MedDRA Coding Basics MedDRA ® trademark is owned by IFPMA on behalf of ICH MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activities 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 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 UK, Health Canada, and the WHO (as Observer). MSSO-DI-6275-16.0.0 2
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MedDRA Coding Basics
MedDRA® trademark is owned by IFPMA on behalf of ICH
MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activitiesPharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board which is composed of the six ICHManagement Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer).
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The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a
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p , py gthird party, permission for reproduction must be obtained from this copyright holder.
Course Objectives/Overview
• Learn the reasons we “code” data• Gain knowledge of MedDRA’sGain knowledge of MedDRA s
structure, scope, and characteristics• Learn about the MedDRA Term• Learn about the MedDRA Term
Selection: Points to Considerdocumentdocument
• Learn some basic coding approaches, including some coding “pearls”
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including some coding pearls
Wh D W C d ?Why Do We Code?
What Is “Coding”?
Code
1 : a systematic statement of a body of law; especially one given statutory force
2 : a system of principles or rules <moral code>2 : a system of principles or rules <moral code>3 a : a system of signals or symbols for communication
b : a system of symbols (as letters or numbers) used t t i d d ft t ito represent assigned and often secret meanings
4 : genetic code5 : a set of instructions for a computer
MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entireterminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry,post marketing, and for data entry, retrieval, evaluation, and presentation.
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Scope of MedDRAOUT
Medical conditionsIndications
Not a drug dictionary
Frequency qualifiers
IN
IndicationsInvestigations (tests, results)
Medical and surgical proceduresMedical, social, family history
( y p yp )• Nervous system disorders• Pregnancy, puerperium and perinatal
conditionsP hi t i di d
• General disorders and administration site conditions
• Hepatobiliary disordersI t di d
• Psychiatric disorders• Renal and urinary disorders• Reproductive system and breast disorders• Respiratory, thoracic and mediastinal disorders• Immune system disorders
• Infections and infestations• Injury, poisoning and procedural
complications
Respiratory, thoracic and mediastinal disorders• Skin and subcutaneous tissue disorders• Social circumstances• Surgical and medical procedures
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p• Investigations• Metabolism and nutrition disorders
PTs in the following SOCs only appear in that particular SOC and not in others, p ,i.e., they are not multi-axial
• Investigations• Investigations• Surgical and medical procedures• Social circumstances• Social circumstances
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Rules for Primary SOC Allocation• PTs for diseases signs and symptoms are assigned to• PTs for diseases, signs and symptoms are assigned to
prime manifestation site SOC• Congenital and hereditary anomalies terms have SOC
C l f l l d d d SOCCongenital, familial and genetic disorders as Primary SOC• Neoplasms terms have SOC Neoplasms benign,
malignant and unspecified (incl cysts and polyps) as g p ( y p yp )Primary SOC – Exception: Cysts and polyps have prime manifestation site SOC
as Primary SOC
• Infections and infestations terms have SOC Infections and infestations as Primary SOC
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Primary SOC Priority
If a PT links to more than one of the exceptions, the following priority will be used to determine primary SOC:primary SOC:
1st: Congenital, familial and genetic disorders2nd: Neoplasms benign, malignant and2 : Neoplasms benign, malignant and
unspecified (incl cysts and polyps)3rd: Infections and infestations
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MedDRA Term Selection:MedDRA Term Selection:Points to Consider Document
Why Do We Need Coding Conventions?Conventions?
• Differences in medical aptitude of coders• Consistency concerns (many more
“choices” to manually code terms in yMedDRA compared to older terminologies)g )
• Even with an autoencoder, may still need manual coding
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manual coding
MedDRA Term Selection: Points to Consider (MTS:PTC)Points to Consider (MTS:PTC)
• An ICH-endorsed guide for MedDRA users• Provides term selection advice for industry
and regulatory purposes• Objective is to promote accurate and
consistent term selection to facilitate a d t di f h d d tcommon understanding of shared data
• Recommended to be used as the basis for i di id l i ti ’ di
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individual organizations’ coding conventions
MedDRA Term Selection: PTC (cont)• Developed by a working group of the ICH Steering
Committee– Regulators and industry representativesRegulators and industry representatives– EU, Japan, USA– Canadian observer, MSSO, JMO
U d t d t i l ith h M dDRA l• Updated twice yearly with each MedDRA release• Available on MSSO, JMO, and ICH Web sites
– English and JapaneseEnglish and Japanese– Variety of file formats for ease of viewing and editing– Summary of Changes document
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General Term Selection Principles• Quality of Source DataQuality of Source Data• Quality Assurance• Do Not Alter MedDRA• Always Select a Lowest Level Term• Select Only Current Lowest Level Terms• When to Request a Term• When to Request a Term• Use of Medical Judgment in Term Selection• Selecting More than One Term• Check the Hierarchy• Select Terms for All Reported Information, Do Not
Add Information
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Add Information
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Q lit f S D tQuality of Source DataQuality AssuranceQuality Assurance
• Quality of original information impacts quality of outputoutput
• Obtain clarification of data• Can be optimized by careful design of data
ll ti f d t i i f t ffcollection forms and proper training of staff• Organizations’ coding guidelines should be
consistent with MTS:PTCconsistent with MTS:PTC• Review of term selection by qualified individuals• Human oversight of automated coding results
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g g
Do Not Alter MedDRA
• MedDRA is a standardized terminology with a pre-defined term hierarchywith a pre defined term hierarchy
• Users must not make ad hoc structural alterations, including changing thealterations, including changing the primary SOC allocation
• If terms are incorrectly placed, submit aIf terms are incorrectly placed, submit a change request to the MSSO
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Always Select a Lowest Level TermSelect Only Current LLTsSelect Only Current LLTs
• Lowest Level Term that most accurately fl t th t d b ti i f tireflects the reported verbatim information
should be selected• Degree of specificity may be challenging• Degree of specificity may be challenging
– Example: “Abscess on face” select “Facial abscess,” not simply “Abscess”
• Select current LLTs only– Non-current terms for legacy conversion/historical
purposes
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purposes
Wh t R t TWhen to Request a TermUse of Medical JudgmentUse of Medical Judgment
• Avoid company-specific “work-arounds” for MedDRA deficiencies If concept notMedDRA deficiencies. If concept not adequately represented in MedDRA, submit Change Request to MSSO.g q
• If no exact match in MedDRA, use medical judgment to match to an existing term that d t l t th tadequately represents the concept
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S l ti M th O TSelecting More than One TermCheck the HierarchyCheck the Hierarchy
• Can select more than one LLT to represent reported information Document proceduresreported information. Document procedures. – Selecting one term may lead to loss of specificity– Selecting more than one term may lead toSelecting more than one term may lead to
redundant counts• Check the hierarchy above a selected LLT
(PT HLT HLGT SOC) to ens e placement(PT, HLT, HLGT, SOC) to ensure placement accurately reflects meaning of reported term
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S l t T f All R t dSelect Terms for All Reported Information
• Select terms for every AR/AE reported, regardless of causal associationregardless of causal association
• Select terms for device-related events, product quality issues medication errorsproduct quality issues, medication errors, medical and social history, investigations and indications as appropriate
• If diagnosis reported with characteristic signs and symptoms, preferred option is to select term for diagnosis only
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select term for diagnosis only
Do Not Add InformationDo not make diagnosis if only• Do not make diagnosis if only signs/symptoms reported
Reported LLT Selected Comment
Abdominal pain
Abdominal pain, increased serum
Abdominal pain
It is inappropriateto assign an LLT for Serum amylase
i d amylase, and increased serum lipase
gdiagnosis of
“pancreatitis”
increased
Lipase increased
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Lipase increased
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Pitfalls and Solutions• In selecting an LLT for a result of an• In selecting an LLT for a result of an
investigation, parent PT of the selected LLT should contain a qualifier/adjective– E.g., “present/absent”, “increased/decreased”, etc.
• If parent PT of selected LLT does not contain a lifi / dj ti h i d t tlqualifier/adjective, you may have inadvertently
selected an LLT for the test name, not a result– E g “Blood found in urine” select LLT Blood inE.g., Blood found in urine , select LLT Blood in
urine (PT Blood urine present). Do not select LLT Blood urine (PT Blood urine has no qualifier/ dj ti d th t th t t l )
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adjective and thus represents the test name only)
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Pitf ll d S l ti ( t)Pitfalls and Solutions (cont)• Inappropriate terms may be selected by• Inappropriate terms may be selected by
autocoder• Review all autocoding carefully• Review all autocoding carefully
– “Allergic to CAT scan” autocoded as LLT Allergic to catsLLT Allergic to cats
– “Myocardial infarction in the fall of 2000” autocoded as LLT Myocardial infarction and LLT F llLLT Fall
– All medical concepts described after the product is taken should be coded
– Example: “The patient took drug X and developed alopecia, increased LFTs and pancreatitis”. Manufacturer only codes alopecia and increased y pLFTs (missed concept of pancreatitis)
– Example: “The patient took drug X and developed interstitial nephritis which later deteriorated intointerstitial nephritis which later deteriorated into renal failure”. Manufacturer only codes interstitial nephritis (missed renal failure concept)
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Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER
FDA-Defined Coding Errors (cont)• “Soft Coding”
– Selecting a term which is both less specific and less th th M dDRA t i “ ft di ”severe than another MedDRA term is “soft coding”
– Example: “Liver failure” coded as hepatotoxicity or increased LFTsincreased LFTs
– Example: “Aplastic anemia” coded as unspecified anemia
– Example: “Rash subsequently diagnosed as Stevens Johnson syndrome” coded as rash
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Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER
Term Selection Points• Diagnoses and Provisional Diagnoses with or without Signs and g g g
Symptoms• Death and Other Patient Outcomes• Suicide and Self-Harm
Conflicting/Ambiguous/Vague Information• Conflicting/Ambiguous/Vague Information• Combination Terms• Age vs. Event Specificity• Body Site vs Event Specificity• Body Site vs. Event Specificity• Location Specific vs. Microorganism Specific Information• Modification of Pre-existing Conditions• Exposures During Pregnancy and Breast FeedingExposures During Pregnancy and Breast Feeding• Congenital Terms• Neoplasms• Medical and Surgical Procedures
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• Investigations
T S l ti P i t ( t)Term Selection Points (cont)• Medication/Administration Errors, Accidental Exposures and
Occupational ExposuresOccupational Exposures• Misuse, Abuse and Addiction• Transmission of Infectious Agent via Product
Overdose Toxicity and Poisoning• Overdose, Toxicity and Poisoning• Device-related Terms• Drug Interactions
N Ad Eff t d “N l” T• No Adverse Effect and “Normal” Terms• Unexpected Therapeutic Effect• Modification of Effect
l• Social Circumstances• Medical and Social History• Indication for Product Use
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• Off Label Use• Product Quality Issues
Diagnoses and Provisional DiagnosesSINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS
Single diagnosis without signs d t
Single provisional diagnosis ith t i d tand symptoms
•Diagnosis (only possible option)
without signs and symptoms
•Provisional diagnosis (only possible option)possible option)
Example: “Myocardial infarction” select
Example: “Possible myocardial infarction” select
“Myocardial infarction” “Myocardial infarction” (select term as if definitive diagnosis)
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Similar principles apply for multiple diagnoses
Diagnoses and Provisional Diagnoses (cont)SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSISSingle diagnosis with signs/ symptoms
Single provisional diagnosis with signs/symptoms
•Preferred: Diagnosis only •Preferred: Provisional diagnosis and signs/symptoms
Example: “Anaphylactic reaction with rash, dyspnea, hypotension and laryngospasm”
Example: “Possible myocardial infarction with chest pain,dyspnea diaphoresis” select hypotension, and laryngospasm
select “Anaphylactic reaction”
dyspnea, diaphoresis select “Myocardial infarction” “Chest pain”, “Dyspnea”, and “Diaphoresis”
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Diaphoresis
Similar principles apply for multiple diagnoses
Diagnoses and Provisional Diagnoses (cont)SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS
Single diagnosis with signs/ symptoms
Single provisional diagnosis with signs/symptomsymp m
•Alternate: Diagnosis and signs/symptoms
g / ymp m
•Alternate: Signs/symptoms only (as provisional diagnosis may change
No units have been reported. Select LLTGlucose abnormal if
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g fclarification cannot
be obtained.
Investigations (cont)Investigation results consistent with diagnosis• Investigation results consistent with diagnosis
Reported LLT Selected CommentElevated potassium K It is not necessary to Elevated potassium, K
7.0 mmol/L, and hyperkalemia
HyperkalemiaIt is not necessary to select LLT Potassium
increased
• Grouped investigation result termsReported LLT Selected Comment
Increased alkaline phosphatase,
increased SGPT,
Alkaline phosphataseincreased
SGPT increased
Select four individual terms. A single term
such as LLT Liver function tests
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increased SGOT and elevated LDH
SGOT increasedLDH increased
function tests abnormal should not
be selected.
M dDRA D kt B
MSSO’s MedDRA Browsers• MedDRA Desktop Browser
– Download from MSSO Web site– View/search MedDRA and SMQsView/search MedDRA and SMQs– Export functionality
• MedDRA Web-Based Browser– https://www.meddrabrowser.org/dsnavigator/– Requires specific user ID and password
A t ll M dDRA i i E li h d– Access to all MedDRA versions in English and available EU languages (and Chinese, if subscribed)
– View/search MedDRA and SMQs
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View/search MedDRA and SMQs– Export functionality
Browser Demonstration/A h t Fi diApproaches to Finding
the Best LLTthe Best LLT
Assessing the Reported Information• Consider what is being reported. Is it a:
– Clinical condition - Diagnosis, sign or symptom?– Indication?– Test result?Test result?– Injury?– Procedure?
M di ti ?The type of report will
– Medication error?– Product quality issue?– Social circumstance?
influence the way you search for a suitable LLT. It may indicate in which SOC you expect to find the
– Device issue?– Procedural complication?
SOC you expect to find the closest match.
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– Is it a combination of these?
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Coding Example 1
Specificity
The patient suffered from an allergic reaction to an antibiotic
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Coding Example 2
Symptoms
The patient states she has been experiencing cold sweatsexperiencing cold sweats
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Coding Example 3
Investigations
Lab results indicate the patient has increased troponin and increased CPK-MB
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Coding Example 4
Medication errors
Patient took drug Y instead of drug X and became short of breath
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Coding Example 5
Patient demographics
A 2 day old baby was noted to have a mild fever
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Coding Example 6
Indications
A 35 year old woman was taking Drug X to prevent relapses of multiple sclerosis
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Coding Example 7N ti i ttNarrative vignette
A 75-year-old male receiving Drug X for rheumatoid arthritis developed symptomatic aortic valve stenosis. The patient’s medical history is significant for colon cancer and cigarette smoking. He underwent an aortic valve replacementand developed a sternal wound infection
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three days post-surgery.
Coding Example 8
Liver failure secondary to Hep B liver cirrhosis and sepsis leading to shock(from possible spontaneous bacterial peritonitis or bowel perforation)
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Assessing the Reported Information• Liver failure = complication of liver• Liver failure = complication of liver
cirrhosis and Hep BH B d l i f i h i• Hep B = underlying cause of cirrhosis
• Liver cirrhosis = complication of Hep B• Possible spontaneous bacterial
peritonitis or bowel perforation = p pprovisional diagnoses, likely cause of:
• Sepsis
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Sepsis• Shock = complication of sepsis
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Term Selection• Liver failure• Liver failure
– LLT Liver failure
H B li i h i• Hep B liver cirrhosis– No combination term available, select both:
LLT Li i h i– LLT Liver cirrhosis– LLT Hepatitis B
Do not use non current LLT Hep B• Do not use non-current LLT Hep B• Query if abbreviation is unacceptable
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Term Selection (cont)• Sepsis leading to shock• Sepsis leading to shock
– Combination term available, select:LLT Septic shock– LLT Septic shock• Preserves relationship between the conditions• Better choice than LLT Sepsis and LLT Shockp
• Possible spontaneous bacterial peritonitis or bowel perforationp p– Select both provisional diagnoses:– LLT Spontaneous bacterial peritonitis
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– LLT Bowel perforation63
MedDRA Coding “Pearls”Fi t t i t ’ t l d• First, try using reporter’s actual words
• Be aware of MedDRA’s specificity• Exploit MedDRA’s hierarchy – if an LLT
is close to what you need, look at its y ,“siblings” and “parent”
• Check where the LLT lies in MedDRACheck where the LLT lies in MedDRA (i.e., check the hierarchy above to be sure it represents the verbatim term
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sure it represents the verbatim term accurately)
M dDRA C di “P l ” ( t)MedDRA Coding “Pearls” (cont)• Use “top down” and “bottom up” navigation• Use top-down and bottom-up navigation• Try synonyms if it’s not “renal” try
“kid ” t“kidney”, etc. • Use word stems, e.g., “Pancrea”• Search different word orders, “and”, “or” • Use available resources for difficultUse available resources for difficult
verbatim terms (web search, medical dictionaries, colleagues)
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dictionaries, colleagues)
MedDRA Coding “Pearls” (cont)
• And most important of all… get more coding training!g g
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SummaryI thiIn this course, we:• Learned the reasons we “code” data and the
role of a coding terminologyrole of a coding terminology• Reviewed the structure, scope, and
characteristics of MedDRA• Were introduced to the MedDRA Term
Selection: Points to Consider document and f it ifi i i lsome of its specific principles
• Learned basic approaches to coding, including some coding “pearls”