Review Article

A Comparative Scoping Review of Medication Error Reporting in Malaysia and International Healthcare Systems Using the Swiss Cheese Model

Priscila Anesha Visvalingam, Khin Thandar Aung, Ashikin Binti Atan, Suzilawati Binti Mohamed Ariffin, Lee Siew Pien

Kulliyyah of Nursing, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang, Malaysia

Corresponding Author’s Email: priscila.jude@gmail.com

Abstract

Background: Medication errors (MEs) are a persistent global threat to patient safety and underreporting remains widespread. The Swiss Cheese Model (SCM) offers a framework to analyse system-level barriers and defences. Objectives: This scoping review aimed to compare Malaysian and international medication error reporting (MER) practices, map them to the SCM’s six defence layers and identify strategies to strengthen Malaysia’s reporting culture. Methods: Articles included were comprehensively checked for reliability in line with JBI (critical appraisal checklist) and PRISMA-ScR guidelines, hence a systematic search of Scopus, PubMed, Web of Science, ScienceDirect and Google Scholar from (2015–2025) yielded 489 records; 33 studies met inclusion criteria. Results: International studies demonstrated stronger SCM alignment through interdisciplinary reporting, anonymous electronic platforms (e.g., MEDMARX, CIRS), “structured feedback and non-punitive cultures”. By contrast, Malaysian systems showed pharmacist-driven reporting, limited training, punitive cultures and weak feedback mechanisms. Conclusion: Strengthening Malaysia’s MER requires anonymous platforms, just culture policies, structured training and feedback integration, embedding SCM principles to advance safer and more accountable healthcare systems.

Keywords: Global Healthcare; Malaysia; Medication Error Reporting; Nurses; Swiss Cheese Model

Introduction

Medication errors remain a major global patient safety concern, with underreporting limiting improvements in care (Elden & Ismail, 2015). The Swiss Cheese Model (Reason, 2000) conceptualizes errors as system failures arising when multiple defense layers align. World Health Organization (2017) estimates over 3 million annual deaths worldwide due to medication errors, with nearly half considered preventable (Kumar et al., 2022). Underreporting, often exceeding 50%, persists due to “fear of blame, punitive responses and weak feedback” (Alrasheadi, 2019; Alqubaisi et al., 2016). In Malaysia, MOH hospitals issued 68.6 million prescriptions over four years, yielding 17,357 error reports an incidence of 0.025% (Ministry of Health of Malaysia, 2011; 2014).However, actual rates are likely higher, as private sector reporting remains minimal (Samsiah et al., 2016) and underreporting is particularly evident in critical and neonatal care (Chew et al., 2022). Studies also show 403 geriatric prescriptions with MEs, averaging 20 cases daily (Abdullah et al., 2004).

Medication errors remain a major global patient safety concern, with underreporting frequently reported across healthcare settings. In Malaysia, medication error reporting is facilitated through the Medication Error Reporting System; however, previous Malaysian studies suggest that reporting remains low and is affected by fear of blame, unclear procedures and lack of feedback (George et al., 2018; Samsiah et al., 2016). International evidence also shows that fear of punishment, workload and weak feedback systems are common barriers to reporting (Afaya et al., 2021; Alotaibi, 2024).

Globally, the SCM is widely applied in safety science and healthcare to guide reporting and root cause analysis (Collins et al., 2014; Diller et al., 2014; Durstenfeld et al., 2019; Li & Harris, 2006; Neuhaus et

al., 2018; Patterson & Shappell, 2010; Reinach & Viale, 2006; Spiess et al., 2015; Thonon et al., 2020). Tools such as the Human Factors Analysis and Classification System extend its utility in identifying latent system flaws (Diller et al., 2014; Li & Harris, 2006; Patterson & Shappell, 2010; Reinach & Viale, 2006; Wiegmann & Shappell, 2017; Spiess et al., 2015). Structured, system-based frameworks, including the Swiss Cheese–inspired SWISS model, have been proposed for Malaysia to mitigate underreporting through technology adoption (CDSS, e-prescribing), patient involvement, feedback loops and training (Sabila et al., 2018; Chew et al., 2022). However, uptake remains fragmented. By recognizing how multiple defences fail simultaneously, the SCM shifts focus from individual blame to systemic reform (Wiegmann et al., 2022) supporting the call for a standardized national ME reporting system with common nomenclature (Elden & Ismail, 2015). This review aims to investigate the Swiss Cheese Model (SCM) which has demonstrated efficacy in both clinical and academic context of medication error in the healthcare settings.

The Swiss Cheese Model was selected because medication error reporting is not only an individual behavior but also a system-dependent process. The model helps explain how weaknesses in organizational culture, supervision, training, feedback and reporting systems create gaps that allow errors and underreporting to occur. Its strength lies in shifting attention away from blaming individual nurses towards identifying system-level failures (Reason, 2000; Wiegmann et al., 2022).

Ultimately, the SCM strengthens safety culture and provides a framework to compare how healthcare systems address medication error reporting among nurses in Malaysia and globally.

Objectives

• To compare medication error reporting practices between Malaysia and international healthcare systems, identifying similarities, differences and contextual variations.

• To apply the Swiss Cheese Model to examine system-level weaknesses, barriers and facilitators influencing medication error reporting among nurses across settings.

• To propose evidence-based policy and practice reforms aimed at strengthening patient safety, improving reporting infrastructure and enhancing nurse participation in Malaysia’s medication error reporting system.

Methodology

Literature Search and Study Design

This scoping review followed the Joanna Briggs Institute framework (JBI, 2021) and was reported using PRISMA-ScR guidelines. A comprehensive search of Scopus, PubMed, Web of Science, ScienceDirect and Google Scholar identified studies published between January 2015 and April 2025. Only peer- reviewed English-language articles were included. Search strategies used Boolean operators like AND/ OR were utilized to link keywords and Medical Subject Headings (MeSH) in the search strategy the MeSH terms. Studies applying the Swiss Cheese Model or similar systems-based approaches to medication error reporting among nurses or healthcare personnel were included, while non-nursing populations, non-English articles and studies unrelated to system-level reporting were excluded.

Study Selection

Criteria for Inclusion and Exclusion

This review included studies on medication error reporting among nurses and healthcare professionals in hospital and community settings, focusing on adult nursing staff in public or private facilities. Eligible studies applied the Swiss Cheese Model or similar system-level safety frameworks and addressed barriers, interventions, or factors influencing reporting behavior. Hence, accepted study designs included qualitative, cross-sectional, mixed-methods, observational and review studies published between 2015 and 2025.

Countries were not selected in advance. Instead, countries were included based on the availability of published studies that met the inclusion criteria. Therefore, the term “international” in this review refers to evidence from countries represented in the included studies rather than all countries globally. This approach is consistent with scoping review methodology, which aims to map available evidence rather than provide complete global representation. However, countries with limited published research may be underrepresented, especially in regions where “Medication Error Reporting” research is less developed or less frequently published (Mutair et al., 2021) (Table 1).

Table 1: The Inclusion and Exclusion Criteria

Data Extraction

After completing the database search, duplicates were manually removed by the principal reviewer. Titles and abstracts were then screened against inclusion and exclusion criteria using Rayyan (http://rayyan.qcri.org/; Qatar Foundation, Qatar), which supported semi-automated sorting and conflict resolution.

Studies unrelated to reporting systems, nursing, or the Swiss Cheese Model were excluded, with reasons documented. Full-text screening was conducted independently by two reviewers, with disagreements resolved through discussion. The search strategies combined Boolean operators such as "AND" and "OR., keywords and MeSH terms, while included studies were organized using Mendeley for citation tracking. The overall selection process, including records retrieved, excluded and finalized, is illustrated in the PRISMA flow diagram (Table 2).

Table 2: Database Search Strings and Records Retrieved

The databases approach, combined with controlled vocabulary and structured Boolean logic, enhanced the comprehensiveness of the search and reduced the likelihood of missing relevant studies. Thus, by applying variety of search layers MeSH terms, keywords, truncation and field-specific queries captured both indexed and non-indexed articles across discipline-spanning sources (nursing, safety science, pharmacology and organizational studies). This method was consistent with best practices for scoping reviews in safety and healthcare research.

Risk of Bias Assessment

The methodological quality of the included studies was evaluated using the JBI Critical Appraisal Tools tailored to the study designs in question, in accordance with the Joanna Briggs Institute's (JBI) scoping review process. For assessing validity, bias and methodological rigor in qualitative, cross-sectional and mixed-methods research, these instruments are well known.

The following JBI tools were used appropriately since cross-sectional surveys, qualitative research and mixed methods designs made up most of the studies included in this review:

-Clearly stating the goals of the study

-Suitability of the sample and environment

-Valid and trustworthy techniques for gathering data

-Moral considerations

-Transparency in data analysis

-Qualitative interpretations that are reflexive (for relevant studies)

-Two reviewers separately evaluated each study based on standards like:

Disagreements were resolved through discussion and consensus. In line with JBI guidelines, studies were not excluded for methodological quality; instead, appraisal findings contextualized the strength of evidence. Furthermore, grey literature such as abstracts, theses and non-peer-reviewed papers was excluded to ensure rigor and only English-language studies published between 2015 and 2025 were considered. Even though a meta-analysis or quantitative synthesis was not the goal of this scoping review, the quality appraisal assisted in identifying common methodological strengths and limitations throughout the included literature. Notably, a few cross-sectional studies lacked strong support for sample size and a few qualitative studies omitted important details on participant-researcher relationships and researcher reflexivity.

Data Synthesis

Data synthesis was conducted using a narrative, descriptive and thematic approach, consistent with the Joanna Briggs Institute (JBI) methodology for scoping reviews. Because scoping reviews aim to map the breadth and characteristics of available evidence rather than generate pooled effect estimates, no meta-analysis was performed.

First, extracted data from all 33 included studies were organized into a structured evidence matrix capturing authorship, year, country, design, population, reporting practices and alignment with the Swiss Cheese Model (SCM) defense layers. Studies were then coded inductively and deductively. The deductive phase used the six SCM defensive layers error detection, reporting mechanisms, feedback systems, organizational culture, training/competency and system learning as an a priori analytical framework to map system-level strengths and failures across the Malaysian and international literature.

Subsequently, an inductive thematic synthesis was performed to identify recurrent concepts such as fear of blame, lack of anonymity, weak feedback loops, limited training and pharmacist-dominated reporting, which were repeatedly highlighted across Malaysian studies. International studies were similarly synthesized to reveal contrasting themes such as non-punitive environments, the presence of anonymized electronic reporting platforms (e.g., MEDMARX, CIRS), interdisciplinary participation and structured feedback cycles.

Throughout synthesis, patterns were compared within and between countries, enabling the identification of systemic gaps and global best practices. Findings from the appraisal process (e.g., reliance on cross-sectional surveys, self-report bias) were considered during interpretation but did not influence study inclusion. The final synthesis is presented narratively and supported by tables, thematic summaries and SCM-based mapping to illustrate variations in reporting culture, system design and learning mechanisms across healthcare systems.

Grey literature was considered to maintain transparency. As shown in Figure 1, five electronic databases were searched, yielding 489 records. After removing 89 duplicates, 400 articles remained for title and abstract screening, from which 103 proceeded to full-text review. Following application of the inclusion and exclusion criteria, 33 studies were included in the final scoping review. The remaining publications were excluded for reasons such as non-nursing populations, lack of application of the Swiss Cheese Model, or absence of focus on prescription error reporting (Table 2).

Although only 33 studies were included (Figure 1), this number is acceptable for a scoping review because the purpose is to map available evidence, identify patterns and highlight gaps rather than perform statistical generalization. The final number also reflects strict inclusion criteria, especially the focus on medication error reporting, nurses or healthcare professionals and system-level or Swiss Cheese Model-related analysis.

Figure 1: Prisma Chart Describing the Inclusion of the Articles

Description of the Included Studies

This scoping review included 33 studies published between 2015 and 2025, representing a wide geographical distribution across Malaysia, Saudi Arabia, Qatar, China, South Korea, Turkey, Egypt, Indonesia, Kuwait, Lebanon, the Philippines, the United States, the United Kingdom, Ireland, Australia, Japan and the UAE. Malaysia contributed the highest number of studies (n = 8), followed by Saudi Arabia (n = 6) and Qatar (n = 3), reflecting substantial regional interest in medication error reporting (MER). Study designs varied considerably, with cross-sectional surveys dominating the evidence base (n = 18), supported by qualitative interviews and focus groups (n = 7), retrospective incident analyses (n = 3), mixed methods designs (n = 2) and integrative/systematic reviews. Collectively, these studies involved more than 12,000 healthcare professionals, with nurses forming the largest participant group.

Across the 33 studies, a strikingly consistent finding was persistent underreporting of medication errors, driven largely by fear of blame, punitive consequences and hierarchical organizational cultures. Additional barriers included lack of feedback, unclear reporting protocols, high workloads and limited training particularly evident in Malaysia, Saudi Arabia, Indonesia, China and South Korea. Malaysian studies further highlighted underuse of the national MERS-MOH system and uncertainty about what constitutes a reportable error. In contrast, studies from high-income settings such as Ireland, Switzerland, the United States and Australia described more mature safety infrastructures, including anonymous electronic reporting systems, structured audit-and-feedback loops, non-punitive policies and stronger leadership engagement, which collectively improved reporting transparency and learning.

Only a minority of studies applied established theoretical frameworks such as the Theoretical Domains Framework (TDF) or the Swiss Cheese Model (SCM) revealing a gap in theory-informed MER research globally. Overall, the synthesis shows that while high-income countries demonstrate stronger system-

level defenses, middle-income settings, including Malaysia, continue to face cultural and organizational challenges that weaken medication safety systems and inhibit reliable reporting.

Description of the Flow Diagram (Figure 2)

Below the diagram (Figure 2) has described that the Systemic differences in medication error reporting were evident between Malaysia and international systems when mapped through the Swiss Cheese Model (Reason, 2000). In Malaysia, underreporting persists due to pharmacist-dominated reporting, weak feedback, punitive culture and limited training (Chew et al., 2022; George et al., 2018; Yatim & Othman, 2022; Samsiah et al., 2016). By contrast, countries like the US, Switzerland and Ireland demonstrate stronger interdisciplinary reporting, anonymous electronic platforms, feedback loops and non-punitive cultures that foster learning (Afaya et al., 2021). Targeted reforms remain necessary to address Malaysia’s limitations in culture, feedback, training and technology.

Figure 2: The Flow of Swiss Cheese Model

Description of the flow diagram

Figure 2 has described that the Systemic differences in medication error reporting were evident between Malaysia and international systems when mapped through the Swiss Cheese Model (Reason, 2000).In Malaysia, underreporting persists due to pharmacist-dominated reporting, weak feedback, punitive culture and limited training (Chew et al., 2022; George et al., 2018; Yatim & Othman, 2022; Samsiah et al., 2016). By contrast, countries like the US, Switzerland and Ireland demonstrate stronger interdisciplinary reporting, anonymous electronic platforms, feedback loops and non-punitive cultures that foster learning (Afaya et al., 2021). Targeted reforms remain necessary to address Malaysia’s limitations in culture, feedback, training and technology.

This appendix presents the complete literature matrix of the 33 studies included in the scoping review. Each study is characterized by author, year, country, title, design, key findings, recommendations and whether the Swiss Cheese Model (SCM) was applied.

Table 3: Literature Matrix Table

Synthesis of the Included Studies (Table 3)

The 33 studies included in this review collectively demonstrate that medication-error (ME) reporting remains a widespread global challenge shaped by interrelated behavioral, organizational and systemic factors. Research conducted across Malaysia, Saudi Arabia, Qatar, Indonesia, China, South Korea, Turkey, Egypt, the United States, the United Kingdom and Ireland consistently highlight persistent barriers such as fear of blame, punitive organizational cultures, unclear reporting processes, heavy workload, lack of digital systems and limited knowledge of reporting requirements. Malaysian studies spanning NICU, ICU, primary care, tertiary hospitals and general wards reveal particularly strong influences of punitive climate, insufficient managerial support, lack of feedback and inadequate training (Chew et al., 2022; Ishak & Ibrahim, 2024; Mahfodz et al., 2024; Mahmoud et al., 2023; Samsiah et al., 2020).

Methodologically, most studies employed cross-sectional survey designs, providing useful descriptive insights but limiting causal interpretation. A smaller number of qualitative and mixed-methods studies enriched understanding by revealing emotional and cultural barriers such as shame, confidentiality concerns, hierarchical pressure and fear of career repercussions that strongly suppress reporting behavior. Retrospective audits confirmed that reported incidents are overwhelmingly near-misses rather than actual harmful errors, reinforcing substantial underreporting across settings.

Only a few studies used structured theoretical frameworks (e.g., Theoretical Domains Framework, Swiss Cheese Model), while most lacked a behavioral or systems-based lens, limiting their ability to explain how individual intentions interact with organizational conditions. The scarcity of intervention studies with the exception of digital reporting trials and training-based programs further underscores the need for more robust, theory-driven research.

Overall, the evidence from all 33 studies reveals highly consistent patterns: nurses recognize the importance of reporting but are constrained by fear, workload, limited support and systemic deficiencies. These collective gaps justify the need for a comprehensive, such as the SCM to understand and improve medication-error reporting behavior among nurses in Malaysia.

Comprehensive Review of the Selected Studies

The final review comprised 33 studies published between 2015 and 2025, spanning a wide range of health-system contexts. Malaysia contributed the largest share of evidence, with studies conducted in primary care clinics and hospitals across several states, while additional work came from Saudi Arabia, Qatar, South Korea, the United States, the United Kingdom, Ireland, Turkey, Egypt, Indonesia, Kuwait and the United Arab Emirates. Settings were predominantly acute hospitals and primary care clinics, although several multi-country integrative and systematic reviews synthesized findings from mixed settings. Across all studies, the combined sample exceeded 10,000 healthcare professionals, with nurses as the primary focus, but many studies also included pharmacists, physicians and other clinical staff, reflecting the interdisciplinary nature of medication error reporting.

Methodologically, the body of evidence was dominated by cross-sectional survey designs, which examined knowledge, attitudes, self-reported practices and perceived barriers to reporting among nurses and other healthcare professionals (Alshammari et al., 2021; Teoh et al., 2015; Chew et al., 2022; Mahfodz et al., 2024). These were complemented by qualitative studies from Malaysia, Saudi Arabia, the UAE and South Korea that used interviews or focus groups to explore deeper emotional, cultural and organizational influences on reporting behavior (Alotaibi, 2024; Alqubaisi et al., 2016; Samsiah et al., 2016). Retrospective incident-report analyses from Malaysia, Qatar and Saudi Arabia mapped the frequency, stage and severity of reported errors, highlighting large volumes of near misses and prescribing-stage errors (Ali et al., 2017; Yatim & Othman, 2022; Thomas et al., 2021). In addition, mixed-methods studies from Qatar used the Theoretical Domains Framework (TDF) to link behavioral determinants to reporting, while integrative and systematic reviews (Afaya et al., 2021; Gleeson et al., 2020; Mutair et al., 2021) synthesized global evidence on reporting interventions, barriers and systems- level strategies.

Only a minority of the primary studies explicitly adopted formal frameworks, but several showed clear alignments with system-safety principles. Theoretical work drew on the TDF to structure attitudinal and motivational barriers (Alqubaisi et al., 2016; Stewart et al., 2018) and on the NCC MERP taxonomy to categorize medication incidents (Mutair et al., 2021). Others implicitly reflected the Swiss Cheese Model (SCM) by examining latent organizational factors such as leadership, workload, staffing and safety culture, as well as active failures at the point of prescribing and administration. Across Malaysian and international studies, recurrent barriers included fear of blame and legal consequences, lack of anonymity, time pressure and workload, unclear definitions of what constitutes a reportable error and limited or absent feedback once a report was submitted. Several studies also showed that pharmacists were often the main reporters, with nurses and physicians less likely to submit formal incident reports despite recognizing errors (Afaya et al., 2021; Ali et al., 2017; Chew et al., 2022; George et al., 2018; Stewart et al., 2018; Thomas et al., 2021).

At the same time, the evidence identified important facilitators and system-level solutions. International studies reported that anonymous electronic reporting systems, combined with audit and feedback, education and role expansion, were associated with higher reporting rates and stronger engagement of frontline staff (Anderson & Abrahamson, 2017; Gleeson et al., 2020). Integrative reviews and qualitative work highlighted the importance of non-punitive, “just” cultures, clear reporting policies, visible management support and regular training in medication safety and reporting procedures (Afaya et al., 2021; Alotaibi, 2024). In Malaysia, studies suggested that smartphone-based applications, clearer protocols and leadership-endorsed assurance against punishment could increase use of the national Medication Error Reporting System (MERS) and improve reporting in busy clinical environments (George et al., 2018; Samsiah et al., 2020). Collectively, the 33 studies show that while awareness of medication error reporting is high, practice remains constrained by cultural and organizational barriers and that systems aligned with SCM principles anonymous platforms, multidisciplinary involvement, feedback loops and non-punitive cultures are more likely to achieve sustained reporting and learning.

Ethical Approval

Since this scoping review was conducted without the use of human subjects or personal data and was solely based on an examination of publicly available literature, ethical approval was not necessary. By using the Joanna Briggs Institute (JBI) methodology and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, the review complied with ethical research standards. No unpublished or private information was used and all sources are properly referenced.

Results

Nurses’ underreporting of prescription errors was consistently identified in both Malaysian and international studies. Contributing factors included inadequate feedback, lack of anonymity, fear of blame or legal consequences and poor integration of safety practices into daily routines (Chew et al., 2022; George et al., 2018; Samsiah et al., 2016). Fear of punishment and limited institutional support further discouraged reporting (Yatim & Othman, 2022; Alotaibi et al., 2022). Several studies also noted that pharmacists were the primary reporters particularly in Malaysia meanwhile doctors and nurses were less involved (Samsiah et al., 2020). In low- and middle-income countries, nurses frequently report insufficient training and low confidence in using MER systems.

Geographical Distribution of The Included Studies

The included studies were mainly concentrated in Asia and the Middle East. Malaysia contributed 8 studies (24.2%), Saudi Arabia contributed 6 studies (18.2%) and Qatar contributed 3 studies (9.1%). Other countries included China, South Korea, Indonesia, Thailand, the Philippines, Kuwait, the UAE, Egypt, the United States, the United Kingdom, Ireland, Australia and Japan. Representation from Africa and Latin America was minimal.

System-Level Defenses and Gaps in Medication Error Reporting: Evidence from Malaysia and International Healthcare Systems.

This scoping review, guided by the Swiss Cheese Model (Reason, 2000) critically examined 33 studies published between 2015 and 2025 to compare medication error reporting (MER) practices in Malaysia and internationally, map system-level defenses and propose reforms to strengthen reporting culture.

Across the 33 included studies, medication-error reporting systems are clearly intended to function as key system-level defenses, yet they are weakened by structural and cultural gaps. In Malaysia, the Medication Error Reporting System (MERS) and hospital incident-reporting platforms provide formal mechanisms for capturing errors and near misses, with large national datasets demonstrating that most reported events are intercepted before reaching patients (Yatim & Othman, 2022; Ab Rahman et al., 2025). Smartphone and electronic solutions have also been piloted and were well accepted by staff as a way to reduce time burden and improve accessibility (George et al., 2018). Training and pharmacovigilance initiatives such as those described by (Mahfodz et al., 2024) represent additional system defenses designed to enhance nurses’ knowledge, attitudes and practices regarding adverse drug reaction and error reporting.

However, the same body of evidence shows that these defenses are perforated by multiple “holes” consistent with the Swiss Cheese Model. Malaysian primary-care and hospital studies report that nurses frequently encounter unclear definitions of reportable errors, complex or time-consuming forms and limited feedback after reporting (Chew et al., 2022; Ishak & Ibrahim, 2024; Samsiah et al., 2020). Cross- sectional surveys and qualitative syntheses identify punitive culture, hierarchical leadership and poor organizational support as central system-level gaps; nearly one-third of barriers in Malaysian safety- learning systems relate directly to weak leadership, blame and lack of feedback (Mahmoud et al., 2023). These conditions discourage use of existing systems and result in selective or minimal reporting, especially among nurses working in high-risk units such as ICU and NICU where workload is intense and dosing is complex (Chew et al., 2022; Henry Basil et al., 2024).

International studies echo these weaknesses while also illustrating potential defenses. National and hospital-level incident-reporting systems in Qatar, Saudi Arabia, China, South Korea, Turkey, Egypt and Thailand are widely implemented, yet cross-sectional and review evidence shows they are underused because staff fear blame, litigation and reputational harm, or perceive reporting as futile (Afaya et al., 2021; Alrasheeday et al., 2024; Stewart et al., 2018; Yang et al., 2025). Systematic reviews highlight that many interventions to improve reporting education sessions, audit and feedback, or role expansion lack theoretical grounding and are rarely evaluated with robust designs, limiting their long- term impact (Gleeson et al., 2020; Mutair et al., 2021). At the same time, successful examples such as Thailand’s Medication Error Online Program demonstrate that simple, well-designed e-reporting tools integrated into workflow can reduce error rates and enhance system learning (Pongprom et al., 2025).

Overall, the 33 studies show that while formal reporting structures, training programs and digital tools exist as defensive layers, they are compromised by organizational culture, leadership behavior, inadequate guidance and technological limitations. Addressing these system-level gaps through non- punitive policies, leadership development, streamlined digital reporting and theory-driven interventions grounded in frameworks such as SCM and TPB is essential to transform reporting systems from passive repositories into active defenses that genuinely strengthen patient safety in Malaysia and internationally.

Across the 33 included studies, application of the Swiss Cheese Model demonstrates substantial variation between Malaysia and international healthcare systems. In Malaysia, persistent organizational and cultural barriers most notably hierarchical structures, punitive climates, inadequate supervisory support and limited digital infrastructure continue to suppress nurses’ willingness to report medication errors (Chew et al., 2022; Ishak & Ibrahim, 2024; Samsiah et al., 2020). System inefficiencies such as heavy workloads, unclear reporting procedures and insufficient leadership feedback further weaken internal safety defenses.

However, the 33 included studies, Malaysia contributed the highest number of studies (n = 8, 24.2%), followed by Saudi Arabia (n = 6, 18.2%) and Qatar (n = 3, 9.1%). Cross-sectional studies formed the largest design group (n = 18, 54.5%), followed by qualitative studies (n = 7, 21.2%), retrospective studies (n = 3, 9.1%), mixed-methods studies (n = 2, 6.1%) and review studies (n = 3, 9.1%).

In contrast, several international settings have introduced stronger system-level safeguards, including electronic incident-reporting platforms, non-punitive reporting policies, structured leadership feedback and regular safety education (Afaya et al., 2021; Stewart et al., 2018; Yang et al., 2025). These interventions have shown measurable improvements in reporting participation and safety culture.

Overall, findings indicate that while global systems increasingly adopt proactive, technology-driven and learning-focused reporting mechanisms, Malaysian healthcare continues to face entrenched organizational and cultural gaps. Strengthening leadership behavior, enhancing psychological safety, expanding digital reporting systems and implementing theory-driven interventions are essential to improving nurses’ reporting practices and reducing preventable medication-error harm.

Malaysia and International Systems in Comparison

Across the 33 included studies, Malaysian and international healthcare systems show markedly different levels of maturity in medication error reporting structures. Malaysian evidence from primary care, general wards, ICU and NICU settings consistently highlights under-reporting driven by fear of blame, unclear procedures and weak follow-up, despite the presence of a national Medication Error Reporting System (MERS) (Chew et al., 2022; George et al., 2018; Ishak & Ibrahim, 2024; Mahfodz et al., 2024; Samsiah et al., 2020). Reporting is often manual or semi-digital, variably used across units and rarely embedded within theory-driven learning frameworks, while high-risk environments such as NICU and ICU continue to experience substantial error burdens (Ishak & Ibrahim, 2024; Henry Basil et al., 2024). In contrast, studies from Qatar, Europe, East Asia and the Middle East describe more developed system-level defenses, including electronic or web-based reporting platforms, audit-and- feedback cycles and programs explicitly designed to strengthen patient-safety culture (Gleeson et al., 2020; Guo et al., 2025; Stewart et al., 2018; Thomas et al., 2021). Interventions such as online ME programs and structured safety-culture initiatives have been shown to increase reporting rates and reduce error incidence (Afaya et al., 2021; Pongprom et al., 2025). Nevertheless, even in these settings, fear of punitive consequences, face-saving norms and workload pressures remain prominent, particularly in Asian contexts such as Saudi Arabia, South Korea, China, Indonesia and the Philippines (Alrasheeday et al., 2024; Del Puerto, 2024; Jang et al., 2021; Prihartono & Wibowo, 2020; Yang et al., 2025). Overall, the comparison suggests that while international systems have moved further toward non-punitive, digitally enabled, learning-oriented reporting infrastructures, Malaysian practice remains largely descriptive and under-theorized, reinforcing the need for an integrated the SCM, multi-site study focused specifically on nurses’ reporting behavior.

Benefits and Integration of the Swiss Cheese Model

The Swiss Cheese Model (SCM) (Reason, 2000) provided a framework for mapping system-level barriers to safe medication practices. Many studies aligned their findings with SCM defense layers organizational culture, training, feedback, reporting systems and error detection even when not applied directly (Dirik et al., 2019; Relihan et al., 2010). Globally, SCM has been effective in identifying latent system failures and promoting systemic learning through layered interventions such as staff training, automated reporting and just culture leadership. Although its adoption in Malaysia remains limited, local research highlights its potential to strengthen reporting systems (Chew et al., 2022; George et al., 2018; Ishak & Ibrahim, 2024; Mahfodz et al., 2024; Samsiah et al., 2020).

Discussion

Guided by the Swiss Cheese Model (SCM), this scoping review synthesized evidence from 33 studies and demonstrates substantial variation in medication error reporting (MER) practices, system defenses and organizational learning across Malaysia and international healthcare settings. Across Malaysian studies, pervasive structural weaknesses particularly hierarchical authority, fear-driven reporting climates, limited organizational support and low digital integration continue to inhibit transparent reporting among nurses. Although awareness of reporting systems such as MERS exists, Malaysian research consistently revealed underutilization due to punitive cultures, poor feedback, unclear

reporting criteria and substantial workload pressures. These weaknesses reflect gaps across multiple SCM layers, particularly organizational influences, supervisory processes and situational conditions.

In contrast, international studies spanning Qatar, Switzerland, Ireland, China, Indonesia, South Korea, Thailand and Saudi Arabia demonstrate comparatively stronger systemic defenses, characterized by multidisciplinary reporting, electronic or web-based incident platforms (e.g., MEDMARX, CIRS), structured audit-and-feedback systems and leadership-driven patient safety initiatives (Gleeson et al., 2020; Stewart et al., 2018; Thomas et al., 2021). These systems more effectively operationalize SCM principles by establishing non-punitive policies, standardizing reporting workflows and embedding reporting into organizational learning cycles. Several interventions, such as Thailand’s Medication Error Online Program, showed measurable improvements in error reductions and increased reporting (Pongprom et al., 2025), highlighting the potential of digital and system-level enhancements.

However, even in technologically advanced international settings, behavioral and cultural barriers persist. Studies from Indonesia, South Korea, China, Saudi Arabia and the Philippines reported continued dominance of face-saving norms, hierarchical pressure and fear of administrative consequences mirroring patterns observed in Malaysia (Alrasheeday et al., 2024; Del Puerto, 2024; Jang et al., 2021; Prihartono & Wibowo, 2020; Yang et al., 2025). These global consistencies reaffirm that while system design is crucial, nurse behavior is profoundly shaped by cultural context, perceived psychological safety and leadership response all key constructs embedded within SCM.

Overall, the evidence indicates that Malaysia exhibits vulnerabilities across several SCM layers organizational (leadership, culture), supervisory (feedback, accountability) and situational (workload, unclear guidelines) which collectively weaken reporting defenses and sustain underreporting. International systems, though not free of cultural barriers, demonstrate greater alignment with SCM- based best practices through stronger digital infrastructure, structured learning systems and non- punitive environments and the dominance of cross-sectional studies (54.5%) indicates that most available evidence remains descriptive rather than interventional. This limits causal interpretation and highlights the need for more longitudinal and intervention-based studies.

The concentration of studies in Asia and the Middle East suggests that this review is more strongly weighted towards these regions. Therefore, the findings should not be interpreted as fully representative of all international healthcare systems. This regional imbalance highlights the need for more research from underrepresented regions, particularly Africa, Latin America and other low- and middle-income countries.

Future Malaysian research must therefore move beyond descriptive analysis to theory-driven, system- level evaluation. Embedding SCM-guided policies, strengthening digital reporting tools and fostering psychologically safe reporting cultures are essential for improving reporting behavior and enhancing long-term patient safety outcomes.

Future research direction

Future research should adopt interventional and longitudinal designs to evaluate the impact of system- level changes on reporting behaviors and patient safety culture (Dirik et al., 2019). In Malaysia, multi- center studies are needed to track cultural shifts, while integrating behavioral frameworks such as the Theory of Planned Behavior with the Swiss Cheese Model could deepen understanding of nurses’ reporting intentions and barriers. Standardized MER curricula within nursing education, alongside evaluations of training effectiveness, are also essential. Additionally, qualitative studies exploring nurses’ perspectives and lived experiences can provide valuable insights for advancing safety culture and reporting practices.

The Swiss Cheese Model was useful for mapping system-level weaknesses across Malaysian and international medication error reporting systems. It allowed this review to identify failures in organizational culture, leadership, feedback, training and digital reporting infrastructure. However, the model has limitations. It does not fully explain individual behavioral factors such as attitude, perceived control, intention or psychological safety. Therefore, future studies may benefit from integrating the

Swiss Cheese Model with behavioral theories such as the Theory of Planned Behavior or Theoretical Domains Framework (Guo et al., 2025; Stewart et al., 2018).

Furthermore, the inclusion of 33 studies limits the ability to claim full global representation. Therefore, the findings should be interpreted as a synthesis of available published evidence rather than a complete assessment of all international medication error reporting systems. However, this limitation is also an important finding, as it shows that theory-driven research on medication error reporting remains limited.

Based on the results of this scoping assessment, a number of important suggestions are put forth to improve nurse reporting systems for medication errors, especially in Malaysia and to bring local procedures into compliance with international safety standards:

Develop a National Platform for Electronic Reporting

Findings across the 33 studies clearly show that Malaysia urgently needs a centralized, anonymous and user-friendly electronic medication error reporting platform. Malaysian studies consistently highlight that current paper based or fragmented systems are burdensome and discourage reporting, especially due to time constraints, fear of blame and lack of feedback (Chew et al., 2022; Mahfodz et al., 2024; Samsiah et al., 2020). Evidence also shows strong acceptance of digital solutions Malaysian healthcare professionals responded positively to a proposed smartphone reporting app, indicating high readiness for electronic systems (George et al., 2018).

International findings reinforce this direction. Countries using national electronic platforms such as MEDMARX and CIRS demonstrate higher reporting rates, better data quality and improved organizational learning (Anderson & Abrahamson, 2017; Gleeson et al., 2020; Thomas et al., 2021). Digital platforms also successfully reduced medication errors in intervention studies, such as Thailand’s online ME programme that significantly lowered error rates (Pongprom et al., 2025).

Overall, the evidence supports Malaysia adopting a national electronic MER platform that is anonymous, simple to use, mobile-enabled and integrated with feedback mechanisms. Such a system would reduce reporting barriers, strengthen transparency and enhance system-level learning aligning with global best practices and the Swiss Cheese Model’s emphasis on strong organizational defenses.

Establish a Culture of Non-Punitive Reporting

Across the 33 studies reviewed, fear of blame, legal consequences and punitive organizational cultures consistently emerged as the strongest barriers to medication error reporting, especially in Malaysia. Nurses commonly withheld reports due to fear of disciplinary action, damaged professional reputation, or managerial repercussions (Chew et al., 2022; Ishak & Ibrahim, 2024; Samsiah et al., 2016). Similar patterns were observed internationally, where hierarchical structures and fear-based environments suppressed reporting (Alotaibi, 2024; Lee, 2017; Yang et al., 2025). These findings reinforce the need for Malaysian healthcare organizations to adopt an explicit non-punitive “just culture”, supported by leadership behavior, accreditation standards and clear policies that protect staff who report errors (Afaya et al., 2021; Mutair et al., 2021).

The evidence further shows that multidisciplinary participation significantly strengthens reporting systems. In several international studies, pharmacists reported the majority of errors (Ali et al., 2017; Thomas et al., 2021), while physicians and nurses contributed complementary insights into causes and system gaps (Keefer et al., 2017; Stewart et al., 2018). However, Malaysian research revealed inconsistent engagement across professions and underutilization of reporting systems (George et al., 2018; Samsiah et al., 2020). Encouraging all healthcare professionals not only pharmacists to participate, supported by targeted training and feedback loops, improves data completeness, organizational learning and shared accountability.

Together, these findings underscore that strengthening medication error reporting requires non-punitive culture reform and active, multidisciplinary involvement, ensuring that nurses and all healthcare workers feel safe, supported and responsible for contributing to patient safety.

Include Organized Instruction in Patient Safety and Reporting

Across the studies, lack of structured education on patient safety and reporting consistently emerged as a barrier, especially in Malaysia and other Asian settings. Nurses frequently reported uncertainty about what constitutes a reportable error, how to use reporting systems and the legal implications of reporting (Alshammari et al., 2021; Mahfodz et al., 2024; Saada, 2023; Samsiah et al., 2020). International work using behavior-change frameworks such as the TDF showed that motivation, emotion and knowledge are core determinants of reporting behavior (Guo et al., 2025; Stewart et al., 2018). These findings support integrating competency-based training on patient-safety frameworks (e.g. SCM), error identification and reporting protocols into undergraduate curricula and continuing professional development, supported by simulation, case reviews and unit-level coaching (Chew et al., 2022; Dirik et al., 2019; Jang et al., 2021).

Create Feedback Loops and Mechanisms for System Learning

The review showed that lack of feedback after reporting is one of the most demotivating factors for nurses. Malaysian, Gulf and Asian studies all highlighted that staff rarely receive information about what happened to their reports or whether any changes were implemented (Alotaibi, 2024; Chew et al., 2022; Ishak & Ibrahim, 2024; Del Puerto, 2024; Samsiah et al., 2016). Conversely, systems that combined reporting with root-cause analysis, visible policy changes and regular feedback demonstrated better engagement and learning (Elden & Ismail, 2015; Gleeson et al., 2020; Mutair et al., 2021; Thomas et al., 2021). Establishing structured feedback loops such as unit safety briefings, dashboards and debriefs would signal to nurses that reporting leads to real system improvements, thereby reinforcing trust and sustaining reporting behavior.

Investigate Reporting Practices in Malaysian Settings

Malaysian evidence is still dominated by single-site, cross-sectional, self-report studies focusing on specific units such as NICU, ICU, or primary care (George et al., 2018; Ishak & Ibrahim, 2024; Henry Basil et al., 2024; Mahfodz et al., 2024; Mahmoud et al., 2023; Samsiah et al., 2020). These studies consistently identify fear of punishment, workload, digital limitations and weak leadership as key barriers, but cannot clarify causal pathways or long-term effects. In contrast, international work has started to test interventions (e.g. online reporting programs, motivation programs, culture initiatives) with quasi- experimental designs and theory-driven approaches (Massah et al., 2021; Pongprom et al., 2025; Stewart et al., 2018). There is a clear need for multi-center Malaysian research that uses longitudinal, mixed-methods and intervention designs to evaluate how leadership, culture and digital health tools influence nurses’ reporting behavior over time.

Nursing Implications

The 33 studies collectively reaffirm that nurses are the frontline detectors of medication errors but cannot fulfil this role without supportive systems. Consistent implications include the need for: (a) psychologically safe, non-punitive environments that reduce fear of blame (Chew et al., 2022; Lee, 2017; Yang et al., 2025); (b) practical training that strengthens knowledge and confidence in using reporting systems (Alshammari et al., 2021; Mahfodz et al., 2024; Wake et al., 2021); and (c) simple digital tools such as mobile apps, online platforms and e-MAR that reduce workload and streamline documentation (George et al., 2018; Pongprom et al., 2025; Saada, 2023). When combined with strong leadership, coaching behaviours and interprofessional collaboration (Chegini et al., 2020; Stewart et al., 2018; Thomas et al., 2021), these strategies can convert errors into opportunities for learning, ultimately improving patient safety and reinforcing nurses’ professional contribution to medication-safety systems.

Limitations

The study is that most included research relied on cross-sectional surveys and qualitative designs, which are descriptive and cannot establish causal relationships. Many studies used self-reported data, introducing potential bias, and Malaysian evidence was often limited to single-site settings, reducing

generalizability. Additionally, few studies applied formal theoretical frameworks, limiting understanding of how individual behavior interacts with systemic factors in medication error reporting.

Future Scope

Future work should move beyond descriptive surveys toward intervention-focused, theory-driven research and experimental studies are needed to assess the impact of anonymous e-reporting platforms, just-culture policies and feedback interventions on reporting rates and patient outcomes in Malaysian hospitals, building on promising results from Thailand, Iran and Egypt. Mixed-methods and ethnographic designs can unpack the lived emotional and cultural dynamics such as fear, face-saving and power distance highlighted in China, Indonesia, the Philippines and Korea. Integrating behavioural models such as TPB or TDF with SCM will allow researchers to test how attitudes, subjective norms, perceived control and latent system factors jointly influence nurses’ reporting behaviour. Multi-centre national studies will be crucial to track cultural change and guide scalable policy reform.

Conclusion

The application of Swiss Cheese Model as an analytic lens, this review of 33 studies shows that medication-error reporting systems remain fragile, with different levels of maturity across countries. Internationally, several systems have moved towards anonymous electronic platforms, clearer definitions and non-punitive cultures, supported by leadership and structured feedback. In Malaysia, however, persistent “holes” in the organisational and supervisory layers hierarchical cultures, fear of blame, inadequate training and under-developed digital systems continue to suppress reporting among nurses despite high expressed willingness. Embedding SCM principles into policy, technology design and leadership practice offers a structured pathway for strengthening defences and transforming error reporting into a routine learning mechanism.

CRediT Authorship Contribution Statement

P.A.V: Study development, collaboration of ideas, literature review writing, data analysis, manuscript writing, and overall manuscript revision. K.T.A: Academic supervision, methodological guidance, and reviewed the manuscript critically and approved the final version for submission. A.B.A: Manuscript evaluation, provided professional feedback. S.B.M.A: Reviewing the manuscript and provided constructive comments and suggestions. L.S.P: Expert feedback, critical revision of the manuscript, comments and suggestions accordingly.

AI Assistance Declaration

The author hereby declares that, during the preparation of this manuscript, generative AI tools such as ChatGPT, Microsoft Copilot, and Google Gemini were utilized to assist with language enhancement and grammar correction. Following the use of these tools, the author thoroughly reviewed and revised the content and takes full responsibility for the final version of the manuscript, ensuring its accuracy and adherence to the required academic standards.

Conflict of Interest

The authors declare that they have no conflicts of interest.

Acknowledgement

The authors express sincere gratitude to International Islamic University Malaysia (IIUM) for its continuous academic support and for providing the foundation that enabled this work. Deep appreciation is extended to Assistant Prof. Dr. Khin Thandar Aung, Associate Professor Dr Ashikin Binti Atan, Associate Professor Dr Lee Siew Pien, Assistant Professor Dr Suzilawati Binti Mohamed Ariffin for their invaluable guidance, encouragement and thoughtful supervision throughout the development of this review.

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