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……………….