Cost-Effectiveness of Therapeutic Drug Monitoring

Touw, Daniël J.; Neef, Cees; Thomson, Alison; Vinks, Alexander A.

doi:10.1097/00007691-200502000-00004

Cited by 212 publications

(136 citation statements)

References 43 publications

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“…In addition, regular dose adjustments result in further blood sampling, which is costly to the hospital and cumbersome for staff and patients. A one-concentration AUC means that patients are not required to remain as inpatients and adds to the argument of the cost-effectiveness of a coordinated TDM approach (32).…”

Section: Discussionmentioning

confidence: 99%

Bayesian Estimation of Tobramycin Exposure in Patients with Cystic Fibrosis

Barras

Serisier

Hennig

et al. 2016

Antimicrob Agents Chemother

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cFixed tobramycin (mg/kg) dosing is often inappropriate in patients with cystic fibrosis (CF), as pharmacokinetics are highly variable. The area under the concentration-time curve (AUC) is an exposure metric suited to monitoring in this population. Bayesian strategies to estimate AUC have been available for over 20 years but are not standard practice in the clinical setting. To assess their suitability for use in clinical practice, three AUC estimation methods using limited sampling were compared to measured true exposure by using intensive sampling tobramycin data. Adults prescribed once daily intravenous tobramycin had eight concentrations taken over 24 h. An estimate of true exposure within one dosing interval was calculated using the trapezoidal method and compared to three alternate estimates determined using (i) a two-sample log-linear regression (LLR) method (local hospital practice); (ii) a Bayesian estimate using one concentration (AUC 1 ); and (iii) a Bayesian estimate using two concentrations (AUC 2 ). Each method was evaluated against the true measured exposure by a Bland-Altman analysis. Twelve patients with a median (range) age and weight of 25 (18 to 36) years and 66.5 (51 to 76) kg, respectively, were recruited. There was good agreement between the true exposure and the three alternate estimates of AUC, with a mean AUC bias of <10 mg/liter · h in each case, i.e., ؊8.2 (LLR), 3.8 (AUC 1 ), and 1.0 (AUC 2 ). Bayesian analysis-based and LLR estimation methods of tobramycin AUC are equivalent to true exposure estimation. All three methods may be suitable for use in the clinical setting; however, a one-sample Bayesian method may be most useful in ambulatory patients for which coordinating blood samples is difficult. Suitably powered, randomized clinical trials are required to assess patient outcomes.

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Section: Discussionmentioning

confidence: 99%

Bayesian Estimation of Tobramycin Exposure in Patients with Cystic Fibrosis

Barras

Serisier

Hennig

et al. 2016

Antimicrob Agents Chemother

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“…All medicines require circulating levels of the active drug to remain within a known therapeutic range for treatment effectiveness and safety (and, consequently, cost-effectiveness) [63]. Patients may develop immunogenicity against monoclonal TNFi antibodies, by producing anti-drug antibodies, resulting in drug levels reducing below the minimum required by the therapeutic range to be effective [64,65].…”

Section: The Economic Case: In Practicementioning

confidence: 99%

The economic case for precision medicine

Gavan

Thompson

Payne

2018

Expert Review of Precision Medicine and Drug Development

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Introduction: The advancement of precision medicine into routine clinical practice has been highlighted as an agenda for national and international health care policy. A principle barrier to this advancement is in meeting requirements of the payer or reimbursement agency for health care. This special report aims to explain the economic case for precision medicine, by accounting for the explicit objectives defined by decision-makers responsible for the allocation of limited health care resources. Areas covered: The framework of cost-effectiveness analysis, a method of economic evaluation, is used to describe how precision medicine can, in theory, exploit identifiable patient-level heterogeneity to improve population health outcomes and the relative cost-effectiveness of health care. Four case studies are used to illustrate potential challenges when demonstrating the economic case for a precision medicine in practice. Expert commentary: The economic case for a precision medicine should be considered at an early stage during its research and development phase. Clinical and economic evidence can be generated iteratively and should be in alignment with the objectives and requirements of decision-makers. Programmes of further research, to demonstrate the economic case of a precision medicine, can be prioritized by the extent that they reduce the uncertainty expressed by decision-makers.

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“…Accordingly, therapeutic drug monitoring (TDM) has been considered necessary in this population, and has been used since the early 1970s. 16 The most common drugs that should be routinely monitored in the newborn are aminoglycosides and vancomycin, theophylline, caffeine, digoxin, and phenobarbital. 17 TDM consists in the laboratory dosage of a specific drug at designated intervals, that later influences drug prescription.…”

Section: Therapeutic Drug Monitoring and Other Tools For Individualizmentioning

confidence: 99%

“…19 This measurement allows to optimize pharmacotherapy by maximizing therapeutic efficacy, while minimizing adverse events. 16 Furthermore, TDM permits the individualization of drug dosage by maintaining blood drug concentration within a targeted therapeutic range. 20 The use of TDM is very important for monitoring drugs with narrow therapeutic ranges such as aminoglycoside antibiotics, and difficult-to-manage medications.…”

Section: Therapeutic Drug Monitoring and Other Tools For Individualizmentioning

confidence: 99%

Current pharmacotherapy in the newborn

Antonucci¹,

Porcella²

2012

RRN

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Several drugs are used in newborns in spite of the lack of specific clinical research in this particularly vulnerable population with particular needs. In the newborn, the individual response to a drug in terms of efficacy and safety is highly variable, and predicting drug dosing is complex since rapid physiological changes occurring during the perinatal and early postnatal periods affect the pharmacokinetic profile of many drugs. Neonatal disorders such as renal and hepatic diseases may also have significant implications for drug pharmacokinetics. Therefore, pharmacotherapy in the newborn brings difficulties in accurate drug delivery and carries a high risk of adverse drug reactions. In addition, the neonatal population, especially that treated in neonatal intensive care units, is highly exposed to the risk of medication errors, with potentially serious adverse events. This paper reviews some current issues related to neonatal pharmacotherapy that are of paramount importance for the clinician. In particular, the peculiar pharmacokinetics of drugs during the neonatal period and its clinical implications are discussed. The use of therapeutic drug monitoring to individualize drug dosage and to optimize pharmacotherapy is also described. Finally, the relevant issue of medication errors in neonatology is examined in order to highlight their main causes and key strategies in preventing these type of errors. In the future, pharmacometabolomics and other "omic" sciences could play an important role in designing personalized neonatal health care.

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Cost-Effectiveness of Therapeutic Drug Monitoring

Cited by 212 publications

References 43 publications

Bayesian Estimation of Tobramycin Exposure in Patients with Cystic Fibrosis

Bayesian Estimation of Tobramycin Exposure in Patients with Cystic Fibrosis

The economic case for precision medicine

Current pharmacotherapy in the newborn

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