Clinical and economic burden of adverse drug reactions

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Abstract

Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs. Postmarketing drug safety monitoring through pharmacovigilance activities, including mining of spontaneous reporting and carrying out observational prospective cohort or retrospective database studies, allow longer follow-up periods of patients with a much wider range of characteristics, providing valuable means for ADR detection, quantification and where possible reduction, reducing healthcare costs in the process.

Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs. The goal of this review is to explore the epidemiology and the costs of ADRs in routine care.

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Most cited references 59

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Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.

JF Toole, M Goldstein, JR Marler … (1995)

To determine whether the addition of carotid endarterectomy to aggressive medical management can reduce the incidence of cerebral infarction in patients with asymptomatic carotid artery stenosis. Prospective, randomized, multicenter trial. Thirty-nine clinical sites across the United States and Canada. Between December 1987 and December 1993, a total of 1662 patients with asymptomatic carotid artery stenosis of 60% or greater reduction in diameter were randomized; follow-up data are available on 1659. At baseline, recognized risk factors for stroke were similar between the two treatment groups. Daily aspirin administration and medical risk factor management for all patients; carotid endarterectomy for patients randomized to receive surgery. Initially, transient ischemic attack or cerebral infarction occurring in the distribution of the study artery and any transient ischemic attack, stroke, or death occurring in the perioperative period. In March 1993, the primary outcome measures were changed to cerebral infarction occurring in the distribution of the study artery or any stroke or death occurring in the perioperative period. After a median follow-up of 2.7 years, with 4657 patient-years of observation, the aggregate risk over 5 years for ipsilateral stroke and any perioperative stroke or death was estimated to be 5.1% for surgical patients and 11.0% for patients treated medically (aggregate risk reduction of 53% [95% confidence interval, 22% to 72%]). Patients with asymptomatic carotid artery stenosis of 60% or greater reduction in diameter and whose general health makes them good candidates for elective surgery will have a reduced 5-year risk of ipsilateral stroke if carotid endarterectomy performed with less than 3% perioperative morbidity and mortality is added to aggressive management of modifiable risk factors.

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Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality.

D C Classen, S L Pestotnik, R Evans … (1997)

To determine the excess length of stay, extra costs, and mortality attributable to adverse drug events (ADEs) in hospitalized patients. Matched case-control study. The LDS Hospital, a tertiary care health care institution. All patients admitted to LDS Hospital from January 1, 1990, to December 31, 1993, were eligible. Cases were defined as patients with ADEs that occurred during hospitalization; controls were selected according to matching variables in a stepwise fashion. Controls were matched to cases on primary discharge diagnosis related group (DRG), age, sex, acuity, and year of admission; varying numbers of controls were matched to each case. Matching was successful for 71% of the cases, leading to 1580 cases and 20,197 controls. Crude and attributable mortality, crude and attributable length of stay, and cost of hospitalization. ADEs complicated 2.43 per 100 admissions to the LDS Hospital during the study period. The crude mortality rates for the cases and matched controls were 3.5% and 1.05%, respectively (P<.001). The mean length of hospital stay significantly differed between the cases and matched controls (7.69 vs 4.46 days; P<.001) as did the mean cost of hospitalization ($10,010 vs $5355; P<.001). The extra length of hospital stay attributable to an ADE was 1.74 days (P<.001). The excess cost of hospitalization attributable to an ADE was $2013 (P<.001). A linear regression analysis for length of stay and cost controlling for all matching variables revealed that the occurrence of an ADE was associated with increased length of stay of 1.91 days and an increased cost of $2262 (P<.001). In a similar logistic regression analysis for mortality, the increased risk of death among patients experiencing an ADE was 1.88 (95% confidence interval, 1.54-2.22; P<.001). The attributable lengths of stay and costs of hospitalization for ADEs are substantial. An ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.

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The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group.

D Bates, N Spell, D J Cullen … (1997)

To assess the additional resource utilization associated with an adverse drug event (ADE). Nested case-control study within a prospective cohort study. The cohort included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary-care hospitals over a 6-month period. Cases were patients with an ADE, and the control for each case was the patient on the same unit as the case with the most similar pre-event length of stay. Postevent length of stay and total costs. Incidents were detected by self-report stimulated by nurses and pharmacists and by daily chart review, and were classified as to whether they represented ADEs. Information on length of stay and charges was obtained from billing data, and costs were estimated by multiplying components of charges times hospital-specific ratios of costs to charges. During the study period, there were 247 ADEs among 207 admissions. After outliers and multiple episodes were excluded, there were 190 ADEs, of which 60 were preventable. In paired regression analyses adjusting for multiple factors, including severity, comorbidity, and case mix, the additional length of stay associated with an ADE was 2.2 days (P=.04), and the increase in cost associated with an ADE was $3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and $5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were $2595 for all ADEs and $4685 for preventable ADEs. Based on these costs and data about the incidence of ADEs, we estimate that the annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million, respectively. The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events. Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs.

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Author and article information

Journal

Journal ID (nlm-ta): J Pharmacol Pharmacother

Journal ID (iso-abbrev): J Pharmacol Pharmacother

Journal ID (publisher-id): JPP

Title: Journal of Pharmacology & Pharmacotherapeutics

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 0976-500X

ISSN (Electronic): 0976-5018

Publication date (Print): December 2013

Volume: 4

Issue: Suppl1

Pages: S73-S77

Affiliations

[1] Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

Author notes

Address for correspondence: Janet Sultana, Policlino Universitario G. Martino, Via Consolare Valeria Gazzi, Messina, Italy. E-mail: jaysultana@ 123456gmail.com

Article

Publisher ID: JPP-4-73

DOI: 10.4103/0976-500X.120957

PMC ID: 3853675

PubMed ID: 24347988

SO-VID: 5c4f8352-cbea-4bb3-9330-9cd101cff571

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This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Clinical and economic burden of adverse drug reactions

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Most cited references 59

Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.

Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality.

The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group.

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