Post marketing surviellance

1. POST MARKETING SURVEILLANCE
(PMS)
Submitted to:
Mrs. Sushma Verma
(Assistant Prof., NIET)
Submitted by:
Shalini Singh
(M.PHARM)
(Pharmaceutics)
1st Semister

2. INTRODUCTION
• Post marketing surveillance is the practice of monitoring the safety
of pharmaceutical drugs or medical devices after it has been
released into the market for public use.
• No fixed duration
• No fixed population
• Starts immediately after marketing
• Report all ADRs
• Help to detect
o Drug interaction
o New use of drugs
o Rare ADRs

3. LIMITATIONS OF PRE-MARKETING
CLINICAL TRIALS
• Narrow population- often not providing sufficient data
on special groups
• Narrow indication studies
• Short duration
• Rare ADRs may not get detected

4. BENEFITS OF PMS
• Study of:
(In context of drugs)
 low frequency reactions (not identified in clinical trials)
High risk groups
Long term effects
Drug-drug/food interactions
Increased severity and/or reporting frequency of known
reactions

5. (In context of medical devices)
Manufacturing problems
Improvement in quality
Verification of risk analysis
Long term performance
Performance in different user population

6. SOURCES OF PMS INFORMATION
• Expert user groups
• Customer surveys
• Customer complaints and warranty claims
• Literature reviews
• The media

7. METHODS OF PMS
Following four types of studies are generally carried out to identify
drug effects:
• Controlled clinical trials
• Spontaneous or voluntary recording
• Cohort studies
• Case control studies

8. CONTROLLED CLINICAL TRIALS
• Retrospective study
• Directly monitor patients
• Often costly
• Evaluate rare suspected side-effects

9. SPONTANEOUS/VOLUNTARY
REPORTING
• Communication from an individual to a company or regultory
authority
• Submitted voluntarily
• May be encouraged or stimulated by media reports or articles
• In many parts of the world adverse event reports are submitted
electronically using a defined message standard by physicians
and other health providers and hospitals which may act to alert
FDA and pharmaceutical firms.

10. COHORT STUDIES
• Prospective study
• Planned in advance and carried out over a future period
of time
• Non-random
• Investigate the cause of disease
• Establish links between risk factors and health out
comes

11. CASE CONTROL STUDY
• Identify patients with the adverse effects to be studied (the
cases)
• Compare them with a sample (the controls)
• Both ‘the cases’ and ‘the controls’ are drawn from the same
cohort
• Economical

12. REFERENCE
 http://www.fda.gov/Safety/MedWatch
 MedWatch Safety Alerts:
http://www.fda.gov/Safety/MedWatch/ucm287881.ht
m
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryI
nf
ormation/Surveillance/AdverseDrugEffects/ucm082196.htm
# QuarterlyReports

13. THANK YOU