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The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study
Authors:Khalidah A. Alenzi  Najah S. Alanazi  Mohammed Almalki  Homoud alomrani  Fahad O. Alatawi
Affiliation:1. Ministry of Health, Regional Drug Information & Pharmacovigilance Center, Tabuk, Saudi Arabia;2. Pharm D, University of Tabuk, Tabuk, Saudi Arabia;3. Ministry of Health, Umlog Hospital, Tabuk, Saudi Arabia;4. Ministry of Health, Haqel Hospital, Tabuk, Saudi Arabia;5. Ministry of Health, King Fahad Specialist Hospital, Tabuk, Saudi Arabia
Abstract:PurposeThis study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database.MethodsA retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form’s fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022).ResultsFor 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P < 0.05).Antimicrobial drugs (26.9%), hematologic drugs (19.7%), and neuropsychiatric drugs (12.9%) were responsible for most ADRs. Most of the reactions were associated with the use of ciprofloxacin (7.7%), followed by the combination of lopinavir and ritonavir (4.1%). Two deaths resulted from salbutamol and cefazolin use. Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥9) for a causal relationship with the suspected drugs, followed by dermatological events (9.5%).ConclusionsThe spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety.
Keywords:Adverse drug reactions  Naranjo scale  Pharmacovigilance  ADR"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_JBcTSZTu1v"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Adverse drug reaction  KSA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_euOeJmKxHO"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  The Kingdom of Saudi Arabia  MOH"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_sNGPZdacXT"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  The Saudi Ministry of Health  RDIC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_1f8wf84XEp"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Regional Drug Information Center  WHO"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_LUxVeLoJCt"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  The World Health Organization  SFDA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  pc_zDXBz2KOan"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Saudi Food and Drug Authority
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