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 twice 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 Abuse may occur with a single use, sporadic use limited to, “getting high”(euphoria). or persistent use of the product. Example Reported LLT Selected Comment Athlete used anabolic steroid preparation to Steroid abuse enhance performance Patient occasionally uses opioid product to Opioid abuse, episodic use get high LLT Intentional use by Drug abuse Patient deliberately incorrect route (PT ingested the topical Intentional product use medication for its issue) provides additional Intentional use by incorrect psychoactive effect information about the nature route of the drug abuse See Section 3.24.1 and 3.24.2 for additional references to terms in MedDRA. “abuse” Addiction For the purposes of term selection and analysis of MedDRA-coded data, addiction is an overwhelming desire by a patient or consumer to take a drug for non-therapeutic purposes together with inability to control or stop its use despite harmful consequences. Addiction can occur because drug induces physical dependence and consequently a withdrawal syndrome, but this is not an essential feature; and addiction can occur
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 twice 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 Athlete used anabolic steroid preparation to enhance performance Steroid abuse Patient occasionally uses opioid product to get high Opioid abuse, episodic use Patient deliberately ingested the topical medication for its psychoactive effect Drug abuse Intentional use by incorrect route LLT Intentional use by incorrect route (PT Intentional product use issue) provides additional information about the nature of the drug abuse See Section 3.24.1 and 3.24.2 for additional references to “abuse” terms in MedDRA. Addiction For the purposes of term selection and analysis of MedDRA-coded data, addiction is an overwhelming desire by a patient or consumer to take a drug for non-therapeutic purposes together with inability to control or stop its use despite harmful consequences. Addiction can occur because drug induces physical dependence and consequently a withdrawal syndrome, but this is not an essential feature; and addiction can occur
000240_termselptc_r4_16_sep2018_rl.docx