Cohort study for evaluation of dose omission without justification in a teaching general hospital in Bahia, Brazil

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1 International Journal of Quality in Health Care, 2016, 28(3), doi: /intqhc/mzw016 Advance Access Publication Date: 11 February 2016 Research Article Article Cohort study for evaluation of dose omission without justification in a teaching general hospital in Bahia, Brazil BARTYRA LEITE 1, SOSTENES MISTRO 2, CAMILE CARVALHO 1, SANJAY R. MEHTA 3, and ROBERTO BADARO 4 1 Pharmacy Department, University Hospital Professor Edgard Santos, Bahia, Brazil, 2 Multidisciplinary Institute of Health, Federal University of Bahia, Brazil, 3 Department of Medicine, University of California, San Diego, CA, USA, and 4 Department of Medicine and Diagnostic, Federal University of Bahia, Salvador, Brazil Address reprint requests to: Bartyra Leite, University Hospital Professor Edgard Santos - Pharmacy Department, Rua Augusto Viana, s/n, Canela, Salvador, Bahia, Brazil. Tel: ; Fax: ; bartyraleite@gmail.com Accepted 10 January 2016 Abstract Objective: To evaluate the incidence of medication errors due to dose omissions and the reasons for non-administration of medications. Design: A cohort study blinded to the nursing staff was conducted for 5 consecutive days to evaluate administration of prescribed medications to selected inpatients. Setting: A major academic teaching hospital in Brazil. Participants: Dispensed doses to patients in medical and surgical wards. Main Outcome Measures: Doses returned to pharmacy were evaluated to identify the rate of dose omission without a justification for omission. Results: Information was collected from 117 patients in 11 wards and 1119 doses of prescribed medications were monitored. Overall, 238/1119 (21%) dispensed doses were not administered to the patients. Among these 238 doses, 138 (58%) had no justification for not being administered. Failure in the administration of at least 1 dose occurred for 58/117 (49.6%) patients. Surgical wards had significantly more missed doses than that in medical wards (P = 0.048). The daily presence of a pharmacist in the wards was significantly correlated with lower frequency of omission errors (P = 0.019). Nervous system medications were missed more significantly than other medications (P < 0.001). No difference was noted in the omission doses in terms of route of administration. Conclusions: High incidence of omission errors occurs in our institution. Factors such as the deficit of nursing staff and clinical pharmacists and a weak medication dispensing system, probably contributed to incidence detected. Blinding nursing staff was essential to improve the sensibility of the method for detecting omission errors. Key words: medication error, dose omission, patient safety Introduction Hospital pharmacists are responsible for medication coordination and dispensing services, medication therapy management, assisting physicians and patients in therapeutic decisions, as well as monitoring medication administration and adherence [1]. Monitoring inappropriately administered medication or missing doses is one of the most difficult challenges for hospitals that have not fully implemented a computerized medication administration system [2, 3]. The The Author Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved 288

2 Hospital medication errors Patient Safety 289 development and application of audit routines into medication distribution systems by pharmacy departments have substantially decreased medication errors (MEs) [1, 4, 5]. MEs are under-reported across the world, especially in developing countries [6]. A recent study of MEs in the UK revealed error rates of 10.8% in prescribing, 9.9% in dispensing and 59% in medication administration during the medication delivery process [7]. In the USA, median error rates (interquartile range) were 7 errors per 100 (2 14) medication orders, 52 (8 227) errors per 100 admissions and 24 (6 212) errors per 1000 patient days [6]. A systematic review of the literature indicates that error rates varied from 7.1 to 90.5% for prescribing and from 9.4 to 80% for administration in the Middle East countries [8]. In São Paulo, Brazil, a study showed 305 MEs over a 30-day period in medication therapy and administration by using 3 different strategies to collect data. The mean (SD) was 6.9 (±6.8) MEs per patient. The most frequent types were omission (71.1%), mistimed doses (11.5%) and prescribing errors (4.6%) [9]. In another study in Goiás, Brazil, report books used by nursing staff were analyzed and a total of 230 MEs were identified, most of which occurred in the preparation and administration of medications by nursing staff (64.3%). Breakdown of these errors included 50.9% due to omission, 16.5% due to wrong dose, 13.5% due to wrong time and 12.2% due to inadequate administration techniques [10]. In both studies, the omission rates were influenced by medication shortages at the hospital. Here, we analyzed the rate of dose omission in medications prescribed and dispensed from the pharmacy to the wards in a University Hospital, by using a blind observational method. Methods Design of study This was an observational, nursing staff-blinded, cohort study for 5 consecutive days with a 24-h follow-up to monitor the administration of prescribed medications to selected patients in a University Hospital. Characteristics of the study site The study was conducted at the Professor Edgard Santos University Hospital, Bahia, Brazil. The institution was organized into 13 inpatient units with 333 active beds distributed in 2 intensive care units, 5 surgical wards and 6 medicine wards. The hospital pharmacy service dispenses medications under a distribution system that uses paper copies of prescriptions for each patient. Doses were prepared by pharmacy technicians, confirmed by a pharmacist and then dispensed covering a 24-h period. The medications were dispensed at preset times for each inpatient unit and at the same time, medications not administered from the previous period were collected. Subsequently, these returned medications were checked for packaging integrity, as well as identification, and returned to pharmacy stocks. The nurses at this hospital did not routinely explain the reasons for returning medications to the pharmacy. During the study period, only 2 of the 11 medical surgical wards had the presence of a clinical pharmacist. These clinical pharmacists were responsible for review of prescriptions, monitoring of medication adverse reactions, nursing continued education, medication reconciliation and therapeutic monitoring. Inclusion and exclusion criteria Adult inpatients with prescribed medications for regular use were included in this study. Patients whose prescriptions contained medications as needed only (e.g. symptomatic medications for fever, pain and nausea), which are not previously scheduled, and for which, we did not have to know in advance the right time of administration, were excluded from the study. Oral liquid and topical medications that are dispensed by pharmacy in multi-dose packages, patients for whom medications were not dispensed in the evaluated times and patients in intensive care units were also excluded from this study. Data collection Data from each patient were collected on two occasions and by two different observers. Each day, patients who met the inclusion criteria were selected randomly using a computer-generated list. Thus, the same patient could be included in the study more than once, but was analyzed as a new patient. Upon receiving the prescriptions for the selected patients, an observer (Ob-1) filled two different data collection forms for each patient. On the first form, patient identification data and medications prescribed with their respective doses and regimens were recorded. The second form recorded patient s identification and all administration schedules provided by nurses, without identification of the prescribed medications. The second observer (Ob-2) utilized this second form (prepared by Ob-1) to perform a direct check on medications in the patient s medication cart (i.e. determining if the dose was removed for administration to the patient according to the schedule). Ob-2 checked the patient medication cart every hour after the scheduled time for the administration of a dose (this interval was used so that possible delays were not confused with omissions). At each check, Ob-2 recorded all medications and doses present in the patient s medication cart, without having the information about the prescribed medications and the ones to be administered. After 24 h, Ob-1 requested the records of patients included in the study and verified justifications for any missed medication dose and Ob-2 recorded all medications that were returned to the pharmacy. At the end of data collection, the observers performed a comparison between both completed forms from each study subject and the reason for the failure to administer each dose was recorded. A modified version of the model adopted by Gilliand et al. [11] was used to classify the reasons for medication return. The model adopted by Gilliand consisted of a tool filled by the nurses with the justifications for the return of medications to the hospital pharmacy, but the author does not work with omission error and hence, medications returned without justification were characterized as Other. In our study, cases without any justification for missed doses were considered as MEs by omission. A pilot study with 26 patients was conducted to evaluate the consistency of data collection method and supporting sample size calculation. Data from the pilot study were not included in the analysis. Figure 1 summarizes the flow of data collection. All health care professionals involved in the management of the patients (doctors, nurses and nursing technicians) were blind to the objectives and methodology of the study. Observers were pharmacists who previously worked in the studied care units in order to avoid the so-called Hawthorne Effect [12]. This effect is related to the influence of the observer s presence on the execution of activities by the observed subject. The medications identified were categorized according to the Anatomical Therapeutic Chemical (ATC) Code classification. Sample size and selection of patients In the pilot study, it was observed that about 2500 doses per day, and an average of 10 doses per patient were dispensed from the pharmacy to the inpatient units. The sample size was calculated based on a

3 290 Leite et al. Figure 1 Algorithm for summary of data collection procedure. predicted missed dose rate of 21% according to the observations in the pilot study, based on an α error of 0.05 and confidence interval (CI) of 95%, which resulted in 232 doses (24 patients). The collection was performed for 5 consecutive days to avoid bias caused by the variability of nursing staff during the week. Statistical analysis Data analysis was performed using STATA 12.0 software. The Poisson regression model with robust variance was applied in both univariate and multivariate analysis to identify the association between variables and the main effect of outcome (dosing omission). The error rate by omission of doses was considered as the main outcome for the analysis and omission was defined as all doses not administered to patients and without a justification for omission. Potential confounders examined include (i) Type of inpatient unit (medical or surgical), because of the difference in the number of prescribed medications and the complexity of nursing care; (ii) Presence of clinical pharmacist, since they provided routine monitoring of doses administered and continuing education to the nursing staff about the safe use of medications; (iii) Route of administration, the difference in complexity between the preparation and administration of oral and injectable medications; and (iv) Schedule of medication administration, since the nursing staff were less in number at night. Ethical issues The project was approved by the Research Ethics Committee of the Professor Edgard Santos University Hospital Complex, under number 27/2010, and was executed in agreement with the Institutional Nursing Service Director. Results Information was collected from 117 patients distributed among the selected wards for 5 consecutive days, and 1119 doses were monitored in total. Table 1 describes the main characteristics of the collected data and studied variables. Table 1 Main features of data collected in the selected wards Variables No. of doses % Type of ward Medical Surgical Presence of pharmacist With Without ATC a Anti-infective Cardiovascular Nervous system Others Route of administration Via parenteral Via oral/enteral Time of administration Morning (06:00 12:00) Afternoon (14:00 18:00) Night (20:00 05:00) Medication administration Doses administered Doses returned Overall, 238/1119 (21%) doses were not administered to patients and returned to the pharmacy. Among the 238 doses returned, 138 (58%) had no justification for not being administered. Thus, 12% (138/1119) of all dispensed doses were omitted without any recorded justifications. Figure 2 demonstrates why doses were not administered to the included patients. Failure in administration of at least 1 medication dose occurred in 58/117 (49.6%) patients and more than one dose in a single day in 37 (31.6%) patients. Nervous system medication was the therapeutic class that was more prone to omission error. Among the total doses evaluated, 298 (26.6%) corresponded to nervous system and 80 (27%) of these were omitted without justification. This corresponds to 34% (80/238) of all omission doses in the collection period.

4 Hospital medication errors Patient Safety 291 Table 2 shows the association between omitted doses and the studied variables. As shown in this table, the surgical ward had significantly more missed doses than the medical ward (P = 0.048). In addition, the wards without the daily presence of a pharmacist for monitoring medication therapy had a significantly higher frequency of missing dose (P = 0.024). Interestingly, nervous system medications such as analgesics, anticonvulsants and antipsychotics were missed more significantly than other groups (P < 0.001). There was no difference in the frequency of missing doses administered via different routes of administration. Discussion This report documents the high daily rate of omission errors in prescribed and dispensed doses of medications to inpatients at a University Teaching Hospital in Brazil. An unacceptable high rate (58%) of omission errors occurred without any reported justification. In 1962, Barker demonstrated the effect of medication distribution system on medical errors rates [13]. In the case of traditional medication distribution system, omission errors ranged from 2.1 to 9.1% Figure 2 Frequency of causes for non-administration of scheduled doses. Table 2 Association between dose omission and the studied variables compared with lower rates of % while using a unit dose dispensing system (UDDS) [14]. Since our hospital does not use a UDDS, we had guaranteed that all prescribed medications were distributed to the medication carts of each patient included in this study. More than 12% of all scheduled doses were omitted without any justification documented in the patients medical records. This incidence of omission errors observed in our hospital was at least 2-fold higher than that observed in a study conducted in the USA [15]. This high incidence rate noted in our results may be explained by the methodology used to conduct the study. Blind observation for medication administration was used to avoid any effect on nursing staff behavior. Other observational studies have not used this strategy and the knowledge about the observation of staff activities was directly implicated in the observed error rates reported by other authors [15 21]. Silva et al. [10] used a retrospective methodology to seek medication omission records in patient files and found a frequency of omission errors (50.9%) similar to ours, but they reported the medication shortage in the institution as the main contributing factor for the increase in omission error rate. In our study, there were no reported medication shortages in the pharmacy during data collection. Although we expected a higher rate of omission error in the medical wards, in actual, higher numbers were observed in the surgical wards. We hypothesize that this could be due to the increased workload on the staff in the post-surgical wards, where patients require 100% of their toilet, cleaning and dressing activities to be assisted by the nursing staff. The overload of nursing activities in patient care may produce delays or errors in the preparation and administration of medications. Medications classified as Nervous System by ATC, such as those for the treatment of psychiatric disorders, anticonvulsants and analgesics, were the most common medication class omitted. One reason could be the large number of prescribed medications in this class. The lack of difference in the omission errors by different administration routes can be interpreted as the consequence of lower proportion of medications prescribed for parenteral administration. However, this pathway has previously been associated with a higher rate of MEs due to the generally high complexity in preparation and administration of injectable medications [10]. Variables Rate of omissions (%) Univariate analysis Multivariate analysis RR 95% CI P-value RR 95% CI P-value Type of wards Medical Surgical ) Presence of pharmacist With Without ) ) ATC a Anti-infective Cardiovascular Nervous system < Others Route of administration Via parenteral Via oral/enteral Time of administration Morning (06:00 12:00) Afternoon (14:00 18:00) Night (20:00 05:00)

5 292 Leite et al. Nursing care involves a complex organizational system where factors such as medication administration and assistance in daily activities are coupled with time-related pressures, and result in opportunities for errors [10]. It is expected that errors occur most frequently during morning, when the staff change shift and most of the medication administration occur [21]. However, in our study we did not observe a difference between the schedules of medication administration and omission rates. MEs, in general, are events arising from multifactorial causes and the identification of high rates of these events should initiate an investigation of systematic failures that can contribute to these errors [22]. Despite not having been an object of study, we found some factors commonly described with errors elsewhere present in our institution. The absence of a UDDS has been described as an important source of ME at hospitals [14]. In a multicenter study conducted in the USA, the frequency of omission errors was 30% in hospitals with varied medication distribution systems [15], while a study conducted in 1970 and repeated in 1982 in a hospital with UDDS, demonstrated error rates of 2.7 and 4.8%, respectively [14, 23]. The presence of a clinical pharmacist was recently demonstrated as an effective measure to reduce MEs by omission [24] as these professionals perform a broad spectrum of activities such as prescription assessment, medication carts review, therapeutic monitoring, patient and healthcare education and medication reconciliation, which may improve the quality of patient care and reduce rates of MEs. Our study showed a statistically significant difference in the incidence of these errors when comparing units with and without pharmacists. However, in multivariate analysis, this variable lost significance. The most likely cause for this fact is that only 2 of the 11 units studied had pharmacists working in direct patient care. Thus, the insufficient number of pharmacists in the units could also be one of the contributing factors to the high rate of errors. Another important factor is the deficit of 68% of needed nurses and 29% of needed nursing technicians in our hospital, according to the guidelines based on the Resolution 293/2004 of the Brazilian Federal Council of Nursing. Errors related to the nursing staff practices are directly associated with the following factors: professionals who exceed the acceptable number of daily work hours, and scarce human resources that also directly imply the excess hours of nurse work. Furthermore, the overload of nursing activities creates dissatisfaction among professionals, and this is also related to major adverse events and errors attributed to healthcare work [20, 25, 26]. Involving the patient and patients family in the administration of prescribed medications process may help to reduce MEs [27]. The biggest stakeholders are the patients themselves, and although they are not responsible for their own treatment, they are the last barriers for preventing MEs. Some information about the used medications, such as indications and schedules, should be provided by healthcare staff (especially by the clinical pharmacist) to the patients and their family during hospitalization, since greater knowledge about their treatment is closer to an effective therapeutic outcome. We believe that this approach can provide a significant reduction in omission errors. One limitation of this study was the fact that the information about justification for non-administration of medications was exclusively collected from patient charts. Reasonable justifications may not have been recorded in cases where the administration of antipyretics, analgesics or antiemetic medications were deemed unnecessary by nurses even if they were scheduled. Despite of the high rate in dose omission observed in this study, these data can be underestimated since our method was not sensitive to detect situations in which doses were removed from the medication carts but were not administered to the patients or returned to the pharmacy. These may occur due to abnormal causes that would not be recorded in the charts such as lost, stolen or medication abuse. Given the impossibility of establishing a method to measure this type of omission, the authors assumed that doses not found in medication carts are administered doses [14]. This is the first documented study on medication administration omission to inpatients, carried out with blinded health care team in a University Teaching Hospital in South America. Our results should be used as a starting point for a detailed investigation of the causes that would have contributed to the high incidence of MEs by omission. Conclusion This study found a high incidence of MEs by omission of doses in a Brazilian teaching hospital. Factors such as lack of a UDDS, insufficient number of clinical pharmacists and the deficit in the nursing staff probably contributed to the high incidence of omissions. As demonstrated, blinding nursing staff was an essential strategy to improve the sensibility of the method for detecting omission errors. Funding This work was support by the University Hospital Professor Edgard Santos Institutional grant for drug development and approved by the Research Ethical Committee of the hospital under the number: 27/2010. References 1. Broekemeier RL, Brewer PE, Johnson MK. Audit mechanism for hospital drug distribution. Am J Hosp Pharm 1980;37: Wilson AL, Hill JJ, Wilson RG et al. 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