Recommended
More Related Content
What's hot
What's hot (20)
Similar to Fda med watch
Similar to Fda med watch (20)
More from Sridhar S
Recently uploaded
Recently uploaded (20)
Fda med watch
- 1. Presented By:- Sridhar S 1st M.Pharmacy Pharmaceutical Regulatory Affairs JSS College of Pharmacy Mysuru-15
- 2. Definition MedWatch is the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program. MedWatch is used for reporting an adverse event, founded in 1993 this system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also disseminates medical product safety alerts such as recalls and other clinical safety communications via its website, email list
- 3. Reporting Adverse Events to FDA Industry ICH E2B electronic standard (clinical safety data management) MedWatch form 3500A Public MedWatch 3500 MedWatch 3500B
- 4. Med Watch 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
- 5. Mission 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) Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
- 6. 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
- 7. Reporting In to MedWatch What, when, how and why to report What All clinical medical products When If serious and any adverse reaction How Online, or mail/fax/phone Why Every report can make a difference
- 8. What is a serious adverse event 1) Death 2) Life-threatening adverse drug experience 3) Inpatient hospitalization or prolongation of existing hospitalization (for > 24 hours) 4) Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- 9. 5) Congenital anomaly/birth defect 6) Important Medical Event (IME) that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience
- 10. Forms to reporting to FDA FORM FDA 3500-Voluentary reporting For use by healthcare professionals, consumers, and patients. Submit the completed form using built-in postage-paid mailer, or fax. FORM FDA 3500B-Voluentary reporting for consumers A consumer-friendly version of the 3500 reporting form. Submit the completed form using address on page 3 of the form, or fax.
- 11. FORM FDA 3500A-Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel Online Reporting Form (Voluntary Reporting) Report serious adverse events online for human medical products, including potential and actual product use errors, product quality problems, and therapeutic inequivalence/failure. The introductory page features additional information and instructions.
- 12. PATIENT INFORMATION Medical device Product detail Reporter information
- 13. FORM 3500A FORM 3500B
- 15. Safety reporting portal To report adverse events with tobacco products or dietary supplements online, use the Safety Reporting Portal Tobacco If you experience a problem with a tobacco product, such as an unexpected health or safety issue, report it online using the Safety Reporting Portal. Dietary Supplements Dietary supplements include vitamins, minerals, herbs, amino acids, whey protein, creatine, and weight loss pills
- 16. Radiation-emitting Products The radiation emitting products like medical devices and radio isotopes are reported to the FDA by safety reporting portal Any accidental radiation occurrences arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce
- 18. MedWatch Website Safety Reporting Information Monthly Safety Summaries Individual Safety Alerts
- 19. Who Should Submit a Safety Report? Organizations and people in certain professional roles, such as the following:- Food Manufacturers, Processors, Packers, and Holders Researchers An applicant of an approved drug product or a manufacturer, distributor or packer listed on the label of any drug product Drug Manufacturers Dietary supplement manufacturers, packers, and distributors
- 20. Others, including healthcare providers, public health officials, and other professionals, as well as consumers and concerned citizens, may voluntarily submit reports if they encounter safety issues with a product and/or unanticipated harmful effects that they believe are related to a product.
- 21. What to Report to FDA MedWatch Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures for:- Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT)
- 22. Medical devices (including in vitro diagnostic products) Combination products Special nutritional products (infant formulas, and medical foods) Cosmetics Foods/beverages (including reports of serious allergic reactions)
- 23. What Not to Report to FDA MedWatch Tobacco: Tobacco product problems should be reported to the Safety Reporting Portal. Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/esub/index Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
- 24. Mandatory reporting by regulated industry: Drugs and Biologics Applicable Regulations Devices Reporting on Dietary Supplements Reporting on Veterinary Medicine Products Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and Where to Send Them
- 25. What Happens to Your Report 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 studies as needed are conducted
- 26. What Happens to Your Report 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
- 27. What happens when you report a serious ADE Special programs • Prescribing or dispensing limitations • Laboratory testing documentation • Registries for a particular product Product withdrawal or product recall This depends upon the Adverse event occurred
- 28. 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
- 29. FDA MedWatch Summary Understand how the FDA monitors medical product safety Learn how to voluntarily report adverse events to FDA Understand 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
- 30. Reference https://en.wikipedia.org/wiki/MedWatch https://www.fda.gov/Safety/MedWatch/SafetyInformation/defa ult.htm https://www.fda.gov/Safety/MedWatch/SafetyInformation/Safe tyAlertsforHumanMedicalProducts/ucm535957.htm https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?a ction=reporting.home https://www.fda.gov/TobaccoProducts/PublicHealthScienceRes earch/ucm377563.htm https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid= ee0609ca-f995-4ca3-99db-aa1ce4d564ee