An introduction to the WHO Drug Dictionaries

Anna Mattsson, Support Executive

Outline • Introduction • Introduction to The WHO Drug Dictionaries • How we can help you • Q&A

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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The WHO Drug Dictionaries

© 2015 Anna Mattsson, Uppsala Monitoring Centre

What is coding? Staderm Staderm given

a lot of Nurfenpro Pain killer Nurfenpro

Brufen Brufen 40

Ibuprofeno

AIbuprofen blue pill piconol

Ibuprofen Ibuprofen from Glaxo Ibbuprofen Ibuprofen

Nurofen used A bunch of Nurofen against migraine medicines migraine

Staderm tablets

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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The added value of WHO Drug Dictionaries Nurfenpro

Brufen

Staderm

Ibuprofen Drug code Ibuprofen

Ibuprofeno

piconol Nurofen migraine Ibuprofen © 2015 Anna Mattsson, Uppsala Monitoring Centre

The WHO Drug Dictionaries A source of international drug names • Holds information on trade name, active ingredient, MAHolder, strength etc. • Up to date • Produced quarterly – customers can choose subscription for 1,2 or 4 times per year • Delivered in flat ASCII-files • WHO Drug Dictionary Browser © 2015 Anna Mattsson, Uppsala Monitoring Centre

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Dictionary types CRT Japan

WHO DD

WHO DDE

WHO HD

DDC

SDGs

© 2015 Anna Mattsson, Uppsala Monitoring Centre

Formats – B & C B-format:

C-format:

Tradolan (Tramadol hcl) N02AX Drug code: 005992 02 029

Tradolan (Tramadol hcl) N02AX Drug Code: 00599202029 •Sweden, Finland, Norway, Austria •Nordic Drugs, Lannacher •Tablets, Ampoules, Liquids, Supp. •100 mg, 150 mg, 200 mg

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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Dictionary formats

B

WHO DD

WHO DDE

WHO HD

DDC

C

© 2015 Anna Mattsson, Uppsala Monitoring Centre

The Drug Code • The Drug Code is the unique key in the B format and it is used also in the C format. • Unique identifier of a Product name • The code gives you information about the – Active ingredient(s) – Salt or ester variants of the ingredient – The Drug name

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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The Drug Code • The code can be used as a key in the case report or clinical data • The Drug Code is an aggregation of Drug Record Number (Drecno), Sequence Number 1 and Sequence Number 2.

© 2015 Anna Mattsson, Uppsala Monitoring Centre

Drug Record Number (DrugRecNo) • The first six characters in the Drug Code • The Drug record number (drecno) is the same for all entries containing the same active ingredient or unique combination of active ingredients. DrugRecNo

Seq 1

Seq 2

Name

000005

01

001

Ampicillin

000200

01

001

Paracetamol

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Sequence Number 1 • Character 7-8 in the Drug Code • The Sequence Number 1 (Seq1) identifies the salt or the ester of the active ingredient in single ingredient product. • The number ‘01’ identifies the base substance, without any salt or ester, and values above ‘01’ will identify salts and esters. Drecno

Seq 1

Seq 2

Name

000005

01

001

Ampicillin

000005

02

001

Ampicillin sodium

000005

03

001

Ampicillin trihydrate

© 2015 Anna Mattsson, Uppsala Monitoring Centre

Sequence Number 2 Character 9-11 in the Drug Code The Sequence Number 2 (Seq2) identifies trade names and in some cases a synonym to a generic name

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Seq 2 - example Drecno

Seq 1

Seq 2

Name

000005

01

001

Ampicillin

000005

01

002

Ampicin

000005

01

003

Binotal

000005

02

001

Ampicillin sodium

000005

02

002

Binotal

000005

02

003

Polycillin-n

© 2015 Anna Mattsson, Uppsala Monitoring Centre

Analysis with different levels of precision • Drug Code • SDGs • ATC code

helps you aggregate statistics on higher levels: – A02BC identifies all Proton pump inhibitors – Omeprazole, Lansoprazole, Pantoprazole etc – A02B - all drugs for Peptic Ulcer and GORD – A02 – all drugs for Acid Related Disorders – A – all drugs that act on the alimentary tract

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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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) – Validation Service

• Development of Coding Conventions – Set of rules on how to deal with scenarios – Include versioning aspects – Granularity of coding

– Training and background of coders – Let UMC assist you! © 2015 Anna Mattsson, Uppsala Monitoring Centre

WHO Drug Dictionary Support • As a subscriber you have full access to our support services • We are here for YOU! • Contact us!

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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WHO Drug Dictionary Support • Technical-, Pharmaceutical questions or Missing Drug name • Browser questions • Customer meetings • User Group Meetings • Licence issues • Webinars

© 2015 Anna Mattsson, Uppsala Monitoring Centre

WHO Drug Dictionary Support

•Technical questions

000001010016N INN 01 854METHYLDOPA 000001010024T04 124UNS 01 041ALDOMET 000001010032T67 05UNS 01 044PRESINOL 000001010040T68 09UNS 01 044DOPAMET 000001010057T69 08UNS 01 044HYPERPAXA 000001010065T69 06UNS 01 044SEMBRINA 000001010073T70 25UNS 01 044HYPERPAX

© 2015 Anna Mattsson, Uppsala Monitoring Centre

/00000101/

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WHO Drug Dictionary Support • Pharmaceutical questions

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WHO Drug Dictionary Support • Missing Drug name

Contact us and we can add the Drug or give you a coding suggestion

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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WHO Drug Dictionary Support WHO DD Browser

Test accounts

Webinars

© 2015 Anna Mattsson, Uppsala Monitoring Centre

WHO Drug Dictionary Support • User Group meetings

© 2015 Anna Mattsson, Uppsala Monitoring Centre

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WHO Drug Dictionary Support • Webinars WHO Drug Dictionaries Best Practices – practical examples Validation request What's New in 2014 with FAQs Standardised Drug Groupings (SDGs) in-depth webinar Codes and ID's - How to identify different groupings of drugs in the WHO DDs What's New in June with FAQs UMC’s support for CDISC Standards What’s New in September and Introduction to Cross Reference ATC 5 Re cap from User Group meeting

© 2015 Anna Mattsson, Uppsala Monitoring Centre

WHO Drug Dictionary Training Main chapters

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The User Group Portal • http://usergroup.umc-products.com/ • User Guide • Best Practise • Important messages

• User group meetings • etc

© 2015 Anna Mattsson, Uppsala Monitoring Centre

Contact us:

• [email protected] • [email protected]

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Uppsala and the Fyris River © 2015 Anna Mattsson, Uppsala Monitoring Centre

Uppsala and the Fyris River © 2015 Anna Mattsson, Uppsala Monitoring Centre

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© 2015 Anna Mattsson, Uppsala Monitoring Centre

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Thank You! Anna [email protected]

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