Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/33179
Title: Clinical standards for the management of adverse effects during treatment for TB.
Austin Authors: Singh, K P;Carvalho, A C C;Centis, R;D Ambrosio, L;Migliori, G B;Mpagama, S G;Nguyen, B C;Aarnoutse, R E;Aleksa, A;van Altena, R;Bhavani, P K;Bolhuis, M S;Borisov, S;van T Boveneind-Vrubleuskaya, N;Bruchfeld, J;Caminero, J A;Carvalho, I;Cho, J G;Davies Forsman, L;Dedicoat, M;Dheda, K;Dooley, K;Furin, J;García-García, J M;Garcia-Prats, A;Hesseling, A C;Heysell, S K;Hu, Y;Kim, H Y;Manga, S;Marais, B J;Margineanu, I;Märtson, A-G;Munoz Torrico, M;Nataprawira, H M;Nunes, E;Ong, C W M;Otto-Knapp, R;Palmero, D J;Peloquin, C A;Rendon, A;Rossato Silva, D;Ruslami, R;Saktiawati, A M I;Santoso, P;Schaaf, H S;Seaworth, B;Simonsson, U S H;Singla, R;Skrahina, A;Solovic, I;Srivastava, S ;Stocker, S L;Sturkenboom, M G G;Svensson, E M;Tadolini, M;Thomas, T A;Tiberi, S;Trubiano, J;Udwadia, Z F;Verhage, A R;Vu, D H;Akkerman, O W;Alffenaar, J W C;Denholm, J T
Affiliation: Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
Laboratório de Inovações em Terapias, Ensino e Bioprodutos (LITEB), Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy.
Public Health Consulting Group, Lugano, Switzerland.
Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzania, Kibong´oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania.
Woolcock Institute of Medical Research, Viet Nam and University of Sydney, NSW, Australia.
Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.
Grodno State Medical University, Grodno, Belarus.
Asian Harm Reduction Network and Medical Action Myanmar, Yangon, Myanmar.
Indian Council of Medical Research-National Institute for Research in Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia.
Departement of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Departement of Medicine Solna, Division of Infectious Diseases, Karolinska Institutet, Stokholm, Sweden
Department of Pneumology. University General Hospital of Gran Canaria "Dr Negrin", Las Palmas, Spain
Paediatric Department, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia, Portugal.
Sydney Infecious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia
Departement of Medicine Solna, Division of Infectious Diseases, Karolinska Institutet, Stokholm, Sweden
Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
Tuberculosis Research Programme, SEPAR (Sociedad Española de Neumología y Cirugía Torácica), Barcelona, Spain.
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa
Parramatta Chest Clinic, Parramatta, NSW, Australia.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Sydney Infectious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Tuberculosis Department Latin American Society of Thoracic Diseases, Lima, Peru.
Department of Infectious Diseases and Microbiology, The Children´s Hospital at Westmead, Westmead, NSW, Australia.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Centre of Excellence in Infectious Diseases Research, Antimicrobial Pharmacodynamics and Therapeutics Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, México City, Mexico.
Division of Paediatric Respirology, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia.
Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique, Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique.
Infectious Disease Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
German Central Committee Against Tuberculosis (DZK), Berlin, Germany.
Hospital Muniz and Instituto Vaccarezza, Buenos Aires, Argentina.
Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA.
Universidad Autonoma de Nuevo Leon, Facultad de Medicina, Neumología, CIPTIR, Monterrey, Mexico.
Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
TB/HIV Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia,
Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia,
Division of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin General Hospital, Bandung, Indonesia.
University of Texas Health Science Center at Tyler, Tyler, TX, USA.
Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Department of TB & Respiratory Diseases, National Institute of TB & Respiratory Diseases, New Delhi, India.
Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus.
National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia.
University of Texas Health Science Center at Tyler, Tyler, TX, USA
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands
Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant´Orsola, Bologna, Italy
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India.
Department of Paediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Department of Pulmonary Diseases and Tuberculosis, Groningen, Haren, the Netherlands
Westmead Hospital, Sydney, NSW, Australia
Victorian Infectious Disease Unit, Royal Melbourne Hospital, VIC, Australia.
Department of Public Health TB Control, Metropolitan Public Health Services, The Hague, The Netherlands.
ALOSA (Active Learning over Sanitary Aspects) Academy, Spain.
Departement of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa
Department of Pediatrics, University of Wisconsin, Madison, WI, USA.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy
Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.
Centre for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Department of Medicine, The University of Texas at Tyler School of Medicine, TX, USA
Department of Clinical Pharmacology and Toxicology, St Vincent´s Hospital, Sydney, NSW, Australia.
Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Infectious Diseases
Tuberculosis Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands.
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.
Department of Pharmacy Practice, Texas Tech University Health Science Center, Dallas, TX, USA.
Issue Date: 1-Jul-2023
Publication information: The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease 2023; 27(7)
Abstract: BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE.METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards.RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.CONCLUSION: These standards provide a person-centred, consensus-based approach to minimise the impact of AE during TB treatment.
URI: https://ahro.austin.org.au/austinjspui/handle/1/33179
DOI: 10.5588/ijtld.23.0078
ORCID: 
Journal: The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
Start page: 506
End page: 519
PubMed URL: 37353868
ISSN: 1815-7920
Type: Journal Article
Subjects: Tuberculosis/diagnosis
Tuberculosis/drug therapy
Drug-Related Side Effects and Adverse Reactions/etiology
Appears in Collections:Journal articles

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