6017-1700 Coding with MedDRA · – Used in interface between EudraVigilance and EU Risk ......

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Coding with MedDRA

MedDRA was developed under the auspices of the International Conference on Harmonisation ofInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals 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 ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the p ( , , , , , ),Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer).

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Disclaimer and Copyright Notice

This presentation is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under aincorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the presentation is acknowledged at all times. In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation. Any impression that the adaption, modification or translation of the original presentation is endorsed or sponsored by the ICH must be avoided. The presentation is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original presentation be liable for any claim, damages t e C o t e aut o s o t e o g a p ese tat o be ab e o a y c a , da agesor other liability arising from the use of the presentation.The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.

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Course Overview

• MedDRA backgroundM dDRA’ d h i i• MedDRA’s structure, scope, and characteristics

• MedDRA maintenance• Coding conventions• Synonym lists• QA of coding• MedDRA Term Selection: Points to Consider• MedDRA Term Selection: Points to Consider

document• Hands-on coding exercises

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MedDRA Background

What is MedDRA?

Med = MedicalD = Dictionary for

R = RegulatoryA = Activities

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MedDRA’s Purpose

• Facilitate the exchange of clinical information th h t d di tithrough standardization

• Important tool for product evaluation, monitoring, communication, electronic records exchange, and oversight

• Supports coding (data entry) and retrieval and analysis of clinical information about humananalysis of clinical information about human medical products including pharmaceuticals, biologics, vaccines, and drug-device combination products

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MedDRA and the MSSO

• International support and development of t i lterminology

• Foster use of MedDRA through communications and educational offerings

• “Custodians”, not owners, of the terminology• JMO (partner organization for Japanese-language

MedDRA)MedDRA)• Governed by a Management Board (industry,

regulators, multi-national, other interested parties)

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MedDRA Definition

MedDRA is a clinically-validated international di l t i l d b l tmedical terminology used by regulatory

authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, anddata entry, retrieval, evaluation, and presentation.

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Where MedDRA is Used

Individual Case Safety Reports and Safety SummariesRegulatory Authority and Industry Databases

Clinical Study ReportsInvestigators’ Brochures

Core Company Safety InformationMarketing Applications

PublicationsPrescribing Information

AdvertisingMSSO-DI-6017-17.0.0 10

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Regulatory Status

• US FDA– Used in several databases including FAERS (drugs

and biologics), VAERS (vaccines), and CAERS (foods, dietary supplements, cosmetics)

– 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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Regulatory Status (cont)

• European Union– EudraVigilance databaseEudraVigilance database

• Clinical trial SUSARs (Suspected Unexpected Serious Adverse Reactions)

• Post-authorization Individual Case Safety Reports (ICSRs)• Requires current version of MedDRA or the one previous to it

– Good pharmacovigilance practices (GVP) specifically mention MedDRA

– Pharmacovigilance legislation covers suspected adverse g g preactions from:

• Use inside and outside terms of marketing authorization• Overdose, misuse, abuse, and medication errors• Occupational exposures

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Regulatory Status (cont)

• European Union (cont)– Used in interface between EudraVigilance and EU Risk g

Management Plan– Used throughout Summary of Product Characteristics

(labeling) • ICH M4E Guideline on Common Technical Document

– Recommended in adverse event summary tables• Canada

– Used in Canada Vigilance database– Recommended/preferred terminology for adverse reaction

reporting and Product Monograph (labeling)

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MedDRA Overview

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Scope of MedDRA

Not a drug di i

Frequency lifi

INOUT

Medical conditionsIndications

Investigations (tests, results)Medical and surgical proceduresMedical, social, family history

Medication errorsProduct quality issuesD i l t d i

dictionary

Patient demographicterms

qualifiers

Numerical values forresults

IN

Device-related issuesPharmacogenetic terms

Toxicologic issuesStandardized queries

Not an equipment, device,diagnostic product dictionary

Clinical trial study design terms

Severity descriptors

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MedDRA Structure

System Organ Class (SOC) (26)System Organ Class (SOC) (26)

High Level Group Term (HLGT) (334)

High Level Term (HLT) (1,720)

Preferred Term (PT) (20 559)Preferred Term (PT) (20,559)

Lowest Level Term (LLT) (72,637)

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System Organ Classes

• Blood and lymphatic system disorders• Cardiac disorders

• Musculoskeletal and connective tissue disorders• Cardiac disorders

• Congenital, familial and genetic disorders• Ear and labyrinth disorders• Endocrine disorders• Eye disorders• Gastrointestinal disorders• General disorders and administration site

conditions• Hepatobiliary disorders

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

• Nervous system disorders• Pregnancy, puerperium and perinatal

conditions• Psychiatric disorders• Renal and urinary disorders• Reproductive system and breast disorders• Hepatobiliary disorders

• Immune system disorders• Infections and infestations• Injury, poisoning and procedural

complications • Investigations• Metabolism and nutrition disorders

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

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High Level Group Terms

Subordinate only to SOCs and superordinate grouping for one or more HLTsfor one or more HLTs

SOCCardiac disorders

HLGTCoronary artery

disorders

HLGTCardiac

arrhythmias

HLGTCardiac valve

disorders

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High Level Terms

Subordinate to HLGTs and superordinate grouping for th PT li k d t itthe PTs linked to it

SOCCardiac disorders

HLGTCa diac a h thmiasCardiac arrhythmias

HLTCardiac conduction

disorders

HLTRate and rhythm disorders NEC

HLTSupraventricular

arrhythmiasMSSO-DI-6017-17.0.0 19

Preferred Terms

SOC Cardiac disorders

Represents a single medical conceptSOC Cardiac disorders

HLGT Cardiac arrhythmias

HLT Rate and rhythm disorders NEC

PTArrhythmia

PTBradycardia

PTTachyarrhythmia

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SOC = Cardiac disorders

Lowest Level Terms

Synonyms, lexical variants, sub-elements

HLT = Rate and rhythm disorders NEC

HLGT = Cardiac arrhythmias

PT ArrhythmiaPT = Arrhythmia

LLTArrhythmia

LLTDysrhythmias

LLTArrhythmia

NOS LLT (Non-current)Other specified cardiac

dysrhythmiasMSSO-DI-6017-17.0.0 21

Non-Current Terms

• Flagged at the LLT level in MedDRAN t d d f ti d• Not recommended for continued use

• Retained to preserve historical data for retrieval and analysis

• Terms that are vague, ambiguous, out-dated, truncated, or misspelled

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

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MedDRA Codes

• Each MedDRA term assigned an 8-digit i d t ti ith “1”numeric code starting with “1”

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

electronic submission types (e.g., E2B)New terms are assigned sequentially• New terms are assigned sequentially

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Codes and Languages

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A Multi-Axial Terminology

• Multi-axial = the representation of a medical concept in multiple SOCsconcept in multiple SOCs– Allows grouping by different classifications– Allows retrieval and presentation via different data

sets• Purpose of Primary SOC

– Determines which SOC will represent a PT during l ti d t t tcumulative data outputs

– Is used to support consistent data presentation for reporting to regulators

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SOC = Respiratory, thoracic and SOC = Infections and

A Multi-Axial Terminology (cont)

SOC Respiratory, thoracic andmediastinal disorders

HLGT = Respiratory tract infections

HLGT = Viral infectious disorders

SOC Infections and infestations

HLT = Viral upper respiratorytract infections

HLT = Influenza viral infections

PT = InfluenzaMSSO-DI-6017-17.0.0 26

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Rules for Primary SOC Allocation

• PTs for diseases, signs and symptoms are assigned to prime manifestation site SOCmanifestation site SOC

• Congenital and hereditary anomalies terms have SOC Congenital, familial and genetic disorders as Primary SOC

• Neoplasms terms have SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) as 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 ti th f ll i i it ill b dexceptions, the following priority will be used

to determine primary SOC:1st: Congenital, familial and genetic disorders2nd: Neoplasms benign, malignant and

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

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A Multi-Axial Terminology (cont)

PTs in the following SOCs only appear in that ti l SOC d t i th i thparticular SOC and not in others, i.e., they

are not multi-axial

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

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SOC Congenital, familial and genetic disorders -Example

PT HLT HLGT SOC

Congenital Viral infections Infections and CongenitalCongenital HIV infection

Viral infections congenital

Infections and infestations congenital

Congenital, familial and genetic disorders (P)

Congenital neonatal infections

Neonatal and perinatal conditions

Pregnancy, puerperium and perinatal conditions

Retroviral infections

Viral infectious disorders

Infections and infestations

Acquired immunodeficiency syndromes

Immunodeficiency syndromes

Immune system disorders

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Conditions vs. Investigations

PT HLT HLGT SOCPT HLT HLGT SOC

Pregnancy test positive

Reproductive hormone analyses

Endocrine investigations (incl sex hormones)

Investigations

Pregnancy Normal pregnancy,

Pregnancy, labour,

Pregnancy, puerperium

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

labour and delivery

delivery and postpartum conditions

and perinatal conditions

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Standardised MedDRA Queries (SMQs)

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

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

Osteonecrosis

9 S Q l bl d 0• 94 SMQ topics available in MedDRA v17.0• More information on MedDRA website

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MedDRA Maintenance

MedDRA Maintenance

• MedDRA is a user-responsive terminology • Users may submit change requests (CRs) to the MSSOUsers may submit change requests (CRs) to the MSSO

for consideration– Each organization: up to 100 CRs per month– For simple changes (PT and LLT levels), notification of

final disposition within 7-10 working days– Complex changes above PT level received all year round.

Posted for users’ comments mid-year.• Twice yearly official updates

– 1 March X.0 release (Complex and simple changes)– 1 September X.1 release (Simple changes only)

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WebCR

• Web-based tool for Change Requests (CR)– URL: https://mssotools.com/webcr/– Via the Change Request Information page

• Ability to submit CRs online• Immediate confirmation• Review unsubmitted CRs onlineReview unsubmitted CRs online• Ability to query CR history back to v5.1

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Proactive MedDRA Maintenance

• What is the proactive approach?C ti /i t d i t ll b th MSSO– Corrections/improvements made internally by the MSSO

– General changes suggested by users• Submitting ideas

– Send to MSSO Help Desk. Justification is helpful.– Example: Review placement of bruise and contusion terms to

facilitate coding and analysisEvaluation of proposals• Evaluation of proposals– MSSO is not obligated to respond– Proactive approach does not replace usual CR process

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MedDRA Version Analysis Tool (MVAT)

• Web-based (https://mssotools.com/mvat)• Free to all users• Allows for comparison of any two versions• Features

– Version Report Generator (produces exportable report comparing any two versions)Data Impact Report (identifies changes to a specific set– 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 MedDRA term or code)

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MSSO’s MedDRA Browsers

• MedDRA Desktop and Web-Based Browsers– View/search MedDRA and SMQs– Support for all MedDRA languages– Export functionality

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MedDRA Browser Demonstration and Instruction

Coding Exercises

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Assessing the Reported Information

• Consider what is being reported. Is it a:– Clinical condition - Diagnosis, sign or symptom?Clinical condition Diagnosis, sign or symptom?– Indication?– Test result?– Injury?– Procedure?– Medication error?– Product quality issue?– Social circumstance?– Device issue?

The type of report will influence the way you search for a suitable LLT. It may indicate in whichDevice issue?

– Procedural complication?

– Is it a combination of these?

It may indicate in which SOC you expect to find the closest match.

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MedDRA Browsing Tips

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

Search different word orders “and” “or” etc• Search different word orders, “and”, “or”, etc.• Use available resources for difficult verbatim terms (web

search, medical dictionaries, colleagues)

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Exercise 1

Th ti t t t h h b i i h d hThe patient states she has been experiencing headaches, dizziness and vertigo.

_______________ 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.

_______________ LLT _______________ PT

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Exercise 4

A six year old boy was admitted for antipsychotic toxicity after accidentally ingesting the remaining tablets in the bottle.

_______________ LLT _______________ PT_______________ LLT _______________ PT

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Exercise 5

The patient’s insulin pump was noted to be broken.

_______________ LLT _______________ PT

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Why Do We Need Coding Conventions?

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

to manually code terms in MedDRA compared to older terminologies)

• Even with an autoencoder, may still need l dimanual coding

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

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

representation of data– Secondary SOC allocations allow for different “views” of

the data

Thi t f h h ld b d ti l• This type of approach should be done cautiously

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Synonym Lists • Recurring verbatims – one-time assignment to an LLT• Promotes consistency• Increases likelihood of autoencoding “hit” • Maintenance required

Verbatim LLT CommentThrobbing above temple

Aching all over headPulsing pain in head

Headache

l f l

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Muscular pain in legs Myalgia of lower extremities

LLT Myalgia of lower extremities is a better

choice than LLT Muscular pain since it

captures both the event and body site

QA Reports

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

• Check for adherence to/deviation from coding conventions

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

terms; coded term to verbatims; by SOC, etc.)

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• Provides term selection advice for industry and

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

advice for industry and regulatory purposes

• Objective is to promote accurate and consistent term selection to facilitate a common understanding of shared dataof shared data

• Recommended to be used as basis for individual organization’s own coding conventions

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MedDRA Term Selection: PTC (cont)

• Developed by a working group of the ICH Steering CommitteeCommittee– Regulators and industry representatives– EU, Japan, USA– Canadian observer, MSSO, JMO

• Updated twice yearly with each MedDRA release• Available on MedDRA and JMO websites

English and Japanese– English 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” isselecting terms, a “preferred option” is identified but this does not limit MedDRA users to applying that option. Organizations should be consistent in their choice of option.

• Section 4.1 – Versioning (Appendix)g ( pp )– 4.1.1 Versioning methodologies– 4.1.2 Timing of version implementation

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General Term Selection Principles

• Quality of Source Data• Quality Assurance• Quality Assurance• Do 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 TermSelecting More than One Term• Check the Hierarchy• Select Terms for All Reported Information, Do Not Add

Information

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Quality of Source DataQuality Assurance

• Quality of original information impacts quality of outputoutput

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

collection forms and proper training of staff• Organizations’ coding guidelines should be

consistent with MTS:PTCf l b l f d d d l• Review of term selection by qualified individuals

• Human oversight of automated coding results

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Do Not Alter MedDRA

• MedDRA is a standardized terminology with a d f d h hpre-defined term hierarchy

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

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

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Always Select a Lowest Level TermSelect Only Current LLTs

• Lowest Level Term that most accurately reflects ythe reported verbatim information should be selected

• Degree of specificity may be challenging– Example: “Abscess on face” select “Facial abscess,”

not simply “Abscess”• Select current LLTs only• Select current LLTs only

– Non-current terms for legacy conversion/historical purposes

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When to Request a TermUse of Medical Judgment

• Avoid company-specific “work-arounds” for M dDRA d fi i i If t t d t lMedDRA deficiencies. If concept not adequately represented in MedDRA, submit Change Request to MSSO.

• If no exact match in MedDRA, use medical judgment to match to an existing term that adequately represents the concept

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Selecting More than One TermCheck the Hierarchy

• Can select more than one LLT to represent reported i f ti D t dinformation. Document procedures. – Selecting one term may lead to loss of specificity– Selecting more than one term may lead to redundant

counts• Check the hierarchy above a selected LLT (PT, HLT,

HLGT, SOC) to ensure placement accurately reflects meaning of reported term

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Select Terms for All Reported Information

• Select terms for every AR/AE reported, dl f l i tiregardless of causal association

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

i tappropriate

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Do Not Add Information

• Do not make diagnosis if only signs/symptoms reported

Reported LLT Selected Comment

Abdominal pain,

Abdominal pain

It is inappropriate to S lincreased serum

amylase, and increased serum lipase

assign an LLT for diagnosis of “pancreatitis”

Serum amylase increased

Lipase increased

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Autoencoder Pitfalls

• Inappropriate terms may be selected by autoencoderautoencoder

• Review all autoencoding carefully– “Allergic to CAT scan” autoencoded as:

LLT Allergic to cats– “Myocardial infarction in the fall of 2000”

autoencoded as:autoencoded as:LLT Myocardial infarction LLT Fall

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FDA-Defined Coding Errors

• Missed ConceptsMissed 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 LFTs (missed concept of pancreatitis)

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

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

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FDA-Defined Coding Errors (cont)

• “Soft Coding”– Selecting a term which is both less specific and less

severe than another MedDRA term is “soft coding”– Example: “Liver failure” coded as hepatotoxicity or

increased LFTs – Example: “Aplastic anemia” coded as unspecified anemia– Example: “Rash subsequently diagnosed as Stevens– Example: Rash subsequently diagnosed as Stevens

Johnson syndrome” coded as rash

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

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Term Selection Points

• Diagnoses and Provisional Diagnoses with or without Signs and SymptomsD th d Oth P ti t O t• Death and Other Patient Outcomes

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

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Term Selection Points (cont)

• Medication/Administration Errors, Accidental Exposures and Occupational ExposuresMi Ab d Addi ti• Misuse, Abuse and Addiction

• Transmission of Infectious Agent via Product• Overdose, Toxicity and Poisoning• Device-related Terms• Drug Interactions• No Adverse Effect and “Normal” Terms• Unexpected Therapeutic Effect• Modification of Effect• Social Circumstances• Social Circumstances• Medical and Social History• Indication for Product Use• Off Label Use• Product Quality Issues

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Diagnoses and Provisional Diagnoses

SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSISDEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis without signs and symptoms

•Diagnosis (only possible option)

Single provisional diagnosis without signs and symptoms

•Provisional diagnosis (only possible option)

Example: “Myocardial infarction” Example: “Possible myocardial p y select “Myocardial infarction”

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

Similar principles apply for multiple diagnoses71MSSO-DI-6017-17.0.0

Diagnoses and Provisional Diagnoses (cont)

SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis with signs/ symptoms

•Preferred: Diagnosis only

Single provisional diagnosis with signs/symptoms

•Preferred: Provisional diagnosis and signs/symptoms

Example: “Anaphylactic reactionwith rash dyspnoea

Example: “Possible myocardial infarction with chest painwith rash, dyspnoea,

hypotension, and laryngospasm” select “Anaphylactic reaction”

infarction with chest pain,dyspnoea, diaphoresis” select “Myocardial infarction” “Chest pain”, “Dyspnoea”, and “Diaphoresis”

Similar principles apply for multiple diagnoses 72MSSO-DI-6017-17.0.0

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SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis with signs/ symptoms

•Alternate: Diagnosis and signs/symptoms

Single provisional diagnosis with signs/symptoms

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

Example: “Anaphylactic reaction Example: “Possible myocardial p p ywith rash, dyspnoea, hypotension, and laryngospasm” select “Anaphylactic reaction”, “Rash”, “Dyspnoea”, Hypotension”, and “Laryngospasm”

p yinfarction with chest pain,dyspnoea, diaphoresis” select “Chest pain”, “Dyspnoea”, and “Diaphoresis”

Similar principles apply for multiple diagnoses 73MSSO-DI-6017-17.0.0


• Always include signs/symptoms not associated with diagnosis

Reported LLT Selected

Myocardial infarction, chest pain dyspnoea diaphoresis

Myocardial infarction Jaundice (note that jaundice is

pain, dyspnoea, diaphoresis, ECG changes and jaundice

( jnot typically associated with

myocardial infarction)

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What Terms to Select?

• Sepsis leading to shock from possible spontaneous bacterial peritonitis or bowelspontaneous bacterial peritonitis or bowel perforationSepsis?Shock?Septic shock?Spontaneous bacterial peritonitis?Spontaneous bacterial peritonitis?Bowel perforation?

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Conflicting/Ambiguous Information

• First, try to obtain more specific informationReported LLT Selected Comment

Hyperkalaemia 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

mEq/L is a low result, not high)

“GU” could be either “genito-

GU pain Pain

GU could be either genitourinary” or “gastric ulcer”. If additional information is not available, then select a term to reflect the information that

is known, i.e., LLT Pain

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Vague Information

• First, try to obtain more specific informationReported LLT Selected Comment

Turned green Unevaluable event

“Turned green” reported alone is vague; this could

refer to a patient condition or even to a product (e.g., pills)

Patient had a medical problem of unclear type

Ill-defined disorder

Since it is known that there is some form of a medical disorder, LLT Ill-defined

disorder can be selected

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• Clinical complication of IUDIUD li i (PT M di l d iIUD complication (PT Medical device complication)?Intra-uterine death (PT Foetal death)?Unevaluable event?

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

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Combination Terms

• One condition is more specific than the other

• A MedDRA combination term is available


Arrhythmia due to atrial fibrillation Atrial fibrillation

Hepatic function disorder (acute hepatitis)

Hepatitis acute

R t d LLT S l t dReported LLT Selected

Retinopathy due to diabetes Diabetic retinopathy

Rash with itching Itchy rash

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Combination Terms (cont)

• If splitting provides more clinical information, select more than one termmore than one term

• In all cases of combination terms, apply medical judgment


Diarrhoea and vomiting DiarrhoeaVomitingVomiting

Wrist fracture due to fall Wrist fracture

Fall

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

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Investigations

• Medical condition vs. investigation result


Hypoglycaemia HypoglycaemiaLLT Hypoglycaemia

links to SOC Metabolism and

nutrition disorders

Decreased glucose Glucose decreased LLT Glucose decreased

links to SOC Investigations

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Investigations (cont)

• Unambiguous investigation result

• Ambiguous investigation result


Glucose 40 mg/dL Glucose low Glucose is clearly

below the reference range


His glucose was 40 Glucose abnormal

No units have been reported. Select LLTGlucose abnormal if

clarification cannot be obtained.

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Investigations (cont)

• Investigation results consistent with diagnosis

• Grouped investigation result termsReported LLT Selected Comment


Elevated potassium, K 7.0 mmol/L, and hyperkalaemia

Hyperkalaemia It is not necessary to select LLT Potassium

increased


Increased alkaline phosphatase,

increased SGPT, increased SGOT and

elevated LDH

Alkaline phosphataseincreased

SGPT increasedSGOT increasedLDH increased

Select four individual terms. A single term

such as LLT Liver function tests

abnormal should notbe selected.

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• Testing showed increased serum creatinineand BUN with increased BUN/creatinine ratioand BUN, with increased BUN/creatinine ratio

Increased serum creatinine?BUN increased?Blood urea nitrogen/creatinine ratio increased?Renal function tests NOS abnormal?

• CSF was positive for Candida spp.p ppCandidal meningitis?Candida test positive?

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Medication Errors

See Appendix B of MedDRA Introductory Guide for Concept DescriptionsConcept Descriptions

“Top-down” navigation in HLGT Medication errors is best approach for term selection

• Medication error with clinical consequencesReported LLT Selected

Patient was administered wrong drug and experienced hypotension

Wrong drug administeredHypotension

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

drug and experienced a rash

Drug name confusionWrong drug administered

Rash

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Medication Errors (cont)

Important to record occurrence or potential occurrence of medication error

• Medication error without clinical consequencesReported LLT Selected Comment

Medication was given intravenously instead of intramuscularly without

sequelae

Intramuscular formulation administered by other

routeNo adverse effect

If specifically reported that there is no adverse

effect, acceptable to select LLT No adverse

effect

Pharmacist notices that the names of two drugs

are similar and is concerned that this may

result in a medication error

Circumstance or information capable of leading to medication

error

LLT Drug name confusion could be an

optional additional term to select. Note: this

example is a potential medication error.

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Overdose, Toxicity and Poisoning

If overdose, poisoning or toxicity is explicitly reported select the appropriate termreported, select the appropriate term

• Overdose with clinical consequences

• Overdose without clinical consequences


Stomach upset from study drug overdose

Stomach upsetOverdose

Reported LLT Selected Preferred Option

Patient received an overdose of medicine without any adverse

consequences

Overdose

OverdoseNo adverse effect

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What Term to Select?

• Doctor prescribed the wrong drug. The pharmacist noticed the error before giving the d t th ti tp g gdrug to the patient.Wrong drug administered?Drug prescribing error?Intercepted drug prescribing error?

• Unintentionally took more than maximum recommended dose due to dispensing errorAccidental overdose?Incorrect dose administered?Drug dispensing error?

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Misuse, Abuse and Addiction

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Coding Exercises

• Narratives and short verbatimsAssess the reported terms• Assess the reported terms– Identify what concepts are reported (diagnosis, death,

investigations, etc.)• Refer to the appropriate sections of the MTS:PTC for

guidance on term selection– For example, Section 3.2 for death terms

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

• Use browser to search for and select LLTs (also record PT and primary SOC)

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Specific Tips for NarrativeExercises

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

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

as needed)– Indications– Medical history– Social history

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Sample Narrative

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

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Course Summary

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

including primary SOC allocation rules– Coding conventions, synonym lists, and coding QA– Introduction to the MedDRA Term Selection:

Points to Consider documentC di i– Coding exercises

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MSSO Contacts

• Website– www.meddramsso.com

• Email– [email protected]

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6017-1700 Coding with MedDRA · – Used in interface between EudraVigilance and EU Risk ......

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