contact Occupational exposures For the purposes of term selection and analysis of MedDRA-coded data, occupational exposure encompasses the exposure to an agent (including therapeutic “chronic” products) during the normal course of and could include additional one’s occupation, scenarios in specific regulatory regions. For example, occupational exposure may additionally relate to a more acute, accidental form of exposure that occurs in the context of occupation. In these regions, occupational exposure for healthcare workers one’s could be of particular interest. Example Reported LLT Selected Comment Physical therapist developed a photosensitivity Occupational exposure to drug rash on hands after Exposure via skin contact exposure to an Photosensitive rash containing pain relief cream that she applied to a patient Pathologist chronically Exposure to Occupational exposure to toxic exposed to formaldehyde formaldehyde is a agent developed nasopharyngeal known risk factor for Nasopharyngeal carcinoma carcinoma this type of malignancy An additional term for occupational exposure Nurse splashed injectable e.g., LLT – Inadvertent exposure to drug drug in her own eye Occupational exposure Excess tears resulting in excessive to drug 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
contact Occupational exposures For the purposes of term selection and analysis of MedDRA-coded data, occupational exposure encompasses the “chronic” exposure to an agent (including therapeutic products) during the normal course of one’s occupation, and could include additional scenarios in specific regulatory regions. For example, occupational exposure may additionally relate to a more acute, accidental form of exposure that occurs in the context of one’s occupation. In these regions, occupational exposure for healthcare workers could be of particular interest. Example Reported LLT Selected Comment Physical therapist developed a photosensitivity rash on hands after exposure to an pain relief cream that she applied to a patient Occupational exposure to drug Exposure via skin contact Photosensitive rash Pathologist chronically exposed to formaldehyde developed nasopharyngeal carcinoma Occupational exposure to toxic agent Nasopharyngeal carcinoma Exposure to formaldehyde is a known risk factor for this type of malignancy 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 containing
9491-1900_termselptc_r4_11_mar2016_rl.docx