PILLS: Patient Information

Language Localisation System

Evaluation Workshop
Berlitz GlobalNET - Luton 30 Nov 2001

PILLS is a preparatory action European

eContent project, ECD-3310-26904.

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The PILLS Consortium

Technical team:
 Information Technology Research Institute (ITRI), University of Brighton UK
 Dr. Donia Scott, Professor of Computational Linguistics, Director of ITRI
 Dr. Richard Power, Reader in Computational Linguistics

 Medical Informatics Institute, University of Freiburg, Germany

 Dr. Stefan Schulz, MD, PhD in Public Health

Market research team:

 Berlitz GlobalNET Ireland
 Rose Lockwood, Director of Research

 Berlitz GlobalNET UK
 Dawn Murphy - Consultant

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Objectives for the day

 What we want to do
 Explain the rationale for the project
 Explain how the PILLS system works
 Show you the system working, and let you use it
 Get your advice and feedback on whether and how we undertake
further development of the system

 What we want you to do

 Advise us on whether we have correctly understood the publishing
requirements and challenges in the pharma industry
 Give feedback on regulation and localisation issues
 Experience PILLS for yourself
 Give feedback (and evaluation) on functionality, applicability of PILLS
 Collectively explore ideas for further development

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Agenda

 The pharmaceutical business environment

 Challenges for pharmaceutical publishing

 Regulation, harmonisation and localisation

 The PILLS solution

 Demonstration and test drive

 Evaluation

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The business environment

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Pharma industry trends and challenges

 Consolidation
 quest for market share in highly competitive market
 product line integration, premium on comprehensive solutions,
efficiencies in distribution and service

 Globalisation
 driven by changing policies (free trade), regulatory shifts
(harmonisation)
 leveraging sales & marketing for larger customers, exploiting global
opportunities

 Impact of technology
 shorter product cycles, faster time-to-market
 Internet effect: new purchaser buying-power, shifts in the value chain
(new intermediaries), new market segmentations

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CONSOLIDATION - global market increasingly
concentrated in large companies
global
mark et
share (%)
Company 2000 location of HQ
Pfizer 7% US
GlaxoSmithKline 7% UK
Merck 5% US
AstraZeneca 5% UK
Bristol-Myers Squibb 4% US
Novartis 4% CH
J&J 4% US
Aventis 4% FR
Pharmacia 3% US
AHP 3% US
Lilly 3% US
Roche 3% CH
Total Top 12 52%
Source: IMS Health

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CONSOLIDATION - highly competitive market,
e.g. for psychiatric drugs...
Narcolepsy Social Phobia Depression Mania Psychosis
• Shire • GlaxoSK • BMS • Abbott • Boehringer
• GlaxoSK • Pfizer • Forest • Roxane • Endo
• GlaxoSK • GlaxoSK • Janssen
Anxiety OCD • Hoescht • Solvay • Lilly
• Abbott • Lilly • ICN • Novartis
• BMS • Novartis • Lederle • Ortho
• ICN • Pfizer • Lilly ADHD • Pfizer
• Pfizer • Merck • Abbott • Schering
• GlaxoSK
• P&U • Novartis • Novartis • GlaxoSK
• Solvay
• Roche • Organon • Shire • Watson
• Sanofi • Pfizer • GlaxoSK • Zeneca
Obesity • Schering
• Carnrick • Solvay
Bulimia • Gate/Teva Panic Alcoholism
• Zeneca
• Lilly • Knoll • Pfizer • Boehringer
• Medeva • P&U • Dupont
Smoking • Roche • Roche • Wyeth-Ayerst
• GlaxoSK • GlaxoSK • GlaxoSK
Source: SAS

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GLOBALISATION - distribution of global
pharmaceutical sales in 2000 (US$ 318 billion)

6%6%
North America

16% Europe
48% Japan
Latin America

24% ROW

52% of the industry is non-US

Source: IMS Health

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GLOBALISATION - proportion of non-US sales
for top suppliers
Merck US 47%
AstraZeneca UK 46%
GlaxoSmithKline UK 45%
Pharmacia US 42%
AHP US 40%
Eli Lilly US 40%
Bristol-Myers Squibb US 38%
Johnson & Johnson US 34%
Pfizer US 34%
Schering-Plough US 30%
Source: IMS Health

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Changes driven by the Internet

 Supply-chain relationships
 Use of intranets for electronic exchange of research, compliance and
product info
 Integration with manufacturer, packaging supplier, sub-tier supplier
systems

 Customer relationships
 Direct, transparent markets
 Pressure on cost and turnaround
 High visibility

 Relationships with doctors, pharmacists, patients

 Direct-to-consumer trends
 “e-Detailing”

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New channels to regional and global markets

 Fast growth in hospital e-procurement take-up in the US

 currently $6.3 billion market
 grew by over $1.6 billion in 2000

 Integration of European procurement market

 e.g. NHS Supplies (UK) linking with other European providers to
benchmark prices across Europe
 likely to catch up with the US as Web infrastructure solidifies

 Localisation becomes competitively significant in cross-

border markets

 Flexible publishing solutions needed

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 Challenges for
pharmaceutical publishing

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Impact of these trends on pharma publishing

 Technical publishing issues

 information design, Web architecture, multiple publishing formats

 Information ecology - leveraging content for multiple publishing

requirements, e.g.
 marketing, labeling, instructions for use, operator manuals
 brochures, leaflets, manuals, support documentation (Print, CD, Web)

 Language and culture

 translation, adaptation to local conditions, symbology

 Legal & regulatory

 local and regional conformance

 Industry-specific trends
 good practice, standards

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New levels of market exposure through Web
publishing

 Globally available product showcases

 In regional and global markets
 With diverse cultural and social norms, business cultures
 Increasing communication across language barriers

 Increasingly localised, with

 Content highly adapted to local conditions
 Combining local content with global product information

 With a mix of document and format types, stylistic forms

and registers, variations in presentation of the same or
similar content.

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Info on Prozac, from the Eli Lilly site,
http://www.prozac.com/prescribing_info.jsp

Official
Package
Insert

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…and on WebMD, http://my.webmd.com/content/article/

“PIL-type”
info
provided
by Lilly

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…and from the VHN compendium site,
http://emc.vhn.net/public/

SPC

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…and the SPC for Fluoxetine (Prozac “generic”)
on the European Product Index site

SPC in English linked on

the Swedish regulator’s
site
http://www3.mpa.se/spc/

License holder:
A/S GEA
Farmaceutisk Fabrik
(licensed in SE, DK,
FI, NE, UK)

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“Monograph-type” info on the Mosby drug
information site, http://www.genrx.com/genrxfree/

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…and Mosby’s version of a PIL in English and
Spanish

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Patient Insert info on Trazodone on Thomson
Micromedex site, http://www.micromedex.com/products
(Prozac/Fluoxetine
not available in the
“free sample docs”
on this site!)

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Fluoxetine content on the BNF site (linked from
VHN), http://bnf.vhn.net/home/

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Info on Fluctin (Lilly brand name in Germany) from
the Netdoktor site, http://www.netdoktor.de
This site is
published
in Danish,
Norwegian,
Swedish,
German
(2 versions
for AT &
DE) and
English

Patient
info in
German

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Merck’s Fluoxetine on the Netherlands Medicine
Evaluation Board site, http://www.cbg-meb.nl/nl/prodinfo

SPC
in Dutch

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 Information flow - pharmaceutical data
Web Delivery / Multi-Language
The goal:
common data sources
for multiple documents SPC Product “Label” (Official
in multiple languages (EU) Packet) Inserts (US)

Health
Portals
Clinical Compliance Physician Patient
R&D
Trials Dossiers Info Info

Patient
A question: Monographs Inserts
can this be done across PILs (US)
and between pharma (EU)
companies? USP BNF EP

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Regulation, harmonisation
and localisation

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The context for regulatory change

 ICH

 Changing European regulatory regime:

 EMEA, EDQM
 Mutual Recognition Procedure
 Pharmacopoeia

 ...with similar content also published in less regulated

environments such as Web portals

 Dramatic impact on use and re-use of pharma product

info...

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EMEA: documents required in the regulatory
process
Other IND PSUR Docs/
DERN /Pre-Qualification Agency Meeting Reports
Reporting

NDA: New Drug Submission Verification Adverse Event Medical

Application Docs Evaluation Docs Report

Clinical Trial Study Plan: Consultation Reports:

Methods & CM&C and Registrations Committee Answer Drafts
Measurements (e.g. DMFs) and Reporting

Submission Development
(Case, Refs, Tasking) Consultation/Expert
Reports: Clinical Data Agency Response Docs

Submission Package
Assembly: QA & Report
QM: Quality Management
Reporting (CQI) SPC: Summary of
Product Characteristics
QA Reporting: Trial
Methods Compliance
Adverse Event Coding
Case by Case Drug Product Listing(s)
Submissions: Labeling,
Consultation Reports:
PILs, Advertisements
Preclinical
Adverse Events
Reporting: Spontaneous
Risk Assessment on QA Regulatory Process until
& Mandatory Periodic
& Reporting Protocols Approval or Withdrawal

(Average 100,000 pages)

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 Organisation of the EDQM
European Directorate for the Quality of Medicines

Prepares EP
monographs for
drugs with
marketing
approvals

The European
Pharmacopoeia
was inaugurated in
1964 through a
convention under
the Council of
Europe

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Parties to the European Pharmacopeia Convention

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Language requirements for Pharmacopoeia

Languages x9:
Pharmacopeia
Bosnian, Croatian, Cypriot
Greek, Icelandic, Macedonian,
Languages: Norwegian, Slovakian, Languages x12:
EU13 (11+2 in European Economic Slovenian, Turkish CEEC
Area) Bulgarian, Cypriot Greek,
Danish, Dutch, English, Finnish, Czech, Estonian, Hungarian,
French, German, Greek, Latvian, Lithuanian, Maltese,
(Icelandic), Italian, (Norwegian), Polish, Romanian, Slovakian,
Portuguese, Spanish, Swedish, Slovenian

Total European languages = 29:

Bosnian, Bulgarian, Croatian, Cypriot Greek,
Czech, Danish, Dutch, English, Estonian,
Finnish, French, German, Greek, Hungarian,
Icelandic, Italian, Latvian, Lithuanian,
Macedonian, Maltese, Norwegian, Polish,
Portuguese, Romanian, Slovakian,
Slovenian, Spanish. Swedish, Turkish

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Pharma localisation challenges

 13 EU languages – legal requirement for central

authorisations

 New countries joining EU (8 new languages anticipated

in the near term)

 20 days to produce translations

 1000s of documents

 Updates may be several times a year

 Version control challenge

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The PILLS approach

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How PILLS works

WYSIWYM Natural Language Generation Output format

Authoring

Label Label XML Paper

Enter PIL PIL
information SPC SPC

Master
document Label
Feedback Label
PIL
text PIL Web
SPC SPC

Create/Update
Master CD
Document Generate Output Documents

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PILLS concepts

 Domain model
 Pharmaceutical/medical concepts, eg ingredients
 NOT just a dictionary

 WYSIWYM – Symbolic authoring

 Author selects concepts from domain model
 Menu-driven editor
 Author “writes” MASTER DOCUMENT
 Author = product specialist

 Natural Language Generation

 Automatically creates text from concepts using linguistic rules
 Different style, terminology etc depending on doc type
 Generates document in any language for which linguistic rules are
available

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How does PILLS compare with other
technologies?
 Word processing
 Templates/old documents/previous versions
 New doc for each doc type
Translation
 Translation bottleneck
bureau 1

Translation
bureau 2

Local opco

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How does PILLS compare with other
technologies?
 Document management (XML)
 Re-use at component level
 Less linguistic flexibility
 Translation reduced but still required for new text
<side-effect>If you experience
<dose>The usual dose for
adults and children over 12 is any of the following, stop
one to three tablets every 12 taking the medicine
hours.</dose> immediately and tell your
doctor: unexplained
wheezing, shortness of
How to take your medicine
breath, skin rash, itching,
The usual dose for
adults and children bruising or facial
over 12 is one to three
tablets every 12 hours.
swelling.</side-effect>
Will I have any problems?
If you experience any
of the following, stop
taking the medicine
immediately …

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How does PILLS compare with other
technologies?
 Machine translation
 Write source doc
 Quality issues – MT first has to understand the source language

MT System

Source
documents
Natural Natural
language language Translations
understanding generation

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Why take the PILLS approach?

 Save time by creating multiple documents from

one master document

 Save time by avoiding translation step

 Automatically conform to regulatory

requirements re content

 Manage change by editing master document

only

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PILLS demonstration

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Discussion and evaluation
 General impression and relevance of the PILLS system
 initial impression, relevance

 The PILLS authoring process

 acceptable? usable? the “master document” concept? the authoring
interface/method?

 Benefits and/or drawbacks of the PILLS approach

 benefits? problems? compatibility issues?

 Possible improvements to PILLS

 changes? requirements/conformance? types of documents?

 Exploitation of PILLS
 would/could you participate? other applications?

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Thank you!

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