05/04/2013 1 Coding with Confidence Hilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited) Tomás Moraleda (Medical Officer – MSSO) 25th Annual EuroMeeting EuroMeeting 4-6 March 2013 RAI, 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 registered reserved. 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. 2
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05/04/2013
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Coding with ConfidenceHilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited)
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.
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
• 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”
Diagnoses and Provisional Diagnoses (cont)
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
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
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
• 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
• “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
• “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.”
Ex. 2: Suggested Terms
,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
Pitfalls and Solutions, 2
) 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
Pitfalls and Solutions, 3
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
• “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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• “Eye clinic nurse reported accidentally using a vial of an unpreserved injectable
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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• “Eye clinic nurse reported accidentally using a vial of an unpreserved injectable
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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• “Eye clinic nurse reported accidentally using a vial of an unpreserved injectable
Ex. 3: Suggested Terms
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
Ex. 3: Suggested Terms
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 ”
Ex. 3: Suggested Terms
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”
Ex. 4: Suggested Terms
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.”
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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• Acute hepatitis B
• “dark urine” ?
• Skin? ..Yellow skin
Ex. 5. AE. Suggested terms
• dark urine ..?– Bilirubin urine
– Urine bilirubinincreased
– Choluria• (since it is an
– Yellow skin
– Jaundice
• Monoarthritis
• Investigations– HBsAg
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
• Acute hepatitis B
• “dark urine” ..?– Bilirubin urine
– Urine bilirubinincreased
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.
• Acute hepatitis B
• “dark urine” ..?– Bilirubin urine
– Urine bilirubinincreased
• Skin? ..– Yellow skin
– Jaundice
• Monoarthritis
• Investigations– Choluria
• Appetite lost
• Investigations– HBsAg
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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
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.
• Neoplasm malignant
• Neutropenia
• Retinitis
• Candida retinitis
• Cotton wool spots
• Nuchal rigidity
• Obnubilation
• Candidiasis
• Disseminated candidiasis
• Fundoscopyabnormal
• Candida test positive
• Candidal meningitis
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• Chemotherapy
• Neoplasm malignant
• High temperature
• Nuchal rigidity
Ex. 6 Suggested terms
• Neoplasm malignant
• 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