FormalPara Key Points

Most Ugandan HCPs approved the establishment of a national ME reporting system.

Only one in five HCPs disclosed that they had ever committed potentially harmful MEs.

Two in three HCPs valued patient involvement in ME reporting.

1 Introduction

Medication errors (MEs) are the commonest preventable cause of patient harm [1] and have been associated with increased morbidity, mortality, and healthcare costs [2, 3]. Medication errors can arise at the prescribing, dispensing, or administration stages of the medication use process, and may or may not have adverse consequences [4]. The scope of pharmacovigilance (PV), defined as the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) or any other drug-related problems [5], was broadened to incorporate the reporting of MEs [6, 7]. Through ME reporting systems, detection and root-cause analysis of MEs can identify individual and system weaknesses that should be addressed to improve patient safety [8]. However, MEs are largely under-reported [9], which undermines quality improvement and risk management in healthcare [10].

Studies conducted in the more developed countries have observed that the success of ME reporting systems relies on their ability to create a “no-blame-culture,” to encourage confidentiality of reported information, or to provide an option for reporter anonymity. The system should encourage ease of use, voluntary reporting, root-cause analysis of reported MEs, and giving timely feedback of error analysis results and recommendations to ME reporters [11, 12]. Fernald et al. [13] have observed that ME reporting systems that keep the identity of the reporter confidential receive higher quality ME reports when compared with anonymous ME reporting systems where the reporter does not reveal his/her identity. Furthermore, reporter anonymity has been reported to make follow-up difficult [14]. Healthcare professionals (HCPs) are a lynchpin in the effective functioning of ME reporting systems [12], both as a key source of ME reports and as users of the information arising from the analysis of these ME reports. In addition to promoting transparency and safe medication practices by HCPs, involving patients in their care is a crucial facet in promoting a safety culture in healthcare [15].

Globally, the World Health Organization–Uppsala Monitoring Centre (WHO–UMC) operates an international database, Vigibase, which receives spontaneous suspected adverse reaction reports from National Pharmacovigilance Centres (NPCs) from over 80 countries [16]. The database contained over 10 million reports by April 2015 and the oldest reports date back as early as 1968 [17]. The USA Institute for Safe Medication Practices, established over 35 years ago, is a voluntary ME reporting system for HCPs which can be accessed through an online platform [18]. Similarly, the European Medicines Agency (EMA), which started in 1995, operates a web-based system (Eudravigilance) to monitor medication safety reports within the European Union (EU). Eudravigilance was established in 2001 and has since 2012 been empowered by EU legislation to receive information on ADRs resulting from MEs [19].

In African countries, ME reporting systems have hardly been embraced [20]. However, even when their establishment is scaled up, both existing and new ME reporting systems face the challenge of inherent weaknesses in African healthcare systems including but not limited to counterfeit and substandard medicines, unavailability of fundamental infrastructure, shortage of human resources for health, limited awareness or interest of HCPs in PV activities, weak medicines regulatory and PV systems, and scarce financial resources [7, 21]. Information is scarce on involvement of African HCPs in voluntary ME reporting systems, including HCPs’ expectations of these reporting systems, and the likely disclosure of harmful MEs made either in person or by their colleagues. However, findings from medical audits conducted in Africa suggest that the extent of ME occurrence in these settings might even be a bigger problem than suspected ADRs, and that ME detection and prevention may be possible [22–24].

Uganda’s NPC is yet to establish a formal ME reporting and evaluation system. A functional spontaneous ADR reporting system has been operational since 2005 with 14 regional pharmacovigilance centres [25, 26]. The Ugandan NPC’s mandate has been extended to integrate ME reporting [27]. However, data on HCPs’ readiness, their attitudes to, and characteristics associated with ME reporting in our resource-limited setting are lacking.

We assessed the attitudes and the personal and professional characteristics of Ugandan HCPs related to integration of ME and ADR reporting systems, patient involvement in ME reporting, and disclosure of having made potentially harmful MEs either in person or by other HCP colleagues.

2 Methods

2.1 Study Design and Sampling Procedure

From May 2012 to February 2013, HCPs anonymously self-completed a survey questionnaire on their attitudes towards the occurrence and reporting of MEs in purposively selected geographically representative public and private health facilities in Uganda. These facilities included the national referral hospital, six regional referral and district hospitals, health centres II to IV, and private health facilities within the catchment areas of the regional referral hospitals [26]. Eligible HCPs included those involved in the prescribing, transcribing, dispensing, and administration of medications to patients. Trained research assistants obtained separately held written informed consent from the HCPs before inviting them to complete a self-administered questionnaire. The questionnaires did not capture respondent HCPs’ identities but were tracked using serial numbers. Sampling frames (staff lists) in each selected health facility were not easily obtainable, therefore probability sampling of HCPs was not achieved. In addition, several contacts were made with willing but usually busy HCPs and delays to return completed questionnaires by those who accepted the invitation were common. Thus neither the refusal rate of invited HCPs nor the return rate of completed questionnaires by cadre were reliably recorded [26].

2.2 Data Collection and Management

The self-administered questionnaire elicited demographic and professional information, and attitudes of HCPs towards the occurrence and reporting of MEs in Uganda. Attitudes were measured using five items of a categorical nature (yes/no), and 17 statements on a five-point Likert scale with the categories: strongly disagree, slightly disagree, neutral, slightly agree, and strongly agree (see ESM Appendix).

All data were entered into a databank using EpiData 3.1.

2.3 Statistical Analysis

Questionnaire responses were summarized as frequencies and percentages.

We used Principal Components Analysis (PCA) and Exploratory Factor Analysis (EFA) techniques on the 22 variables primarily to identify and combine or drop multicollinear variables that would affect subsequent regression analyses. The data reduction PCA technique was employed to identify and combine redundant (highly correlated) variables into fewer uncorrelated components, of which none were identified. The structure detection EFA technique was used, in addition, to determine if there were underlying latent relationships between the variables on attitudes to ME reporting. However, EFA did not successfully extract any factor solution(s) that adequately represented sets of individual variables. Thus, individual variables were retained in subsequent regression analyses.

Likert scales were dichotomized into agree or other (disagree and neutral). We used binary logistic regression to assess demographic, professional, and attitudinal factors associated with four key variables, namely: “Integration of the ME and ADR reporting systems”, “Patient participation in the reporting of MEs”, “Disclosure by a respondent HCP that they had ever committed MEs that had the potential to harm patients”, and “Having ever seen other HCPs commit MEs that had the potential to harm patients”.

Variables that were logically thought to measure similar constructs were not simultaneously fitted into the same regression models due to their inevitably high correlation. The following four variables were thought to measure similar fundamental facets of ME reporting: “Establishment of a national system for reporting Medication Errors (MEs)”, “Integration of the ME and Adverse Drug Reaction (ADR) reporting systems”, “Mandatory or voluntary reporting of MEs”, and “Patient participation in ME reporting”. Other pairs of variables thought to measure similar constructs were: “Having seen others commit medication errors that had the potential to harm patients” and “Having committed medication errors that had the potential to harm patients”; “Disruptions in continuity of patient care, such as shift changes, can be detrimental to patient care” and “Important issues are well communicated at shift changes”; “Personal details of the person who made an error should be reported” and “I may hesitate to use a reporting system for MEs because I am concerned about being identified”; and “I would recommend a non-disciplinary approach to encourage HCPs to report MEs” and “There is a culture of blame in healthcare”.

Regression coefficients were expressed as odds ratios (ORs) with their 95 % confidence intervals (CIs) and were obtained using Stata 12.0 [28]. To take account of the multiplicity of potential covariates, we focused attention only on influential factors for which P < 0.01. We accounted for missing data using the missing-assigned approach where low-frequency missing data were meaningfully assigned to an existing category [26].

3 Results

3.1 Study Population

A total of 1345 HCPs self-completed the questionnaire, representing a response rate of 67 % (n = 2000). Mean age of HCPs was 32.4 years (SD = 8.9) and females were the majority (60 %; 804/1345). About three-fifths (58 %; 156/271; n = 275) of doctors reported that they had given verbal prescriptions to attending nurses in the previous year, and 54 % (376/693; n = 792) of nurses stated that they regularly transcribed prescriptions.

3.2 Attitudes to the Reporting of Medication Errors (MEs)

Most of the surveyed HCPs (91 %; 1174/1289) agreed that Uganda should have a national ME reporting system, 58 % (734/1261) agreed that the ME reporting system should be integrated into the ADR reporting system, and 65 % (819/1267) stated that patients should participate in ME reporting (see Table 1 ).

Table 1 Attitudes to medication error (ME) reporting by healthcare professionals, Uganda, 2013
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Eighty-five percent (1125/1326) of HCPs agreed that reported MEs should be used to find the root causes of the MEs, while organizational leadership and support were needed in ME reporting according to 82 % (1081/1324) of respondent HCPs. Sixty-two percent (806/1308) of HCPs believed that there is a culture of blame within the healthcare system, with 33 % (436/1315) reporting that they would hesitate to use a ME reporting system due to concerns about being identified, and 31 % (412/1328) agreeing that personal details of the person who made an error should be reported (see Table 1).

3.3 Disclosure of MEs

Eighteen percent (235/1310) of HCPs disclosed that they had ever made MEs that had the potential to harm patients, while 41 % (542/1323) acknowledged that they had ever identified potentially harmful MEs that were committed by other HCPs (see Table 1) (χ 2 = 64.7 (1 df), P < 0.001). Forty-seven percent (623/1327) of the HCPs had either disclosed that they had committed, in person, potentially harmful MEs or had witnessed the involvement of other HCPs. Thirty-nine percent (519/1315) of HCPs agreed that they were more likely to make MEs in tense or hostile (stressful) working conditions (see Table 1).

3.4 Characteristics of Healthcare Professionals (HCPs) Who Endorsed Integration of the ME and Adverse Drug Reaction (ADR) Reporting Systems

Older HCPs [at least 30 years old (OR = 1.5; 95 % CI: 1.15–1.87)] or those who had made suggestions on how to improve the ADR reporting system (OR = 1.5; 95 % CI: 1.11–1.93) were more likely to endorse integration of the ME and ADR reporting systems. However, integration was less likely to be promoted by non-nurses (OR = 0.5; 95 % CI: 0.39–0.65) and HCPs who had ever encountered a fatal ADR (OR = 0.6; 95 % CI: 0.43–0.80) (see Table 2).

Table 2 Characteristics of 1261a healthcare professionals (HCPs) who endorsed integration of medication error (ME) reporting into the existing adverse drug reaction (ADR) reporting system, Uganda, 2013
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3.5 Characteristics of HCPs Who Endorsed Patient Participation in ME Reporting

Healthcare professionals who valued root-cause analysis of reported MEs (OR = 1.6; 95 % CI: 1.11–2.18), those who reported inadequate communication at shift changes (OR = 1.4; 95 % CI: 1.10–1.87), or who agreed that both actual and potential MEs should be reported (OR = 1.4; 95 % CI: 1.10–1.88), and those who conceded that there is lack of time for reporting MEs (OR = 1.5; 95 % CI: 1.12–2.00) were more likely to endorse patient participation in ME reporting (see Table 3).

Table 3 Characteristics of 1267a healthcare professionals (HCPs) who endorsed patient participation in medication error (ME) reporting, Uganda, 2013
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3.6 Characteristics of HCPs Who Disclosed that They had Ever Committed Potentially Harmful MEs

The need for confidentiality (OR = 1.6; 95 % CI: 1.14–2.14) and working in stressful conditions (OR = 2.0; 95 % CI: 1.47–2.77) were the characteristics of HCPs more likely to disclose that they had ever committed potentially harmful MEs. However, self-disclosure of MEs was less likely from HCPs who agreed that both actual and potential MEs should be reported (OR = 0.6; 95 % CI: 0.44–0.85) or those who were hesitant to report ADRs (OR = 0.6; 95 % CI: 0.47–0.87) (see Table 4).

Table 4 Characteristics of 1310a healthcare professional (HCPs) who disclosed that they had ever committed potentially harmful medication errors (MEs), Uganda, 2013
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3.7 Characteristics of HCPs Who Ever Identified Potentially Harmful MEs Committed by Other HCPs

Attachment to a hospital-level health facility (OR = 1.7; 95 % CI: 1.23–2.30), reporting that there is a culture of blame in healthcare (OR = 1.6; 95 % CI: 1.28–2.11) or working in stressful conditions (OR = 1.4; 95 % CI: 1.12–1.84); and being a non-nurse (OR = 1.5; 95 % CI: 1.15–1.92) or having ever encountered a fatal ADR (OR = 1.5; 95 % CI: 1.13–2.05) were associated with having ever identified potentially harmful MEs committed by other HCPs (see Table 5).

Table 5 Characteristics of 1323a healthcare professional (HCPs) who ever identified potentially harmful medication errors (MEs) committed by their colleagues, Uganda, 2013
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4 Discussion

Nine in ten HCPs agreed that Uganda should have a national ME reporting system, suggesting their willingness to embrace this reporting system. However, eight in ten HCPs reported the need for organizational leadership and support in ME reporting, a systems approach that would likely enhance their readiness to report MEs [29]. Uganda is yet to establish a formal ME reporting system, though a well established spontaneous ADR reporting system, coordinated by the NPC, has existed since 2005 [25, 26]. Despite the HCPs’ optimism for the establishment of a national ME reporting system, the national statistics for voluntary ADR reporting indicate that only 0.44 % of Ugandan HCPs report suspected ADRs annually [26]. Therefore ME under-reporting by HCPs might still be a major challenge. Moreover, voluntary ME and ADR under-reporting continue to be a healthcare system challenge worldwide [30, 31]. However, voluntary ME and ADR reporting systems are still a cornerstone to medication safety programs globally [30, 32].

Three in five HCPs agreed that the ME reporting system should be integrated with the ADR reporting system. Holmstrom et al. [20] identified Zambia as an example of an African country that operates an integrated national ME and ADR reporting system. Rwanda was another African country with a local ME reporting system but whose setting was not clearly defined [20]. The integration of ME and ADR reporting could save the resources otherwise needed to maintain separate systems, but might potentially compromise the quality of reporting [33] and overwhelm the existing voluntary ADR reporting system [26] in our resource-limited setting. Bencheikh et al. [34] have suggested that pharmacovigilance centers, poison control centers, and patient safety organizations may operate independently but work closely together with regulatory bodies to promote patient safety while avoiding duplicity of functions.

The study also identified the characteristics of HCPs who endorsed integration of the ME and ADR reporting systems. Older HCPs and those who suggested ways to improve the ADR reporting system were more likely to support integration of the ME and ADR reporting systems, and these two categories of HCPs were previously found to be ardent ADR reporters [26]. Non-nurses (doctors, pharmacists, pharmacy technicians, clinical officers, and others), however, were less likely to support the integration of the two reporting systems. Kiguba et al. [26] have reported that in Uganda non-nurses are more likely than nurses to recognize suspect ADRs, although no significant difference has been observed in ADR-reporting rates between the two HCP cadre-levels. The reasons for the lower than expected ADR reporting rate by non-nurses when compared with nurses might partly explain the observed lower likelihood of non-nurses to support integration of the ME and ADR reporting systems. Sarvadikar et al. [35] and Milch et al. [36] reported varying attitudes to ME reporting among different cadres of HCPs in the USA, with higher reporting rates being registered by nurses than by doctors. The nurse-cadre-targeted adverse event training campaigns conducted in the USA setting could explain the higher enthusiasm by the American nurses to report MEs, and highlights the benefits of training programmes [36]. However, in Uganda more investigations are needed to identify the reasons why Ugandan non-nurses, when compared with nurses, seem to have less enthusiasm for pharmacovigilance. HCPs who had ever encountered fatal ADRs did not favor integration of the ME and ADR reporting systems, probably for fear of litigation or punishment if reported fatal ADRs were linked to reported MEs committed by these HCPs [8]. Conducting multiple health facility-based interventions including sensitization and training campaigns that target all Ugandan HCP-cadres could be beneficial. The interventions should address the needs of non-nurses and younger HCPs. In addition, a non-punitive organizational-level approach such as confidential ME reporting should be adopted.

Our research team drafted a ward-based ME reporting form and a tracking log that will be tested in a longitudinal study on hospitalized patients, in conjunction with a modified ward-tailored ADR reporting form developed for the same study [26].

Three-fifths of HCPs agreed that patients should participate in ME reporting. This is a laudable proportion of HCPs in support of the drive by the WHO World Alliance for Patient Safety to increase patient involvement in the promotion of a safety culture in healthcare [37]. Moreover, the first African regional patients for patient safety workshop was held in Uganda in 2011; this brought together patients, HCPs, and healthcare policy makers to share experiences of harm in healthcare [38]. Lack of time for ME reporting and inadequate communication, for instance at shift changes, were identified characteristics of HCPs who promoted patient participation in ME reporting. Possible explanations advanced for lack of time to report MEs include absence of perceived benefit, the extra burden associated with reporting, lack of clarity on what to report, and severity of illness [39]. Fernald et al. [13] found that 71 % of the MEs in their setting were attributed to communication problems. Patients may help to bridge the communication gaps that arise in healthcare, especially at shift changes. However, patient-related factors such as lack of confidence or inadequate medical knowledge are potential barriers to their involvement in ME reporting [37]. That notwithstanding, Weingart et al. [40] demonstrated that patients identified adverse events that were unaccounted for in the medical records and/or were not covered in the hospital incident reporting system [40]. Valuing root-cause analysis and reporting of both actual and potential MEs were the other characteristics of HCPs more likely to promote patient participation in ME reporting. Ugandan health facilities should institute regular audits of medication use by patients to identify MEs. Harmful and potentially harmful MEs identified in the audits should be subjected to root-cause analysis [41]. The learning derived from root-cause analysis of both harmful and apparently minor MEs or near misses can foster system improvements and reduce the risks associated with healthcare [14, 32]. In our planned cohort study, incident MEs among hospitalized patients will be assessed using root-cause analysis. We shall involve patients to obtain insight into their medication use experiences while in hospital.

One in five HCPs disclosed that they had committed potentially harmful MEs, while two in five reported that they had seen other HCPs make MEs that had the potential to harm patients. About half (47 %; 623/1327) of HCPs had either disclosed that they had ever committed potentially harmful MEs in person or had witnessed the involvement of other HCPs. Similar rates of ME disclosure by African HCPs have been reported in anesthesia practice in Nigeria (56 %; 24/43) [42] and in South Africa (39 %; 33/84) [43]. The willingness of HCPs in our setting to disclose both harmful and potentially harmful MEs merits further investigation. Currently, there is no protective legislation for reporting MEs in Uganda. Recognizing that a ME has occurred, irrespective of who is involved, is a first step in the ME reporting process. However, protective legislation for ME reporters if instituted may likely allay their fears of punitive action and promote ME reporting.

Three-fifths of doctors reported that they gave verbal prescriptions to nurses and more than half of nurses reported that they regularly transcribed prescriptions (a responsibility for doctors and pharmacists in Uganda). Thus, more opportunities for MEs may arise from doctors’ verbal prescriptions and from nurse-transcriptions. Therefore both practices ought to be discouraged.

HCPs who preferred confidential ME reporting and those who agreed that they had a higher likelihood to commit MEs in stressful situations were more likely to disclose that they had previously committed potentially harmful MEs. A highly stressful work environment for HCPs can arise from emergency situations and low staffing levels, thus leading to excessive workloads and fatigue, among others, all of which may promote error-prone working conditions [44]. The situation in sub-Saharan Africa is compounded by the shortage of human resources for health, with nine physicians per 100,000 population and 55 nurses/midwives per 100,000 population: 64 HCPs (physicians/nurses/midwives) per 100,000 population when combined, which is far below the WHO target of at least 228 HCPs per 100,000 population [45]. Whereas healthcare systems that create less tense or non-hostile working conditions for HCPs might lower the incidence of harmful MEs, reporting systems that foster confidentiality of reported information and/or those that have an option for anonymity of the ME reporter might encourage increased participation of HCPs in healthcare quality improvement and risk management systems [12]. It is worth noting, however, that confidential ME reports seem to provide higher quality information than anonymous ME reports [13]. Healthcare professionals who agreed that the system should report both actual and potential MEs were significantly less likely to admit that they had committed harmful MEs. Hesitancy might explain this finding given that diffident ADR reporters [26] were also less likely to admit that they had committed MEs that were potentially harmful to patients.

Respondent HCPs who acknowledged that they had ever seen others commit potentially harmful MEs were more likely to be non-nurses or to have ever encountered a fatal ADR. At the organizational level, they were more likely to be attached to hospital-level health facilities, to have cited that there exists a blame culture in healthcare, or to have reported working in stressful working conditions. Organizational-level factors have been reported to dominate over individual-level factors as major contributors to the occurrence of MEs [46]. Rather than blame or penalize individual HCPs, employing a “no-blame” systems approach could reduce the incidence of MEs and stimulate HCPs’ participation in ME reporting initiatives [29], hence promoting delivery of safer healthcare to Ugandan patients.

This study had limitations. First, HCPs may have provided socially desirable responses on sensitive questions such as being less likely to disclose that they had ever committed potentially harmful MEs. Since we used anonymous self-administered questionnaires, this bias might have been diminished. Second, some variables measured similar attitudinal constructs and may have presented challenges of multiplicity during data analysis; however, we did not fit logically similar variables into the same regression models, and we focused attention only on influential factors for which P < 0.01. In addition, factor analysis and principal components analysis techniques were employed to identify any groups of variables that could be combined into single factors or components, respectively, although none were identified. Third, probability sampling was not practicable; however, the large sample size is a key strength of this study. Fourth, we did not pose open-ended questions or conduct qualitative interviews to triangulate these research findings. Accepting the invitation to complete an anonymous self-administered questionnaire was received with much apprehension, especially when potential respondent HCPs noticed the section on MEs. Due to the sensitivity of this subject, and to encourage HCPs’ participation in this survey, we structured the MEs section to contain only closed-ended questions. However, we believe that the results of this study have generated hypotheses that can be investigated further using different or similar methods of inquiry.

5 Conclusions

Most Ugandan HCPs approved the establishment of a national ME reporting system. However, as the program is implemented, sensitization and training of HCPs on how to identify and report MEs will be necessary. A non-punitive healthcare environment and patient involvement may promote ME disclosure and reporting in Uganda and possibly other African countries.