up Safe using a standardized reporting form. The data collected includes basic demographic information, anesthetic details, causes, levels of harm, and judgements as to the preventability of the events.

Each case submitted to Wake Up Safe is assigned a unique identifying number so each subject remains anonymous within the Wake Up Safe database and to any investigators using the data. Each institution has access to its own data and the aggregate group data, but specific institutional data is not identifiable by other institutions. Protected health information is not collected. Demographic and adverse event data from each institution are reported approximately quarterly (Table 1). Institutional research review board requirements to send deidentified data for subsequent research purposes varied for individual institutions and have included the waiver of any requirement (since deidentified data is classified as nonhuman data), exempt approval, or expedited approval.

Table 1.
Table 1.:
Institutional Data Reported to Wake Up Safe

In September 2016, we analyzed all medication error events reported to Wake Up Safe from when the organization began collecting reports in the first quarter of 2010. To maintain deidentification, only the year of the event is recorded in the database. Each event was independently reviewed by 2 authors. Excluded events included those that were deemed not to involve a medication error or appeared to be a duplicate event. Adverse drug reactions resulting from the correct use of a medication (eg, hypotension, respiratory depression, allergic reaction, etc) were excluded.

Medication errors were classified by: (1) medication category; (2) phase of administration when the error occurred: prescribing, preparation, or administration3,11,12; (3) bolus or infusion error; (4) provider type and level of training; (5) harm as defined by the National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) (Table 2)13; and (6) perceived preventability as interpreted by the submitting institution. Harm scores are reported by institutions when events are submitted to Wake up Safe, but the standard scoring system is designed for harm events that reach the patient and does not apply to all included medication errors in this dataset. Instead, all included medication errors were independently reviewed and categorized by 2 investigators (L.L., L.M.) based on the NCC-MERP harm scale specifically designed for medication errors.

Table 2.
Table 2.:
NCC-MERP Harm Classification13

Because this was a retrospective observational study, descriptive statistics were used for all analyses.


During the time period analyzed, Wake Up Safe received the details of 2087 adverse events during 2,316,635 anesthetics. Of these, 366 were submitted as medication-related events. Ninety reports were excluded: 76 adverse drug reactions, 13 deemed not to be a medication error, and 1 duplicate event. A total of 276 medication errors were analyzed. Because denominators of total cases from all institutions were not reported concurrently with their reported medication error events, we were unable to calculate the incidence per case of a medication error occurrence. However, medication errors constituted the third highest category of safety events reported to Wake up Safe, behind cardiac and respiratory events.

Medication errors involved at least 13 different types of drugs administered in the perioperative period, and most commonly involved opioids and sedative/hypnotics (Table 3).

Table 3.
Table 3.:
Types of Medications Involved in Errors

The primary type of medication error was categorized by the phase of handling: during preparation (N = 30), prescribing (N = 67), or administration (N = 179; Table 4). The most common error type was administration of the wrong dose (N = 84), followed by syringe swap (accidental administration of the wrong syringe, N = 49). Fifty-seven (21%) reported medication errors involved medication infusions as opposed to bolus administrations.

Table 4.
Table 4.:
Medication Errors by Phase of Delivery

Seventeen provider types committed medication errors (Figure 1). Comparative analyses between providers were not possible because of the lack of denominator data for each type of provider. Physician anesthesia providers accounted for 178 of the 276 (64%) events reported. Attending anesthesiologists accounted for more medication error reports than any other provider type. For all levels of physician anesthesiologists (attending, fellow, resident), administration of the wrong dose (19, 23, and 19 events, respectively) and syringe swap (15, 6, and 14 events, respectively) were most common. The most common errors made by nurse anesthetists were prescribing errors (incorrect knowledge of correct dose), and administration of wrong dose. Although Figure 2 demonstrates that the preponderance of medication error reports was associated with anesthesia providers, it is notable for the inclusion of other types of health care personnel involved in perioperative care. Local anesthesia overdose by the surgical team was reported 3 times, and misprogramming of infusion pumps or incorrect medication administration of medications by postanesthesia care unit nurses also occurred. Because of the way the data was reported, there is no way to determine the root causes (eg, slips, lapses) of these types of errors. Several reports described incorrect preparation of medication lines (eg, a surgical technician accidently flushed a central line with epinephrine instead of heparin, a surgical fellow accidently flushed an externalized ventricular drain with heparin solution, an anesthesia technician accidently primed a pressure transducer with an aminocaproic acid solution), and a surgical resident accidently injected thrombin into a wound instead of local anesthetic. Two medication error reports described an overdose by a parent or guardian. In 1, the parent misread the instructions and gave a 3.5-times overdose of oxycodone. The other involved a miscommunication about how much acetaminophen to administer at home, resulting in a relative overdose to the child.

Figure 1.
Figure 1.:
Reported medication errors categorized by provider type.
Figure 2.
Figure 2.:
Distribution of NCC-MERP levels of harm in the reported medication errors as described in Table 2. NCC-MERP indicates NCC-MERP, National Coordinating Council for Medication Error Reporting and Prevention.

Over 80% of reported medication errors reached the patient and more than half of these events caused patient harm (NCC-MERP event categories E–I; Figure 2). Fifteen events (5%) required a life sustaining intervention. Fifty-one events did not have enough information for the reviewers to determine a level of harm.

Figure 3.
Figure 3.:
Distribution of perceived preventability of the reported medication errors.

Nearly all cases (97%) were perceived by the reporting institution to be either likely or certainly preventable (Figure 3).


The importance of medication errors by anesthesia personnel was originally highlighted as early as 1978.14 A variety of studies have since attempted to further delineate the problem, but reporting and recall bias have limited accurate estimation of incidence and the harm it incurs to pat-ients.3,4,8,15–20 Medication errors that reach the patient have been shown to have a high potential for harm.6

Our findings revealed that medication errors occurred most frequently during the administration phase of the anesthetic, particularly with administration of the wrong dose and syringe swaps. Harm occurred in half of the reported medication errors that reached the patient, and a large majority of the reported errors were deemed preventable. The Wake Up Safe database was originally designed to compile harm events, and although reporting of all medication errors are requested of participating institutions, it is possible that the medication errors in this database have a higher frequency of harm events than is representative of pediatric anesthesia practice because those events are more reliably submitted. Opioids were the medication type most commonly implicated in an error. Although we are unable to derive a risk probability to a specific medication type because we do not have data on the total number of administrations by type (opioids are one of the most commonly administered medications in anesthesia practice), it does allow for targeted recognition and proactive prevention of errors.

The same limitation applies to provider type. Although we were not able to determine the denominators of anesthesia providers in the total numbers of cases to determine if 1 group of providers made more errors, our data contain reports of errors from all types of providers. Thus, system changes that target minimization of medication errors are necessary for all provider groups.

We were unable to reliably calculate the incidence medication errors in participating institutions because the reporting of errors from each institution was not necessarily concomitant with reporting of denominators from these institutions. Previous reports that have looked at the incidence of medication errors during general anesthesia describe an incidence of 1 in several hundred in different centers throughout the world.3,5,16,19,21 We suspect that the Wake Up Safe system, which was design to collect the qualitative aspects of patient harm, underestimates the true incidence of errors due to lack of cognizance of the error by the provider or reluctance on part of the anesthesia provider to report the error in a nonanonymous reporting system within their own institution. Similarly, the quality of the data reported to this database relies on the reporting infrastructure and culture of the individual participating institutions, which likely varies between institutions. One of the most important limitations when attempting to gather incidence data on medication errors is the fact that errors often go unnoticed because the effect of these errors on the patient are undiscernible physiologically during a general anesthetic.22,23 Effective risk management depends crucially on establishing a reporting culture.24 This has been recently cited in an extensive literature review as the number one recommendation to understand and ultimately improve medication safety in the operating room.20

It is also possible that there is something inherently different about the pediatric anesthesia environment and the drug preparation process that produces a different incidence of medication errors. It makes sense that it would be higher for pediatric patients in whom a large variation in weight results in nonstandardized dosing (eg, 50–100 mcg fentanyl for most anesthetized adult patients regardless of body weight). It is not surprising that dosing errors are the most common error type in pediatric anesthesia practice, given that calculation of a weight-based dose by the pediatric anesthesia provider is required for most intravenous medications. The strength of the Wake Up Safe reporting system is the ability to examine reports in detail to determine patterns of error and then devise appropriate solutions.

The types of errors highlighted in this study present opportunities for targeted intervention. Reason25 originally described 2 main ways in which humans make errors that ultimately contribute to adverse events: failures of execution and intention. Failures of execution happen when the plan is adequate, but the actions do not go as intended. This can occur with a slip (wrong actions associated with an attention failure) or a lapse (missed actions and omissions associated with a memory failure). An example is picking up the wrong medication or transcribing a prescribed dose incorrectly.26 A failure of intention is when the actions may go as planned but the plan is inadequate to achieve the intended result, otherwise referred to as mistakes. A relevant example would be the miscalculation of a dose of medication that results in an overdose. Human error is almost impossible to predict or control effectively and happens to experienced providers. However, human error does not occur in isolation and is heavily influenced by the nature of the task and the workplace conditions. The greatest gain in safety can be achieved through modification of the workplace.25 One of the limitations of a voluntarily reported deidentified database such as Wake Up Safe, is that we were unable to separate out the reported errors into Reason’s specific categories (eg, slip versus lapse, etc). However, by reporting all the types errors that were made and their relative frequency, institutions can undertake targeted proactive interventions.

Administration dosing errors and syringe swaps are highlighted as our 2 most frequent error types, both of which are failures in execution. Specific strategies to address these error types have been proposed. Standardized prefilled syringes that are prepared and supplied to the anesthesia provider will completely eliminate ampule/vial swap and may decrease the risk of syringe swap with more prominent, standardized labeling.27 If these are not available, improvements in manual syringe labeling8 and standardization of medication organization in the anesthesia workspace can help mitigate vial and syringe swap errors and may reduce the incidence of dosing errors by reducing the cognitive load of the anesthesia provider functioning in a standardized work environment.28,29 Syringe swap, the accidental administration of the correctly labeled but wrong medication may be more reliably prevented with improved technology. Point of care bar-coding systems show promise20,30–32 but many limitations to implementation remain, such as cost, availability, and technological barriers. For many centers, currently, the easiest and most efficacious low-cost strategy is standardization of the anesthesia workspace and environment to minimize variation in drug preparation and administration.29 The end result is to reduce human variability, which has been found to successfully avert errors. High reliability organizations that have reduced error rates despite high risk or complexity, minimize variability, promote productive and safe practices, and always analyze for the next potential error.24

A sizable portion (57/276, 21%) of our reported medication errors involved medications prepared as infusions. Infusion drug errors are common, especially when using computerized patient infusion devices.33,34 In nonoperating room areas throughout most hospitals, errors in preparation of drug infusions are minimized using a “2 provider check” before administering the infusion. This process helps insure the “5 Rights” of medication delivery: the correct patient, medication, dose, time, and route.30,35 The 2-person check can be logistically challenging to implement in the operating room environment as it is common to have a sole anesthesia provider with 1 circulating nurse who has competing priorities. The often fast-paced operating room environment adds to the complexity of administering medications quickly, correctly, and safely. The incorporation of additional safety checks that add to the anesthesia provider’s workload may be difficult to implement reliably and will require additional resources for education and coaching. Some institutions utilize pharmacy personnel or nurses from the postanesthetic care unit as the second checker. As more institutions adopt integrated electronic medical records (EMRs), it may be used as an electronic double check. After the provider programs the pump, medication entry into the EMR will confirm the rate of the medication before it is initiated. EMR can also be used to confirm the correct dose of a bolus drug administration using an internal preprogrammed library or a link to the hospital’s pharmacy library. Utilizing this technology to confirm the correct dose of medication administration using an internal preprogrammed library and the patient’s preentered weight may also mitigate bolus medication dosing errors, the most common error type that was identified in this study.

In conclusion, we used the Wake Up Safe database on pediatric anesthesia complications to examine the patterns of medication errors by anesthesia providers and other perioperative personnel. Our findings of the most common types of errors can provide guidance on future preventative strategies. Many of these errors will likely be preventable with the use of prefilled medication syringes to avoid accidental ampule swap, bar-coding at the point of medication administration to prevent syringe swap and to confirm the proper dose, and 2-person checking of medication infusions for accuracy. Institutions should target these interventions by addressing the challenges and obstacles to implementation of these important safety measures.


The authors acknowledge the assistance of Christie Wolf, MBS, Manager, Data Managers/Project Director of Axio Research, LLC, Seattle, WA, for expert database analysis and much helpful information that made this article possible.

Participating Institutions

The following hospitals have contributed their patient data to Wake Up Safe during the period of data analysis for this publication: Akron Children’s Hospital, Akron, OH; Ann and Robert H. Lurie Children’s Hospital, Chicago, IL; Arkansas Children’s Hospital, Little Rock, AR; Cardinal Glennon Children’s Hospital, St. Louis, MO; Children’s Hospital and Medical Center, Omaha, NE; Children’s Hospital of Boston, Boston, MA; Children’s Hospital Los Angeles, Los Angeles, CA; The Children’s Hospital of Philadelphia, Philadelphia, PA; Children’s Hospital of Pittsburgh, Pittsburgh, PA; Children’s Medical Center, Dallas, TX; Children’s Hospital of Minnesota, Minneapolis, MN; Children’s National Medical Center, Washington DC; Cincinnati Children’s Hospital Medical Center, Cincinnati, OH; Colorado Children’s Hospital, Denver, CO; Cook Children’s Hospital, Fort Worth, TX; Emory Children’s Center, Atlanta, GA; Johns Hopkins All Children’s Hospital, St. Petersburg, FL; Johns Hopkins Children’s Center, Baltimore, MD; Kaiser Oakland Medical Center, Oakland, CA; Lucile Salter Packard Children’s Hospital at Stanford, Palo Alto, CA; Medical University of South Carolina, Charleston, SC; Montefiore Children’s Hospital, Bronx, NY; Monroe Carell Jr Children’s Hospital at Vanderbilt, Nashville, TN; Morgan Stanley Children’s Hospital of Columbia University Medical Center, New York, NY; Nationwide Children’s Hospital, Columbus, OH; Nemours/Alfred I DuPont Hospital for Children, Wilmington, DE; Phoenix Children’s Hospital, Phoenix, AZ; Seattle Children’s Hospital, Seattle, WA; St. Jude Children’s Research Hospital, Memphis, TN; Texas Children’s Hospital, Houston, TX; University of Michigan C. S. Mott Children’s Hospital, Ann Arbor, MI; Women and Children’s Hospital of Buffalo, Buffalo, NY.


Name: Lauren M. Y. Lobaugh, MD.

Contribution: This author helped conception of the study, data analysis, and manuscript preparation.

Name: Lizabeth D. Martin, MD.

Contribution: This author helped conception of the study, data analysis, and manuscript preparation.

Name: Laura E. Schleelein, MD.

Contribution: This author helped conception of the study, data analysis, and manuscript preparation.

Name: Donald C. Tyler, MD, MBA.

Contribution: This author helped conception of the study, data analysis, and manuscript preparation.

Name: Ronald S. Litman, DO.

Contribution: This author helped conception of the study, data analysis, and manuscript preparation.

This manuscript was handled by: James A. DiNardo, MD, FAAP.


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