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47922

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

Article

Last updated: 22 Jan 2023

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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.

DOI

10.21608/bfpc.2019.7213.1000

Keywords

Adverse drug reactions, antineoplastic agents, immunomodulating agents, pharmacovigilance, spontaneous reporting

Authors

First Name

Samar

Last Name

Gouda

MiddleName

O.

Affiliation

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University.

Email

samar.osama@pharma.cu.edu.eg

City

-

Orcid

-

First Name

Amr

Last Name

Saad

MiddleName

A.

Affiliation

Egyptian Pharmaceutical Vigilance Center.

Email

amr4278@yahoo.com

City

-

Orcid

-

First Name

Maggie

Last Name

Abbassi

MiddleName

M.

Affiliation

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University.

Email

maggie.abbassi@pharma.cu.edu.eg

City

-

Orcid

-

First Name

Samar

Last Name

Farid

MiddleName

F.

Affiliation

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University.

Email

samar.farid@pharma.cu.edu.eg

City

-

Orcid

-

Volume

57

Article Issue

1

Related Issue

7424

Issue Date

2019-06-01

Receive Date

2019-09-12

Publish Date

2019-06-01

Page Start

96

Page End

103

Print ISSN

1110-0931

Online ISSN

2090-9101

Link

https://bfpc.journals.ekb.eg/article_47922.html

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https://bfpc.journals.ekb.eg/service?article_code=47922

Order

8

Type

Original Article

Type Code

771

Publication Type

Journal

Publication Title

Bulletin of Faculty of Pharmacy, Cairo University

Publication Link

https://bfpc.journals.ekb.eg/

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Details

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Article

Created At

22 Jan 2023