A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019
Welcome to this WHODrug Webinar!
This session is broadcasted live and hosted by the Uppsala Monitoring Centre. The audio will be muted until the session starts. To test your audio in advance, please do a soundcheck within the GoToWebinar application. All attendees will be muted during the entire webinar. For most webinars, handouts will be provided and can be located in the handouts section of the GoToWebinar control panel. Any questions? Please write them in the questions log throughout the webinar and we’ll try to address as many as possible in the end of the session. After the session you will be asked to complete a webinar survey. As we are continuously trying to improve our webinars, your feedback is important. Enjoy the session!
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Introduction to WHODrug Global Marilina Castellano, Product Specialist, UMC Sara Strese, Terminology Specialist, UMC
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Who are we?
Marilina Castellano Sara Strese Product Specialist, Terminology Specialist, UMC UMC
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How to interact today
Type your comments Q: Hi, could you please repeat and questions here the concept from slide n.2? throughout the webinar Download handouts from the panel
Or from the webinars https://www.who-umc.org/user- library (available area/whodrug/webinars-library/ 36hours after the webinar
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Outline – checklist for new WHODrug users
✓ UMC and WHODrug ✓ What is in WHODrug Global ✓ Dictionary Structure - Formats - Drug code - Drug classification ✓ How to code ✓ Keep up-to-date ✓ Q&A
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Uppsala Monitoring Centre and WHODrug
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WHODrug Insight WHODrug Global is provided as part of a subscription to WHODrug Global
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WHODrug Global – enabling detailed analysis of drug data
E.g. market withdrawal or new drug-drug interaction or adverse event in SPC Decision E.g. by using Drug Code, ATC classifications or SDGs Data aggregation & analysis WHODrug Global E.g. from a clinical trial or Drug coding spontaneous reports in post-marketing safety #CDISCChina | #ClearDataClearImpact 9
Drug data collection
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Drug verbatim
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Users of WHODrug
Vendor
Sponsor
CRO
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I am a WHODrug user! what else do I have access to?
✓ Browse the dictionary data - Insight ✓ Create customised drug groupings - Insight ✓ Request a new record – Change Request ✓ Up-version your study data – CAT ✓ Download the latest documents, and watch the most recent webinars - User Area ✓ Acquire information on your partner's License status - License Validation service
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UMC account
• UMC username and password • WHODrug users are eligible for personal UMC accounts depending on their subscription status • Use it to access tools and services at https://www.who-umc.org/whodrug/access-tools/ • Access to the Download area is given only to delivery and appointed delivery contacts • Contact [email protected] for any enquiries
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What is in WHODrug Global?
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Types of drugs in WHODrug
Conventional Biological drugs drugs
Herbal drugs Chemotherapy regimens
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Sources of information
• IQVIA • Monitoring new drug approvals • ICSRs All new inclusions • Change Requests must be verified in reliable references!
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Information in WHODrug
• Drug name • Country of sales • Drug code • MAH • Active ingredient/Substance name • Pharmaceutical form • ATC classification • Pharmaceutical strength
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A drug name can be:
A medicinal product with a trade name A generic substance name
Loxoprofen
A medicinal product with a generic trade name An undefined drug belonging to a defined group of drugs
Propionic acid derivatives
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Active ingrediens
Preferred name = Preferably an International Nonproprietary Name (INN) of a substance Synonym name = Other established substance name Generic name = Substance name
Preferred Paracetamol name
Synonym name Acetaminophen
Synonym APAP name
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Umbrella Records
Umbrella record Records representing defined groups or types of drugs
ORAL ANTIDIABETICS Antibiotics (Drug code: 90003101001) (Drug code: 90046601001)
DIURETICS CONTRACEPTIVES (Drug code: 90015301001) (Drug code: 90113401001)
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NOS records
NOS = Not Otherwise Specified Records represent groups of substances to be used as ingredients in WHODrug records
Lactobacillus nos Vitamin D nos (Drug code: 074961 01 001) (Drug code: 075039 01 001)
Allergens nos Herbal nos (Drug code: 073984 01 001) (Drug code: 074927 01 001)
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Non-Unique Names in the B3-format
Identical drug names with different sets of ingredients Additional information is appended to make non-unique records unique
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WHODrug structure
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Information structure
Preferred – Ampicillin base name
Trade name – Ascillin
Preferred – Ampicillin sodium salt name
Preferred – Ampicillin potassium salt name
Trade name – Suractin
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B3- and C3-Formats
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WHODrug are presented in two formats
One dictionary - available in two formats: B3 & C3 -format
Which one should I use?
End user decides: both are available for download
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Information in the WHODrug Formats
• B3 – essential information • Drug names • Drug Codes • Active ingredients • ATC classifications • C3 – additional information • Countries of sales • Marketing Authorisation Holders • Pharmaceutical forms • Pharmaceutical strengths
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The difference between B3 and C3
B3 format:
C3 format:
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B3-format: ✓ WHODrug record • Drug code • Drug name • ATC code and text • Active ingredients
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✓ WHODrug record C3-format: • Drug code • Drug name • ATC code and text • Active ingredients • Country of sales • Pharmaceutical forms • Marketing Authorization holder • Strength
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The Drug Code
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Information structure
Preferred – Ampicillin base name
Trade name – Ascillin
Preferred – Ampicillin sodium salt name
Preferred – Ampicillin potassium salt name
Trade name – Suractin
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The Drug Code
• The Drug Code is the unique key in the B3- format and is also used in the C3-format • Unique identifier of a drug name • The code gives you information about the: ▪ Active moiety(ies) ▪ Variations of Active moiety(ies) ▪ The drug name
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Information structure
Preferred – Ampicillin 000005 01 001 base name
Preferred – Ampicillin sodium 000005 02 001 salt name
Preferred – Ampicillin potassium 000005 04 001 salt name
Trade name – Suractin 000005 04 002
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The Drug Code
• The Drug Code is an aggregation of: • Drug Record Number (DrugRecNo) • Sequence Number 1 (Seq1) • Sequence Number 2 (Seq2)
Drug Sequence Sequence Drug Record Number 1 Number 2 Code Number
00020001004
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Analysis with different levels of precision
▪ 000005 04 002 identifies the trade name suractin with the active substance: Ampicillin potassium ▪ 000005 04 identifies all medicinal products with the active substance: Ampicillin potassium ▪ 000005 identifies all products with ampicillin (all salt/base variations) ▪ Both 000005 01 001 and 000005 02 001 are Preferred Names - Drug Code ending with 001. A Preferred Name corresponds to an active substance or a combination of active substances, and connects all trade names with the same active substance(s).
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Drug classification
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All drug names in WHODrug are classified to reflect their labelled indications of use -
Why the patient took aspirin aspirin?
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In WHODrug drug names are classified by o ATC o Herbal ATC o UMC created ATC codes
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WHODrug Global
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The ATC System
• ATC = Anatomical Therapeutic Chemical • Maintained by the WHO Collaborating Centre for Drug Statistics Methodology • Developed for analysis of drug utilization
www.whocc.no/atc_ddd_index
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14 Main Groups
• A Alimentary tract and metabolism • B Blood and blood forming organs • C Cardiovascular system • D Dermatologicals • G Genito-urinary system & sex hormones • H Systemic hormonal preparations, excl. sex hormones • J General antiinfectives, systemic • L Antineoplastics and immunosuppressants • M Musculo-skeletal system • N Central nervous system • P Anti-parasitic products • R Respiratory system • S Sensory system • V Various
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5 ATC Levels
Available up to level 4 in WHODrug
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Official and UMC-assigned ATC codes
Active Ingredient(s) ATC Gabapentin N02BG, Other analgesics and antipyretics umc-assigned N03AX, Other antiepileptics official N07XX, Other nervous system drugs umc-assigned
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The Herbal ATC System (HATC)
• Originally developed by UMC • Follows the same principles as the conventional ATC classification system
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HATC Example
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Example Hierarchy for A02A in WHODrug Insight
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UMC Created ATC Codes
• V90, UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE
• V91, HOMEOPATHIC PREPARATION
• V98, INVESTIGATIONAL DRUG
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Drug classification B3- vs C3-format
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00002701001 B3 Acetylsalicylic acid C3 A01AD, B01AC, M02AC, N02BA
Aspirin Aspirin A01AD, B01AC, N02BA M02AC, N02BA
Trombyl Trombyl A01AD, B01AC, B01AC M02AC, N02BA
ATC same as preferred name Higher precision of ATC assignments
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How to code
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Coding Conventions
Before trial start make sure to agree on coding conventions: ▪ Agreement between teams (or Sponsor and CRO) on all aspects of coding, correct Dictionary and version etc. ▪ Agreement between stakeholders (biostatisticians, coders, data managers, IT, etc) Development of Coding Conventions ▪ Set of rules on how to deal with scenarios ▪ Granularity of coding ▪ Include versioning aspects ▪ Training and background of coders
WHODrug Best Practices: https://www.who-umc.org/user-area/whodrug/full-whodrug-library/whodrug-best-practices-current-version/
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Keep up-to-date
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Visit the UMC homepage
www.who-umc.org
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Online WHODrug Training
https://www.who-umc.org/whodrug/training/online-whodrug-training/
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Documents – WHODrug library
• User Guides • Best Practices • Newsletters • Other documents
https://www.who-umc.org/user-area/whodrug/full-whodrug-library/
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WHODrug User Group meetings
https://www.who-umc.org/whodrug/user-group-meetings/
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Register to User Group meeting in India
https://www.anpdm.com/newsletterweb/464051407943435D4576474159/4 24B514A7540435F4B7040405B4471
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WHODrug Webinars
https://www.who-umc.org/user-area/whodrug/webinars-library/
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WHODrug Support
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Q&A
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Thank You! Marilina Castellano, [email protected] Sara Strese, [email protected] [email protected]
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