The FDA regulates pharmacovigilance for drugs in the US through various reporting requirements and guidelines. Reports of adverse events are collected in the FDA's Adverse Event Reporting System (AERS) database. The FDA's Office of Surveillance and Epidemiology oversees pharmacovigilance and is comprised of three divisions that monitor postmarketing drug safety. Manufacturers are required to submit periodic safety reports, while healthcare providers and consumers can voluntarily report adverse events. The FDA analyzes AERS data to identify safety issues and communicate findings to promote public health.

1. By
Rajath.s

2.  Regulation followed by u.s fda for
pharmacovigilance.
 Postmarketing Safety Reporting Regulation
and Guidance
 Suspected Adverse Drug Reaction (SADR)
Proposed Rule
 Adverse Event Reporting System (AERS)
 Pharmacovigilance Practice at FDA

3. Three Divisions Within OSE:
Division of Drug Risk Evaluation
(DDRE)
Division of Medication Errors and
Technical Support (DMETS)
Division of Surveillance, Research
and Communication Support
(DSRCS)

4.  310.305 - “Grandfathered” drugs (pre-
1938)
 314.80 - Postmarketing drugs
 314.98- Generic drugs
 600.80- Biologics
 No reporting requirements for OTC drugs
except for:
 NDA-switched OTC products
 Timed release dosage forms
21 CFR §310.502(a)(14)

5.  Death
 Life-threatening
 Hospitalization (initial or prolonged)
 Disability
 Congenital anomaly
 Important medical events

6.  Database originated in 1969 (SRS)
 AERS implemented in Nov 1997
• Reports from Spontaneous Reporting
System (SRS) migrated with mapping of
COSTART to MedDRA
 More structured data, more detailed
coding terminology, and greater capacity
 Electronic submissions (E2BM)

7.  Codify ICH-developed guidelines toward
global harmonization
 Increase quality of reports
 Include medication errors
 Timely acquisition, evaluation and
submission of safety information to
promote public health

8.  Manufacturer Reports (mandatory): ~94%
of reports
 Health care professional, consumer,
and literature
 15-day reports - Foreign and domestic,
serious and unexpected (unlabeled)
 Periodic reports - Quarterly for 3 years
from approval, then annually
 Direct Reports (voluntary): ~6% of reports
 Health care professionals and consumers

9.  Passive surveillance system
 Under-reporting exists
 Quality of the reports is
variable/incomplete
 Duplicate reporting occurs
 Incidence rate cannot be determined
• Numerator is uncertain
• Denominator can only be projected

10. Applies to postmarketing
activities
Involves all activities relating to
monitoring of product safety
• Collection
• Detection
• Assessment of adverse effects or
risks of products

11.  Details of adverse event (AE)
 Baseline patient status (age, co-morbid
conditions, concomitant medications, risk
factors)
 Therapy details (dose, dates/duration of use)
 Temporal relationship to drug
 Dechallenge and rechallenge information
 Method of diagnosis of AE
 Clinical course of AE including outcomes
 Lab results at baseline and during event

12.  Safety issue of interest identified
 AERS search for related cases
• Use of MedDRA-cases coded at PT level
 Customize search (broad or narrow) as
appropriate; can combine various
MedDRA terms/levels into one search
 Case definition established; cases
reviewed
 Additional cases: Literature, WHO,
foreign regulators

13.  Depends on Good Reporting Practice to
acquire quality case information to
perform case-level review or case-series
• Acquire complete information during
initial contacts and subsequent follow
up
• Entail a focused line of questioning

14.  Compares observed frequency of reports
for specific drug/event combination to
expected frequency of reports for that AE
in entire AERS database (Empirical
Baysian scores ≥ 2 worthy of
investigation)
 Provides additional support to the case
report evaluation and other safety
information

15.  Office of Surveillance and Epidemiology
http://www.fda.gov/cder/offices/ods/de
fault.htm
 Adverse Event Reporting System
http://www.fda.gov/cder/aers/default.h
tm
 Reporting Regulations
 Guidances
 Updates

16. Thank u ..