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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]
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