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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
Company
global
market
share (%)
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...
Depression
BMS
Forest
GlaxoSK
Hoescht
ICN
Lederle
Lilly
Merck
Novartis
Organon
Pfizer
Schering
Solvay
Zeneca

Psychosis
Boehringer
Endo
Janssen
Lilly
Novartis
Ortho
Pfizer
Schering
GlaxoSK
Watson
Zeneca
Alcoholism
Boehringer
Dupont
Wyeth-Ayerst
Panic
Pfizer
P&U
Roche
GlaxoSK
Mania
Abbott
Roxane
GlaxoSK
Solvay
ADHD
Abbott
Novartis
Shire
GlaxoSK
Bulimia
Lilly
Anxiety
Abbott
BMS
ICN
Pfizer
P&U
Roche
Sanofi
Smoking
GlaxoSK
Narcolepsy
Shire
GlaxoSK
OCD
Lilly
Novartis
Pfizer
GlaxoSK
Solvay
Social Phobia
GlaxoSK
Pfizer
Obesity
Carnrick
Gate/Teva
Knoll
Medeva
Roche
GlaxoSK
Source: SAS
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GLOBALISATION - distribution of global
pharmaceutical sales in 2000 (US$ 318 billion)
48%
24%
16%
6%
6%
North America
Europe
Japan
Latin America
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
License holder:
A/S GEA
Farmaceutisk Fabrik
(licensed in SE, DK,
FI, NE, UK)
SPC in English linked on
the Swedish regulators
site
http://www3.mpa.se/spc/
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Monograph-type info on the Mosby drug
information site, http://www.genrx.com/genrxfree/
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and Mosbys 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
Patient
info in
German
This site is
published
in Danish,
Norwegian,
Swedish,
German
(2 versions
for AT &
DE) and
English
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Mercks 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
SPC
(EU)
USP
Monographs
Product Label (Official
Packet) Inserts (US)
BNF EP
Patient
Inserts
(US)
PILs
(EU)
Web Delivery / Multi-Language
R&D
Clinical
Trials
Compliance
Dossiers
Patient
Info
Physician
Info
The goal:
common data sources
for multiple documents
in multiple languages
A question:
can this be done across
and between pharma
companies?
Health
Portals
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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
DERN /Pre-Qualification
QA Reporting: Trial
Methods Compliance
Submission Package
Assembly: QA & Report
Clinical Trial Study Plan:
Methods &
Measurements
Consultation Reports:
Preclinical
Submission Development
(Case, Refs, Tasking)
NDA: New Drug
Application
Risk Assessment on QA
& Reporting Protocols
Agency Meeting Reports
Submission Verification
Docs
Consultation Reports:
CM&C and Registrations
(e.g. DMFs)
Consultation/Expert
Reports: Clinical Data
QM: Quality Management
Reporting (CQI)
Adverse Event Coding
Case by Case
Adverse Events
Reporting: Spontaneous
& Mandatory Periodic
Other IND PSUR Docs/
Reporting
Adverse Event Medical
Evaluation Docs Report
Committee Answer Drafts
and Reporting
Agency Response Docs
SPC: Summary of
Product Characteristics
Drug Product Listing(s)
Submissions: Labeling,
PILs, Advertisements
Regulatory Process until
Approval or Withdrawal
(Average 100,000 pages)
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Prepares EP
monographs for
drugs with
marketing
approvals
Organisation of the EDQM
European Directorate for the Quality of Medicines
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:
EU13 (11+2 in European Economic
Area)
Danish, Dutch, English, Finnish,
French, German, Greek,
(Icelandic), Italian, (Norwegian),
Portuguese, Spanish, Swedish,
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
Languages x12:
CEEC
Bulgarian, Cypriot Greek,
Czech, Estonian, Hungarian,
Latvian, Lithuanian, Maltese,
Polish, Romanian, Slovakian,
Slovenian
Languages x9:
Pharmacopeia
Bosnian, Croatian, Cypriot
Greek, Icelandic, Macedonian,
Norwegian, Slovakian,
Slovenian, 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
Feedback
text
Enter
information
WYSIWYM
Authoring
Create/Update
Master
Document
Master
document
SPC
PIL
Label
SPC
PIL
Label
SPC
PIL
Label
Label
SPC
PIL
Generate Output Documents
Natural Language Generation Output format
Paper
Web
CD
XML
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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 bottleneck


Translation
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
<dose>The usual dose for
adults and children over 12 is
one to three tablets every 12
hours.</dose>

<side-effect>If you experience
any of the following, stop
taking the medicine
immediately and tell your
doctor: unexplained
wheezing, shortness of
breath, skin rash, itching,
bruising or facial
swelling.</side-effect>
How to take your medicine
The usual dose for
adults and children
over 12 is one to three
tablets every 12 hours.
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
Translations
Source
documents
Natural
language
understanding
Natural
language
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!