Prospects of Establishing a Saudi Version of the United States Food and Drug Administration Orange Book
| Autor: | Rawan Alenazi, Shatha Asiri, Saja Almazrou, Wejdan R. Alsharif, Badr Aljohani, Ghadah S. Almuaythir, Yazed AlRuthia, Hala H. Alrasheed, Bushra M. Alghamdi, Maryam Alarfaj, Ahmed L. Alaofi, Omar Almazroo |
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| Rok vydání: | 2021 |
| Předmět: |
Discussion group
business.industry 030503 health policy & services Health Policy Supply chain media_common.quotation_subject education Biomedical Engineering Public relations humanities Purchasing Food and drug administration 03 medical and health sciences Patient safety 0302 clinical medicine Generic drug Quality (business) 030212 general & internal medicine Formulary 0305 other medical science business media_common |
| Zdroj: | Health Policy and Technology. 10:120-125 |
| ISSN: | 2211-8837 |
| Popis: | Background The 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). Method To 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. Results The 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. Conclusion The 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. |
| Databáze: | OpenAIRE |
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