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Abstract

Several pharmacy standards exist within high-income countries for measuring standards of practice in clinical and hospital settings. Following the implementation of diverse hospital pharmacy standards in low- and middle-income countries (LMICs) like Nepal such as the hospital pharmacy service guideline 2015, minimum service standards, this study aims to assess compliance with Good Pharmacy Practice (GPP) standards as per the codes for sales and distribution of drugs (CSDD) 2024 guideline in one of the provincial hospital of Nepal, as a quality improvement project. A cross-sectional study design was conducted within the Hetauda Hospital pharmacy section to check the compliance nature of hospital pharmacy practice standards using the 16 components and 121 indicators mentioned in the CSDD, implemented by the National Drug Regulatory Authority of Nepal, Department of Drug Administration. CSDD is a publicly available guideline consisting of 5 chapters and 20 sections, where the codes specifically focus on structural, human resources, storage and documentation, pharmacovigilance, GPP, good storage and distribution practice license-related provisions. Following the checklist provided in the CSDD, data were collected and entered into the MS Excel and analyzed in terms of frequency and percentage compliance. If the indicators were found to be 100% compliant, it was categorized as fully compliant, if the indicators were scored from (>50%-99.9%), it was categorized as partially compliant whereas if it was in between (0.0%-≤50%), it was categorized as poorly compliant. Out of a total of 121 indicators mentioned in the CSDD, only 74 (61.2%) were compliant. Only 6 domains were fully compliant (100%), whereas 7 domains were partially compliant (≥50%-99.9%) and 10 domains were poorly compliant (<50%-0.0%). Following the CSDD guidelines, it was found that the hospital pharmacy lacked in domains such as quality policy, service strategy, training, client complaints, product recalls, counseling services, medication records, client follow-up and referral, and self-inspection process, underscoring the need for prompt attention and an action plan from the Drug and Therapeutic Committee and the executives.

Keywords

pharmacy service cross-sectional studies quality improvemernt developed countries developing countries follow-up studies Nepal pharmacovigilance pharmacy workforce hospitals referral and counseling consultation

High-income countries are well equipped with standards of pharmacy practice for clinical and hospital settings.

This study uses a cross-sectional design to assess the good pharmacy practice standards in a provincial hospital of Nepal, a low-middle-income country, using a publicly available guideline, codes for sales and distribution of drugs (CSDD) developed by the National Drug Regulatory Authority of Nepal.

Out of a total of 121 indicators in the CSDD guideline, only 74 (61.2%) were compliant.

It was found that the hospital pharmacy lacked in domains such as quality policy, service strategy, training, client complaints, product recalls, counseling services, medication records, client follow-up and referral, and self-inspection process, and therefore underscores a prompt attention from the Drug and Therapeutic Committee and the executives.

The study guideline can act as a potent tool for quality improvement within the hospital pharmacy section of Nepal to check for adherence to good pharmacy practice standards.

Introduction

Standards of pharmacy practice encompass principles of patient-centered care, privacy, professional training, continuous education, integrity, accountability, and the ethical obligations of non-maleficence and beneficence.^1-9 These standards aim to optimize patients’ health outcomes through effective communication, safe dispensing practices, clinical pharmacy expertise, and ongoing professional development of pharmacy personnel.^1,5-7

High-income countries (HICs) have well defined pharmacy practice guidelines that helps pharmacy professionals fulfill their roles and responsibilities while identifying and addressing potential gaps.^1,2,5,6 For example, the American Society of Health-System Pharmacist’s (ASHP) Guidelines: Minimum Standard for Pharmacies in Hospitals, (USA, 2013) establishes core elements such as practice management, medicine use, distribution, storage, evaluation of effectiveness and research.¹ Similarly, the General Pharmaceutical Council Standards for Registered Pharmacies (UK, 2018), outline 5 principles focusing on patient-centered care, staff empowerment, appropriate premises, safe medication management, and supporting facilities.⁴ The European Statements of Hospital Pharmacy (2016) further reinforce quality by addressing 44 key aspects of hospital pharmacy practice across European health systems.⁹ Together, these examples highlight a strong commitment to structured, quality-driven pharmacy services in HICs.

In contrast, low- and middle-income countries (LMICs) face persistent challenges that hinder the implementation of good pharmacy practice (GPP). These challenges^10-13 are broadly categorized in Table 1.

Table 1.

Key Challenges to Implementing Good Pharmacy Practice (GPP) in Low- and Middle-Income Countries (LMICs).

Category	Description
Regulatory and governance gaps^10-12	Weak regulatory frameworks, inadequate enforcement, and limited oversight.
Infrastructure and resource limitations^10,11,13	Insufficient facilities, technology, and financial investment in pharmacy services.
Human resource constraints^10,11,13	Shortages of trained professionals and a lack of continuous professional development opportunities.
Educational and training gaps^10,11,13	Limited access to structured training programs and professional capacity-building.
Systemic and communication barriers¹³	Poor coordination and communication between healthcare providers lead to fragmented care.

Adopting international guidelines from HICs can support LMICs in strengthening pharmacy practice standards; however, successful implementation depends on strong commitment from policymakers, universities, professional associations, and pharmacists themselves.

The joint FIP/WHO guidelines on GPP define it as “GPP is the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care.”⁸ In Nepal, the National Good Pharmacy Practice Guidelines (draft, 2005) and the joint FIP/WHO GPP guidelines have been referenced in efforts to promote GPP.^8,14 Prior studies, such as those conducted in Hetauda sub-metropolitan city of Bagmati Province, have examined community pharmacy practice, but hospital pharmacies have often been overlooked.¹⁵ Within Nepal’s hospital pharmacies, persistent gaps remain, such as the absence of documented quality policies, limited training opportunities, lack of systematic complaint handling, and weak monitoring of dispensing and storage practices. These deficiencies restrict the delivery of safe, patient-centered care. Although national guidelines such as the Hospital Pharmacy Service Guideline 2015 exist,¹⁶ there is limited evidence on how well provincial hospital pharmacies adhere to GPP standards. To address this gap, we conducted a quality improvement project in a provincial hospital using the Codes for Sales and Distribution of Drugs (CSDD) guideline¹⁷ developed by Nepal’s National Drug Regulatory Authority. This study evaluates current GPP adherence and provides a foundation for an action plan to strengthen hospital pharmacy practice in Nepal.

Methods

A cross-sectional study design was conducted at one of the provincial hospital of Bagmati Province, Nepal. Hospital pharmacy of Hetauda hospital (executed by provincial government) was included in the study, whereas the community pharmacies, non-governmental/private executed pharmacies within the Hetauda sub-metropolitan city and hospital pharmacies of the remaining provincial government executed hospitals were excluded from the study. The study assesses the pharmacy standards by one of the provincial hospital of Nepal using a standard and publicly available¹⁷ guideline implemented by the National Drug Regulatory Authority of Nepal, Department of Drug Administration (DDA), as a quality improvement project. The aims of this study were presented at the hospital’s Drug and Therapeutics Committee (DTC) meeting held on July 1, 2025, where permission to conduct the study was granted (Decision number 5) and validated through signatures from all committee members. Ethical approval was not required, as this was a quality improvement project that did not involve patients. We have reported the study as per the Standards for QUality Improvement Reporting Excellence (SQUIRE) 2.0 guideline.¹⁸

Study Site

Hetauda hospital’s¹⁹ pharmacy department is a separate department under the hospital organogram, focused on providing pharmaceutical services (Figure 1). Hetauda Hospital is a government-run 300-bed secondary class B provincial hospital out of the 13 hospitals in the Bagmati Province, Nepal, currently providing clinical services to more than 800 patients daily.¹⁹ The huge number of patients consume the services through social health insurance provided through the Health Insurance Board, Government of Nepal.²⁰ According to the Hospital’s Management Information System, the pharmacy department provides service to around 1000 patients on a daily basis. Following the rise in the patients. including referrals and visits from the nearby district to this hospital¹⁹ also underscores the need to strengthen each department, including the hospital pharmacy section. Hence, we chose this study site as a quality improvement project to identify the adherence to GPP. Currently, there are 4 different sections within the hospital pharmacy, that is, Inpatient and Outpatient department pharmacy (IPD and OPD Pharmacy), emergency and geriatric pharmacy, drug information unit and pharmacovigilance cell (DIUPVC) and hospital pharmacy store section. The IPD and OPD pharmacy provides hospital pharmacy services to patients admitted to the inpatient section and patients who visit the outdoor patient department.

Figure 1.

Different sections within the hospital pharmacy.

The IPD and OPD pharmacy section has 6 dedicated counters equipped with computers and a pharmacy information management system (PIMS). Another section under the dispensing area is the emergency and geriatric pharmacy, which is focused on the emergency patients and the elderly population (>70 years) visiting the OPD section. The hospital also has its own DIUPVC, which is involved in drug information, pharmacovigilance services, formulary development, information preparation, education and communication materials, and medication counseling.²¹ The hospital store is entirely dedicated to inventory management, from preparing purchase orders to receiving the products from the supplier. It is also involved in procuring medicines based on the demand and budget of the hospital pharmacy.

Tools Used to Measure Standards of Practice: Nepalese Context

Hospital Pharmacy Service Guideline 2015 is the cornerstone guideline regarding pharmacy in the context of Nepal that has shaped today’s hospital pharmacy practice.^16,21 The inclusion of a provision for the development of DTC, its roles and responsibilities of pharmacy professionals, and a section dealing with pharmacy economic affairs has played a vital role in addressing and strengthening hospital pharmacy practice. Similarly, the development of Minimum Standards Service (MSS)^22-25 by the Ministry of Health and Population (MoHP) also serves as a potent standard for strengthening pharmacy practice. The inclusion of hospital pharmacy services within the section II “Clinical Service Management standards” consists of several standards/indicators for pharmacy services and applies to primary, secondary and tertiary hospitals.^22-25 National Good Pharmacy Practice Guidelines (draft), 2005 deals with the GPP standards such as premises, human resources, quality improvement, complaints and handling, documentation, medication management process, counseling services, pharmacovigilance, training, and self-improvement.¹⁵ Using these tools can be a medium to identify and prioritize the minimum requirement that needs to be within the pharmacy to ensure GPP and its standards. In this study, we depict the adherence to GPP using CSDD,¹⁷ a novel practice to identify gaps and prepare an action plan for the hospital pharmacy. The National Drug Regulatory Authority of Nepal (DDA) was responsible for implementing CSDD as per the Drug Registration Regulation, 2038 rule 11, as specified in its description.¹⁷ With 5 chapters and 20 sections, the codes specifically focus on structural, human resources, storage and documentation, pharmacovigilance, GPP, good storage and distribution practice license-related provisions (Supplemental File 1). Chapter 5 “Miscellaneous” section 17 describes the steps in obtaining the GPP (16 components/121 indicators) along with storage and distribution license by following the indicators outlined in the CSDD schedule first and second.¹⁷ Two authors, NP and PS completed the checklist through discussion and analyzing each indicator physically along with the documentation process. In case of confusion, the problems were solved through discussion with the dispensing and hospital pharmacy in charge.

Data Analysis

Once the data were collected, they were entered into Microsoft Excel 2013. Data were analyzed in terms of frequency and percentage compliance. If the indicators were found to be 100% compliant, it was categorized as fully compliant, if the indicators were scored from (>50%-99.9%), it was categorized as partially compliant; whereas if it was in between (0.0%-≤50%), it was categorized as poorly compliant. Four different columns were created as “Indicators/contents as per CSSD 2080”, “Checklist”, “number of indicators complied” and “comments” to represent the status of adherence to GPP. Scoring thresholds for domain compliance were arbitrarily defined and not validated against an external standard.

Result

Out of 121 indicators mentioned in the CSDD, only 74 (61.2%) were compliant (Table 2). Only 6 domains (100%) were fully compliant, whereas 7 domains (≥50%-99.9%) were partially compliant, and 10 domains were poorly compliant (<50-0.0%).

Table 2.

Number of Indicators Complied to Domains Mentioned in CSDD.

Domain/subdomain mentioned in CSDD	Total indicators	Complied	Percentage complied in reference to the total indicators in domains/subdomains
Premise (1.1-1.14)	14	10	71.4%
Furniture, fixtures, and equipment (1.2.1-1.2.6)	6	5	83.3%
Personnel (2.1.1-2.1.6)	6	5	83.3%
Quality policy (3.1.1-3.1.5)	5	1	20.0%
Service strategy (4.1.1-4.1.6)	6	1	16.7%
Training (5.1.1-5.1.9)	9	3	33.3%
Client complains (6.1.1-6.1.4)	4	0	0.0%
Product recalls and returns (6.2.1-6.2.4)	4	1	25.0%
Documentation (7.1.1-7.1.4)	4	2	50.0%
General (8.1.1-8.1.2)	2	2	100.0%
Vendor selection (8.2.1-8.2.3)	3	3	100.0%
Procurement (8.3.1-8.3.4)	4	4	100.0%
Storage management (9.1.1-9.1.12)	12	10	83.3%
Prescription handling (10.1.1-10.1.5)	5	5	100.0%
Correctness of prescribed medicines (10.2.1)	1	1	100.0%
Filling/dispensing prescriptions (10.3.1-10.3.8)	8	6	75.0%
Client information (11.1.1-11.1.5)	5	4	80.0%
Counseling (11.2.1-11.2.4)	4	1	25.0%
Medication records (12.1.1-12.2.2)	2	0	0.0%
Client follow-up and referral (12.2.1-12.2.4)	4	2	50.0%
Health promotion and response to symptoms (13.1.1-13.1.6)	6	4	66.7%
Pharmacovigilance (14.1.1-14.1.3)	3	3	100.0%
Self-inspection (15.1 [15.1.1]-15.2 [15.2.1])	4	1	25.0%
Total	121 (100%)	74 (61.2%)

Following the CSDD standards, it was found that the hospital pharmacy lacked quality policy, service strategy, training, client complaints, product recalls, counseling services, medication records, client follow-up and referral, and self-inspection process. Domains such as premise, furniture, fixtures, equipment, personnel, storage management, filling/dispensing prescriptions, client information, health promotion and response to symptoms were partially compliant. Poorly and partially compliant domains underscore the need to develop a proper action plan to improve pharmacy performance in the coming days. While the fully complied indicators were general affairs, vendor selection, procurement, prescription handling, correctness of prescription, and pharmacovigilance, the room for improvement still exists. The information regarding the “Indicators/contents as per CSSD 2080”, “Checklist”, “number of indicators complied” and “comments” is mentioned in Supplemental File 2.

Discussion

To our knowledge, this study is a first and novel one, as it assesses the GPP standards within 1 of the 13 provincial hospitals of Bagmati Province, Nepal, as a quality improvement project. Among the 121 indicators mentioned in the CSDD, 74 (61.2%) were compliant, indicating a positive status. However, the lack of focus on significant indicators such as quality policy, service strategy, training, client complaints, product recalls, counseling services, medication records, client follow-up and referral, and self-inspection process opens up room for discussion and improvement.

A quality improvement project must be part of a hospital pharmacy practice.²⁶ It is imperative to have a quality policy that ensures patient-centered care and enhances the therapy’s overall effectiveness.²⁶ These quality improvement projects and policies should be integrated with standard operating procedures (SOPs) and structured quality frameworks. A recent quality improvement study from a hospital pharmacy in Dubai demonstrated that applying the OCTAGON-P framework alongside Lean 5S significantly improved organization, standardization, medication safety, and patient-centered services, highlighting the value of such models in enhancing operational efficiency and overall quality in hospital pharmacy settings.²⁷

Almost all pharmacy standards from high-income countries focus on training pharmacy professionals.^1-9 In contrast to these standards, the effectiveness of the training program in our study site was found to be poor. This could be due to the lack of budget for conducting the training sessions, the lack of resources, and even the lack of dedication. It has also been found that staff are easily demotivated because of a lack of such training. Literature assessing the practice, perception, and obstacles to pharmaceutical care among hospital pharmacists in Nepal also concluded that over half of the population during the study time had no training. The study also focused on how good perception scores were observed from participants who received training.²⁸ Several studies point out that focusing on team-based training sessions integrated with education could be conducted by the management team to improve patient outcomes and safety in healthcare settings.^29,30

Literature reports on how patient complaints and their documentation are crucial in improving the overall working culture and consumer satisfaction.³¹ One review also highlights how quality and safety cases account for 33.7% of all complaints, where management handling issues accounted for 35.1%, and the relationship between patient and staff accounted for less than 30%.³¹ The lack of a complaint handling system within the hospital (Table 2) underscores the need to prepare the complaint handling section within the pharmacy section. Such complaints and the drug recall system must be reviewed by committee members from the DTC to ensure effective plans (Figure 2).

Figure 2.

Focusing on poor indicators to achieve patient outcomes.

Documentation is a major standard that must be updated to fulfil the standards of practice.³² Either through training or educational intervention, pharmacist performance can be elevated in terms of documentation [either as pharmaceutical care plans such as Subjective, Objective, Assessment, Plan (SOAP) and Data Assessment and Plan (DAP)], thus improving the health-related outcomes.^32,33 SOAP format is generally used by healthcare workers for clinically reasoning to assess, diagnose and treat the patient based on the information provided where it is separated in 4 sections: subjective (containing the patient view, information, chief complaints, history of illness and associated factors), objective (mainly laboratory and radiological findings), assessment (critically analyzing based on previous subjective and objective results), and plan (focusing on the rational therapy with education)³⁴ while DAP includes analyzing the data (patient screening data, and observable data), assessment (critically analyzing the patient conditions, symptoms and diagnosis) followed by plan (based on both treatment plan is prepared).³⁵

Despite 6 dedicated counters in IPD and OPD and 3 dedicated counters in Emergency and geriatric pharmacy, the counseling services are limited to dispensing and providing information on the dosage regimen. The space is congested, thus leading to confusion among patients, too. This opens up room for improvement in establishing dedicated counseling centers or medication counseling rooms for needy patients, such as the elderly population, pediatrics, pregnancy, people with disabilities and patients under multiple medications. Another gap within the hospital pharmacy section is the lack of integration of medication records or the establishment of electronic medical records (EHRs). Despite PIMS within the pharmacy section, PIMS is limited only to inventory management, billing and maintaining sales records. Due to a lack of integration of patient clinical information, laboratory investigations, and adverse drug reactions, the medication management process becomes difficult. The literature also concludes that using EHR enhances the efficiency of workflow in clinical pharmacy, reducing medication errors and improving communication among healthcare professionals.^36-38 The pharmacist’s role in health promotion also looks lacking. The medication counseling centers can promote health and provide information regarding several communicable and non-communicable diseases. Finally, the pharmacist’s role in self-inspection and that of several other healthcare professionals are crucial in finding out the gaps and helping elevate pharmacy status. Representatives from the Ministry of Health and institutions affiliated with ministries could also be a part of the inspecting team, which could identify gaps in inventory management, dispensing practices, and public health promotion. In a nutshell, it is crucial to focus on these gaps to ensure they are fulfilled and the standards of pharmacy practice are elevated.

Strengths and Limitations

This study can act as a potent tool for quality improvement within the hospital pharmacy section of Nepal. The findings can be disseminated at the DTC meetings to ensure proper coordination, discussion and budget planning. The findings can also be disseminated to the Ministry of Health of Bagmati province, highlighting the need to improve the hospital’s pharmacy practice.

Despite these strengths, the study also had limitations. The study was conducted in a single provincial hospital, limiting the generalizability of findings to other regions or hospital types. There was no inter-rater reliability assessment. Similarly, using a checklist-based observational approach without triangulation could have introduced potential biases. The study also didn’t include any inferential statistics. Scoring thresholds for domain compliance were arbitrarily defined and not validated against an external standard, thus limiting our score analysis. Similarly, the study did not assess patient outcomes or satisfaction, critical measures in evaluating the impact of pharmacy practice quality. While this study is limited to a single setting, future research can be conducted among all the provincial government hospital pharmacies to identify their adherence to GPP standards using CSDD. Future research should also emphasize the level of education of pharmacists and pharmacy assistants with various domains of CSDD, along with the implementation of an action plan in the provincial hospitals of Bagmati province. Future studies must focus on integrating tools such as Lean Six Sigma³⁹ and plan-do-study-act (PDSA)⁴⁰ as these contribute to improvements in hospital pharmacy operations, including medication safety, workflow efficiency, and patient satisfaction. Following the study findings, future research could also be conducted in multiple locations of Nepalese hospital pharmacy settings in combination with interviews or surveys to gather more in-depth information on the standards of hospital pharmacy practice.

Conclusion

High-income countries have established comprehensive standards of pharmacy practice that emphasize patient-centered care, adequate premises and resources, counseling services, proper documentation, and effective medication therapy management. In Nepal, as an LMIC, efforts have begun to introduce similar standards; however, implementation remains limited. This study assessed the current status of pharmacy practice in a provincial hospital using the CSDD as a quality improvement framework. The analysis revealed critical gaps in areas such as quality policy, service strategy, staff training, complaint handling, product recall mechanisms, counseling services, medication record-keeping, client follow-up and referral, and self-inspection processes. These findings highlight the urgent need for a structured action plan to strengthen adherence to GPP standards and to enhance the quality of hospital pharmacy services in Nepal. Importantly, the results provide evidence to inform policymakers, regulatory bodies, and healthcare institutions in designing targeted interventions that can bridge current gaps, align hospital pharmacy practice with international standards, and ultimately improve patient outcomes.

Supplemental Material

sj-docx-1-inq-10.1177_00469580251385399 – Supplemental material for Assessing Adherence to Good Pharmacy Practices in a Provincial Hospital in Nepal: A Quality Improvement Perspective

Supplemental material, sj-docx-1-inq-10.1177_00469580251385399 for Assessing Adherence to Good Pharmacy Practices in a Provincial Hospital in Nepal: A Quality Improvement Perspective by Nabin Pathak, Prerana Shrestha, Shreya Dhungana and Sunil Shrestha in INQUIRY: The Journal of Health Care Organization, Provision, and Financing

Supplemental Material

sj-docx-2-inq-10.1177_00469580251385399 – Supplemental material for Assessing Adherence to Good Pharmacy Practices in a Provincial Hospital in Nepal: A Quality Improvement Perspective

Supplemental material, sj-docx-2-inq-10.1177_00469580251385399 for Assessing Adherence to Good Pharmacy Practices in a Provincial Hospital in Nepal: A Quality Improvement Perspective by Nabin Pathak, Prerana Shrestha, Shreya Dhungana and Sunil Shrestha in INQUIRY: The Journal of Health Care Organization, Provision, and Financing

Footnotes

Acknowledgements

The authors would like to thank https://app.diagrams.net/ for helping us create . We would also like to thank all the pharmacy professionals and staff in the dispensary and main hospital pharmacy store section for providing us with relevant information.

ORCID iDs

Nabin Pathak

Prerana Shrestha

Shreya Dhungana

Sunil Shrestha

Ethical Considerations

This study was reviewed and approved by the hospital’s Drug and Therapeutics Committee (DTC) during its meeting on July 1, 2025 (Decision number 5). As this was a quality improvement project focused on evaluating pharmacy practices and did not involve patients, formal ethical approval from an institutional review board was not required.

Author Contributions

Conceptualization: NP. Methodology: NP, PS. Data extraction: NP. Data management: NP, PS, SD. Data synthesis: NP, SD. Data analysis: NP, SD. Writing—original draft: NP, PS, SD Writing—reviewing and editing: SS.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

All the data are available within the study.

Supplemental Material

Supplemental material for this article is available online.

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