FDA MedWatch and Patient Safety

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FDA MedWatch and Patient Safety
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FDA MedWatch and Patient SafetyImpact of Adverse
Events on the Publics Health

• 400 B.C. Hippocrates
• 1999 Institute of Medicine IOM Report
• Adverse Drug Events ADEs
• Voluntary Reporting of Serious Unexpected
  Adverse Events

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FDA MedWatch and Patient SafetyMedWatch program
goals

• Reporting IN
• Educate about importance of reporting
• Facilitate the reporting
• Improve the quality of the reports
• Safety Information OUT
• Disseminate clinically useful, new safety
  information to providers and patients

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FDA MedWatch and Patient SafetyLearning
Objectives

• Outline FDAs role in post-marketing safety
  surveillance for medical products
• Describe the reporting IN to MedWatch
• Discuss how reports are used by the FDA
• Identify ways MedWatch disseminates safety
  information about medical products to both
  healthcare professionals and their patients

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FDA MedWatch and Patient Safety Mission and
History

• Protecting the public health by assuring the
  safety, efficacy, and security of human ...
  drugs, biological products, medical devices,
  cosmetics, and products that emit radiation.
  from FDA Mission Statement www.fda.gov
• Helping the public get the accurate,
  science-based information they need to use
  medicines and foods to improve their health.
• The first U.S. consumer protection agency
• 1906 Pure Food and Drugs Act
• 1938 Food Drug and Cosmetics Act
• 1962 Kefauver/Harris amendments
• 1993 FDA MedWatch Program

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FDA MedWatch and Patient Safety How FDA
Evaluates Medical Product Safety

• Pre-Market Review and Approval
• FDA does not develop or routinely test
  products itself
• FDA reviews the results of laboratory,
  animal, and human clinical testing done by
  companies
• Post-Market Monitoring for Safety
• Careful review of adverse experiences with
  products once they are marketed

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FDA MedWatch and Patient Safety The Benefits and
Limitations of Clinical Trials

• What Clinical Trials Do Well
• Determine with some certainty that the product is
  effective and the common serious adverse events
  are identified

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FDA MedWatch and Patient Safety The Benefits and
Limitations of Clinical Trials

• The Limitations of Clinical Trials
• Seldom more than 3000 patients
• Patients with complicated medical conditions
  often excluded
• Patients receiving certain concurrent meds are
  often excluded
• Pediatric and elderly populations may be excluded
• Trials often last only weeks to months
  identification of reactions due to long term use
  or latent effects is difficult

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FDA MedWatch and Patient Safety Why
Post-marketing surveillance is necessary

• Why are adverse events monitored?
• How are adverse events detected once a product is
  available for use in the U.S.?
• Even after many years, reports will identify new
  safety problems

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Reporting In to MedWatch What, when, how and why
to report

• What
• All clinical medical products
• When
• If serious
• How
• Online, or mail/fax/phone
• Why
• Every report can make a difference

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Reporting In to MedWatch What products to report
on

• Drugs
• Prescription
• Over the Counter
• Medical Devices
• Biologics, except vaccines

• Special Nutritional Products
• Dietary supplements
• Infant formulas
• Medical foods
• Cosmetics

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Reporting In to MedWatch What To Report

• Serious Adverse Events
• Drugs, biologics, devices, cosmetics and special
  nutritional products
• Product Quality Problems
• Suspect counterfeit
• Contamination, instability
• Poor packaging, labeling
• Defective components
• Therapeutic failures
• Medication and Device Use Errors

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Reporting In to MedWatch What is a serious
adverse event

• Any event that
• Is fatal
• Is life-threatening
• Is permanently/significantly disabling
• Requires or prolongs hospitalization
• Causes a congenital anomaly
• Requires intervention to prevent permanent
  impairment or damage

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Reporting In to MedWatch How to report

• Onlinewww.fda.gov/medwatch
• Phone1-800-FDA-1088
• Fax1-800-FDA-0178
• Mail

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Reporting In to MedWatch How to report
Patient
Product
Description of Event or Problem
Reporter
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Reporting In to MedWatch Why Report?

• Every report can make a difference
• Walla Walla, WA Oncologist
• Sacramento, CA Nurse
• Houston, TX - Dentist
• Tallahassee, FL Pharmacist
• Portland, ME Physician assistant
• Even a few voluntary reports from individual
  reporters can become a signal and lead to a
  label change or other FDA action.

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What Happens to Your Report

• When you report an ADE for a drug or biologic
• When you report a product quality problem for a
  drug or device
• When you report a medication or device use error

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What Happens to Your ReportWhen you report a
serious adverse event

• Report captured in a database
• Database monitored by an FDA professional
• Review of a case series
• Consultation with medical review division and
  manufacturer
• Further epidemiological studies as needed

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What Happens to Your ReportWhen you provide
information on a serious ADE

• Labeling or Educational Options
• Boxed Warning
• Drug-drug, drug-food interaction warnings
• Monitoring recommendations
• Dosage adjustments for sub-populations
• Contraindications, Warnings, Precautions or
  Adverse Reactions
• Medication Guide

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What Happens to Your ReportWhen you report a
serious ADE

• Special programs
• Prescribing or dispensing limitations
• Laboratory testing documentation
• Registries
• Product withdrawal

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What Happens to Your ReportWhen you report a
product quality problem

• For problems due to
• Product design
• Manufacturing quality or distribution/storage
• Counterfeit product
• FDA can
• Work with manufacturer to issue a recall of
  product
• Request a modification in product design
• Request a modification in manufacturing process
• Improve instructions or warnings for use

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What Happens to Your ReportWhen you report a
medication or device use error

• Errors and near misses
• All reports are monitored and evaluated
• For errors due to
• Name confusion of drugs
• Packaging or labeling of drugs
• Device use
• FDA can
• Request name change or modification
• Request packaging/labeling changes
• Modify instructions for device use

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How MedWatch Sends Safety Information To You

• Each Report Can Make a Difference

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How MedWatch Sends Safety Information
Broadcasting new safety information

• Website www.fda.gov/medwatch
• E-list
• Partners Program

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How MedWatch Sends Safety Information MedWatch
Website Safety Information
Monthly Safety Summaries
Individual Safety Alerts
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How MedWatch Sends Safety Information MedWatch
E-list notification

• E-mail notification of individuals of new
  postings on website
• 54,000 subscribers in 2005
• E-list notification example

Company X and FDA revised the WARNINGS and
PRECAUTIONS sections of the prescribing
information to provide updated information about
oligohidrosis (decreased sweating) and
hyperthermia, which have been reported in product
X-treated patients. Oligohidrosis and
hyperthermia may have potentially serious
sequelae, which may be preventable by prompt
recognition of symptoms and appropriate
treatment.
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How MedWatch Sends Safety Information MedWatch
Partners Program

• 170 Organizations
• Health professional
• Medical
• Nursing
• Pharmacy
• Consumer
• Healthcare media and news

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How MedWatch Sends Safety Information Use of
new digital technologies

• Portable drug reference
• Regular updates of references weekly/monthly

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FDA MedWatch and Patient SafetySummary

• Understand how the FDA monitors medical product
  safety
• Learn how to voluntarily report adverse events to
  FDA
• Appreciate how reports are used by the FDA to
  improve product safety
• Know the methods used by FDA to send new safety
  information about medical products to providers
  at the point of care

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FDA MedWatch and Patient Safety

• Visit us online atwww.fda.gov/medwatch

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FDA MedWatch and Patient Safety Self-Learning Quiz
The following slides contain 16 questions to test
your knowledge and comprehension of the material
presented in the tutorial, FDA MedWatch and
Patient Safety.
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FDA MedWatch and Patient Safety Self-Learning Quiz

• The FDA MedWatch goals are
• To educate healthcare providers and patients
  about the importance of reporting serious adverse
  events
• To disseminate medical product safety information
  to clinicians and consumers
• To change labeling of drugs and other medical
  products
• A B only
• All of the above
• The Federal Food, Drug, and Cosmetic Act requires
  drug manufacturers to document the safety of new
  drugs prior to marketing. True False
• Prior to 1938, federal law did not require a
  drugs manufacturer to test a drug for safety
  before it was sold. True False
• The FDA is considered a consumer protection
  agency. True False

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FDA MedWatch and Patient Safety Self-Learning Quiz

• The FDA conducts clinical trials in order to
  evaluate medical products. True False
• A limitation of clinical trials is
• Too many patients
• Pediatric and elderly populations may be excluded
• Long term use is studied
• Patients use too many other medications
• Submitting a MedWatch report may be done by all
  of the following except
• Fax
• In person
• Mail
• Phone
• Online

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FDA MedWatch and Patient Safety Self-Learning Quiz

• Products to report to MedWatch include all of the
  following except
• Over-the-counter drugs
• Medical devices
• Vaccines
• Medical foods
• Cosmetics
• The MedWatch program receives reports about
• Serious adverse events
• Product quality problems
• Medication use errors
• Device use errors
• A B
• All of the above

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FDA MedWatch and Patient Safety Self-Learning Quiz

• A serious adverse event is one that is
• Fatal
• The cause of a congenital anomaly
• Life threatening
• A C
• All of the above
• The four core elements to a MedWatch report
  include all of the following except
• Patient identifier
• Patients age, gender and weight
• Product name
• Reporter name
• Narrative description of adverse event, product
  quality problem or product use error

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FDA MedWatch and Patient Safety Self-Learning Quiz

• Serious adverse event reports of unexpected and
  unlabeled events may lead to a
• Boxed warning
• Medication guide
• Risk management plan
• A B
• All of the above
• A product quality problem that should be reported
  to the FDA MedWatch program may be related to
• Product design
• Counterfeit product
• Therapeutic failure
• Instructions for use
• A, B, C
• All of the above

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FDA MedWatch and Patient Safety Self-Learning Quiz

• A medication or device use error that should be
  reported to the FDA may be related to
• Name confusion
• Packaging or labeling confusion
• A B
• None of the above
• The MedWatch program website disseminates the
  following safety information
• Individual safety alerts associated with Dear
  Healthcare Professional letters
• Monthly safety labeling change summaries
• Public health advisories
• A B
• All of the above

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FDA MedWatch and Patient Safety Self-Learning Quiz

• Safety information from MedWatch is disseminated
  by all of the following methods except
• E-mail notifications
• PDAs and other handhelds
• Partners program
• Mailed newsletter