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! 1 Introduction to WHODrug Global Marilina Castellano, Product Specialist, UMC Sara Strese, Terminology Specialist, UMC 2 Uppsala Monitoring Centre 1 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 Who are we? Marilina Castellano Sara Strese Product Specialist, Terminology Specialist, UMC UMC 3 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 4 Uppsala Monitoring Centre 2 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 5 Uppsala Monitoring Centre and WHODrug 6 Uppsala Monitoring Centre 3 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 7 WHODrug Insight WHODrug Global is provided as part of a subscription to WHODrug Global 8 Uppsala Monitoring Centre 4 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 9 Drug verbatim 10 Uppsala Monitoring Centre 5 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 Users of WHODrug Vendor Sponsor CRO 11 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 12 Uppsala Monitoring Centre 6 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 13 What is in WHODrug Global? 14 Uppsala Monitoring Centre 7 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 Types of drugs in WHODrug Conventional Biological drugs drugs Herbal drugs Chemotherapy regimens 15 Sources of information • IQVIA • Monitoring new drug approvals • ICSRs All new inclusions • Change Requests must be verified in reliable references! 16 Uppsala Monitoring Centre 8 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 Information in WHODrug • Drug name • Country of sales • Drug code • MAH • Active ingredient/Substance name • Pharmaceutical form • ATC classification • Pharmaceutical strength 17 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 18 Uppsala Monitoring Centre 9 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 19 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) 20 Uppsala Monitoring Centre 10 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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) 21 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 22 Uppsala Monitoring Centre 11 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 WHODrug structure 23 Information structure Preferred – Ampicillin base name Trade name – Ascillin Preferred – Ampicillin sodium salt name Preferred – Ampicillin potassium salt name Trade name – Suractin 24 Uppsala Monitoring Centre 12 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 B3- and C3-Formats 25 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 26 Uppsala Monitoring Centre 13 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 27 The difference between B3 and C3 B3 format: C3 format: 28 Uppsala Monitoring Centre 14 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 B3-format: ✓ WHODrug record • Drug code • Drug name • ATC code and text • Active ingredients 29 ✓ WHODrug record C3-format: • Drug code • Drug name • ATC code and text • Active ingredients • Country of sales • Pharmaceutical forms • Marketing Authorization holder • Strength 30 Uppsala Monitoring Centre 15 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 The Drug Code 31 Information structure Preferred – Ampicillin base name Trade name – Ascillin Preferred – Ampicillin sodium salt name Preferred – Ampicillin potassium salt name Trade name – Suractin 32 Uppsala Monitoring Centre 16 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 33 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 34 Uppsala Monitoring Centre 17 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 35 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). 36 Uppsala Monitoring Centre 18 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 Drug classification 37 All drug names in WHODrug are classified to reflect their labelled indications of use - Why the patient took aspirin aspirin? 38 Uppsala Monitoring Centre 19 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 In WHODrug drug names are classified by o ATC o Herbal ATC o UMC created ATC codes 39 WHODrug Global 40 Uppsala Monitoring Centre 20 A basic introduction to WHODrug Global WHODrug webinar, December 10, 2019 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 41 14 Main Groups • A Alimentary tract and metabolism • B Blood and blood forming organs • C Cardiovascular system • D Dermatologicals