6017-1601 Coding with MedDRA · Coding with MedDRA ... • An international multi-lingual...

Coding with MedDRA

MedDRA® trademark is owned by IFPMA on behalf of ICH

MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activitiesPharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board which is composed of the six ICHManagement Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer).

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p , py gthird party, permission for reproduction must be obtained from this copyright holder.

Course Overview

• MedDRA background• MedDRA’s structure, scope, and characteristics• MedDRA maintenance• Coding conventions• Synonym lists• QA of codingQ g• MedDRA Term Selection: Points to Consider

document

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• Hands-on coding exercises

M dDRA B k dMedDRA Background

What is MedDRA?

Med = MedicalD Di ti fD = Dictionary for

R = RegulatoryA = Activities

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Obj ti f M dDRAObjectives for MedDRA Development p

Result of an ICH initiative (M1) To provide:

• An international multi-lingual terminology St d di d i ti b t

To provide:

• Standardized communication between industry and regulators

• Support of electronic submissionsSupport of electronic submissions• Application through all phases of the

development cycle

MSSO-DI-6017-16.0.1 77

Obj ti f M dDRAObjectives for MedDRA Development (cont)p ( )

Cl ifi ti f id f li i l

To provide (cont):

• Classification for a wide range of clinical informationSupport for multiple medical product• Support for multiple medical product areas

• A terminology that saves time• A terminology that saves time, resources, and money

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MedDRA and the MSSO

• International support and development of terminology

• Foster use of MedDRA through communications and educational offerings“C t di ” t f th t i l• “Custodians”, not owners, of the terminology

• JMO (partner organization for Japanese-language MedDRA)language MedDRA)

• Governed by a Management Board (industry, regulators, multi-national, other interested

MSSO-DI-6017-16.0.1 9

g , ,parties)

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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R l t St tRegulatory Status• US FDA• US FDA

– Used in several databases including FAERS (drugs and biologics), VAERS (vaccines), and CAERS (foods, dietary supplements, cosmetics)

• FAERS and VAERS accept LLTs and PTs• CAERS accepts PTsCAERS accepts PTs

– Recommended terminology for adverse event reporting in several Proposed Rules

• Japanese Ministry of Health, Labour and Welfare– Mandatory use in electronic reporting

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• LLTs and PTs accepted

Regulatory Status (cont)• European Union• European Union

– EudraVigilance database• Clinical trial SUSARs (Suspected Unexpected Serious Adverse

R ti )Reactions)• Post-authorization Individual Case Safety Reports (ICSRs)• Use MedDRA LLTs (current version or the one previous to it)

N PV l i l i d d i f– New PV legislation covers suspected adverse reactions from:• Use inside and outside terms of marketing authorization• Overdose, misuse, abuse, and medication errors, , ,• Occupational exposures

– Good pharmacovigilance practices (GVP) specifically mention MedDRA

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MedDRA

R l t St t ( t)Regulatory Status (cont)• European Union (cont)• European Union (cont)

– Used in interface between EudraVigilance and EU Risk Management Plang

– Used throughout Summary of Product Characteristics (labeling)

d l h l• ICH M4E Guideline on Common Technical Document– Recommended in adverse event summary tables

C n d• Canada– Recommended/preferred terminology for adverse

reaction reporting and Product Monograph (labeling)

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reaction reporting and Product Monograph (labeling)

13

MedDRA OverviewMedDRA Overview

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

15

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

High Level Group TermSubordinate only to SOCs and superordinategrouping for one or more HLTs

SOCCardiac disordersCardiac disorders

HLGTCoronary artery

HLGTCardiac

HLGTCardiac valve

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y ydisorders arrhythmias disorders

Subordinate to HLGTs and superordinate grouping

High Level TermSubordinate to HLGTs and superordinate grouping for the PTs linked to it

SOCCardiac disorders

HLGTCardiac arrhythmias

HLT HLT HLT

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HLTCardiac conduction

disorders

HLTRate and rhythm disorders NEC

HLTSupraventricular

arrhythmias

Examples of PTs

SOC = Cardiac disorders

HLGT = Cardiac arrhythmias

HLT = Rate and rhythm disorders NEC

PT PT PT

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PTArrhythmia

PTBradycardia

PTTachyarrhythmia

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

d t d t i i SOCused to determine primary SOC:1st: Congenital, familial and genetic disorders2nd: Neoplasms benign malignant and2nd: Neoplasms benign, malignant and

unspecified (incl cysts and polyps)3rd: Infections and infestations3 : Infections and infestations

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SOC C it l f ili lSOC Congenital, familial and genetic disorders - Example

PT HLT HLGT SOC

Congenital HIV

Viral infections congenital

Infections and infestations

Congenital, familial andHIV

infectioncongenital infestations

congenitalfamilial and genetic disorders (P)

Congenital Neonatal and PregnancyCongenital neonatal infections

Neonatal and perinatal conditions

Pregnancy, puerperium and perinatal conditions

Retroviral infections

Viral infectious disorders

Infections and infestations

Acquired Immunodeficiency Immune

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Acquired immunodeficiency syndromes

Immunodeficiency syndromes

Immune system disorders

Conditions vs. Investigations

PT HLT HLGT SOC

Pregnancy test iti

Reproductive h

Endocrine i ti ti

Investigationspositive hormone

analysesinvestigations (incl sex hormones)

Pregnancy Normal pregnancy, labour and d li

Pregnancy, labour, delivery and

t t

Pregnancy, puerperium and perinatal

diti

Be careful to distinguish between a condition and an

delivery postpartum conditions

conditions

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Be careful to distinguish between a condition and an investigation or a result of an investigation

Standardised MedDRA Queries (SMQs)(SMQs)

• Groupings of terms from more than one SOC related to defined medical condition or area ofrelated to defined medical condition or area of interest

• Examples:• Examples:– Lack of efficacy/effect; Rhabdomyolysis/myopathy;

Osteonecrosis

• 90 SMQ topics available in MedDRA v16.0• More information on MSSO Web site

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More information on MSSO Web site

MedDRA MaintenanceMedDRA Maintenance

MedDRA Maintenance• MedDRA is a user responsive terminology • Subscribers may submit change requests to the

MSSO for considerationMSSO for consideration– Core and basic subscribers: 100 change requests

(CRs) per month( ) p– For simple changes (PT and LLT levels), notification

of supplemental change within 7-10 working daysW kl l l h d MSSO W b– Weekly supplemental changes posted on MSSO Web site

– Complex changes above PT level received all year

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Complex changes above PT level received all year round. Posted for subscribers’ comments mid-year.

MedDRA Maintenance (cont)

• Twice yearly official updates1 S t b X 1 l (Si l h l )– 1 September X.1 release (Simple changes only)

– 1 March X.0 release (Complex and simple h )changes)

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WebCR• Web based tool for Change Requests (CR)• Web-based tool for Change Requests (CR)

– URL: https://mssotools.com/webcr/– Via the Change Request Information page– Via the Change Request Information page

• Ability to submit CRs online• Immediate confirmation• Immediate confirmation• Review unsubmitted CRs online

Abili CR hi b k 5 1• Ability to query CR history back to v5.1

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Ch R t J tifi tiChange Request Justification Statements

• Justification statement always required • Inadequate justification – “Term does not• Inadequate justification – Term does not

exist in MedDRA”• Adequate justification – statement of need• Adequate justification statement of need• Support with definitions and references (PDFs

preferred)preferred)• Examples of need:

– Term needed to code an indication

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Term needed to code an indication– Concept is being reported in a clinical trial

37

Proactive MedDRA Maintenance

• What is the proactive approach?– Corrections/improvements made internally by the MSSO– General changes suggested by users

• Submitting ideas– Send to MSSO Help Desk. Justification is helpful.– Example: Consider consolidation of HLTs with only one PT

l f l• Evaluation of proposals– MSSO is not obligated to respond

P ti h d t l l CR

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– Proactive approach does not replace usual CR process

MedDRA Version Analysis Tool (MVAT)• Web-based (https://mssotools.com/mvat)• Free to all subscribers• Allows for comparison of any two versions• Features

– Version Report Generator (produces exportable report comparing any two versions)D t I t R t (id tifi h t ifi– Data Impact Report (identifies changes to a specific set of MedDRA terms or codes uploaded to MVAT)

– Search Term Change (identifies changes to a single

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Search Term Change (identifies changes to a single MedDRA term or code)

39

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

MedDRA Browser Demonstration and Instruction

Coding ExercisesCoding Exercises

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

– Device issue?– Procedural complication?

SOC you expect to find the closest match.

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– Is it a combination of these?

43

MedDRA Browsing Tips• First try using actual words from reporter• First, try using actual words from reporter• Use “top-down” and “bottom-up” approaches• Look at the “neighbors” g• Check the hierarchy• Consider synonyms, e.g., “Liver” and “Hepatic”• Use word stems, e.g., “Pancrea”• Search different word orders, “and”, “or”, etc.

U il bl f diffi lt b ti t ( b• Use available resources for difficult verbatim terms (web search, medical dictionaries, colleagues)

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Exercise 1

The patient states she has been experiencing headaches, dizziness and vertigo.

LLT → PT_______________ LLT → _______________ PT_______________ LLT → _______________ PT_______________ LLT → _______________ PT

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Exercise 2

Lab results indicate an increase in erythrocytes.

_______________ LLT → _______________ PT

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Exercise 3

Drug was contaminated with Staphylococcus.ug as co ta ated t Stap y ococcus

_______________ LLT → _______________ PT

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Exercise 4

A three year old boy was admitted for loratadine toxicity t ee yea o d boy as ad tted o o atad e to c tyafter accidentally ingesting the remaining tablets in the bottle.

_______________ LLT → _______________ PTLLT → PT_______________ LLT → _______________ PT

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Exercise 5

The patient’s insulin pump was noted to be broken.e pat e t s su pu p as oted to be b o e

_______________ LLT → _______________ PT

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Coding with MedDRACoding with MedDRA

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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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

Can I Make Coding Conventions Specific to My Company/Product?to My Company/Product?

• MedDRA may reduce the need to do this• MedDRA may reduce the need to do this because:– Increased size/granularity results in more accurateIncreased size/granularity results in more accurate

representation of data– Secondary SOC allocations allow for different

“ i ” f th d t“views” of the data

• This type of approach should be done cautiously

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cautiously

Synonym Lists b d d f l• Can be derived from existing term lists or

directly from verbatimsF i b t l b ti• For recurring, but unusual, verbatims – one-time assignment to a MedDRA termEnforces consistency by limiting choices once• Enforces consistency by limiting choices once MedDRA term is assigned

• Increases likelihood of autoencoding “hit”• Increases likelihood of autoencoding hit• Natural outgrowth of a legacy data

conversion

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conversion• Maintenance required

Synonym List Examples

Verbatim LLT Comment

Throbbing above templetemple

Aching all over headPulsing pain in head

Headache

Myalgia of lower

LLT Myalgia of lower extremities is

a better choice Muscular pain in legs

Myalgia of lower extremities

than LLT Muscular pain since it

captures both the

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captures both the event and body site

55

Synonym List Maintenance

• For new MedDRA versions, run synonyms against new MedDRA LLTs– Identify new non-current LLTs that are on

synonym list; flag for recoding– Identify possible new current direct matchesIdentify possible new current direct matches

• Remaining challenge is to determine if “better medical matches” have been addedmedical matches have been added (essentially, a manual process)

• Communicate results to users of synonym list

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y y

QA Reports

• Allows reviewers to check for consistency (both auto-encoded and y (human-coded terms)

• Check for adherence to/deviation from /coding conventions

• Check for emerging drifts/biasesg g /• Multiple data views (verbatims to coded

terms; coded term to verbatims; by

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; ; ySOC, etc.)

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MSSO-DI-6017-16.0.1 59

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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MTS:PTC Points of Note

• In some cases with more than one option for selecting terms, a “preferred option” is identified but this does not limit MedDRA users to applying that option.O gani ations sho ld be consistent in theiOrganizations should be consistent in their choice of option.Section 4 1 Versioning (Appendix)• Section 4.1 – Versioning (Appendix)– 4.1.1 Versioning methodologies

4 1 2 Timing of version implementation

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– 4.1.2 Timing of version implementation

General Term Selection PrinciplesQ lit f S D t• Quality of Source Data

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

Add I f i

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Add Information

63

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

MSSO-DI-6017-16.0.1 64

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

MSSO-DI-6017-16.0.1 65

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

MSSO-DI-6017-16.0.1 66

purposes

When 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

MSSO-DI-6017-16.0.1 67

Selecting 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

MSSO-DI-6017-16.0.1 69

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

MSSO-DI-6017-16.0.1

Lipase increased

70

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 )

MSSO-DI-6017-16.0.1

adjective and thus represents the test name only)

71

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

MSSO-DI-6017-16.0.1 72

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)

MSSO-DI-6017-16.0.1 73

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

MSSO-DI-6017-16.0.1 74

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

MSSO-DI-6017-16.0.1 75

• 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

MSSO-DI-6017-16.0.1 76

• 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)

MSSO-DI-6017-16.0.1 77

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”

MSSO-DI-6017-16.0.1 78

Diaphoresis


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”

MSSO-DI-6017-16.0.1 79

“Laryngospasm”


What Terms to Select?

S l d h k f bl• Sepsis leading to shock from possible spontaneous bacterial peritonitis or bowel perforationbowel perforationSepsis?Shock?Septic shock?Spontaneous bacterial peritonitis?Bowel perforation?

MSSO-DI-6017-16.0.1 80

Diagnoses and Provisional Diagnoses (cont)

• Always include signs/symptoms not associated• Always include signs/symptoms not associated with diagnosis

Reported LLT Selected

Myocardial infarction, chest pain, dyspnea, diaphoresis, ECG changes and jaundice

Myocardial infarction Jaundice (note that jaundice is

not typically associated with d l f ) ECG changes and jaundice myocardial infarction)

MSSO-DI-6017-16.0.1 81

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


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

MSSO-DI-6017-16.0.1

that is known, i.e., LLT Pain

82

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


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

MSSO-DI-6017-16.0.1 83


Cl l l f• Clinical complication of IUDIUD complication (PT Medical device complication)?complication)?Intra-uterine death (PT Foetal death)?Unevaluable event?

• Hypoglycemia (blood glucose = 200 mg/dL)Blood glucose abnormal?Blood glucose increased?Hypoglycemia?

MSSO-DI-6017-16.0.1 84

Hypoglycemia?

Combination Terms• One condition is more specific than the other• One condition is more specific than the other


Arrhythmia due to atrialfibrillation Atrial fibrillation

• A MedDRA combination term is available


Retinopathy due to diabetes Diabetic retinopathy

MSSO-DI-6017-16.0.1 85

Combination Terms (cont)If splitting provides more clinical information• If splitting provides more clinical information, select more than one term

• In all cases of combination terms, apply medical , pp yjudgment

Reported LLT Selectedp

Diarrhea and vomiting DiarrheaVomiting

Wrist fracture due to fall Wrist fractureFall

MSSO-DI-6017-16.0.1 86


l d f h l• Retinal disease from HIV with near total blindness (R and L)Retinal damage?Retinal damage?Retinal disorder?HIV disease?HIV disease?Blindness?HIV retinopathy?Blindness both eyes?

MSSO-DI-6017-16.0.1 87

Investigations

• Medical condition vs. investigation result


LLT HypoglycemiaHypoglycemia Hypoglycemia

yp g ylinks to SOC

Metabolism and nutrition disorders

Decreased glucose Glucose decreased LLT Glucose

decreased links to SOC Investigations

MSSO-DI-6017-16.0.1 88

SOC Investigations

Investigations (cont)Unambiguous investigation result• Unambiguous investigation result


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

MSSO-DI-6017-16.0.1 89

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

MSSO-DI-6017-16.0.1 90

increased SGOT and elevated LDH

SGOT increasedLDH increased

function tests abnormal should not

be selected.

What Terms to Select?• Testing showed increased serum• Testing showed increased serum

creatinine and BUN, with increased BUN/creatinine ratioBUN/creatinine ratioIncreased serum creatinine?BUN increased?BUN increased?Blood urea nitrogen/creatinine ratio increased?Renal function tests NOS abnormal?Renal function tests NOS abnormal?

• CSF was positive for Candida spp.Candidal meningitis?

MSSO-DI-6017-16.0.1 91

Candidal meningitis?Candida test positive?

Medication ErrorsSee Appendix B of MedDRA Introductory Guide for pp y

Concept Descriptions“Top-down” navigation in HLGT Medication errors

is best approach for term selectionis best approach for term selection

• Medication error with clinical consequencesqReported LLT Selected

Patient was administered wrong Wrong drug administereddrug and experienced hypotension

g gHypotension

Because of similar sounding drug names, the patient took the wrong

Drug name confusionWrong drug administered

MSSO-DI-6017-16.0.1 92

p gdrug and experienced a rash

g gRash

Medication Errors (cont)Important to record occurrence or potentialImportant to record occurrence or potential

occurrence of medication error• Medication error without clinical consequences

Reported LLT Selected CommentMedication was given

i t l i t d f Intramuscular

formulation If specifically reported that there is no adverse intravenously instead of

intramuscularly without sequelae

formulation administered by other

routeNo adverse effect

that there is no adverse effect, acceptable to select LLT No adverse

effectPh i t ti th t Pharmacist notices that the names of two drugs

are similar and is concerned that this may

Circumstance or information capable of leading to medication

LLT Drug name confusion could be an

optional additional term to select. Note: this

MSSO-DI-6017-16.0.1 93

yresult in a medication

error

gerror example is a potential

medication error.

Overdose, Toxicity and PoisoningIf overdose, poisoning or toxicity is explicitly , p g y p y

reported, select the appropriate term

• Overdose with clinical consequences• Overdose with clinical consequencesReported LLT Selected

Stomach upset from study drug Stomach upset

• Overdose without clinical consequences

p y goverdose

pOverdose


Patient received an overdose of medicine Overdose LLT No adverse

MSSO-DI-6017-16.0.1 94

overdose of medicine without any adverse

consequences

OverdoseNo adverse effect effect can also be

selected

Wh t T t S l t?What Term to Select?• Doctor prescribed the wrong drug. The

fp g g

pharmacist noticed the error before giving the drug to the patient.W d d i i t d?Wrong drug administered?Drug prescribing error?Intercepted drug prescribing error?Intercepted drug prescribing error?

• Unintentionally took more than maximum recommended dose due to dispensing errorAccidental overdose?

MSSO-DI-6017-16.0.1 95

Incorrect dose administered?Drug dispensing error?

Medication Errors Reported toMedication Errors Reported toEudraVigilance (EV) g ( )

• Examined selected medication error terms from MedDRA (Overdose terms excluded)( )• Grouped medication error terms related to medicines by Anatomical Therapeutic Chemical (ATC) classification system• Retrieved individual cases reported to EV in post-authorisation phase (includes non-serious adverse reactions reported periodically for centrally authorised products (CAPs)reported periodically for centrally authorised products (CAPs) in accordance with previous Volume 9A)

MSSO-DI-6017-16.0.1 96Acknowledgement: Dr. Sabine Brosch, EMA

Medication Error Cases inMedication Error Cases in EudraVigilanceg

MSSO-DI-6017-16.0.1

Proportion of medication error reports ~ double from outside EEA

97Acknowledgement: Dr. Sabine Brosch, EMA

M di ti E b ATC ClMedication Errors by ATC Class

*

Examples:

MSSO-DI-6017-16.0.1

Medication errors associated with ATC Group Nervous System refer mainly to treatment non-compliance with antipsychotics ** Incorrect dosing*** Problems injecting immunosuppressant leading to incomplete dosing (No ADR)

98Acknowledgement: Dr. Sabine Brosch, EMA

M di ti E A i t d ithMedication Errors Associated withSerious ADRs

% used as some productsfall into more than one category


M di ti E bMedication Errors byEMA Internal Groupingsp g


Mi Ab d Addi tiMisuse, Abuse and Addiction New MTS:PTC Section

MSSO-DI-6017-16.0.1 101

Coding Exercises• Narratives and short verbatims• Narratives and short verbatims• Assess the reported terms

– Identify what concepts are reported (diagnosis, y p p ( g ,death, investigations, etc.)

• Refer to the appropriate sections of the MTS:PTC for guidance on term selectionMTS:PTC for guidance on term selection– For example, Section 3.2 for death terms

• Use MTS:PTC preferred options (forget your• Use MTS:PTC preferred options (forget your organization’s conventions)

• Use browser to search for and select LLTs

MSSO-DI-6017-16.0.1 102

(also record PT and primary SOC)

Specific Tips for Narrative Exercises

• Overall, coding principles are the same as for short verbatim exercises

• Code all of the following:– Events (including procedures and ( g p

investigations as needed)– Indications– Medical history– Social history

MSSO-DI-6017-16.0.1

y

103

Sample Narrative

A 75-year-old male receiving Drug X for rheumatoid arthritis developed an arearheumatoid arthritis developed an area of darkened skin on his chest. The patient’s medical history is significantpatient s medical history is significant for peripheral vascular disease and cigarette smoking The skin lesion wascigarette smoking. The skin lesion was excised; it was revealed to be a seborrhoeic wart

MSSO-DI-6017-16.0.1

seborrhoeic wart.

104

Course SummaryI thi d• In this course, we covered:– A review of MedDRA’s scope and structure,

including primary SOC allocation rulesincluding primary SOC allocation rules– Coding conventions, synonym lists, and

coding QAcoding QA– Introduction to the MedDRA Term

Selection: Points to Consider document– Coding exercises

MSSO-DI-6017-16.0.1 105

MSSO Contacts• Web site• Web site

– www.meddramsso.com

E il• E-mail– [email protected]

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

• Fax (USA)

MSSO-DI-6017-16.0.1 106

Fax (USA)– +1 571.313.2345

6017-1601 Coding with MedDRA · Coding with MedDRA ... • An international multi-lingual...

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