The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets
Introduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients’ safety using pantoprazole-containing products recall as a case study in terms of the occurrence...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-07-01
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| Series: | Saudi Pharmaceutical Journal |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1319016423000932 |
| _version_ | 1797797221037506560 |
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| author | Aljoharah M. Algabbani Walid A. Alkeridy Mohammed A. Alessa Adel A. Alrwisan |
| author_facet | Aljoharah M. Algabbani Walid A. Alkeridy Mohammed A. Alessa Adel A. Alrwisan |
| author_sort | Aljoharah M. Algabbani |
| collection | DOAJ |
| description | Introduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients’ safety using pantoprazole-containing products recall as a case study in terms of the occurrence of potential drug-drug interactions (pDDIs). Methods: This retrospective study used de-identified electronic health records of adult patients who had a prescription for oral proton pump inhibitors (PPIs) including pantoprazole, esomeprazole, lansoprazole, or omeprazole from April 2020 through September 2021 from a large tertiary care hospital. The study outcome definition was the prevalence of pDDIs in PPIs users before and after the recall date (March 2021). Changes in the prevalence of pDDIs were modeled using interrupted time-series. The rate ratio of pDDIs in the 12 months before and 6 months after the recall was modeled using negative binomial regression. Results: A total of 1,826 pDDIs were identified, and the median monthly prevalence of pDDI before the recall was 102.5 which increased to 115.5 after the recall. A change in the level of pDDIs occurred immediately after the recall date, followed by a gradual decrease over time. The rate of pDDIs was 69% higher after the recall compared to the baseline (rate ratio 1.69; 95% confidence interval, 0.75–1.91). Discussion: Recall of pantoprazole-containing products was associated with a higher rate of pDDIs. However, the prevalence of pDDIs gradually decreased over time. We highlight the importance of planning of recall process and coordinating all potential stakeholders to avoid potential harms.Word count: 1450. |
| first_indexed | 2024-03-13T03:44:55Z |
| format | Article |
| id | doaj.art-bada8c84ac4a4e0491d95e61229a82b5 |
| institution | Directory Open Access Journal |
| issn | 1319-0164 |
| language | English |
| last_indexed | 2024-03-13T03:44:55Z |
| publishDate | 2023-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Saudi Pharmaceutical Journal |
| spelling | doaj.art-bada8c84ac4a4e0491d95e61229a82b52023-06-23T04:42:34ZengElsevierSaudi Pharmaceutical Journal1319-01642023-07-0131711811185The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the marketsAljoharah M. Algabbani0Walid A. Alkeridy1Mohammed A. Alessa2Adel A. Alrwisan3Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Corresponding author at: Pharmaceutical and Medical Devices Research Division, Executive Department of Research & Studies, Saudi Food and Drug Authority (SFDA), Northern Ring Branch Road, Hittin, Riyadh 13513, Saudi Arabia.King Saud University, Department of Medicine, College of Medicine, Riyadh, Saudi Arabia; University of British Columbia, Department of Medicine, Geriatric Division, Vancouver, Canada; General Administration of Home Health Care, Therapeutic Affairs Deputyship, Ministry of Health, Riyadh, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaSaudi Food and Drug Authority, Riyadh, Saudi ArabiaIntroduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients’ safety using pantoprazole-containing products recall as a case study in terms of the occurrence of potential drug-drug interactions (pDDIs). Methods: This retrospective study used de-identified electronic health records of adult patients who had a prescription for oral proton pump inhibitors (PPIs) including pantoprazole, esomeprazole, lansoprazole, or omeprazole from April 2020 through September 2021 from a large tertiary care hospital. The study outcome definition was the prevalence of pDDIs in PPIs users before and after the recall date (March 2021). Changes in the prevalence of pDDIs were modeled using interrupted time-series. The rate ratio of pDDIs in the 12 months before and 6 months after the recall was modeled using negative binomial regression. Results: A total of 1,826 pDDIs were identified, and the median monthly prevalence of pDDI before the recall was 102.5 which increased to 115.5 after the recall. A change in the level of pDDIs occurred immediately after the recall date, followed by a gradual decrease over time. The rate of pDDIs was 69% higher after the recall compared to the baseline (rate ratio 1.69; 95% confidence interval, 0.75–1.91). Discussion: Recall of pantoprazole-containing products was associated with a higher rate of pDDIs. However, the prevalence of pDDIs gradually decreased over time. We highlight the importance of planning of recall process and coordinating all potential stakeholders to avoid potential harms.Word count: 1450.http://www.sciencedirect.com/science/article/pii/S1319016423000932Drug-drug interactionsProton pump inhibitorPPIDrug withdrawalsRecallPatients safety |
| spellingShingle | Aljoharah M. Algabbani Walid A. Alkeridy Mohammed A. Alessa Adel A. Alrwisan The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets Saudi Pharmaceutical Journal Drug-drug interactions Proton pump inhibitor PPI Drug withdrawals Recall Patients safety |
| title | The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets |
| title_full | The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets |
| title_fullStr | The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets |
| title_full_unstemmed | The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets |
| title_short | The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets |
| title_sort | inadvertent consequences of drug recalls a case study of a recall of pantoprazole generics from the markets |
| topic | Drug-drug interactions Proton pump inhibitor PPI Drug withdrawals Recall Patients safety |
| url | http://www.sciencedirect.com/science/article/pii/S1319016423000932 |
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