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Dr.Swaralipi Ghosh

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� MedWatch is the Food and Drug Administration¶s reportingsstem for adverse events founded in 1993.

 An adverse event is any undesirable

experience associateyd with the use of amedical product.

� The FDA Safety Information and Adverse Event ReportingProgram.

� It is the FDA gateway for finding clinically important safety

information and reporting serious problems with humanmedical products.

� MedWatch allows consumers to report serious problems thatthey suspect are associated with the drugs and medicaldevices they use. Reporting can be done on line, by phone,

or by submitting the MedWatch 3500 form by mail or fax.

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When the FDA does a post marketing review of drugs for safety, they

gather information from clinical trials and MedWatch reports.Unfortunately, when people have adverse reactions to drugs, theirprescribing physicians don't like to file such reports. As a result, the FDAis often unaware of the level of risks associated with the drugs that theyhave sanctioned safe for the American public.

 You can help.

If you or your loved ones have ever had an adverse reaction to adrug, file a MedWatch report. Adverse events include: suicide,

suicidal thoughts, unusual aggressiveness, hallucinations,psychotic behavior, lack of growth, stroke, elevated heart rate,or any concerning side effect.

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Impact 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] R eport

� Adverse Drug Events [ADEs]

� Voluntary R eporting of Serious Unexpected Adverse Events

�� MedWatchMedWatch program goals :program goals :

�R eporting IN� Educate about importance of reporting

� Facilitate the reporting

� Improve the quality of the reports

�Saf ety Information OUT� Disseminate clinically useful, new safety information to providers

and patients

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� The communication of INFORMATIONINFORMATION that leads to

improvement in the safe use of medical products usedin clinical care

� Serious AE¶s, product problems and medicationerrors ININ to MedWatch

� Timely safety alerts OUT to our audiences

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y Outline FDA¶s role in post-marketing safetysurveillance for medical products

y

Describe the reporting IN to MedWatchy Discuss how reports are used by the FDA

y Identify ways MedWatch disseminates safetyinformation about medical products to both healthcareprofessionals and their patients

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� ³Protecting the public health by assuring the safety,efficacy, and security of human ... drugs, biologicalproducts, medical devices, « cosmetics, and products thatemit radiation.´ from FDA Mission Statement [www.fda.gov]

� Helping the public get the accurate, science-basedinformation they need to use medicines and foods toimprove 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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What help does Medwatch do?

The MedWatch system collects reports of adverse reactionsand quality problems, primarily with drugs and medical

devices, but also for other FDA-regulated products (e.g.,dietary supplements, cosmetics, medical foods, and infantformulas).

Voluntary reporting by healthcare professionals, consumers,and patients is conducted on a single, one-page reporting

form (Form FDA 3500) Reporting can be conducted online, by phone 1-800-FDA-

1088, or by submitting the MedWatch 3500 form by mail orfax 1-800-FDA-0178.

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The MedWatch system is intended to detect safety hazard signalsfor medical products.

If a signal is detected, the FDA can issue medical product safetyalerts or order product recalls, withdrawals, or labeling changesto protect the public health. Important safety information isdisseminated to the medical community and the general public viathe MedWatch web site and the MedWatch E-list.

Raw data from the MedWatch system, together with adverse drugreaction reports from manufacturers as required by regulation,are part of a public database

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Pre-Market R eview and Approval� FDA does not develop or routinely test productsitself 

� FDA reviews the results of laboratory, animal,and human clinical testing done by companies

Post-Market Monitoring for Saf ety

� Careful review of adverse experiences withproducts once they are marketed

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� 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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��Serious Adverse EventsSerious Adverse Events

� Drugs, biologics, devices, cosmetics and special nutritionalproducts

��

Product Quality Problem

sProduct Quality Problem

s� Suspect counterfeit

� Contamination, instability

� Poor packaging, labeling

� Defective components

� Therapeutic failures

��Medication and Device Use ErrorsMedication and Device Use Errors

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��DrugsDrugs

� Prescription

� Over the Counter

��Medical DevicesMedical Devices��Biologics, except vaccinesBiologics, except vaccines

��Special Nutritional ProductsSpecial Nutritional Products

� Dietary supplements

� Infant formulas� Medical foods

��CosmeticsCosmetics

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Any event that «

� Is fatal

� Is life-threatening

� Is permanently/significantly disabling

� Requires or prolongs hospitalization

� Causes a congenital anomaly

� Requires intervention to prevent permanentimpairment or damage

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OnlineOnline

www.fda.gov/medwatchwww.fda.gov/medwatch

PhonePhone

11--800800--FDAFDA--10881088

FaxFax

11--800800--FDAFDA--01780178

MailMail

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� https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

� Click the BEGIN button to report serious adverse events for human medical

products, including potential and actual product use errors and productquality problems associated with the use of:

- FDA-regulated drugs,

- biologics (including human cells, tissues, and cellular and tissue-based

products)

- medical devices (including in vitro diagnostics)- special nutritional products and cosmetics

MedWatch Online Voluntary Submission Form 3500 A. PATIENT INFORMATION1. Patient Identifier 2. Age (at Time of Event):

orDate of Birth:

(MM/DD/YYYY) 3. Sex Female Male 4. Weight lbs or kgsFor product problems with no adverse event, leave this section blank.Javascript MUST be enabled.

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PatientPatient

ProductProduct

Description of EventDescription of Eventor Problemor Problem

R eporterR eporter

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Every report can m

ake a diff erenceEvery report can m

ake a diff erence

Even a few voluntary reports from

individual reporters can become a µsignal¶ and lead to a label changeor other FDA action.

 Walla Walla, WAWalla Walla, WA ±± OncologistOncologist

Sacramento, CASacramento, CA ±± NurseNurse

Houston, TX Houston, TX -- DentistDentist

Tallahassee, FLTallahassee, FL ±± PharmacistPharmacistPortland, MEPortland, ME ±± Physician assistantPhysician assistant

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��When 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 andmanufacturer

Further epidemiological studies as needed�� When 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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��When you report a serious ADEWhen you report a serious ADE S   pecial programs

� Prescribing or dispensing limitations

� Laboratory testing documentation

� Registries

P roduct withdrawal 

��When 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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Each R eport Can Make a Diff erenceEach R eport Can Make a Diff erence

Broadcasting new safety informationBroadcasting new safety information

� Website:www.f da.gov/medwatch

� E-list

� Partners Program

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��When you report a medication or device When you report a medication or device use erroruse error

�Errors and µnear 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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Individual Safety AlertsMonthly Safety Summaries

MedWatch Website Saf ety Information

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MedWatch E-List Notification

* E-mail notification ofindividuals of newpostings on website

* 54,000 subscribers in 2005

EE--list notification example:list notification example:

C ompany  X and  FDA r evised  the WARNINGS and  PRE C  AUTIONS sections of  C ompany  X and  FDA r evised  the WARNINGS and  PRE C  AUTIONS sections of  the  pr esc r ibing infor mation to  pr ovide u pdated  infor mation about  the  pr esc r ibing infor mation to  pr ovide u pdated  infor mation about  oligohid r osisoligohid r osis (dec r eased  sweating) and  hyper ther mia, which have been (dec r eased  sweating) and  hyper ther mia, which have been 

r epor ted  in  pr od uct  X r epor ted  in  pr od uct  X--t r eated   patients. t r eated   patients. Oligohid r osisOligohid r osis and  hyper ther mia may  and  hyper ther mia may  have  potentially  ser ious have  potentially  ser ious sequelaesequelae, which may  be  pr eventable by   pr ompt   , which may  be  pr eventable by   pr ompt  r ecognition of  symptoms and  appr opr iate t r eatment. r ecognition of  symptoms and  appr opr iate t r eatment. 

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��Use of digital technologiesUse of digital technologies

�Portable drug reference

�Regular updates of references weekly/monthly

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THANK YOUTHANK YOU