Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center
Gouda, S., Saad, A., Abbassi, M., Farid, S. (2019). Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center. EKB Journal Management System, 57(1), 96-103. doi: 10.21608/bfpc.2019.7213.1000
Samar O. Gouda; Amr A. Saad; Maggie M. Abbassi; Samar F. Farid. "Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center". EKB Journal Management System, 57, 1, 2019, 96-103. doi: 10.21608/bfpc.2019.7213.1000
Gouda, S., Saad, A., Abbassi, M., Farid, S. (2019). 'Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center', EKB Journal Management System, 57(1), pp. 96-103. doi: 10.21608/bfpc.2019.7213.1000
Gouda, S., Saad, A., Abbassi, M., Farid, S. Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center. EKB Journal Management System, 2019; 57(1): 96-103. doi: 10.21608/bfpc.2019.7213.1000

Adverse drug reactions of antineoplastic and immunomodulating agents reported to the Egyptian Pharmaceutical Vigilance Center

Bulletin of Faculty of Pharmacy, Cairo University
Article 8, Volume 57, Issue 1, 2019, Page 96-103  XML PDF (333.89 K)
Document Type: Original Article
DOI: 10.21608/bfpc.2019.7213.1000
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Authors
Samar O. Gouda1; Amr A. Saad2; Maggie M. Abbassi1; Samar F. Farid1
1Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University.
2Egyptian Pharmaceutical Vigilance Center.
Abstract
The aim of this study was to evaluate the pattern of Adverse Drug Reactions (ADRs) related to antineoplastic and immunomodulating agents in Egypt. We extracted all ADR reports of antineoplastic and immunomodulating agents (Anatomical Therapeutic Chemical (ATC) code L) that were reported to Egyptian Pharmaceutical Vigilance Center (EPVC) from January 2011 to December 2015 using VigiLyze TM. Afterwards, these reports were analyzed and categorized by age, sex, reporter qualification, seriousness, type of ADRs, medications, indications of use and causality. During the study period, 1905 reports related to antineoplastic and immunomodulating agents were received; 44.6% of which were reported by consumers and 56.8% by health care professionals. ADRs were serious in 13.3% and 65.1% of the cases reported by consumers and healthcare professionals, respectively. Approximately half (52.5%) of the reported ADRs occurred in females and only 8.4% occurred in children. Half of the reported ADRs ( 51.5%) occurred in middle aged group (45- 64 years). The most reported classes at the therapeutic level were immunostimulants (ATC code L03) and antineoplastic agents (ATC code L01). The most frequently reported medication was peg-interferon alfa-2a. The majority of ADRs were of the type "general disorders and administration site conditions" and "gastrointestinal disorders". In conclusion, ADRs caused by immunostimulants especially interferons have higher tendency to be reported in Egypt especially in the middle-aged group. Additionally, the study has shown that serious ADRs of antineoplastic and immunomodulating agents were more likely to be reported by healthcare professionals rather than consumers.
Keywords
Adverse drug reactions; antineoplastic agents; immunomodulating agents; pharmacovigilance; spontaneous reporting
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