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result(s) for
"Drug-Related Side Effects and Adverse Reactions - economics"
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Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment
by
Selles, William de Lima
,
Miyamoto, Gisela Cristiane
,
Moura, Giovanni Marini
in
Adjuvants
,
Adult
,
Aerobics
2024
One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer.
We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention.
This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the χ
test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies.
The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025.
Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works.
Registro Brasileiro de Ensaios Clínicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz.
DERR1-10.2196/60828.
Journal Article
Structured Pharmacist Review of Medication in Older Hospitalised Patients: A Cost-Effectiveness Analysis
by
Gillespie, Paddy
,
O’Sullivan, David
,
McCarthy, Suzanne
in
Aged
,
Aged, 80 and over
,
Cost-Benefit Analysis
2016
Background
A recent cluster randomised controlled trial (RCT) conducted in an Irish hospital evaluating a structured pharmacist review of medication (SPRM), supported by computerised clinical decision support software (CDSS), demonstrated positive outcomes in terms of reduction of adverse drug reactions (ADR).
Objective
The aim of this study was to examine the cost effectiveness of pharmacists applying an SPRM in conjunction with CDSS to older hospitalised patients compared with usual pharmaceutical care.
Method
Cost-effectiveness analysis alongside a cluster RCT. The trial was conducted in a tertiary hospital in the south of Ireland. Patients in the intervention arm (
n
=
361) received a multifactorial intervention consisting of medicines reconciliation, deployment of CDSS and generation of a pharmaceutical care plan. Patients in the control arm (
n
=
376) received usual care from the hospital pharmacy team. Incremental cost effectiveness was examined in terms of costs to the healthcare system and an outcome measure of ADRs during an inpatient hospital stay. Uncertainty in the analysis was explored using a cost-effectiveness acceptability curve (CEAC).
Results
On average, the intervention arm was the dominant strategy in terms of cost effectiveness. Compared with usual care (control), the intervention was associated with a decrease of €807 [95 % confidence interval (CI) −3443 to 1829;
p
= 0.548) in mean healthcare cost, and a decrease in the mean number of ADR events per patient of −0.064 (95 % CI −0.135 to 0.008;
p
= 0.081). The probability of the intervention being cost effective at respective threshold values of €0, €250, €500, €750, €1000 and €5000 was 0.707, 0.713, 0.716, 0.718, 0.722 and 0.784, respectively.
Conclusions
Based on the evidence presented, SPRM/CDSS is likely to be determined to be cost effective compared with usual pharmaceutical care. However, neither incremental costs nor effects demonstrated a statistically significant difference, therefore the results of this single-site study should be interpreted with caution.
Journal Article
A Systematic Review of Economic Evaluations of Pharmacogenetic Testing for Prevention of Adverse Drug Reactions
by
Pirmohamed, Munir
,
Roberts, Daniel
,
Hughes, Dyfrig A.
in
Adverse and side effects
,
Cost-Benefit Analysis
,
Drug-Related Side Effects and Adverse Reactions - economics
2016
Background
Pharmacogenetics offers the potential to improve health outcomes by identifying individuals who are at greater risk of harm from certain medicines. Routine adoption of pharmacogenetic tests requires evidence of their cost effectiveness.
Objective
The present review aims to systematically review published economic evaluations of pharmacogenetic tests that aim to prevent or reduce the incidence of ADRs.
Methods
We conducted a systematic literature review of economic evaluations of pharmacogenetic tests aimed to reduce the incidence of adverse drug reactions. Literature was searched using Embase, MEDLINE and the NHS Economic Evaluation Database with search terms relating to pharmacogenetic testing, adverse drug reactions, economic evaluations and pharmaceuticals. Titles were screened independently by two reviewers. Articles deemed to meet the inclusion criteria were screened independently on abstract, and full texts reviewed.
Results
We identified 852 articles, of which 47 met the inclusion criteria. There was evidence supporting the cost effectiveness of testing for
HLA
-
B*57:01
(prior to abacavir),
HLA
-
B*15:02
and
HLA
-
A*31:01
(prior to carbamazepine),
HLA
-
B*58:01
(prior to allopurinol) and
CYP2C19
(prior to clopidogrel treatment). Economic evidence was inconclusive with respect to
TPMT
(prior to 6-mercaptoputine, azathioprine and cisplatin therapy),
CYP2C9
and
VKORC1
(to inform genotype-guided dosing of coumarin derivatives),
MTHFR
(prior to methotrexate treatment) and factor V Leiden testing (prior to oral contraception). Testing for
A1555G
is not cost effective before prescribing aminoglycosides.
Conclusions
Our systematic review identified robust evidence of the cost effectiveness of genotyping prior to treatment with a number of common drugs. However, further analyses and (or) availability of robust clinical evidence is necessary to make recommendations for others.
Journal Article
Predicting the Impact of Adverse Events and Treatment Duration on Medical Resource Utilization-Related Costs in Hepatitis C Genotype 1 Treatment-Naïve Patients Receiving Antiviral Therapy
by
Kleintjens, Joris
,
Akpo, Essè Ifèbi Hervé
,
Cerri, Karin
in
Adverse and side effects
,
Analysis
,
Anemia
2015
Objectives
Studies on medical resource utilization (MRU) and related costs are important for evaluating the potential patient management and cost-effectiveness implications of antiviral treatments for hepatitis C virus (HCV) infection. The objectives of this study were (i) to compare the MRU and related costs for two treatment approaches; (ii) to identify the main drivers of resource use and costs; and (iii) to assess the effects of various treatment regimen attributes on MRU-related costs in a UK clinical setting.
Methods
The analysis used data collected alongside the simeprevir (SMV) phase III trials for treatment-naïve genotype 1 HCV-infected patients; these data covered outpatient consultations with specialists, emergency room visits and hospital admissions. Logistic regressions were constructed to estimate the predictors of resource utilization, and a two-part multivariable analysis model was used to determine the total costs of treatment in the UK.
Results
Data on 731 patients receiving SMV plus pegylated interferon and ribavirin (SMV/PegIFN/R) or PegIFN/R were included in the analysis. While MRU was similar between the SMV and PegIFN/R groups, MRU-related costs were significantly lower in the SMV group than in the PegIFN/R group (
P
< 0.05). High body mass index (
P
< 0.05), severe fibrosis (
P
< 0.05), shortened treatment duration to 24 weeks (
P
< 0.05), and anaemia and rash during treatment (
P
< 0.001) were identified as predictors of hospitalization and outpatient visits and as drivers of total costs. Univariate sensitivity analyses suggested that shortened treatment duration and lower occurrence of rash lead to large cost savings.
Conclusion
This study identified both baseline and on-treatment antiviral therapy characteristics as drivers of MRU-related costs for HCV patients following antiviral therapy. The shortened treatment duration and reduction in rash due to treatment with SMV triple therapy lead to substantial non-drug cost savings, compared with PegIFN/R treatment. This suggests that there are potential patient management and cost-effectiveness implications associated with the choice of specific antiviral treatments.
Journal Article
Medication-related adverse events in health care—what have we learned? A narrative overview of the current knowledge
2022
PurposeAlthough medication-related adverse events (MRAEs) in health care are vastly studied, high heterogeneity in study results complicates the interpretations of the current situation. The main objective of this study was to form an up-to-date overview of the current knowledge of the prevalence, risk factors, and surveillance of MRAEs in health care.MethodsElectronic databases (PubMed, MEDLINE, Web of Science, and Scopus) were searched with applicable search terms to collect information on medication-related adverse events. In order to obtain an up-to-date view of MRAEs, only studies published after 2000 were accepted.ResultsThe prevalence rates of different MRAEs vary greatly between individual studies and meta-analyses. Study setting, patient population, and detection methods play an important role in determining detection rates, which should be regarded while interpreting the results. Medication-related adverse events are more common in elderly patients and patients with lowered liver or kidney function, polypharmacy, and a large number of additional comorbidities. However, the risk of MRAEs is also significantly increased by the use of high-risk medicines but also in certain care situations. Preventing MRAEs is important as it will decrease patient mortality and morbidity but also reduce costs and functional challenges related to them.ConclusionsMedication-related adverse events are highly common and have both immediate and long-term effects to patients and healthcare systems worldwide. Conclusive solutions for prevention of all medication-related harm are impossible to create. In the future, however, the development of efficient real-time detection methods can provide significant improvements for event prevention and forecasting.
Journal Article
Evaluation of Amphetamine-Related Hospitalizations and Associated Clinical Outcomes and Costs in the United States
2018
Despite indications of increasing amphetamine availability and psychostimulant deaths in the United States, evidence across data sources is mixed, and data on amphetamine-related hospitalizations are lacking.
To clarify trends in amphetamine-related hospitalizations and their clinical outcomes and costs in the United States.
This repeated, cross-sectional study used hospital discharge data from the Healthcare Cost and Utilization Project National Inpatient Sample. The nationally representative sample included US adults (n = 1 292 300) who had amphetamine-related hospitalizations between January 1, 2003, and December 31, 2015. Multivariable logistic and Poisson regression models were used to examine in-hospital mortality and length of stay. Analysis of these data was conducted from November 2017 to August 2018.
Amphetamine dependence or abuse or amphetamine poisoning.
Annual hospitalizations, in-hospital mortality, length of stay, transfer to another facility, and costs.
Over the 2003 to 2015 study period, there were 1 292 300 weighted amphetamine-related hospitalizations. Of this population, 541 199 (41.9%) were female and 749 392 (58.1%) were male, with a mean age of 37.5 years (95% CI, 37.4-37.7 years). Amphetamine-related hospitalizations, compared with other hospitalizations, were associated with age younger than 65 years (98.0% vs 58.0%; P < .001), male sex (60.3% [95% CI, 59.7%-60.8%] vs 41.1% [95% CI, 40.9%-41.3%]), Medicaid coverage (51.2% [95% CI, 49.8%-52.7%] vs 17.8% [95% CI, 17.5%-18.1%]), and residence in the western United States (58.5% [95% CI, 55.9%-61.0%] vs 18.9% [95% CI, 18.0%-19.8%]). Amphetamine-related hospitalizations declined between 2005 and 2008, and then increased from 55 447 hospitalizations (95% CI, 44 936-65 959) in 2008 to 206 180 hospitalizations (95% CI, 95% CI, 189 188-223 172) in 2015. Amphetamine-related hospitalizations increased to a greater degree than hospitalizations associated with other substances. Adjusted mean length of stay (5.9 [95% CI, 5.8-6.0] vs 4.7 [95% CI, 4.7-4.8] days; P < .001), transfer to another facility (26.0% [95% CI, 25.3%-26.8%] vs 18.5% [95% CI, 18.3%-18.6%]; P < .001), and mean in-hospital mortality (28.3 [95% CI, 26.2-30.4] vs 21.9 [95% CI, 21.6-22.1] deaths per 1000 hospitalizations; P < .001) were higher for amphetamine-related than other hospitalizations. Annual hospital costs related to amphetamines increased from $436 million (95% CI, $312 million-$559 million) in 2003 to $2.17 billion (95% CI, $1.95 billion-$2.39 billion) by 2015.
Given that amphetamine-related hospitalizations and costs substantially increased between 2003 and 2015, pharmacologic and nonpharmacologic therapies for amphetamine use disorders and a coordinated public health response are needed to curb these rising rates.
Journal Article
Reasons for excluding adverse events in cost-effectiveness analyses of vaccines: A survey amongst authors
2025
Although vaccines must adhere to the strictest safety standards in medicine, adverse events (AE) do occur occasionally. Even when clinically negligeable, these AE can still have health-economic implications, affecting the cost-effectiveness of vaccines. A review revealed that only 25 % of recent health-economic studies on childhood vaccines incorporated AE. In this study, we reached out to all corresponding authors of the reviewed articles who excluded AE to understand their rationale for exclusion (response rate 40 % (27/67)). The predominant reasons for not including AE were (1) that these were deemed too rare and insufficiently relevant (17/27, 65 %), (2) analysts adhered to previous methodologies that excluded AE (10/27, 35 %) and (3) there was a lack of sufficient data (9/27, 33 %). We argue that AE deserve more attention from analysts and that more efforts are needed to develop conceptual methods and collect data that enable meaningful incorporation in CEAs.
•AE are excluded from most economic evaluations of (childhood) vaccines.•We investigated the reasons behind exclusion in a sample of authors of recent studies.•The most important reason stated was that AE were deemed to be irrelevant for cost-effectiveness.•We argue that AE can be an important factor of cost-effectiveness and must be analysed.•More research is needed to collect better data to enable a meaningful quantification of AE.
Journal Article
New estimates of the costs of adverse events in patients with cancer
by
Sussell, Jesse
,
Schuldt, Robert
,
Patel, Achal
in
Adult
,
Adverse and side effects
,
Adverse events
2025
The cost of adverse events (AEs) is a critical component of healthcare economic models for cancer treatment; however, few comprehensive estimates of these costs exist. Previous studies focused on costs related to specific AEs, cancer types, or treatment regimens. This study assesses the incremental costs of AEs across 13 cancer types by applying the most current diagnosis schema (International Statistical Classification of Diseases and Related Health Problems [ICD-10]) to patients diagnosed between 2016 and 2022. Data were acquired from US insurance claims and included adult patients who were diagnosed and treated for breast, pancreatic, bladder, lung, prostate, colorectal, skin, liver, head and neck, non-Hodgkin lymphoma, follicular lymphoma, multiple myeloma, or chronic lymphocytic leukemia cancer. We selected 54 AEs for analysis based on their frequency of occurrence, relevance based on severity, and availability of ICD-10 diagnostic codes. We matched patient treatment episodes (the period from initiation of a distinct treatment regimen until discontinuation, change of treatment, or end of data availability) for patients experiencing a specific AE to treatment episodes of similar patients not experiencing that same AE in a 1:1 ratio. We generated estimates for AEs of any severity, severe AEs, and individual tumor types. Our analyses evaluate 392,566 treatment episodes from 110,791 patients. In pooled analyses across tumor types, incremental costs for AEs of any severity (with ≥ 100 treatment episodes) ranged from -$488 for photosensitivity to $ 29,331 for allergic reaction. Incremental costs for severe AEs (with ≥ 50 treatment episodes) ranged from$16 for dizziness to $ 18,841 for gastrointestinal bleeding. This study provides a comprehensive assessment of the economic burden of AEs in cancer care and generates a range of estimates to be used as inputs in future economic models.
Journal Article
Clinical and economic impact of pharmacist interventions to identify drug-related problems in multidisciplinary cancer care: a prospective trial
by
Villeminey, Clémentine
,
Ribault, Matthieu
,
Perrin, Germain
in
Adverse and side effects
,
Aged
,
Antimitotic agents
2025
Abstract
Background
The prescription of antitumor drugs has often been associated with drug-related problems. Pretherapeutic multidisciplinary risk assessment programs including pharmaceutical care have been established to secure the initiation of injectable and oral antitumor therapies. This prospective cross-sectional double-center study evaluated the clinical and economic impact of the pharmacist in detecting drug-related problems in patients initiating antitumor therapies.
Materials and Methods
Following pharmaceutical consultations, pharmaceutical interventions were validated by a multidisciplinary team. A committee of independent clinical experts assessed the potential clinical impact of drug-drug interactions. The association of clinical variables with pharmaceutical interventions was tested using a multivariate logistic regression model. Pharmacist cost of the program was assessed by valuing pharmacists’ time at their salaries and compared with potentially avoided costs.
Results
Four hundred thirty-eight patients with solid tumors were included: 62% males, mean age of 65 ± 13 years, and average of 6 medications. Half of the patients required at least one pharmaceutical intervention and independent factors associated with pharmaceutical interventions were the number of medications (5-9 vs <5: OR = 2.91 [95% CI 1.82-4.65], P < .001) and the type of antitumor treatment (immunotherapy vs intravenous chemotherapy: OR = 0.35 [95% CI 0.18-0.68], P = .002). One hundred seventy-four out of 266 pharmaceutical interventions (130 patients) involved clinically significant drug-drug interactions. Pharmacist costs were estimated to range between €4899 and €6125. Average costs were estimated at €11.4-14.3 per patient. Avoided hospitalization costs were estimated to be €180 633.
Conclusion
Clinical pharmacists contribute to the cost-effective reduction of drug-related problems in pre-therapeutic assessment programs for patients with cancer.
Pre-therapeutic multidisciplinary risk assessment programs including pharmaceutical care have been established to secure the initiation of injectable and oral antitumor therapies. This study evaluated the clinical and economic impact of the pharmacist in detecting drug-related problems in patients initiating antitumor therapies.
Graphical Abstract
Graphical Abstract
Journal Article
Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients
2004
Abstract Objective To ascertain the current burden of adverse drug reactions (ADRs) through a prospective analysis of all admissions to hospital. Design Prospective observational study. Setting Two large general hospitals in Merseyside, England. Participants 18 820 patients aged > 16 years admitted over six months and assessed for cause of admission. Main outcome measures Prevalence of admissions due to an ADR, length of stay, avoidability, and outcome. Results There were 1225 admissions related to an ADR, giving a prevalence of 6.5%, with the ADR directly leading to the admission in 80% of cases. The median bed stay was eight days, accounting for 4% of the hospital bed capacity. The projected annual cost of such admissions to the NHS is £466m (€706m, $847m). The overall fatality was 0.15%. Most reactions were either definitely or possibly avoidable. Drugs most commonly implicated in causing these admissions included low dose aspirin, diuretics, warfarin, and non-steroidal anti-inflammatory drugs other than aspirin, the most common reaction being gastrointestinal bleeding. Conclusion The burden of ADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs. Although many of the implicated drugs have proved benefit, measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.
Journal Article