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Approaching ApplicationMedDRA
BySomnath MondalTechnical Associate (PVPI)STM-AMCKolkata
25th March, 2014
Term Selection Points to Consider
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
Scope of the documents:
Term selection for data entry of Adverse events
Adverse drug reaction
Medical history
Social history
Indications
Investigatios
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)
Let discuss certain Examples
Brittle hair No Exact matchMedDRA Search: LLT
-Term Selection
Hair texture abnormalHair Disorder
hair
If an exact match cannot be found, use a specific existing term.
Metastatic Gall BladderNo Exact matchMedDRA 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
No scope for either Subtraction
or Addition
of information
Abdominal pain
Increased Serum Amylase
It is inappropriate to assign a diagnosis “Pancreatitis”
Abdominal painTerm Selection
Increased Serum Amylase Increased Serum Lipase
Increased Serum Lipase
Symptoms of What ?
Anaphylactic reactionRash, dysponea, hypotension, laryngospasm
Anaphylactic reactionTerm Selection
If both a diagnosis and its characteristics sign and symptoms are reported, it is sufficient to select a term for diagnosis.
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 infractionTerm Selection
Jaundice
Provisional Diagnosis
Possible Myocardial infraction,
If only a provisional diagnosis is reported without additional clinical information it should be assigned as if a confirm.
Myocardial infractionTerm Selection
(Probable, presumed, likely, questionable) ?
Chest pain, diaphoresis, ECG changes Jaundice(Possible Myocardial infraction)
Myocardial infractionTerm 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.
Chest pain, dysponea, diaphoresis, Jaundice(Possible Myocardial infraction)
Alternatively, it is considered sufficient to select terms for only sign & symptoms
DiaphoresisChest painTerm Selection
DysponeaJaundice
Differential Diagnosis
Pulmonary embolism, Myocardial infraction, Congestive heart failure
If multiple provisional diagnoses without sign & symptoms, terms for each provisional diagnosis can be selected.
Myocardial infractionPulmonary embolismTerm Selection
Congestive heart failure
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 breathChest painTerm Selection
blood pressure decreasedCyanosis
Death due to Myocardial infraction
Myocardial infractionTerm Selection
Why is it So?
Death is an out come and is not considered to be an AE/ADR.
Death
Other patient
outcomes
Constipation, ruptured bowel, peritonitis, sepsis
Patient died
Ruptured bowel Constipation Term Selection
Peritonitis Sepsis
Death?It must be captured as the outcome.
A patient was found dead
Term SelectionFound dead
Why?
If the only information is reported as death, then the most specific death term available should be selected.
Is it outcome?
Hospitalization due to congestive heart failureTerm SelectionCongestive heart failure
Patient outcomese.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.
A patient was hospitalizedTerm SelectionHospitalization
So when the only information reported is
the outcome term, then the most specific term available should be selected.
Conflicting Ambiguous
Vague Information
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.
PainTerm 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.
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 eventTerm Selection
Combination terms
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 fibrillationTerm Selection
Hepatic function disorders (Acute hepatitis)
If one of the term is more specific than others
The most specific term should be selected.
Hepatitis acuteTerm Selection
Retinopathy due to diabetes
The term exists that describes the combination, it should be selected/used.
Diabetes retinopathyTerm Selection
Rash with itching
The term exists that describes the combination, it should be selected/used.
Itchy RashTerm Selection
Diarrhoea ash Vomiting
If splitting provides more specific clinical information of an ADR it is considered appropriate to select more than one term.
DiarrhoeaTerm Selection
Vomiting
DIC due to sepsis
DiarrhoeaTerm Selection
Vomiting
If splitting provides more specific clinical information, hence more than one term must be used.
Wrist fracture due to fall
Wrist fractureTerm Selection
Fall
If splitting provides more specific clinical information, hence more than one term must be used.
Pain due to cancer
Cancer painTerm 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.
Shortness of breath due to cancer
Shortness of breathTerm 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.
Body site Vs.
Event specificity
Skin rash on face
Rash on faceTerm 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.
Skin rash on face and neck
Skin rashTerm Selection
If a term contain multiple body site and all link the same PT, the relevant medical event should be selected.
Location Vs.
Infectious agent
Pneumococcal Pneumonia
Pneumococcal PneumoniaTerm Selection
If a term with both specific location and organism/infection is available, ir should be selected.
Respiratory Chlamydial infection
Chlamydial infectionTerm Selection
If the suitable term is not available, the infective agent should generally have priority during selection of term
Respiratory Chlamydial infection
Respiratory infectionTerm Selection
It is also acceptable to select infection site term alone.
Respiratory Chlamydial infection
Respiratory infectionTerm Selection
It is also acceptable to select term for both the concepts.
Chlamydial infection
To be continued……………….