3.27 Off Label Use – The wording in this section: The concept of label use” relates to situations where the product is “off intentionally used for a medical purpose not in accordance with the authorised product information. Was changed as follows (note the addition of a second sentence): The concept of label use” relates to situations where the product is “off intentionally used for a medical purpose not in accordance with the authorised product information. When recording off label use, consider that product information and/or regulations/requirements may differ between regulatory regions. 3.27.1 Off label use when reported as an indication The wording in this section: If a medical condition is reported as an indication along with label use”, the “off preferred option is to select terms for the medical condition and LLT Off label use or other appropriate LLTs linked to PT Off label use. Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available. Was changed as follows (note the use of condition/indication” to indicate “medical that these are the same concept): If a medical condition/indication is reported with label use”, the “off is to select terms for the medical condition/indication and off preferred option label use. Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available. The Example table: Example Reported LLT Selected Comment Used off label Off label use Off label use in paediatric Refers to a population patients of patients
3.27 – Off Label Use The wording in this section: The concept of “off label use” relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorised product information. Was changed as follows (note the addition of a second sentence): The concept of “off label use” relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorised product information. When recording off label use, consider that product information and/or regulations/requirements may differ between regulatory regions. 3.27.1 Off label use when reported as an indication The wording in this section: If a medical condition is reported as an indication along with “off label use”, the preferred option is to select terms for the medical condition and LLT Off label use or other appropriate LLTs linked to PT Off label use. Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available. Was changed as follows (note the use of “medical condition/indication” to indicate that these are the same concept): If a medical condition/indication is reported with “off label use”, the preferred option is to select terms for the medical condition/indication and off label use. Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available. The Example table: Example Reported LLT Selected Comment Used off label Off label use Off label use in paediatric patients Refers to a population of patients