Seriousness of adverse events: medical judgment is important
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《英国医生杂志》
EDITOR—In his letter asking for definition of "serious" and "severe" adverse reactions Frankenfeld does not take into account what the Council for International Organisations of Medical Sciences specifies.1 2
Important medical events that may not be immediately life threatening or result in death or hospitalisation but may jeopardise the patient or require intervention to prevent one of the other outcomes listed in the definition of seriousness (death, life threatening, hospitalisation or extended existing hospitalisation, severe disability or incapacity, congenital anomaly or birth defect) should also be considered as serious. Seriousness criteria therefore do not need redefinition, but good medical judgment should be exercised when deciding if an adverse event or reaction is or is not serious.
Javier Borja, drug safety manager
J Uriach y Compa?ía, SA 08184 Palau de Plegamans, Barcelona, Spain fv-borja@uriach.com
Esther Donado, senior clinical research assistant
J Uriach y Compa?ía, SA 08184 Palau de Plegamans, Barcelona, Spain
Mario Souto, head of pharmacovigilance
Biometrica, Artistides Maillol 15, 08028 Barcelona
Competing interests: None declared.
References
Frankenfeld C. "Serious" and "severe" adverse drug reactions need defining. BMJ 2004;329: 573. (4 September.)
Council for International Organisations of Medical Sciences. Current challenges in pharmacovigilance: pragmatic approaches. Report of CIOMS working group V. Geneva: CIOMS, 2001.
Important medical events that may not be immediately life threatening or result in death or hospitalisation but may jeopardise the patient or require intervention to prevent one of the other outcomes listed in the definition of seriousness (death, life threatening, hospitalisation or extended existing hospitalisation, severe disability or incapacity, congenital anomaly or birth defect) should also be considered as serious. Seriousness criteria therefore do not need redefinition, but good medical judgment should be exercised when deciding if an adverse event or reaction is or is not serious.
Javier Borja, drug safety manager
J Uriach y Compa?ía, SA 08184 Palau de Plegamans, Barcelona, Spain fv-borja@uriach.com
Esther Donado, senior clinical research assistant
J Uriach y Compa?ía, SA 08184 Palau de Plegamans, Barcelona, Spain
Mario Souto, head of pharmacovigilance
Biometrica, Artistides Maillol 15, 08028 Barcelona
Competing interests: None declared.
References
Frankenfeld C. "Serious" and "severe" adverse drug reactions need defining. BMJ 2004;329: 573. (4 September.)
Council for International Organisations of Medical Sciences. Current challenges in pharmacovigilance: pragmatic approaches. Report of CIOMS working group V. Geneva: CIOMS, 2001.