Clinical standards for the dosing and management of TB drugs

• DOI: 10.5588/ijtld.22.0188
• Publication Date: 2022-07-12T09:46:56Z
• Authors: J. W. C. Alffenaar; S. L. Stocker; L. Davies Forsman; A. Garcia-Prats; S. K. Heysell; R. E. Aarnoutse; O. W. Akkerman; A. Aleksa; R. van Altena; W. Arrazola de Oñata; P. K. Bhavani; N. van‘t Bovenein...; A. C. C. Carvalho; R. Centis; J. M. Chakaya; D. M. Cirillo; J. G. Cho; L. D´Ambrosio; M. P. Dalcolmo; P. Denti; K. Dheda; G. J. Fox; A. C. Hesseling; H. Y. Kim; C. U. Köser; B. J. Marais; I. Margineanu; A. G. Märtson; M. Munoz Torrico; H. M. Nataprawira; C. W. M. Ong; R. Otto-Knapp; C. A. Peloquin; D. R. Silva; R. Ruslami; P. Santoso; R. M. Savic; R. Singla; E. M. Svensson; A. Skrahina; D. van Soolingen; S. Srivastava; M. Tadolini; S. Tiberi; T. A. Thomas; Z. F. Udwadia; D. H. Vu; W. Zhang; S. G. Mpagama; T. Schön; G. B. Migliori
• Keywords: Economics; FOS: Political science; Antitubercular Agents; Developmental Pharmacology in Pediatric Drug Use; Clinical Pharmacy - Radboud University Medical Center; Cardiorespiratory Medicine and Haematology; qv_771; Political science; Therapeutic Drug Monitoring; Statistics; Reference Standards; tuberculosis; pharmacokinetics; pharmacodynamics; adverse drug reaction; management; dosing; Drug Monitoring; Humans; Reference Standards; Health Personnel; Patient Care; dosing; 3. Good health; Dosing; tuberculosis; 5.1 Pharmaceuticals; Pharmacokinetics of Antibiotics in Critically Ill Patients; 6.1 Pharmaceuticals; wf_360; Medicine; Patient Safety; wf_200; Development of treatments and therapeutic interventions; Drug Monitoring; Drug; pharmacokinetics; management; Health Personnel; MEDLINE; adverse drug reaction; Delphi method; FOS: Law; Polypharmacy and Inappropriate Medication Use in Elderly; Therapeutic drug monitoring; Microbiology; 7.3 Management and decision making; Rare Diseases; Clinical Research; Health Sciences; pharmacodynamics; Clinical Standard Series; FOS: Mathematics; Humans; Tuberculosis; Intensive care medicine; Drug Dosing; Economic growth; Pharmacology; Health care; Evaluation of treatments and therapeutic interventions; Orphan Drug; Good Health and Well Being; Pediatrics, Perinatology and Child Health; Antimicrobial Resistance; Management of diseases and conditions; Patient Care; Geriatrics and Gerontology; Radboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences; Law; Mathematics

BACKGROUND: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on ‘best practice´ for dosing and management of TB drugs.METHODS: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants.RESULTS: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified.CONCLUSION: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.