Adverse Drug Reaction (ADR) as a Cause of Hospitalization at a Government Hospital in Saudi Arabia: A Prospective Observational Study

Author(s): Nouf Alayed*, Bushra Alkhalifah, Munirah Alharbi, Naief Alwohaibi, Maryam Farooqui

Journal Name: Current Drug Safety

Volume 14 , Issue 3 , 2019

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Graphical Abstract:


Background: ADRs represent a substantial burden on health care resources worldwide and are considered as one of the leading causes of morbidity and mortality which significantly affects hospitalization rates. However, ADR related hospital admissions are not well explored in Saudi Arabia.

Objective: The current study aims to evaluate ADR-related admissions at King Saud Hospital, Unaizah, Qassim, Saudi Arabia.

Methods: A prospective, observational study was conducted at King Saud Hospital Unaizah. Over a period of 6 months, patients above 12 years of age who visited the Emergency Department (ED) with an ADR were included in this study. The investigators collected patient data by reviewing the patient's medical records and the ED records for admission. The Naranjo algorithm was used to assess the causality of the suspected ADR, and Hartwig’s Severity Assessment Scale was used to assess the severity of the ADR.

Results: Out of 4739 admissions to the wards, 38 (0.801%) were related to an ADR. The majority of patients were male (52.6%), with a mean age of ± 49.08 years. The total length of hospital stay was 565 days with a mean of ± 14.87 days. The causality assessment shows that 35 (92.1%) cases were probable ADRs, whereas 3 (7.9%) cases were possible ADRs. Moreover, the severity assessment showed that 6 (15.1%) cases were mild, and 27 (71.1%) and 5 (13.2%) cases were moderate and severe, respectively. In regard to the outcome of patients, most patients recovered after the ADR, and 2 ADRs resulted in the death of the patient.

Conclusion: Our study shows that ADRs as a cause of hospitalization in Qassim population is considerably low. However, ADRs may contribute to morbidity and mortality and result in a considerable financial burden.

Keywords: Adverse drug reactions, ADR monitoring, prevalence, naranjo algorithm, DRPs, Hartwig’s severity assessment scale.

WHO Meeting on the Role of the Hospital in International Drug Monitoring International drug monitoring: The role of the hospital, report of a WHO meeting. Geneva . 18-23 November, 1969.
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. The Lancet 2000; 356(9237): 1255-9.
Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ 1998; 316(7140): 1295-8.
Bordet R, Gautier S, Le Louet H, Dupuis B, Caron J. Analysis of the direct cost of adverse drug reactions in hospitalised patients. Eur J Clin Pharmacol 2001; 56(12): 935-41.
Howard R, Avery A, Howard P, Partridge M. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: Observational study. Qual Saf Health Care 2003; 12(4): 280-5.
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18820 patients 2004; 329(7456): 15-9.
Pouyanne P, Haramburu F, Imbs JL, Bégaud B. Admissions to hospital caused by adverse drug reactions: Cross sectional incidence study. BMJ 2000; 320(7241): 1036.
Pfaffenbach G, Carvalho O, Bergsten-Mendes G. Drug adverse reactions leading to hospital admission. Rev Assoc Med Bras 2002; 48(3): 237-41.
Sabry N, Farid S, Dawoud D. Drug-related problems in cardiac children. Minerva Pediatr 2016; 68(2): 89-95.
Al-Olah Y. Al Thiab KJAoSm.. Admissions through the emergency department due to drug-related problems. 2008; 28(6): 426.
Khan LM, Al-Harthi SE, Saadah OI. Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR. Saudi Pharm J 2013; 21(3): 261-6.
Ministry of Health; Annual Statistical Book 2017.Available from:.
Alshammari TM, Alshakka M, Aljadhey H. Pharmacovigilance system in Saudi Arabia. Saudi Pharm J 2017; 25(3): 299-305.
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49(9): 2229-32.
Aljadhey H, Mahmoud MA, Ahmed Y, et al. Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: The (ADESA) prospective cohort study. BMJ Open 2016; 6(7): 1-8.
Schurig AM, Böhme M, Just KS, et al. Adverse Drug Reactions (ADR) and emergencies: The prevalence of suspected adr in four emergency departments in Germany. Dtsch Arztebl Int 2018; 115(15): 251.
Al-Arifi M, Abu-Hashem H, Al-Meziny M, Said R, Aljadhey HJSPJ. Emergency department visits and admissions due to drug related problems at Riyadh military hospital (RMH) Saudi Arabia. Saudi Pharm J 2014; 22(1): 17-25.
Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR. Pirmohamed MJPo. Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes. PLoS One 2009; 4(2): e4439.
Franceschi M, Scarcelli C, Niro V, et al. Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit. Drug Saf 2008; 31(6): 545-56.
Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med 2008; 168(17): 1890-6.
Pedrós C, Quintana B, Rebolledo M, Porta N, Vallano A. Arnau JMJEJoCP. Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission. Eur J Clin Pharmacol 2014; 70(3): 361-7.
Gallelli L, Siniscalchi A, Palleria C, et al. Adverse drug reactions related to drug administration in hospitalized patients. Curr Drug Saf 2017; 12(3): 171-7.
Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45(3): 301-8.
Hajjar ER, Hanlon JT, Artz MB, et al. Adverse drug reaction risk factors in older outpatients. Am J Geriatr Pharmacother 2003; 1(2): 82-9.
Onder G, Pedone C, Landi F, et al. Adverse drug reactions as cause of hospital admissions: Results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc 2002; 50(12): 1962-8.
Ahern F, Sahm LJ, Lynch D, McCarthy S. Determining the frequency and preventability of adverse drug reaction-related admissions to an Irish University Hospital: A cross-sectional study. Emerg Med J 2014; 31(1): 24-9.
van der Hooft CS, Dieleman JP, Siemes C, et al. Adverse drug reaction-related hospitalisations: A population-based cohort study. Pharmacoepidemiol Drug Saf 2008; 17(4): 365-71.
Pratico AD, Longo L, Mansueto S, et al. Off-Label use of drugs and adverse drug reactions in pediatric units: A Prospective, multicenter study. Curr Drug Saf 2018; 13(3): 200-7.

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Article Details

Year: 2019
Published on: 17 September, 2019
Page: [192 - 198]
Pages: 7
DOI: 10.2174/1574886314666190520105330

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