Good distribution practice of pharmaceuticals in private sector in Juba, South Sudan

Abstract

Background: Good distribution practice (GDP) is regarded as the cornerstone of pharmaceutical quality control. In order to ensure product quality after a batch has left the manufacturing facility and to manage consumer complaints. Despite signs that the worst of the country's crisis (South Sudan) is subsiding, the pharmaceutical industry, faces weak points in the distribution processes of pharmaceutical products provide an avenue for counterfeit as well as illegally imported, stolen and substandard medicines to enter the supply chain. This is a concern in both developed and developing countries. The aim of the study, is to assess the compliance of private pharmaceutical wholesalers with Good Distribution Practices (GDP) in Juba, South Sudan.

Methods: A descriptive-quantitative research design was employed to systematically investigate the compliance of private pharmaceutical wholesalers with Good Distribution Practices. This design allowed the researchers to examine the existing conditions, gather primary and secondary data, and provide an accurate representation and understanding of the current scenario in the pharmaceutical distribution sector. The descriptive-quantitative approach facilitated the collection of reliable data, which helped in identifying trends, patterns, and relationships among variables, enabling a comprehensive assessment of pharmaceutical wholesalers' compliance with GDP. The data was collected using structured questionnaire, to collect data on various aspects of GDP compliance and WHO MQAS assessment tool, Module V was used, it guided the in conducting structured observations of the warehouses and the distribution facilities of the pharmaceutical wholesalers. The sample for this study consisted of a total of 86 private pharmaceutical distributors/wholesalers across Juba city.

Findings: Likert scale was used to measure the responses of the participants, and the data was analyzed using frequency distribution and percentages. The findings of the study showed that the majority of the private pharmaceutical wholesalers had some level of compliance with GDP, but there were gaps in some areas. For instance, some warehouses did not have adequate temperature monitoring systems and there was no record of temperature monitoring during transport. Additionally, the study found that some personnel did not wear protective clothing while handling pharmaceutical products. Regarding the implementation of regulations and policies, study found that there were gaps in the documentation and archiving of evidence for quality evaluation before product release from the warehouse. Furthermore, there were no clear guidelines on how to investigate market complaints and how to perform root cause analysis to identify the cause of the complaints. The study also identified several factors that influence GDP practices, including the availability of resources, the level of staff training, and the level of management commitment to GDP practices. The study found that the most influential factor in enhancing good distribution practices was the availability of resources.

Conclusion: The study highlights the importance of implementing and enforcing GDP guidelines in the pharmaceutical supply chain to ensure the availability and distribution of safe and effective medicines to the population. The findings provide valuable insights for policymakers, regulatory authorities, and private pharmaceutical wholesalers in Juba, South Sudan, and other low-resource settings facing similar challenges in implementing GDP guidelines.

implementing GDP guidelines. Recommendations: Formal GDP Training: Develop and implement structured and comprehensive GDP training programs for all staff involved in the pharmaceutical distribution process. Regular internal audits will help in identifying areas of non compliance and facilitate timely interventions to enhance GDP adherence. Leverage Technology: Integrate innovative technologies such as blockchain to enhance the transparency, security, and Collaborative Approaches: Foster collaborations between pharmaceutical entities, regulatory bodies, and other stakeholders to share knowledge. Development of GDP Compliance Tools: Develop and deploy robust tools and framework