Application of plan-do-study-act (PDSA) cycle for implementation of good pharmacy practice standards: A quality improvement interventional study in a Tertiary care central Hospital of Nepal

Abstract

Objectives

The global shift toward patient-centered clinical pharmacy services is governed by Good Pharmacy Practice (GPP) standards. However, implementing these in low-middle income countries (LMICs) remains challenging due to resource and infrastructure constraints. This study aimed to implement GPP standards at a central tertiary hospital using the Plan-Do-Study-Act (PDSA) cycle.

Methods

A prospective, interventional quality improvement study was conducted at a tertiary care central hospital over five months. Intervention included functional decentralization of services, development of 21 Standard Operating Procedure (SOPs) using the ALCOA+ framework, and staff training. Four longitudinal audits were performed using an expanded 125-indicator Department of Drug Administration (DDA) checklist. Root cause analysis (RCA) via the “5 Whys” technique addressed implementation barriers.

Results

Overall median GPP compliance increased from 57.1% (IQR: 25.0%–77.8%) to 100.0% (IQR: 100.0%–100.0%) by final audit (p < 0.0001). High-compliance domains rose from 17.6% to 88.2%. The Hodges-Lehmann estimator indicated a median improvement of 43.7% (95% CI: 22.2% - 62.5%). Qualitative analysis revealed that documentation gaps were rooted in ergonomic friction rather than incompetence; relocating logbooks to dispensing counters resolved these issues. A ceiling effect was observed in store management (91.7% compliance) due to fixed architectural constraints.

Conclusion

The PDSA model is an effective framework for driving rapid quality improvement in resource-limited pharmacy settings. Success was achieved not only through procedural changes but by transitioning staff culture from a “money-driven” mindset to “professional ownership”. This study provides a scalable roadmap for GPP implementation and suggests that national audit tools should adopt tier-specific indicators for tertiary facilities.

Introduction

The global landscape of pharmacy services has undergone substantial reforms, transitioning from a traditional product-oriented dispensing model to patient-centered clinical service.1, 2 Modern pharmacy services aim to optimize health outcomes through effective communication, clinical expertise, and the minimization of dispensing errors. Beyond clinical care, these modern frameworks mandate robust logistic management and continuous professional development.³ As medicines experts, pharmacist are uniquely positioned within the healthcare delivery system to contribute significantly to public health initiatives ranging from disease prevention to chronic disease management.⁴ Globally, these professionals mandates are governed by Good Pharmacy Practice (GPP) guidelines. The International Pharmaceutical Federation (FIP) and the World Health Organization (WHO) jointly defines GPP as the evidence-based practice that responds directly to the needs of those using pharmacy services. The GPP guideline encompasses five major domains: Medication Management, Patient Care, Ethical Standard, Quality Assurance and Regulatory Compliance.⁵ The systematic implementation of these guidelines has demonstrated a positive impact on increasing patient health outcomes, reducing medication errors, decreasing healthcare cost, and ensuring a systematic supply chain.⁶ In developed nations these standards are well-established through national guidelines such as Professional Practice Standard in Australia,⁷ the ASHP Minimum Standard for Pharmacies in Hospital in the USA,⁸ and aligned FIP/WHO guidelines across Europe⁹ and the UK. Conversely, their implementation in Low-Middle-Income countries (LMICs) remains a complex challenge.¹⁰ Evidence suggests that pharmacy services in LMICs, fall below standard and remain profit-oriented. Persistent barriers- including resources constrains, inadequate physical infrastructures, medication unavailability, lack of clear institutional guidelines, and weaker regulatory systems- create significant gap between theoretical standards and real-world care delivery system11, 12.

In Nepal, the endorsement of the Hospital Pharmacy Service Guideline-2072 marked a shift from basic supply chain management toward comprehensive clinical services.¹³ To align domestic practice with the international standards, Department of Drug administration (DDA) promulgated the Codes for Sales and Distribution of the Drugs-2080 (CSSD) and DDA have developed a self-audit checklist for formal GPP certification.¹⁴ However, while this national framework serves as a vital pillar, the roadmap for translating theoretical standards into practice within the high-pressure environment of a tertiary care hospital remains poorly defined. To date no community or hospital pharmacy in Nepal has achieved formal GPP certification.¹⁵ This gap is largely attributable to persistent barriers including resource, constraints, the absence of structural implementation frameworks, and inadequately enforced regulatory pathways.¹⁶ A baseline study conducted in Nepalese provincial hospital reported a GPP compliance score of 61.2%, highlighting critical, systematic gaps in quality policy, service strategy, documentation, counseling, medication records, and self-inspections.¹⁷

Bridging these operational gaps require moving beyond static, point-in-time audits toward a structured iterative framework capable of driving continuous quality improvement. Plan-Do-Study-Act (PDSA) cycle provides a robust methodology for identifying systemic failures, testing a small scale operational changes and fostering institutional adaption.¹⁸ This iterative approach is particularly essential for navigating the financial and infrastructural constraints inherent in resource limited healthcare systems.19, 20 Therefore, this study was designed as an implementation intervention utilizing the PDSA model to guide the systematic adaption of GPP guideline as central tertiary care governmental hospital in Nepal. We hypothesize that by utilizing the PDSA cycle, the institution could systematically identify the root cause analysis of non-compliance, deploy targeted standard workflows, and achieve full institutional readiness for GPP certification.

Methods

Study design and setting

This was a prospective, interventional quality improvement study utilizing PDSA to implement GPP standards. This study was conducted at Bharatpur Hospital, a 500-bed central tertiary care governmental hospital of Nepal that provides services to its nearby 10 districts. The study was carried out over a five-month duration, from July last 2025 to January 2026. A driver diagram was developed to map the relationship between the study aim, the primary drivers of quality and the specific change ideas tested over the four iterative PDSA cycles (Fig. 1A). The study was reported in accordance with Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) checklist to ensure transparency and systematic documentation (SQUIRE Checklist).²¹

Fig. 1.

PDSA Framework 2.

Ethical consideration

The study was conducted as an institutional quality improvement initiative focused exclusively on the operational process and system-level compliance with national Good Pharmacy practice Standard. The study received the formal administration approval from the Hospital Management and Drugs and Therapeutics committee. Since the study did not include any human subjects, clinical interventions, formal institutional review board was deemed exempt and a formal ethical approval was waived by the hospital management.

Intervention design

PDSA framework was adopted as intervention for this study (Fig. 1B). PDSA is four stage iterative method used for problem solving and continuous quality improvement.¹⁸

Plan Phase (Month 1)

After getting approval from the hospital management and Drug and Therapeutic Committee of the hospital, a multidisciplinary GPP implementation team was formed with 7 members including hospital administrator, hospital manager, hospital accountant, pharmacy in-charge, a clinical pharmacist, senior nursing staff, and one pharmacy graduate outside of facility who have prior knowledge on quality improvement, led by RG (clinical pharmacist). The team established Specific, Measurable, Achievable, Relevant, and Time-bound (SMART) objectives. Planning included finalization of the self-audit checklist and audit schedules; identifying and securing the human, technical, and budgetary assets required; and overall study projection. A baseline audit was conducted immediately to establish the pre-intervention compliance level.

Do Phase (Month 2–3)

The pharmacy department was functionally coded as Bharatpur Hospital Pharmacy (BHP) and its services were decentralized and categorized. (Fig. S1). To standardize the work flow, 21 Standard operating Procedures (SOPs) and corresponding departmental logbooks were developed (Table S1). This documentation framework was structured based on the ALCOA+ framework, comprising the principles of Attributability, Legibility, Contemporaneousness, Originality and Accuracy, was applied to all SOPs and logbooks. Following the tool development, mandatory training sessions were conducted for all pharmacy staffs to standardize real time data logging. At the conclusion of the phase, an interim implementation audit was conducted.

Study Phase (Month 4)

This phase involved the systematic documentation review of all the complied audit forms and departmental logbooks. Observed Operational deviations, data entry gaps, or procedural non-compliance were documented and reviewed among unit in-charges to identify performance gaps. For all primary deviations, a systematic Root Cause Analysis (RCA) was performed,²² utilizing the 5 Whys method, a parsimonious yet effective problem-solving technique, to iteratively probe the cause-and-effect relationships underlying identified errors.²³ Following the resolutions of the initial deviations,an evaluative audit was conducted.

Act Phase (Month 5)

Corrective Action and Preventive Actions (CAPA) were deployed based on the thematic findings of RCA. Operational changes were institutionalized and a final audit was performed to verify the facility readiness for the certification.

Tool and scoring

The primary tool used for this study was the GPP Self-audit checklist promulgated by the DDA, Nepal. While the standard DDA checklist consists of 121 indicators across 15 domains, this study expanded the tool to 125 indicators across 17 domains to incorporate specialized tertiary services. These additional domains were; Compounding Pharmacy (1 indicator), and Research (3 indicators) (Table S2). Each indicator was evaluated on a binary (Yes/No) scale and given a scores of 1 or 0 respectively.

Audit process

To ensure the objectivity and validity of the GPP compliance assessments, a standardized dual-audit protocol was implemented. Each audit was conducted simultaneously yet independently by two trained members of the GPP implementation team to ensure inter-rate reliability. Auditors performed evaluations independently; the final score for each indicator was calculated as the arithmetic mean of these two blind assessments. A formal provision was established to mitigate significant observer bias. In the event of a variance exceeding 10% in the aggregate compliance scores between the primary auditors, a third independent auditor was to be engaged. Under the discrepancy protocol, the two most concordant scores between the three auditors would be utilized for the final analysis. Throughout the five-month study period, the inter-rater variance remained consistently below the 10% threshold; consequently the involvement of a third-party auditor was not required.

Audit timeline and frequency

A longitudinal audit schedule was established to monitor the iterative progress of the GPP implementation, strategically aligned with the key milestones of the PDSA cycle. A total of four formal audits were conducted over the five-month study period (Table 1). The Baseline Audit established the pre-intervention state, while subsequent audits (Interim and Evaluative) provided data to evaluate the intervention. The cycle culminated in a Final Audit to verify institutional readiness for formal certification.

Table 1.

Chronological progression of GPP compliance and key observations across PDSA intervention milestone.

*p < 0.0001 (Wilcoxon signed-rank test comparing baseline to final audit compliance); ^†Kendall's coefficient of concordance (W = 0.72) across the four phases.

Data analysis

Data collected during four distinct audit phases were analyzed to evaluate the impact of PDSA-based intervention on GPP compliance. Compliance score was quantified using the DDA GPP checklist and the compliance percentage for each of the 17 domains was calculated as the ratio of obtained score to the maximum possible score. Compliance percentage was further categorized into compliance levels as high (more than 90%), moderate (60–89%) and low (less than 60%). Due to the non-normal distribution of compliance score, the overall compliance percentage was determined as median of the domain compliance percentage. These were done during each self-inspection phases to obtain baseline compliance, interim compliance, evaluative compliance and final compliance. Furthermore, absolute increase and relative increase was determined by comparing baseline compliance and final compliance; however, relative increase metric was excluded for domains with 0% baseline compliance. The progression of compliance across the four audit phases was mapped to visualize the continuous quality improvement trend.

Wilcoxon signed-rank test was utilized to determine the statistical significance of the improvement between the baseline (pre-intervention) and final (post-intervention) audit. Hodges-Lehmann estimator was applied to estimate the median difference between baseline and final scores along with 95% confidence interval. Kendall's coefficient of concordance (W) was calculated to assess the agreement in the ranking of the 17 domains across the four inspection phases. A p-value of less than 0.05 was established as threshold for statistical significance.

Qualitative analysis of deviations

For the qualitative analysis, data were gathered during the study phase through the structured Root Cause Analysis (RCA) sessions and focus group discussion within the pharmacy staffs. Detailed, anonymized field notes were compiled and transcribed verbatim. To ensure methodological rigor and control for investigator bias, thematic coding was performed independently by two primary investigators using a deductive approach mapped to four pre-defined structural themes (Ergonomic, Financial, Behavioral, and Organizational Culture). Inter-coder agreement was verified through consensus reconciliation, achieving an initial Cohen's kappa (κ) of 0.84, with all minor coding variances resolved via mutual arbitration before final data synthesis.

Results

Overall GPP compliance

The implementation of PDSA-based interventions resulted in a substantial shift in the pharmacy's GPP compliance profile (Table 1). At the baseline audit, the overall median compliance was 57.1% (IQR: 25.0%–77.8%), characterized by a significant lack of SOPs and clinical service documentation. Following the primary intervention phase (Do phase), the interim implementation audit showed a leap to a median compliance of 100.0% (IQR: 85.7%–100.0%). This high level of compliance was maintained and further refined throughout the evaluative audit phase. After addressing minor documentation gaps and sub-unit confusions via CAPA, the final audit confirmed a sustained and absolute compliance of 100.0% (IQR: 100.0%–100.0%) across all measured parameters, indicating full readiness for formal certification. The velocity of improvement is visualized in the run chart (Fig. 2A), which tracked the mean compliance score across four audit phases. The most significant “jump” occurred between the baseline (52.1%) and interim (91.7%) phases, coinciding with the deployment of 21 SOPs and training. The trend continued upward through minor iterative corrections to reach a final mean of 96.3%. This apparent discrepancy between the final median compliance of 100.0% and the final mean of 96.3% reflects the non-normal distribution of domain scores: three domains did not achieve 100% compliance (Store Management; Medication Records and Client Follow-up; Health Promotion and Response to Minor Symptoms), which depresses the mean below 100% while the median remains at 100.00%.

Fig. 2.

Run Chart Please proceed accordingly.

Statistical analysis confirmed that the observed improvements were both significant and highly coordinated. The Wilcoxon signed-rank test revealed a statistically significant increase between baseline and final audits (p < 0.0001). The effect size (r) was 0.57, indicating a large practical impact of the PDSA interventions. Furthermore, Kendall's coefficient of concordance (W = 0.72) demonstrated a strong agreement in the upward ranking of domains across the four phases. The Hodges-Lehmann estimator indicated a median improvement of 43.7% (95% CI: 22.2% - 62.5%).

Domain-specific compliance

Analysis of compliance levels revealed a total migration of domains from poor to high performance (Table 2). At baseline audit, the majority of domains (52.9%) were categorized as low compliance, with only 17.6% achieving high compliance. Following the implementation of SOPs, the interim audit saw an immediate elimination of all low-compliance domains, while the proportion of high-compliance domains nearly quadrupled to 64.7%. By the final audit, the pharmacy achieved a dominant high-compliance profile, with 88.2% of all domains reaching the high threshold and remaining 11.8% falling into the moderate category. The radar chart (Fig. 2B) illustrated the transformation from an irregular, low-compliance baseline shape to a near-perfect circular quality footprint by the final phases.

Table 2.

Comparative analysis of domain-wise GPP compliance percentage from baseline to final assessment across 17 domains.

Domains	Total Possible Score	Compliance (%)		Compliance Increase (%)
		Baseline	Final	Absolute⁎	Relative
Premises, Furniture, Fixtures and Equipment	20	75.0	95.0	20.0	26.7
Personnel	6	100.0	100.0	0.0	0.0
Quality Policy	5	0.0	100.0	100.0	0.0
Service Strategy	6	0.0	100.0	100.0	0.0
Training	9	55.6	100.0	44.4	80.0
Client Complaints and Product Recall	8	50.0	100.0	50.0	100.0
Documentation	4	25.0	100.0	75.0	300.0
Vendor Selection and Procurement	9	77.8	100.0	22.2	28.6
Store Management	12	91.7	91.7	0.0	0.0
Prescription Handling, Filling and Dispensing	14	57.1	100.0	42.9	75.0
Client Information and Counseling	9	77.8	100.0	22.2	28.6
Medication Records and Client Follow-up	6	66.7	83.3	16.7	25.0
Health Promotion and Response to Minor Symptoms	6	33.3	66.7	33.3	100.0
Pharmacovigilance	3	100.0	100.0	0.0	0.0
Self –inspection	4	75.0	100.0	25.0	33.3
Research	3	0.0	100.0	100.0	0.0
Compounding Pharmacy	1	0.0	100.0	100.0	0.0

^⁎Hodges-Lehman median difference: 43.7% (95%CI: 22.2% - 62.5%; Effect size (r = 0.57).

Analysis of the 17 functional domains revealed that 13 domains reached 100% compliance by the final audit as compared to 2 domains during the baseline audit (Table 2). Domains starting with zero compliance, such as Quality Policy; Service Strategy; Research; and Compounding Pharmacy, achieved full compliance following the PDSA intervention. Among the domains that did not achieve full compliance in final audit, store management domain showed zero relative increase and domain remained still throughout the PDSA cycle with compliance of 91.7%. Documentation domain showed the highest relative increase (300%). Although Health Promotion and Response to Minor Symptoms showed a high relative increase (100%), it remained with the lowest overall final compliance of 66.7%, followed by Medication Records and Client Follow-up domain (83.3%). The indicator level compliance evaluation across the four audit phases revealed the specific indicators that resulted in lack of total compliance in certain domains (Table S3). Specifically no improvement in indicator 12.2.2 (provision of a referral slip) resulted in lowest final compliance scores of Medication Records and Client Follow-up domain. Similarly no improvement in indicator 13.1.2 (pharmacist's participation in health promotion campaigns) and 13.1.6 (provision of onsite rapid testing services) resulted in lowest final compliance scores of Health Promotion and Response to Minor Symptoms domain.

Systemic barrier analysis and targeted interventions

While the quantitative audits showed high compliance, the “Study” phase identified several “surface-level” deviations that required deep-seated systemic corrections. The 5 Whys analysis revealed that operational failures were predominantly concentrated within four structural domains: Ergonomic, Financial, Behavioral and Organizational culture. Table 3 outlines the definitive qualitative matrix linking these structural themes to specific root causes and targeted intervention. The analysis identified that documentation compliance was a matter of physical proximity: by relocating logbooks to the dispensing counter, the ergonomic friction of real-time logging was removed. The intervention successfully transitioned the staff's motivation from monetary rewards to professional development, such as institutional support for attending national and international conferences.

Table 3.

Thematic categorization of GPP Deviations and Strategic CAPA.

Theme	Identified Deviation	The 5 Whys Analysis	Identified Root Cause	Theory-Based Intervention (CAPA)	Participant Quotes
Environmental or Ergonomic	Minor documentation gaps in clinical logbooks	1. Why? Incomplete entries in the counseling unit. 2. Why? High patient volume during peak hours. 3. Why? Staff prioritized dispensing over real-time logging. 4. Why? Logbooks were not ergonomically placed. 5. Why? Workflow layout did not support contemporaneous recording.	Inefficient physical placement of documentation tools relative to high-volume workflows.	Relocated logbooks to dispensing counters and implemented “Contemporaneous Recording” reminders to align with ALCOA+ standards.	“We don't skip documentation because we are lazy; we skip it because when there are 50 patients in line, stepping away from the dispensing window to walk to a central desk to fill out a logbook causes a massive bottleneck.” (P1, Staff Pharmacist) “Once the logbooks were physically moved right next to our dispensing trays during Cycle 2, logging became a muscle memory action rather than an extra chore.” (P4, Pharmacy Assistant)
Financial	Malfunctioning of the Temperature Monitoring devices.	1. Why? Temperature was not recorded? 2. Why? Not log book Maintained? 3. Why? Staff unaware of the Failure Mode? 4. Why? Not fixed Immediately? 5. Why? Finance department sees as low priority?	Inadequate allocation of the resources for maintenance and ensuring the availability of the Resources.	Informed Hospital Administration about the resources and applying for the budget allocation for the proper repair, calibration and maintenance of the instruments.	We can reorganize the shelves and documentation perfectly through our own effort, but we cannot physically repair these monitoring instruments or install climate systems without a dedicated institutional budget approval.”(P3, Department Unit Head)
Attitudinal	Low involvement of the staff on accepting the implementation.	1.Why? Low Involvement in Maintaining Log Books? 2.Why? Not Self Aware of the Involvement? 3.Why? Staff ignored of the GPP Guidelines? 4.Why? Staff Unaware of the professional benefits of complying these guidelines? 5.Why? Staff always talks about Financial Paybacks for complying these guidelines?	Lack of Professional ownership among the pharmacist. Cultural and Motivational gap as well.	Professional development workshop, training was conducted. On financial aspect staffs were made assured to pay them for the professional development (Attending National, International Conference) rather than direct Monetary paybacks.	Initially, the new guidelines felt like extra work imposed by management who don't have to face the crowd. We wondered why we should stretch ourselves without any financial payback.”(P2, Staff Pharmacist) “Knowing the hospital will support our professional development, like sponsorship for national conferences, reframed this for us. It made us look at our role as clinical professionals.”(P6, Clinical Pharmacist)
Organizational Culture	Feeling of the extra burden on the workplace.	1.Why? They feel burden? 2.Why? They only manage for Crowd Control? 3.Why? They still deviate after proper training? 4.Why? Workflow didn't manage? 5.Why? Non- Compliant to the Job Description and Guidelines endorsed by department?	Psychological and operational friction. Professional Integrity and Accountability Crisis.	Making aware of the professional code of the Conducts. Employing Non-conformity for the repeated deviations.	“The volume of patients makes us feel like crowd-control technicians rather than pharmacists. When you are that exhausted, following every line of a new SOP feels like an extra operational burden.”(P5, Staff Pharmacist) Tying the protocols to our formal job descriptions and being held accountable to the professional code of conduct forced us to take individual ownership.”(P7, Pharmacy Officer)

Discussion

As the first Good Pharmacy Practice (GPP) implementation study conducted in central tertiary care hospital in Nepal using Plan-Do-Study-Act (PDSA) model, the transition from a baseline compliance of 57.1% to a median of 100% validates our primary theory: GPP implementation in Nepal's central hospitals depends less on resource abundance and more on strategic reduction of ergonomic barriers and the professionalization of the pharmacy workforce. The iterative nature of the PDSA framework enabled this study to identify deep-seated barriers and perform real-time adjustments, transforming the theoretical DDA checklist into a living operational reality through a continuous learning loop. The baseline compliance of 57.1% initially appears lower than the 61.2% reported in a recent provincial hospital study.¹⁷ However, this variance is attributable to the more rigorous evaluative standards applied in this study. By incorporating two self-identified specialized domains- Research, and Compounding Pharmacy-, this study expanded 121-indicator GPP checklist to 125 indicator to capture specialized tertiary care services. When these specialized domains are excluded, the baseline compliance aligns closely with provincial findings, suggesting that the initial disparity reflects a more comprehensive assessment rather than a lack of foundational adherence.

RCA validated our initial theory that documentation failure stemmed from ergonomic friction rather than negligence. Logbooks located outside the primary workflow forced staff to choose between patient service and meticulous record-keeping during peak hours. Applying the ALCOA+ framework and relocating tools directly to the dispensing counter removed this operational framework, confirming that GPP implementation in low-and Middle- economic income countries (LMIC) must prioritize human-factor engineering to make the easiest path most compliant.24, 25 Similarly, transitioning from a ‘money-driven’ culture to one of ‘professional ownership’ via non-monetary incentives proved critical for long-term sustainability. While resource constraints often explain low compliance in LMICs, this study suggests behavioral incentives are equally critical. Leveraging institutional support for professional development-such as funding for national and international conferences- addressed the psychological burden and perceived ‘extra work’ identified by RCA.²⁶ This reframing of the pharmacist's role from a crowd control technician to a healthcare professional is essential for maintaining standards in the resource-limited settings.

The absolute increase in compliance within Quality Policy; and Quality Strategy domain highlights the efficacy of the “Plan” and “Do” phase of PDSA cycle, where the formal endorsement of institutional frameworks provided the administrative necessities to mandate standardize operations. This transition from an informal working culture to policy-driven environment represents a fundamental shift toward systemic quality improvement. Furthermore, 100% compliance achieved in the newly integrated Research and compounding pharmacy demonstrates that a systematic quality cycle can effectively bridge advanced operational gaps, even though extemporaneous preparation remains at infancy stage in many developing countries.²⁷ By aligning with the Minimum Service Standard (MSS) for Tertiary Care Hospitals in Nepal, the pharmacy service has successfully transitioned from a traditional dispensing model into a comprehensive clinical and academic entity.²⁸

Conversely, the lower final compliance in the domains of Medication Records and Client Follow-up (83.88%); and Health Promotion and Response to Minor Symptoms (66.67%) domains highlights a structural mismatch in national GPP indicator rather than a failure of PDSA model. As a central tertiary referral hub affiliated by Health Insurance Board and Government of Nepal, the facility's clinical resources are prioritized for specialized tertiary care rather than primary health promotion campaigns or basic diagnostic screening.²⁹ Instead of duplicating the primary care function, the pharmacy institutionalized a specialized Counseling Unit to focus on high-level pharmaceutical care, including drug-drug interaction assessments, therapeutic duplication monitoring, strategic counseling on dose tapering and rational drug use. Furthermore, the outbound referral slip indicator (12.2.2) is contextually limited within the pharmacy counter scope of a central tertiary hospital. Macro-level interfacility transfer protocols for specialized conditions are managed at the institutional administrative level rather than at the pharmacy dispensing counter; consequently, this indicator falls outside the direct operational scope of the PDSA pharmacy improvement cycle. These findings suggest that the current DDA checklist utilizes a “one-size-fits-all” approach that requires tier-specific reform to distinguish between the distinct service mandates of community and tertiary settings.

Another notable finding in this study was the relative stagnancy of the Store Management domain, which achieved a compliance score of 91.7% during the baseline audit and remained at this level throughout the entire PDSA cycle. Unlike other domains that reached absolute compliance through procedural changes, Store Management demonstrated a “ceiling effect”. Specifically, the requirement for a physical quarantine area for incoming medicines remained non-compliant due to pre-existing architectural limitations and space constraints within the hospital. This phenomenon suggests that while PDSA model is highly effective at optimizing process-oriented workflows – such as documentation and dispensing – it faces inherent limitations when confronted with the fixed structural and financial constraints,³⁰ confirming that full GPP certification in older tertiary facilities may require dedicated capital investment and administrative intervention to overcome built environmental barriers.

Strengths and limitations

A primary strength of this study is the establishment of a robust implementation framework for GPP using PDSA model, which offers a replicable roadmap for other healthcare institutions. By integrating the 5 Whys framework for RCA, the study provides qualitative depth, allowing for the identification and resolution of systemic barriers rather than focusing solely on the quantitative scores. To rigorously control for researcher bias and the potential risk of subjective “self-grading” by the implementation team, the study utilized a dual-auditor blind protocol backed by a third-party arbitration protocol for any variance exceeding 10%. Furthermore, because the primary national DDA self-audit checklist relies entirely on a strict binary (Yes/No) evaluation of visible verification, the potential for personal interpreter bias was minimized. These findings serve as a valuable evidence base for the regulatory bodies to inform future policy amendments and foster continuous quality improvement of the hospital pharmacy services in Nepal.

However, several limitations must be acknowledged. First, while the rapid transition from a 57.1% baseline to a 100% median compliance score over a five-month period reflects genuine systemic success, the high visibility of the intervention team introduces the potential for a temporary Hawthorne effect among pharmacy staff. Although the compliance gains were fundamentally rooted in permanent, structural modifications (such as the institutionalization of 21 SOPs and the physical relocation of logbooks to dispensing counters), a formal post-intervention sustenance audit conducted by an independent external body is required to verify long-term compliance. Second, as a single center study, the findings may not be fully generalizable; multi-center longitudinal studies are required to validate the reliability of PDSA framework across diverse tertiary settings. Additionally, the Wilcoxon signed-rank test was performed on 17 domain-level paired observation, which represent the complete population of GPP domains at this facility rather than a statistical sample. While statistically appropriate for this paired non-normal comparison and supported by the large effect size (r = 0.57), the small domain count limits the generalizability of statistical inferences to facilities with different domain structures. Finally, the five-month study period captures immediate implementation and short-term optimization trends, but it does not evaluate long-term compliance sustainability, nor does it directly measure the clinical impact of these operational improvements on direct patient health outcomes or medication error rates.

Conclusion

This study demonstrates that the transition from traditional dispensing to a GPP-compliant clinical pharmacy model is achievable in a high-volume tertiary care setting through systematic application of PDSA cycle. Our findings validate the theory that primary barriers to GPP implementation in Nepal are not merely a lack of resources, but rather ergonomic friction and monetary-centric professional culture. Through the strategic decentralization of the services and the systematic development of comprehensive SOPs, the hospital pharmacy transitioned from a baseline GPP compliance of 57.1% to an absolute median compliance of 100.0%. Beyond the numerical scores, the iterative “Study” and “Act” phases provided deep qualitative insights into the barrier to implementation. This study revealed documentation failures was primarily rooted in ergonomic friction rather than lack of competence, which was successfully resolved by applying ALCOA+ principles and optimizing the physical workspace. Most importantly, the transition from a “money-driven” mindset to a “professional ownership” culture serves as the critical indicator for the long term sustainability of the GPP standards in resource-limited settings. Ultimately, this implementation framework provides a scalable model for other tertiary care hospitals in Nepal and similar LMICs, proving that high-standard pharmaceutical care is achievable through structure planning and dedicated professional commitment.

CRediT authorship contribution statement

Roshan Giri: Writing – review & editing, Writing – original draft, Visualization, Validation, Project administration, Methodology, Investigation, Formal analysis, Data curation, Conceptualization. Rohit Agrawal: Writing – review & editing, Writing – original draft, Visualization, Formal analysis, Data curation. Sabin Raj Lamichhane: Writing – review & editing, Visualization, Project administration, Investigation, Data curation. Rachana Mahatara: Writing – review & editing, Visualization, Data curation.

Declaration of competing interest

None.

Appendix A. Supplementary data

Supplementary material