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Transcript of Terminologies for coding of adverse reactions and drug information...
Terminologies for coding of adverse reactions
and drug information
PV Training Course
Uppsala 2-13 May, 2011
Anders Viklund, MSc Pharm
Uppsala Monitoring Centre
Anders Viklund, Uppsala Monitoring Centre
Purpose & Outline
• To facilitate training in PV tools using terminologies– VigiFlow (input/analysis)
– VigiSearch/VigiMine (analysis)
• Reactions (MedDRA, WHO-ART)
• Drugs (WHO DD, ATC, SDG)
• Relevant medical background (ICD, MedDRA)
• Death causes (ICD-10, MedDRA)
• Diagnosis (ICD-10, MedDRA)10 min
20 min
20 min
Anders Viklund, Uppsala Monitoring Centre
An 86-year-old female with bipolar disorder was admitted with anxiety,insomnia, fatigue, and acute renal failure. Although lithium levels were normal,lithium had been discontinued and replaced with carbamazepine100 mg daily 2 days prior to admission. She was also takinghydralazine 100 mg three times daily for hypertension for 2 years withno dosage change in 8 months. On hospital day 8, she developed feverand conjunctivitis followed by oral erosions and painful lesions on her nose,ears, back, and fingers.On examination, she appeared acutely ill and was febrile (38.4°C). Bilateralconjunctivitis with exudative discharge and periorbital edema was noted.Tense vesicles and bullae with surrounding erythema were noted on her scalp,nose, and back. The skin overlying the cartilaginous portions of both ears waserythematous and edematous with focal bullous change.The noncartilaginous lobes appeared normal. Erosions were noted on thehard palate and gingival mucosa. Tender hemorrhagic bullae wereprominent on distal and lateral fingers.Laboratory testing revealed elevated C-reactive protein at 14 mg/dl(normal = 0 to 1 mg/dL) and erythrocyte sedimentation rate of 72 mm/hour(normal = 0 to 17 mm/hour).
Case report in free text
Anders Viklund, Uppsala Monitoring Centre
An 86-year-old female with bipolar disorder was admitted with anxiety,insomnia, fatigue, and acute renal failure. Although lithium levels were normal,lithium had been discontinued and replaced with carbamazepine100 mg daily 2 days prior to admission. She was also takinghydralazine 100 mg three times daily for hypertension for 2 years withno dosage change in 8 months. On hospital day 8, she developed feverand conjunctivitis followed by oral erosions and painful lesions on her nose,ears, back, and fingers.On examination, she appeared acutely ill and was febrile (38.4°C). Bilateralconjunctivitis with exudative discharge and periorbital edema was noted.Tense vesicles and bullae with surrounding erythema were noted on her scalp,nose, and back. The skin overlying the cartilaginous portions of both ears waserythematous and edematous with focal bullous change.The noncartilaginous lobes appeared normal. Erosions were noted on thehard palate and gingival mucosa. Tender hemorrhagic bullae wereprominent on distal and lateral fingers.Laboratory testing revealed elevated C-reactive protein at 14 mg/dl(normal = 0 to 1 mg/dL) and erythrocyte sedimentation rate of 72 mm/hour(normal = 0 to 17 mm/hour).
Case report in free text
Anders Viklund, Uppsala Monitoring Centre
An 86-year-old female with bipolar disorder was admitted with anxiety,insomnia, fatigue, and acute renal failure. Although lithium levels were normal,lithium had been discontinued and replaced with carbamazepine100 mg daily 2 days prior to admission. She was also takinghydralazine 100 mg three times daily for hypertension for 2 years withno dosage change in 8 months. On hospital day 8, she developed feverand conjunctivitis followed by oral erosions and painful lesions on her nose,ears, back, and fingers.On examination, she appeared acutely ill and was febrile (38.4°C). Bilateralconjunctivitis with exudative discharge and periorbital edema was noted.Tense vesicles and bullae with surrounding erythema were noted on her scalp,nose, and back. The skin overlying the cartilaginous portions of both ears waserythematous and edematous with focal bullous change.The noncartilaginous lobes appeared normal. Erosions were noted on thehard palate and gingival mucosa. Tender hemorrhagic bullae wereprominent on distal and lateral fingers.Laboratory testing revealed elevated C-reactive protein at 14 mg/dl(normal = 0 to 1 mg/dL) and erythrocyte sedimentation rate of 72 mm/hour(normal = 0 to 17 mm/hour).
Case report in free text
Anders Viklund, Uppsala Monitoring Centre
Patient Background Drug ADR Lab test
86-year Bipolar disorder Lithium Fever ElevatedC-reactive protein
female Anxiety Carbamazepine Conjunctivitis High erythrocytesedimentation rate
Insomnia Hydralazine Oral erosions Normal whiteblood cell count
Fatigue Skin lesions Lowhemoglobin
Acute renal failure
Periorbitaledema
Erythema
Hemhorrhagicbullae
Extracted case information
Anders Viklund, Uppsala Monitoring Centre
Freedom versus structure
Free text Coded dataComplete representationof complex data
Flexible, expressive, familiar
Computerised retrieval and analysis easy and efficientLanguage independence
Computerised retrieval and analysis difficult
Data entry requirestransformation of theinformation
risk of loss/distortion
Anders Viklund, Uppsala Monitoring Centre
A mix between structuredfields and free text boxes
An ADR reporting form
Anders Viklund, Uppsala Monitoring Centre
code text 0014001 Erythema multiforme0014003 Erythema annulare0015001 Erythema nodosum0028001 Rash erythematous0028002 Erythema plantar0028003 Erythema0028009 Erythema palmar0042003 Erythema multiforme severe0047006 Application site erythema0080003 Lupus erythematosus discoid
Terminology list
MATCH!
Erythema
Anders Viklund, Uppsala Monitoring Centre
code text 0041006 Skin erosion0059003 Auditory meatus external erosion0328009 Erosion gingival1854002 Lip erosion
MATCH!
Oral Erosion
NO MATCH!
Erosion gingival
Oral erosions=
Erosion gingival
National Centre staff
Anders Viklund, Uppsala Monitoring Centre
Challenges when using terminologies
STEVENS - JOHNSON SYNDROME STEVEN JOHNSON SYNDROMS
STEVENS JOHSON SYNDROME STEVEN JOHNSON SYNDROME
STEVENS-JOHNSON SYNDROMES STEVEN JOHNSON'S SYNDROME
STEVENS-JHONSON SYNDROME STEVEN JOHNSON SYNDROM
GINGIVAL EROSION PHOTOSENSITIVITY REACTION ALLERGICEROSION GINGIVAL REACTION PHOTOSENSITIVITY ALLERGIC
REACTION ALLERGIC PHOTOSENSITIVITY
SOB, DYSPNOEA, BREATH SHORTNESS
• Synonyms
• Spelling variations
• Word ordering
Anders Viklund, Uppsala Monitoring Centre
Terminologies in the WHO ICSR database
WHO-ARTWHO Adverse Reaction Terminology
MedDRAMedical Dictionary for Regulatory Activities
ICDInternational Classification of Diseases
WHO DDWHO Drug Dictionary
ATCAnatomical Therapeutic Chemical classification system
Anders Viklund, Uppsala Monitoring Centre
PV tools used by UMC
• VigiFlow™– An ICSR* management system.
– Can be used for both coding and analysing reports
• VigiSearch™/VigiMine™– A search and statistics tool operating on the
WHO global ICSR database, VigiBase™
ICSR = Individual Case Safety Report
Anders Viklund, Uppsala Monitoring Centre
Use VigiFlow to code this reaction.
VigiFlow Coding ReactionsTASK 1
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions
The VigiFlow reaction coding interface
Hierarchy level
Search type
Submitsearch
Chooselanguage
Entersearch text
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding ReactionsWHO-ART & MedDRA
• WHO-ART and MedDRA are two terminologies used for coding of reactions.
• Both terminologies are used in the WHO global ICSR database.
• Both terminologies have hierarchical structures
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions WHO-ART and MedDRA comparison
MedDRA• Comprehensive - relevant for drug
regulation area and medical information
• Complex – contains also terms not relevant for ADR monitoring
• Easy integration with companies
• Standard terminology in EU, USA, and Japan
• Maintained by the MedDRA-MSSO
WHO-ART• Only for adverse reaction
monitoring. Much smaller in size
• Easy to use, less training needed.
• Developed for spontaneous reporting
• Maintained by the UMC
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions Why both MedDRA and WHO-ART
• Some countries/companies have decided to use MedDRA and some WHO-ART when coding ICSRs.
• UMC tools must be able to handle data coded in both MedDRA and WHO-ART since both terminologies are approved in the WHO programme.
• All WHO-ART terms are linked to corresponding MedDRA terms. In a case report both terms are displayed
• All MedDRA terms cannot be linked to a WHO-ART term since MedDRA is much more diverse
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions
System Organ Class32
High level term189
Preferred Term2 178
Included Term3 624
MedDRA 12.0WHO-ART 2011-02-15
System Organ Class26
High level group term333
High level term1 699
Preferred Term18 483
Low Level Term48 676
SOC
HLGT
HLT
PT
LLT
SOC
HLT
PT
IT
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions Hierarchy levels
System Organ Class(SOC)
Included Term(IT)
group of preferred terms involving the same body organ
group of similar preferred terms
principal terms for coding and presentation
terms similar topreferred terms
Preferred Term(PT)
High level term(HLT)
High level group term(HLGT)
Low Level Term(LLT)
group of similar high level terms
MedDRAspecific
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions Gastric Ulcer
System Organ Class(SOC)
Included Term(IT)
GASTRO-INTESTINAL SYSTEM DISORDERS
Gastric ulcerPreferred Term(PT)
High level term(HLT)
Peptic ulcer
Stomach ulcerUlcus ventriculiPyloric ulcerLarge intestinal ulcerGastric irritationGastrointestinal irritationGastric ulcer helicobacter
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions Gastric Ulcer
VigiFlow browser tree for reactions
Anders Viklund, Uppsala Monitoring Centre
Use VigiFlow to search for this reaction.
VigiFlow Search ReactionsTASK 2
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Reactions
The VigiFlow search and statistics module
Hierarchy level
Search typeSubmitsearch
Chooselanguage
Entersearch text
Anders Viklund, Uppsala Monitoring Centre
Browse• Start from a System
Organ Class and drill down to the term you are looking for
• Enter part of or the entire term in the search field and the matching terms appear in a tree structure
QUESTION: Do you know what you are looking for or are you just browsing?
Locate – Search by text
VigiFlow Search Reactions
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Reactions Gastric Ulcer
System Organ Class(SOC)
Included Term(IT)
BODY AS A WHOLE
Influenza-like symptomsPreferred Term(PT)
High level term(HLT)
No HL-term
Influenza-like symptomsFlu-like syndrome
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Reactions Search by text
The VigiFlow reaction browser module
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Reactions Browse
The VigiFlow reaction browser module
Leave emptyChange to SOC Press search
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Reactions
Please note:
When looking for cases involving “Influenza-like symptoms” – a preferred term;
• The search can be done on System Organ Class level – “Body as a whole” and all cases of interest are retrieved.
• Because “Influenza-like symptoms” is a term included under the SOC “Body as a whole”
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search ReactionsTASK 3
Use VigiSearch to find cases with this reaction:
Anders Viklund, Uppsala Monitoring Centre
System Organ Class(SOC)
Included Term(IT)
GASTRO-INTESTINAL SYSTEM DISORDERS
Gastric ulcerPreferred Term(PT)
High level term(HLT)
Peptic ulcer
Stomach ulcerUlcus ventriculiPyloric ulcerLarge intestinal ulcerGastric irritationGastrointestinal irritationGastric ulcer helicobacter
VigiSearch/VigiMine Search ReactionsGastric Ulcer in WHO-ART
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search ReactionsThe search interface
Choose terminology
Choose level
Add search text
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding DrugsTASK 4
Use VigiFlow to code this drug.
Naprosyn®
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Drugs
The VigiFlow coding interface:
Enter drug name or part of name
Naprosyn
Anders Viklund, Uppsala Monitoring Centre
• A database with information about medicinal products from all over the world– links products with the same ingredients (brands, generics)
– links products containing the same base substance, but different salt/esters
• Information is provided in a consistent and structured way– allows easy and flexible data retrieval and analysis
• It provides useful groupings of data– allows different levels of precision
– useful for both data input and output
• It is continuously updated
VigiFlow Coding DrugsThe WHO Drug Dictionary (WHO-DD)
Anders Viklund, Uppsala Monitoring Centre
• The majority of the entries refer to conventional (chemical substance) medicinal products
but the database also includes:
– herbal remedies
– vaccines
– biotech products
– blood products
– diagnostic substances
– contrast media
VigiFlow Coding DrugsTypes of medicinal products in WHO-DD
Anders Viklund, Uppsala Monitoring Centre
M01 – Antiinflammatory and antirheumatic products
M01AE – Propionic acid derivatives
M01AE02 - Naproxen
Naprosyn®
Naprosyn®, UK
Naprosyn®, UK, enterotablet, Roche
Naprosyn®, UK, enterotablet, Roche, 250 mg
Therapeutic subgroup
ATC
Naprosyn®, UK, enterotablet
Pharmacological subgroup
Chemical subgroup
Chemical substance, Generic level (ingredients)
Proprietary name (trade name)
Country
Pharmaceutical form
Market Authorization Holder
Strength
Naproxen sodium Salt level
M – Musculo-skeletal system Anatomical main group
M01A – Antiinflammatory and antirheumatic products, non steroids
VigiFlow Coding DrugsThe WHO Drug Dictionary (WHO-DD)
Anders Viklund, Uppsala Monitoring Centre
• Which level should I choose?– Choose the level according to the information you have
available
– Tradename level is best. Generic level is good. You can also add an ATC group to describe e.g concomitant medication
– DD is updated continuously, your own national drug reference list is of great importance, if not already implemented. You can also suggest drugs to be added.
• Note: Do not spend time looking for drug information you do not think is important.
VigiFlow Coding DrugsThings to think about
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search DrugsTASK 4
Use VigiFlow to search for this substance.
fluoxetine
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Drugs Search by text
VigiFlow Search & Statistics interface:
choose level
enter search text
fluoxetine
Anders Viklund, Uppsala Monitoring Centre
N06 – Psychoanaleptics
N06AB – Selective Serotonin Reuptake Inhibitors
N06AB03 - Fluoxetine
Therapeutic subgroup
Pharmacological subgroup
Chemical subgroup
Chemical substance, Generic level (ingredients)
N – Nervous system Anatomical main group
N06A – Antidepressants
VigiFlow Search DrugsThe WHO Drug Dictionary (WHO-DD)
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Drugs Search by text
Please note:
When searching for cases on active substance level you will also include:
• cases where the basefluoxetine is reported
• cases with a reportedfluoxetine salt
• cases with a reported productconnected to the fluoxetine base/salt
Base
Salt
Tradename
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Drugs Search by browsing (ATC search)
VigiFlow Search & Statistics interface:
TASK:Find all
SSRI –SelectiveSerotoninReuptakeInhibitors
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search DrugsAnatomical Therapeutic Chemical
classification system (ATC)
• The ATC classification is issued by the WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway
• Medicinal products are classified according to the main therapeutic use in 14 different groups (see previous slide)
• Each group is divided into five levels (e.g. Nervous system group)
N06 – Psychoanaleptics
N06AB – Selective Serotonin Reuptake Inhibitors
N06AB03 - Fluoxetine
2nd level - Therapeutic subgroup
3rd level - Pharmacological subgroup
4th level - Chemical subgroup
5th level - Chemical substance
N – Nervous system 1st level - Anatomical main group
N06A – Antidepressants
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Search Drugs Search by browsing (ATC search)
VigiFlow Search & Statistics interface:
7 more …
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search DrugsTASK 5
Use VigiSearch to search for this drug.
fluoxetine
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search Drugs Search by text
VigiSearch query interface:
choose level enter search text
fluoxetine
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search Drugs Search by text
VigiSearch query interface:
Anders Viklund, Uppsala Monitoring Centre
VigiSearch/VigiMine Search Drugs Search by browsing
VigiSearch query interface:
Task: Find all SSRIs
choose level ATCpress magnifier
Anders Viklund, Uppsala Monitoring Centre
• ATC groups and Substance (generic level) are usual in search criteria.
• VigiSearch/VigiMine is more optimized for browsing than VigiFlow Search & Statistics
• In VigiFlow you can also add product country and market authorization holder.
Analysis DrugsAbout drug analysis in VigiSearch/Vigimine and VigiFlow
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding Usage ofInternational Classification of Diseases (ICD)
Anders Viklund, Uppsala Monitoring Centre
• The ICD is the international standard diagnostic classification for all general epidemiological, many health management purposes and clinical use
• It is used to classify diseases and other health problems recorded on many types of health and vital records including death certificates and health records
• Maintained by WHO in Geneva.
VigiFlow Coding ICDThe International Classification of Diseases
Anders Viklund, Uppsala Monitoring Centre
• Patient– Death related information
• Relevant Medical History
• Relevant Past Drug Theraphy– Theraphy
• Drugs– Indication
• Assessment– Sender’s diagnosis
VigiFlow Coding ICDUsage of ICD in VigiFlow
Anders Viklund, Uppsala Monitoring Centre
VigiFlow Coding ICDICD Hierarchy 1st level
VI G00-G99 Diseases of the nervous system