Example Reported LLT Selected Comment Used off label Off label use Refers to a population Off label use in paediatric Drug use in unapproved of patients patients population LLT Adult product Drug X given to a 10 year Adult product administered administered to child is old boy; the drug is not to child linked to PT Off label indicated for use below 18 years use 3.27.2 Off label use when reported with an AR/AE If an AR/AE occurs as a result of off label use, the preferred option is to select LLT Off label use, or other appropriate LLTs linked to PT Off label use, and a term for the medical condition in addition to a term for the AR/AE. Alternatively, select a term for the medical condition and a term for the AR/AE. Example Reported LLT Selected Preferred Option Off label use Patient was administered a drug Stroke off label for pulmonary Pulmonary hypertension hypertension and suffered Stroke a stroke Pulmonary hypertension 3.28 Product Quality Issues – It is important to recognize product quality issues as they may have implications for patient safety. They may be reported in the context of adverse events or as part of a product quality monitoring system.
Example Reported LLT Selected Comment Used off label Off label use Off label use in paediatric patients Drug use in unapproved population Refers to a population of patients Drug X given to a 10 year old boy; the drug is not indicated for use below 18 years Adult product administered to child LLT Adult product administered to child is linked to PT Off label use 3.27.2 Off label use when reported with an AR/AE If an AR/AE occurs as a result of off label use, the preferred option is to select LLT Off label use, or other appropriate LLTs linked to PT Off label use, and a term for the medical condition in addition to a term for the AR/AE. Alternatively, select a term for the medical condition and a term for the AR/AE. Example Reported LLT Selected Preferred Option Patient was administered a drug off label for pulmonary hypertension and suffered a stroke Off label use Stroke Pulmonary hypertension Stroke Pulmonary hypertension 3.28 – Product Quality Issues It is important to recognize product quality issues as they may have implications for patient safety. They may be reported in the context of adverse events or as part of a product quality monitoring system.
9491-1600_termselptc_r4_5_mar2013.docx