Title: FDA MedWatch and Patient Safety
1FDA MedWatch and Patient Safety
2FDA 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
3FDA 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
4FDA 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
5FDA 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
6FDA 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
7FDA 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
8FDA 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
9FDA 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
10Reporting 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
11Reporting 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
12Reporting 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
13Reporting 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
14Reporting In to MedWatch How to report
- Onlinewww.fda.gov/medwatch
- Phone1-800-FDA-1088
- Fax1-800-FDA-0178
- Mail
15Reporting In to MedWatch How to report
Patient
Product
Description of Event or Problem
Reporter
16Reporting 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.
17What 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
18What 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
19What 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
20What Happens to Your ReportWhen you report a
serious ADE
- Special programs
- Prescribing or dispensing limitations
- Laboratory testing documentation
- Registries
- Product withdrawal
21What 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
22What 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
23How MedWatch Sends Safety Information To You
- Each Report Can Make a Difference
24How MedWatch Sends Safety Information
Broadcasting new safety information
- Website www.fda.gov/medwatch
- E-list
- Partners Program
25How MedWatch Sends Safety Information MedWatch
Website Safety Information
Monthly Safety Summaries
Individual Safety Alerts
26How 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.
27How MedWatch Sends Safety Information MedWatch
Partners Program
- 170 Organizations
- Health professional
- Medical
- Nursing
- Pharmacy
- Consumer
- Healthcare media and news
28How MedWatch Sends Safety Information Use of
new digital technologies
- Portable drug reference
- Regular updates of references weekly/monthly
29FDA 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
30FDA MedWatch and Patient Safety
- Visit us online atwww.fda.gov/medwatch
31FDA 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.
32FDA 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
33FDA 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
34FDA 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
35FDA 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
36FDA 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
37FDA 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
38FDA 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