J'S' Hull

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J.S. Hull
Risk Management Program Communications Plan
Vice President General ManagerCentral Nervous
System andGastrointestional Division
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Risk Management StrategyAn Integrated Approach
Program Evaluation
Risk Definition
Communication

• Appropriate Use Program
• Healthcare Practitioners
• Pharmacists
• Patients

• Testing Comprehension of Communication Vehicles
• Tracking Awareness and Source of Knowledge
• Lotronex Utilization Study
• Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
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Communication Objectives

• Appropriate patient selection
• Management of constipation
• Recognition of signs and symptoms of possible
  ischemic colitis and recommended action

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Communications ProgramTarget Audiences

• Healthcare practitioners
• Hospital and retail pharmacists
• Patients who are prescribed Lotronex

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Communication Vehicles

• Dear HCP letter
• Appropriate Use program
• Enhanced print/website materials
• Updated healthcare practitioner speaker programs
• Supplemental training of salesforce

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Dear HCP Letter

• Initial communication highlighting label changes
  within 3 weeks of FDA approval, including
• PCPs, IMs, GEs and OB/GYNs
• Pharmacists
• FNPs and PAs

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Communication Vehicles

• Dear HCP letter
• Appropriate Use Program
• Enhanced print/website materials
• Updated healthcare practitioner speaker programs
• Supplemental training of salesforce

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Appropriate Use Program

• Objective
• Convey and reinforce communication objectives
• Integrated comprehensive materials
• Distinctive graphics

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Appropriate Use Program
Retail/Hospital Pharmacist
Patient on LOTRONEX
Physician And Office Staff

• Health Care Professional
• Sample packets/Starter kits for patients
• Appropriate Patients Booklet
• Patient Selection Card
• FAQs
• 800 Reminder items

• Pharmacist
• Letter
• Stickers
• Patient Brochure
• PPI

• Phase I
• Sample packets with Important Information
• Phase II
• Starter Kit
• Sample pack
• Brochure
• Symptom diary
• BRC for more information
• 800 Reminder items

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Appropriate Use ProgramPhysicians and Office
Staff Materials

• Letter introducing program
• Appropriate Patient Selection cards - a
  checklist to determine patients appropriate for
  Lotronex that also can serve as reminder in
  patients file
• Physician brochure - with discussion of
  appropriate use of Lotronex
• Frequently asked Questions and Answers card
• Reminder item with a professional 1-800

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Appropriate Use ProgramPhysician and Office
Staff Materials
Patient Selection
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Physician Booklet
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• Appropriate patient selection
• Management of constipation
• Recognition and management of signs and symptoms
  of possible ischemic colitis

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Patient Selection Card
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Frequently Asked Questions
Health Care Practitioner Letter

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800 Reminder Items
Pending Discussion with FDA
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Appropriate Use ProgramPharmacists

• Letter introducing program
• Patient brochures - to accompany prescription
• Supplies of patient package inserts
• Prescription bottle stickers - for use when
  Lotronex is dispensed
• Computer system flags - for PBMs and major chain
  pharmacies to remind pharmacists to use bottle
  sticker and patient brochures

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Appropriate Use ProgramPatient Materials

• Starter kit distributed by physician to patients
  prescribed Lotronex
• Reinforces communication objectives

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Patient Starter Kit Phase I

• Sample package enhanced to include
• Prominently placed sticker drawing attention to
  important information inside package
• Important Information card
• Patient package insert
• Prescribing information
• Patient brochure accompanying sample package

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Important Information Card

• LOTRONEX is intended...
• LOTRONEX is NOT for you if
• Potential Side Effects

Pending Label Finalization
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Patient Starter Kit Phase I

• 1-800 and website provided in sample package
  offer repeated exposure to Important
  Information and to follow-up information in
• 3-phase mailing
• Newsletter

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Appropriate Use ProgramPatients Phase I
Sample Package
Important Information

• Appropriate patient selection
• Management of constipation
• Recognition and management of signs and symptoms
  of possible ischemic colitis

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See Important Information Inside
Important Information Card
Pending Discussion with FDA
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Patient Starter Kit Phase II

• Kit will prominently display Appropriate Use
  Messages and will include
• Sample package with sticker and inserts (Phase I)
• Patient brochure
• Symptom diary
• Business reply card offering 3-phase mailing and
  newsletter
• Reminder item encouraging patients to access
  1-800 and website

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Phase II Appropriate Use Program
Sample Package
Symptom Diary
See Important Information Inside
Business Reply Card
800 Reminder Items
Patient Brochure
Patient Starter Kit
Patient Letters
Newsletter
Pending Discussion with FDA
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Communication Vehicles

• Dear HCP letter
• Appropriate Use Program
• Enhanced print/website materials
• Updated healthcare practitioner speaker programs
• Supplemental training of salesforce

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Print/Web Site Materials

• Prominently present Appropriate Use messages
• Used by
• Glaxo Wellcome sales representatives
• Customer Response Center
• Clinical Investigators
• Medical Information Department
• Speakers Bureau

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Examples of Print Materials

• Sales brochures and visual aids
• Prescribing information
• Patient education brochures
• Panels for medical conventions
• Journal advertising

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Communication Vehicles

• Dear HCP letter
• Appropriate Use Program
• Enhanced print/website materials
• Updated Healthcare practitioner speaker programs
• Supplemental training of salesforce

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Updated Healthcare Practitioner Speaker Programs

• Training of speakers
• Pre and Post training survey
• Understanding of revised labeling as condition
  for speaking engagements
• Distribution of revised slide sets

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Communication Vehicles

• Dear HCP letter
• Appropriate Use Program
• Enhanced print/website materials
• Updated healthcare practitioner speaker programs
• Supplemental training of salesforce

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Supplemental Salesforce Training

• Face-to-face training on key communication
  objectives for Lotronex
• All training materials updated to emphasize
  Appropriate Use messages
• Competency testing to ensure salesforce
  understanding of changes to prescribing
  information

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Risk Management StrategyAn Integrated Approach
Risk Definition
Program Evaluation
Communication

• Appropriate Use Program
• Healthcare Practitioners
• Pharmacists
• Patients

• Testing Comprehension of Communication Vehicles
• Tracking Awareness and Source of Knowledge
• Lotronex Utilization Study
• Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
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Risk Management ProgramTesting

• Testing messages for comprehension
• Tracking awareness and source of knowledge

Comprehension
ModificationsBased on Data
Awareness
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Measurement Timeline
Comprehension of Message
Baseline
Dec 00
June 01
Dec 01

• Phase 1

Phase 2
Phase 3
Phase 4
Implement Communications Program
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Message Comprehension

• Research prior to implementation
• Physicians, IBS patients, pharmacists
• Interviews conducted by experienced, third-party
  professionals
• Geographically representative cities
• Iterative improvement

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Tracking Awareness/Source of Knowledge

• Quantitative research
• Telephone interviews conducted by market
  research professionals
• Four testing phases
• Geographic representation across United States
• Methodology will remain consistent from phase to
  phase, allowing data to be trended and
  significant changes to be identified

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Communications Program

• Reaches target audiences
• Supports appropriate patient selection
• Enhances healthcare professional knowledge