دورية أكاديمية
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Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

التفاصيل البيبلوغرافية
العنوان: Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.
المؤلفون: Almutairi M; Saudi Food and Drug Authority, 3904 Northern Ring Road, Hittin 1351307148, Riyadh, Saudi Arabia. mm.mutairi@sfda.gov.sa., Algabbani A; Saudi Food and Drug Authority, 3904 Northern Ring Road, Hittin 1351307148, Riyadh, Saudi Arabia., Alasiri A; Saudi Food and Drug Authority, 3904 Northern Ring Road, Hittin 1351307148, Riyadh, Saudi Arabia., Alhomaidan A; Saudi Food and Drug Authority, 3904 Northern Ring Road, Hittin 1351307148, Riyadh, Saudi Arabia., Alqahtani AS; Saudi Food and Drug Authority, 3904 Northern Ring Road, Hittin 1351307148, Riyadh, Saudi Arabia.
المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jul; Vol. 58 (4), pp. 689-695. Date of Electronic Publication: 2024 Mar 28.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
أسماء مطبوعة: Publication: 2020- : Cham, Switzerland : Springer International Publishing
Original Publication: Thousand Oaks, CA : Sage Publications, [2013]-
مواضيع طبية MeSH: Drug Recalls*, Saudi Arabia ; Retrospective Studies ; Humans ; Drug Industry ; Product Recalls and Withdrawals
مستخلص: Purpose: This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects.
Methods: A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports.
Results: During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies.
Conclusion: The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.
(© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
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فهرسة مساهمة: Keywords: Drug recalls; Pharmaceutical companies; Recalls announcement; SFDA
تواريخ الأحداث: Date Created: 20240328 Date Completed: 20240612 Latest Revision: 20240612
رمز التحديث: 20240613
DOI: 10.1007/s43441-024-00635-4
PMID: 38546962
قاعدة البيانات: MEDLINE
الوصف
تدمد:2168-4804
DOI:10.1007/s43441-024-00635-4