Non-reporting of Medication Administration Errors among Nurses in Qatar

Background: Prompt recognition and reporting of Medication Administration Errors (MAE) are paramount in ensuring patient safety in hospitals. The data on under-reporting MAE in Middle East Area is limited. Aim: The study intended to estimate the percentage of fear factor and explore the perception of nursing professionals regarding the reason for the occurrence and underreporting of MAE. Design: A cross-sectional design was utilized to conduct the current study. Place and Duration of Study: The study was conducted in eight hospitals working under Public health sector of Qatar between August and September 2016 Methodology: The data were collected with a purposive sample of 487 clinical nurses employed by the public health sector of Qatar who responded to a pre-designed online questionnaire. Results: The perceived prevalence of fear factor in non-reporting MAE was 23.45%, 95% confidence interval (C.I).: 16% to 33%. The single factor confirmatory factor analysis (CFA) model explained 65% of the variance in the fear factor of nonreporting of medication administration errors. The highest mean score in the subscale of reasons for non-reporting of MAEs includes fear (mean 0.652±1.671) and administrative responses (mean 0.304±1.466), and reporting processes (mean 0.505±1.669), whereas disagreement over hospital definition (mean -1.158±1.528) of error was the least significant reason for nonreporting of MAE by the clinical nurses. Original Research Article Hassan et al.; JPRI, 33(60B): 591-604, 2021; Article no.JPRI.81118 592 Conclusion: The study focuses on quantifying the fear factor and underscores the Nurses' fear about the professional consequences of reporting MAE. The findings in this study not only provide evidence concerning the fear of reporting MAE but also shed light on the contributing factors and reasons for the nonreporting of MAE. Nursing leadership needs to concentrate on modifying existing strategies and policies to more comprehensible approaches to reporting errors.


INTRODUCTION
Patient safety is considered the cornerstone of good health care and one of the metrics for assessing a sound health care system. Despite the international focus on patient safety and safe health care, medication administration errors remain prevalent. A safe administration of medication has a critical role in ensuring patient safety in the hospital. The challenges to this component are dual -the occurrence of Medication Administration Errors and the nonreporting of these errors. MAEs pose a public health concern since these medications have the potential to cause serious harm to patients, warranting the attention of the health system towards their prevention and regular reporting. In addition to the serious risk to the patients, it is also associated with huge global health care costs [1] and has potentially grave implications for the reputation of organizations as well as the psychological well-being of the health professionals involved [2].
The National Coordinating Council for Medication Error Reporting and Prevention defines "A medication error is 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. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use." [3]. This may occur at any phase of the medication process: prescribing, dispensing, transcribing, and administration errors and which are considered multi-disciplinary, structural, and systemic factors.
A recently published mixed-methods study that explored barriers of medication error reporting among the health care professionals reveals that health care professionals, including nurses, had critical concerns about the process and consequences of reporting errors [4]. Many of the barriers to reporting of MAE stated in the literature include fear of adverse personal and career consequences following reporting, disagreement over the definition of MAE, organizational culture and workflow, lack of knowledge [4,5,6,7,8]. The systematic review shows that organizational barriers like organizational culture, error reporting system, and management style play a major role in reporting medication errors [9]. A recent study from Qatar revealed that the barriers to error reporting include the fear of submitting the report; the risk for further investigation and adverse effects on performance evaluations and career advancement; the impact on relationships with colleagues; and lack of confidentiality in handling reported incidents [4].
The timely reporting of errors can reduce the complications of medication errors and improve the safety and health of the patients. A systematic review of literature that explored medication errors across the countries of the middle east reported that the quality and reporting of errors needs to be improved [10]. A systematic review showed that the prevalence of medication errors ranges from 2% to 94% [11] however, the estimated incidence of reported medication errors from Qatar was 0.044%. errors [12]. The data indicates a possible non-reporting of medication errors. The nurses who are primarily assigned the task of medication administration in hospitals usually assume or are assigned the responsibility of MAE in most situations, in this context, it is important to explore the perspectives of nurses [13][14][15][16][17][18][19]. The primary aim of this study is to estimate the percentage of fear factors perceived by the nurses for non-reporting of MAE. Also, this study explores the potential factors influencing MAE and the other possible causes of nonreporting MAE, from the perspectives of clinical nurses working in a hospital.

Design
This cross-sectional study was conducted to estimate the percentage of fear factors in the non-reporting of MAE, potential causes of MAE, and the possible reasons for non-reporting of MAE from the perceptive of clinical nurses. This study was executed at eight hospitals functioning under the public health sector in Qatar between August to September 2016.

Participants
The clinical nurses who indicated an interest in participating through an online survey were recruited in this study. 487 clinical nurses who had at least 1 year of experience in administering or preparing medication to their patients as part of routine work were responded to the survey and the data collected using the Survey Monkey software. The nurses during the preceptorship period and nursing managers were excluded from the study.
The eight facilities consist of approximately 9000 nurses in different levels from registered nurses up to executive director level. The study population includes only clinical nurses and the expected number of clinical nurses working during the study period was approximately 5000 [20]. As there is no previous study available in Qatar regarding the prevalence of the fear in reporting MAE, assuming 50% of the nurses might have fear of reporting MAE, considering 5% alpha error, design effect of 1.2 and 10% incomplete survey questionnaire, 460 nurses would be sufficient in sample size in this study. The responses collected from 670 participants, 487 met the inclusion criteria used for analysis.

Study Instrument
A validated self-administered questionnaire developed by Gladstone and Wakefield in the form of the 'Modified Gladstone scale' and 'Wakefield Tool' was used to collect data [21,22,23] with their permission. Demographic information data were collected to identify the participant's characteristics: gender, age, nationality, level of education, total years of clinical experience, and experience in the current clinical facility.
The face validity and content validity of the survey questionnaires were assessed for their appropriateness in the Arab scenario. The content validity of all items of the questionnaire was assessed by five experts on the relevance of the instrument, understandability/clarity of the statement, comprehensiveness, and significance in relation to the objective of the study and the cultural context of the country [24]. The experts rated each item for relevance on a 4-point scale, highly relevant [4], quite relevant [3] somewhat relevant [2] not relevant [1]. Individual-level content validity (ICVI), scale level content validity (S-CVI)/Average (scale level content validity index with the average method), and SCVI/universal average method (UA) were calculated with the responses of the experts on agreement of relevance. The I-CVI was calculated based on the number of experts providing a score of 3 or 4 divided by the total number of experts and the I-CVI score should not be less than 0.78 if more than 5 experts evaluated the tool [25]. The I-CVI score of the questionnaire was calculated at 0.88. To calculate the S-CVI, two different indices were calculated: 1) the proportion of the items on the tool scored as valid by the experts (ratings of 3 and 4 only) (universal agreement by experts = S-CVI/UA) and 2) the average score of the items rated by the expert either 3 or 4 (average agreement by experts = S-CVI/Ave). The calculated S-CVI/UA and the S-CVI-Ave were 0.93 and 0.98 accordingly. The accepted standard score for S-CVI/UA and the S-CVI-Ave up to 0.90 is considered an excellent score [24].
The composite questionnaire consists of 36 questions divided into four sections includes:why do medication errors occur (10 items), reasons for non-reporting of medication errors in their respective units (16 items), demographic (6items), and professional characteristics (4 items).
In section A of the questionnaire, the participants were asked to rank the possible causes of medication errors in their unit, based on 'the modified Gladstone scale' [21,22] from 1-10, in which 1 indicating the most frequent reason of MAE whereas 10 indicates the least possible cause of MAE in their respective units. In section B of the questionnaire, the participants were asked the reason for non-reporting medication errors adapted from Wakefield et al's scale [23], to rate their opinions in 6-point scores from strongly agree to strongly disagree, whereas sections C and D of the questionnaire cover the demographic and professional characteristics of the participants included the personal estimation of the proportion of all types of medication errors reported in their unit.

Data Collection
The study was invited for all the clinical nurses working in a Public hospital in Qatar. The participants were recruited through an open invitation in the hospital intranet. The survey was conducted online over two months using a purposive sampling method. The electronic version of the questionnaire was distributed through the nurse's official email group. The information sheet stated the purpose of the study, the average time required for the study (15-20 minutes), and the participants were allowed to refuse or withdraw from the study. once the participants proceed with the survey, it was considered as their consent for participation. The participation was completely voluntary and anonymous. The hospital website alert promoted online participation throughout the study period. Two reminders were sent to the participants at an interval of two weeks to encourage their participation. The survey was opened for every nurse and the software disabled the possibilities of duplication. The response received during the study period taken for analysis and the collected data was kept confidential.

Data Analysis
The data were collected by survey monkey software and transferred to Microsoft Excel Spreadsheet for analysis. The collected data were analyzed using Statistical Programme for Social Sciences (SPSS) Version 27. Sociodemographic characteristics and prevalence of MAE reporting were descriptively analyzed and presented in frequencies and percentages. The reasons for the occurrence of MAE were ranked according to the scores received for each item between 1-10 in which 1 means most frequent and 10 means least frequent causes for medication errors. CFA was conducted to define the underlying constructs that contributed to the non-reporting of medication administration errors. To make qualitative and quantitative data comparable for use in advance statistical analysis, 16 items of 6-point Likert's scale in Wakefield scale regarding the reason for not reporting medication error were coded "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree" and, "strongly agree" as -3, "-2", "-1", "+1", "+2" and "+3" respectively. The fear items have been calculated in proportion using the formula Σ (reported items)/Σ (highest value of that item) × 100 for each item [24]. The average percentage of the fear factor has been calculated as fear index.

Participant Characteristics
Based on the results, out of the 670 responses received during the two-month study period, 487 completed responses were used for analysis. Table:1 showed the socio-demographic and professional characteristics of the participants. The majority of the study participants were females (78%), aged between 20 and 40 years (80.9%), working in the inpatient unit (39.3%), and predominantly of Asian ethnicity (82.1%). A major proportion of the participants was holding a minimum of a bachelor's degree in Nursing. (82.5%) and with less than 10 years of working experience in current clinical facilities (82.75%). A large proportion of the study participants (80.2%) responded that they frequently administered medications as part of their routine work and nearly half of them reported (47.6%) that they were working in different units to cover the shortage of staff or additional staff requirements during emergencies. A Major proportion of nurses (59.5%) reported that the actual reporting of medication errors in their respective units was between 0-20%.
The estimated mean percentage of a fear factor was 23.4, which suggests that the presence of consequences of reporting medication errors hinders the nurses from reporting medication administration errors. Fear 50th and 75 th percentiles were 33% and 66% respectively. Figure:1 showed the predisposing factors of MAE in different units across the corporation. Based on the ranking of the participants the first five causes of medication administration errors in their units were, nurse fails to check patient's name band with the Medication Administration Record (MAR), physician's order being difficult to read or illegible, labels/packaging are of poor quality or damaged, confusion between two drugs with similar names and physician prescribes the wrong dose. The least frequent reason for medication errors reported by the participants was the tired and exhausted condition of nurses.  The confirmatory factor analysis of factors that leads to nonreporting of medication administration errors in different units. Based on maximum likelihood estimation the comparative fit index (CFI) = 0.80, Tucker lewit fit index (TLI) =0.77 where Root Mean Square Error of Approximation (RMSEA) was 0.11 more than 0.08. A single factor CFA of 16 items was conducted to assume the correlation between the items with the single common factor. The study adopted the fear factor as a common factor to correlate with the other 16 items on the scale. The chi-square value for the model (chi2_ms (104) 752.99 P=0.00) suggests that the model is well fit and consistent with the covariance data. The model explained 65% of the variance in the fear factor of nonreporting of medication administration errors. Table 2 summarizes the reasons why medication errors are not reported by the clinical nurses. The Wakefield scale was divided into four subscales: Fear, disagreement over error, reporting effort, and administrative responses. When considering the subscale 'fear' has 5 items. The highest score was given to the statement that agreed for fear factor was 'Nurses could be blamed if something happens to the patient as a result of the medication error' (mean=1.179 ± 2.108). Whereas 'Nurses are afraid the physician will reprimand them for the medication error' received the lowest score in subscale fear (mean=0.160±2.110).
The subscale 'disagreements over errors' had 3 items, the highest score of the agreement was given to the statement that the 'Nurses do not recognize an error occurred' (Mean= 0.986±1.953) and the lowest mean score given to the statement 'Nurses do not agree with the hospital's definition of a medication error'(mean=-1.381±1.827).
Another subscale 'reporting process' had 3 items in which the highest score of agreement belongs to 'Filling out an incident report for a medication error took too much time'(mean= -0.103±2.035) and the lowest score belonged to 'Nurses may not think the error was not important enough to be reported' (mean = -1.027 ±2.078). Finally, the fourth subscale 'administrative responses' had 5 items, in which the highest score of agreement received to the statement 'When medication errors occur, nursing administration focuses on the individual rather than looking at the systems as a potential cause of the error' (mean =0.961±2.067) and lower score given to 'the expectation that medications are given exactly as ordered is unrealistic' (mean= -0.774±1.935). In summary, the highest mean score in the subscale of reasons for why MAE was not reported by nurses was found to be fear, administrative responses followed by reporting process and the least significant reason was disagreement over errors.
The subscale 'disagreement over errors' was statistically significant with the gender, the males were more in disagreement with the errors defined by the hospital management compared with the female nurses (Male -0.

DISCUSSION
This study intended to estimate the fear factor of nonreporting of MAE, also this study explores the perceptions of nursing professionals regarding the reasons for the non-reporting of MAE and potential Causes of MAE in their units. Nursing professionals play a prominent role in health care delivery and drug administration, and they are important elements of the healthcare system. From that point of view, it is nurses themselves who can provide clear insights into why medication errors occur and why MAE does not get promptly reported. The CFA was conducted to identify the latent construct fear factor which could lead to MAE. The existing literature suggests that fear is one of the prominent factors that could be responsible for nonreporting of MAE. The current study estimated that fear of reporting MAE by the clinical nurses was 23.45%.  [4,8,26,15]. Many studies have supported the influence of fear as a key factor in the nonreporting of medication errors [27,13,14]. In contrast, a survey of pharmacists shows that fear of being blamed was the least reason for reporting medication errors [18]. A recent study in Qatar pointed that fear of the consequence of reporting and blaming culture is prevalent in the organization [4]. According to our findings, Fear was considered as the primary reason that can hinder the nurses from reporting of MAEs. The majority of the participants (64.5%) agree with the five fear items of nonreporting of MAE. Hence the fear factor dominates, there is a likelihood of reducing reporting of medication administration errors, furthermore, the study from Qatar shows that the estimated incidence of reported medication errors (0.044%) is very low [12].
The second influential factor of nonreporting MAE was the administrative response. Several studies supported the impediments to the report of MEA were the lack of support from the management, absence of positive feedback, and the lack of job security [15]. A study in the middle east has used similar tools to explore the nurses' perceptions of underreporting of medication errors shows that their primary reason for nonreporting of MAE was administrative responses [26]. The five items related to the administrative responses include, nursing administration focuses on the individual rather than looking at the systems, the responses by nursing administration do not match the severity of the error, lack of positive feedback, the medication errors consider as the measurement of quality of nursing care and more emphasis on medication error. In our study, the five items of the subscale administrative responses were agreed upon by 59.3 percent of the participants.
Nurses may be willing to disclose medication errors if the reporting process is simple and short. Many studies have reported that their organization does not have an effective method to report medication errors [16] and in many institutions, it is a time-consuming process [15,17]. A recent study from Qatar reported that the majority of the participants agreed with reporting MAE is a simple and short process [10]. This is consistent with the findings of the current study, reporting process is the third reason for the nonreporting of MAE. The majority of participants (58.3%) disagree with the three items of the reporting process that indicated that the existing MAE reporting process is convenient to the enduser.
In the current study least significant reason for MAE nonreporting was dis-agreements over the definitions of MAEs. The reasons for disagreement over errors included nurses do not agree with hospitals' definitions of medication errors, failure to recognize that an error occurred, and the medication errors not being clearly stated. According to Kang, the participants believed that the near-miss incidents were not necessary to report since no harm was caused to the patient [18]. A study based on the middle east [26], disagreement over errors was the fourth leading factor of nonreporting errors, which was consistent with our study results. This strongly supported the ability of nurses to identify what constituted medication error as per the definition of the organization and recognition of error when it occurs.
A different study explored the potential causes of Medication errors, which includes inadequate information on new medications, poor communication between nurses and physicians, frequent changes in medication orders by physicians, unclear medication orders by physicians, 'look alike' medications, wrongly labeled medication, incorrectly set up in infusion devices, and confusion over the different types of infusion devices [1,18]. A study in Jordan [19] explored the human factors contributing to MAE including insufficient staffing, heavy workload, lack of proper training for nurses, and interruption during medication administration. The top five reasons identified from our study sharply coincide with listed reasons include nurses, failing to check MAR physician's order being difficult to read or illegible, labels/ packaging being of poor quality or damaged, confusion between two drugs with similar names followed by physician prescribes the wrong dose.
The socio-demographic characteristics of the participants (except education) did not seem to have any association with the underlying constructs of reasons for MAE. This pointed out the fact that all nurses are equally vulnerable to medication errors. The type of nursing unit was found to be no impact on the likelihood of MAE. However, this finding was contradicted with the results of another study conducted in Saudi Arabia, where the current work department was found to be significantly associated with the occurrence of MAE [29]. The most reasonable explanation for this would be that nurses were more likely to be tired and distracted in busier units. These units could create more favorable circumstances for equipment and drug chart-related, medical teamrelated, and drug-related determinants of MAE. However, there is no significant association between the unit of working with any subscales of the nonreporting of MAE in the current study.
In comparison to those with only a diploma in nursing, participants with higher educational qualifications (Bachelor of Science Nursing or Master of Science nursing) were less prone to fear, reporting effort, administrative responses, and disagreement over errors defined by the management [14]. Nurses with higher education are more aware of the need of reporting medication errors. This underlines the need for continuing education in minimizing medication errors and improving the quality of health care. The actual reporting of MAE was observed to be rather low in our study (the majority reported the range to be 0-20%). This was in accordance with other studies which was reported comparable proportions, 20%, and 22% respectively [30,29]. Interestingly, a study from the middle east examined the preference of patients and families regarding the disclosure of medication errors. Most participants strongly agree that they should be informed if there has been a medication error [31].
In summary, the results of this study emphasize that the under-reporting of medication errors is a fact. In the healthcare industry, the safe administration of medication is a highly challenging task. But it will be more critical if we are uncertain about the problem of the underreporting of medication errors remains unsolved. Further studies are necessary to focus on exploring the experience of nurses who reported MAE and the challenges facing the healthcare team when disclosing MAE to patients and families. These two studies will help to explore the other aspect of the nonreporting of MAE.

CONCLUSION
The primary implication of the study is the need to create a positive work environment with human work circumstances, conducive work schedules, and adequate staff patterns, which also nurtures free and fearless communication between the nursing professionals and the nursing management team. This will not only reduce the occurrence of MAE but also encourage good reporting practices. The need for continuing education for nurses to update and reinforce the definitions and standards of safe health care is another major inference. Even though the nurses have consensus and clarity regarding "what constitutes an MAE", a regular in-service training and continuous reinforcement focusing on this topic are mandatory. A major inference that can be drawn from this finding is that even within a facility, the context-specific requirements of each facility may be different, mandating appropriate levels of additional support for nurses working in hectic settings.

LIMITATION
This study was successful to estimate the percentage of the fear factor that influences the non-reporting of MAE, other reasons for nonreporting and potential causes of MAE. However, there were four inevitable limitations. First, this study employed a non-random sampling method to cover a large number of the population. Second, Since the participants were recruited from the nurse's hospital email group and data collected by online survey. There are chances that those nurses who did not participate in this study have different perceptions. Third, Medication administration errors and underreporting are highly sensitive issues that might influence the low rate of participation. Finally, there might be other factors that were not addressed in this study that can contribute to the medication errors and nonreporting of errors.

CONSENT
As per the institutional IRB recommendation Wavier of informed consent has been taken and preserved by the author(s).

ETHICAL APPROVAL
The study was reviewed and approved by the institutional review board (IRB) of the Medical Research Centre (protocol #14165/14). The study was conducted fully in conformance with principles of the "Declaration