This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they have been approved for public use. PMS is important because clinical trials have limitations in terms of patient population size, duration, and ability to detect rare or long-term effects. Sources of PMS information include spontaneous reporting, studies using medical databases, and manufacturer monitoring. Common PMS methods include spontaneous reporting of adverse drug reactions, cohort studies, and case control studies. PMS can help identify new safety issues and provide more information on drug risks and benefits in diverse patient populations.

1. PMS (POST MARKETING Surveillance)
Submitted To: Submitted By:
Prof. Dr. Harish Dureja Sandeep
( P’ceutical Department M.Pharma
M.D.U , Rohtak ) (DRA)Ist Sem.
Roll no.:1854

2. INDEX
 Introduction
 History
 Benefits of PMS
 Sources of PMS
 Types of surveillance
 Method of surveillance
 Manufacturer PMS system
 References

3. PHASES OF CLINICAL TRIALS
Phase 0 : micro dosing
Phase I : First in man- Safety
Phase II: First in Patient- Dose , dosage forms
Phase III: Efficacy , ADRs
Post-marketing Surveillance or
Phase –IV : Evaluation of in the real
clinical setting.

5. Introduction
 Post marketing surveillance refers to
any means of obtaining information about a
product after it has been approved for public
use.
 Section 505(0)(3) authorizes FDA to require
certain post marketing studies and clinical
trials for prescription drugs approved under
section 505(b) and biological product approved
under section 351. cont…

6.  Post-marketing surveillance of drug therefore
play an
important role to discover an undesirable effect
that might present at risk.
 It provide additional information on the
benefit and risk of the drugs.

7. HISTORY
 In the 1960 at least two serious drugs reactions were
observed in many patient . thalidomide causes limbs
deformities (phocomelia).
 The PMA, senator Edward Kennedy (D-Mass.) suggested
that a better system was need for monitoring the use and
effects of prescription drug after they are marketed.
 As a result, the joint commission on Prescription Drugs Use
was established in 1976,funded largely by the drug industry,
with the mandate to design a post-marketing surveillance
system to detect , quantify and describe the anticipated and
unanticipated effects of marketed drugs.
 The delayed discovery of the adverse effects spurred effects
to improve post-marketing surveillance.

8. POST-MARKETING SURVEILLANCE
 No fixed duration/Patient population
 Starts immediately after marketing
 Report all ADRs
 Help to detect
 Rare ADRs
 Drug interaction
 Also new uses for drugs[sometimes called
Phase V]

9. Limitations of Premarketing Clinical Trials
 Size of the patient population studied
 Narrow population - often not providing
sufficient data on special groups
 Narrow indications studied
 Short duration

10. Benefits of Post-marketing Monitoring :
The ability to study the following:
•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

11. SOURCES OF PMS INFORMATION:
The following may be considered as sources of
information :
 Expert user groups
 Customer surveys
 Customer complaints and warranty claims
 Post CE-market clinical trials.
 Literature reviews
 The media

12. Types of Post-marketing Surveillance
 Spontaneous/voluntary reporting of cases
 National (FDA MedWatch)
 Local or Regional (Joint Commission Requirement)
 Scientific literature publications
 Postmarketing studies (voluntary or required)
 Observational studies (including automated healthcare
databases)
 Randomized clinical trials
 Active surveillance
 Drug-Induced Liver Injury Network (DILIN)
 Sentinel initiative

13. Spontaneous Reports
 A communication from an individual (e.g.
health care professional, consumer) to a
company or regulatory authority
 Describes a suspected adverse event(s)
 Passive and voluntary reports

14. Factors Affecting Reporting
 Media attention
 Litigation (class action lawsuits)
 Nature of the adverse event
 Type of drug product and indication
 Length of time on market
 Extent and quality of manufacturer’s surveillance system
 Rx or OTC product status
 Reporting regulations

16. FDA Adverse Event Reporting System (FAERS)
 Computerized database
 Spontaneous reports
 Contains human drug and therapeutic biologic
reports
 > 7 million reports since 1969

17. FAERS Strengths
 Includes all U.S. marketed products
 Includes all uses
 Includes broad patient populations: elderly,
children, pregnant women, co-morbidities
 Simple, relatively inexpensive reporting system
 Especially good for events with a rare
background rate
cont….

18.  Useful for events that occur shortly after
exposure
 Detection of events not seen in clinical trials
(“signal generation”)
 Identification of trends, possible risk factors,
populations, and other clinically significant
emerging safety concerns

19. Safety Signal
 Reported information on a possible causal
relationship between an adverse event and a drug
 The relationship being previously unknown or
incompletely documented
 Supported by multiple case reports
 New unlabeled adverse events
 An observed increase in a labeled event OR a greater
severity or specificity
 New interactions
 Newly identified at-risk population

20. Use of Data Mining
 Mathematical tool identifies higher-than-
expected frequency of product-event
combinations
 Tool for hypothesis generation
 Supplements FAERS data review
 Does not replace expert clinical case review

21. Developing a Case Series
 Identify a well-documented case in FAERS,
published literature, data mining, or other sources
to identify a safety signal.
 Using our knowledge of the clinical course of the
disease, formulate a case definition which may
include both clinical features and laboratory
findings, sometimes even demographic
information if we believe the safety signal is for a
specific population.
 Complete a thorough database search for
additional cases.

22. Regulatory Actions
 Labeling changes – i.e. Warnings, Precautions,
Adverse Reactions
 Pharmacovigilance activities - enhanced
surveillance (e.g., expedited reporting), registry,
epidemiology studies
 Risk Evaluation and Mitigation Strategy (REMS)
Communication plan, restricted use
 Drug Safety Communication (DSC)
 Market withdrawal

23. METHODS OF SURVEILLANCE:
Thus, four types of studies are generally
used to identify drugs effects:
1. Controlled clinical trials,
2. Spontaneous or voluntary recording
3. Cohort studies
4. Case control studies

24. CONTROLLED CLINICAL TRIALS:
 To minimize bias through such method as
 randomization
 Directly monitor patients for the duration of
 studies.
 For evaluating a drug’s efficacy and safety.
 They are often costly.

25. SPONTANEOUS REPORTING:
A communication from an individual (e.g:
health care professional, consumer) to a company
or regulatory authority .
 This describes a suspected adverse event(S)
 But the actual incidence of adverse drug
reaction can not be determined through
spontaneous reporting.

26. COHORT STUDIES:
 Studies follow a defined group of patient for a
period of time.
 Patient are not randomly assigned
CASE CONTROL STUDIES:
 Case control studies identify patient with the
adverse effects to be studied, and compare
them with the sample drawn from the same
cohort that gave rise to cases.

27. MANUFACTURER PMS SYSTEM:
These are some of the type of
knowledge and feed back which can achieved
from a PMS system.
 Detection of some manufacturing problems.
 Product quality improvement.
 Conformation (or otherwise) of risk analysis.
 Knowledge of long term
performance/reliability and /or chronic
complication.

28.  Knowledge of performance in different user
population.
 Feedback on indication of use.
 Feedback on instruction for use.
 Feedback on use with other devices.
 Feedback on customer satisfaction.
 Feedback on continuing market viability.

29. How to report to MedWatch

31. How to Report:
Online(www.fda.gov/medwatch)
Download the form Mail
Fax 1–800–332–0178
For questions about the form: 1–800–332–1088

32. References
 http://www.fda.gov/Safety/MedWatch
 MedWatch Safety Alerts:
http://www.fda.gov/Safety/MedWatch/ucm287881.htm
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInf
ormation/Surveillance/AdverseDrugEffects/ucm082196.htm#
QuarterlyReports
 FOOD AND DRUGS ADMINISTRATION, Supplementary
reports to contracts and grants committee on
Medicaid”, from the division of Drugs
Experience, BUREAU OF DRUGS,1982, 10-32.

33. Thank You