© 2009 ParagonRx

Effective Patient Communication: Improving on Medication GuidesEffective Patient Communication: Improving on Medication Guides

Jeff Fetterman

President and CEO

Jeff Fetterman

President and CEO

© 2009 ParagonRx

FDAAA Sets Higher Bar for Medication GuidesFDAAA Sets Higher Bar for Medication Guides

REMS assessment

is elevating interest

in effectiveness of

Medication Guides

for patients

© 2009 ParagonRx

Are Medication Guides Sufficiently Effective?Are Medication Guides Sufficiently Effective?

Three points of evidence suggests the need to augment Med Guides to effectively communicate safety messages:

I. Comprehension study of a Medication Guide

II. Study of a drug facts box to communicate medication benefits and risks

III. Literature defining adult learning principles

© 2009 ParagonRx

I. Comprehension Study of Medication GuideI. Comprehension Study of Medication Guide

Objectives Evaluate patient comprehension of product safety messages Identify ways to improve comprehension

Interviews of patients conducted at multiple locations Patient Cohort (n=23)

Individuals diagnosed with condition for which product is indicated

Assessment Reviewed product Medication Guide Administered written test Interviewed by research associate

Source: Data on file, research commissioned by ParagonRx, December 2008.

© 2009 ParagonRx

0 5 10 15 20 25

Q1

Q2

Q3

Q4

Q5

23

13

23

15

23

Number of Patients Correctly Responding

Patient Safety Message Comprehension Questionairre Performance (n=23)

QuestionnaireQuestionnaire PerformancePerformance

Questions About Risk

© 2009 ParagonRx

Question 6: What is the most important information you should know about the product?

The interviews indicated there were some misunderstandings

Incorrect7

(31%)

Correct on prompting

4(17%)

Correct Unaided

12(52%)

Question 6 Safety Message Recall

Most of the incorrect responses focused on knowing how to correctly take the product and did not necessary indicate a lack of understanding regarding risks.

Safety Message Recall Safety Message Recall

© 2009 ParagonRx

Patient Recommendations to Improve the GuidePatient Recommendations to Improve the Guide

Start Med Guide with description of medication, indication for use, and benefit

This was conveyed repeatedly as very important

Patients want to know what the drug is and how it might benefit them before they are presented with the risks

Place key risk statements in a summary box on first page then expand on it later in the Med Guide

Keep all risk statements in one area of the Med Guide

Use callout boxes and other format and graphical methods to emphasize the most important information

© 2009 ParagonRx

II. Communicating Drug Benefits and Harms II. Communicating Drug Benefits and Harms with a Drug Facts Box: Two Randomized Trialswith a Drug Facts Box: Two Randomized Trials

Objective

Determine if drug safety box improves knowledge and affects judgment about prescription medications

Study involved 231 adults nationwide

Two DTC drug ads for each of two indications

Control

Brief summary replaced by “Drug Facts Box” providing side-by-side description of benefits and risks

Assessment

Choice of correct drug for indication

Accurate perception of benefits and side effects

Source: Schwartz, LM, Woloshin S, Welch,HG Annals of Int Med, April 2009

© 2009 ParagonRx

FindingsFindings

“Drug Facts Box” improved patient knowledge

Contains fewer elements presented in structured format

Better choices between drug and symptoms

Patients able to choose the superior drug

Corrected overestimation of benefit in prevention setting

Patients demonstrated accurate perception of drug benefits and side effects

Focused reader’s attention and minimized cognitive burden

© 2009 ParagonRx

III. Study Findings Are Consistent With TheoryIII. Study Findings Are Consistent With Theory

Adult learning principles define elements of effective learning:

Curriculum – a clear plan for presenting required information

Enablers – tools that enable the learner to use the knowledge in their personal situations

Application – learners are shown how to use the knowledge

Interactivity – information is presented in a variety of ways that address diverse learning styles

Source: Davis D., et. al., JAMA, September 1, 1999

© 2009 ParagonRx

Example of Tool That Enables ApplicationExample of Tool That Enables Application

“Implementation of a checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals”

Source: Haynes, Alex B., M.D., M.P.H., et. al. NEJM, Jan 29, 2009

© 2009 ParagonRx

Summary of Insights for Risk CommunicationsSummary of Insights for Risk Communications

Patients qualitatively prefer:

Knowledge of benefit as a context for understanding risk

Formatting and callout boxes to aid comprehension

Drug Fact Box describing benefits and risks improved patient knowledge and choices

Enabling tools such as checklists help to apply knowledge to behavior change

Provides an opportunity for improvement if REMS assessments determine Med Guides are insufficient to achieve goals

© 2009 ParagonRx

References and AcknowledgementsReferences and Acknowledgements

References Schwartz L, Woloshin S, Welch H. Communicating Drug Benefits and Harms With a Drug Facts Box: Two

Randomized Trials. Ann Intern Med. 2009;150(8) Davis D, O’Brien MA, Freemantle N, Wolf F, Mazmanian P, Taylor-Vaisey A. Impact of Formal Continuing

Medical Education: Do Conferences, Workshops, Rounds, and Other Traditional Continuing Education Activities Change Physician Behavior or Health Care Outcomes? JAMA. 1999;282(9):867-874.

Alex B. Haynes, M.D., M.P.H., Thomas G. Weiser, M.D., M.P.H., William R. Berry, M.D., M.P.H., Stuart R. Lipsitz, Sc.D., Abdel-Hadi S., Breizat, M.D., Ph.D., E. Patchen Dellinger, M.D., Teodoro Herbosa, M.D., Sudhir Joseph, M.S., Pascience L. Kibatala, M.D., Marie, Carmela M. Lapitan, M.D., Alan F. Merry, M.B., Ch.B., F.A.N.Z.C.A., F.R.C.A., Krishna Moorthy, M.D., F.R.C.S., Richard K. Reznick,M.D., M.Ed., Bryce Taylor, M.D., Atul A. Gawande, M.D., M.P.H., for the Safe Surgery Saves Lives Study Group, A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population, NEJM. 2009; 360(5):491-499.

Acknowledgements Thanks to support by Blaise Hollot and Marc DeLuca

Contact information

Jeff FettermanPresident & CEO, ParagonRx2751 Centerville RoadWilmington, DE 19808302-502-0400jfetterman@paragonrx.com