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.

1
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

2
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

3
Agenda

The pharmaceutical business environment

Challenges for pharmaceutical publishing

Regulation, harmonisation and localisation

The PILLS solution

Demonstration and test drive

Evaluation

4
The business environment

5
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 Hoescht Solvay Lilly
OCD
Abbott Lilly ICN Novartis
BMS Novartis Lederle Ortho
ICN Lilly ADHD Pfizer
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

8
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

14
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.

15
Info on Prozac, from the Eli Lilly site,
http://www.prozac.com/prescribing_info.jsp
http://www.prozac.com/prescribing_info.jsp

Official
Package
Insert

16
and on WebMD, http://my.webmd.com/content/article/
http://my.webmd.com/content/article/

PIL-type
info
provided
by Lilly

17
and from the VHN compendium site,
http://emc.vhn.net/public/
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 regulators
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/
http://www.genrx.com/genrxfree/

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and Mosbys version of a PIL in English and
Spanish

21
Patient Insert info on Trazodone on Thomson
Micromedex site, http://www.micromedex.com/products
http://www.micromedex.com/products

(Prozac/Fluoxetine
not available in the
free sample docs
on this site!)

22
Fluoxetine content on the BNF site (linked from
VHN), http://bnf.vhn.net/home/
http://bnf.vhn.net/home/

23
Info on Fluctin (Lilly brand name in Germany) from
the Netdoktor site, http://www.netdoktor.de
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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Mercks Fluoxetine on the Netherlands Medicine
Evaluation Board site, http://www.cbg-meb.nl/nl/prodinfo
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

33
The PILLS approach

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How PILLS works

WYSIWYM Natural Language Generation Output format

Authoring
Ge

h
rm

is
gl
Label Label an XML Paper

En
Enter PIL PIL
information SPC SPC

Master
document Label
Feedback Label
PIL
text PIL Web
SPC SPC
Ot
he nch
r e
Create/Update Fr
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

37
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
any of the following, stop
adults and children over 12 is
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

38
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

41
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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