Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Medication Patient/consumer or No Yes 3.15 error healthcare provider Off label use Yes Healthcare provider Yes 3.27 3.16.1 Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional and inappropriate use of a product over-the-counter or – prescription other than as prescribed or not in accordance with the authorized – product information. Example Reported LLT Selected Patient deliberately ingested the topical Intentional use by incorrect route medication Patient deliberately took the medication for two days longer than instructed on Intentional use beyond labeled duration the product label 3.16.2 Abuse For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use of a product over-the counter or – prescription for a perceived reward or desired non-therapeutic effect including, – but not Abuse may occur with a single use, sporadic limited to, “getting high”. use or persistent use of the product. Example Reported LLT Selected Athlete used anabolic steroid Steroid abuse preparation to enhance performance Patient occasionally uses opioid product Opioid abuse, episodic use to get high
Abuse Yes Patient/consumer No 3.16.2 Addiction Yes Patient/consumer No 3.16.3 Medication error No Patient/consumer or healthcare provider Yes 3.15 Off label use Yes Healthcare provider Yes 3.27 3.16.1 Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional and inappropriate use of a product – over-the-counter or prescription – other than as prescribed or not in accordance with the authorized product information. Example Reported LLT Selected Patient deliberately ingested the topical medication Intentional use by incorrect route Patient deliberately took the medication for two days longer than instructed on the product label Intentional use beyond labeled duration 3.16.2 Abuse For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use of a product – over-the counter or prescription – for a perceived reward or desired non-therapeutic effect including, but not limited to, “getting high”. Abuse may occur with a single use, sporadic use or persistent use of the product. Example Reported LLT Selected Athlete used anabolic steroid preparation to enhance performance Steroid abuse Patient occasionally uses opioid product to get high Opioid abuse, episodic use
9491-1600_termselptc_r4_5_mar2013.docx