Prospects of Establishing a Saudi Version of the United States Food and Drug Administration Orange Book |
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| Authors: | Yazed AlRuthia Badr Aljohani Wejdan R. Alsharif Hala H. Alrasheed Bushra M. Alghamdi Shatha Asiri Maryam Alarfaj Ghadah S. Almuaythir Saja Almazrou Omar Almazroo Ahmed Alaofi Rawan Alenazi |
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| Affiliation: | 1. Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia;2. Pharmacoeconomics Research Unit, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia;3. King Abdullah International Medical Research Centre (KAIMRC), King Saud bin Abdulaziz University for Health Sciences (KSAU-HS), College of Medicine, Ministry of National Guard Health Affairs (MNGHA), Riyadh, Saudi Arabia;4. William Harvey Research Institute, Queen Mary University of London, Charterhouse Square, London, United Kingdom;5. Pharmacy Practice Department, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia;6. Chief of Drug Evaluators and Head of Preclinical Studies Section, Saudi Food and Drug Authority, Riyadh, Saudi Arabia;7. Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia |
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| Abstract: | BackgroundThe recent incidents of generic drug recalls have shaken the public confidence in the quality of generic drugs in Saudi Arabia. Therefore, many clinicians and health policymakers are calling for the establishment of a national reference or formulary that rates different generic drugs based on their therapeutic equivalence to the listed reference drugs, such as the Orange Book of the United States Food and Drug Administration (USFDA).MethodTo explore the prospects of establishing a Saudi version of the USFDA Orange Book, the Saudi discussion group of the American Association of Pharmaceutical Scientists (AAPS) called for a group meeting to discuss the issue with stakeholders representing different sectors (regulatory, industry, purchasing and supply chain, and patient safety). The meeting was audio-recorded and transcribed verbatim. Thereafter, the text was reviewed and analyzed.ResultsThe participants agreed that there is no national guide or reference that can be used in generic substitution. Moreover, it was indicated that the Saudi Food and Drug Authority (SFDA) is working on establishing a Saudi version of the USFDA Orange Book, which will help in choosing the right generic drugs whenever medication substitution is performed to ensure patient safety.ConclusionThe establishment of a Saudi version of the USFDA Orange Book would help healthcare providers in choosing the right generic drug for their patients, which will hopefully improve health outcomes. |
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