Study area and period
The study was conducted among nurses working at referral hospitals of Amhara regional state which are Debre Birhan, Felegehiwot, Debremarkos, Gondar and Dessie referral hospitals from March 1-30, 2019. Debrebirhan, Felegehiwot, Debremarkos, Gondar and Dessie referral hospitals are found 130 km, 564km, 299km, 748and 400 km away from the capital city of Ethiopia, Addis Ababa respectively. According to data obtained from 2019 health management information system team of each hospital, there are 147, 295, 181, 453 and 170 BSc and 39, 106, 34, 137, and 78 diploma nurses working in Debrebirhan, Felegehiwot, Debremarkos, Gondar and Dessie referral hospitals respectively.
A multicenter hospital based cross sectional study triangulated with observation was conducted.
All nurses who were working at referral hospitals of Amhara region were considered as Source Population whereas those nurses who were randomly selected from Amhara referral hospitals during the study period were regarded as Study population.
Nurses with a minimum of six month working experience and involved in direct patient care were included whereas those nurses who were not involved in medication administrations practice and the ones serving in administrative positions were excluded.
Sample Size Determination
Using single population proportion formula, 95% confidence interval, 5% margin of error, a reasonable estimate for the proportion of medication administration error from a prior study (51.8 %) and adding 10% non-response rate, a sample of 422 nurses was reached. For the observational part of the study, 10% of the sample size (42) nurses were involved.
To select 422 nurses from the total five referral hospitals in Amhara region, all hospitals were first listed down with their respective nurse number after which sample size was proportionally allocated to each hospital. Then, the sampling frame was prepared for each hospital by having lists of nurses from the hospitals’ nursing director and human resource management. Finally, eligible nurses of each hospital were selected by simple random sampling technique (Figure 1).
Operationally defined terms
Medication administration error: is any kind of error in ten rights (right patient, medication, dose, route, time, assessment, education, to refuse, evaluation and documentation(wrong performance)) that can harm patient and its occurrence can be prevented and controlled by health professionals by checking the ten rights of MAE.
Wrong medication error: Medication administered to the patients that were not on the patient's medication chart.
Wrong dose error: Medication dose or quantity different from that of the standard dose.
Over dose: a drug or substance in quantities greater than the standard dose.
Under dose: a drug or substance in quantities less than the standard dose.
Wrong time error: Administration of medications 30 minutes earlier or later from its scheduled administration time.
Wrong route error: The actual route of medication administration differs from the
recommended route of medication administration.
Wrong patient error: Patient misidentification during medication administration.
Wrong education error: Administering medication without informing patient about the medication being administered.
Wrong right to refuse error: no acceptance when legally responsible person has refused of the medication being administered.
Wrong assessment error: not assessing the patient and not testing the result to determine safeness and appropriateness of medication.
Wrong evaluation error: after medication is administered, the patient is not assessed for any adverse effect and effectiveness of medication.
Wrong documentation error: Incorrectly and incompletely documented in medication administration record sheet, and there is a mismatch between what is being documented and administered.
Current working unit: the unit that nurses is working during data collection.
Duration in specific unit: length of stay in the current working unit.
Poor communication: no communication about the time when the next dose is due and while facing problems during medication administration.
Data collection procedures
A semi structured self-administered questionnaire was used to collect data on nurses’ socio demographic characteristics (salary, institution where the nurse earned educational award, year of experience, etc), work related factors (nurse to patient ratio, lack of written guideline for medication administration, poor communication with other nurses while facing problems, current working unit, lack of reporting mechanism to medication errors and duration in specific unit), professional related factors (lack of training and inability to follow ten rights of medication administration practice) and other factors contributing for MAEs (Unclear verbal order, illegible physicians hand writing, wrong prescription and dispensing, look like drugs, nurses’ prescription in place of physicians, nurse administer medication prepared by another nurse and physicians’ frequent alteration of their orders). Moreover, prevalence of MAE, reporting trends of nurses about medication error and types of MAEs were considered. Ten trained diploma nurses were involved in collecting data from the questionnaire.
Using a structured observation checklist, five diploma nurses working in other units of each hospital observed nurses to gather data on their adherence to the directly observable nine rights of medication administration. Observation was made on medications given at times from 5:00 am to 7:00 am. After observation, patients’ medical record was reviewed to get a record of ordered medication with its dose, route, time and other profile of the patient.
Data quality control
In order to assure data quality, the questionnaire and observational checklist were adapted from previous studies (5, 9, 26). Before two weeks of actual data collection, both the questionnaire and observational checklist were pretested on 21 nurses working at Funeteselam General Hospital after which some modifications were made accordingly.
To minimize bias, the nurses weren’t informed of being observed while medicating their patients. Moreover, one day training and clear orientation was provided for data collectors and supervisors on the process of data collection. During data collection, data collectors were closely monitored and guided by five BSC nurse supervisors for complete and appropriate collection of the data and reporting to the principal investigator was done on a daily basis. The collected data were double entered into Epidata version 4.2 by two data clerks for validation purpose. The entered data were multivariate analyzed for statistical adjustment of possible confounders.
Data processing and analysis
The collected data were cleaned manually, coded and entered into Epi data version 4.2 and exported to STATA Version 12 statistical software for data transformation and further analysis. Descriptive statistics like frequencies, proportion, and summary statistics (mean, median, IQR and standard deviation) were used to describe the study population in relation to relevant variables and presented in tables and graphs. Multi-collinearity between the study variables was diagnosed using standard error and correlation matrix. The assumptions for binary logistic regression model were first checked and then bivariable analysis was carried out to identify candidate variables (p<0.25) for multivariable analysis. Using these candidate variables, multivariable analysis was performed to investigate statistically significant independent predictors of medication administration error by adjusting for possible confounders. Finally, variables whose p- value less than 0.05 (p<0.05) from multivariable analysis were declared as statistically significant. Adjusted odds ratio with 95% CI was considered to identify the strength of association between medication administration error and its predictors.
A formal letter of ethical clearance and approval was obtained from DMU, health Sciences College of ethical clearance. Then official letter was written from administrative bodies of each hospital to each unit of respective hospitals. The respondents were not requested to write their name, to answer the questions alone and by assuring individual response were not reported. Data collection was made after written voluntary consent is taken from each participating nurse after informing about study. The observational study was conducted after the administrators of the hospitals gave their consent to do so and the data collecting nurses interfered during observation of medication administration when error was perceived as life threatening.