Additional Therapeutic Sections in Concept Intentional? By Whom? Use? this Document Misuse Yes Patient/consumer Yes* 3.16.1 Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Patient/consumer Medication No or healthcare Yes 3.15 error professional Healthcare Off label use Yes Yes 3.27 professional * Definitions of misuse may not always include the concept of therapeutic use; misuse may be similar to the concept of abuse in some regions. Select the most specific term available and always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information. In some cases, it may be appropriate to select more than one MedDRA LLT to represent the reported information. Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional use for a therapeutic purpose by a patient or consumer of a product – or prescription other than as prescribed or not in accordance with the – authorised product information. Example Reported LLT Selected Patient deliberately took the medication Intentional misuse in dosing frequency daily instead of once daily Abuse For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use by a patient or consumer of a product over-the counter – or prescription for a perceived reward or desired non-therapeutic effect including, but – not limited to, high”(euphoria). Abuse may occur with a single use, sporadic use “getting or persistent use of the product. Example Reported LLT Selected Comment
Concept Intentional? By Whom? Therapeutic Use? Additional Sections in this Document Misuse Yes Patient/consumer Yes* 3.16.1 Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Medication error No Patient/consumer or healthcare professional Yes 3.15 Off label use Yes Healthcare professional Yes 3.27 * Definitions of misuse may not always include the concept of therapeutic use; misuse may be similar to the concept of abuse in some regions. Select the most specific term available and always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information. In some cases, it may be appropriate to select more than one MedDRA LLT to represent the reported information. Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional use for a therapeutic purpose by a patient or consumer of a product – or prescription – other than as prescribed or not in accordance with the authorised product information. Example Reported LLT Selected Patient deliberately took the medication daily instead of once daily Intentional misuse in dosing frequency Abuse For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use by a patient or consumer of a product – over-the counter or prescription – for a perceived reward or desired non-therapeutic effect including, but not limited to, “getting high”(euphoria). Abuse may occur with a single use, sporadic use or persistent use of the product. Example Reported LLT Selected Comment
000012_termselptc_r4_13_mar2017_RL.docx