Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh
Hailye Birhane1*, Mojahidul Islam1, Damen H/mariam2, Vijender Singh1
1School of Pharmacy, Sharda University, Plot No. 32, 34, Knowledge Park III, Greater Noida, U. P. 201310, India.
2Addis Ababa University, College of Health Science, School of Public Health, Addis Ababa, Ethiopia.
Volume - 14,
Issue - 3,
Year - 2021
Objective: To Characterize spontaneously reported pediatric adverse drug reactions (ADRs) in Ethiopia. Method: The detail of reported pediatric ADRs data to Ethiopian national Pharmacovigilance (PV) center during the 5year period (May/2014 to 2019) was collected. Data collection was done using the suspected ADRs reporting form and a retrospective analysis was done after excluding incomplete data’s. The data were analyzed in respect of age, sex, rate of reporting, suspected ADRs, suspected drugs, seriousness, onset and outcome. Result: Pediatric ADRs reporting rate was 0.9 per million children per year. A total of 218 reports containing 294 suspected drugs, 460 ADRs and 354 affected body systems (SOCs) were reported from government and private health facilities. Out of which, 53.6% were females. A majority, 201 (92.2%) and 166 (76%) reports were submitted by government health facilities and pharmacists respectively. >75% of ADRs affecting the skin, general disorders and nervous system. >75% of drugs associated with ADRs were anti-infective drugs 206 (70%) followed by nervous system drugs 20 (6.8%). Among anti-infective drugs, antibiotics, antiretroviral and ant-tuberculosis drugs represented 97% of drugs responsible for ADRs and 25% of ADRs were serious. Conclusion: Pediatric ADRs reporting rate was very low and public health program medicine safety monitoring is inadequate in Ethiopia. This suggests that the ADRs monitoring system was generally weak. Anti-infective drugs and nervous system drugs were responsible for the majority of ADRs and for all reported fatalities. The most common adverse reactions in pediatrics were skin disorders.
Cite this article:
Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. doi: 10.5958/0974-360X.2021.00266.3
Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. doi: 10.5958/0974-360X.2021.00266.3 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-3-55
1. VA Center for Medication Safety and VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel, Adverse Drug Events, Adverse Drug Reactions and Medication Errors. (2006) Frequently Asked Questions
2. Roger W. and Cate W, eds. Clinical Pharmacy and Therapeutics. 5th Edition, China. 2012
3. WHO. Promoting safety of medicines for children. France. (2007). ISBN 978-92-4-156343-7
4. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. (2002); 54: 665–70.
5. J. Corny, D. Lebel, J-F Bussieres. Unlicensed and Off-Label Drug Use in Children before and After Pediatric Governmental Initiatives. J Pediatr Pharmacol Ther: 2015; 20 (4):316–328
6. Ferrajolo C, Avillach P, Bonhoeffer J, et al. Drug Safety in Children: Focus on hepatic concerns. (2014). PhD thesis. Erasmus Universiteit Rotterdam
7. Parthasarath G, Haruger A, Undela K. Pharmacovigilance Research in India: A Five-Year Literature Review. Proc Indian Natn Sci Acad 84 No. 1. (2018). pp. 225-232
8. Cliff-Eribo KO. Adverse drug reactions in West Africa. PhD thesis, University of Nottingham. 2016. Academic Division of Child Health, Derbyshire Children’s Hospital, Derby, United Kingdom. Access from: http://eprints.nottingham. ac.uk/31289/1/ adverse%20 drug% 20 reacti ONS % 20in %20west%20 Africa.pdf
9. Cliff-Eribo KO, Sammons H, Choonara I.: Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases, Expert Opinion on Drug Safety, (2016). DOI: 10.1080/14740338.2016.1221921
10. Eshetie TC, Hailemeskel B, Mekonnen N, et al. Adverse drug events in hospitalized children at Ethiopian University Hospital: a prospective observational study. BMC Pediatrics. (2015). DOI 10.1186/s12887-015-0401-0
11. Bergicho M, Mohammed MA, Wabe NT. Assessment of the pattern of drug prescribing in pediatrics ward in tertiary setting hospital in Addis Ababa, Ethiopia. Gaziantep Med J 2012;18(2): 61-65. DOI: 10.5455/GMJ-30-2012-73
12. Bill and Melinda Gates Foundation. A Report to the Safety and Surveillance Working Group. 2013
13. Aagaard L, Strandell J, Melskens L, et al. Global Patterns of Adverse Drug Reactions Over a Decade Analyses of Spontaneous Reports to VigiBase. Drug Saf. (2012); 35 (12): 1171-1182.
14. Haggar H. Ampadu1, Jarno Hoekman, Marieke L. de Bruin, et al. Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase. Drug Saf (2016) 39:335–345 DOI 10.1007/s40264-015-0387-4
15. EMEA. Guideline on conduct of Pharmacovigilance for medicines used by the paediatric population. Doc. Ref. EMEA/CHMP/235910/2005. UK. London. 2005
16. International Conference on Harmonisation. Clinical Investigation of Medicinal Products in the Paediatric Population (E11). 2000. Available: http://www.ich.org/products/ guidelines/efficacy/ efficacy- single/ article/clinical- investigation-of- medicinal- products-in-the- pediatric-population. html. Accessed 12October 2019
17. Batel-Marques F, Mendes D, Alves C, et al. Activity of the central pharmacovigilance unit, Acta Med Port 2015 Mar-Apr;28(2):222-23
18. Central Statistical Agency (CSA) [Ethiopia] and ICF. Ethiopia Demographic and Health Survey. 2016. Addis Ababa, Ethiopia, and Rockville, Maryland, USA: CSA and ICF.
19. Adhikari A, Bhattacharjee N, Bhattacharya S, et al. Evaluation of Adverse Drug Reactions in Tertiary Care Hospital of Kolkata, West Bengal, India.J Young Pharm, (2017);9(3):311-314
20. World Health Oganization. The WHO Adverse Reaction Terminology (WHO-ART). 2005. Available: http://www.umc-products.com/ Dyn Page.aspx?id= 73589&mn1= 1107&mn2 = 1664. Accessed 12/12/2019.
21. Cliff-Eribo KO, Choonara I, Dodoo A, et al. Adverse Drug Reactions in Ghanaian Children - Review of reports from 2000 to 2012 in VigiBase. Expert Opin Drug Saf. 2015 Oct 5:1-7.
22. World Health Oganization. Anatomical Therapeutic Chemical (ATC) Classification System. 2013. Available: http://www.whocc.no/atc_ddd_index/. Accessed 12/08/2019.
23. Lima EC, Matos GC, Vieira JM, et al. Suspected adverse drug reactions reported for Brazilian children: cross-sectional study. J Pediatr (Rio J). 2018. https://doi.org/10.1016/j.jped.2019.05.019. Accessed on 13/09/2019
24. Potchoo Y, Yerima M, Gnandi TT, et al. Analysis of Adverse Reactions Related to Drugs and Vaccines Received at the National Centre for Pharmacovigilance from 2009 to 2016 in Togo. Pharmacology & Pharmacy, 2018. 9, 344-356. https://doi.org/10.4236/pp.2019.98027. Accessed 15/11/2019
25. Cliff-Eribo KO, Sammons H, Star K, et al. Adverse Drug Reactions in Nigerian Children - A Retrospective Review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012. Paediatr Int Child Health. 2015 Sep 8:2046905515Y0000000059.
26. Rosli R, Ming LC, Abd Aziz N, et al. A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients. PLoS ONE. 2016; 11(6): e0155385. doi:10.1371/journal.pone.0155385
27. FMOH. Annual Health Sector Performance - EFY 2010 (2017/18). 20th ARM. 2018. Version -1. Addis Ababa, Ethiopia
28. Aldea A, García Sanchez-Colomer M, Fernandez Quintana E, et al. Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009. Eur J Clin Pharmacol, Sep; 68 (9):1329-38., 2012.
29. Ferrajolo C, Capuano A, Rossi F, et al. Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012. Expert Opin Drug Saf, 2014. 13 Suppl 1: p. S9-20.
30. Schirm E, Tobi H, Puijenbroek Ep, et al. Reported adverse drug reactions and their determinants in Dutch children outside the hospital. Pharmacoepidemiol Drug Saf, 2004. 13(3): p. 159-65.
31. Olsson S, Pal SN, Dodoo A. Pharmacovigilance in resource-limited countries. Expert Rev Clin Pharmacol. 2015; 8:449–60
32. Lense TG. and Mohammed GD. Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia. BioMed Research International. Volume 2016, Article ID 5728462, http://dx.doi.org/10.1155/2019/5728462. Accessed on 13/12/2019
33. Wubshet H, Akshaya S, Bhagavathulab, et al. Knowledge, attitude and practices towards adverse drug reaction reporting in Gondar, Ethiopia. JPHSR 2014, DOI 10.1111/jphs.12065 ISSN 1759-8885
34. Barzaga Arencibia Z, Lopez Leyva A, Mejías Pena Y, et al. Pharmacovigilance in children in Camaguey Province, Cuba. European Journal of Clinical Pharmacology, 2012. 68(7): p. 1079-1084.
35. Smyth RMD, Gargon E, Kirkham J, et al. Adverse Drug Reactions in Children—A Systematic Review. PLoS ONE. 2012; 7(3): e24061. doi:10.1371/journal.pone.0024061
36. Jr., Arthur J. Atkinson, Abernethy Darrell R., Daniels Charles E., Dedrick Robert L., Markey Sanford P. Principles of clinical pharmacology, 2nd edition. Elsevier Inc. USA.2007
37. Soldin O. Porat and Soldin SJ. Review: Therapeutic Drug Monitoring in Pediatrics. Ther Drug Monit. 2002. February; 24(1): 1–8.
38. Rosli R, Dali AF, Aziz NA, et al. MM. Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia. Front. Pharmacol. 8:30. Doi: 10.3389/fphar.2017.00030
39. Lombardi N, Crescioli G, Bettiol A, et al. Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study. 2018. BMC Pharmacology and Toxicology; 19:16
40. C. Ferrajolo A. Capuano G. Trifiro, et al. Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 – 2012. Expert Opin. Drug Saf. (2014). 13(Suppl.1):S9-S20
41. Salvo F, Polimeni G, Moretti U, et al. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. Journal of Antimicrobial Chemotherapy (2007) 60, 121–126. doi:10.1093/jac/dkm111
42. Castro-Pastrana LI, Ghannadan R, Rieder MJ, et al. Coetaneous adverse drug reactions in children: an analysis of reports from the Canadian Pharmacogenomics Network for Drug Safety (CPNDS). (2011). J Popul Ther Clin Pharmacol Vol 18 (1):e106-e120.
43. Abdela J, Assefa A, Shamele S. Prevalence of Adverse Drug Reactions among Pediatric Patients on Antiretroviral Therapy in Selected Hospitals in Eastern Ethiopia: 8-Year Retrospective Cross-Sectional Study. Journal of the International Association of Providers of AIDS Care. Volume 18: 1-7. 2019
44. Oshikoya KA, Lawal S, Oreagba IA, et al. Adverse Events in HIV- infected Children on Antiretroviral Therapy at a Teaching Hospital in Lagos, Nigeria: A Retrospective Study. Adv Pharmacoepidem Drug Safety. 2012; 1:117.
45. Aronson JK. Meyler's side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. Elsevier. 2015
46. Star K. Safety of Medication in Pediatrics. Acta Universitatis Upsaliensis. Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine 883. 81 pp. Uppsala. 2013. ISBN 978-91-554-8632-7.
47. Jiao F, Shamsi BH, Yan X, et al. Clinical analysis and study of 844 children with adverse drug reactions in China. Biomedical Research 2018; 29 (7): 1484-1488
48. Carnovale C, Brusadelli T, Zuccotti G, et al. Importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy. Expert Opin Drug Saf, 2014. 13 Suppl 1: p. S1-8.
49. Kimland E, Rane A, Ufer M, et al. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf, 2005. 14(7): p. 493-9.
50. Aagaard L. and EH Hansen. Adverse drug reactions in children reported by European consumers from 2007 to 2011. Int J Clin Pharm, 2014. 36(2): p. 295-302.
51. Carleton BC, Smith MA, Gelin MN, et al. Paediatric adverse drug reaction reporting: understanding and future directions. Can J Clin Pharmacol, 2007. 14(1): p. e45-57.
52. Johann‐Liang R., Wyeth Jo, Chen Min, et al. Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. Pharmacoepidemiol Drug Saf, 2009. 18(1): p. 24- 7.
53. Ray WA, Murray KT, Hall K, et al. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012; 366:1881–1890. [PubMed: 22591294]
54. Svanstrom H, Pasternak B, Hviid A. Use of azithromycin and death from cardiovascular causes. N Engl J Med. 2013; 368:1704–1712. [PubMed: 23635050]
55. Hong ST. Albendazole and Praziquantel: Review and Safety Monitoring in Korea. Infect Chemother 2018; 50(1):1-10 ISSN 2093-2340 (Print). ISSN 2092-6448 (Online)