coding with confidence - meddra with confidence ... pregnancy normal pregnancy, labour and delivery...

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Coding with ConfidenceHilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited)

Tomás Moraleda (Medical Officer – MSSO) 25th Annual

EuroMeetingEuroMeeting4-6 March 2013RAI, Amsterdam

Netherlands

The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers members chapters councils Special Interest Area

Disclaimer

volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.

These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved Drug Information Association DIA and DIA logo are registeredreserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

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MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical R i t f R i t ti f Ph ti l f

About MedDRA

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 Medicines and Healthcare products Regulatory Agency (MHRA) of the UKHealthcare products Regulatory Agency (MHRA) of the UK, the Health Canada, and the WHO (as Observer).

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• Describe how to code clinical safety

Learning Objectives

data accurately and consistently with MedDRA

• Apply the principles described in the ICH-endorsed “MedDRA Term Selection: Points to Consider”Selection: Points to Considerdocument

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• MedDRA refresher

“M dDRA T S l ti P i t t

Workshop Overview

• “MedDRA Term Selection: Points to Consider” document

• Browsing and coding tips and tricks

• Practical exercises

B t ti• Best practices

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MedDRA Refresher

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MedDRA is a clinically-validated international medical terminology used by

MedDRA Definition

international medical 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 entrypost-marketing, and for data entry, retrieval, evaluation, and presentation.

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Scope of MedDRA

DiseasesDiagnoses

Not a drug dictionary

Frequency qualifiersINOUT

DiagnosesSigns

SymptomsTherapeutic indicationsInvestigation names &

qualitative resultsMedical & surgical proceduresMedical, social, family history

Medication errors

y

Patient demographicterms

Numerical values forresults

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Product quality, device issues

Not an equipment, device,diagnostic product dictionary

Clinical trial study design terms

Severity descriptorsTerms from other terminologies

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System Organ Class (SOC) (26)

MedDRA Structure

High Level Group Term (HLGT) (334)

High Level Term (HLT) (1,717)

Preferred Term (PT) (20 057)Preferred Term (PT) (20,057)

Lowest Level Term (LLT) (71,326)

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MedDRA Version 16.0

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System Organ Classes

• Blood and lymphatic system disorders• Cardiac disorders• Congenital, familial and genetic disorders

• Musculoskeletal and connective tissue disorders

• Neoplasms benign, malignant and unspecified (i l t d l )• Ear and labyrinth disorders

• Endocrine disorders• Eye disorders• Gastrointestinal disorders• General disorders and administration site

conditions• Hepatobiliary disorders• Immune system disorders

(incl cysts and polyps)• Nervous system disorders• Pregnancy, puerperium and perinatal

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

Ski d b i di d

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• Infections and infestations• Injury, poisoning and procedural

complications • Investigations• Metabolism and nutrition disorders

• Skin and subcutaneous tissue disorders• Social circumstances• Surgical and medical procedures• Vascular disorders

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SOC = Cardiac disorders

MedDRA hierachy

HLT = Rate and rhythm disorders NEC

HLGT = Cardiac arrhythmias

PT = Arrhythmia LLTPT Arrhythmia

LLTArrhythmia

LLTDysrhythmias

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LLTArrhythmia

NOS

LLT (Non-current)Other specified cardiac

dysrhythmias

• Non-current terms are flagged at the LLT level within MedDRA

Non-Current Terms

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

preserve historical data for retrieval and analysis

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

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

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• Each MedDRA term assigned an 8-digit numeric code

MedDRA Codes

• The code is non-expressive

• Codes can fulfill a data field in various electronic submission types (e.g., E2B)

• Initially assigned alphabetically by term starting with 10000001starting with 10000001

– New terms are assigned sequentially

• Critical for “upversioning”

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• Multi-axial = the representation of a medical concept in multiple SOCs

A Multi-Axial Terminology

– Allows grouping by different classifications

– Allows retrieval and presentation via different data sets

• Purpose of Primary SOC– Determines which SOC will represent a PTDetermines which SOC will represent a PT

during cumulative 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 = Influenza

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• PTs in the following SOCs only appear in that particular SOC and not in others; i e

A Multi-Axial Terminology (cont)

that particular SOC and not in others; i.e., they are not multi-axial:

– Investigations

– Surgical and medical procedures

– Social circumstances

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• PTs for diseases, signs and symptoms are assigned to prime manifestation site SOCC it l d h dit li t h SOC

Rules for Primary SOC Allocation

• 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 y y

as Primary SOC

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

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• If a PT links to more than one of the exceptions, the following priority will be

Primary SOC Priority

used to determine primary SOC:

1st: Congenital, familial and genetic disorders

2nd: Neoplasms benign, malignant and nspecified (incl c sts and pol ps)unspecified (incl cysts and polyps)

3rd: Infections and infestations

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Conditions vs. Investigations

PT HLT HLGT SOC

Pregnancy test Reproductive Endocrine InvestigationsPregnancy test positive

Reproductive hormone analyses

Endocrine investigations (incl sex hormones)

Investigations

Pregnancy Normal pregnancy, labour and delivery

Pregnancy, labour, delivery and postpartum

Pregnancy, puerperiumand perinatalconditions

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

delivery postpartum conditions

conditions

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

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• There are two PTC documents

MedDRA PTC Documents

– Term Selection

– Data Retrieval and Presentation

• Using MedDRA is a big step forward

Using MedDRA the• Using MedDRA the same way is a leap toward harmonization

21www.diahom

• Differences in medical aptitude of coders

Why Do We Need Coding Conventions?

• Consistency concerns (many more “choices” to manually code terms in MedDRA compared to older terminologies)

• Even with an autoencoder, will still need manual coding and reviewmanual coding and review

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• An ICH-endorsed guide for MedDRA users• Developed to promote medically accurate

MedDRA Term Selection: Points to Consider

Developed to promote medically accurate and consistent use of MedDRA in exchange of data (ultimately, for “medically meaningful” retrieval and analysis)

• Current version available on MedDRACurrent version available on MedDRA MSSO Web site (http://www.meddramsso.com/subscriber_library_ptc.asp)

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• In cases with more than one option for selecting terms, the “preferred option” is

MedDRA Term Selection PTC (cont)

g , p pidentified but this does not restrict MedDRA users from selecting one of the alternative options. 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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• Quality of Source Data• Quality Assurance

General Term Selection Principles

• 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 Termg• Check the Hierarchy• Select Terms for All Reported Information, Do Not Add

Information

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

Do Not Alter MedDRA

p y• Users must not make ad hoc structural

alterations, including changing the primary SOC allocation

• If terms are incorrectly placed, or the concept is missing submit a changeconcept is missing, submit a change request to the MSSO

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• Can be derived from existing term lists or directly from verbatims

Synonym Lists

• For recurring, but unusual, verbatims – one-time assignment to a MedDRA term

• Enforces consistency by limiting choices once MedDRA term is assigned

• Increases likelihood of autoencoding “hit”

• Natural outgrowth of a legacy data conversion

• Maintenance required

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Synonym List Examples

Verbatim LLT Comment

Throbbing above templetemple

Aching all over headPulsing pain in head

Headache

Muscular pain in legsMyalgia of lower

LLT Myalgia of lower extremities is a better choice than LLT Muscular pain

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Muscular pain in legsextremities

LLT Muscular pain since it captures

both the event and body site

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• Lowest Level Term that most accurately reflects the reported verbatim

Always Select a Lowest Level Term

reflects the reported verbatim information should be selected

• Degree of specificity may be challenging– Example: “Abscess on face” select “Facial abscess ” not simply “Abscess”Facial abscess, not simply Abscess

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• Diagnoses and Provisional Diagnoses with or without Signs and Symptoms

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

Term Selection Points

• 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 FeedingExposures During Pregnancy and Breast Feeding• Congenital Terms• Neoplasms• Medical and Surgical Procedures• Investigations

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• Medication/Administration Errors, Accidental Exposures and Occupational Exposures

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

Term Selection Points (cont)

g• Overdose, Toxicity and Poisoning• Device-related Terms• Drug Interactions• No Adverse Effect and “Normal” Terms• Unexpected Therapeutic Effect• Modification of Effect• 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 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” select

Example: “Possible myocardial infarction” select

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f“Myocardial infarction”

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

Similar principles apply for multiple diagnoses

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Diagnoses and Provisional Diagnoses (cont)

SINGLE DIAGNOSISDEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis with signs/ Single provisional diagnosis with g g gsymptoms

•Preferred: Diagnosis only

g p gsigns/symptoms

•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

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hypotension, and laryngospasm select “Anaphylactic reaction”

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


SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS

Single diagnosis with signs/ Single provisional diagnosis with 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 reactionwith rash dyspnea hypotension

Example: “Possible myocardial infarction with chest pain

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with rash, dyspnea, hypotension, and laryngospasm” select “Anaphylactic reaction”, “Rash”, “Dyspnea”, Hypotension”, and “Laryngospasm”

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

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• Always include signs/symptoms not associated with diagnosis


g

Reported LLT Selected

Myocardial infarction, chest pain dyspnea diaphoresis

Myocardial infarction Jaundice (note that jaundice is

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pain, dyspnea, diaphoresis, ECG changes and jaundice

jnot typically associated with

myocardial infarction)

• First, attempt to obtain more specific information

Conflicting/Ambiguous/Vague Information

Reported LLT Selected CommentReported LLT Selected Comment

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 mEq/L is a low result,

not high)

GU pain Pain “GU” could be either

“genito-urinary” or “gastric l ” i “ i ” i

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GU pain Pain ulcer”. Since “pain” is definite, select LLT Pain

Congestion Unevaluable event “Congestion” reported alone is vague; this can

refer to multiple organs and physiologic processes

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• One condition is more specific than the other

Combination Terms


• A MedDRA combination term is available


Arrhythmia due to atrial fibrillation Atrial fibrillation


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p

Retinopathy due to diabetes Diabetic retinopathy

• If splitting provides more clinical information, select more than one termI ll f bi ti t l di l

Combination Terms (cont)

• In all cases of combination terms, apply medical judgment


Diarrhea and vomiting DiarrheaVomiting

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Wrist fracture due to fall Wrist fractureFall

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• No MedDRA term including both microorganism and anatomic location

Location Specific vs. Microorganismspecific infection

Reported LLT Selected Preferred Option

Comment

Respiratory chlamydial

Chlamydial infection Respiratory infection

Represents both microorganism

specific infection and anatomic

location Represents

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chlamydial infection Respiratory infection

Represents location-specific

infection

Chlamydial infection Represents

microorganism specific infection

• MedDRA term includes body site and event information

Body Site vs. Event Specificity


• No MedDRA term that includes body site and event. Event information has priority.

Reported LLT Selected Comment


Skin rash on face Rash on face

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Skin rash on chest Skin rash

In this instance, there is no available term for a skin rash

on the chest

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• No MedDRA term that includes body site and event. Exercise judgment; body site may take priority.

Body Site vs. Event Specificity (cont)

priority.


Cyanosis at injection Injection site

Cyanosis implies a generalized disorder.

In this example, selecting LLT Cyanosis

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y jsite

jreaction

g ywould result in loss of

important medical information and

miscommunication.

Procedure and diagnosis are reported

• If a procedure is reported with a diagnosis, the preferred option is to select terms for both the

Reported LLT Selected Preferred Option Comment

Selecting term for the procedure may indicate severity of

the condition

preferred option is to select terms for both the procedure and diagnosis. Alternatively, select a term only for the diagnosis.

Liver transplantation due to liver injury

Liver transplantation Liver injury

Liver injury

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EU PV Directive:

Impacts on MedDRAImpacts on MedDRA and MTS:PTC Document

• Impacts on MedDRA and MTS:PTC document

Directive Covered Topics

document

• ISO ICSR [E2B (R3)]

• Patient Reporting

• Safety Signal Detection Responsibilities

• New CT 3 (Clinical Trials Safety• New CT 3 (Clinical Trials Safety Reporting)

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EU PV Directive

Drug Information Association www.diahome.org 45

http://ec.euroa.eu/health/files/eudralex/vol-1/dir_2010_84_en.pdf

Chapter 17

Member States should operate a pharmacovigilance

EU Pharmacovigilance Directive

p p gsystem to collect information that is useful for the monitoring of medicinal products, including information on suspected adverse reactions arising from use of a medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisationoutside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.

Drug Informwww.diahom

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• Noxious and unintended effects resulting from authorized use of a medicinal product at normal doses

• There is regulatory interest in “special situations”

Amended Definition of Adverse Reaction

There is regulatory interest in special situations• Off label use

• Overdose

• Misuse

• Abuse

• Medication errors

• Occupational exposure

• MedDRA covers most such concepts and can expand as needed through Change Requests

• MTS:PTC provides definitions and coding examples.

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Medication Errors

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• Appendix B in MedDRA Introductory Guide

Medication Errors (cont.)

• To assist in understanding and appropriate use of medication error and product quality issue terms in regulatory reporting

• Medication error descriptions developed by FDA and MSSOFDA and MSSO

• Note that Occupational Exposures has been added to section name

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• 3.15.1 Medication/Administration Errors

Medication Errors (cont.)

– 3.15.1.1 Medication errors reported with clinical consequences

– 3.15.1.2 Medication errors and potential medication errors reported without clinical consequences

– 3.15.1.3 Medication errors in the context of labeled i t tiinteractions

– 3.15.1.4 Do not infer a medication error

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• There can be overlap between product quality issues and medication errors

Medication Errors and Product Quality Issues

• An example of both a product quality issue and a medication error is provided

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Accidental Exposures

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Occupational Exposures

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Occupational Exposures (cont.)

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Misuse, Abuse and Addiction

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• Currently 7 terms in MedDRA

Misuse – Terms in MedDRA

• Note that misuse is considered intentional

• LLT Unintentional device misuse is therefore not a misuse concept

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Misuse (cont.)

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Misuse (cont.)

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Abuse

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Abuse (cont.)

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Addiction

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Addiction (cont.)

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• Prior to MedDRA Version 8.0, only one term existed - PT Medication error

Expansion of Medication Error Terms

• Medication error section expanded in v8.0– Added HLGT Medication errors in SOC Injury,

poisoning and procedural complications• HLT Maladministrations

• HLT Medication errors due to accidental exposures

• HLT Medication monitoring errorsHLT Medication monitoring errors

• HLT Overdoses

• HLT Medication errors NEC

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Off Label Use

3.27 – Off Label Use

The concept of “off label use” relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorized product information.

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Off Label Use (cont.)

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Off Label Use (cont)

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Off Label Use (cont)

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FDA- DefinedFDA- Defined Coding Errors

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• Missed Concepts– All medical concepts described after the product is

k h ld b d d

FDA-Defined Coding Errors

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 developed interstitial nephritis which later deteriorated into renalinterstitial 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

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

FDA-Defined Coding Errors (cont)

g psevere 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

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

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– Deer ria– Big fat ugly cow

Animal Pharma: Challenging Verbatims

– Hippo tension– Wanted to take an elephant dump– Mousy feeling in chest– Beasting R arm– Menstrual clams– Seeing people in room, seeing chickens at windowg p p , g– Seeing stars and chicken farting– Patient recently began new job where he works

around chicken wings and barbecue sauce

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MedDRA Data Retrieval and Presentation: Points to Consider

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Data Retrieval and Presentation PTC

• An ICH-Endorsed Guide for MedDRA users on Data OutputOutput

• Developed by an ICH Expert Working Group• Provides data retrieval and presentation options for

industry or regulatory purposes• Objective is to promote understanding of implications

that various options for data retrieval have on accuracy and consistency of final output

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accuracy and consistency of final output• Current version available on MedDRA MSSO Web site

(http://www.meddramsso.com/subscriber_library_ptc.asp)

Data Retrieval PTC: Points Addressed

• General Principles– Quality of Source Datay– Documentation of Data Retrieval and Presentation Practices– Do Not Alter MedDRA – Organization-Specific Data Characteristics – Characteristics of MedDRA that Impact Data Retrieval and

Analysis– MedDRA Versioning

• General Queries and Retrieval

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General Queries and Retrieval• Standardised MedDRA Queries• Customized Searches

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Definition of SMQ

• Result of cooperative effort between CIOMS and ICH (MSSO)

• Groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest

• Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data etc related to

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and other physiologic test data, etc., related to medical condition or area of interest

• Intended to aid in case identification

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As of Version 16.0, a total of 90 in production

• Peripheral neuropathy• Pregnancy and neonatal

topics

SMQs in Production - Examples

• Agranulocytosis• Anaphylactic reaction• Cerebrovascular disorders• Convulsions• Depression and

suicide/self injury

topics• Pseudomembranous colitis• Rhabdomyolysis/myopathy• Severe cutaneous adverse

reactions• Systemic lupus

erythematosussuicide/self-injury• Hepatic disorders• Ischaemic heart disease• Lack of efficacy/effect

erythematosus• Chronic kidney disease• Malignant lymphomas• Hypersensitivity

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Thank You

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Practical Experience

Applying Coding Principles and Conventions

Hilary VassHilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited)

Tomás Moraleda (Medical Officer – MSSO)

• Examples: assessing verbatims and selecting MedDRA® terms

Overview

selecting MedDRA terms

• Interactive Ex.s

• Pitfalls and solutions

• Tips for coding medication errors and product quality issues and for handlingproduct quality issues and for handling abbreviations

• Sharing best practices

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• First step: Consider what is being reported– Is it a clinical condition - Diagnosis, sign or symptom?

– Is it an indication?

Assessing the reported term

– Is it an indication?

– Is it a test result?

– Is it trauma?

– Is it a procedure?

– Is it a medication error?

– Is it a product quality issue?

– Is it a social circumstance?

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

– Is it a device issue?

– Is it a procedural complication?

– Is it a combination of these?

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

• A good browser is a key component

• Use “top-down” and “bottom-up” approaches

MedDRA Browsing Tips

• First, try using actual words from reporter

• Consider synonyms, e.g., “Liver” and “Hepatic”

• Use word stems, e.g., “Pancrea”

• Search different word orders, “and”, “or”, etc.

• Use available resources for difficult verbatim terms (web search medical dictionaries colleagues)search, medical dictionaries, colleagues)

• Check the hierarchy

• Look at the “neighbors”

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• “Death due to liver failure secondary to Hep B liver cirrhosis”

Example 1: Complications and Outcomes

Hep B liver cirrhosis

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• “Death due to liver failure secondary to Hep B liver cirrhosis”

Example 1: Assessing the Verbatim

Hep B liver cirrhosis– Hep B = original medical condition

– Liver cirrhosis = complication of Hep B

– Liver failure = complication of liver cirrhosis and Hep B, proximal cause of death

– Death = outcome

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• “Death due to liver failure secondary to Hep Bliver cirrhosis”

Example 1: Term Selection

• Check for applicable combination terms – none• Hep B: LLT Hepatitis B SOC Infections and

infestations– Do not use non-current LLT Hep B (PTC 2.5)– Query if abbreviation is unacceptable

W ld t d t d if ti t k t– Would not need to code if patient known to have had Hep B at baseline (PTC 3.5.5)

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• Liver cirrhosis, Liver failure: LLT Liver cirrhosis and LLT Liver failure both

Example 1: Term Selection, cont.

SOC Hepatobiliary disorders– Neither term is adequately expressed by

the other or by LLT Hepatitis B• Death: outcome

Do not code (PTC 3 2 1)– Do not code (PTC 3.2.1)

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• “Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel

Example 2: Complications and Provisional Diagnoses

spontaneous bacterial peritonitis or bowel perforation)”

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• “Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel

Example 2: Assessing the Verbatim

spontaneous bacterial peritonitis or bowel perforation)”

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• “Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel perforation)”Check for applicable combination terms:

Example 2: Term Selection

• Check for applicable combination terms: – LLT/PT Septic shock found– Better than coding to both LLT/PT Sepsis and

LLT/PT Shock (preserves relationship)• SBP or bowel perforation:

– Potential causes of the septic shock– Uncertain if both conditions were actually

present (likely a differential diagnosis)

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• Code both provisional diagnoses for best capture:

Example 2: Term Selection, cont.

p– LLT Spontaneous bacterial peritonitis

PT Peritonitis bacterial SOC Infections and infestations

– LLT Bowel perforationPT Intestinal perforationSOC Gastrointestinal disorders

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• “Death due to liver failure secondary to Hep B liver cirrhosis and sepsis from

Examples 1 & 2: Actual Verbatim

Hep B liver cirrhosis and sepsis from spontaneous bacterial peritonitis or bowel perforation”

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• “Retinal disease from HIV with near total blindness (R and L)”

Ex. 1: Complications. Which ones would you choose?

blindness (R and L)– LLT Retinal damage

– LLT Retinal disorder

– LLT HIV disease

– LLT Blindness

– LLT HIV retinopathy

– LLT Blindness, both eyes

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• “Retinal disease from HIV with near total blindness (R and L)”

Ex. 1: Suggested Terms

( )– LLT Retinal damage (goes to injury SOC)– LLT Retinal disorder (combo term available)– LLT HIV disease (combo term available)– LLT Blindness (not the most specific LLT)

LLT HIV retinopathy (good combo term)– LLT HIV retinopathy (good combo term)– LLT Blindness, both eyes (most specific

term for this reported condition)

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• If patient known to have had HIV at baseline (can’t tell here)

Ex.1: Why not also code the HIV?

( )• Combination term was available• Check hierarchy for PT AIDS retinopathy:

– Primary SOC: Infections and infestations, HLT Retroviral infections

– Secondary SOCs: Eye disorders Immune– Secondary SOCs: Eye disorders, Immune system disorders

• Coded event will display in infections SOC

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• “Testing showed increased serum creatinine and BUN with increased

Ex. 2: Lab Tests. Which oneswould you choose?

creatinine and BUN, with increased BUN/creatinine ratio.”a) LLT Increased serum creatinine, LLT BUN

increased

b) LLT Increased serum creatinine, LLT BUN increased LLT Blood urea nitrogen/creatinineincreased, LLT Blood urea nitrogen/creatinine ratio increased

c) LLT Renal function tests NOS abnormal

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• “Testing showed increased serum creatinine and BUN, with increased BUN/creatinine ratio.”


,a) LLT Increased serum creatinine, LLT BUN

increased (does not capture the abnormal ratio)

b) LLT Increased serum creatinine, LLT BUN increased, LLT Blood urea nitrogen/creatinine ratio increased

) LLT R l f ti t t NOS b l (d tc) LLT Renal function tests NOS abnormal (do not lump together per PTC 3.14.4; loss of specificity; also not NOS, as abnormalities were specified)

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• Do not lose information by lumping

• Do not add information by coding to a

Pitfalls and Solutions, 1

• Do not add information by coding to a diagnosis that is not explicitly stated in the verbatim Reread verbatim carefully, resist any internal or external pressure to code to unstated diagnoses– If the physician who actually saw the patient

was not comfortable committing to a diagnosis, why should you be?

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• Terms that sound like something they aren’t (eg, LLT Blood urine) Read through the other PTs


) gunder that HLT– LLT/PT Blood urine vs. LLT/PT Blood urine present

(lab test name vs. lab test result)

• Not finding the most specific term Combine bottom-up and top-down searches, use judicious translations – For “osteoporosis due to advanced age”, select

LLT/PT Senile osteoporosis, not LLT/PT Osteoporosis

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• “Autocoder specials” (ie, inappropriate terms selected by autocoder) Review


y )all weight-based autocoding carefully, apply medical judgment

• Inadvertently sacrificing detail at the PT level to capture detail in an LLT Check hierarchyy– For “intermittent migraine headaches”, use

LLT Migraine headache PT Migraine, not LLT Intermittent headache PT Headache

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• “Eye clinic nurse reported accidentally using a vial of an unpreserved injectable

Ex. 3: Medication Errors and Product Quality Issues

using a vial of an unpreserved injectablemedication on more than one patient and complained that the warning on the label stating that it was for single use only was too small to read. One of the patients de eloped an injection site infection ”developed an injection site infection.

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• Spend some time reading through the available terms and hierarchies, for familiarity

Tips for Coding Medication Errors and Product Quality Issues

y

• Read the LLTs to better understand the meaning of the PTs:– For example, PT Wrong technique in drug usage

process includes LLTs like Wrong injection technique, Tablet crushed incorrectly, and Inhalation not administered correctlyadministered correctly.

• Code all elements: medication errors, product quality issues, and associated adverse events

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Ex.3: Assessing the Verbatim

using a vial of an unpreserved injectable medication on more than one patient and complained that the warning on the label stating that it was for single use only was too small to read. One of the patients de eloped an injection site infection ”developed an injection site infection.

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Ex. 3: Medication Error Which option would you choose?

using a vial of an unpreserved injectablemedication on more than one patient.”a) LLT Medication error

b) LLT Circumstance or information capable of leading to a medication error

) LLT M lti l f i l d tc) LLT Multiple use of single-use product

d) LLT Poor quality drug administered

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using a vial of an unpreserved injectablemedication on more than one patient.”a) LLT Medication error (not specific)

b) LLT Circumstance or information capable of leading to a medication error (error occurred)

) LLT M lti l f i l d tc) LLT Multiple use of single-use product

d) LLT Poor quality drug administered (presumes poor quality)

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• “Eye clinic nurse complained that the warning on the label stating that it was for

Ex. 3: Product Quality IssueWhich option would you choose?

warning on the label stating that it was for single use only was too small to read.”a) LLT Product label issue

b) LLT Product quality issue

c) LLT Product label missing text

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• “Eye clinic nurse complained that the warning on the label was too small to


warning on the label…was too small to read.”a) LLT Product label issue (note: label refers to

the actual label on the product)

b) LLT Product quality issue (too general)

) LLT P d t l b l i i t t (t tc) LLT Product label missing text (text was there, just too small)

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• “One of the patients developed an injection site infection ”

Ex. 3: Adverse EffectWhich option would you choose?

injection site infection.a) LLT Infection

b) LLT Injection site infection

c) LLT Eye infection

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• “One of the patients developed an injection site infection ”


injection site infection.a) LLT Infection (too general)

b) LLT Injection site infection

c) LLT Eye infection (presumes eye)

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• “Patient with reactive depression due to the recent passing of his spouse

Ex. 4: Overdose & Self-Harm

the recent passing of his spouse attempted suicide by intentionally taking a handful of his diuretic tablets.”

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• “Patient with reactive depression due to the recent passing of his spouse

Ex.4: Assessing the Verbatim

the recent passing of his spouseattempted suicide by intentionally taking a handful of his diuretic tablets.”

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• “Patient with reactive depression due to the recent passing of his spouse”

Ex. 4: Depression/Loss Which options would you choose?

the recent passing of his spouse

1) LLT Depression or LLT Reactive depression?

2) LLT Death of spouse or no code at all?

SOC Social circumstances

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• “Patient with reactive depression due to the recent passing of his spouse”


p g p

1) LLT Depression or LLT Reactive depression?

LLT Reactive depression (same PT, but more specific)

2) LLT Death of spouse or no code at all?

SOC Social circumstances

See PTC 3.23 (generally do not enter as AE; could enter under medical/social history; consult local conventions)

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• “Patient attempted suicide by intentionally t ki h df l f hi di ti t bl t ”

Ex. 4: Overdose/Self-HarmWhich options would you choose?

taking a handful of his diuretic tablets.”

1) LLT Attempted suicide or

LLT Suicidal behavior?

2) LLT Diuretic abuse or)

LLT Drug overdose deliberate self-inflicted or

LLT Drug toxicity due to intentional overdose?

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• “Patient attempted suicide by intentionally taking a handful of his diuretic tablets.”

Ex. 4. Suggested Terms

g

1) LLT Attempted suicide (exact match)LLT Suicidal behavior (different PT)

2) LLT Diuretic abuse (refers to something else)LLT Drug overdose deliberate self-inflicted ug o e dose de be ate se ctedLLT Drug toxicity due to intentional overdose (no toxicity was reported)

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Ex. 5. “Exposures”

While preparing to administer of a blood transfusion, a nurse stabbed herself with the ,needle and subsequently developed acute hepatitis B, with dark urine, fever, loss of appetite, yellow skin and mono-arthritis. Lab tests showed HBsAg 12 weeks later. Further investigation revealed that transfusion bloodinvestigation revealed that transfusion blood was contaminated with HBV and that the nurse had received one only dose of HBV vaccine.

Ex. 5. Assessing verbatims

While preparing to administer of a blood transfusion, a nurse stabbed herself with the ,needle and subsequently developed acute hepatitis B, with dark urine, fever, loss of appetite, yellow skin and mono-arthritis. Lab tests showed positive HBsAg 12 weeks later Further investigation revealed thatlater. Further investigation revealed that transfusion blood was contaminated with HBV and that the nurse had received one only dose of HBV vaccine.

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• Acute hepatitis B

• “dark urine” ?• Skin? ..

– Yellow skin

Ex. 5. Adverse Event. Which oneswould you choose?

• dark urine ..?– Bilirubin urine

– Urine bilirubinincreased

– Choluria

• Appetite lost

– Yellow skin

– Jaundice

• Monoarthritis

• Investigations– HBsAg

Appetite lost

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• “dark urine” ?

• Skin? ..Yellow skin

Ex. 5. AE. Suggested terms

• dark urine ..?– Bilirubin urine


– Choluria• (since it is an

– Yellow skin

– Jaundice

• Monoarthritis


observation, not a test)

• Appetite lost

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Ex. 5 (AE). [ Dx + S/S = Dx only ]

Single definitive diagnosis with signs/symptoms: Preferred diagnosis only


• “dark urine” ..?– Bilirubin urine


Ch l i

• Skin? ..– Yellow skin

– or Jaundice ?

• Monoarthritis

• Investigations– Choluria

• Appetite lost– HBsAg

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note that, despite hepatitis B has pain in joints, a localized monoarthritis isnot typically associated with it)

Ex. 5 (AE). Investigation consistentwith Dx

When investigation results are reported with a diagnosis, select only a term for the diagnosis if investigation resultsare consistent with the diagnosis.


• “dark urine” ..?– Bilirubin urine


• Skin? ..– Yellow skin

– Jaundice

• Monoarthritis

• Investigations– Choluria

• Appetite lost


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– Transmission of an infectious agent via product

• Transfusion-transmitted i f ti di ?

– Accidental injury

– Accidental exposurewhile administering drug

Ex. 5. Exposure. Which would youchoose?

infectious disease ?

– Hepatitis B immunisation

– Incomplete course of vaccination

– Occupational exposure while preparing product for

e ad s e g d ug

– Exposure to devicecontaminated with bodyfluid

• (under PT Exposure tocontaminated device)

– Exposure to body fluidadministration

– Needle stick/puncture• (under PT Injury associated

with device)

p y

– Exposure via blood

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Ex. 5. Exposure. Table 1SOC HLGT HLT PT LLT

Genrl- Complications associated with device

Complications associated with device NEC

Injury associated with device

Needle stick/puncture

Infec- Ancillary infectious topics Infectious transmissions Transmission of an infectious agent via product

Transmission of an infectious agent via product


Transfusion-transmitted infectious disease

Inj&P- Exposures, chemical injuries and poisoning

Exposures to agents or circumstances NEC

Exposure to body fluid Exposure to body fluid

Exposure to contaminated device

Exposure to device contaminated with body fluid

Occupational exposures Occupational exposure to product

Occupational exposure while preparing product for administration

Pathways and sources of Exposure via blood Exposure via blood

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exposure

Inj&P- Injuries NEC Non-site specific injuries NEC

Injury Accidental injury

Inj&P- Medication errors Accidental exposures to product

Accidental exposure to product

Accidental exposure while administering drug

Maladministrations Incomplete course of vaccination

Incomplete course of vaccination

Surg- Therapeutic procedures and supportive care NEC

Immunisations Hepatitis B immunisation Hepatitis B immunisation

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– Transmission of an infectious agent via product

• Transfusion-transmitted i f ti di ?

– Accidental injury

– Accidental exposurewhile administering drug

Ex. 5. Exposure. Suggested terms

infectious disease ?

– Hepatitis B immunisation

– Incomplete course of vaccination

– Occupational exposure while preparing product for

e ad s e g d ug

– Exposure to devicecontaminated with bodyfluid

• (under PT Exposure tocontaminated device)

– Exposure to body fluidadministration

– Needle stick/puncture• (Under PT Injury associated

with device)

p y

– Exposure via blood

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Ex. 5. Exposure. Table 2.

SOC HLGT HLT PT LLT

Genrl‐ Complications associated with device Complications associated with device NEC

Injury associated with device Needle stick/puncture

Hepat‐ Hepatic and hepatobiliary disorders Cholestasis and jaundice Jaundice Jaundice

Infec‐ Ancillary infectious topics Infectious transmissions Transmission of an infectious agent via product



Transfusion‐transmitted infectious diseasevia product disease

Infec‐ Viral infectious disorders Hepatitis viral infections Acute hepatitis B Acute hepatitis B

Inj&P‐ Exposures, chemical injuries and poisoning

Exposures to agents or circumstances NEC

Exposure to body fluid Exposure to body fluid

Exposure to contaminated device Exposure to device contaminated with body fluid

Occupational exposures Occupational exposure to product Occupational exposure while preparing product for administration

Pathways and sources of exposure Exposure via blood Exposure via blood

Inj&P‐ Injuries NEC Non‐site specific injuries NEC Injury Accidental injury

Inj&P‐ Medication errors Accidental exposures to product Accidental exposure to product Accidental exposure while administering drug

Maladministrations Incomplete course of vaccination Incomplete course of vaccination

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Inv‐ Hepatobiliary investigations Liver function analyses Bilirubin urine Bilirubin urine

Urine bilirubin increased Urine bilirubin increased

Inv‐ Microbiology and serology investigations

Virus identification and serology Hepatitis B surface antigen HBsAg

Metab‐ Appetite and general nutritional disorders

Appetite disorders Decreased appetite Appetite lost

Musc‐ Joint disorders Arthropathies NEC Monarthritis Monoarthritis

Renal‐ Urinary tract signs and symptoms Urinary abnormalities Choluria Choluria

Skin‐ Epidermal and dermal conditions Dermal and epidermal conditions NEC

Yellow skin Yellow skin

Surg‐ Therapeutic procedures and supportive care NEC

Immunisations Hepatitis B immunisation Hepatitis B immunisation

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Neutropenic patient under chemotherapytreatment presented with retinitis with cotton

Ex. 6. “Do Not Add Information”

treatment presented with retinitis with cottonlike lesions in fundoscopy. One week later, patient was hospitalized with high fever, nuchal rigidity and obnubilation. CSF waspositive for Candida app, and hematogenous candidiasis was suspectedhematogenous candidiasis was suspected.

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• Chemotherapy

• Neoplasm malignant

• High temperature

• Nuchal rigidity

Ex. 6. Which would you choose.


• Neutropenia

• Retinitis

• Candida retinitis

• Cotton wool spots

• Nuchal rigidity

• Obnubilation

• Candidiasis

• Disseminated candidiasis

• Fundoscopyabnormal

• Candida test positive

• Candidal meningitis

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• Chemotherapy


• High temperature

• Nuchal rigidity

Ex. 6 Suggested terms


• Neutropenia

• Retinitis ¿?

• Candida retinitis ¿?

• Cotton wool spots

• Nuchal rigidity

• Obnubilation

• Candidiasis ¿?

• Disseminatedcandidiasis ¿?

• Fundoscopyabnormal

• Candida test positive

• Candidal meningitis

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A 49-year-old female developed intestinal graft-versus-host disease (GVHD) which

Ex. 7. About “versioning”

graft versus host disease (GVHD) which prolonged hospitalization. The patient received her first study platelet transfusion on 08 July 2010. The patient’s medical history includes NK leukemia and vaginal hysterectomyhysterectomy.

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A 49-year-old female developed intestinalgraft-versus-host disease (GVHD) whichgraft versus host disease (GVHD) which prolonged hospitalization. The patient received her first study platelet transfusion on 08 July 2010. The patient’s medical history includes NK leukemia and vaginal hysterectomyhysterectomy.

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Reported event 10.0 10.1

New terms and “re-coding”

GVHD (unspec.) GVHD (as a whole). No diferentiation.

Undetermined

GVHD skin Skin

GVHD liver Liver

GVHD intestine Intestine

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Reported event 10.0 10.1

New terms and “re-coding”

GVHD (unspec.) GVHD (as a whole). No diferentiation.

Undetermined

GVHD skin Skin

GVHD liver Liver

GVHD intestine Intestine

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Version update

v13.1 v14.0 V14.1 v15.0 v15.1

2 MedDRA versions per year (March

and

Integrated analysis: MedDRA v15.1

Study A data lock

Study B data lock

September)

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Pharmacovigilance

Study C data lock

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• A 75-year-old male diagnosed with coronary insufficiency developed anginal pain on 21 Feb

Ex. 8. Procedure and diagnosis are reported

2010 resulting in hospitalization while enrolled in a randomized, open-label study. The patient’s medical history is significant for triple bypass graft surgery 2006, postural hypotension and stage D prostate carcinoma. On 26 Feb 2010, the patient underwent percutaneous transluminal coronary p yangioplasty with stent placement in the right coronary and proximal left anterior descending arteries.

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• A 75-year-old male diagnosed with coronary insufficiency developed anginal pain on 21Feb10

Ex. 8. Assessing the Verbatim

resulting in hospitalization while enrolled in a randomized, open-label study. The patient’s medical history is significant for triple bypass graft surgery 2006, postural hypotension and stage D prostate carcinoma. On 26Feb10, the patient underwent percutaneous transluminal coronary p yangioplasty with stent placement in the right coronary and proximal left anterior descending arteries.

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• A 75-year-old male diagnosed with ..– coronary insufficiency ..

Ex. 8. Time profile and term types

• .. developed anginal pain on 21Feb10 resulting in hospitalization while enrolled in a randomized, open-label study. – The patient’s medical history is significant for triple bypass

graft surgery 2006, postural hypotension and stage D prostate carcinoma.

• On 26Feb10, the patient underwent percutaneoustransluminal coronary angioplasty with stent placement in the right coronary and proximal left anterior descending arteries.

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• Train investigators to avoid reporting abbreviationsC id t t i th b ti th t i ht

Tips for Handling Abbreviations

• Consider context in the verbatim that might disambiguate the abbreviation

• Consider using the ARGH Biomedical Acronym Resolver to look up various meanings of acronyms and their frequency of use in Medline– Longer acronyms might be specific enough to code

• Consider specifying that a certain medical• Consider specifying that a certain medical acronym dictionary will be used (>1 meaning query)

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• “Trauma of right knee during skiing in FRANCE”

• “Endorses smoking marijuana once per day”

Funny Verbatims

Endorses smoking marijuana once per day

• “Just her time to go”

• “Tongue stud”

• “Brain feels like a lava lamp”

• “Fungus left feet”

• “Feeling like Gumby”

• “Loss of sensibility in pubic area”

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In this workshop we:

• Reviewed key principles in the “MedDRA

Summary

Reviewed key principles in the MedDRATerm Selection: Points to Consider”document

• Learned practical approaches to coding consistently, accurately, and with

fidconfidence

• Engaged in practical Ex.s and shared best practices

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Learner AssessmentAssessment

Concerning the pre-defined primary SOC allocations in MedDRA, which of the following statements is true?

Learner Assessment

statements is true?

a. They should never be changed

b. Coders should choose whichever primary SOC they prefer when coding

c. Data reviewers should alter the primary SOCs to p yfit the product’s AE profile

d. They should be changed only through the MSSO’s Change Request process

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According to the preferred option in the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim “Abdominal cramps vomiting

Learner Assessment

the verbatim Abdominal cramps, vomiting, diarrhea, (food poisoning), Athlete’s foot”?

a. Abdominal cramps, Vomiting, Diarrhea, Food poisoning

b. Acute gastroenteritis

c. Food poisoning, Athlete’s foot

d. Athlete’s foot63

According to the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim

Learner Assessment

“Markedly elevated ALT and AST after starting study drug”?

a. Hepatitis drug-induced

b Transaminases increasedb. Transaminases increased

c. ALT increased, AST increased

d. Hypertransaminasemia

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According to the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim

Learner Assessment

“Patient expired because of a drug administration error (gave wrong antiarrhythmic)”?

a. Cardiac death, Drug toxicity

b Wrong drug administeredb. Wrong drug administered

c. Expired drug used

d. Death, Drug administration error

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Thank you!(¿? please)(¿? please)