1. A 1 Alosetron 2000 6/26 Vice President & General Manager Central Nervous System and Gastrointestional Division J.S. Hull Risk Management Program Communications Plan

2. A 2 Alosetron 2000 6/26 Epidemiologi c Research Program Evaluation Systematic Evaluation Risk Definition Mechanisti c Studies Clinical Studies Risk Management Strategy An Integrated Approach Communication Appropriate Use ProgramAppropriate Use Program Healthcare PractitionersHealthcare Practitioners PharmacistsPharmacists PatientsPatients Testing Comprehension of Communication VehiclesTesting Comprehension of Communication Vehicles Tracking Awareness and Source of KnowledgeTracking Awareness and Source of Knowledge Lotronex Utilization StudyLotronex Utilization Study Ongoing pharmacovigilanceOngoing pharmacovigilance

3. A 3 Alosetron 2000 6/26 Communication Objectives Appropriate patient selectionAppropriate patient selection Management of constipationManagement of constipation Recognition of signs and symptoms of possible ischemic colitis and recommended actionRecognition of signs and symptoms of possible ischemic colitis and recommended action

4. A 4 Alosetron 2000 6/26 Communications Program: Target Audiences Healthcare practitionersHealthcare practitioners Hospital and retail pharmacistsHospital and retail pharmacists Patients who are prescribed Lotronex ®Patients who are prescribed Lotronex ®

5. A 5 Alosetron 2000 6/26 Communication Vehicles “Dear HCP” letter“Dear HCP” letter “Appropriate Use” program“Appropriate Use” program Enhanced print/website materialsEnhanced print/website materials Updated healthcare practitioner speaker programsUpdated healthcare practitioner speaker programs Supplemental training of salesforceSupplemental training of salesforce

6. A 6 Alosetron 2000 6/26 “Dear HCP” Letter Initial communication highlighting label changes within 3 weeks of FDA approval, including:Initial communication highlighting label changes within 3 weeks of FDA approval, including: –PCPs, IMs, GEs and OB/GYNs –Pharmacists –FNPs and PAs

7. A 7 Alosetron 2000 6/26 Communication Vehicles “Dear HCP” letter“Dear HCP” letter “Appropriate Use” Program“Appropriate Use” Program Enhanced print/website materialsEnhanced print/website materials Updated healthcare practitioner speaker programsUpdated healthcare practitioner speaker programs Supplemental training of salesforceSupplemental training of salesforce

8. A 8 Alosetron 2000 6/26 Appropriate Use Program Objective: Convey and reinforce communication objectivesConvey and reinforce communication objectives Integrated comprehensive materialsIntegrated comprehensive materials Distinctive graphicsDistinctive graphics

9. A 9 Alosetron 2000 6/26 Appropriate Use Program Retail/Hospita l Pharmacist Patient on LOTRONEX ® Physician And Office Staff Health Care Professional Health Care Professional Sample packets/Starter kits for patients Sample packets/Starter kits for patients Appropriate Patients Booklet Appropriate Patients Booklet Patient Selection Card Patient Selection Card FAQs FAQs 800 # Reminder items 800 # Reminder itemsPharmacist Letter Letter Stickers Stickers Patient Brochure Patient Brochure PPI PPI Phase I: Sample packets with “Important Information” Sample packets with “Important Information” Phase II: Starter Kit Starter Kit Sample pack Sample pack Brochure Brochure Symptom diary Symptom diary BRC for more information BRC for more information 800 # Reminder items 800 # Reminder items

10. A 10 Alosetron 2000 6/26 Appropriate Use Program Physicians and Office Staff Materials Letter introducing programLetter introducing program “Appropriate Patient Selection” cards - a checklist to determine patients appropriate for Lotronex that also can serve as reminder in patient’s file“Appropriate Patient Selection” cards - a checklist to determine patients appropriate for Lotronex that also can serve as reminder in patient’s file Physician brochure - with discussion of appropriate use of LotronexPhysician brochure - with discussion of appropriate use of Lotronex “Frequently asked Questions and Answers” card“Frequently asked Questions and Answers” card Reminder item with a professional 1-800 #Reminder item with a professional 1-800 #

11. A 11 Alosetron 2000 6/26 Appropriate Use Program Physician and Office Staff Materials Lorem ipsum ad hocum diplorus habeus impsenium id gradius evresius Lorem ipsum ad hocum diplorus habeus impsenium id gradius evresius divitus Lorem ipsum ad hocum diplorus habeus impsenium id gradius evresius hocum diplorus habeus impsenium id gradius      Patient Selection Lorem ipsum ad hocum diplorus habeus impsenium id gradius evresius Patient Selection Card 800# Reminder Items Lorem ipsum ad hocum diplorus Frequently Asked Questions Lorem ipsum Ad hocum diplorus Habeus impsenium D gradius evresius ideleus fragellis galim credensius. O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus O matenus graneus il tropeus vellum. Lorem ipsum ad hocum Impsenium o gradius matrisetro Evresius vadeum drisus Cavis Metro epsilun adeus sivaneum Health Care Practitioner Letter Appropriate patient selectionAppropriate patient selection Management of constipationManagement of constipation Recognition and management of signs and symptoms of possible ischemic colitisRecognition and management of signs and symptoms of possible ischemic colitis Physicia n Booklet **Pending Discussion with FDA

12. A 12 Alosetron 2000 6/26 Appropriate Use Program Pharmacists Letter introducing programLetter introducing program Patient brochures - to accompany prescriptionPatient brochures - to accompany prescription Supplies of patient package insertsSupplies of patient package inserts Prescription bottle stickers - for use when Lotronex is dispensedPrescription 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 brochuresComputer system flags - for PBMs and major chain pharmacies to remind pharmacists to use bottle sticker and patient brochures

13. A 13 Alosetron 2000 6/26 Appropriate Use Program Patient Materials Starter kit distributed by physician to patients prescribed LotronexStarter kit distributed by physician to patients prescribed Lotronex Reinforces communication objectivesReinforces communication objectives

14. A 14 Alosetron 2000 6/26 Patient Starter Kit: Phase I Sample package enhanced to include: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 packagePatient brochure accompanying sample package

15. A 15 Alosetron 2000 6/26 Important Information Card LOTRONEX® is intended...LOTRONEX® is intended... –  LOTRONEX® is NOT for you if…LOTRONEX® is NOT for you if… –  Potential Side Effects…Potential Side Effects… – – **Pending Label Finalization

16. A 16 Alosetron 2000 6/26 Patient Starter Kit: Phase I 1-800 # and website provided in sample package offer repeated exposure to “Important Information” and to follow-up information in1-800 # and website provided in sample package offer repeated exposure to “Important Information” and to follow-up information in –3-phase mailing –Newsletter

17. A 17 Alosetron 2000 6/26 Appropriate Use Program Patients: Phase I Sample Package See Important Information Inside See Important Information Inside Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus fragellis galim credensius. O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus fragellis galim credensius. O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius Patient Package Insert **Pending Discussion with FDA Appropriate patient selectionAppropriate patient selection Management of constipationManagement of constipation Recognition and management of signs and symptoms of possible ischemic colitisRecognition and management of signs and symptoms of possible ischemic colitis Prescribing Information Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus fragellis galim credensius. O matenus Important Information “Important Information” Card Appropriate patient selectionAppropriate patient selection Management of constipationManagement of constipation Recognition and management of signs and symptoms of possible ischemic colitisRecognition and management of signs and symptoms of possible ischemic colitis Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus fragellis galim credensius. O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius ideleus fragellis galim credensius. O matenus graneus il tropeus vellum. Lorem ipsum ad hocum diplorus habeus impsenium o gradius evresius

18. A 18 Alosetron 2000 6/26 Patient Starter Kit: Phase II Kit will prominently display “Appropriate Use Messages” and will includeKit 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

19. A 19 Alosetron 2000 6/26 Phase II: Appropriate Use Program 800 # Reminder Items Patient Starter Kit Business Reply Card Patient Letters Newsletter Sample Package See Important Information Inside See Important Information Inside Sympto m Diary Patient Brochu re **Pending Discussion with FDA

20. A 20 Alosetron 2000 6/26 Communication Vehicles “Dear HCP” letter“Dear HCP” letter “Appropriate Use” Program“Appropriate Use” Program Enhanced print/website materialsEnhanced print/website materials Updated healthcare practitioner speaker programsUpdated healthcare practitioner speaker programs Supplemental training of salesforceSupplemental training of salesforce

21. A 21 Alosetron 2000 6/26 Print/Web Site Materials Prominently present “Appropriate Use” messagesProminently present “Appropriate Use” messages Used byUsed by –Glaxo Wellcome sales representatives –Customer Response Center –Clinical Investigators –Medical Information Department –Speakers Bureau

22. A 22 Alosetron 2000 6/26 Examples of Print Materials Sales brochures and visual aidsSales brochures and visual aids Prescribing informationPrescribing information Patient education brochuresPatient education brochures Panels for medical conventionsPanels for medical conventions Journal advertisingJournal advertising

23. A 23 Alosetron 2000 6/26 Communication Vehicles “Dear HCP” letter“Dear HCP” letter “Appropriate Use” Program“Appropriate Use” Program Enhanced print/website materialsEnhanced print/website materials Updated Healthcare practitioner speaker programsUpdated Healthcare practitioner speaker programs Supplemental training of salesforceSupplemental training of salesforce

24. A 24 Alosetron 2000 6/26 Updated Healthcare Practitioner Speaker Programs Training of speakersTraining of speakers Pre and Post training surveyPre and Post training survey Understanding of revised labeling as condition for speaking engagementsUnderstanding of revised labeling as condition for speaking engagements Distribution of revised slide setsDistribution of revised slide sets

25. A 25 Alosetron 2000 6/26 Communication Vehicles “Dear HCP” letter“Dear HCP” letter “Appropriate Use” Program“Appropriate Use” Program Enhanced print/website materialsEnhanced print/website materials Updated healthcare practitioner speaker programsUpdated healthcare practitioner speaker programs Supplemental training of salesforceSupplemental training of salesforce

26. A 26 Alosetron 2000 6/26 Supplemental Salesforce Training Face-to-face training on key communication objectives for LotronexFace-to-face training on key communication objectives for Lotronex All training materials updated to emphasize “Appropriate Use” messagesAll training materials updated to emphasize “Appropriate Use” messages Competency testing to ensure salesforce understanding of changes to prescribing informationCompetency testing to ensure salesforce understanding of changes to prescribing information

27. A 27 Alosetron 2000 6/26 Epidemiologi c Research Systematic Evaluation Risk Definition Mechanisti c Studies Clinical Studies Risk Management Strategy An Integrated Approach Program Evaluation Testing Comprehension of Communication VehiclesTesting Comprehension of Communication Vehicles Tracking Awareness and Source of KnowledgeTracking Awareness and Source of Knowledge Lotronex Utilization StudyLotronex Utilization Study Ongoing pharmacovigilanceOngoing pharmacovigilance Communication Appropriate Use ProgramAppropriate Use Program Healthcare PractitionersHealthcare Practitioners PharmacistsPharmacists PatientsPatients

28. A 28 Alosetron 2000 6/26 Risk Management Program: Testing Testing messages for comprehensionTesting messages for comprehension Tracking awareness and source of knowledgeTracking awareness and source of knowledge Awarene ss Modification s Based on Data Comprehensi on

29. A 29 Alosetron 2000 6/26 Measurement Timeline Phase 1 Baseline Phase 2 Phase 3 Phase 4 Dec ‘00 June ‘01 Dec ‘01 Comprehensi on of Message Implement Communicatio ns Program

30. A 30 Alosetron 2000 6/26 Message Comprehension Research prior to implementationResearch prior to implementation Physicians, IBS patients, pharmacistsPhysicians, IBS patients, pharmacists Interviews conducted by experienced, third-party professionalsInterviews conducted by experienced, third-party professionals Geographically representative citiesGeographically representative cities Iterative improvementIterative improvement

31. A 31 Alosetron 2000 6/26 Tracking Awareness/ Source of Knowledge Quantitative researchQuantitative research Telephone interviews conducted by market research professionalsTelephone interviews conducted by market research professionals Four testing phasesFour testing phases Geographic representation across United StatesGeographic representation across United States Methodology will remain consistent from phase to phase, allowing data to be trended and significant changes to be identifiedMethodology will remain consistent from phase to phase, allowing data to be trended and significant changes to be identified

32. A 32 Alosetron 2000 6/26 Communications Program Reaches target audiencesReaches target audiences Supports appropriate patient selectionSupports appropriate patient selection Enhances healthcare professional knowledgeEnhances healthcare professional knowledge