MULTIPLE DIAGNOSES DEFINITIVE DIAGNOSES PROVISIONAL DIAGNOSES Multiple definitive diagnoses without signs/symptoms Multiple diagnoses (only possible option) Multiple provisional diagnoses without signs/symptoms Multiple provisional diagnoses (only possible option) Multiple definitive diagnoses with signs/symptoms Preferred: Multiple diagnoses only Alternate: Diagnoses and signs/symptoms Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 3 Multiple provisional diagnoses with signs/symptoms Preferred: Multiple provisional diagnoses and signs/symptoms Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 4 EXAMPLES Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnoea, diaphoresis Myocardial infarction Chest pain Dyspnoea Diaphoresis Chest pain Dyspnoea Diaphoresis
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
Reported LLT Selected Comment Weight loss Weight loss Unclear if the purpose is to induce weight loss or to treat an underweight patient Immunosuppression Immunosuppression Unclear if the purpose is to induce or to treat immunosuppression Complex indications Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances. Reported LLT Selected Comment Treatment of aggression in autism Aggression The products do not treat the underlying autism, thalassaemia, or myocardial infarction, but they do address the associated signs/symptoms (aggression, chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, LLT Thalassaemia major, or LLT Myocardial infarction based on regional regulatory requirements. Treatment of chronic iron overload in thalassaemia major Chronic iron overload Prevention of atherothrombotic events in patients with myocardial infarction Atherothrombosis prophylaxis Indications with genetic markers or abnormalities For indications that describe a genetic marker or abnormality associated with a medical condition, select a term for both the medical condition and the genetic marker or abnormality. Example Reported LLT Selected Non small cell lung cancer with K-ras mutation Non-small cell lung cancer K-ras gene mutation Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words “prevention” and “prophylaxis” are synonymous in the context of MedDRA). Example