FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public n Managing the Risks of Medical Product Use.

Slides:

Advertisements

Similar presentations

10/20/ The Pharmaceutical Industry and Their Influence on Pain Management in the ED J. David Haddox, DDS, MD VP, Risk Management & Health Policy.

Advertisements

ADVERSE EVENT REPORTING

Adverse Event Reporting. Reporting Adverse Events Adverse Events (AEs) are “... any untoward medical occurrence in a subject that was not previously identified.

Introduction to Regulation

Pharmacovigilance and Risk Management Chapter 17.

RAC Study Group Chapter 16

Objectives Why we need DHCPL Situations that call for a DHCPL Definitions DHCPL itself–content, presentation, process Target audience Current and future.

Field Investigators: ADE Detectives. Section One Introduction to the Team and Their Roles.

Clinical Pharmacy’s Role in Research Trials Sheree Miller Pharm.D. Investigational Drug Service University of Washington Medical Center.

FDA MedWatch and Patient Safety. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006  The Act defines a ‘serious adverse event’

Patient Safety Initiatives Kelly Cronin Director, Patient Safety and Outcomes Research Office of Policy and Planning Office of the Commissioner FDA.

Medical Informatics "Medical informatics is the application of computer technology to all fields of medicine - medical care, medical teaching, and medical.

Driving Home the Point: Medicines, Impaired Driving, and You Ali Mohamadi, MD Medical Officer Professional Affairs and Stakeholder Engagement RADD-ONDCP.

Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information Which Form 4 to Use?

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO.

SERIOUS ADVERSE EVENTS REPORTING Elizabeth Dayag IRB Administrator Naval Medical Center Portsmouth.

What Makes a Good Medical Device Adverse Event Report?

Adverse Events and Unanticipated Problems Presented by: Karen Jeans, PhD, CCRN, CIP COACH Program Analyst.

Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT.

H. Lundbeck A/S21-Sep-151 Pharmacovigilance during clinical development SAE reporting, ASUR and PSUR IFF Seminar, 21. February 2007.

Responsibilities and Principles of Drug Administration

Adverse Drug Event Reporting

Reporting Adverse Effects. What to report? (you do not need to be certain, just suspicious!) ADRAC encourages the reporting of all suspected adverse reactions.

Preventing Surgical Complications Prevent Harm from High Alert Medication- Anticoagulants in Primary Care Insert Date here Presenter:

PROPRIETARY NAME EVALUATION AT FDA Jerry Phillips, RPh Associate Director for Medication Error Prevention Office of Drug Safety December 4, 2003.

Florida Agency for Health Care Administration Florida Center for Health Information and Policy Analysis Florida Public Health Association - Medical Director’s.

1 Best Practices in Stakeholder Involvement Paul J. Seligman, M.D., M.P.H. Associate Director, Safety Policy & Communication Center for Drug Evaluation.

Communication of Drug Safety Information Food and Drug Administration Center for Drug Evaluation & Research Public Hearing December 8, 2005.

This material was developed by Oregon Health & Science University, funded by the Department of Health and Human Services, Office of the National Coordinator.

EAE Training EAE Reporting and Assessment Overview DAIDS Regional Training Event, Regulatory Compliance Center Kampala, Uganda, September 2009 DAIDS Regional.

Drug Safety and Risk Management Advisory Committee May 18-19, Overview of Drug Safety Challenges Gerald J. Dal Pan, MD, MHS Director Division of.

Smallpox Vaccine Safety and Reporting Adverse Events Department of Health and Human Services Centers for Disease Control and Prevention December 2002.

1 Serious Adverse Events Following Falsely Elevated Glucose Measurements Resulting from Administration of an IGIV Product Containing Maltose BPAC Meeting,

FDA1 Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics) Min Chen, M.S., R.Ph. Min Chen, M.S., R.Ph. Associate Director Division.

General Regulatory Issues in the Development of Drugs Intended for Treatment of Chronic Illness Sharon Hertz, M.D. Medical Officer Division of Anesthetic,

July 15, Postmarketing Safety Evaluation of Approved Drugs and Risk Management Victor F. C. Raczkowski, MD, MS Director, Office of Drug Safety July.

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

1 Presentation of the Pharmaceutical Research and Manufacturers of America at FDA Part 15 Hearing on Communication of Drug Safety Information December.

October 28, F OOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 (FDAAA) and Risk Evaluation and Mitigation Strategies (REMS) Presented to the Ninth.

Postmarketing Pharmacovigilance Practice at FDA Lanh Green, Pharm.D., M.P.H. Office of Surveillance and Epidemiology June 21, 2006.

European Patients’ Academy on Therapeutic Innovation Introduction to pharmacovigilance Monitoring the safety of medicines.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) Question 1: Messages about Risk A. Based.

Informatics Technologies for Patient Safety Presented by Moira Jean Healey.

1 Overview of Pediatric Safety Reporting and Role of the Committee Pediatric Advisory Committee Meeting November 18, 2005 Solomon Iyasu, M.D., M.P.H. Acting.

FDA Risk Communication Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee February 28, 2008.

8 Medication Errors and Prevention.

1 Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia and/or Hemoglobinuria following Rh o (D) Immune Globulin Intravenous Administration.

FDA’s Patient Advocacy Programs: Patient Representative Program & Patient Network Andrea Furia-Helms, MPH James Valentine, MHS Office of Special Health.

Pharmacy Agencies Drug Development and Control Health Science Pharmacy Technician Virginia Parker.

Postmarketing Pharmacovigilance English D. Willis, MD Clinical Risk Management Merck Research Laboratories June 1, 2012.

Module 6 Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) Training for Inactivated Poliovirus Vaccine (IPV) introduction.

27 June 2000Victor F. C. Raczkowski, M.D.1 Risk-Management Options Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory Committee 27 June.

FDA Notifications and Medwatch Form Requirements Adverse Event Reporting for OTC Drugs and Dietary Supplements.

Complaint Handling Medical Device Reporting May 19, 2016 Rita Harden, Director Customer Relations & Regulatory Reporting.

Medicines Authority 203,Level 3, Rue D’Argens, Gzira,GZR 1368 Tel: (+356) Fax: (+356) ov.mt Reporting.

The Working Group on Medical Measurements The 23rd Forum Meeting

FHIR Adverse Event Resource

Critical Care Services Pharmacist Royal Manchester Children’s Hospital

Reasonable Assurance of Safety and Effectiveness: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division.

3. Key definitions Multi-partner training package on active TB drug safety monitoring and management (aDSM) July 2016.

عناوین برنامه واهداف ADR ونقش آن در ایمنی دارویی محاسبات دارویی

9. Introduction to signal detection

Pharmacovigilance (PV)

68.3 million errors (28% of total) cause moderate or serious harm

Patient Involvement in the Development and Safe Use of

Model Enhanced Classification of Serious Adverse Events

Tobey Clark, Director*, Burlington USA

8 Medication Errors and Prevention.

Presentation transcript:

FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public n Managing the Risks of Medical Product Use

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

MedWatch a change in focus to 2003 n MedWatch, The FDA Adverse Event Reporting Program n MedWatch, The FDA Medical Products Reporting and Safety Information Program n MedWatch, The FDA Safety Information and Adverse Event Reporting Program

MedWatch our mission in 2003 n FDA’s mission: Assure that safe and effective medical products are available to Americans n Safe means that: n Risks are managed n Quality is assured n Health fraud is pursued n Advertising is appropriate n Information is available

MedWatch our role in post-marketing risk management n risk identification - MedWatch n gather information n risk evaluation - Office of Drug Safety n evaluate information n risk intervention - Review Divisions n modify product use strategy n risk communication - MedWatch n disseminate new use information

MedWatch our outreach strategies n Providing value for HCPs by n improving the timely BROADCASTING OUT of clinically important medical product safety information n to justify n the REPORTING IN of serious and unexpected AE’s and product problems

MedWatch our outreach strategies

n MedWatch website n notification to Partners n notification to MedWatch e-list n Push technologies to handhelds

MedWatch website link link n Safety Information Retrieval n Adverse Event Reporting for Drugs and Medical Devices n Continuing Education n Regulatory Information

MedWatch our website link link link n What’s New n Safety Information n Submit Report n How to Report n Download Forms

MedWatch our website link What’s New…… Weidner’s eyedrops [OTC] Hepatitis A vaccine [biologic] Kava [dietary supplement] Lamicatal [dispensing errors] Inapsine [ Rx drug] link

MedWatch our website Safety Information Safety Alerts Safety labeling changes

Safety Information Retrieval n Dear Healthcare Professional Letters n Safety Labeling Changes n Recalls - class I n Withdrawals n Public Health Advisories n Safety-related labeling changes

Safety-related labeling changes but not prompting a Dear Healthcare Professional letter n “Clinically important” safety labeling updates n dosing and administration n interactions n high risk populations n new adverse reaction profile

Notification “join the MedWatch e-list” n MedWatch Partners n 170 organizations [health professionals and consumers] who take alerts and disseminate to their members n MedWatch e-list MedWatch e-list MedWatch e-list n 28,000 individuals who sign up at website for brief reminder of posting of all safety alerts, public health advisories, recalls

MedWatch Reporting In one form for all voluntary reporting [1993- present]

MedWatch our website Report Online Report Online Report Online Report Online

Medwatch why report? n Each report can make a difference n Even after long use of a product, uncertainties will remain. n Example n Depakote Depakote Depakote n approved in 1982 n in 2001, new indications, new populations

Medwatch what to report n Serious adverse events, product problems and medical errors associated with: n Drugs [Rx and OTC] n Biological products n Medical devices n Dietary supplements and herbal products

Medwatch what to report n Serious means: n Death n Life-threatening n Hospitalization [either initial or prolonged] n Disability n Congenital anomaly n Intervention required to prevent permanent impairment or damage

Medwatch what to report n Product problems are: defective or malfunctioning medical products about which there is a concern about quality, performance, or safety

Medwatch what to report n Examples of product problems n inaccurate or unreadable product labeling n packaging or product mix-up n suspected contamination n questionable stability n defective devices

Medwatch what not to report n Vaccine-related problems are reported to: n n Vaccine Adverse Event Reporting System (VAERS) Vaccine Adverse Event Reporting System (VAERS) n Veterinary medicine-related problems are reported to: n n

Medwatch how to reach us n n FDA-1088 n FDA-0178

The Future n Computerized Medical Records n the potential to facilitate reporting of suspected serious adverse events n the potential for clinical reminders about: n previous drug reaction history n drug-drug, drug-food interactions n dosage adjustments n new safety alerts

The Future n Hand-Helds [PDA’s] n Portable drug reference information n e-Pocrates [650,000 users] n Instant updates of database at time of synchronization n Medication prescribing by PDA wireless linkages n safety information pop-ups during Rx prescribing n Reporting In application loaded in PDA

Medwatch If It’s Serious, We Need To Know n n FDA-1088 [phone] n FDA-0178 [fax]