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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.
Pathak et al. (Mon,) studied this question.