Conclusions
Preventable ADRs are a common and important cause of hospitalisation and
in-patient’s morbidity and mortality in Nigeria. NSAIDs and OHA were the
most commonly implicated drugs resulting in upper GI bleeding and
hypoglycaemia respectively. The most common life-threatening ADRs that
resulted in the highest number of deaths were caused by antimicrobial
agents and herbal medications. Enlightenments campaign against
irrational drugs use among the people, and strategic planning for
intense follow up of ADRs in Nigeria are advocated.
Acknowledgment
The abstract from the study was presented at International Society for
Pharmacoepidemiology (ISPE) Conference of Pharmacoepidemiology and
Therapeutic Rick (ICPE) in Philadelphia, USA, in August 2019.
Author Contributions
ADAA conceived the research, was actively involved with data collection,
analysis, interpretation, and drafting of the research paper. WAA
participated in the development of the research, data collection, data
analysis, interpretation and preparation of the first draft of the
research paper. IAA and KSA participated in development of the
manuscript. All authors read and approved the final manuscript.
Ethical approval
Approval for this study was given by the University of Ibadan/University
College Hospital (UI/UCH) Institution Review Board (IRB) and Ethics
Review committee. Written informed consent was obtained from study
participants.
Conflict of Interest
The authors declare no conflict of interest
Funding
The authors received no funding for this work.
Data availability
The data is available with the corresponding author on request
REFERENCES
1. Camargo AL, Ferreira MBC, Heineck
I. Adverse drug reactions: a cohort study in internal medicine units at
a university hospital. Eur J Clin Pharmacol. 2006;62(2):143-9.
2. Angamo MT, Chalmers L, Curtain CM,
Bereznicki LRE. Adverse-Drug-Reaction-Related Hospitalisations in
Developed and Developing Countries: A Review of Prevalence and
Contributing Factors. Drug Saf. 2016;39(9):847-57.
3.
Formica D, Sultana J, Cutroneo PM,
Lucchesi S, Angelica R, Crisafulli S, et al. The economic burden of
preventable adverse drug reactions: a systematic review of observational
studies. Expert Opin Drug Saf. 2018;17(7):681-95.
4. White TJ, Arakelian A, Rho JP.
Counting the costs of drug-related adverse events.
Pharmacoeconomics. 1999;15(5):445-58.
5. Davies E, Green C, Mottram D,
Pirmohamed M. Adverse drug reactions in hospital in‐patients: a pilot
study. J Clin Pharm Ther. 2006;31(4):335-41.
6. Kongkaew C, Noyce PR, Ashcroft DM.
Hospital admissions associated with adverse drug reactions: a systematic
review of prospective observational studies. Ann Pharmacother.2008;42(7):1017-25.
7. Khan LM, Al-Harthi SE, Saadah OI,
Al-Amoudi AB, Sulaiman MI, Ibrahim IM. Impact of pharmacovigilance on
adverse drug reactions reporting in hospitalized internal medicine
patients at Saudi Arabian teaching hospital. Saudi Med J.
2012;33(8):863-8.
8. Mehta U, Durhein D, Blockman M,
Kredo T, Grunden R, Barnes K. Adverse drug reactions in adult medical in
patients in a South African hospital serving a community with a high
HIV/AIDs prevalence: prospective observational study. Br J Clin
Pharmacol 2008;65:396-406. Br J Clin Pharmacol 2008;65:11.
9. Salami T, Asalu A, Samuel S.
Prevalence of cutaneous drug eruptions in adult Nigerians with HIV/AIDS.
Niger Postgrad Med J. 2010;17(2):160.
10. Adedapo A, Ademowo O, Adedapo K,
Demissie K, Osinubi O. Potential toxicity of Chlorpheniramine plus
chloroquine for the treatment of childhood malaria. Niger J Clin Pract.
2009;12(3).
11. Ashaye A, Adedapo A, Olusanya B,
Adeoti C. Conjunctival hyperaemia and other ocular adverse effects on
healthy African subjects after single dosing with 0.004% Travoprost.
Afr J Med Med Sci. 2007;36(1):37-42.
12. Oshikoya KA, Awobusuyi JO.
Perceptions of doctors to adverse drug reaction reporting in a teaching
hospital in Lagos, Nigeria. BMC Clin Pharmacol. 2009;9:14.
13. Bello SO, Umar MT. Knowledge and
attitudes of physicians relating to reporting of adverse drug reactions
in Sokoto, north-western Nigeria. Ann Afr Med. 2011;10(1):13-8.
14. Okezie EO, Olufunmilayo F.
Adverse drug reactions reporting by physicians in Ibadan, Nigeria.
Pharmacoepidemiol Drug Saf. 2008;17(5):517-22.
15. Ohaju-Obodo JO, Iribhogbe OI.
Extent of pharmacovigilance among resident doctors in Edo and Lagos
states of Nigeria. Pharmacoepidemiol Drug Saf. 2010;19(2):191-5.
16. Organization WH. Safety of
Medicines: A guide to detecting and reporting adverse drug reactions.
Geneva: World Health Organization; 2002 2002. WHO/EDM/QSM/2002.2.
17.
Hallas J, Harvald B, Gram LF,
Grodum E, Brosen K, Haghfelt T, et al. Drug related hospital admissions:
the role of definitions and intensity of data collection, and the
possibility of prevention. J Intern Med. 1990;228(2):83-90.
18. Organization WH. The Uppsala
Monitoring Centre. Safety monitoring of medicinal products. Guidelines
for setting up and running a Pharmacovigilance Centre. 2000.
19. Rawlins M, Thompson J.
Pathogenesis of adverse drug reactions. Textbook of Adverse Drug
Reactions. 1977:10-31.
20.
Maxwell S. Therapeutics and good
prescribing, Adverse outcomes of drug therapy. In: Davidson’s Principles
and Practice of Medicine. 22nd Edition. Editors Walker
BR, Colledge NR, Ralston SH, Penman ID. Churchill Livingstone Elsevier
Edinburgh 2014 pg18-39.
21. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et
al. Adverse drug reactions as cause of admission to hospital:
prospective analysis of 18 820 patients. BMJ.2004;329(7456):15-9.
22. Bouvy JC, De Bruin ML,
Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a
review of recent observational studies. Drug Saf. 2015;38(5):437-53.
23.
Alvarez
PA, Bril F, Castro V, Meiville I, Gonzalez CD, Centurion IG, et al.
Adverse drug reactions as a reason for admission to an internal medicine
ward in Argentina. Int J Risk Saf Med. 2013;25(3):185-92.
24.
Giardina C, Cutroneo PM, Mocciaro
E, Russo GT, Mandraffino G, Basile G, et al. Adverse Drug Reactions in
Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting
in Hospital Ward) Study. Front Pharmacol. 2018;9:350.
25. Lagnaoui R, Moore N, Fach J,
Longy-Boursier M, Bégaud B. Adverse drug reactions in a department of
systemic diseases-oriented internal medicine: prevalence, incidence,
direct costs and avoidability. Eur J Clin Pharmacol. 2000;56(2):181-6.
26. Camargo AL, Cardoso Ferreira MB,
Heineck I. Adverse drug reactions: a cohort study in internal medicine
units at a university hospital. Eur J Clin Pharmacol. 2006;62(2):143-9.
27. Tumwikirize WA, Ogwal-Okeng JW,
Vernby A, Anokbonggo WW, Gustafsson LL, Lundborg SC. Adverse drug
reactions in patients admitted on internal medicine wards in a district
and regional hospital in Uganda. Afr Health Sci. 2011;11(1):72-8.
28. Awofisayo O, Awofisayo O, Iferi
I, Akpan O. The pattern of sale and use of non-steroidal
anti-inflammatory drugs in rural and urban centres in Nigeria. Trop J
Pharmaceut Res. 2008;7(3):1013-8.
29.
Rukewe A, Otegbayo JA, Fatiregun A.
Clinical characteristics and outcome of patients with upper
gastrointestinal bleeding at the emergency department of a tertiary
hospital in Nigeria. Ann Ib
Postgrad Med. 2015;13(2):89-93.
30.
Mouton JP, Njuguna C, Kramer N,
Stewart A, Mehta U, Blockman M, et al. Adverse drug reactions causing
admission to medical wards: A cross-sectional survey at 4 hospitals in
South Africa. Medicine (Baltimore). 2016;95(19).
31.
Awodele O, Aliu R, Ali I, Oni Y,
Adeyeye CM. Patterns of adverse drug reaction signals in NAFDAC
pharmacovigilance activities from January to June 2015: safety of drug
use in Nigeria. Pharmacol Res Perspect. 2018;6(5):e00427-e00427.
32.
Saka B, Gnassingbe W, Akakpo S,
Mahamadou G, Teclessou J, Mouhari-Toure A, et al. Reasons for inpatient
admissions to the dermatology department in Lomé, Togo : Trends between
1992 to 2005 and 2005 to 2016. Med Sante Trop. 2018;28(3):270-2.
33. Lerch M, Mainetti C, Terziroli
Beretta-Piccoli B, Harr T. Current Perspectives on Stevens-Johnson
Syndrome and Toxic Epidermal Necrolysis. Clin Rev Allergy
Immunol. 2018;54(1):147-6.
34. Rodríguez-Martín S, Martín-Merino
E, Lerma V, Rodríguez-Miguel A, Gonazalez O, Gonazalez-Herrada C, et al.
Incidence of Stevens-Johnson syndrome/toxic epidermal necrolysis among
new users of different individual drugs in a European population: a
case-population study. Eur J Clin Pharmacol. 2019;75(2):237-46.
35.
Saka B, Barro-Traoré F, Atadokpédé
FA, Kobangue L, Niamba PA, Adegbidi H, et al. Stevens-Johnson syndrome
and toxic epidermal necrolysis in sub-Saharan Africa: a multicentric
study in four countries. Int J Dermatol. 2013;52(5):575-9.
36.
Kongpan T, Mahasirimongkol S,
Konyoung P, Kanjanawart S, Chumworathayi P, Wichukchinda N, et al.
Candidate HLA genes for prediction of co-trimoxazole-induced severe
cutaneous reactions. Pharmacogenet Genomics. 2015;25(8):402-11.
37.
Carr DF, Bourgeois S, Chaponda M,
Takeshita LY, Morris AP, Castro EM, et al. Genome-wide association study
of nevirapine hypersensitivity in a sub-Saharan African HIV-infected
population. J Antimicrob Chemother. 2017;72(4):1152-62.
38. Kiguba R, Ononge S, Karamagi C,
Bird SM. Herbal medicine use and linked suspected adverse drug reactions
in a prospective cohort of Ugandan inpatients. BMC Complement Altern
Med. 2016;16:145.
39. Kiguba R, Karamagi C, Bird SM.
Incidence, risk factors and risk prediction of hospital-acquired
suspected adverse drug reactions: a prospective cohort of Ugandan
inpatients. BMJ Open. 2017;7(1):e010568-e010568.
40.
van Hunsel F, van de Koppel S,
Skalli S, Kuemmerle A, Teng L, Wang JB, et al. Analysis of Hepatobiliary
Disorder Reports Associated With the Use of Herbal Medicines in the
Global Suspected ADR Database Vigibase. Front Pharmacol. 2019;10:1326.
41. Alomar MJ. Factors affecting the
development of adverse drug reactions (Review article). Saudi Pharm J.
2014;22(2):83-94.
42. Zopf Y, Rabe C, Neubert A, Hahn
EG, Dormann H. Risk factors associated with adverse drug reactions
following hospital admission: a prospective analysis of 907 patients in
two German university hospitals. Drug Saf. 2008;31(9):789-98.
43. Sneha SG, Simhadri K, Subeesh VK,
Sneha SV. Predictors of adverse drug reactions in geriatric patients: An
exploratory study among cancer patients. South Asian J Cancer.
2019;8(2):130-3.
44.
Chan SL, Ang X, Sani LL, Ng HY,
Winther MD, Liu JJ, et al. Prevalence and characteristics of adverse
drug reactions at admission to hospital: a prospective observational
study. Br J Clin Pharmacol. 2016;82(6):1636-46.
Table 1: Sociodemographic characteristics of the patients admitted into
the medical wards