# Presentation: 597089

## J.S. Hull

**J.S. Hull**

**Risk Management Program Communications Plan**

## Risk Management StrategyAn Integrated Approach

_**Program Evaluation**_

**Systematic Evaluation**

_**Risk Definition**_

**Mechanistic Studies**

**Clinical Studies**

**Risk Management Strategy****An Integrated Approach**

_**Communication**_

**Appropriate Use Program**
**Healthcare Practitioners**
**Pharmacists**
**Patients**

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

## Communication Objectives

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

## Communications Program:Target Audiences

**Healthcare practitioners**
**Hospital and retail pharmacists**
**Patients who are prescribed Lotronex****®**

## Communication Vehicles

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

## “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**

## Communication Vehicles

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

## Appropriate Use Program

**Objective:**
**Convey and reinforce communication objectives**
**Integrated comprehensive materials**
**Distinctive graphics**

## 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**

**Notes:**
THIS SLIDE IS TO BE INSERTED BEFORE SLIDE 83; 

FORMERLY SLIDE “9” OF ORIGINAL AGENCY PRESENTATION

## Appropriate Use ProgramPhysicians 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 patient’s file**
**Physician brochure - with discussion of appropriate use of Lotronex**
**“****Frequently asked Questions and Answers” card**
**Reminder item with a professional 1-800 #**

## Appropriate Use ProgramPhysician and Office Staff Materials

**Appropriate Use Program****Physician and Office Staff Materials**

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***Patient Selection***

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**Patient Selection Card**

**800# Reminder Items**

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**Frequently Asked  Questions**

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**Health Care**
**Practitioner Letter**

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

**Physician Booklet**

****Pending Discussion with FDA**

**Notes:**
THIS SLIDE IS TO REPLACE 
SLIDE 85; 

FORMERLY SLIDE “18” OF ORIGINAL AGENCY PRESENTATION

## Appropriate Use ProgramPharmacists

**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**

## Appropriate Use ProgramPatient Materials

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

## 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**

## Important Information Card

**LOTRONEX® is intended...**
****
** **
**LOTRONEX® is NOT for you if...**
****
****
****
**Potential Side Effects...**
** **
** **

****Pending Label Finalization**

## 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**

## Appropriate Use ProgramPatients: Phase I

**Appropriate Use Program****Patients: Phase I**

**Sample Package**

***See Important***
***Information Inside***

****Pending Discussion with FDA**

_**Important Information**_

**“****Important Information”**
**Card**

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

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**Notes:**
THIS SLIDE IS TO REPLACE 
SLIDE 91; 

FORMERLY SLIDE “14” OF ORIGINAL AGENCY PRESENTATION

## 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**

## Phase II: Appropriate Use Program

**Phase II: Appropriate Use Program**

**800 # Reminder Items**

**Patient Starter Kit**

**Business Reply Card**

**Patient Letters**

**Newsletter**

**Sample Package**

***See Important***
***Information Inside***

**Symptom Diary**

**Patient**
**Brochure**

****Pending Discussion with FDA**

**Notes:**
THIS SLIDE IS TO REPLACE 
SLIDE 93; 

FORMERLY SLIDE “16” OF ORIGINAL AGENCY PRESENTATION

## Communication Vehicles

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

## 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**

## Examples of Print Materials

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

## Communication Vehicles

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

## 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**

## Communication Vehicles

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

## 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**

## Risk Management StrategyAn Integrated Approach

**Systematic Evaluation**

_**Risk Definition**_

**Mechanistic Studies**

**Clinical Studies**

**Risk Management Strategy****An Integrated Approach**

_**Program Evaluation**_

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

_**Communication**_

**Appropriate Use Program**
**Healthcare Practitioners**
**Pharmacists**
**Patients**

## Risk Management Program:Testing

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

**Awareness**

**Modifications****Based on Data**

**Comprehension**

## Measurement Timeline

**Phase 1**

**Baseline**

**Phase 2**

**Phase 3**

**Phase 4**

**Dec ‘00**

**June ‘01**

**Dec ‘01**

**Comprehension of Message**

**Implement Communications Program**

**Notes:**
THIS SLIDE IS TO BE INSERTED BEFORE SLIDE 103 

FORMERLY SLIDE “28” OF ORIGINAL AGENCY PRESENTATION (Word “Wave” has been replaced with “Phase” and “Comprehension of Message” was placed above Phase I mark.)

## Message Comprehension

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

## 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**

## Communications Program

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