POST MARKETING

SURVEILLANCE
AnoopInder Kaur

Drugs
Articles intended for use in the
diagnosis, cure, mitigation,
treatment, or prevention of
disease" and
Articles (other than food)
intended to affect the structure or
any function of the body of man
or other animals"

Drugs
Recognized by an official pharmacopoeia or
formulary.
Use in the diagnosis, cure, mitigation,
treatment, or prevention of disease.
Affect the structure or any function of the
body

Drug development- Why?

Lifestyle
changes
Environment

Resistance in
microbes
Co infections

Clinical trials
Practice helping certify a new drug
molecule as safe and efficacious for
human use before reaching the
market.

Phases of CT

Restrictions of phases

Small population
Lesser indications
Concomitant medicines
Stringent Inclusion Criteria

Why PMS?
Safety assurance
Adverse effects
Available to General
Population
Wider range of patients
conditions
Potential of chronic use

Objectiv
es

Collect more information on benefits, risks and optimal use.

Evaluate doses or schedules
Demonstrate wider use
Provide data on other patient populations or states of disease
Document the use of the drug over longer periods of time
Focus on pharmacoeconomic
Identify patient use issues that could slow or impede the
sale of the product

Types
Active:

Periodic Safety Update Reports- submitted every 6

months for 2 years of
approval

Advantages

Safety- off label use,

concomitantly used drugs,
vulnerable population, long
duration use, differences in
prescription.
Recognise rarest ADRs
Increased severity, frequency of
known ADRs
New use
No sample size restrictions
Drug-Drug/Food Interactions

Criticism

Patients bear expenses.

Pseudo scientific excuse.
Luring doctors.
Unethically performed.
No claim, insurance to
patients.

ADR Reporting Systems

MedWatch: US
Yellow Card: UK
Health Canada: Canada
European Medicine Agency:
Europe
CDSCO (PVP): India

Regulations
CFR Title 21 Part 310.305: Records and reports
concerning adverse drug experiences on marketed
prescription drugs for human use without approved new
drug applications.
CFR Title 21 Part 312.32: IND Safety Reporting.
CFR Title 21 Part 314.80: Post marketing reporting of
adverse drug experiences.
Dietary Supplements: Voluntary Reporting
CFR Title 21 Part 355: Over The Counter Drugs

PMS In India
Pharmacovigilance
programme in 2010 by
CDSCO.
PV Centres all over.
Regular reporting.
179 ADR centres till 2014

Distribution of ADR reports based

of types of senders

PvP Performance Report

2014-2015

Top Ten Drugs Reported to

cause ADRs

PvP Performance Report

2014-2015

Wherever the ART OF

MEDICINE is loved, there
also is love of HUMANITY

Hippocr
ates