Regulatory Compliance of Labels and Product Information Leaflets for Medicines Distributed in the Private Sector in South Sudan

Abstract

Patient information leaflets (PILs) and labels are important for rational use of medicines as they provide additional information for patients on the medicines dispensed to them. In developing countries, this potential cannot be fully harnessed unless manufacturers provide medicines with labels and PILs that meet regulatory standards for content and user-friendliness. In South Sudan, it is not known if manufacturers uphold standards of these labels and PILs once their products are approved for distribution in the country. This study explored the degree to which medicines distributed in South Sudan comply with regulatory requirements for labels and PILs. A cross-sectional survey was conducted at selected pharmacies in Juba, the capital city of South Sudan. Labels and PILs from tracer medicines (based on the WHO priority list of medicines for children and women) were retrieved and assessed for compliance with regulatory requirements. Clients leaving the pharmacies were also interviewed about their prescriptions and understanding of the PILs. This study demonstrated that availability of essential medicines for maternal and child health is limited in the private sector is limited (66% overall). Furthermore, the availability and quality of labels and PILs leave a lot to be desired (79% complied with labeling requirements; 68% complied for PIL. There was a tendency for compliance of products from certain countries to be particularly poor. PILs were given out for only 38% of medicines dispensed. Most patients (92%) leaving the pharmacy did not know contraindications for the medicines dispensed, while majority (83%) had no idea what they should do if they had forgotten to take their medicine on time. Limited availability of essential medicines in the private sector has implications on universal health coverage, as a good proportion of patients seek health care services through the private sector. Labels and PILs are essential for education on their medication and impact on rational use of medicines. Moving forward, the regulatory authority in South Sudan would benefit from establishing and implementing strict guidelines that compel importers to adhere to licensing conditions related to labels and PILs up to the last mile of the supply chain. Frequent post-marketing authorization inspections should be used to check on these aspects with punitive measures taken against non-compliant distributors.