FDA FDA MedWatch MedWatch

and and Patient SafetyPatient Safety

FDA FDA MedWatch MedWatch

and and Patient SafetyPatient Safety

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetyImpact of Adverse Events on the Public’s HealthImpact of Adverse Events on the Public’s 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 SafetyFDA MedWatch and Patient SafetyMedWatch program goalsMedWatch 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 SafetyFDA MedWatch and Patient SafetyLearning ObjectivesLearning Objectives

Outline FDA’s 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 SafetyFDA MedWatch and Patient Safety Mission and HistoryMission 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 SafetyFDA 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 SafetyFDA MedWatch and Patient Safety The Benefits and Limitations 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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The 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

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

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FDA MedWatch and Patient SafetyFDA 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 Reporting In to MedWatch What, when, how and why to reportWhat, 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 Reporting In to MedWatch What products to report onWhat 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 Reporting In to MedWatch What To ReportWhat 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 Reporting In to MedWatch What is a serious adverse eventWhat 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 Reporting In to MedWatch How to reportHow to report

Reporting In to MedWatch Reporting In to MedWatch How to reportHow to report

• Onlinewww.fda.gov/medwatch

• Phone1-800-FDA-1088

• Fax1-800-FDA-0178

• Mail

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Reporting In to MedWatch Reporting In to MedWatch How to reportHow to report

PatientPatient

ProductProduct

Description of Event Description of Event or Problemor Problem

ReporterReporter

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Reporting In to MedWatch Reporting In to MedWatch Why Report?Why Report?

Every report can make a difference

Walla Walla, WA – OncologistSacramento, CA – NurseHouston, TX - DentistTallahassee, FL – PharmacistPortland, 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 ReportWhat 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 ReportWhat Happens to Your ReportWhen you report a serious adverse eventWhen 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 ReportWhat Happens to Your ReportWhen you provide information on a serious ADEWhen 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 ReportWhat Happens to Your ReportWhen you report a serious ADEWhen 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 ReportWhat Happens to Your ReportWhen you report a product quality problemWhen 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 ReportWhat Happens to Your ReportWhen you report a medication or device use errorWhen 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 How MedWatch Sends Safety Information To YouInformation To You

Each Report Can Make a DifferenceEach Report Can Make a DifferenceEach Report Can Make a DifferenceEach Report Can Make a Difference

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How MedWatch Sends Safety InformationHow MedWatch Sends Safety Information

Broadcasting new safety informationBroadcasting new safety information

• Website www.fda.gov/medwatch

• E-list

• Partners Program

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How MedWatch Sends How MedWatch Sends Safety Information Safety Information MedWatch Website Safety InformationMedWatch Website Safety Information

Individual Safety Alerts

Monthly Safety Summaries

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How MedWatch Sends Safety How MedWatch Sends Safety

InformationInformation MedWatch E-list notificationMedWatch E-list notification

How MedWatch Sends Safety How MedWatch Sends Safety

InformationInformation MedWatch E-list notificationMedWatch E-list notification

• E-mail notification of individuals of new postings on website

• 54,000 subscribers in 2005

E-list notification example:E-list notification example:

Company X and FDA revised the Company X and FDA revised the WARNINGSWARNINGS and and PRECAUTIOPRECAUTIONS sections of the NS sections of the prescribing information to provide updated information about oligohidrosis (decreased prescribing information to provide updated information about oligohidrosis (decreased sweating) and hyperthermia, which have been reported in product X-treated patients. sweating) and hyperthermia, which have been reported in product X-treated patients. Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be preventable by prompt recognition of symptoms and appropriate treatmentpreventable by prompt recognition of symptoms and appropriate treatment.

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How MedWatch Sends How MedWatch Sends Safety InformationSafety Information MedWatch Partners ProgramMedWatch Partners Program

• 170 Organizations–Health professional

• Medical

• Nursing

• Pharmacy

–Consumer–Healthcare media and news

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How MedWatch Sends How MedWatch Sends Safety InformationSafety Information Use of new digital technologiesUse of new digital technologies

• Portable drug reference

• Regular updates of references weekly/monthly

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySummarySummary

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 SafetyFDA MedWatch and Patient Safety

Visit us online at

www.fda.gov/medwatchVisit us online at

www.fda.gov/medwatch

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-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 SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

1. The FDA MedWatch goals are:a) To educate healthcare providers and patients about the importance

of reporting serious adverse eventsb) To disseminate medical product safety information to clinicians and

consumers c) To change labeling of drugs and other medical productsd) A & B onlye) All of the above

2. The Federal Food, Drug, and Cosmetic Act requires drug manufacturers to document the safety of new drugs prior to marketing. True False

3. Prior to 1938, federal law did not require a drug’s manufacturer to test a drug for safety before it was sold. True False

4. The FDA is considered a consumer protection agency. True False

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

5. The FDA conducts clinical trials in order to evaluate medical products. True False

6. A limitation of clinical trials is:a) Too many patientsb) Pediatric and elderly populations may be excludedc) Long term use is studiedd) Patients use too many other medications

7. Submitting a MedWatch report may be done by all of the following except:a) Faxb) In personc) Maild) Phonee) Online

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

8. Products to report to MedWatch include all of the following except:a) Over-the-counter drugsb) Medical devicesc) Vaccinesd) Medical foodse) Cosmetics

9. The MedWatch program receives reports about:a) Serious adverse eventsb) Product quality problemsc) Medication use errorsd) Device use errorse) A & B f) All of the above

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

10.A serious adverse event is one that is:a) Fatalb) The cause of a congenital anomalyc) Life threateningd) A & C e) All of the above

11.The four core elements to a MedWatch report include all of the following except:a) Patient identifierb) Patient’s age, gender and weightc) Product named) Reporter namee) Narrative description of adverse event, product quality problem or

product use error

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

12.Serious adverse event reports of unexpected and unlabeled events may lead to a:a) Boxed warning b) Medication guidec) Risk management pland) A & Be) All of the above

13.A product quality problem that should be reported to the FDA MedWatch program may be related to:a) Product designb) Counterfeit productc) Therapeutic failured) Instructions for usee) A, B, & Cf) All of the above

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

14.A medication or device use error that should be reported to the FDA may be related to: a) Name confusionb) Packaging or labeling confusionc) A & Bd) None of the above

15.The MedWatch program website disseminates the following safety information:a) Individual safety alerts associated with Dear Healthcare Professional

lettersb) Monthly safety labeling change summariesc) Public health advisoriesd) A & Be) All of the above

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FDA MedWatch and Patient SafetyFDA MedWatch and Patient SafetySelf-Learning QuizSelf-Learning Quiz

16.Safety information from MedWatch is disseminated by all of the following methods except: a) E-mail notificationsb) PDAs and other handheldsc) Partners programd) Mailed newsletter