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At least 19 recordsLinked to original sources
PubMed1978

[Problems and possible errors in monitoring drug side effects at the hospital (author's transl)].

Special problems and possible errors in drug monitoring were discussed by analyzing three cases of hospital treated patients. The first one showed how easily side effects of drug can be falsely diagnosed and treated as a drug independent complicating disease. Furthermore, the active principle of the drug had to be differentiated from several potentially inducing substances. In the second case, the wrong diagnosis of a drug induced illness caused an intermission of a vital basic therapy. The lateron developing signs were interpreted as symptoms of the primary disease but they might also have been caused by drugs given later. For the third case it should be pointed out that side effects can be provoked during long- or short-term treatment by changing the diet. For drug monitoring it is therefore equally necessary to watch the drugs as well as the living circumstances.

Adult↗
PubMedDate not supplied

Therapeutic drug monitoring: measurements of antiepileptic and barbiturate drug levels in blood by gas chromatography with nitrogen - selective detector.

The nitrogen-specific detector for gas chromatography consists of a non-volatile rubidium silicate bead, around which nitrogen-containing compounds are pyrolyzed. Speed, sensitivity, specificity, accuracy, small sample size and minumum sample handling are characteristics of the nitrogen detector that render it superior to conventional gas chromatographic detectors. The detector has been utilized to effect a simple and rapid quantitation of allobarbital, amobarbital, butabarbital, heptabarbital, pentabarbital, phenobarbital and secobarbital, plus the anticonvulsants diphenylhydantoin and primidone. Extraction of the drugs from acidified serum into organic solvent containing internal standard is followed by oncolumn methylation with methanolic trimethylphenyl ammonium hydroxide. The drugs, separated on a column of 3 percent OV-101 on Gas-Chrom Q, 100-120 mesh are readily quantitated by simple calculations based on peak-height ratios. Therapeutic drug monitoring is discussed in relation to recent concepts of drug-protein binding, drug-drug interactions, drug biotransformation and problems of multiple drug therapy.

Amobarbital↗
PubMed1976

Pharmacokinetic interpretation of data gathered during therapeutic drug monitoring.

We review some pharmacokinetic principles that can facilitate interpretation of data obtained during therapeutic drug monitoring: the one- and two-compartment models, volume of drug distribution, drug clearance, organ clearance, bioavailability, first-pass effect, chronic or repetitive dosing, and use of urine and saliva to measure drug clearance and drug binding to plasma proteins, respectively. We also describe use of saliva to estimate rapidly, conveniently, and noninvasively the concentration of the free, pharmacologically active form of the drug as well as the fraction of drug bound to plasma protein.

Administration, Oral↗
PubMed1979

The 1978 College of American Pathologists Therapeutic Drug Monitoring Interlaboratory Survey Program.

In 1978 the College of American Pathologists introduced a Therapeutic Drug Monitoring Interlaborabory Survey Program. Each participant recieved six vials of lyophilized human serum on two occasions, approximately 13 weeks apart. The specimens contained various combinations of 12 drugs in subtherapeutic, therapeutic, and toxic concentrations. The drugs included in the specimens were phenytoin, phenobarbital, primidone, ethosuximide, carbamazepine, digoxin, procainamide, N-acetylprocainamide, quinidine, theophylline, lithium, and gentamicin. The weighed-in quantity of each drug was used as the target value for that drug. The specimens were analyzed by a variety of analytic methods. Statistics were calculated for all results regardless of the analytic method used and for each individual method. This report presents the data from the Program.

Anticonvulsants↗
PubMed2026

Therapeutic-drug-monitoring-based ATG Targeted Dosing Strategy in Unmanipulated Haploidentical Haematopoietic Stem Cell Transplantation: a randomized, multicenter, phase 3 clinical trial.

Anti-thymocyte globulin (ATG) has been a standard prophylaxis for graft-versus-host disease (GVHD). However, the pharmacokinetics of ATG in vivo vary significantly, and weight-based fixed dosing may not optimize efficacy while minimizing toxicity. We investigated the clinical results of a therapeutic-drug-monitoring (TDM)-based, dose-optimized ATG strategy versus weight-based fixed dosing in haploidentical haematopoietic stem cell transplantation (NCT05166967). Patients were randomly assigned in a 1:1 ratio to receive a targeted dose of ATG or a fixed dose of 10&#x202f;mg/kg. The primary endpoint was the 365-day graft-versus-host disease-free and relapse-free survival (GRFS). From January 1, 2022, to January 16, 2024, 204 patients were enrolled, with 102 patients in each group. The 365-day GRFS was higher in the targeted dose group (66.7%) than in the fixed dose group (50.0%; hazard ratio [HR], 0.666; 95% confidence interval [CI], 0.4456 to 0.9954; P&#x202f;=&#x202f;0.048). The cumulative incidence of moderate to severe chronic GVHD at day 365 was significantly lower in the targeted dose group (9.8%; 95% CI, 5.0 to 16.5) compared with the fixed dose group (22.5%; 95% CI, 15.0 to 31.1; P&#x202f;=&#x202f;0.026). Fewer grade 3-5 infections were reported in the targeted dose group (44.1%) than in the fixed dose group (70.6%; P&#x202f;<&#x202f;0.001). More patients in the targeted dose group achieved optimal ATG exposure (P&#x202f;=&#x202f;0.007) and superior CD4+ T-cell reconstitution (P&#x202f;=&#x202f;0.002). These findings support the clinical utility of a TDM-based individualized ATG dosing strategy that balances efficacy and toxicity for GVHD prophylaxis in allogeneic stem cell transplantation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05166967.

Humans↗
PubMed1979

The logistics of drug monitoring.

Although opinions differ to some extent there is increasing belief in the value of monitoring plasma levels for effective therapy with neuropsychiatric drugs, especially with anticonvulsants. Monitoring should not be on a comprehensive and routine basis, but should be selective and discriminating. In these circumstances the expenditure incurred on the laboratory operations involved might work out for Britain at about pounds 5 million per year. This figure should be compared to a total annual expenditure from the prescribing of neuropsychiatric medication amounting to an estimated pounds 40 million per year. The benefits thus achieved in patient care, together with the possible economies in prescribing, could well merit this monitoring exercise. In terms of personnel and administration, the laboratory facilities could be organized on a regional, or on a district general hospital, basis.

Costs and Cost Analysis↗