Medication errors are 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 [This chart review identified 311 drug related incidents (30.9% of total 1006 reported incidents) over a period of fifteen years. Human error contributed in 66% of the MEs and 32% of the errors showed a deviation from standard practice. Medication, handling, and administration accounted for 60% of the reports. Thirty eight percent of the errors resulted in harm to the patients. Out of 86 ADEs reported there were 23 serious and 5 life-threatening errors (28%). The actual harm that came to the patients was 1.6%. Neuromuscular blockers, narcotic analgesics, sedatives, and vasopressors contributed in 67% of the errors.
There are different methods to detect and report medication errors or ADEs, like self -reporting, incident reporting, manual chart review, automated computerized surveillance or direct observation. Each has its value and limitations, but all highlight the problematic areas that need attention. Critical incident analysis is a process of collecting and reviewing reports in a way that helps in identifying trends in terms of frequency and harm. The process identifies contributing factors, and is helpful in education, research, development of policies, guidelines budget and planning, to provide safe anesthesia care [5, 6]. It is a low-cost measure of value in LMICs.
Our hospital serves as a tertiary care center in the area. A CI reporting program was initiated in our department in year 1995. These incidents are periodically reviewed and presented in departmental academic meetings where staff is also reminded on how to and when to fill the CI forms . Once the error is reported the root cause must be analyzed, preventive measure instituted and shared with others. Quality Improvement Issues (QII) meetings were initiated in the department in year 2000, where errors were selected for taking further action and corrective strategies were prioritized. All incidents are reported anonymously on voluntary basis. This simple quality improvement and risk reduction measure helped us in improving the standard of anaesthetic care in our setup with low resources, where the lowering cost is an important aspect of implementing new safety measures .
Several corrective strategies related to medications were put in place. Strategies that had significant effect were standardization of syringe sizes for specific drugs, and changes in printed self-adhesive labels where the drug name and concentration were made bold. Another additional strategy was the change in the floor stock that was reduced for some medications. The supervision of trainees for drug dilutions was made more stringent by trainers, and a file “standard dilution of vasoactive medication” was made available in the operating room (OR) suite. It was also observed that one person responsible for all phases of medication handling was an error reduction strategy and was recommended. Syringe standardization for different medication had already been in place in the department but CI still resulted due to deviation from the standards. One of the possible reasons of this deviation was the “subjective practices” without following the set standards. One of the steps in reducing such errors was regular reminders and presentation in departmental CI meetings which were followed by a “lesson to learn” e mail generated by the departmental CI coordinator after each meeting and shared with all staff.
One third of the MEs were classified as human errors (HE). These usually happened because of personnel preferences and non-adherence to existing standard processes. The hospital also switched the manuals of policies and guidelines from hard copies to the online version during 2010 to 2015. All new inductees in the department were also instructed during the orientation program to go through these online resources. There is still no formal sign off that they have read and understand. It could be one of the reasons of deviation from practice when systems in place are not followed properly. The future task is to ensure compliance to this step. Repetition of HE after corrective measures have been put in place is regarded as negligence. Its recurrence can only be prevented by sharing these reports, educating, training, and updating the existing staff as well as new employees in the department.
As regards phase of drug handling, over-dosage was the most common administration error followed by wrong medicine, in-efficient medication, and under-dosage. The common causes of 38 cases of over-dosages were misunderstanding either verbal orders or deviation from standard dilutions. This is similar to what was reported by Sakagudin et al who observed communication error as a main cause rather than lack of knowledge . They rectified such errors by standardization of oral instructions (for e.g., “Inject 1.5 cc, 6 mg of Vecuronium out of ampoule containing 4mg/cc”.) and making it a rule to repeat the given instructions .
The causes of administration of wrong medication in our study were syringe swap or ampoule swap and deviation from syringe standardization. In the OR there are two common mechanisms responsible for error during administration processes. The first was during preparation of the medication syringe from drug vial/ampoule by choosing wrong ampoule and diluting it to an unintended concentration. The second possibility was by accidentally picking up of wrong syringe/ampoule i.e., “syringe swap” which may happen because of distraction, inattention, or heavy workload. An observation was that breaking all ampoules at the same time and then filling all the syringes increased the risk of filling wrong medication in a syringe as well as label swap, it was reinforced to open and fill ampoules one by one. Lobaugh et al reported an incidence of administration errors (65%) close to our findings but studied it in pediatric cases . In contrast Sanduende et al documented 42% errors during this phase 11. Use of prefilled syringe has decreased preparation errors in some places 12. We practice this for a few medications like opioids, but the rest are prepared by the anesthesiologist pre- induction. However, from the LMIC perspective it needs to be remembered that there is an additional cost involved in provision of pre-filled syringes.
Labelling also played important role in these errors. There is a controversy whether color coding of labels decreases or increases MEs. It was also observed that some incidents happened at times of shortage of color-coded labels resulting in use of white stickers which resulted in wrong medications being administered in 23 reports. Cheeseman and colleagues noted that addition of color to labels increased the speed of recognition; while Haslam and colleagues state that the process of implementing the International Color Coding System increased their rate of medication errors due to a change in the system [13, 14]. In our experience there was a decrease in ME after the introduction of standardized color-coded labels for frequently used medications in year 2007 as shown in figure 1. These colored labels were initially only applicable to medications that were prepared by anesthesiologists in OR. In 2018 our department adopted international color-coded labels for all medications used. Abeysekera et al recommended further investigations to determine if color coded printed labels were effective in reducing medication error .
According to a report by the Australian Incident Monitoring Study, neuro-muscular blockers (NMB) and opioids were the most frequently administered drugs in cases of wrong medication . We also observed the same trend in our study, though NMBs were the highest number of errors (n=102), but one of these were “ineffective medicine” where response of medicine was not achieved after a full calculated dose. Another impact of this inefficacy of NMBs is decreased satisfaction of surgical colleagues as well as frequent repeated doses and increase in cost. Action was taken by the pharmacy in ensuring cold chain and change of vendor (shown in Table 1). In contrast to our findings Kentaro et al reported opioids and cardio-stimulants/vasopressors as the most common medications found in their study .
The harm because of ME can vary from minor physiological disturbance to life threatening morbidity and mortality. The incidence reported in literature varies from 0.01–11% [2, 17, 18]. In our patients this figure was 1.6% without any mortality. This was similar to a Brazilian study by Thomas et al where they found morbidity and mortality with irreversible damage in 1.75% patients . Nanji et.al from USA also reported a similar incident (1.6%) of life-threatening events, none were fatal .
In order to prevent ME one needs to improve knowledge, increase reporting and sharing of incidents, vigilance; simulation-based teaching, orientation of the set standards to the new inductees in the department and development of clear communication. In 2019 Nanji identified several such strategies and further updated it in 2020 based on the recommendation of multi-regional associations for patient and medication safety to prevent perioperative MEs and/or ADEs. These were based on technology solution, standardization, elimination of lookalike medication vials and labels, pharmacy solution, and improvement in institutional culture . Keeping the limitations of LMIC in mind we propose cost effective process-based interventions. Whether one uses technology or process, the first and foremost thing is to strengthen, design and comply with the processes of institution and the existing guidelines. Medication lay out is important to prevent syringe swaps and we applied it by keeping all cardiac medications in a separate bin at a separate place and it worked well. High alert labels on medications was one of the strategies that we found effective in preventing MEs.
Based on our review, we plan to introduce some further strategies within the department. One of these is an anesthesia drug checklist before every case, revision of syringe size for sedatives, implementation of change of practice to break, fill and label one ampoule at a time, before breaking the second ampoule, and introduction of syringes with color coded plungers. We also plan to introduce medication safety workshops based on common incidents, at least once a year. We are also deliberating whether to form a group or committee to monitor medication errors and provide weekly pictorial alerts. All new trainees, faculty members and technicians must go through all the guidelines and policies during orientation week and a simple quiz can be developed to certify that they have read as well as understood.
There are certain limitations to our study: firstly, it is a single Centre observation study, reporting was voluntary, and it was a retrospective review of a database. This could miss some unreported incidents as well as factual details of reports. CIR has its own limitation like under reporting, physician bias and their own perspective in the report , lack of denominator, lack of sensitization of the value of reporting and delayed action after group discussion.