Prevalence of Cutaneous Adverse Drug Reactions According to Iraqi Pharmacovigilance Center; A retrospective study for 11 years (2010-2021)

Ahmed Sami; Mohammed Mahmood Mohammed; Manal M. Younus

doi:10.32947/ajps.v24i3.1070

Authors

Ahmed Sami Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq
Mohammed Mahmood Mohammed Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad
Manal M. Younus Iraqi Pharmacovigilance Center, Ministry of Health

DOI:

https://doi.org/10.32947/ajps.v24i3.1070

Keywords:

cutaneous adverse drug reactions, Iraqi pharmacovigilance center, VigiBase, VigiLyze

Abstract

Background: Cutaneous Adverse Drug Reactions (CADRs) are among the leading causes of morbidity and mortality. Insufficient data exists on cutaneous adverse reactions, as many of these reactions are not reported due to their constantly changing patterns and the interaction of multiple risk factors.

Aim: This study aims to evaluate the prevalence of cutaneous reactions in Iraq and find the most commonly involved active ingredients with the commonest skin manifestations.

Method: A retrospective study based on the safety reports of patients having cutaneous reactions that were collected and submitted to VigiBase by the Iraqi Pharmacovigilance Center between 2010 and 2021. The study involved the analysis of gender, age, medicines, type of CADR, and seriousness of more than 4,300 reports.

Results: Skin rash was the most commonly reported CADR, and antibiotics were the leading drug class; ceftriaxone and vancomycin were responsible for 40.3% and 16.2% of the cases caused by antibiotics only, respectively. The mean age of the patients was 28 years, and the male-to-female ratio was 0.78:1. Out of the total number of cases, more than 1300 were deemed serious, and 15 patients have passed away.

Conclusion: Iraq comes in the 51^st place among other countries in the number of skin and skin-related ADR cases. Older adults are at higher risk of developing serious CADRs. Ceftriaxone and rash were the leading drug and cutaneous manifestations, respectively.

References

- Thomas D. Clinical Pharmacy Education, Practice and Research: Clinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research. 1st ed. Elsevier; 2018. 540 p.

- Drago F, Cogorno L, Agnoletti AF, Ciccarese G, Parodi A. A retrospective study of cutaneous drug reactions in an outpatient population. Int J Clin Pharm. 2015 Jul;37(5):739–43.

- Verma R, Vasudevan B. Dermatological Emergencies. 1st ed. CRC Press; 2019. 638 p.

- Schubert C, Desai M, Patwardhan M, Lievano F, Islam SS, Chand DH, et al. Causality assessment and examples of adverse drug reactions (drug-induced liver injury, renal, skin, and major adverse cardiac events). Pharmacovigilance: A Practical Approach. Elsevier; 2018. p. 47–67.

- Duong TA, Valeyrie-Allanore L, Wolkenstein P, Chosidow O. Severe cutaneous adverse reactions to drugs. Vol. 390, The Lancet. Lancet Publishing Group; 2017. p. 1996–2011.

- Bircher AJ (Andreas J), Maibach HI, Brockow K, Barbaud A. Cutaneous drug hypersensitivity : clinical features, mechanisms, diagnosis, and management. 1st ed. Springer; 2022. 369 p.

- Qiancheng D, Qinghai Z, Jing C, Fang X, Jianyun L, Jinhua H. Severe cutaneous adverse drug reactions of Chinese inpatients: A meta-analysis. An Bras Dermatol. 2017;92(3):345–9.

- Tariq H. Analysis of clinico-etiological pattern of adverse cutaneous drug reactions. Vol. 33, Journal of Pakistan Association of Dermatologists. 2023. p. 172–7.

- Bansal A, Agrawal A, Sharma L, Jain S. A Comparative Study of Active and Passive Adverse Drug Reaction Reporting Systems in Terms of False Reporting Rate. Scripta Medica (Banja Luka). 2020;51(4):223–7.

- Noori YA, Arif IS, Younus MM, Mohammed MM. Analysis of Azithromycin adverse events in COVID-19 Patients reported to Iraqi Pharmacovigilance center in 2020. Al Mustansiriyah Journal of Pharmaceutical Sciences. 2022 Oct 24;22(3):35–42.

- Dittrich ATM, Smeets NJL, de Jong EFM, Kämink JL, Kroeze Y, Draaisma JMT, et al. Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care. Pharmaceuticals. 2022 Sep 1;15(9).

- Schurer M. Spontaneous Reporting • Global Pharmacovigilance [Internet]. Global Pharmacovigilance. 2019 [cited 2023 Jul 13]. Available from: https://globalpharmacovigilance.tghn.org/articles/spontaneous-reporting/

- Shear NH, Dodiuk-Gad RP. Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions. 1st ed. Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions. Springer; 2019. 314 p.

- Organization WH. The selection and use of essential medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2019 (‎including the 21st WHO model list of essential medicines and the 7th WHO model list of essential medicines for children)‎ [Internet]. 2019. 639 p. Available from: https://apps.who.int/iris/handle/10665/330668

- Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf [Internet]. 1999;20(2):109–17. Available from: https://pubmed.ncbi.nlm.nih.gov/10082069/

- A. Noori Y, S. Arif I, M. Younus M, Mahmood Mohammed M. Analysis of hydroxychloroquine adverse events in COVID-19 patients reported throughout Iraqi pharmacovigilance center in VigiBaseTM: A study based on WHO database. F1000Research 2022 11:923. 2022 Aug 11;11:923.

- Couper M. Safety of Medicines [Internet]. 2002. p. 20. Available from: http://whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002.2.pdf

- Loscalzo J, Fauci AS, Kasper DL, Hauser SL, Longo DL (Dan L, Jameson JL. Harrison’s Principles of Internal Medicine. 21st ed. Loscalzo J, Fauci AS, Kasper DL, Hauser SL, Longo DL (Dan L, Jameson JL, editors. McGraw-Hill Education; 2022. 4384 p.

- Machoń N, Lewandowska J, Zdanowska N, Placek W, Owczarczyk-Saczonek A. Cutaneous Adverse Drug Reactions (CADRs)—Statistical Analysis of the Causal Relationship between the Drug, Comorbidities, Cofactors, and the Cutaneous Reaction—A Single-Centered Study. Int J Environ Res Public Health. 2022 Jul;19(13):7982.

- Goutham S, Rajendran N. Patterns of Cutaneous Drug Reactions: A Review. SBV Journal of Basic, Clinical and Applied Health Science. 2020 Jul;2(4):134–7.

- Hina IIA, Masood S, Jamil S, Tabassum S, Jalil P, Ghulam U. Prevalence of Clinical Spectrum of Cutaneous Adverse Drug Reactions in Patients Presenting at a Tertiary Care Hospital in Pakistan. Cureus. 2021 Jul;13(4).

- Farshchian M, Ansar A, Zamanian A, Rahmatpour-Rokni G, Kimyai-Asadi A, Farshchian M. Drug-induced skin reactions: A 2-year study. Clin Cosmet Investig Dermatol. 2015 Jul;8:53–6.

- Yang F, Chen Z, an Chen S, Zhu Q, Wang L, Xiong H, et al. Clinical profile of cutaneous adverse drug reactions: a retrospective study of 1883 hospitalized patients from 2007 to 2016 in Shanghai, China. Eur J Dermatol. 2020 Jul;30(1):24–31.

- Jha N, Alexander E, Kanish B, Badyal D. A study of cutaneous adverse drug reactions in a tertiary care center in Punjab. Indian Dermatol Online J. 2018;9(5):299.

- Akpinar F, Dervis E. Drug Eruptions: An 8-year Study Including 106 Inpatients at a Dermatology Clinic in Turkey. Indian J Dermatol. 2012 Jul;57(3):194.

- Martins JC, Seque CA, Porro AM. Clinical aspects and therapeutic approach of drug-induced adverse skin reactions in a quaternary hospital: a retrospective study with 219 cases. An Bras Dermatol. 2022 Jul;97(3):284–90.

- Mejía DVR, Zwiener RD, Villa RC, Ramírez LF, Espinosa DLS, Zanacchi VA, et al. Severe Cutaneous Adverse Reactions to Drugs in Latin America: The RACGRAD Study. J Investig Allergol Clin Immunol. 2021;31(4):322–31.

- Ashifha S, Vijayashree J, Vudayana K, Chintada D, P P, G P, et al. A Study of Cutaneous Adverse Drug Reactions at a Tertiary Care Center in Andhra Pradesh, India. Cureus. 2023 Jul;

- Yang SC, Chen CB, Lin MY, Zhang ZY, Jia XY, Huang M, et al. Genetics of Severe Cutaneous Adverse Reactions. Front Med (Lausanne). 2021 Jul 15;8:652091.

- Khan DA, Banerji A, Bernstein JA, Bilgicer B, Blumenthal K, Castells M, et al. Cephalosporin Allergy: Current Understanding and Future Challenges. Journal of Allergy and Clinical Immunology: In Practice. 2019 Jul;7(7):2105–14.

- Choi JY, Choi JH, Kim MG, Rhie SJ. Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database. Pharmaceuticals (Basel). 2021 Jul;14(5).

- Malhotra SK, Kaur B, Kaur I. A prospective study of clinical spectrum of cutaneous adverse drug reactions and their incidence in Indian population. IP Indian Journal of Clinical and Experimental Dermatology. 2021 Jul;7(2):143–7.

- Karunakar P, Rao GV, Rajesh KK. Clinico etiological study of adverse cutaneous drug reactions. International Journal of Research in Dermatology. 2019 Jul;5(3):559.

- Dubrall D, Just KS, Schmid M, Stingl JC, Sachs B. Adverse drug reactions in older adults: A retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. BMC Pharmacol Toxicol. 2020 Mar 23;21(1).

- Woo SD, Yoon J, Doo GE, Park Y, Lee Y, Lee SH, et al. Common causes and characteristics of adverse drug reactions in older adults: a retrospective study. BMC Pharmacol Toxicol [Internet]. 2020 Dec 1 [cited 2023 Sep 28];21(1):1–9. Available from: https://bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-020-00464-9

- Davies EA, O’Mahony MS. Adverse drug reactions in special populations – the elderly. Br J Clin Pharmacol [Internet]. 2015 Oct 1 [cited 2023 Sep 28];80(4):796–807. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/bcp.12596

- Thong BYH, Tan TC. Epidemiology and risk factors for drug allergy. Br J Clin Pharmacol. 2011 Jul;71(5):684.

- 38. Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharmaceutical Journal. 2014 Jul;22(2):83–94.

- Cebeci D, Yaşar Ş, Aytekin S, Göktay F, Güneş P, Makalesi A. An epidemiological and clinical analysis of cutaneous drug eruption: A cohort of 164 patients. Journal of Surgery and Medicine. 2020 Jul;4(12):1147–51.