Medication Errors Related to Warfarin from a Safety Reporting System Database

Saleh Alanazi1-3, Hessa Al Muqati1*, Huda Al Enazi1, Tahani Alsufian1, Thamer AlOtaibi1, Hind AlBadli1, Amirah Alsaleh1, Sara Al Mowalad1 and Salah Al Dekhail1,3 1Pharmaceutical Care Services, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Saudi Arabia 2King Abdullah International Medical Research Center, Saudi Arabia 3King Saud Bin Abdulaziz University for Health Sciences, Saudi Arabia

entry, medication errors, such as those involving anticoagulant medications, are common [7,8]. We chose warfarin in our study since the use of this medication has increased dramatically over the past several decades [9]. Moreover, according to U.S. Food and Drug Administration reporting system, warfarin is considered one of the top ten medications associated with serious adverse events such as bleeding [9]. The incidence of warfarin-related adverse drug events and person-affected outcomes have not yet been reported in our institution. This research aims to shed light on this subject.
The aim of this study is to analyze safety reports that included warfarin as a medication error or near-miss at King Abdulaziz Medical City (KAMC), National Guard Health Affairs, Central Region, to optimize the reporting of incidents in the safety reporting system and to determine the factors contributing to errors in warfarin prescriptions.

Design
Single-center retrospective cohort study.

Setting
The research was conducted in the King Abdulaziz Medical City-Riyadh Ministry of National Guard Health Affairs. The research was initiated in August 2017.

Data Source
In this study, we used reports from 2013 to 2016 related to warfarin that were collected from the organization's safety report system database.

Research Instrument
The safety reporting system (SRS) refers to an electronic web-based tool utilized to report safety reports, collate related information and feedback. Reports to the SRS database are freetext fields with no minimum amount of information required to complete the report safety process. The contributing factors were described and analyzed using a fishbone diagram (Ishikawa).

Statistical Analysis
The data were extracted and described, and the analysis was performed to determine the number of yearly reports, contributing factors, and person-affected outcomes. Descriptive analyses were performed to determine the frequencies and characteristics of warfarin errors reported during the study period.

Results
A total of 78 adverse incidents were included in the study from 2013 to 2016 ( Figure 1); 73% of them did not reach the patient, and 26.9% reached the patient. Out of the 26.9% (n=21), 16 did not cause harm, and only 5 of the patients needed monitoring to confirm no harm (Figure 2). The patient-affected outcomes are categorized alphabetically from A to I according to severity (Table   1) [10,11]. The analysis of the contributing factor was applied in the fishbone diagram for the incidents that reached the patients. Under the material factors, the IT/network problems were one of the main reasons for the incidents. In addition to personnel-related factors, other factors included a lack of quality control in the application of an independent double-check system for high-alert medications, miscommunication among staff and a lack of staff education. We also found that the workload and work environment had an impact on errors with respect to staffing deficiencies (Figure 3).

Limitations
The present study had some limitations. Like other voluntary reporting systems, the safety reporting system is inherently prone to underreporting. In addition, there is a lack of similar studies related to the reporting of medication errors, especially in the Middle East and for warfarin in particular.

Conclusion
There was an increase in warfarin-reported incidents throughout the years, which is an indication of an increased