MedDRA Point to consider

Approaching Usage of MedDRA

1. Approaching Application MedDRA By Somnath Mondal Technical Associate (PVPI) STM-AMC Kolkata 25 th March, 2014 Term Selection Points to Consider

2. Objectives: Promote Consistent term Selection Organization should document their term selection strategies in a specific guidelines The guidelines should be consistent with the Point to Consider documents of MSSO

3. Scope of the documents: Term selection for data entry of Adverse events Adverse drug reaction Medical history Social history Indications Investigatios

4. Level of Term Selection: SOC HLGT HLT PT Lowest Level Term (LLT) Current LLT Terms related to this is used for the purpose of Data archival, analysis and retrieval Lowest Level Term (LLT)

5. Let discuss certain Examples

6. Brittle hair No Exact match MedDRA Search: LLT - Term Selection Hair texture abnormal Hair Disorder hair If an exact match cannot be found, use a specific existing term.

7. Metastatic Gall Bladder No Exact match MedDRA Search: LLT - Metastatic or Gall bladder If an exact match cannot be found, it is more appropriate to select › 1 Associated term Term Selection Gall Bladder Cancer And/or Metastasis

8. No scope for either Subtraction or Addition of information

9. Abdominal pain Increased Serum Amylase It is inappropriate to assign a diagnosis “Pancreatitis” Abdominal pain Term Selection Increased Serum Amylase Increased Serum Lipase Increased Serum Lipase Symptoms of What ?

10. Anaphylactic reaction Rash, dysponea, hypotension, laryngospasm Anaphylactic reaction Term Selection If both a diagnosis and its characteristics sign and symptoms are reported, it is sufficient to select a term for diagnosis .

11. Myocardial infraction, Chest pain, diaphoresis, ECG changes Jaundice Terms should be selected for signs & symptoms that are not generally recognized as part of that diagnosis . Myocardial infraction Term Selection Jaundice

12. Provisional Diagnosis

13. Possible Myocardial infraction, If only a provisional diagnosis is reported without additional clinical information it should be assigned as if a confirm. Myocardial infraction Term Selection ( Probable, presumed, likely, questionable) ?

14. Chest pain, diaphoresis, ECG changes Jaundice (Possible Myocardial infraction) Myocardial infraction Term Selection Jaundice If both provisional diagnosis and its characteristics sign and symptoms are reported, it is sufficient to select a term for only provisional diagnosis.

15. Chest pain, dysponea, diaphoresis, Jaundice (Possible Myocardial infraction) Alternatively, it is considered sufficient to select terms for only sign & symptoms Diaphoresis Chest pain Term Selection Dysponea Jaundice

16. Differential Diagnosis

17. Pulmonary embolism, Myocardial infraction, Congestive heart failure If multiple provisional diagnoses without sign & symptoms, terms for each provisional diagnosis can be selected. Myocardial infraction Pulmonary embolism Term Selection Congestive heart failure

18. Pulmonary embolism, Myocardial infraction, Congestive heart failure If multiple provisional diagnoses reported together with sign & symptoms, it is sufficient to select terms for only sign & symptoms, Chest pain, shortness of breath, blood pressure decreased, cyanosis Shortness of breath Chest pain Term Selection blood pressure decreased Cyanosis

19. Death due to Myocardial infraction Myocardial infraction Term Selection Why is it So? Death is an out come and is not considered to be an AE/ADR.

20. Death Other patient outcomes

21. Constipation, ruptured bowel, peritonitis, sepsis Patient died Ruptured bowel Constipation Term Selection Peritonitis Sepsis Death? It must be captured as the outcome.

22. A patient was found dead Term Selection Found dead Why? If the only information is reported as death, then the most specific death term available should be selected. Is it outcome?

23. Hospitalization due to congestive heart failure Term Selection Congestive heart failure Patient outcomes e.g. Hospitalization/ disability etc . are the criteria to be considered whether the ADR/ AE is Serious or non Serious. Hence, are generally not considered to be ADR/AE.

24. A patient was hospitalized Term Selection Hospitalization So when the only information reported is the outcome term, then the most specific term available should be selected.

25. Conflicting Ambiguous Vague Information

26. Hyperkalemia with a serum potassium of 1.6 mEq/L. When conflicting information is reported , attempts should be made to obtain more specific information. As per MedDRA Exclusion Criteria Numerical values are excluded from Coding. How will one code the above terminology? Serum potassium abnormal Term Selection But when Clarification attempts have failed How do coder Code? An appropriate closely associated term should be selected.

27. Pain Term Selection GU pain Genito-urinary Gastric ulcer ? How will one Code? When ambiguous information is reported , attempts should be made to obtain more specific information. But when Clarification attempts have failed An appropriate available term should be selected.

28. A patient experienced every listed adverse event When vague information is reported , attempts should be made to obtain more specific information. But when Clarification attempts have failed An appropriate available term should be selected. Unevaluable event Term Selection

29. Combination terms

30. Arrhythmia due to atrial fibrillation If one of the term is a diagnosis and there is a characteristics sign and/or symptom. The diagnosis term can be selected. Atrial fibrillation Term Selection

31. Hepatic function disorders (Acute hepatitis) If one of the term is more specific than others The most specific term should be selected. Hepatitis acute Term Selection

32. Retinopathy due to diabetes The term exists that describes the combination, it should be selected/used. Diabetes retinopathy Term Selection

33. Rash with itching The term exists that describes the combination, it should be selected/used. Itchy Rash Term Selection

34. Diarrhoea ash Vomiting If splitting provides more specific clinical information of an ADR it is considered appropriate to select more than one term. Diarrhoea Term Selection Vomiting

35. DIC due to sepsis Diarrhoea Term Selection Vomiting If splitting provides more specific clinical information, hence more than one term must be used.

36. Wrist fracture due to fall Wrist fracture Term Selection Fall If splitting provides more specific clinical information, hence more than one term must be used.

37. Pain due to cancer Cancer pain Term Selection If reported term is a combination of an event and a pre-existing condition and more specific combination term does not exist it is pragmatic to select a term for the event .

38. Shortness of breath due to cancer Shortness of breath Term Selection If reported term is a combination of an event and a pre-existing condition and more specific combination term does not exist it is pragmatic to select a term for the event .

39. Body site Vs. Event specificity

40. Skin rash on face Rash on face Term Selection If the reported term describes both body site location and the event available, the term with both specific body site and the event should be selected.

41. Skin rash on face and neck Skin rash Term Selection If a term contain multiple body site and all link the same PT, the relevant medical event should be selected.

42. Location Vs. Infectious agent

43. Pneumococcal Pneumonia Pneumococcal Pneumonia Term Selection If a term with both specific location and organism/infection is available, ir should be selected.

44. Respiratory Chlamydial infection Chlamydial infection Term Selection If the suitable term is not available, the infective agent should generally have priority during selection of term

45. Respiratory Chlamydial infection Respiratory infection Term Selection It is also acceptable to select infection site term alone.

46. Respiratory Chlamydial infection Respiratory infection Term Selection It is also acceptable to select term for both the concepts. Chlamydial infection

47. To be continued……………….