fda adverse event reporting requirements for otc drugs
Post on 11-Feb-2017
137 Views
Preview:
TRANSCRIPT
FDA Notifications and Medwatch Form Requirements
Adverse Event Reporting for OTC Drugs and Dietary
Supplements
The Background – What You Need to Know
Adverse Event (AE) reporting regulations implement the
Dietary Supplement & OTC Drug Consumer Protection Act of 2006 (Public Law 109-462).
FDA regulations for adverse event reporting went into effect
in December 2007. Product label must contain the address (street address or P.O. Box) or
phone number at which company or other responsible person will receive a serious
adverse event report.
Serious Adverse Event (SAE) reporting is required for all
OTC Drugs and Dietary Supplements.
Products That Are Covered
All OTC monographed drugs (Rx to OTC drugs are already required to
report AEs).
All dietary supplements including vitamins, minerals, herbal or other botanical products, amino acids, or
any dietary substance used to supplement the diet by increasing the
total dietary intake.
When the Personal Care Products Safety Act becomes law, cosmetics
will also be covered.
Death: Report if the patient’s death is
suspected of being associated with use of
the product by the patient.
Life-Threatening: Report if the person was at
substantial risk of dying at time of the adverse event or if suspected that continued use of
product could result in a person’s death.
Hospitalization: Report if admission to the hospital was caused by or related
to an adverse event associated with use of
the product. Emergency Room treatment is
sometimes reported too.
Disability: Report if the adverse event resulted in
a significant or permanent change,
impairment or damage to the person’s body function/structure or
quality of life.
Spontaneous abortion, congenital anomaly or birth defect associated
with a product use must also be reported to the
FDA.
Definition of a Serious Adverse Event (SAE)
Section 761(a)(2) of the F,D, & C Act
FDA Notifications - Voluntary SAE Reporting
FDA encourages healthcare professionals to report serious adverse events to the agency for tracking purposes.
FDA’s Center for Food Safety & Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse events and product complaints related to CFSAN regulated products, including foods, dietary supplements and cosmetics.
CFSAN encourages voluntary AE reports for cosmetics and conventional foods.
If a company receives a report of a serious adverse event, you should report it to CAERS even if reporting isn’t mandatory for the product (e.g. a food or cosmetic).
FDA Notifications
Many serious adverse events are reported to FDA directly by consumers, hospitals, or healthcare professionals.
If FDA receives a serious adverse event report about a company’s product they will contact you and you must keep that report on file. Often FDA notification comes with a request for more information and submission of a Medwatch form with product label.
Medwatch Form Requirements (Form 3500A)
Medwatch form must identify the injured person (name, age, sex, full address, etc.). Initials are used to protect privacy.
An identifiable initial reporter of the event.
Identity and contact information for the responsible party (i.e. the manufacturer, packer, or distributor representative submitting the AE report to FDA).
Name of the specific product that is suspected of causing the adverse event (not just a brand name).
Description of the serious adverse event with outcome.
Address for Medwatch Form Hard Copy Submission
DIETARY SUPPLEMENTS: FAX NUMBER FOR ALL AEs:1 800 332 - 0178
FDA Center Food Safety & NutritionOffice of Food Defense, HFS -115100 Paint Brach ParkwayCollege Park, MD. 20740
OTC DRUGS:
FDA Center Drug Evaluation & ResearchCentral Document Room5901-B Ammendale RoadBeltsville, MD. 20705-1266
Online Reporting of Medwatch Forms
Or http://www.fda.gov/Safety/MedWatch/default.htm
Go to the FDA website
(www.fda.gov), click on “Drugs” and enter “MEDWATCH form”.
Click on “Download form” or click on “Recalls & Alerts”
and see bullet called “MEDWATCH.”
Click on “Report serious adverse events online.”
Thank You
For organizational training on adverse event reporting and FDA compliance, visit
www.complianceonline.com.
top related