Accidental exposures and occupational exposures Accidental exposures The principles for Section 3.15.1 (Medication errors) also apply to accidental exposures. Example Reported LLT Selected Comment Accidental drug intake by Child accidentally took child and grandmother’s pills experienced projectile vomiting Vomiting projectile The term “exposure to” captures the agent of exposure, i.e., a Father applying topical steroid Accidental exposure to product, and the to his arms accidentally product by child term “exposure via” exposed his child to the drug captures the Exposure via skin contact by carrying her route/vehicle of exposure, i.e., skin 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 Occupational exposure to drug photosensitivity rash on hands after exposure to an Exposure via skin contact NSAID-containing pain Photosensitive rash relief cream that she applied to a patient Exposure to Pathologist chronically Occupational exposure to toxic formaldehyde is a exposed to formaldehyde agent known risk factor for developed nasopharyngeal this type of Nasopharyngeal carcinoma carcinoma malignancy
Accidental exposures and occupational exposures Accidental exposures The principles for Section 3.15.1 (Medication errors) also apply to accidental exposures. Example Reported LLT Selected Comment Child accidentally took grandmother’s pills and experienced projectile vomiting Accidental drug intake by child Vomiting projectile Father applying topical steroid to his arms accidentally exposed his child to the drug by carrying her Accidental exposure to product by child Exposure via skin contact The “exposure to” term captures the agent of exposure, i.e., a product, and the “exposure via” term captures the route/vehicle of exposure, i.e., skin 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 NSAID-containing 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
000240_termselptc_r4_16_sep2018.docx