Best Practices in Stakeholder Involvement (Text Version)

Slide Presentation from the AHRQ 2008 Annual Conference

On September 10, 2008, Paul J. Seligman, M.D., M.P.H., made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (4.4 MB).

Slide 1

Best Practices in Stakeholder Involvement

• Paul Seligman, M.D., M.P.H.
  Associate Director, Safety Policy & Communication
  Center for Drug Evaluation and Research
  U.S. Food and Drug Administration (FDA)

• Partnerships to Advance Therapeutics (PATHs) Annual Meeting
  September 2008

• U.S. Food and Drug Administration
  Protecting and Promoting Public Health

Slide 2

Challenges—Drug Products

• 10,000+ products marketed in U.S.:
  • Branded
  • Generic
  • Over-the-counter
• For wide variety of uses and conditions:
  • Life saving
  • Preventative
  • Symptomatic
• Over 900 safety-related label changes/year:
  • Warnings, precautions, adverse events

Slide 3

Challenges—Drug Products

• Everyone uses drugs:
  • Language
  • Health literacy
• Information everywhere:
  • Professional label
  • Consumer Medication Information
  • Patient Package Inserts
  • Medication Guides
  • FDA Alerts

Slide 4

Reaching the Audience

• The Role of Partners:
  • MedWatch
  • Patient Safety News
  • Meeting the needs of 'busy' healthcare professionals and their patients
  • Providing easy and quick access to timely and actionable information

Slide 5

FDA Patient Safety News

• The slide is an image of the U.S. FDA Web site FDA Patient Safety News (PSN), http://www.fda.gov/psn. Tabs include:
  • View Broadcast
  • Search Broadcasts
  • Network Partners
  • Report a Problem
  • Contact Us
  • PSN Home
• Text on the slide describes the site: FDA Patient Safety News is a televised series for health care personnel, carried out on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics, and medial devices; on FDA safety notifications and product recalls; and on ways to protect patients when using medical products.
  • Join Our Mailing List
  • View Broadcasts:
    • Windows Media
    • Real Media

Slide 6

Food and Drug Administration MedWatch

• 105,000+ LISTSERV subscribers
• 160 healthcare professional and consumer groups who participate in partner program

Slide 7

MedWatch

Safety Information OUT

• Broadcasting safety information by:
  • MedWatch Web site
  • MedWatch E-list & RSS feed
  • MedWatch Partners program

Slide 8

MedWatch Home Page

• Slide includes image of Medwatch home page, http://www.fda.gov/medwatch.
  Red arrows point to key elements of the site:
  • Stay Informed
  • Subscribe to the E-list [105,000 recipients]
  • What's New
  • Safety Information
  • Medical Product Reporting

Slide 9

MedWatch Partners

• Infectious Disease Society of America
• American Society of Health-System Pharmacists
• Texas Medical Society
• Medscape
• ePocrates

Slide 10

MedWatch Partners

• Power of leveraging by partners
• Bextra withdrawal and MedWatch alert Apr. 2005

Slide includes images of MedWatch alerts. Red arrows point from descriptive text to alerts

• Medwatch E-mail alert to Medscape
• WebMD Medscape web posting
• Medscape listserv notice sent to over 220,000 individuals

Slide 11

MedWatch

• Partners Program
• Medscape

Slide includes images of Medscape alert. Blue arrow points from descriptive text to blue circle surrounding alert title "FDA Announces Nationwide Recall of All Methylin Chewable Tablets."

• MedWatch safety alert for recall of drug product is broadcast to clinicians on Medscape Web sites and by email to Medscape listservs

Slide 12

New England Journal of Medicine (NEJM) /Physician's FirstWatch E-mail drug/device safety alerts each morning

Slide includes image of Physician's FirstWatch Web page. Red arrows point from descriptive text to MedWatch links on page.

• Links to MedWatch alerts

Slide 13

American Society of Anesthesiologists MedWatch safety alert

Slide includes images of American Society of Anesthesiologists Web page. Red arrows point from alert image on Web site to FDA data summary.

• Data Summary

Slide 14

Risk Communication

Use of electronic tools for dissemination

• E-mail notification; RSS feeds
• PDAs, MP3 and other portable devices
  • Drug reference databases
  • Other clinical resources
• Integration in Electronic Medical Records

Slide 15

Risk Communication

Use of electronic tools for dissemination

• Hand-Held PDAs:
  • Portable drug reference information:
    • e-Pocrates
      • —>300,000 active MD subscribers
      • —>300,000 'other'; subscribers
        • RN—60K; NP—29K
  • Instant updates of database and 'DocAlerts'; at time of synchronization
  • Wireless 'push'; of safety info to handheld

Slide 16

My Epocrates

• First step towards more personalized experience:
  • Search history
  • Request specialized content (v2)
• Better highlight content/features:
  • Drug warnings, safety alerts
  • MedTools, mCME, DocAlerts, Formulary
  • New monographs

Slide contains image of PalmPilot with red circle around "Clinical Updates" "New drugs added in May."

Slide 17

DocAlert® message content

• Epocrates clinical includes:
  • Gov't (MedWatch, the Centers for Disease Control and Prevention [CDC], Department of Health and Human Services [HHS], Centers for Medicare and Medicaid Services [CMS])
  • Content providers—Reuters, InfoPOEMs, Primary Psychiatry and other trusted sources
  • National specialty and state medical associations
• DocAlert content includes:
  • Safety alerts/product recalls
  • New journal articles
  • Clinical trial information

Slide contains image of PalmPilot with Epocrates DocAlert message.

Slide 18

Making the FDA Web site More Accessible

This slide has no additional text.

Slide 19

Making the FDA Web site More Accessible

Slide contains image of FDA Web site Consumer Health Information Consumer Updates page.

Slide 20

FDA's Risk Communication Products/Outlets

This slide has no additional text.

Slide 21

Risk Communication Outlets

• For Healthcare Professionals:
  • Drug Safety Newsletter:
    • http://www.fda.gov/cder.dsn/default.htm
  • MedWatch LISTSERV:
    • http://www.fda.gov/medwatch/index.html
  • Healthcare Professional Information Sheets
  • Patient Safety News:
    • http://www.accessdata.fda.gov/scripts/cdrh.cfdocs/psn/index.cfm

Slide 22

Drug Safety Newsletter

• http://www.fda.gov/cder/dsn/default.htm

Slide contains an image of FDA Drug Safety Newsletter.

Slide 23

FDA Healthcare Professional Sheet

Information for Healthcare Professionals
Fentanyl Transdermal System (marketed as Duragesic and generics)

FDA ALERT 7/15/2005; Update 12/21/2007: This update highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system.

In July 2005, FDA issued a Public Health Advisory and Information for Healthcare Professionals that emphasized the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), (marketed as Duragesic and generics). Despite these efforts FDA has continued to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain n opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source.

Slide 24

Risk Communication Outlets

• For Patients and the General Public:
  • Public Health Advisory
  • Early Communication of an Ongoing Safety Review
  • NEW Consumer Information Web site
    http://www.fda.gov/consumer/default.htm
  • Podcasts

Slide 25

Drug Safety Communications have been used to.

• Inform about an emerging drug safety concern
• Respond to a Citizen's Petition request
• Summarize a new Risk Management Program
• Describe a risk (and actions to take) when we request new safety labeling
• Share FDA's perspective on an issue raised by another drug regulatory agency
• Other situations yet to be defined!

Slide 26

Drug Safety Public Health Advisories & Health Care Professional Information Sheets

• 85 drugs with safety postings in calendar 2007.
  • 10 Public Health Advisories
  • 21 Healthcare Provider Information Sheets
  • 4 Early Communications

Slide 27

Risk Communication Challenges

• Striking the right balance
• Communicating complex information simply
• Deciding when to inform when data is early & evolving
• Anticipating & managing unintended consequences
• Balancing communication of emerging risk with known benefit

Slide 28

What we do know.

• Healthcare professional and public feedback is very positive
• Cited in news, newsletter and scientific journals
• Redistributed by:
  • Medical information vendors
  • Healthcare institutions
  • Medical and consumer organizations

Slide 29

What we don't yet know.

• What is the best way to communicate to our target audiences?
  • Language and reading levels
  • Venues beyond the written word-videos, podcasts, tool kits
• What is our reach and how do we broaden it?
• How do we measure effectiveness?