1. Introduction

Managing patients with coagulation disorders is influenced by several factors, including the medication’s narrow therapeutic window, variability in dose-response relationships, communication gaps between patients and physicians regarding dosing, and issues with patient adherence [1]. To address these factors and overcome the complexities of anticoagulation management, many countries have developed care models, including patient-centered models that emphasize patient self-management and self-testing, as well as pharmacist-managed, pharmacist-assisted, and nurse-managed care models [1,2]. Running a pharmacist-managed anticoagulation clinic (PMAC) offers many benefits to patient health [1,3,4]. A systematic review comparing the quality of warfarin anticoagulation control between outpatient PMACs and routine medical care found that the PMAC had better anticoagulation control and lower bleeding, thromboembolic events, and healthcare utilization [4]. The PMAC also improved patient knowledge of warfarin use and international normalized ratio (INR) control, leading to high patient satisfaction with the service [5].

A previous study explored the motivations behind establishing the first PMAC in Saudi Arabia, detailing its implementation process and its impact on anticoagulation management, adverse events, and patient satisfaction [6]. The findings indicated that the clinic had a favorable influence on patient care, as evidenced by the increased number of patients with INRs within range and patient satisfaction scores. The PMAC reduced time pressures on physicians, allowing them to focus on other patient care issues. Further advantages of the PMAC included lower costs of care, fewer concurrent medication interactions, and fewer adverse medication-related events while treatment objectives were still met [6]. The clinic’s implementation resulted in the expansion of pharmacy services, with an increased possibility of improving patient care. For example, a prospective observational study conducted in an ambulatory care setting in Riyadh City found that patients followed in the PMAC had higher time in therapeutic range (TTR) than those observed in a physician-managed clinic [7]. A study in Abha City suggested that pharmacist interventions can improve patients’ health-related quality of life when taking warfarin. Thus, the involvement of competent pharmacy personnel should be prioritized for both routine and critical patient care [8]. Based on national and international evidence, the Clinical Pharmacy Department of the General Administration of Pharmaceutical Care at the Saudi Ministry of Health (MOH) established the Clinical Practical Guidance for Warfarin Monitoring [9]. However, despite improvements in anticoagulation management and the availability of different models of care worldwide, PMACs have not been widely adopted in MOH hospitals. For example, only one of the seven MOH hospitals in Jeddah has a PMAC, while the MOH hospitals in Makkah and Taif do not. This qualitative study, therefore, aimed to explore pharmacists’ perspectives on the barriers and facilitators to implementing PMACs within MOH hospitals in the Makkah Region, where PMACs remain largely absent despite national clinical guidance, representing a critical gap between policy intent and real-world practice.

2. Methods

3. Results

A total of 12 pharmacists responded to the recruitment effort and met the inclusion criteria. Eleven pharmacists were interviewed; one pharmacist was unable to participate due to time constraints. The average length of the interviews was 20 ± 10 minutes, and the interviewer followed the same guide for all the interviews. The participants were pharmacists aged 31–40 years, representing both male and female pharmacists with varying professional roles and career stages. They worked in different MOH hospitals in the Makkah Region: Jeddah (n = 6), Makkah (n = 4), and Taif (n = 1). Seven participants were clinical pharmacists, two were pharmaceutical care leaders, and two were regular pharmacists. Four participants had implemented a PMAC in their working hospitals. S2 File outlines the participants’ relevant characteristics.

The thematic analysis revealed two core thematic categories: barriers and facilitators to implementing PMACs. The subtheme barriers were professional and interprofessional barriers, organizational and operational barriers, and patient-related barriers. In contrast, the facilitators’ sub-themes were workforce capacity and training, leadership and interprofessional support, organizational and patient support mechanisms, and infrastructure and digital resources.

4. Discussion

This is the first in-depth national study on the barriers and facilitators to implementing PMAC services at MOH hospitals. The barriers identified in this study related to limitations in the healthcare system, pharmacists’ lack of support and expertise, and physician resistance. Patients’ poor commitment to follow-up or rejection of the care provided in the clinic were other barriers. In contrast, the main facilitators identified were the development of the healthcare system and support for professionals involved in PMAC provision. While CFIR and KTA were used to analyze the data and identify key barriers, they do not provide specific intervention strategies. Therefore, the Behavior Change Wheel (BCW) was used as an interpretive framework to conceptually map the identified barriers to potential behavioral domains. BCW is widely used in healthcare settings, including pharmacy practice, to develop behavior-change interventions [22,23]. Using the COM-B model, barriers were broadly categorized according to Capability, Opportunity, and Motivation. These categories interact in this “Behavior system” to produce the desired behavior, affecting these constituents [22]. This approach was intended to support interpretation of findings and generate hypotheses for future intervention development, rather than to prescribe specific implementation strategies. The intervention functions identified through BCW (e.g., training, environmental restructuring, persuasion, and incentivization) should therefore be considered exploratory and illustrative, particularly given the study’s qualitative and context-specific design [22].

In this study, barriers related to healthcare professionals included the lack of appreciation for the role of pharmacists by other healthcare providers. This barrier corresponds to the reflective motivation category in the BCW framework and contributes to a lack of trust between pharmacists and physicians. One study reported similar findings, in which pharmacists expressed negative feelings about properly utilizing their clinical skills in PMACs [24]. Current and previous findings suggest that pharmacists’ motivation to implement and continue running PMACs would increase if physicians in Saudi Arabia became more supportive of the clinics and their positive outcomes [25]. Given the emphasis on collaboration in the Saudi healthcare system, this support could be fostered through regular communication that clearly outlines the benefits of PMACs for improving patient care [26,27]. For example, engaging physicians in pharmacy staff meetings with presentations or distributing concise materials highlighting successful outcomes can help raise awareness of pharmacists’ roles and the advantages of the PMAC model [22,28].

Physicians’ resistance was another reported barrier categorized under psychological capability. The initial physician resistance may be rooted in broader systemic factors. For example, physicians in Saudi Arabia have primarily perceived pharmacists as dispensers of medications rather than having clinical roles [29]. Unclear role definitions and the limited integration of clinical pharmacy services within the MOH system may contribute to the undervaluation of pharmacists’ clinical competencies [29,30]. This perception has been reinforced by the limited availability of interprofessional education opportunities during medical and pharmacy training, resulting in inadequate exposure to collaborative practice models [31]. These systemic factors may explain why physicians initially lacked confidence in the PMAC model and why direct exposure to pharmacists’ clinical skills was necessary to overcome these preconceptions. However, our findings contradict those in the literature. For example, physicians in a previous New Zealand study had a good relationship with pharmacists. They suggested keeping the PMAC available for their patients, alongside strong support for a nationwide rollout [24]. Most participating physicians expressed confidence in the pharmacists’ management and the reliability of INR results. However, some did not refer medically unstable patients to the clinic. Similarly, most pharmacists believed that their relationships with physicians had strengthened after the implementation [24]. The variations in these results could be attributed to differences in culture and the appreciation and development of the pharmacist position (i.e., pharmacy as a career is still evolving in Saudi Arabia, despite a significant need for clinical pharmacists). To overcome physician resistance, our participants reported that pharmaceutical leaders had worked to increase physicians’ confidence in the PMAC by allowing them to attend the first few clinics to ensure the clinical pharmacists’ competencies in running the clinic. Previous Saudi studies have also suggested that increasing physicians’ awareness of the benefits of pharmacist involvement in medication management may help mitigate their resistance [28,29]. Regular workshops that define the roles of clinical pharmacists and showcase successful peer-positive outcomes of PMACs in contemporary healthcare settings can facilitate change. These activities align with BCW intervention functions: education, persuasion, and modeling [22,28,29]. Moreover, previous studies have suggested that providing new physicians with exposure or training related to health system models that integrate clinical pharmacy services, such as PMACs, may support their understanding and confidence in pharmacist-led care [28].

At the system level, this study identified several barriers, including clinical pharmacist shortages and a lack of training, which were mapped to the environmental opportunity component of the BCW framework. Similar challenges have been reported in a previous study, including a lack of independently trained and adequately qualified clinic staff [1]. In the literature, centralized, multidisciplinary approaches to anticoagulant management have been described as potential ways to address workforce limitations. Participants in the current study had a similar suggestion. In addition, both BCW theory and international studies support continuous education and training as relevant mechanisms for addressing skill gaps and a limited workforce capacity [1,22,25,32]. These findings should be interpreted as exploratory and intended to inform future research and service development rather than as definitive implementation recommendations.

In our study, most participants reported that the absence of a designated area for the clinic resulted in recurrent changes to the PMAC location, which impacted clinic workflows. Longer waiting times for patients requiring frequent follow-up/monitoring were also identified in one study as a barrier to current PMAC services and were categorized as an environmental opportunity [6,22]. The authors suggested locating a large PMAC in the heart of the cardiology clinic, accompanied by updated, computerized medical references and databases to provide the necessary support, resources, and access to patient information [6]. This solution is an enablement intervention function in BCW theory. Another solution suggested in the current study was the provision of a virtual clinic as an environmental restructuring intervention in BCW theory. Alanazi et al. supported this suggestion during the COVID-19 pandemic. They found that the median (IQR) TTR% for the in-person clinic was 54.6 (27.3), compared to 50 (33.3) for the virtual clinic, with no statistically significant difference in TTR between the two clinic types (P = 0.07). However, telemedicine was considered a positive strategy to reduce patients’ hospital visits and offered effective remote evaluation when patients were socially isolated during emergencies [33]. Another promising approach identified in a recent local study to address hospital overcrowding is the implementation of point-of-care testing (POCT) [34]. POCT enables rapid clinical decision-making in terms of diagnosis, treatment choice, and monitoring, offering efficacy, safety, and convenience [1,25,34,35]. This solution would require the environmental restructuring and modeling of the results [22]. The POCT may also overcome issues related to INR testing that were reported in this study and the literature, which are identified as environmental opportunity barriers. For example, Tadesse et al. found that inconsistent reporting of INR findings and patients’ extended waiting times were concerns that prevented patients from taking the test and forced them to obtain testing from different sources. Consequently, the results were difficult to interpret due to the different test calibration ranges and standards of practice among laboratories, which also impacted outcomes-based anticoagulant dosage recommendations [1].

Patient-related barriers were also highlighted in this study, particularly patients’ poor commitment to follow-up appointments and refusal of care. These were identified as psychological capability barriers to implementing PMAC, in contrast to findings reported in the literature. It was shown that PMACs fostered good relationships between pharmacists and patients, largely due to the sit-down nature of consultations and one-on-one time spent with patients. Patients have thus become more aware and appreciative of the role and capacity of pharmacists in managing their health [36]. Drawing on the BCW framework and existing literature, patient education and supportive environmental approaches have been described as potential mechanisms to address such challenges [22,37]. For example, reminder systems for follow-up appointments have been discussed in prior studies as illustrative strategies that may support continuity of care [37]. In the Saudi context, telehealth mobile applications (e.g., Seha, Mawid, Tawakklna) have been appreciated by patients as acceptable tools to facilitate the delivery of their care and remind them of their appointments [38]. However, public trust in such applications remains necessary. Building strong relationships with pharmacists and physicians (within the PMAC model) is key to fostering trust and increasing acceptance of telehealth applications and clinical pharmacy services [38]. These observations should be viewed as exploratory and intended to inform future research rather than to prescribe specific interventions. A summary of recommendations for practice and improvement strategies is provided in Table 1.

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Table 1. Participants identified potential strategy domains mapped to barriers in PMAC implementation (exploratory analysis).

https://doi.org/10.1371/journal.pone.0342079.t001

Although this study primarily explored the barriers and facilitators from the pharmacists’ perspective, it is essential to acknowledge that other institutional factors may also impact the service implementation and success. For example, a previous local study highlighted how the healthcare setting and the high number of patients visiting the anticoagulation clinic could affect appointment availability, follow-up frequency, and consequently, patient outcomes [39]. Other Saudi studies have also reported that more intensive follow-up is required for patients at the initiation phase of warfarin therapy, those with uncontrolled INR, high thrombotic risk, or recent medication changes, all of which could affect treatment success if the PMAC has limited capacity [6,34,39]. Strong collaboration among healthcare providers has also been identified as a key contributor to the overall success of the PMACs [6]. Anticoagulation management requirements may also vary according to the type of anticoagulant used and influence PMAC implementation. For example, direct oral anticoagulants (DOACs) require different patient education and follow-up approaches compared with warfarin, which may lead to distinct barriers to their integration within PMACs. Barnes et al. (2019) reported that key barriers to integrating DOAC care in anticoagulation clinics include low provider awareness of DOAC-related services, financial challenges associated with providing care to DOAC patients, and ambiguity among clinical staff regarding the scope of DOAC care [16]. These findings suggest that incorporating DOAC-related workflows into PMACs may require tailored training and updated funding models to ensure effective service delivery.

This qualitative study identified key themes and perspectives on a broad topic that could not be obtained from the survey respondents. The research team considered triangulation and different techniques to ensure the trustworthiness of the findings. However, some limitations remained. First, despite employing both purposive and convenience sampling strategies and using multiple recruitment channels, including formal channels (e.g., professional work groups) and informal channels (social media platforms), this study may be subject to selection and nonresponse bias. Pharmacists who chose to participate were likely engaged and positive about the topic, which may have led to nonresponse bias and left some negative perspectives unexplored. Some pharmacists may have overlooked social media invitations, which could have further contributed to the limited diversity of perspectives. Second, the shared professional background between the interviewer and participants may have introduced a social desirability bias, as participants might have provided answers that they perceived as more professionally acceptable. Third, although data saturation was achieved and the qualitative approach provided valuable exploratory insights, this study was limited to pharmacists working in MOH hospitals in a single region (Makkah Region). Excluding private, military, and university hospitals and focusing on a small, pharmacist-only sample may limit the generalizability of the findings to other healthcare sectors/regions in Saudi Arabia, and warrants cautious interpretation of the results. In addition, representation across cities within the Makkah Region was uneven, which may have limited the capture of city-specific organizational or contextual differences. Moreover, perspectives on the implementation of PMAC may vary by pharmacists’ age, position, and career stage, which should be considered when interpreting the findings and assessing their transferability. Future studies should also include perspectives from other stakeholders, such as physicians, patients, and policymakers, to provide a more comprehensive understanding of PMAC implementation. Fourth, despite the use of two sampling strategies to enhance participation, the limited sample size may reflect cultural factors in Saudi Arabia, where qualitative interviews are not commonly used, and some pharmacists may be hesitant to participate or have their conversations recorded. Lastly, this study did not differentiate between patients using oral anticoagulants and those using DOACs. Future studies could explore whether barriers and facilitators differ according to the type of anticoagulant therapy, as patient experiences and management requirements may vary between different users.

5. Conclusion

This study explored the factors influencing the implementation of PMAC service from the perspectives of different stakeholders. The overarching barriers were related to limitations within the healthcare system, while patient-related barriers, such as poor acceptance and commitment to follow-up, were new findings. The literature supports the participants’ suggested solutions and aligns with BCW theory. While the findings are context-specific, they may inform similar initiatives in other MOH hospitals across Saudi Arabia, considering the uniformity of the healthcare system. Additionally, these insights help complete the KTA model’s action cycle by offering potential strategies for implementing, optimizing, and evaluating PMAC services. Further research is needed to explore the views of other stakeholders and quantify the impact of PMACs on both clinical and non-clinical patient outcomes. This could enhance the clinics’ recognition among healthcare professionals, accelerate their expansion, and support long-term sustainability.

Supporting information

Acknowledgments

The authors would like to thank their research collaborators, Razan Saleem Alhamawi, Reem Abdullah Almalki, and Dalal Musallam Alsulami, for their invaluable assistance in transcribing the interviews for our analysis. Their dedication and attention to detail have contributed to the success of this study.