Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

Authors

• Thamir M. Alshammari, From the Department of Clinical Pharmacy (Alshammari), College of Pharmacy, University of Hail, Hail, the Medication Safety Research Chair (Alshammari, Aljadhey), College of Pharmacy, King Saud University, the Department of Clinical Pharmacy (Al-Kathiri, Aljadhey), College of Pharmacy, King Saud University, the Pharmacy Service (Al-Kathiri, Aljadhey), King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia, and the Pharmacovigilance Department (Le Louet), Henri Mondor University Hospital (AP-HP), Créteil, France
• Wa’ad H. Al-Kathiri, From the Department of Clinical Pharmacy (Alshammari), College of Pharmacy, University of Hail, Hail, the Medication Safety Research Chair (Alshammari, Aljadhey), College of Pharmacy, King Saud University, the Department of Clinical Pharmacy (Al-Kathiri, Aljadhey), College of Pharmacy, King Saud University, the Pharmacy Service (Al-Kathiri, Aljadhey), King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia, and the Pharmacovigilance Department (Le Louet), Henri Mondor University Hospital (AP-HP), Créteil, France
• Hervé Le Louet, From the Department of Clinical Pharmacy (Alshammari), College of Pharmacy, University of Hail, Hail, the Medication Safety Research Chair (Alshammari, Aljadhey), College of Pharmacy, King Saud University, the Department of Clinical Pharmacy (Al-Kathiri, Aljadhey), College of Pharmacy, King Saud University, the Pharmacy Service (Al-Kathiri, Aljadhey), King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia, and the Pharmacovigilance Department (Le Louet), Henri Mondor University Hospital (AP-HP), Créteil, France
• Hisham S. Aljadhey, From the Department of Clinical Pharmacy (Alshammari), College of Pharmacy, University of Hail, Hail, the Medication Safety Research Chair (Alshammari, Aljadhey), College of Pharmacy, King Saud University, the Department of Clinical Pharmacy (Al-Kathiri, Aljadhey), College of Pharmacy, King Saud University, the Pharmacy Service (Al-Kathiri, Aljadhey), King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia, and the Pharmacovigilance Department (Le Louet), Henri Mondor University Hospital (AP-HP), Créteil, France

Abstract

Objectives: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. Methods: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. Result: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient’s demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). Conclusion: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports.

Article Type

Research Article

First Page

821

Last Page

828

Recommended Citation

Alshammari, Thamir M.; Al-Kathiri, Wa’ad H.; Louet, Hervé Le; and Aljadhey, Hisham S. (2015) "Completeness of adverse drug reactions reports of the Saudi adverse event reporting system," Saudi Medical Journal: Vol. 36: Iss. 7, Article 8.
DOI: https://doi.org/10.15537/smj.2015.7.11751