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U.S. Department of Health and Human Services

Advisory Committees

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Communicating FDA's Safety Messages. Office of Special Health Issues

Communicating FDA’s Safety Messages


PowerPoint Slides

Slide 1


Communicating FDA’s Safety Messages

Heidi C. Marchand, PharmD
Beth F. Fritsch, R.Ph., M.B.A.
Anna M. Fine, PharmD, MS
Office of Special Health Issues
November 17, 2011
Slide 2
  • Office of Special Health Issues’ Role for Communicating with Patients and Healthcare Professionals (Heidi Marchand)
  • MedWatch Reporting Into FDA (Beth Fritsch)
  • MedWatch Safety Messages (Anna Fine)
Slide 3
FDA Organization – Office of Special Health Issues
Slide 4
OSHI Serves to Bridge Communications
Slide 5
General Communication Webpages
  • FDA Health Professionals
  • Patients
  • MedWatch
  • Interactive Reporting Form
Human Therapeutic Product Safety
  • Medscape FDA MOU
Videos, Commentaries
Continuing Education
Slide 6
Health Professional Webpage
Slide 7
Patient Webpage
Slide 8
  • Accessible from FDA’s webpage
  • Targeted to Healthcare professionals
 Slide 9
OSHI Managed-Electronic Subscriptions
  • Healthcare Professional Update
  • Patient Network News
  • Drug Safety Labeling Changes
  • MedWatch Safety Alerts
  • Hepatitis 
Slide 10
OSHI Tailored Communication
  • Direct communication
  • Presentations
small groups
national meetings
  • Stakeholder calls
  • Multi-media
Slide 11
Communicating FDA’s Safety Messages
MedWatch-Report In
Consumer Form
Beth F. Fritsch, R.Ph., M.B.A.
Slide 12
MedWatch- Reporting IN
How FDA Finds Out About Post Marketing Risk And Safety Issues
  • Reports of serious adverse events
death, life-threatening, required hospitalization, disability or permanent damage, birth defect
  • Reports of medication errors
wrong dose, wrong medication…
  • Reports of product quality issues
contamination, counterfeit, poor packaging or labeling, product mix-ups, device malfunction…
Slide 13
MedWatch Reporting IN
  • Anyone can report a serious problem
Slide 14
Voluntary Reporting IN
Available Formats
  • Paper Form-3500
Postage paid
Fax 1-800-332-0178
  • Online application
Online fillable pdf
Download and print
  • Toll free number
Slide 15          
MedWatch Reports Come IN
AERS Reporting by Healthcare Providers and Consumers by Year
Slide 16
FDA Seeks Input
Slide 17

MedWatch Education Project
New Goal-Develop Consumer Form
  • Reviewed other English-language forms for reporting side effects as well as patient sites that offer reporting mechanisms. 
  • Enlisted writers and a plain language expert to develop a prototype that incorporates plain language principles to maximize readability. 
  • Shared draft materials to various groups within the FDA to obtain feedback. 
Slide 18
MedWatch Consumer Form Timeline
Slide 19
Proposed Consumer MedWatch Form - Announced in Federal Register September 9, 2011
Slide 20
Promotion of Consumer MedWatch Form
  • Outreach
Consumer organizations
Patient advocacy groups
Health professional organizations
Colleges (medical, nursing, pharmacy) 
  • Educational tools
Widgets and button/badge
Video - publicize it through social media (e.g., YouTube)  
Conduct training sessions with consumer advocacy groups
  • Electronic newsletters, e-lists, Twitter
Slide 21
Communicating FDA’s Safety Messages - MedWatch-Out
Anna M. Fine, Pharm.D., M.S.
Slide 22
MedWatch: Adverse Reports Come IN to FDA, Safty Information Goes OUT to the Public

Slide 23
MedWatch Safety Information Out
MedWatch-issued product specific alerts
FDA website
  • MedWatch Safety Alerts
Product-specific, timely alerts for drugs, biologics, devices and special nutritional products
  • Monthly Drug Safety Labeling changes
40-50 drugs with 80-100 changes/month to Boxed Warnings, Warning, Contraindications, Precautions, Adverse Reactions, Medication Guides
Slide 24
Health Professional and MedWatch Communication
  • Distributes important and timely information about safety issues involving medical products via MedWatch safety alerts:
169 MedWatch Alerts for 2010         
78 Drugs and Therapeutic Biologics
50 Medical Devices
  • 430 medical products in 2010 posted safety label changes
Slide 25
Speeding Safety Alerts
  • GovDelivery E-mail
  • Text Message to Cell Phone
  • RSS Feed
  • Twitter
Slide 26
MedWatch Website
Historical Record Safety Alerts
Slide 27
Broadcasting new safety information
MedWatch e-list notification
Slide 28
 [Screen shot of MedWatch TNF-a Blockers Safety Alert]
Slide 29
Screen shot of TNF-a Blockers Safety Alert on IDSA web page]
Slide 30
[Screen shot of TNF-a Blockers Safety Alert on Medscape web page]
Slide 31
MedWatch Survey
Focus Areas
  • Gain a better understanding of who is subscribing to the MedWatch alerts, what their satisfaction is with the service and what their future needs are, further use of our safety message. 
  • Take a closer look at Health Professionals who have subscribed to the alerts and identify changes that can be made to increase their satisfaction with the emails.
Slide 32
Methodology and Background
ACSI Methodology
  • The ForeSee Results methodology uses The American Customer Satisfaction Index (ACSI)
  • The ACSI, developed by the National Quality Research Center at the University of Michigan, has been the leading national indicator of Customer Satisfaction with goods and services in the U.S. economy since 1994. The ACSI is the only cross industry, national indicator that links Customer Satisfaction to financial returns. 
Slide 33
Capturing the Voice of Customer
Slide 34
Satisfaction Survey – FDA Email Survey
Slide 35
Key Finding
Respondents by Role
Slide 36
Health Professionals and Consumers
How Recipients Use E-mails
Slide 37
Health Professionals and Consumers
Other ways of receiving information
Slide 38
Health Professionals and Consumers
Summary of How the Audiences Use MedWatch E-mails
Slide 39
  • OSHI External Communication Overview
  • Reporting Into MedWatch
proposed Consumer Form
  • Reporting Out from MedWatch
survey results
Slide 40
Discussion Topics for the Committee:
  • Does the Committee have any comments for us to consider regarding the Consumer MedWatch Form
  • Feedback on the development of Educational tools to educate Consumer Reporting into FDA
  • Suggestions from the Committee on other methods for dissemination of MedWatch Alerts
  • Discuss other methods/tools to assess MedWatch Safety Alerts integration into practice
Slide 41
Back-Up Slide – Aggregate Results
Slide 42
Back-Up Slide – Custom Questions, FDA Email Survey