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
6
CONSOLIDATION - global market increasingly
concentrated in large companies
Company
Pfizer
GlaxoSmithKline
Merck
AstraZeneca
Bristol-Myers Squibb
Novartis
J&J
Aventis
Pharmacia
AHP
Lilly
Roche
Total Top 12
global
mark et
share (%)
2000
7%
7%
5%
5%
4%
4%
4%
4%
3%
3%
3%
3%
52%
location of HQ
US
UK
US
UK
US
CH
US
FR
US
US
US
CH
Source: IMS Health
7
CONSOLIDATION - highly competitive market,
e.g. for psychiatric drugs...
Narcolepsy
• Shire
• GlaxoSK
Social Phobia
• GlaxoSK
• Pfizer
Anxiety
• Abbott
• BMS
• ICN
• Pfizer
• P&U
• Roche
• Sanofi
OCD
• Lilly
• Novartis
• Pfizer
• GlaxoSK
• Solvay
Bulimia
• Lilly
Smoking
• GlaxoSK
Obesity
• Carnrick
• Gate/Teva
• Knoll
• Medeva
• Roche
• GlaxoSK
Depression
• BMS
• Forest
• GlaxoSK
• Hoescht
• ICN
• Lederle
• Lilly
• Merck
• Novartis
• Organon
• Pfizer
• Schering
• Solvay
• Zeneca
Mania
• Abbott
• Roxane
• GlaxoSK
• Solvay
ADHD
• Abbott
• Novartis
• Shire
• GlaxoSK
Panic
• Pfizer
• P&U
• Roche
• GlaxoSK
Psychosis
• Boehringer
• Endo
• Janssen
• Lilly
• Novartis
• Ortho
• Pfizer
• Schering
• GlaxoSK
• Watson
• Zeneca
Alcoholism
• Boehringer
• Dupont
• Wyeth-Ayerst
Source: SAS
8
GLOBALISATION - distribution of global
pharmaceutical sales in 2000 (US$ 318 billion)
6%6%
16%
North America
Europe
48%
Japan
Latin America
24%
ROW
52% of the industry is non-US
Source: IMS Health
9
GLOBALISATION - proportion of non-US sales
for top suppliers
Merck
AstraZeneca
GlaxoSmithKline
Pharmacia
AHP
Eli Lilly
Bristol-Myers Squibb
Johnson & Johnson
Pfizer
Schering-Plough
US
UK
UK
US
US
US
US
US
US
US
47%
46%
45%
42%
40%
40%
38%
34%
34%
30%
Source: IMS Health
10
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”
11
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 crossborder markets

Flexible publishing solutions needed
12
Challenges for
pharmaceutical publishing
13
Impact of these trends on pharma publishing

Technical publishing issues



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


information design, Web architecture, multiple publishing formats
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
Official
Package
Insert
16
…and on WebMD, http://my.webmd.com/content/article/
“PIL-type”
info
provided
by Lilly
17
…and from the VHN compendium site,
http://emc.vhn.net/public/
SPC
18
…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)
19
“Monograph-type” info on the Mosby drug
information site, http://www.genrx.com/genrxfree/
20
…and Mosby’s version of a PIL in English and
Spanish
21
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!)
22
Fluoxetine content on the BNF site (linked from
VHN), http://bnf.vhn.net/home/
23
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
24
Merck’s Fluoxetine on the Netherlands Medicine
Evaluation Board site, http://www.cbg-meb.nl/nl/prodinfo
SPC
in Dutch
25
Information flow - pharmaceutical data
The goal:
common data sources
for multiple documents
in multiple languages
R&D
Web Delivery / Multi-Language
SPC
(EU)
Product “Label” (Official
Packet) Inserts (US)
Clinical Compliance Physician Patient
Trials
Dossiers
Info
Info
A question:
can this be done across
and between pharma
companies?
Monographs
PILs
(EU)
Health
Portals
Patient
Inserts
(US)
USP BNF EP
26
Regulation, harmonisation
and localisation
27
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...
28
EMEA: documents required in the regulatory
process
DERN /Pre-Qualification
Agency Meeting Reports
Other IND PSUR Docs/
Reporting
NDA: New Drug
Application
Submission Verification
Docs
Adverse Event Medical
Evaluation Docs Report
Clinical Trial Study Plan:
Methods &
Measurements
Consultation Reports:
CM&C and Registrations
(e.g. DMFs)
Committee Answer Drafts
and Reporting
Consultation/Expert
Reports: Clinical Data
Agency Response Docs
Submission Development
(Case, Refs, Tasking)
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
Consultation Reports:
Preclinical
Risk Assessment on QA
& Reporting Protocols
Adverse Events
Reporting: Spontaneous
& Mandatory Periodic
Drug Product Listing(s)
Submissions: Labeling,
PILs, Advertisements
Regulatory Process until
Approval or Withdrawal
(Average 100,000 pages)
29
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
30
Parties to the European Pharmacopeia Convention
31
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,
Languages x9:
Pharmacopeia
Bosnian, Croatian, Cypriot
Greek, Icelandic, Macedonian,
Norwegian, Slovakian,
Slovenian, Turkish
Languages x12:
CEEC
Bulgarian, Cypriot Greek,
Czech, Estonian, Hungarian,
Latvian, Lithuanian, Maltese,
Polish, Romanian, Slovakian,
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
32
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
34
How PILLS works
WYSIWYM
Authoring
Enter
information
Natural Language Generation
Label
PIL
Label
PIL
SPC
Create/Update
Master
Document
XML
Paper
SPC
Master
document
Feedback
text
Output format
Label
PIL
SPC
Label
PIL
Web
SPC
CD
Generate Output Documents
35
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
36
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
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
<dose>The usual dose for
adults and children over 12 is
one to three tablets every 12
hours.</dose>
How to take your medicine
The usual dose for
adults and children
over 12 is one to three
tablets every 12 hours.
<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>
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
language
understanding
Natural
language
generation
Translations
39
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
40
PILLS demonstration
41
Discussion and evaluation

General impression and relevance of the PILLS system


The PILLS authoring process


benefits? problems? compatibility issues?
Possible improvements to PILLS


acceptable? usable? the “master document” concept? the authoring
interface/method?
Benefits and/or drawbacks of the PILLS approach


initial impression, relevance
changes? requirements/conformance? types of documents?
Exploitation of PILLS

would/could you participate? other applications?
42
Thank you!
43