THE ORANGE BOOK PROTOCOL FOR HANDLING THE DISCONTINUED DRUG

Arifa Banu*, Mariya Begum, Shireen Begum, Maheen Juverin

ABSTRACT

The Orange Book Protocol for handling discontinued drugs is an important resource for healthcare professionals, pharmacists, and patients. When a drug is discontinued, it can have significant implications for patient care, drug availability, and regulatory compliance. The Orange Book Protocol guides how to manage the discontinuation of drugs in a way that ensures patient safety and continuity of care. Our review article examines the process of adding drugs to the discontinued section, focusing on recent additions and with their identification, monitoring, and reporting according to FDA guidelines. We explore how manufacturers can access this information and provide practical guidelines for navigating the discontinuation process. By addressing gaps and challenges, our work contributes to a better understanding of drug availability and patient safety. One of the key aspects of the Orange Book Protocol is the identification of discontinued drugs. This involves regularly checking the FDA's Orange Book, which lists approved drug products with therapeutic equivalence evaluations. Once a drug has been identified as discontinued, the Orange Book Protocol guides how to manage existing supplies of the drug. In addition to managing existing supplies, the Orange Book Protocol also addresses the communication of discontinuation to healthcare providers and patients. Another important aspect of the Orange Book Protocol is the reporting of drug discontinuations to the FDA. By reporting discontinuations, healthcare professionals and drug manufacturers contribute to the overall safety and effectiveness of the drug supply chain. The Orange Book Protocol also emphasizes the importance of post-discontinuation monitoring. Healthcare professionals are encouraged to monitor patients who were previously taking the discontinued drug to assess their response to alternative treatments and identify any adverse effects. This ongoing monitoring is essential for ensuring that patients continue to receive high-quality care following the discontinuation of a drug.

Keywords: FDA, Orange Book, drug discontinuation, guidelines.