Abstract

Introduction: The SFDA internal records showed that several pharmaceutical entities (National Unified Procurement Company (NUPCO) and Saudi Food and Drug Authority (SFDA) are overlapping in their tasks within the system of drug availability in the Saudi market. This may have led to difficulties in terms of contacting which entity when drug shortages occur. This study aimed to identify stakeholders’ understanding of drug shortage, the internal process of reporting a drug shortage to the SFDA, and to evaluate the clarity of the communication channels and the stakeholder’s satisfaction regarding drug shortage reporting system at SFDA. Method: A cross-sectional study conducted between December 2020 and August 2021. The study consisted of three separate surveys targeting the main stakeholders including healthcare institution (hospitals and pharmacies), NUPCO, and registered pharmaceutical companies/storage) with a response rate of (68.07%). The survey consists of three main parts: knowledge, practice, and perception of drug shortage reporting system at SFDA. Results: Healthcare institution defined drug shortages as unavailability of the product after confirmation of unavailability by the agent by 65.3% and low stock generic product by 44.9%. Nonetheless, 67.3% of healthcare institutions planned for inventory stock based on several factors such as the need of the stock/product and consumption of the products per different periods. Moreover, NUPCO identified the drug shortages by two factors when the stock of brand drug is zero and after pharmaceutical companies confirm the unavailability of the product. Additionally, all of the stakeholders were aware of SFDA communication channels for drug shortages. Conclusion: Based on our results, the internal workflow of stakeholders on the issue of drug shortages was reviewed and most responses provided a general overview of the internal processes for handling drug shortages, reporting steps, and submitting drug shortage reports. Nonetheless, when it comes to choosing the right provider for a healthcare facility, price and delivery time are major factors that influence their decision. In addition, it is recommended that further investigation of internal workflows be conducted to measure aspects that may affect the clarity and quality of services provided by the SFDA.

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