Abstract
Keywords
Introduction
Good Pharmacy Practice (GPP) guidelines are pivotal for ensuring the safe and efficient provision of services within pharmacies, contributing significantly to the global healthcare landscape. GPP encompasses the principles of pharmaceutical care, serving as a framework for meeting and elucidating these responsibilities.1,2 In Nepal, community pharmacies, including those situated in Hetauda Sub-metropolitan city, play a crucial role as essential healthcare providers. With over 28,000 registered pharmacy outlets nationwide, they offer accessible healthcare services to the populace. 3
A community pharmacy serves as a local healthcare hub, offering vital pharmacy services to its surrounding area. Staffed by qualified pharmacists with the necessary qualification and expertise, it dispenses medications and provides professional healthcare assistance to the community. 4 In Nepal, it is commonly referred to as “ausadhi pasal” or “medicine shops,” are typically managed by paramedical staff members, such as nurses, auxiliary nurse midwives (ANMs), health assistants (HAs), and community medicine assistants (CMAs). The Council for Technical Education and Vocational Training (CTEVT) has introduced a 3-year pharmacy diploma program in Nepal aimed at providing manpower for pharmacies. While some pharmacy assistants pursue further education, others choose to continue working in the field.5-8 Those who advance in their profession typically hold a pharmacy diploma and may include HA and CMA, who oversee pharmacies and provide minor medical attention to patients.9,10 So, the extent of their training may not encompass certain advanced skills required for comprehensive pharmaceutical care. So, it is imperative to note that, according to the Drug Act 2035, only assistant pharmacists and pharmacists are eligible for registration with the Nepal Pharmacy Council (NPC) and authorized to operate a community pharmacy lawfully under the supervision of the Department of Drug Administration (DDA). 8 ,11-13
The International Pharmaceutical Federation (FIP), representing pharmacists and pharmaceutical scientists worldwide, plays a pivotal role in advocating for the improvement of pharmaceutical services in community and hospital pharmacies. While GPP guidelines are prevalent in numerous countries globally, including Australia, South Africa, Thailand, the USA, Jordan, and France, their implementation in Nepal has been inconsistent. 14 Efforts led by the DDA and NPC, supported by the World Health Organization (WHO), and commenced the establishment of national good pharmacy practice guidelines in Nepal in 2003. However, concerns persist regarding the inconsistent implementation of GPP and the lack of documented information across various regions of Nepal, as evidenced by previous studies.15,16
This research endeavors to evaluate the compliance of pharmacies in Hetauda with GPP guidelines, recognizing the significance of aligning practice with established standards to enhance medication safety and the quality of pharmaceutical services. By addressing these concerns, the aim is to contribute to the advancement of public health initiatives within the region.
Methods
Study Design, Study Period and Site
This cross-sectional descriptive study was conducted at community pharmacies situated in Hetauda sub metropolitan city in Makawanpur district, which is the capital of Bagamati province, Nepal. It lies in the 27°25′ N latitude and 85°02′ E longitude and is situated at a level of 300 to 390 m above the sea level. 17 The data collection was performed from June 2023 to August 2023.
Study Population
The study population comprised community pharmacies located in Hetauda submetropolitan city listed in the directory of Birgunj, DDA. There are around 227 registered pharmacies in Makawanpur district as recorded in Birgunj, DDA.18,19
Inclusion Criteria
Community pharmacy located within Hetauda sub-metropolitan city
Exclusion Criteria
Ayurvedic and homeopathic pharmacy
Wholesale pharmacy, hospital pharmacy, and government-run free drug distribution centers
Sample Size
The sample size was calculated using the list of registered community pharmacies obtained from the DDA directory. The community pharmacies located at Makawanpur district were used for the sampling frame. The sample size was determined using Cochran’s formula for estimation of a proportion (n =
Data Collection Tool
After examining earlier surveys of a similar nature, questionnaire was developed in English with certain alterations. The data gathering questionnaire underwent a review and validation process once it was developed. The developed questionnaire was then tested with 9 community pharmacy practitioners (CPPs) who are available at pharmacy during our visit to ensure readability and comprehension 21 (10% of 85), which were randomly selected CPPs working in different community pharmacies with similar settings to the study site. Colleagues in the pharmacy department completed the face validation of the questionnaire, and subject specialists in community pharmacy, pharmacy practice, and statistician were consulted to complete the process. Cronbach’s alpha was calculated and came out at .7, indicating that the test items’ reliability and consistency are satisfactory. 22 The results of the pre-testing were not included in the final data analysis, with the exception of changes made to the questionnaire, such as paraprahsing sentences and improving grammar and wording.
The final version of the data collection questionnaire consisted of 9 sections, each addressing specific aspects of community pharmacies. Section 1 evaluated premises with 5 items, Section 2 assessed the qualifications of CPPs with 3 items, and Section 3 focused on quality policy with 1 item. Sections 4 to 7 included 2, 2, 3, and 4 items, respectively, covering services, documentation, procurement procedures, and drug storage-related questions. Section 8 extensively covered prescription handling capacity with 16 items, while section 9 evaluated medication dispensing with 2 items. The maximum possible scores for sections 1 through 9 includes 5, 3, 1, 2, 2, 3, 4, 16, and 2 with a total maximum score of 38. Each accurate response during direct observation and questioning of CPPs received a score of 1, while each incorrect response received a score of 0.
Data Collection Procedure
During the initial phase, the pharmacist from the study team visited various pharmacies to establish communication and explain the objectives of the investigation. Subsequently, respondents were requested to furnish written informed consent, ensuring anonymity and voluntary involvement in the study. The final data were obtained through interviews with CPPs and the completion of a data collection form. The questionnaire typically required between 15 to 20 minutes to complete.
Ethical Approval
The Institutional Research Committee (IRC) of Madan Bhandari Academy of Health Sciences, Hetauda, Nepal (IRC-020-079) granted ethical permission prior to the commencement of the study.
Statistical Analysis
Statistical Package for the Social Sciences (SPSS), version 23 (SPSS, Inc., Chicago, IL, USA), was used for performing data analysis. Normality of distribution of continuous variables was tested using the Shapiro–Wilk test at 5% level of significance. The continuous variables were displayed as mean ± standard deviation (SD), while the categorical variables were displayed as frequencies and percentages.
23
Text, figures, and tables were used to show the results of a descriptive analysis that was done with frequencies and percentages. To ascertain association between qualifications of pharmacy in charge with other categorical variable Pearson Chi-square test (χ²) was employed.
Results
The study’s findings are summarized across various aspects: premises, personnel, quality policy, services, documentation, procurement, storage, prescription handling, and dispensing. Of the 95 community pharmacies approached, 9 did not participate, with response rate of 90.52%. The overall compliance with GPP indicators was notably low at 56.21%, with mean score of 21.36 out of a possible 38.
Complete adherence to GPP guidelines was absent among all surveyed pharmacies. Procurement practices achieved the highest score at 86.6%, commonly observed across many pharmacies. Conversely, the quality policy parameter (section 3) received a meager 11.62%. A detailed breakdown of parameter scores is presented in Table 1.
Average Score in Different Parameters of GPP Guidelines at Pharmacies of Hetauda Submetropolitan City, Nepal (n = 86).
With regard to premises (Section 1) it revealed that 95.3% of the surveyed pharmacies maintained cleanliness. Among these, 60.5% offered pure drinking water to patients, and 69.8% had waste collection boxes. Conversely, 48.8% lacked sufficient space for dispensing and sales, and 86% did not possess computers. Comprehensive premises parameter details are presented in Table 2.
Premises Parameters.
Evaluation of Section 2 qualifications of pharmacy personnel, a mere 16.3% possessed pharmacists with bachelor’s degrees, 32.6% employed assistant pharmacists holding diploma degrees, while 51.2% had individuals with diverse qualifications like CMA, HA, and others. Remarkably, 55.8% of pharmacy in-charges had pursued supplementary training in the field of pharmacy. During our survey of various pharmacies, it was noted that 97.7% of the personnel were not wearing aprons.
Regarding the service parameters (Section 4) it was observed that 55.8% of pharmacies offered counseling services, while 39.5% provided home delivery of drugs. With regard to documentation (Section 5) the majority (84.9%) of the pharmacies prominently displayed their registration certificates for patient visibility. In the domain of narcotics, 73.3% of community pharmacies refrained from selling such drugs, with 26.7% doing so without proper record mechanisms.
Concerning procurement parameters (Section 6) 95.3% of pharmacies asserted adherence to safe, effective, and socioeconomically acceptable procurement practices. An overwhelming majority (98.8%) sourced medicines from authorized channels, although only 66.3% claimed to stock essential and lifesaving drugs. Regarding storage (Section 7), 44.2% of pharmacies were equipped with refrigeration facilities for drugs requiring cold storage. Detailed insights into procurement and storage parameters are outlined in Table 3.
Procurement and Storage of Drugs.
Regarding prescription (Section 8) only 18.6% of pharmacies had prescriptions managed by pharmacists. In 44.2% of pharmacies, assistant pharmacists were responsible for prescriptions, while in 31.4% of cases, other personnel took charge. Merely 5.8% of pharmacies had healthcare assistants (HAs) handling prescriptions.
Upon assessing prescription handling practices, it was evident that the personnel displayed proficiency in this aspect. The majority of pharmacies meticulously recorded essential information, including client names, therapeutic classifications, drug appropriateness, legalities, dosages, refill details, and prescriber signatures. However, only 47.7% of pharmacies demonstrated awareness of various drug interactions. Further insights can be found in Table 4.
Prescription Reading and Checking.
Among the 86 pharmacies, medication dispensing (section 9) was performed by 11.6% pharmacists, 44.2% assistant pharmacists, 7.0% healthcare assistants (HAs), and 37.4% other personnel.
No significant association was found between the qualification of pharmacy in charge and the space of pharmacy (
Association of Pharmacy Incharge with Other Parameters of GPP.
Indicates statistically significant at
Discussion
The low overall compliance of 56.21% with GPP indicators among community pharmacies is a matter of concern, as it indicates a substantial gap in adherence to best practices in pharmaceutical care. This finding is consistent with previous studies that have highlighted challenges in implementing GPP guidelines in various healthcare settings. 5 The lack of complete compliance with GPP guidelines among community pharmacies indicates the need for further attention and interventions to improve the quality and safety of pharmaceutical services provided to the public. The low compliance rates observed in this study could be attributed to various factors. Firstly, a lack of awareness and understanding of GPP guidelines among pharmacy staff might contribute to the low overall adherence rate. Continuous education and training programs on GPP should be implemented to enhance the knowledge and skills of pharmacy professionals. 24
The results of this study reveal a significant area of concern in the compliance of community pharmacies with the GPP guidelines, specifically in the premises parameter, which obtained only 57% compliance. This finding is similar to the study done by Acharya and Khanal 25 among pharmacy in western Nepal in which only premises parameter was average with the score of 3.22 (64.40%). This finding indicates that many community pharmacies are not meeting the required standards in terms of their physical premises, which is a fundamental aspect of providing safe and quality pharmaceutical services. The premises parameter in GPP encompasses various aspects, including the layout and design of the pharmacy, storage conditions, cleanliness, and adherence to safety regulations. Poorly designed pharmacy layouts may hinder efficient workflows and contribute to medication errors. 26 Another significant concern is the lack of technological integration in pharmacies. The study found that a substantial 86% of the pharmacies were not equipped with computers or any software. This finding correlate with the finding of Gyawali et al 27 in which only 30.7% of pharmacies in Bhaktapur were equipped with computer.
The results reveal that a significant proportion, 95.3%, of the pharmacies was reported to be neat and clean. This high percentage of clean pharmacies is encouraging as it reflects a commitment to maintaining hygienic environments for both the staff and patients. This is consistent with the importance of cleanliness in healthcare settings, which can have a positive impact on patient satisfaction and overall health outcomes. 25 However, some concerning issues were also identified in the study. A notable finding is that 48.8% of the pharmacies reported insufficient space for dispensing and selling purposes. Limited space can hinder the efficient delivery of pharmaceutical services and patient counseling. 28
The qualifications and training of pharmacy personnel play a crucial role in ensuring the quality and safety of pharmaceutical services provided to patients. The findings of this study highlight some important aspects related to the qualifications and practices of pharmacy incharge and personnel within the observed pharmacies. The study reveals that a significant percentage of pharmacies have personnel with varying levels of qualifications. Only 16.3% of the pharmacies have a pharmacist in charge with a bachelor’s degree in pharmacy. This indicates that a substantial portion of pharmacies may lack the expertise and knowledge required to provide comprehensive pharmaceutical care. Pharmacists with bachelor’s degrees typically undergo extensive education and training in pharmaceutical sciences, drug interactions, and patient counseling, making them well-equipped to handle various aspects of pharmacy practice. 29 Furthermore, 32.6% of pharmacies have assistant pharmacists with diploma degrees, and 51.2% have personnel with degrees like CMA, HA and other similar qualifications. Pharmacists, particularly those with bachelor’s degrees, are better positioned to offer accurate medication advice, assess drug interactions, and provide patient education. 30 This finding is very similar to the finding of Gyawali et al 13 study done in community pharmacies of Pokhara, Nepal. Another concerning finding is that during visits to different pharmacies, 97.7% of the personnel were not wearing aprons. Aprons are a fundamental part of maintaining hygiene and preventing contamination in a pharmacy setting. The lack of apron usage raises questions about the adherence to basic hygiene practices within these pharmacies, potentially impacting patient safety and the overall cleanliness of the environment. 31
The fact that 73.3% of community pharmacies did not sell narcotics drugs is indicative of a potential commitment to responsible pharmaceutical practices. Narcotics drugs, due to their potential for abuse and addiction, are subject to strict regulations and monitoring by regulatory authorities in most countries. The decision of a significant number of community pharmacies not to engage in the sale of narcotics drugs may reflect a cautious approach toward avoiding potential legal and ethical complications associated with these substances. 32 However, the presence of 26.7% of pharmacies selling narcotics drugs without proper record mechanisms is a matter of concern. Effective record-keeping is a crucial aspect of pharmacy practice, particularly when dealing with controlled substances like narcotics. The absence of proper record mechanisms in these pharmacies not only raises regulatory compliance issues but also poses risks related to potential unauthorized distribution and lack of accountability and this finding is similar with finding of the Poudel et al. 33
The observation that personnel in the observed pharmacies were proficient in handling prescriptions and paying attention to essential details is a positive finding. However, the relatively lower awareness (47.7%) about different drug interactions is a noteworthy aspect. Pharmacists play a crucial role in identifying and mitigating drug interactions to prevent harm to patients. Lack of awareness about drug interactions could lead to unintentional prescribing of medications that may have harmful interactions, compromising patient safety and well-being. 34
Significant association was only found between the qualification of pharmacy in charge and availability of computer (
Conclusion
It is concerning to note that none of the community pharmacies were found to be fully compliant with all the GPP guidelines developed by FIP and Nepal Pharmacy Council. This suggests a widespread issue in the implementation of best practices, raising questions about the quality and safety of pharmaceutical services provided to the public. These finding s emphasize the need for targeted interventions and improvements to enhance compliance with GPP guidelines in community pharmacies in Nepal.
Supplemental Material
sj-docx-1-inq-10.1177_00469580241273254 – Supplemental material for Assessing the Indicators of Good Pharmacy Practice in Community Pharmacies: A Cross-Sectional Study
Supplemental material, sj-docx-1-inq-10.1177_00469580241273254 for Assessing the Indicators of Good Pharmacy Practice in Community Pharmacies: A Cross-Sectional Study by Biswash Sapkota, Bipindra Pandey, Anisha Karki and Aashish Malla in INQUIRY: The Journal of Health Care Organization, Provision, and Financing
Footnotes
Author’s Contributions
Declaration of Conflicting Interests
Funding
Informed Consent
Date of Ethical Clearance
Supplemental Material
References
Supplementary Material
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