Dr.

Swaralipi Ghosh

MedWatch is the Food and Drug Administrations reporting sstem for adverse events founded in 1993.

An adverse event is any undesirable experience associateyd with the use of a medical product.

The FDA Safety Information and Adverse Event Reporting Program. It is the FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. MedWatch allows consumers to report serious problems that they suspect are associated with the drugs and medical devices they use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax.

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, their prescribing physicians don't like to file such reports. As a result, the FDA is often unaware of the level of risks associated with the drugs that they have sanctioned safe for the American public.

You can help. If you or your loved ones have ever had an adverse reaction to a drug, 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.

Impact 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

MedWatch 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

The communication of INFORMATION that leads to improvement in the safe use of medical products used in clinical care Serious AEs, product problems and medication errors IN to MedWatch Timely safety alerts OUT to our audiences

y y y

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

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 1938 1962 1993

Pure Food and Drugs Act Food Drug and Cosmetics Act Kefauver/Harris amendments FDA MedWatch Program

What help does Medwatch do?  The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas).  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-FDA1088, or by submitting the MedWatch 3500 form by mail or fax 1-800-FDA-0178.

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

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

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

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

What All clinical medical products When If serious How Online, or mail/fax/phone Why Every report can make a difference

 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

 Drugs

Prescription Over the Counter

Devices Biologics, except vaccines Special Nutritional Products

Dietary supplements Infant formulas Medical foods

Cosmetics

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

 Online
www.fda.gov/medwatch

 Phone
1-800-FDA-1088 800-FDA-

 Fax
1-800-FDA-0178 800-FDA-

 Mail

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 product quality problems associated with the use of: - FDA-regulated drugs, - biologics (including human cells, tissues, and cellular and tissuebased products) - medical devices (including in vitro diagnostics) - special nutritional products and cosmetics MedWatch Online Voluntary Submission Form 3500 A. PATIENT INFORMATION 1. Patient Identifier 2. Age (at Time of Event): or Date of Birth: (MM/DD/YYYY) 3. Sex Female Male 4. Weight lbs or kgs

For product problems with no adverse event, leave this section blank. Javascript MUST be enabled.

Patient Product

Description of Event or Problem

Reporter

Every report can make a difference

Even a few voluntary reports from individual reporters can become a signal and lead to a label change or other FDA action.

When 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 When 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

 When

you report a serious ADE

Special programs Prescribing or dispensing limitations Laboratory testing documentation Registries

Product withdrawal

When


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

Each Report Can Make a Difference Broadcasting new safety information

E-list Partners Program

 When

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

can:

Request name change or modification Request packaging/labeling changes Modify instructions for device use

MedWatch Website Safety Information

Individual Safety Alerts

Monthly Safety Summaries

MedWatch E-List Notification * E-mail notification of individuals of new postings on website

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 Xhave potentially serious sequelae, which may be preventable by prompt sequelae, recognition of symptoms and appropriate treatment.

 Use

of digital technologies

Portable

drug reference Regular updates of references weekly/monthly

THANK YOU