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FDA MedWatch and Patient Safety

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Outline FDA's role in post-marketing safety surveillance ... are used by the FDA ... FDA reviews the results of laboratory, animal, and human clinical ... – PowerPoint PPT presentation

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Title: FDA MedWatch and Patient Safety


1
FDA MedWatch and Patient Safety
2
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

3
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

4
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

5
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

6
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

7
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

8
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

9
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

10
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

11
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

12
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

13
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

14
Reporting In to MedWatch How to report
  • Onlinewww.fda.gov/medwatch
  • Phone1-800-FDA-1088
  • Fax1-800-FDA-0178
  • Mail

15
Reporting In to MedWatch How to report
Patient
Product
Description of Event or Problem
Reporter
16
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.

17
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

18
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

19
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

20
What Happens to Your ReportWhen you report a
serious ADE
  • Special programs
  • Prescribing or dispensing limitations
  • Laboratory testing documentation
  • Registries
  • Product withdrawal

21
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

22
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

23
How MedWatch Sends Safety Information To You
  • Each Report Can Make a Difference

24
How MedWatch Sends Safety Information
Broadcasting new safety information
  • Website www.fda.gov/medwatch
  • E-list
  • Partners Program

25
How MedWatch Sends Safety Information MedWatch
Website Safety Information
Monthly Safety Summaries
Individual Safety Alerts
26
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.
27
How MedWatch Sends Safety Information MedWatch
Partners Program
  • 170 Organizations
  • Health professional
  • Medical
  • Nursing
  • Pharmacy
  • Consumer
  • Healthcare media and news

28
How MedWatch Sends Safety Information Use of
new digital technologies
  • Portable drug reference
  • Regular updates of references weekly/monthly

29
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

30
FDA MedWatch and Patient Safety
  • Visit us online atwww.fda.gov/medwatch

31
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.
32
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

33
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

34
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

35
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

36
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

37
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

38
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
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