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PubMed1990

Therapeutic drug monitoring reduces toxic drug reactions: a meta-analysis.

Therapeutic drug monitoring (TDM) is commonly employed to optimize the dosing of certain drugs, including digoxin, aminoglycosides, theophylline, and phenytoin. Studies were reviewed in order to (a) evaluate the effect of TDM on the occurrence of toxic drug reactions (TDRs) and (b) identify factors that may modify or invalidate the relationship. In 14 studies, monitored patients suffered fewer toxic drug reactions than nonmonitored patients (odds ratio = 0.35, 95% confidence interval, 0.13 to 0.89). The average effect size was larger in studies that utilized a control group for comparisons rather than a before-and-after study design. TDM appeared to be most beneficial for patients taking theophylline or digoxin. Issues that must be addressed in future TDM service evaluations include (a) study design, (b) adverse patient selection, (c) insufficient sample size, (d) incomplete or inconsistent description of the TDM service, and (e) incomplete, inconsistent, or absent description of criteria for reporting TDRs.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1983

Therapeutic drug monitoring of psychotropic drugs in children.

In several areas of medicine, therapeutic drug monitoring (TDM) has been proven to be a very useful tool for optimizing the therapeutic potential of various drugs and for minimizing the risk of adverse events. In pediatrics the value of TDM is generally accepted for drugs such as Theophylline and/or antiepileptics, but it is still strongly questioned for classes of drugs such as neuroleptic and tricyclic antidepressants. However, in the last 5 years evidence has been produced indicating that TDM may be a very useful tool in pediatric neuropsychiatry too. In fact, if on the one side therapeutic windows have been defined for major neuroleptics and tricyclic antidepressants, on the other side clear relationships between drug plasma concentrations and the incidence and severity of adverse reactions have been reported. Data derived from our own experience of 5 years of TDM in pediatric neuropsychiatry will be described together with data from the literature. It appears that at least for four major drugs, Haloperidol, Chlorpromazine, Imipramine, and Chlorimipramine, drug plasma levels monitoring during chronic treatment does help in a significant manner in optimizing the treatment.

Adolescent↗
PubMed1998

Capillary electrophoresis for therapeutic drug monitoring.

Therapeutic drug monitoring is commonly used in both the ambulatory and hospital patient care settings. Routine measurement of concentrations of therapeutic agents in biological fluids is critical for certain drugs to maintain therapeutic benefit with minimizing drug-associated toxicities. Many analytical laboratory techniques are currently available to measure drug concentrations in biological samples. Recently there has been an increased interest in the use of capillary electrophoresis (CE) for measuring concentrations of therapeutic drugs in patient samples. However, while there are numerous reports of CE being used to measure drug concentrations in solution and pharmaceutical dosage forms, there are relatively few reports of the use of CE for measuring therapeutic agents in patient samples. The purpose of this paper is to provide an overview of methods currently used to measure therapeutic drugs in patient samples along with possible future trends for the use of CE in therapeutic drug monitoring.

Drug Monitoring↗
PubMed1993

Who is ordering all those cyclosporin concentrations and how do they use them? An audit of cyclosporin therapeutic drug monitoring.

Therapeutic drug monitoring is used for the immunosuppressant drug, cyclosporin, even though it is often unclear what concentration should be targetted. At St. Vincent's Hospital, Sydney, a polyclonal, whole blood immunoassay is used to measure cyclosporin and metabolites. The objective of the present study was to audit how the concentration results produced by the laboratory were actually used to adjust dosage. Each transplantation unit was asked about their policy for dosage adjustment and which therapeutic range was used. The audit criteria were considered to be passed if the action taken based on a concentration result was (a) predictable based solely on the concentration and its relationship to the stated therapeutic range (e.g., dosage increased if concentration was below therapeutic range) or (b) based on clinical considerations (e.g., dosage decreased because of increased serum creatinine). Data were collected for the actions taken following 347 concentration results over a 6-week period. Audit criteria were fulfilled for 246 (71%) of the results. The majority of the cyclosporin concentrations (75%) were determined for the cardiopulmonary unit; 66% of these fulfilled audit criteria. Approximately two-thirds of all the cyclosporin concentrations requested were followed up by appropriate action based on stated therapeutic ranges or documented clinical reasons.

Cyclosporine↗
PubMed2003

Analysis of eighteen antidepressants, four atypical antipsychotics and active metabolites in serum by liquid chromatography: a simple tool for therapeutic drug monitoring.

Therapeutic drug monitoring necessitates efficient, fast and reliable analytical methods validated by external quality control. We therefore devised an isocratic reversed-phase HPLC method with ultraviolet detection and optimised this to quantify mirtazapine, reboxetine, moclobemide, venlafaxine, O-desmethylvenlafaxine, paroxetine, fluvoxamine, fluoxetine, norfluoxetine, sertraline, citalopram, amitriptyline, nortriptyline, imipramine, desipramine, doxepin, nordoxepin, clomipramine, norclomipramine, trimipramine, mianserine, maprotiline, normaprotiline, amisulpride, clozapine, norclozapine, quetiapine, risperidone and 9-OH-risperidone in human serum. After solid-phase extraction of the drugs and metabolites, the chromatographic separation was achieved on a Nucleosil 100-Protect 1 column with acetonitrile-potassium dihydrogenphosphate buffer as mobile phase. The method was validated for therapeutic and toxic serum ranges. A linear relationship (r>0.998) was obtained between the concentration and the detector signal. Recoveries were between 75 and 99% for the drugs and metabolites. The accuracy of the quality control samples, expressed as percent recovery, ranged from 91 to 118%; intra- and inter-assay-relative standard deviations were 0.9-10.2% and 0.9-9.7%, respectively. Additional external quality control is carried out since 3 years. This method is applicable to rapidly and effectively analyze serum or plasma samples for therapeutic drug monitoring of about 30 antidepressants and atypical antipsychotics.

Antidepressive Agents↗
PubMed1999

Gas chromatography-mass spectrometry assay method for the therapeutic drug monitoring of the antiepileptic drug tiagabine.

A gas chromatography-mass spectrometry assay method suitable for the therapeutic drug monitoring of the antiepileptic drug tiagabine is described. Tiagabine and its desmethylated analogue used as internal standard were first extracted from serum by liquid-liquid extraction using an ethyl ether-isobutanol 98:2 mixture. Tiagabine and the internal standard were then methylated in the organic phase in presence of methanol by means of a safe and stable diazomethane derivative. After evaporation, the reconstituted extracts were chromatographed on a crosslinked phenyl methyl siloxane capillary column and detected by mass fragmentometry at m/z = 156. No other antiepileptic drug possibly administrated in polytherapy and no metabolite were found to interfere in the assay. The limit of quantification was 5 ng/ml. The precision and the accuracy were found to be suitable for the therapeutic drug monitoring of tiagabine.

Anticonvulsants↗
PubMed1983

The benefits of drug monitoring in patients with bacterial meningitis, eg, chloramphenicol monitoring.

Regular drug monitoring during therapy with chloramphenicol sodium succinate is actually recommended by expert centers. In this report a case of meningitis due to Salmonella typhimurium is described, which underlines the necessity of examining both the chloramphenicol and the chloramphenicol succinate concentrations. It is suggested that medical microbiologists and clinicians should be encouraged to take advantage of new, quick, and sensitive methods for drug monitoring in order to achieve optimal therapy.

Chloramphenicol↗
PubMed2003

Drug delivery systems: polymers and drugs monitored by capillary electromigration methods.

In this paper, different electromigration methods used to monitor drugs and polymers released from drug delivery systems are reviewed. First, an introduction to the most typical arrangements used as drug delivery systems (e.g., polymer-drug covalent conjugates, membrane or matrix-based devices) is presented. Next, the principles of different capillary electromigration procedures are discussed, followed by a revision on the different procedures employed to monitor the release of drugs and the degradation or solubilization of the polymeric matrices from drug delivery systems during both in vitro and in vivo assays. A critical comparison between these capillary electrophoretic methods and the more common chromatographic methods employed to analyze drugs and polymers from drug delivery systems is presented. Finally, future outlooks of these electromigration procedures in the controlled release field are discussed.

Chromatography, High Pressure Liquid↗
PubMed1995

A comparison of the OPUS and TDx analysers for antiepileptic drug monitoring.

Therapeutic drug monitoring of a variety of antiepileptic drugs is used routinely as a guide to individualising the drug treatment of patients with epilepsy. Thin dry film multilayer immunoassays (OPUS) for carbamazepine, phenytoin, phenobarbitone, and valproic acid were evaluated and compared with fluorescence polarisation immunoassay (TDx), using commercially available control material and patient sera. For the OPUS, the within-batch coefficient of variation (CV) for the different drugs in the control material varied between 3.9% (phenobarbitone) and 8.1% (valproic acid). The between-batch CVs varied between 5.3% (valproic acid) and 18.3% (carbamazepine). The comparative between-batch CVs for the TDx varied between 2.0% (phenytoin) and 7.0% (valproic acid). Analysis of 209 patient samples containing carbamazepine, phenytoin, phenobarbitone, or valproic acid demonstrated significant correlation between the two analytical methods, with correlation coefficients of 0.9336, 0.9560, 0.9448, and 0.9618, with slopes of the regression lines of 0.9042, 0.8663, 1.1368, and 1.1244, respectively. It is concluded that both the TDx and OPUS instruments exhibit comparable performance for the analysis of carbamazepine, phenobarbitone, phenytoin, and valproic acid in patient samples. Moreover, the OPUS instrument, with its facilities of random assay access and statim analysis, may be useful in an outpatient setting in which a major consideration would be a rapid turnaround of patient assay results.

Anticonvulsants↗
PubMed1995

Validation of a quick modeling program generating clearance estimates at steady state for routine therapeutic drug monitoring.

Therapeutic drug monitoring (TDM) of chronic treatments is justified for several reasons, including relative over- or underdosage due to variable individual elimination, pharmacokinetic interactions in drug combinations, and noncompliance. In all these circumstances, the prescribing physician is interested in having an estimation of the patient's clearance of the drug, even from one measurement. We compare a validated bayesian program, USC*Pack of Jelliffe, found difficult to use in daily routine, with a "home-made" program. The latter, which is capable of taking data from a clinical database, will generate a graphic simulation of daily plasma drug concentrations together with an estimation of steady-state clearance more rapidly than does USC*Pack. Both programs were run with only one measured plasma level. The patients were 83 children or young adults treated with phenobarbital (PB), carbamazepine (CBZ), and/or Valproic acid (VPA) who were resistant to monotherapy and who were to be sampled two to four times between doses. Drugs were routinely assayed by high-performance liquid chromatography (HPLC). Despite the rough character of Phacile (numeric integration and adjustment of only two of three parameters, without an acknowledged minimization algorithm), the results are comparable to those obtained with USC*Pack for estimating clearance and predicting plasma drug concentrations. Phacile algorithm, although simple, has proven of interest in routine TDM and as an introduction for medical students to the bayesian approach of population pharmacokinetics.

Adolescent↗
PubMed2002

Correlation of serum and salivary carbamazepine concentration in epileptic patients: implications for therapeutic drug monitoring.

Therapeutic drug monitoring (TDM) of carbamazepine (CBZ) in saliva is an attractive alternative, because its collection is painless, non-invasive and simpler than drawing blood. Salivary drug levels, also closely reflect the free drug concentration. The aim of the study was to evaluate the suitability of saliva in routine TDM of CBZ in adult epileptic patients. Blood and saliva samples were taken simultaneously at 0 hours and 24 hours of CBZ dosing from 31 epileptic patients, receiving CBZ monotherapy for three or more months. Levels of CBZ in both these fluids were measured by high performance liquid chromatography. Strong and highly significant correlation was found between serum and salivary CBZ concentration (r = 0.659, p<0.001). Estimation of CBZ level in saliva is thus a practicable, valid and convenient method of TDM in epileptic patients.

Adolescent↗
PubMed1998

Economic impact of aminoglycoside toxicity and its prevention through therapeutic drug monitoring.

Therapeutic drug monitoring (TDM) of aminoglycoside antibacterials with the goal of minimising toxicity and maximising effectiveness has become routine. Successful management of serious infections requires the ability to achieve therapeutic peak concentrations, while maintaining low trough concentrations will assist in avoiding nephrotoxicity. Reported nephrotoxicity rates range from 1.7 to 58% and depend on the definition used, the patient group studied, concomitant drug therapy used and whether TDM services have been provided. TDM services have been shown to reduce aminoglycoside nephrotoxicity. The costs of providing TDM averages $US301.87 (1997 values) per patient and the cost for each use of nephrotoxicity is estimated at $US4583 (1997 values). In order for the costs of providing a TDM service to 100 patients ($US30,187) to be offset by cost savings due to decreasing nephrotoxicity, the service would need to be able to reduce nephrotoxicity by 6.6%, resulting in a saving of $US30,248. The ability to achieve this saving is dependent on the characteristics of the population in which aminoglycoside therapy is used. In populations where high rates of nephrotoxicity (e.g. > 15%) would be expected, TDM services are cost justified. In populations where nephrotoxicity is low (e.g. < 5%), TDM service is not justified for this purpose. In order to provide a cost-efficient approach to TDM, resources should be focused on providing service to high risk patient groups.

Aminoglycosides↗
PubMed2006

[Therapeutic drug monitoring (TDM) of psychotropic drugs: a consensus guideline of the AGNP-TDM group].

In psychiatry, therapeutic drug monitoring (TDM) is an established procedure for most psychotropic drugs. However, as its use in everyday clinical practice is far from optimal, the AGNP-TDM group has worked out consensus guidelines to assist psychiatrists and laboratories involved in drug analysis. Based on a thorough analysis of available literature, 5 levels of recommendation were defined with regard to TDM of psychoactive drugs, from 1) (strongly recommended) to 5) (not recommended). A list of indications for TDM, alone or in combination with pharmacogenetic tests is presented. Instructions are given with regard to preparation of TDM, analytical procedures, reporting and interpretation of results and the use of information for patient treatment. Using the consensus guideline will help to ensure optimal clinical benefit of TDM.

Drug Monitoring↗
PubMed1999

[Population pharmacokinetic analysis of theophylline: relationship between serum concentrations and clinical effects in therapeutic drug monitoring].

Therapeutic drug monitoring (TDM) of theophylline is essential duties at hospital pharmacy in Japan. The relationship between serum concentrations and clinical effects of theophylline has been investigated. The pharmacokinetics of theophylline was determined from the concentration of theophylline in the serum which were calculated on the basis of TDM for patients administered theophylline. The one-compartment model as a pharmacokinetic model was assumed. The relationship between clinical effects of theophylline and the predicted concentrations calculated using population parameters was evaluated. The obtained parameters are ka(h-1) = 0.223, ke(h-1) = 0.047 (1-0.0025.age(y) (p.o.) and 0.076(1-0.0025.age(y)) (d.i.v.), Vd(1/kg) = 0.733 (p.o.) and 0.830 (d.i.v.). The bioavailability is 0.732, and theophylline/aminophylline is 0.846. The model including no serum creatinine as a variational factor was considered to be best. The following three groups were used as a clinical evaluation; effective as theophylline therapy was 43%, no change of the clinical status after administration of theophylline was 42%, and aggravation after administration of theophylline was 15%. There is no relationship between the predicted concentration using parameters of the final model and these three groups. These results suggest that TDM of theophylline should be assessed in terms of clinical effects and also suggests that in should be kept monitoring from the viewpoint of the prevention of toxic effects in the theophylline therapy.

Administration, Oral↗
PubMed1982

Analytical problems facing the development of electrochemical transducers for in vivo drug monitoring: an overview.

Even though significant progress has been made in the development of electrodes for the in vivo detection of catecholamines, oxygen, and various cations, there has been little research on the feasibility of continuously monitoring drugs in whole blood by electrochemical sensing devices. Electroanalytical problems associated with the development of such electrochemical transducers include the need for increased sensitivity and specificity, decreased biological matrix interferences, more rapid response times, improved miniaturization, and more reliable calibration procedures. We present a critical evaluation of potentiometric, conductometric, and amperometric techniques, with a brief review of basic principles and recent advances in ion-selective electrodes, chemical-sensing field-effect transistors, amperometric enzyme electrodes, and electrochemical immunosensors.

Drug Therapy↗
PubMedDate not supplied

Drug interferences with plasma assays in therapeutic drug monitoring.

In this article, many of the reports which describe the various assay procedures for 8 of the most commonly monitored drugs in plasma (digoxin, gentamicin, phenobarbitone, phenytoin, procainamide, quinidine, salicylates and theophylline) are reviewed, together with studies dealing with interferences of other drugs with these assays. Factors which are evaluated include whether the interference was studied when the drug was taken by a patient or a volunteer or by adding it to serum in vitro, the concentration or dose of the interfering drug (when reported), and the clinical implications of the interference. Suggestions as to how to eliminate some of these potential sources of interference are made.

Anti-Bacterial Agents↗
PubMed1984

Therapeutic drug monitoring.

Therapeutic drug monitoring (TDM), a clinical laboratory technology that measures drug concentrations to regulate drug dosage, has become an important treatment aid in both inpatient and ambulatory care. TDM laboratory methods, including immunoassay (EIA, FIA, and RIA) and chromatographic techniques, are used to assay blood, urine, and saliva samples of patients taking therapeutic drugs; TDM is also useful in identifying abused drugs. This assessment describes specific drug assay techniques, their respective advantages and disadvantages, and costs. TDM's contribution to treatment outcomes, its impact on existing services, implications for laboratory personnel, and the extent of the TDM marketplace are discussed. Future techniques and TDM's contribution to reducing the length of patient stays are also reviewed.

Autoanalysis↗