FDA’s MedWatch ProgramFDA’s MedWatch ProgramOutreach to Healthcare Professionals and Outreach to Healthcare Professionals and the Publicthe Public

Managing the Risks of Medical Managing the Risks of Medical Product UseProduct Use

MedWatch MedWatch our product is safety informationour product is safety information

The communication of The communication of INFORMATIONINFORMATION that leads to improvement in the safe that leads to improvement in the safe use of medical products used in clinical use of medical products used in clinical carecare Serious AE’s, product problems and Serious AE’s, product problems and

medication errors medication errors ININ to MedWatch to MedWatch Timely safety alerts Timely safety alerts OUTOUT to our audiences to our audiences

MedWatchMedWatch a change in focus - 1993 to 2003a change in focus - 1993 to 2003

1993 - MedWatch, The FDA Adverse Event 1993 - MedWatch, The FDA Adverse Event Reporting ProgramReporting Program

1998- MedWatch, The FDA Medical Products 1998- MedWatch, The FDA Medical Products Reporting and Safety Information ProgramReporting and Safety Information Program

2001 - MedWatch, The FDA Safety 2001 - MedWatch, The FDA Safety Information and Adverse Event Reporting Information and Adverse Event Reporting ProgramProgram

MedWatchMedWatch our mission in 2003our mission in 2003

FDA’s mission:FDA’s mission: Assure that Assure that safesafe and and effective medical products are effective medical products are availableavailable to to AmericansAmericans

Safe means that:Safe means that: Risks are managedRisks are managed Quality is assuredQuality is assured Health fraud is pursuedHealth fraud is pursued Advertising is appropriateAdvertising is appropriate Information is availableInformation is available

MedWatchMedWatch our role in post-marketing risk managementour role in post-marketing risk management

risk identification - risk identification - MedWatchMedWatch gather informationgather information

risk evaluation - Office of Drug Safetyrisk evaluation - Office of Drug Safety evaluate information evaluate information

risk intervention - Review Divisionsrisk intervention - Review Divisions modify product use strategymodify product use strategy

risk communication - risk communication - MedWatchMedWatch disseminate new use informationdisseminate new use information

MedWatchMedWatch our outreach strategiesour outreach strategies

Providing value for HCPs byProviding value for HCPs by improving the timely improving the timely BROADCASTING BROADCASTING

OUTOUT of clinically important medical of clinically important medical product safety informationproduct safety information

to justifyto justify the the REPORTING INREPORTING IN of serious and of serious and

unexpected AE’s and product problemsunexpected AE’s and product problems

MedWatchMedWatch our outreach strategiesour outreach strategies

MedWatchMedWatch our outreach strategiesour outreach strategies

MedWatch websiteMedWatch website E-mail notification to PartnersE-mail notification to Partners E-mail notification to MedWatch e-listE-mail notification to MedWatch e-list Push technologies to handheldsPush technologies to handhelds

MedWatch websiteMedWatch websitewww.fda.gov/medwatchwww.fda.gov/medwatchlinklink

Safety Information RetrievalSafety Information Retrieval Adverse Event Reporting for Drugs Adverse Event Reporting for Drugs

and Medical Devices and Medical Devices

Continuing EducationContinuing Education Regulatory InformationRegulatory Information

MedWatchMedWatchour websiteour website linklink

What’s NewWhat’s New Safety InformationSafety Information Submit ReportSubmit Report How to ReportHow to Report Download FormsDownload Forms

MedWatchMedWatchour websiteour websitelink link

What’s New……What’s New……Weidner’s eyedrops [OTC]Weidner’s eyedrops [OTC]

Hepatitis A vaccine [biologic]Hepatitis A vaccine [biologic]

Kava [dietary supplement]Kava [dietary supplement]

Lamicatal [dispensing errors]Lamicatal [dispensing errors]

Inapsine [ Rx drug]Inapsine [ Rx drug]

MedWatchMedWatchour websiteour websiteSafety InformationSafety Information Safety AlertsSafety Alerts

Safety labeling Safety labeling changeschanges

Safety Information RetrievalSafety Information Retrieval

Dear Healthcare Professional LettersDear Healthcare Professional Letters Safety Labeling ChangesSafety Labeling Changes Recalls - class IRecalls - class I WithdrawalsWithdrawals

Public Health AdvisoriesPublic Health Advisories Safety-related labeling changesSafety-related labeling changes

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

““Clinically important” safety labeling Clinically important” safety labeling updatesupdates dosing and administrationdosing and administration interactions interactions high risk populationshigh risk populations new adverse reaction profilenew adverse reaction profile

E-mail NotificationE-mail Notification“join the MedWatch e-list”“join the MedWatch e-list” MedWatch Partners MedWatch Partners

170 organizations [health professionals and consumers] who 170 organizations [health professionals and consumers] who take alerts and disseminate to their memberstake alerts and disseminate to their members

MedWatch e-listMedWatch e-list 28,000 individuals who 28,000 individuals who

sign up at website for sign up at website for

brief reminder of posting brief reminder of posting

of all safety alerts, publicof all safety alerts, public

health advisories, recallshealth advisories, recalls

MedWatchMedWatchReporting InReporting In

one form for all voluntaryone form for all voluntaryreporting [1993- present]reporting [1993- present]

MedWatchMedWatchour websiteour website

Report OnlineReport Online Report OnlineReport Online

MedwatchMedwatchwhy report?why report?

Each report can make a differenceEach report can make a difference Even after long use of a product, Even after long use of a product,

uncertainties will remain.uncertainties will remain. ExampleExample

Depakote Depakote DepakoteDepakote

approved in 1982approved in 1982 in 2001, new indications, new populationsin 2001, new indications, new populations

MedwatchMedwatchwhat to reportwhat to report

Serious adverse events, product Serious adverse events, product problems and medical errors problems and medical errors associated with:associated with: Drugs [Rx and OTC]Drugs [Rx and OTC] Biological productsBiological products Medical devicesMedical devices Dietary supplements and herbal productsDietary supplements and herbal products

MedwatchMedwatchwhat to reportwhat to report

Serious means:Serious means: DeathDeath Life-threateningLife-threatening Hospitalization [either initial or prolonged]Hospitalization [either initial or prolonged] DisabilityDisability Congenital anomalyCongenital anomaly Intervention required to prevent permanent Intervention required to prevent permanent

impairment or damageimpairment or damage

MedwatchMedwatchwhat to reportwhat to report

Product problems are:Product problems are:

defective or malfunctioning medical defective or malfunctioning medical products about which there is a concern products about which there is a concern about quality, performance, or safetyabout quality, performance, or safety

MedwatchMedwatchwhat to reportwhat to report

Examples of product problemsExamples of product problems inaccurate or unreadable product labelinginaccurate or unreadable product labeling packaging or product mix-uppackaging or product mix-up suspected contaminationsuspected contamination questionable stabilityquestionable stability defective devicesdefective devices

MedwatchMedwatchwhat not to report what not to report

Vaccine-related problems are reported Vaccine-related problems are reported to:to: Vaccine Adverse Event Reporting System (VAERS)

Veterinary medicine-related problems Veterinary medicine-related problems are reported to:are reported to: www.fda.gov/cvm/index/ade/adetoc.htm

MedwatchMedwatchhow to reach ushow to reach us

www.fda.gov/medwatchwww.fda.gov/medwatch 1-800-FDA-10881-800-FDA-1088 1-800-FDA-01781-800-FDA-0178

The FutureThe Future

Computerized Medical RecordsComputerized Medical Records the potential to facilitate reporting of the potential to facilitate reporting of

suspected serious adverse eventssuspected serious adverse events the potential for clinical reminders about:the potential for clinical reminders about:

previous drug reaction historyprevious drug reaction history drug-drug, drug-food interactionsdrug-drug, drug-food interactions dosage adjustmentsdosage adjustments new safety alertsnew safety alerts

The FutureThe Future

Hand-Helds [PDA’s]Hand-Helds [PDA’s] Portable drug reference Portable drug reference

informationinformation e-Pocrates [650,000 users]e-Pocrates [650,000 users] Instant updates of database at time of synchronizationInstant updates of database at time of synchronization

Medication prescribing by PDA wireless Medication prescribing by PDA wireless linkageslinkages

safety information pop-ups during Rx prescribingsafety information pop-ups during Rx prescribing

Reporting In application loaded in PDAReporting In application loaded in PDA

MedwatchMedwatchIf It’s Serious, We Need To KnowIf It’s Serious, We Need To Know

www.fda.gov/medwatchwww.fda.gov/medwatch 1-800-FDA-1088 [phone]1-800-FDA-1088 [phone] 1-800-FDA-0178 [fax]1-800-FDA-0178 [fax]