FDA

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FDAs MedWatch ProgramOutreach to Healthcare
Professionals and the Public

• Managing the Risks of Medical Product Use

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MedWatch our product is safety information

• The communication of INFORMATION that leads to
  improvement in the safe use of medical products
  used in clinical care
• Serious AEs, product problems and medication
  errors IN to MedWatch
• Timely safety alerts OUT to our audiences

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MedWatch a change in focus - 1993 to 2003

• 1993 - MedWatch, The FDA Adverse Event Reporting
  Program
• 1998- MedWatch, The FDA Medical Products
  Reporting and Safety Information Program
• 2001 - MedWatch, The FDA Safety Information and
  Adverse Event Reporting Program

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MedWatch our mission in 2003

• FDAs mission Assure that safe and effective
  medical products are available to Americans
• Safe means that
• Risks are managed
• Quality is assured
• Health fraud is pursued
• Advertising is appropriate
• Information is available

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MedWatch our role in post-marketing risk
management

• risk identification - MedWatch
• gather information
• risk evaluation - Office of Drug Safety
• evaluate information
• risk intervention - Review Divisions
• modify product use strategy
• risk communication - MedWatch
• disseminate new use information

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MedWatch our outreach strategies

• Providing value for HCPs by
• improving the timely BROADCASTING OUT of
  clinically important medical product safety
  information
• to justify
• the REPORTING IN of serious and unexpected AEs
  and product problems

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MedWatch our outreach strategies
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MedWatch our outreach strategies

• MedWatch website
• E-mail notification to Partners
• E-mail notification to MedWatch e-list
• Push technologies to handhelds

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MedWatch websitewww.fda.gov/medwatchlink

• Safety Information Retrieval
• Adverse Event Reporting for Drugs and Medical
  Devices
• Continuing Education
• Regulatory Information

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MedWatchour website link

• Whats New
• Safety Information
• Submit Report
• How to Report
• Download Forms

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MedWatchour websitelink Whats
NewWeidners eyedrops OTCHepatitis A
vaccine biologicKava dietary
supplementLamicatal dispensing
errorsInapsine Rx drug
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MedWatchour websiteSafety Information Safety
Alerts Safety labeling changes
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Safety Information Retrieval

• Dear Healthcare Professional Letters
• Safety Labeling Changes
• Recalls - class I
• Withdrawals
• Public Health Advisories
• Safety-related labeling changes

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Safety-related labeling changes but not
prompting a Dear Healthcare Professional letter

• Clinically important safety labeling updates
• dosing and administration
• interactions
• high risk populations
• new adverse reaction profile

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E-mail Notificationjoin the MedWatch e-list

• MedWatch Partners
• 170 organizations health professionals and
  consumers who take alerts and disseminate to
  their members
• MedWatch e-list
• 28,000 individuals who
• sign up at website for
• brief reminder of posting
• of all safety alerts, public
• health advisories, recalls

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MedWatchReporting In one form for all
voluntaryreporting 1993- present
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MedWatchour websiteReport Online Report
Online
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Medwatchwhy report?

• Each report can make a difference
• Even after long use of a product, uncertainties
  will remain.
• Example
• Depakote Depakote
• approved in 1982
• in 2001, new indications, new populations

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Medwatchwhat to report

• Serious adverse events, product problems and
  medical errors associated with
• Drugs Rx and OTC
• Biological products
• Medical devices
• Dietary supplements and herbal products

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Medwatchwhat to report

• Serious means
• Death
• Life-threatening
• Hospitalization either initial or prolonged
• Disability
• Congenital anomaly
• Intervention required to prevent permanent
  impairment or damage

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Medwatchwhat to report

• Product problems are
• defective or malfunctioning medical products
  about which there is a concern about quality,
  performance, or safety

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Medwatchwhat to report

• Examples of product problems
• inaccurate or unreadable product labeling
• packaging or product mix-up
• suspected contamination
• questionable stability
• defective devices

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Medwatchwhat not to report

• Vaccine-related problems are reported to
• Vaccine Adverse Event Reporting System (VAERS)
• Veterinary medicine-related problems are reported
  to
• www.fda.gov/cvm/index/ade/adetoc.htm

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Medwatchhow to reach us

• www.fda.gov/medwatch
• 1-800-FDA-1088
• 1-800-FDA-0178

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The Future

• Computerized Medical Records
• the potential to facilitate reporting of
  suspected serious adverse events
• the potential for clinical reminders about
• previous drug reaction history
• drug-drug, drug-food interactions
• dosage adjustments
• new safety alerts

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The Future

• Hand-Helds PDAs
• Portable drug reference
• information
• e-Pocrates 650,000 users
• Instant updates of database at time of
  synchronization
• Medication prescribing by PDA wireless linkages
• safety information pop-ups during Rx prescribing
• Reporting In application loaded in PDA

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MedwatchIf Its Serious, We Need To Know

• www.fda.gov/medwatch
• 1-800-FDA-1088 phone
• 1-800-FDA-0178 fax