MedDRA Coding Basics

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Course Objectives/Overview

• Learn the reasons we “code” data• Gain knowledge of MedDRA’sGain knowledge of MedDRA s

structure, scope, and characteristics• Learn about the MedDRA Term• Learn about the MedDRA Term

Selection: Points to Considerdocumentdocument

• Learn some basic coding approaches, including some coding “pearls”

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including some coding pearls

Wh D W C d ?Why Do We Code?

What Is “Coding”?

Code

1 : a systematic statement of a body of law; especially one given statutory force

2 : a system of principles or rules <moral code>2 : a system of principles or rules <moral code>3 a : a system of signals or symbols for communication

b : a system of symbols (as letters or numbers) used t t i d d ft t ito represent assigned and often secret meanings

4 : genetic code5 : a set of instructions for a computer

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5 : a set of instructions for a computer

Why Do We Code?

• Retrieve• Present• Present• AnalyzeAnalyze• Communicate

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Role of a Terminology

• Provides a TOOL to represent data/ concepts using “place holder” termsconcepts using place-holder terms

• Assists in retrieval, analysis, and h i f d tcomprehension of data

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What Does MedDRA Offer?

• Size and specificity (“granularity”)• Hierarchy/grouping terms• Hierarchy/grouping terms• “Support” SOCs widen data

collection/analysis optionscollection/analysis options• Up-to-date and medically rigorous• User-responsive• User-responsive • STANDARDIZATION

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M dDRA O iMedDRA Overview

MedDRA Definition

MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entireterminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry,post marketing, and for data entry, retrieval, evaluation, and presentation.

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Scope of MedDRAOUT

Medical conditionsIndications

Not a drug dictionary

Frequency qualifiers

IN

IndicationsInvestigations (tests, results)

Medical and surgical proceduresMedical, social, family history

Patient demographicterms

Numerical values forresults, , y y

Medication errorsProduct quality issuesDevice-related issues

Pharmacogenetic termsPharmacogenetic termsToxicologic issues

Standardized queries

Clinical trial study design terms

Severity descriptors

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Not an equipment, device,diagnostic product dictionary

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MedDRA Structure

System Organ Class (SOC) (26)

High Level Group Term (HLGT) (334)

High Level Term (HLT) (1,717)

P f d T (PT) (20 057)Preferred Term (PT) (20,057)

Lowest Level Term (LLT) (71 326)

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Lowest Level Term (LLT) (71,326)

MedDRA Version 16.0

MedDRA Term Level Definitions

• SOC - Highest level of the terminology, andrepresenting an anatomical or physiological system, ti letiology, or purpose

• HLGT - Subordinate to SOC, superordinate grouping for one or more HLTs

• HLT - Subordinate to HLGT, superordinate grouping for one or more PTs

• PT - Represents a single medical concept• PT - Represents a single medical concept• LLT - Lowest level of the terminology, related to a

single PT as a synonym, lexical variant, or quasi-s non m (Note All PTs ha e an identical LLT)

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synonym (Note: All PTs have an identical LLT)

System Organ Classes• Blood and lymphatic system disorders• Cardiac disorders• Congenital, familial and genetic disorders• Ear and labyrinth disorders

• Musculoskeletal and connective tissue disorders

• Neoplasms benign, malignant and unspecified (incl cysts and polyps)• Ear and labyrinth disorders

• Endocrine disorders• Eye disorders• Gastrointestinal disorders

( y p yp )• Nervous system disorders• Pregnancy, puerperium and perinatal

conditionsP hi t i di d

• General disorders and administration site conditions

• Hepatobiliary disordersI t di d

• Psychiatric disorders• Renal and urinary disorders• Reproductive system and breast disorders• Respiratory, thoracic and mediastinal disorders• Immune system disorders

• Infections and infestations• Injury, poisoning and procedural

complications

Respiratory, thoracic and mediastinal disorders• Skin and subcutaneous tissue disorders• Social circumstances• Surgical and medical procedures

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p• Investigations• Metabolism and nutrition disorders

• Vascular disorders

SOC C di di d

Examples of LLTs

HLGT = Cardiac arrhythmias

SOC = Cardiac disorders

HLT = Rate and rhythm disorders NEC

HLGT Cardiac arrhythmias

PT = Arrhythmia

LLTA h th i

LLTDysrhythmias

LLTArrhythmia

NOS LLT (N )

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ArrhythmiaNOS LLT (Non-current)Other specified cardiac

dysrhythmias

Non-Current TermsN t t fl d t th• Non-current terms are flagged at the LLT level within MedDRA

• Not recommended for continued use• Not recommended for continued use• Retained within the terminology to

preserve historical data for retrieval and p ese e sto ca data o et e a a danalysis

• Terms that are vague, ambiguous, out-d t d t t d i ll ddated, truncated, or misspelled

• Terms derived from other terminologies that do not fit MedDRA rules

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that do not fit MedDRA rules

• Each MedDRA term assigned an 8-digitMedDRA Codes

• Each MedDRA term assigned an 8 digit numeric code

• The code is non-expressive• The code is non-expressive• Codes can fulfill a data field in various

electronic submission types (e g E2B)electronic submission types (e.g., E2B)• Initially assigned alphabetically by term

starting with 10000001starting with 10000001– New terms are assigned sequentially

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• Supplemental terms are assigned codes

A Multi-Axial TerminologyM lti i l th t ti f• Multi-axial = the representation of a medical concept in multiple SOCs

All i b diff t l ifi ti– Allows grouping by different classifications– Allows retrieval and presentation via different

data setsdata sets• Purpose of Primary SOC

Determines which SOC will represent a PT– Determines which SOC will represent a PT during cumulative data outputs

– Is used to support consistent data

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Is used to support consistent data presentation for reporting to regulators

A Multi-Axial Terminology (cont)

SOC = Respiratory, thoracic andmediastinal disorders

SOC = Infections and infestations

HLGT = Respiratory tract infections

HLGT = Viral infectious disorders

HLT = Viral upper respiratory HLT = Influenza viralHLT Viral upper respiratorytract infections

HLT Influenza viral infections

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PT = Influenza

A Multi-Axial Terminology (cont)

PTs in the following SOCs only appear in that particular SOC and not in others, p ,i.e., they are not multi-axial

• Investigations• Investigations• Surgical and medical procedures• Social circumstances• Social circumstances

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Rules for Primary SOC Allocation• PTs for diseases signs and symptoms are assigned to• PTs for diseases, signs and symptoms are assigned to

prime manifestation site SOC• Congenital and hereditary anomalies terms have SOC

C l f l l d d d SOCCongenital, familial and genetic disorders as Primary SOC• Neoplasms terms have SOC Neoplasms benign,

malignant and unspecified (incl cysts and polyps) as g p ( y p yp )Primary SOC – Exception: Cysts and polyps have prime manifestation site SOC

as Primary SOC

• Infections and infestations terms have SOC Infections and infestations as Primary SOC

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Primary SOC Priority

If a PT links to more than one of the exceptions, the following priority will be used to determine primary SOC:primary SOC:

1st: Congenital, familial and genetic disorders2nd: Neoplasms benign, malignant and2 : Neoplasms benign, malignant and

unspecified (incl cysts and polyps)3rd: Infections and infestations

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MedDRA Term Selection:MedDRA Term Selection:Points to Consider Document

Why Do We Need Coding Conventions?Conventions?

• Differences in medical aptitude of coders• Consistency concerns (many more

“choices” to manually code terms in yMedDRA compared to older terminologies)g )

• Even with an autoencoder, may still need manual coding

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manual coding

MedDRA Term Selection: Points to Consider (MTS:PTC)Points to Consider (MTS:PTC)

• An ICH-endorsed guide for MedDRA users• Provides term selection advice for industry

and regulatory purposes• Objective is to promote accurate and

consistent term selection to facilitate a d t di f h d d tcommon understanding of shared data

• Recommended to be used as the basis for i di id l i ti ’ di

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individual organizations’ coding conventions

MedDRA Term Selection: PTC (cont)• Developed by a working group of the ICH Steering

Committee– Regulators and industry representativesRegulators and industry representatives– EU, Japan, USA– Canadian observer, MSSO, JMO

U d t d t i l ith h M dDRA l• Updated twice yearly with each MedDRA release• Available on MSSO, JMO, and ICH Web sites

– English and JapaneseEnglish and Japanese– Variety of file formats for ease of viewing and editing– Summary of Changes document

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General Term Selection Principles• Quality of Source DataQuality of Source Data• Quality Assurance• Do Not Alter MedDRA• Always Select a Lowest Level Term• Select Only Current Lowest Level Terms• When to Request a Term• When to Request a Term• Use of Medical Judgment in Term Selection• Selecting More than One Term• Check the Hierarchy• Select Terms for All Reported Information, Do Not

Add Information

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Add Information

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Q lit f S D tQuality of Source DataQuality AssuranceQuality Assurance

• Quality of original information impacts quality of outputoutput

• Obtain clarification of data• Can be optimized by careful design of data

ll ti f d t i i f t ffcollection forms and proper training of staff• Organizations’ coding guidelines should be

consistent with MTS:PTCconsistent with MTS:PTC• Review of term selection by qualified individuals• Human oversight of automated coding results

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g g

Do Not Alter MedDRA

• MedDRA is a standardized terminology with a pre-defined term hierarchywith a pre defined term hierarchy

• Users must not make ad hoc structural alterations, including changing thealterations, including changing the primary SOC allocation

• If terms are incorrectly placed, submit aIf terms are incorrectly placed, submit a change request to the MSSO

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Always Select a Lowest Level TermSelect Only Current LLTsSelect Only Current LLTs

• Lowest Level Term that most accurately fl t th t d b ti i f tireflects the reported verbatim information

should be selected• Degree of specificity may be challenging• Degree of specificity may be challenging

– Example: “Abscess on face” select “Facial abscess,” not simply “Abscess”

• Select current LLTs only– Non-current terms for legacy conversion/historical

purposes

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purposes

Wh t R t TWhen to Request a TermUse of Medical JudgmentUse of Medical Judgment

• Avoid company-specific “work-arounds” for MedDRA deficiencies If concept notMedDRA deficiencies. If concept not adequately represented in MedDRA, submit Change Request to MSSO.g q

• If no exact match in MedDRA, use medical judgment to match to an existing term that d t l t th tadequately represents the concept

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S l ti M th O TSelecting More than One TermCheck the HierarchyCheck the Hierarchy

• Can select more than one LLT to represent reported information Document proceduresreported information. Document procedures. – Selecting one term may lead to loss of specificity– Selecting more than one term may lead toSelecting more than one term may lead to

redundant counts• Check the hierarchy above a selected LLT

(PT HLT HLGT SOC) to ens e placement(PT, HLT, HLGT, SOC) to ensure placement accurately reflects meaning of reported term

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S l t T f All R t dSelect Terms for All Reported Information

• Select terms for every AR/AE reported, regardless of causal associationregardless of causal association

• Select terms for device-related events, product quality issues medication errorsproduct quality issues, medication errors, medical and social history, investigations and indications as appropriate

• If diagnosis reported with characteristic signs and symptoms, preferred option is to select term for diagnosis only

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select term for diagnosis only

Do Not Add InformationDo not make diagnosis if only• Do not make diagnosis if only signs/symptoms reported

Reported LLT Selected Comment

Abdominal pain

Abdominal pain, increased serum

Abdominal pain

It is inappropriateto assign an LLT for Serum amylase

i d amylase, and increased serum lipase

gdiagnosis of

“pancreatitis”

increased

Lipase increased

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Lipase increased

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Pitfalls and Solutions• In selecting an LLT for a result of an• In selecting an LLT for a result of an

investigation, parent PT of the selected LLT should contain a qualifier/adjective– E.g., “present/absent”, “increased/decreased”, etc.

• If parent PT of selected LLT does not contain a lifi / dj ti h i d t tlqualifier/adjective, you may have inadvertently

selected an LLT for the test name, not a result– E g “Blood found in urine” select LLT Blood inE.g., Blood found in urine , select LLT Blood in

urine (PT Blood urine present). Do not select LLT Blood urine (PT Blood urine has no qualifier/ dj ti d th t th t t l )

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adjective and thus represents the test name only)

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Pitf ll d S l ti ( t)Pitfalls and Solutions (cont)• Inappropriate terms may be selected by• Inappropriate terms may be selected by

autocoder• Review all autocoding carefully• Review all autocoding carefully

– “Allergic to CAT scan” autocoded as LLT Allergic to catsLLT Allergic to cats

– “Myocardial infarction in the fall of 2000” autocoded as LLT Myocardial infarction and LLT F llLLT Fall

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FDA-Defined Coding Errors• Missed Concepts• Missed Concepts

– All medical concepts described after the product is taken should be coded

– Example: “The patient took drug X and developed alopecia, increased LFTs and pancreatitis”. Manufacturer only codes alopecia and increased y pLFTs (missed concept of pancreatitis)

– Example: “The patient took drug X and developed interstitial nephritis which later deteriorated intointerstitial nephritis which later deteriorated into renal failure”. Manufacturer only codes interstitial nephritis (missed renal failure concept)

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Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER

FDA-Defined Coding Errors (cont)• “Soft Coding”

– Selecting a term which is both less specific and less th th M dDRA t i “ ft di ”severe than another MedDRA term is “soft coding”

– Example: “Liver failure” coded as hepatotoxicity or increased LFTsincreased LFTs

– Example: “Aplastic anemia” coded as unspecified anemia

– Example: “Rash subsequently diagnosed as Stevens Johnson syndrome” coded as rash

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Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER

Term Selection Points• Diagnoses and Provisional Diagnoses with or without Signs and g g g

Symptoms• Death and Other Patient Outcomes• Suicide and Self-Harm

Conflicting/Ambiguous/Vague Information• Conflicting/Ambiguous/Vague Information• Combination Terms• Age vs. Event Specificity• Body Site vs Event Specificity• Body Site vs. Event Specificity• Location Specific vs. Microorganism Specific Information• Modification of Pre-existing Conditions• Exposures During Pregnancy and Breast FeedingExposures During Pregnancy and Breast Feeding• Congenital Terms• Neoplasms• Medical and Surgical Procedures

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• Investigations

T S l ti P i t ( t)Term Selection Points (cont)• Medication/Administration Errors, Accidental Exposures and

Occupational ExposuresOccupational Exposures• Misuse, Abuse and Addiction• Transmission of Infectious Agent via Product

Overdose Toxicity and Poisoning• Overdose, Toxicity and Poisoning• Device-related Terms• Drug Interactions

N Ad Eff t d “N l” T• No Adverse Effect and “Normal” Terms• Unexpected Therapeutic Effect• Modification of Effect

l• Social Circumstances• Medical and Social History• Indication for Product Use

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• Off Label Use• Product Quality Issues

Diagnoses and Provisional DiagnosesSINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis without signs d t

Single provisional diagnosis ith t i d tand symptoms

•Diagnosis (only possible option)

without signs and symptoms

•Provisional diagnosis (only possible option)possible option)

Example: “Myocardial infarction” select

Example: “Possible myocardial infarction” select

“Myocardial infarction” “Myocardial infarction” (select term as if definitive diagnosis)

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Similar principles apply for multiple diagnoses

Diagnoses and Provisional Diagnoses (cont)SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSISSingle diagnosis with signs/ symptoms

Single provisional diagnosis with signs/symptoms

•Preferred: Diagnosis only •Preferred: Provisional diagnosis and signs/symptoms

Example: “Anaphylactic reaction with rash, dyspnea, hypotension and laryngospasm”

Example: “Possible myocardial infarction with chest pain,dyspnea diaphoresis” select hypotension, and laryngospasm

select “Anaphylactic reaction”

dyspnea, diaphoresis select “Myocardial infarction” “Chest pain”, “Dyspnea”, and “Diaphoresis”

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Diaphoresis

Similar principles apply for multiple diagnoses

Diagnoses and Provisional Diagnoses (cont)SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis with signs/ symptoms

Single provisional diagnosis with signs/symptomsymp m

•Alternate: Diagnosis and signs/symptoms

g / ymp m

•Alternate: Signs/symptoms only (as provisional diagnosis may change

Example: “Anaphylactic reactionwith rash, dyspnea, hypotension,

Example: “Possible myocardial infarction with chest pain,, y p , yp ,

and laryngospasm” select “Anaphylactic reaction”, “Rash”, “Dyspnea”, Hypotension”, and

p ,dyspnea, diaphoresis” select “Chest pain”, “Dyspnea”, and “Diaphoresis”

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“Laryngospasm”

Similar principles apply for multiple diagnoses

Conflicting/Ambiguous Information• First, try to obtain more specific informationFirst, try to obtain more specific information

Reported LLT Selected Comment

LLT S t i Hyperkalemia with a

serum potassium of 1.6 mEq/L

Serum potassium abnormal

LLT Serum potassium abnormal covers both of the reported concepts

(note: serum potassium of 1 6 E /L i l lt mEq/L 1.6 mEq/L is a low result,

not high)

“GU” could be either “genito-urinary” or “gastric

GU pain Pain ulcer”. If additional

information is not available, then select a term to

reflect the information

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that is known, i.e., LLT Pain

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Vague Information• First, try to obtain more specific informationFirst, try to obtain more specific information

Reported LLT Selected Comment

Turned green Unevaluable event

“Turned green” reported alone is vague; this could

refer to a patient condition n t p d t ( or even to a product (e.g.,

pills)

Since it is known that there is s m f m f m dic l Patient had a medical

problem of unclear type Ill-defined disorderis some form of a medical disorder, LLT Ill-defined

disorder can be selected

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Investigations

• Medical condition vs. investigation result

Reported LLT Selected Comment

LLT HypoglycemiaHypoglycemia Hypoglycemia

yp g ylinks to SOC

Metabolism and nutrition disorders

Decreased glucose Glucose decreased LLT Glucose

decreased links to SOC Investigations

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SOC Investigations

Investigations (cont)Unambiguous investigation result• Unambiguous investigation result

Reported LLT Selected Comment

Glucose 40 mg/dL Glucose low Glucose is clearly

below the reference range

• Ambiguous investigation resultReported LLT Selected Comment

His glucose was 40 Glucose abnormal

No units have been reported. Select LLTGlucose abnormal if

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g fclarification cannot

be obtained.

Investigations (cont)Investigation results consistent with diagnosis• Investigation results consistent with diagnosis

Reported LLT Selected CommentElevated potassium K It is not necessary to Elevated potassium, K

7.0 mmol/L, and hyperkalemia

HyperkalemiaIt is not necessary to select LLT Potassium

increased

• Grouped investigation result termsReported LLT Selected Comment

Increased alkaline phosphatase,

increased SGPT,

Alkaline phosphataseincreased

SGPT increased

Select four individual terms. A single term

such as LLT Liver function tests

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increased SGOT and elevated LDH

SGOT increasedLDH increased

function tests abnormal should not

be selected.

M dDRA D kt B

MSSO’s MedDRA Browsers• MedDRA Desktop Browser

– Download from MSSO Web site– View/search MedDRA and SMQsView/search MedDRA and SMQs– Export functionality

• MedDRA Web-Based Browser– https://www.meddrabrowser.org/dsnavigator/– Requires specific user ID and password

A t ll M dDRA i i E li h d– Access to all MedDRA versions in English and available EU languages (and Chinese, if subscribed)

– View/search MedDRA and SMQs

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View/search MedDRA and SMQs– Export functionality

Browser Demonstration/A h t Fi diApproaches to Finding

the Best LLTthe Best LLT

Assessing the Reported Information• Consider what is being reported. Is it a:

– Clinical condition - Diagnosis, sign or symptom?– Indication?– Test result?Test result?– Injury?– Procedure?

M di ti ?The type of report will

– Medication error?– Product quality issue?– Social circumstance?

influence the way you search for a suitable LLT. It may indicate in which SOC you expect to find the

– Device issue?– Procedural complication?

SOC you expect to find the closest match.

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– Is it a combination of these?

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Coding Example 1

Specificity

The patient suffered from an allergic reaction to an antibiotic

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Coding Example 2

Symptoms

The patient states she has been experiencing cold sweatsexperiencing cold sweats

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Coding Example 3

Investigations

Lab results indicate the patient has increased troponin and increased CPK-MB

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Coding Example 4

Medication errors

Patient took drug Y instead of drug X and became short of breath

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Coding Example 5

Patient demographics

A 2 day old baby was noted to have a mild fever

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Coding Example 6

Indications

A 35 year old woman was taking Drug X to prevent relapses of multiple sclerosis

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Coding Example 7N ti i ttNarrative vignette

A 75-year-old male receiving Drug X for rheumatoid arthritis developed symptomatic aortic valve stenosis. The patient’s medical history is significant for colon cancer and cigarette smoking. He underwent an aortic valve replacementand developed a sternal wound infection

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three days post-surgery.

Coding Example 8

Liver failure secondary to Hep B liver cirrhosis and sepsis leading to shock(from possible spontaneous bacterial peritonitis or bowel perforation)

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Assessing the Reported Information• Liver failure = complication of liver• Liver failure = complication of liver

cirrhosis and Hep BH B d l i f i h i• Hep B = underlying cause of cirrhosis

• Liver cirrhosis = complication of Hep B• Possible spontaneous bacterial

peritonitis or bowel perforation = p pprovisional diagnoses, likely cause of:

• Sepsis

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Sepsis• Shock = complication of sepsis

61

Term Selection• Liver failure• Liver failure

– LLT Liver failure

H B li i h i• Hep B liver cirrhosis– No combination term available, select both:

LLT Li i h i– LLT Liver cirrhosis– LLT Hepatitis B

Do not use non current LLT Hep B• Do not use non-current LLT Hep B• Query if abbreviation is unacceptable

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Term Selection (cont)• Sepsis leading to shock• Sepsis leading to shock

– Combination term available, select:LLT Septic shock– LLT Septic shock• Preserves relationship between the conditions• Better choice than LLT Sepsis and LLT Shockp

• Possible spontaneous bacterial peritonitis or bowel perforationp p– Select both provisional diagnoses:– LLT Spontaneous bacterial peritonitis

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– LLT Bowel perforation63

MedDRA Coding “Pearls”Fi t t i t ’ t l d• First, try using reporter’s actual words

• Be aware of MedDRA’s specificity• Exploit MedDRA’s hierarchy – if an LLT

is close to what you need, look at its y ,“siblings” and “parent”

• Check where the LLT lies in MedDRACheck where the LLT lies in MedDRA (i.e., check the hierarchy above to be sure it represents the verbatim term

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sure it represents the verbatim term accurately)

M dDRA C di “P l ” ( t)MedDRA Coding “Pearls” (cont)• Use “top down” and “bottom up” navigation• Use top-down and bottom-up navigation• Try synonyms if it’s not “renal” try

“kid ” t“kidney”, etc. • Use word stems, e.g., “Pancrea”• Search different word orders, “and”, “or” • Use available resources for difficultUse available resources for difficult

verbatim terms (web search, medical dictionaries, colleagues)

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dictionaries, colleagues)

MedDRA Coding “Pearls” (cont)

• And most important of all… get more coding training!g g

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SummaryI thiIn this course, we:• Learned the reasons we “code” data and the

role of a coding terminologyrole of a coding terminology• Reviewed the structure, scope, and

characteristics of MedDRA• Were introduced to the MedDRA Term

Selection: Points to Consider document and f it ifi i i lsome of its specific principles

• Learned basic approaches to coding, including some coding “pearls”

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some coding pearls

MSSO Contacts• Web site• Web site

– www.meddramsso.com

E il• E-mail– mssohelp@mssotools.com

• Telephone– International AT&T Toll Free: 877.258.8280– Direct Dial (USA): +1 571.313.2574

• Fax (USA)

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Fax (USA)– +1 571.313.2345