A systematic review of observational studies evaluating costs of adverse drug reactions

Abstract

IntroductionThe growing evidence of the increased frequency and severity of adverse drug events (ADEs), besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs.ObjectiveTo identify and characterize the best available evidence on ADE-associated costs.MethodsMEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated.ResultsTwenty-nine (94%) longitudinal observational studies and two (7%) cross-sectional studies were included. Twenty-three (74%) studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%). Twenty (65%) studies evaluated any therapeutic group. Twenty (65%) studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7%) also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7,192.36.DiscussionMethodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts.

Cost Analysis of Drug-related Problems in Saudi Arabia: Patients’ and Healthcare Providers’ Perspective

“…The finding showed the highest estimated cost was the patients suffered from adverse drug reaction occurred with the patients and drug therapy to manage them with additional cost sequences. The cost of adverse drug reaction resembles and within range cost what reported by Marques, FB et al [15] The second high cost of patient suffered from drug-related problems was the medications errors that are related poor knowledge of medications errors and absent of patients medication educations program at most hospitals. The cost of medication resembles what reported by Walsh, EK et al [16] The third one was the patient need medications for such disease, but the patient not referred to hospitals for management that's lead to the disease switched from acute to chronic or complications maybe occurred.…”

Incidence of Medication‐Related Harm in Older Adults After Hospital Discharge: A Systematic Review

“…Data on the costs of MRH that are available are predominantly based on hospitalised patients. 43,44 Our findings highlight the crucial need for consensus in defining MRH, collecting MRH data, ascribing causality, and reporting findings. There are multiple definitions for ADR and ADE, 3,5-7 and they can be contradictory.…”

“…An economic analysis of the direct costs from healthcare use attributable to postdischarge MRH in a large, prospective, multicenter study would be a starting point. Data on the costs of MRH that are available are predominantly based on hospitalised patients …”

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

“…The likely impact of standardisation on the various stages of the PV reporting system will be discussed in the next section. The most widespread challenge facing PV is a high level of under-reporting ( [15], [16], [17], [18], [12]), typically attributed to a lack of knowledge, time, and incentive ( [19], [16], [20]), which alludes to the lack of standardised reporting protocols and methodologies. PV also faces socio-cultural challenges, such as the existence of a culture of fear surrounding the reporting of ADRs due to a fear of undue disciplinary action being taken against HCPs ( [21], [22], [19]).…”