An additional term for occupational exposure e.g., LLT – Inadvertent exposure to drug Nurse splashed injectable Occupational drug in her own eye Excess tears exposure to drug – resulting in excessive could also be tearing selected, if applicable to regional requirements Misuse, Abuse and Addiction The concepts of misuse, abuse and addiction are closely related and can pose challenges for term selection since the terms may overlap to some extent; the specific circumstances of each case/reported event may help in consideration for term selection of these concepts. Medical judgment and regional regulatory considerations need to be applied. It may also be useful to consider these concepts as shown in the table below: 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,
Nurse splashed injectable drug in her own eye resulting in excessive tearing Inadvertent exposure to drug Excess tears An additional term for occupational exposure – e.g., LLT Occupational exposure to drug – could also be selected, if applicable to regional requirements Misuse, Abuse and Addiction The concepts of misuse, abuse and addiction are closely related and can pose challenges for term selection since the terms may overlap to some extent; the specific circumstances of each case/reported event may help in consideration for term selection of these concepts. Medical judgment and regional regulatory considerations need to be applied. It may also be useful to consider these concepts as shown in the table below: 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,
000240_termselptc_r4_16_sep2018.docx