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Introduction
Patient safety is a priority in healthcare systems. Consequently, medication errors have become a significant public health concern. According to the World Health Organization's International Classification for Patient Safety, a medication error is “a deviation in a process that may or may not cause harm to patients” and can be classified as a harmful incident (adverse event) or a near miss that can occur throughout the medication-use system1. Hospitalized patients may experience an average of one medication error per day2. Pediatric patients, primarily, are vulnerable to medication errors due to many factors, such as weight-based dosing, the need to dilute medications to administer small amounts, and the inability of young children to self-administer drugs or report side effects3. Previous evidence has shown that 5% to 27% of pediatric prescriptions result in errors4. Recently, a scoping review found that the most prevalent pediatric safety issues were medication-related5. In addition, the treatment for pediatric oncology patients is complex and error-prone. Therefore, correct dosing and administration procedures for antineoplastic chemotherapy are imperative due to toxicity and narrow therapeutic windows6. Thus, quality management of information on near misses and adverse events is necessary to develop processes and systems that improve safety and reduce the risk of preventable medication incidents7,8. Consequently, this observational retrospective study aimed to identify and classify medication errors occurring in an inpatient pediatric antineoplastic chemotherapy facility and evaluate the outcomes of these medication errors.
Methods
Study design
This observational and retrospective study was conducted for 5 months (November 2018-March 2019) in the antineoplastic chemotherapy ward (CW) of the Hospital Infantil de México Federico Gómez. Near misses and adverse events detected in the patient's medical records were reviewed within 24 hours of admission. The CW is a 12-bed unit where pediatric oncology patients receive antineoplastic chemotherapeutic regimens that require at least 76 hours of stay and close monitoring after infusion. Every time a patient is admitted to the CW, the medical record is renewed, so each time a patient is admitted to the CW, the medical record is evaluated as a separate subject. Clinical records were reviewed independently of the treating medical and nursing staff. The study was conducted according to the Declaration of Helsinki and was approved by the Institutional Review Board.
Data sources and measurement
The assessment consisted of reviewing all the medical records available at the CW to identify medication errors. The evaluation was performed using a binnacle in which the identified near misses or adverse events were manually entered. This binnacle was subsequently used to construct a database for statistical analysis. Body surface area and dose were recalculated according to the somatometry data available in the patient's entry note and the recommended standard dose. We adjusted the terminology and classification system described by Weingart et al. to our clinical setting to analyze the near misses and adverse events1,9.
Results
We reviewed 286 medical charts corresponding to 157 pediatric oncology patients. Most patients were male (56.1%), and the median age of the study population was 9 years (IQR, 0.5-17.67). The most frequent diagnosis was leukemia (56.1%), followed by solid tumors (40.1%) and lymphoma (3.8%).
The medication errors evaluated were classified according to the stage of the medication process: ordering, dispensing, administration, monitoring, and documentation. Of the 286 medical records reviewed, 279 (97.6%) had at least one type of error. A total of 962 errors were detected, with an overall rate of 3.36 errors per visit. The three most frequent errors were early or delayed administration of chemotherapeutic agents (23.6%), missing staff signature (20.9%), and incorrect birthdate (18.3%). Meanwhile, the minor common errors were wrong protocol week (0.1%), illegibility (0.1%), and inaccurate date (0.2%). Most medication errors occurred in the documentation stage (66.8%), followed by the administration stage (23.6%) and the ordering stage (9.6%) (Table 1). Of all medication errors, 37.2% had the potential to cause injury, including two errors that resulted in injury. In this regard, medication errors in the ordering stage can evolve into harmful incidents. Therefore, the most common errors were dosing inconsistencies (0.3%) and unjustified concomitant drugs (0.3%).
Table 1 Frequency and type of medication errors
| Stage in the medication process, n (%) | Medication errors detected (n = 962) | n (%) |
|---|---|---|
| Ordering, 92 (9.6) | Different diagnosis through medical chart | 4 (0.4) |
| Incorrect dose | 4 (0.4) | |
| Incorrect patient's registry | 24 (2.5) | |
| Incorrect protocol week | 1 (0.1) | |
| Inconsistencies on medical orders | ||
| Double dosing | 1 (0.1) | |
| Drug ordered twice | 1 (0.1) | |
| Exceeded dose according to BSA | 1 (0.1) | |
| Inconsistencies of dosing | 3 (0.3) | |
| Inconsistencies in the ordered drugs | 1 (0.1) | |
| Concomitant drugs without justification | 3 (0.3) | |
| Medical order without units | 1 (0.1) | |
| Somatometry | ||
| Incorrect | 18 (1.9) | |
| Missing data | 30 (3.1) | |
| Dispensing | Non-detected | — |
| Administration, 227 (23.6) | Anticipated or delayed administration of chemotherapeutic agents | 227 (23.6) |
| Monitoring | Non-detected | — |
| Documentation, 643 (66.8) | Another patient's note | 9 (0.9) |
| Lack of staff signature | 201 (20.9) | |
| Sheet with no birthdate | 13 (1.4) | |
| Sheet with no date | 3 (0.3) | |
| Sheet with no registry | 14 (1.5) | |
| Chart with missing document | 29 (3.0) | |
| Inconsistencies on data | 15 (1.6) | |
| Incorrect data | ||
| Age | 5 (0.5) | |
| Birthdate | 176 (18.3) | |
| Date | 2 (0.2) | |
| Sex | 4 (0.4) | |
| Name | 10 (1.0) | |
| Disordered chart | 29 (3.0) | |
| Orthographic mistakes | 4 (0.4) | |
| Printing error | 70 (7.3) | |
| Blurred or white-out pages | 12 (1.2) | |
| Corrections with pen | 25 (2.6) | |
| Scratching | 18 (1.9) | |
| Illegibility | 1 (0.1) | |
| Typing errors | 3 (0.3) |
BSA, body surface area.
Although we could not identify medication errors in the dispensing and monitoring stages by reviewing the medical records, nurses and medical staff reported errors in these stages. We documented and classified five medication errors that reached the patient (harmful incidents) according to their degree of harm into none (two, 40%), mild (one, 20%), moderate, severe (two, 40%), or death (Table 2).
Table 2 Harmful incidents*
| Stage | Degree of harm | None | Mild | Moderate | Severe | Death |
|---|---|---|---|---|---|---|
| Ordering | Incorrect patient's name on chemotherapy bag | 1 | — | — | — | — |
| Dispensing | Patient unable to acquire medication at the pharmacy due to an incorrect registry on the prescription | 1 | — | — | — | — |
| Administration | Double administration of the chemotherapeutic agent | — | — | — | 1 | — |
| Monitoring | Chemotherapy agent spilled over the patient's bed | — | — | — | 1 | — |
| Patient broke the fasting indication | — | 1 | — | — | — | |
| Documentation | Non-detected | — | — | — | — | — |
*Reported by the medical and nursing staff.
Inpatient pediatric oncology care is a multidisciplinary activity involving many health professionals, from laboratory staff to nursing staff and physicians. In the clinical setting studied, all procedures are performed by different health professionals, and each document in the medical record can be used as evidence of compliance with care protocols. Therefore, it seemed essential to analyze which part of the clinical records, and thus in which stage of the protocol, most errors occurred. Since the 227 errors of early or delayed administration of chemotherapeutic agents were calculated and not registered in the medical records, only 734 medication errors were considered in the analysis. Errors were most frequently found in laboratory results (25%), followed by the clinical history (19.4%) and hospitalization admission notes (18.9%) (Table 3).
Table 3 Frequency of error per document type (n = 734)
| Document type | n (%) |
|---|---|
| Laboratory results | 184 (25.0) |
| Clinic history | 143 (19.4) |
| Hospitalization admission note | 139 (18.9) |
| Authorization for hospitalization | 124 (16.8) |
| Medical orders | 57 (7.7) |
| Evolution | 45 (6.1) |
| General | 29 (3.9) |
| Cover page | 4 (0.5) |
| Procedure | 3 (0.4) |
| Frontal page | 2 (0.3) |
| Other | 4 (0.5) |
Discussion
In our inpatient pediatric oncology care study, we found that 97.6% of medical records contained at least one type of medication error, with a total of 962 errors documented. Of these, 0.5% reached the patient, and only 0.2% resulted in a severe life-threatening harmful incident. Our error rate is higher than that reported in oncology patients by Walsh et al., who stated that 19% of pediatric visits were associated with an error. However, their study was focused on the outpatient setting10.
Cancer patients are at risk for physiological reserves, toxic therapies, and narrow therapeutic indexes, and children even more so due to body-surface dosing, multiple-dose adjustment, and laboratory monitoring. As reported by Weingart et al., ordering errors were more frequent than dispensing errors9. When analyzing medication errors, most studies only consider the ordering stage, as a failure in this stage can have catastrophic consequences. In France, in two settings, 3.1% and 5.2% of prescriptions were found to have errors11,12. Similarly, Nerich et al. and Gandhi et al. reported 1.5% and 3% of prescription errors, respectively13,14. In contrast, Aita et al. in Italy reported that 20% of medication orders had errors15. Here, we report that 9.6% of the errors occurred at this stage, and the most common were somatometry errors, whether incorrect or missing. In pediatric oncology, chemotherapeutic agents are ordered according to the body surface or weight, with low doses compromising efficacy and high doses inducing toxicity; hence, these errors are considered potentially harmful. Fortunately, weights and body-surface areas were corrected, and no error reached the patient. In addition, poor handwriting was considered one of the primary sources of error16, which was not the case in our study since all medication orders were placed on computer systems.
Unfortunately, we could not detect any errors in the dispensing or monitoring stages. In the administration stage, we calculated the time of anticipation or delay of antineoplastic chemotherapy administration according to the institution's protocols and found 227 errors (23.6% of the total). However, some justifiable scenarios cause the delay or anticipation of chemotherapy, such as the presence of a fever, low or high diuresis, medication not available at the time, and staff shortage, among others. A limitation in detecting errors at this stage was that the researcher was not present during antineoplastic chemotherapy administration. Consequently, some errors could have gone undetected.
Aguirrezábal-Arredondo et al. reported that most errors occur in the ordering stage17. However, our findings show that errors were more frequent in the documentation stage in the population studied. Therefore, although not a widely researched area, documentation appears as a critical stage for patient safety. We detected 643 errors (66.8% of the total) at this stage. The most common error was the lack of personnel signature (201, 20.9%), indicating non-compliance with protocols. It is worth mentioning that errors in this stage can be amplified and have consequences in the other stages. We consider that 358 errors (37.2%) were potentially harmful.
Given the importance of safety in medication orders, we analyzed eleven inconsistencies corresponding to 1.1% of all errors. Two of them resulted in harmful incidents; these errors surpassed the safety barriers of dispensing and administration and reached the patient. One was rated as non-harmful, and one caused a severe adverse medication reaction. Another error that became a severe harmful incident occurred during monitoring, when a bag of antineoplastic chemotherapy spilled on a patient, causing injury and contamination.
Medication errors and resulting adverse events occur in all health care settings. Many errors result from complexity or problems in the system or lack of communication among healthcare professionals18. In this study, we identified the stages of the system at which an error was more likely to be made, given that each document represents a different action performed during patient care. Consistent with documentation being the stage at which most errors occur (66.8%), most errors were identified in laboratory results (25%), clinical history (19.4%), and the inpatient admission note (18.9%). However, most of the errors in laboratory results were incorrect birthdates, which are not considered potentially harmful events.
Although the U.S. Institute of Medicine (IOM) recommends computerized order entry systems and other information technology to reduce errors, it is known that errors still occur with automatization18. Fortunately, not all medication errors are harmful. Previous studies have shown that less than 1% of all errors result in a harmful incident, supporting our data that 0.5% of errors reach patients. However, the fact that 97.6% of the medical records contain at least one error indicates significant weakness in the system19.
Fifteen years after the IOM report “To err is human: building a better healthcare system,” patient safety remains a significant challenge20. The magnitude of the problems must first be measured and quantified to improve. Various methods have been used to identify medication errors, but there is no clear gold standard21. Reporting error is necessary but not sufficient to improve performance. Unless reporting is followed by action and implementing changes, safety will not improve22.
Serious illness can further contribute to a suboptimal decision-making environment. System analysis is critical, with a formal evaluation of each step. Computer-assisted decision-making capable of accurately calculating body-surface area, checking for allergies and contraindications, identifying drug interactions, facilitating communication, and introducing ward-based pharmacists and satellite pediatric pharmacies has been shown to reduce the incidence of errors23. The development of a unit dose system can also improve the quality of healthcare, which has been demonstrated by a lower rate of medication errors than the ward stock distribution system16. In our setting, there are no hospital pharmacists. Despite the low incidence of ordering errors detected in our study, the potential severity of these errors gives the pharmaceutical validation process a key role in improving the safety of pediatric oncologic patients24.
Strengths and limitations
The study was not designed to account for all errors fully and was based on a human observer, who may have missed some errors. Our study relied on the method of medical chart review and, therefore, may underestimate medication error rates. Neither patients nor providers were interviewed, nor was administration directly observed. Unlike other studies, our approach was broader than most studies focusing only on ordering errors and harmful incidents. We attempted to detect all types of errors in medical records.
In conclusion, this report identified and classified medication errors occurring in a pediatric oncology clinical setting. Although our error rate was higher than that reported in the literature for children with cancer, we detected only two severe adverse events. However, it is necessary to implement better documentation strategies to reduce the rate of near misses and prevent potential adverse events.
