A Retrospective Study of Pediatric Medication Errors in Saudi Arabia

Abstract

Background: The peculiarities of medication errors (MEs) among the pediatric population in the Middle East have not been adequately explored. In this study, we describe the MEs reported at the largest tertiary hospital in Saudi Arabia. Methods: This study is a retrospective analysis of MEs reported by health care professionals at a large tertiary hospital in Saudi Arabia between 2015 and 2016. Results: There were a total of 9123 MEs involving 84 different medications. In total, 109 382 drugs were ordered. Thus, 8.3 MEs per 100 prescriptions were reported during the study period. Thirty-nine errors (0.4%) reached the patient, but did not cause any harm. Transcribing errors accounted for more than half of the MEs (n = 4856, 53.2%). Physicians were the least likely to report an ME (n = 159, 1.7%), whereas pharmacists reported more MEs than any other health care professional (n = 4924, 54%). The most common drug causes of MEs were paracetamol, salbutamol, and amoxicillin, which accounted for 21.0%, 16.6%, and 12.4% of MEs, respectively, over the study period. Conclusions: Medication errors are common in pediatric care, especially for drugs such as paracetamol and amoxicillin that are frequently prescribed. Transcription error was common in this study and is more likely to be reported by pharmacists.

Introduction

According to the U.S. National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP), a medication error (ME) can be 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 health care professional, patient, or consumer; it may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.¹

It is a major health problem in Saudi Arabia and other countries in the Middle East,² with about one-third of adverse drug events in Saudi Arabia attributed to MEs.³ Therefore, the prevention of MEs is a logical approach toward the minimization of adverse drug events in the country.⁴ On account of varied definitions⁵ and settings, reported ME rates have ranged between 2% and 14%,⁶ with about 1 in 100 cases resulting in significant morbidity and mortality.^4,7

Children are more likely to die on account of MEs than adults.⁸ They are particularly more susceptible to MEs on account of the variations in body weight, body surface area, and their degree of maturity.⁹ Furthermore, the need for dosage calculations based on some of these parameters increases the likelihood of MEs.^10,11 Off-label use of medicines due to lack of suitable formulations also increases the risk of MEs in children.¹² Medication errors can occur at any stage between drug prescribing by the physician and consumption by the child.⁴ They have, however, been reported to be more common during the prescribing and administration stages,¹³ accounting for 72% to 75% and 3% to 37% of MEs in children, respectively.¹⁴

Most of the studies regarding MEs in the Middle East have been conducted among adults.² As such, the peculiarities of MEs among the pediatric population in this region have not been adequately explored. In this study, we describe the MEs reported at the largest tertiary hospital in Saudi Arabia.

Methods

Study Design and Setting

This study is a retrospective cross-sectional study of MEs reported by health care professionals at the King Saud Medical City (KSMC), the largest tertiary hospital in Saudi Arabia. All MEs reported between January 1, 2015, and December 31, 2016, were evaluated by pharmacists at the hospital’s Medication Safety Unit (MSU). Three hospital pharmacists were deployed to the MSU to routinely review all the reported MEs in the hospital. To ensure accuracy of reporting, the patients’ medical record may be requested and the reporter can be contacted for further clarification. The severity of an ME is further assessed using the NCC-MERP index, which is an alphabetical categorization (A-I) of MEs into 9 broad groups, based on the occurrence and outcome of errors. These categories can be further grouped into 4 broad categories, that is, No error, Error with no harm, Error with harm, and Error with death.¹⁵ Medication errors are voluntarily reported using an ME report form, a standardized paper-based form, which is available to health care professionals, in all clinics, wards, and pharmacies within the hospital.

Data Extraction and Analysis

For this study, only data for pediatric patients aged 18 years or younger were included. The information extracted from the report forms included the age group of the patients, sex, route of administration, the year of reporting, the drug cause of ME, the type of ME, stage of error, the severity of the ME, and the occupation of the reporter. The number of drugs prescribed was determined from the hospitals’ electronic prescribing. Both descriptive and inferential statistics were conducted. Chi-square analyses were performed using GraphPad Prism version 5 for Windows, GraphPad Software (La Jolla, California; www.graphpad.com).

Ethical Consideration

The KSMC institutional review board approved this study (IRB number: H1RI-12-Oct16-01).

Results

A total of 109 382 medicines were ordered in 2015 and 2016. In all, 9123 MEs involving 84 different types of medicines were reported. Thus, there were 8.3 MEs per 100 medication orders. There were 6.7 MEs per 100 medication orders in 2015 and 9.6 MEs per 100 in 2016. Most of the patients with MEs were women (n = 5532, 60.6%). There were more ME reports involving children (n = 8087, 88.6%) than adolescents (n = 490, 5.4%), infants (n = 460, 5.0%), or neonates (n = 86, 0.9%). Intravenous medicines were the most common cause of error (n = 2985, 32.7%) (Table 1). Most of the errors were near misses (n = 9009, 98.8%), with only 39 (0.4%) errors reaching the patients (0.4%) (Table 2). Paracetamol, salbutamol, and amoxicillin were the most common causes of MEs, accounting for 21.0%, 16.6%, and 12.4% of MEs, respectively (Figure 1). Antibiotics accounted for 39.1% of all MEs (Figure 2). In all, 472 MEs (5.1%) were on account of high-risk medications, with insulin being the most common cause (Figure 3). In general, more than half of the MEs were transcribing errors (n = 4856, 53.2%), whereas errors during drug administration were the least frequently reported (n = 207, 2.3%) (Table 1). Physicians were the most common source of errors (n = 5314, 58.2%), but were the least likely to report (n = 159, 1.7%). Pharmacists were more likely to report an error (n = 4924, 54%) than any other health care provider. Medication errors on account of wrong frequency were the most common types of error (39.1%); other common types of MEs were wrong drug (12.5%), wrong concentration or strength (12.4%), and wrong dose (11.1%) (Table 3).

Table 1.

Characteristics of Medication Error Reports.

Parameter	No. (%)
Age group
Neonates (<28 d)	86 (0.9)
Infants (1-23 mo)	460 (5.0)
Children (2-11 y)	8087 (88.6)
Adolescents (12-18 y)	490 (5.4)
Gender
Female	5532 (60.6)
Male	3591 (39.4)
Route of administration
Intravenous	2985 (32.7)
Oral	2199 (24.1)
Inhalation	2081 (22.8)
Intramuscular	1166 (12.8)
Unknown	216 (2.4)
Subcutaneous	148 (1.6)
Rectal	116 (1.3)
Topical	83 (0.9)
Intranasal	55 (0.6)
Intraocular	40 (0.4)
Auricular	34 (0.4)
Yearly ME reporting
2015	3219 (35.3)
2016	5904 (64.7)
Yearly number of prescriptions
2015	47 845
2016	61 537
Stages of error
Transcription error	4856 (53.2)
Dispensing error	2558 (28.0)
Prescribing error	1502 (16.5)
Administration error	207 (2.3)
Reporter
Pharmacists	4924 (54.0)
Assistant pharmacists	2142 (23.5)
Nurses	794 (8.7)
Physicians	159 (1.7)
Others	5 (0.1)

Note. ME = Medication error.

Table 2.

Severity of Medication Errors According to NCC-MERP Classification.

Classification	NCC-MERP category	Definition	No. (%)
No error	A	Circumstances or event that have the capacity to cause harm	75 (0.8)
Error, no harm	B	An error occurred, but the error did not reach the patient (near miss)	9009 (98.8)
	C	An error occurred that reach the patient but did not cause patient harm	29 (0.3)
	D	An error occurred that reach the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm	10 (0.1)
Error, harm	E	An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention	0 (0)
	F	An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization	0 (0)
	G	An error occurred that may have contributed to or resulted in permanent patient harm	0 (0)
	H	An error occurred that require intervention necessary to sustain life	0 (0)
Error death	I	An error occurred that may have contributed to or resulted in the patient’s death	0 (0)
Unknown	U	Unknown outcome	0 (0)
Total			9123

Note. NCC-MERP = National Coordinating Council for Medication Error Reporting and Prevention.

Figure 1.

The 20 most common drug causes of medication error.

Figure 2.

Medication errors according to drug class.

Figure 3.

Medication errors from high-alert medications.

Table 3.

Types of Medication Errors Reported Between 2015 and 2016.

Type of error	No. (%)
Wrong frequency	3564 (39.1)
Wrong drug	1139 (12.5)
Wrong concentration/strength	1128 (12.4)
Wrong dose	1016 (11.1)
Wrong duration	574 (6.3)
Wrong route	508 (5.6)
Wrong formulation	446 (4.9)
Diagnosis not mentioned	433 (4.7)
Prohibited abbreviations	144 (1.6)
Wrong time of administration	109 (1.2)
Dose omission	42 (0.5)
Wrong patient	10 (0.1)
Wrong documentation	6 (0.1)
Allergy information missing	4 (0.1)
Total	9123

There was a statistically significant association between the age of the patients and the year of reporting (P < .001). The proportion of neonates with MEs decreased from 1% in 2015 to 0.9% in 2016, infants increased from 3% to 6%, children decreased from 93% to 86.2%, adolescents increased from 2.7% to 6.8%. There was a statistically significant association between the sex of the patients and the year of reporting (P < .001). The proportion of errors involving women decreased from 68.8% in 2015 to 56.2% in 2016, whereas the proportion of medical errors involving men increased from 31.2% in 2015 to 43.8% in 2016. There was a significant association between the year of reporting and the route of administration (P < .001). The proportion of MEs from orally administered drugs decreased from 27.0% in 2015 to 22.5% in 2016, whereas parenteral drugs decreased from 59.6% in 2015 to 40.4% in 2016.

There was a significant association between the source of error and the year of reporting (P < .001), with errors by physicians increasing from 50.2% in 2015 to 62.7% in 2016.

Discussion

We have retrospectively evaluated all pediatric MEs reported by health care providers to the hospital’s Medication Safety Unit over a 2-year period. Medication errors due to wrong frequency of drug administration were the most common, accounting for more than one-third of reported MEs. In general, the most common types of MEs were dose related; this is similar to reports from 2 previous studies in the region.^16,17 Alomary et al¹⁶ reported that 29% of MEs in a Saudi Arabian hospital were dose related, the most of any other type of error. Similarly, Al-Jeraisy et al¹⁷ reported 22% dose-related errors in another Saudi Arabian hospital. Paracetamol, salbutamol, and amoxicillin were the most common drug causes of MEs. The high rates of paracetamol and amoxicillin MEs may be attributed to the high-prescribing rates of these drugs in Saudi Arabia.^18,19 Previous studies in other countries have also reported higher ME rates with paracetamol^20,21 and antibiotics in children.^22,23 However, the high salbutamol ME rate does not mirror the prescribing pattern in the country.^18,19 In contrast to previous studies in adults,^4,7 none of the MEs caused harm to the children. Near misses were very common, with rates similar to those previously reported in an adult study at the same hospital.²⁴ Most of the MEs were transcription errors, which were due to the errors by nurses, who also have access to the physicians’ computerized order entry system. A similar pattern was reported in a study by Knudsen et al,²⁵ which showed that transcription errors constituted about 59% of all MEs in a Danish hospital. Dispensing errors by pharmacy assistants were also common, whereas prescribing errors were mainly attributable to the physicians.

Although our hospital implements an electronic prescribing system and has also incorporated clinical pharmacists into patient care, MEs reporting was particularly high compared with other studies in the region.^16,17 Both of these interventions have been shown to significantly reduce MEs in other centers.^26,27 In one study, the introduction of electronic prescribing was reported to significantly reduce prescribing errors in children from 77.4% to 4.8%.²⁸ Electronic prescribing eliminates the issues with legibility of prescribers’ handwriting and also assists physicians with decision-making by providing them with patient information, such as drug allergy, in addition to providing suggestions for dose and frequency.¹⁰ In another study, MEs reduced significantly by 66% when pharmacists were involved in checking medication orders.²⁷ The high rate of MEs in our hospital, despite the availability of an electronic prescribing system, may be attributed to the fact that there are usually 2 levels of transcription during the prescribing process. First, physicians write their prescription into the patients’ medical file, after which the nurses transcribe them into the computerized order entry system. To minimize the occurrence of MEs, the MSU has recently embarked on the process of ensuring that physicians directly input their prescriptions into the computerized system. Furthermore, better communication between the nurses and physicians is being encouraged. Improved communication among health care providers has been shown to reduce MEs.²⁹ Physicians and pharmacists should verbally communicate how medicines should be taken to the patients, preferably in the patients’ native language. To minimize the risk of prescribing the wrong drugs, generic names of medicines should be written on medication orders. Unclear and illegible prescriptions should be referred back to the physician for clarification.²⁹ Finally, given that the several high-risk medicines require dose calculation, double-checking of calculations by another health care provider before the medicines are administered should be encouraged.

There were some important limitations of this study. First, we have relied on voluntary ME reporting, which have been associated with underreporting due to fear of retribution, insufficient time for reporting, lack of awareness about reporting system, and lack of interest in reporting.³⁰ Second, we have not conducted root cause analyses of the MEs, which would have provided a greater insight into the MEs and used for developing preventative strategies.

Conclusions

Studies regarding MEs in pediatric patients in the Middle East are relatively few compared with those involving adults. We have shown that MEs are attributable to errors across the spectrum of care, from the doctor to the patient, with most of the errors occurring at the transcription stage. Paracetamol, amoxicillin, and salbutamol were the most common drug causes of MEs. Future nationwide and regional evaluation of MEs is desirable. Also, studies examining MEs in specific settings such as the intensive care units, neonatal wards, and emergency wards are required to ensure targeted intervention strategies. Finally, root cause analyses of MEs are desirable, because understanding the reason for an ME is important for developing effective preventative strategy.