PREVALENCE AND TYPES OF MEDICATION ERRORS AT KING ABDULLAH SPECIALIZED CHILDREN HOSPITAL, RIYADH, SAUDI ARABIA

1. College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. 2. College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. 3. Department of Medical Education, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. ...................................................................................................................... Manuscript Info Abstract ......................... ........................................................................ Manuscript History

Prevention of medication errors has become a mandatory process that requires system-wide improvements in many organizations. 7 The first strategy is by making the patients informed about their medication and involving them in the process to to minimize chances of medication error. 2 Literature has supported the utilization of health information technology (HIT)to lower medication error rates and consequently enhance the quality of care. Electronic health records (EHRs) are one popular form for HIT that is commonly used. Recently, there have been an increasing number of hospitals and that are using EHRs across the globe. 8 EHRs are essential to improving patient safety. 9 A well-developed EHR can include variety of features that enhance medication safetyand significantly reduce the rate of medication errorthrough clinical decision support systems with computerized physician order entry (CPOE. 7 Computerized physician order entry implementation resulted in a significant decrease in serious medication error rates by 55% as reported in one of the landmark trial by Bates et al. 10 Furthermore, medication reconciliation is one of the methods that help in preventing medication errors 11 , EHR has made it easy to interface with the medication list and has made them electronically available for prescribers. 12 These technologies have been proven to reduce medication errors in patients across all age groups, but perhaps the age group that will most benefits from implementing the technology are those most likely to be at risk of medication errors including the elderly and children. Medication errors in pediatric patients are common due to many reasons one of which is the need for high accuracy weight-based dose calculations further to the decimal points. 13 McPhillips et al reported that 15% of a 1933 randomly selected children who received new prescriptions had potential dosing errors and 33% of dosing errors occurred in children weighing less than 35 kg. 14 Aljeraisy et al found out that 56 out of every 100 medication orders in the general pediatric ward and pediatric intensive care unit (PICU) at King Abdulaziz Medical City had some error in them. 15 The literature about medication errors in Saudi Arabia is lacking. The objective of this study was to estimate the prevalence of medication errors and identify their types as well as to investigate the common factors contributing to their occurrence at King Abdullah Specialized Children Hospital as hospital with a fully computerized healthcare system that includes all aspects of medical care from records and documentation to order entries.

Method:-
Study design and settings:-This is a chart review based study of all medication orders for all patients of all age groups in King Abdullah Specialized Children Hospital (KASCH), Riyadh, Saudi Arabia between April 2015 and January 2016. KASCH is the first specialist Children's Hospital in the Kingdom of Saudi Arabia with a capacity of 600 inpatient beds not including 60 beds for pediatric emergency and trauma unite, 50 beds for Pediatric Surgical and Medical Day Care and 70 beds in Chemotherapy and Hematology Infusion Area. KASCH is a paperless digital hospital with all patient files maintained in Health Information System known as BestCare system.

Study population, sample size and sampling technique:-
By a consecutive sampling technique, the study included a total of 256,567 samples which represent all medication orders documented in KASCH BestCare System for all patients of all ages who were treated in general and specialized pediatric and adult wards, outpatient clinics, pediatric ER, pediatric High Dependence Unit, and Pediatric Intensive Care Unit in KASCH between April 2015 to January 2016. The Safety Reporting System (SRS) was used to extract all reported medication errors.

Data collection and entry:-
A data collection form was generated to collect extracted medication error reports and data from the electronic database. All variables such as demographics of the patient, drug name, high alert status of the medication, process stage of medication error, error type, location as well as the factors contributing to the error were collected.
Data analysis:-A drug classification system was generated for all medication error reports based on drug names with the help of a PhD. clinical pharmacist to shorten possible answers.
Statistical Package for Social Sciences (SPSS, version 20; SPSS Inc.) was used for data analysis. The categorical variables were described as absolute frequencies and percentages such as gender, high alert status and drug class. Continuous datawas summarized as mean and standard deviation such as age of the patient. Multi-variant and Chisquare test was used to assess the relation of high alert status location. All tests were considered significant when P value is less than 0.05.

Ethical consideration:-Data collection and handling was done after taking permission from King Abdullah International Medical Research Center (KAIMRC) and the Institutional Review Board of King Abdullah International Medical Research
Center.Confidentiality was insured and personal data was not and will not be revealed.

Result:-Overall prevalence and demographic characteristics of the patients:-
This study included 256,567 medication orders that were documented in KASCH BestCare system between April 2015 and January 2016. Of these medication order records, 792 medication errors were reported in the Safety Reporting System (SRS) at a rate of one error per 324 medication orders, or 0.31%.
Malepatients presented51.3% of affected patients.Most Patients were between one and five years of age presenting 207 (30.3%) cases and 122 (17.8%) cases involved patients under the age of one year.Majority of medication errors took place in hospital wards and pharmacies with 319 (40.3%) and 167 (21.1%) cases, respectively [ Table 1].
No statistically significant difference was found between males and females in the rate of overall medication errors, HAME, drug classes, or in any specific medication error event type.

Drug Class Involved:-
Antibiotics ranked as the most commonly involved drugs in medication error reports by a significant margin with 196 (22%) cases, followed by analgesic and antineoplastic agents with 75 cases(8.4%) for each [ Table 2] Vancomycin was the most commonly reported antibioticamong antibiotic errors with 33 (17%) report, acetaminophen in analgesic agent errors with 38 (50.7%) report, Cytarabine& Etoposide in antineoplastic & chemotherapy errors with 10 (13.5%) report, Enoxaparin in anticoagulanterrors with 11 (50%) report, prednisone in steroid errors with 4 (19%) report, and Medazolam in benzodiazepines errors with4 (23.5%) reports as well.
Hospital wards had the highest incidence of HAME with 53(32.1%)cases. However, it presented 16.6% of the total medication errors in the same location. Adult chemotherapy infusion unit had a total incidence of 19(11.5%) HAME cases. However,it presented 54.3% of the total medication error reports in the same location with a p-value of <0.001[ Table 3].
For the high alert medications event types, 41 (24.8%) report were dose related (incorrect, damaged, duplicated, wrong concentration or omitted), 33 (20%) report were delays and 19(11.5%) report were incorrect medication. There were two incidents where high alert drugs were given to the wrong patient (TPN, letrozole) and one incident of narcotic drug loss[ Table 5].

Medication process stages at which errors took place and contributing factors:-
The majority of medication errors took place in the prescribing/ordering stage with 367(46.3%) report, dispensing in 253 (32%) report, and administering in 251(31.7%) report [ Table 6].
Lack of quality control dominated the factors contributing to medication error with 594(75.2%) report, followed by the lack of staff education with 110(13.9%) report, and drug storage and delivery with 59(7.5%) report. Other contributing factors included miscommunication of drug order with 51 (6.5%) report, missing drug information with 50 (6.3%) report, and IT/ network problems 40 (5.1%) report [ Table 7].   100.0% *HAME out of all medication errors in same location(HAME in location/all medication errors in same location). ** High alert medication errors out of total number of HAME (HAME in location/total n of HAME).

Discussion:-
In this study we measured the incidence of medication errors in KASCH and found out that to be 792 errors at rate of0.31%.In a study conducted at an Australian children's hospital over a 4-year period, the reported overall medication error rate was the same as the rate reported in our study of 0.31%. 16 Al Jeraisy et al. reported the rate of medication errors to be 56 per 100 medication orders among inpatient pediatric in a tertiary care center in Saudi Arabia. 15 Similar high rates were reported for the pediatric population in Egypt, Iran, and West Ethiopia at 78%, 53%, and 75% respectively. 18,19 Ghaleb et al. reported 13.2% medication administration errors in the UK. 20 Aljadhy et al. found medication errors to be 32.36 per 100 medication orders among adult patients in four hospitals in Saudi Arabia. 21 The rate of prescribing medication errors in the Middle East ranged between 7.1% and 90.5% (lowest in Saudi Arabia, highest in Bahrain). 19 The rate of the errors reported in our study was low compared to rates in the United States, UK, and Pakistan, where the rates of reported medication errors were 6.9%, 3%, and 5.5%, respectively. 22 Commonly involved drug classes were antibiotics, analgesics and antineoplastic agents which were similar to those reported by other studies. 19,25 Higher error report rates of high-alert medications is an indicator of better error surveillance. 26 Around one-fifth of the medication errors in this study involved high alert drugs, mostly antineoplastic agents, high alert analgesic agents, and anticoagulants.
The lack of quality control was found to be the most contributing factor in our study in around 75%of the cases followed by lack of staff education in around 14%. Miscommunication following patients' transfer across hospital facilities and the lack of following policies and procedures were the factors reported by Manias et al with incidence rate of 33.7% and 22.4%, respectively. Drug characteristics, administration time, heavy workload, and misinterpretation of the order were also suggested as contributing factors. 16 Upon review of the literature we found that dose related errors constitute the majority of medication errors, which was also the case in our study. 15,16,25,27 This warrants implementation and evaluation ofinterventionsaiming to eliminate these errors and maximize patient safety. MacKay et aldemonstrated a decrease in dose-related medication errors in pediatrics by intravenous and oral medication standardization. This decreased workload, wastage, improved outcome, and lowered cost. 28 Barrier et al suggested standardizing the dosing instruments and units. 29 We recommended establishing measures to reduce dose related errors; their efficacy should be determined in further studies.
Finally, these lower rates of reported medication errors could raise the suspicion of underreporting which is a serious obstacle that needs to be addressed. However, this could have been the advantage of utilizing Computerized Physician Order Entry (CPOE) and pharmacist review of prescription as their implementation has shown to decrease medication errors by half. 30,31 In Australia, 86% of adverse events related to medical errors, including medication errors, were not reported. 32 Mansouri et al. stated the barriers for underreporting to be personal fears, administrative barriers, and the reporting process. 33 Reasons for underreporting in the "Hospital incident reporting systems do not capture most patient harm" report were the absence of perceptible error, accustomedness to a common occurrence, expectation of side effects, and high frequency of occurrences. 32 Studies exploring underreporting causes in Saudi Arabia are needed.

Limitations:-
This study did not measure the prevalence of medication error in each and every specific location or department of the hospital. Some errors that did not inflect any serious harm on patients or alarm administrationmay have been underreported. The study did not include the medication error related patient-specific outcome.

Conclusions:-
In conclusion, Medication errors reported in King Abdullah Specialized Children Hospital, Riyadh, Saudi Arabia were less than the international figures. Most commonly involved drug classes were antibiotics, analgesics, and antineoplastic agents. Prevalent types of medication errors were delay, incorrect dose, and loss of medication. Most of the medication errors occurred during the prescribing/ordering stage and the administering stage. Utilizing data in our study to develop strategies that target contributing factors as well as the setting where medication error occur frequently could further decrease its rate. This study can serve as a benchmark to evaluate the progress of medication safety upon implementation of future strategies and measures.