A short brief on PHASE 4/PV/PMS studies.

1. A Presentation on
PHASE-4/ POST MARKETING SURVEILLIANCE
(PMS)/PHARMACOVIGILANCE (PV) STUDIES
SUBMITTED BY: GUIDED BY:
Sakshi Soni Dr. SK Lanjhiyana
M.Pharm 1st sem Assistant Professor
(Pharmaceutics) (Pharmaceutics)

2. Outlinesofthepresentation
Smooth
orientation
to
pharmacovi
gilance
Why do we
need
pharmacovi
gilance?
Overvi
ew AIMS of
PV/PMS
Limitations
of CTs Methods
of
PMS/PV
studies
p

3. PHARMACOVIGILANCE
• Acco. to WHO Pharmacovigilance (PV) is defined as the
science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other drug-related problem.
• Pharmacovigilance (PV) Drug Safety
• Pharmakon -drug +Vigilance -to keep
watch/Monitor/Safety analysis =PHARMACOVIGILANCE

4. Risk/BenefitBalanceofmedications
“wheneveryoutakemedicineyouareatrisk”
Medicinesaresafe! (X)
Approvedmedicinesare safe! (X)
Nomedicineissafe! (X)
Nomedicineiswithout risk (√)

5. Risk/BenefitBalanceofmedications(>1)
Acceptable
Unacceptable

6. PHARMACOVIGILANCE
prevention
of adverse
effects
Assessment
&Understand
ing
Detection

7. OVERVIEW
•ThalidomideDisaster:inGermany
•Tranquilizer launched -1957
• First reports of birthdefects - 1959
• 13reports of birthdefects - 1961
•Withdrawn shortlyafterward
•10000infants affectedby Phocomelia,babies were born
without/very short limbs because of exposure to thalidomide
consumed by the pregnant mothers for morning sickness.
No teratogenicity detected intestis during clinical trials and
prior to launch.
WHO Piolet Research Project for International Drug

8. AIM OF PHARMACOVIGILANCE
PATIENT CARE: To improve patient care & safety in relation to
medicines & all medical & para-medical interventions
PUBLIC HEALTH :To improve public health & safety in relation to the
use of medicines.
RISK BENEFIT & ASSESSMENT: To contribute to the assessment of
benefit, harm, effectiveness and risk of medicines.
COMMUNICATION:To promote understanding, clinical training &
effective communication to health professionals & the public
To promote rational and safe use of medicines.

9. NEED OF PHARMACOVIGILANCE
1. Humanitarian Concern: Insufficient evidence of safety from
clinical trials, Animal experiments & Phase1–3 studiesprior
to to marketing authorization.
2. SAFE USE OF MEDICINES: it has been suggested
that ADRs may cause 5700 deaths per year in UK .
3. ADRs MAY CAUSE SUDDEN DEATH
4. Promoting rational use of medicines
5. Ensuring public confidence
6. Ethical concern not reporting serious reaction is
unethical.
NEED OF
PHARMACOVIGILANCE

11. Limitationsofclinicaltrials
•Small number of patients
studied
•Restricted populations (age,
sex, ethnicity)
•Narrow indications
•Short duration ofdrug
exposure

12. Whoprogramforinternationaldrug
monitoring
• Started 1968
• Located in Uppsala,
Sweden
• Collaborating centre for
maintaining global ADR
database - Vigibase

13. AV
ALID REPOR
TCONSISTSOF:-
 Identifiable patient
 Identifiable drug (pharmaceuticalproduct)
 Identifiablereaction
 Identifiablereporter

14. Whoshouldreport?
• HealthcareProfessionals
• Marketingauthorization holder(MAH)
• Patients& theirrelatives
• Nurses
• Pharmacists
 ORGANISATIONS INVOLVED IN
PHARMACOVIGILANCE
• USFDA
• CDSCO
• EMEA

15. METHODS FOR PMS/PV DETECTION:
1. Controlled CT Studies: Include Double blind
procedure using placebo and new drug product.
2. Spontaneous/Voluntary Recording: Direct
communication of Physician to a company or
Regulatory authority by distributing free samples to the
patients.
3. Cohort(group of peoples)Studies: Exposure and
Un-exposure of new drug is examined. Can be
Prospective(preferred) & Retrospective(criticized).
e.g. Effect of Green tea in MI patients.
4. Case control study: Acc. To outcomes Subjects are
divided into 2 groups i.e. Exposed (risk chances) and

16. REFERENCES:
1.Gildeeva GN and Yurkov VI. Pharmacovigilance
in Russia: Challenges, prospects and current state
of Affairs. J Pharmacovigil. 2016;4:206.
2. Saygi S, et al. Pharmacovigilance Awareness
among the Community Pharmacists and
Pharmacy Students in the Turkish Republic of
Northern Cyprus. J Pharmcovigil. 2016;4:206
3.Rehan HS, et al. Physicians guide
to pharmacovigilance:terminology and
causality assessment. Eur J Intern Med. 2009;20:3-8.
4. Sanaa A, et al. Awareness and Perception of National
Pharmacovigilance center among Lebanese Medical Staff.
J Pharmacovigilance.2016;4:199.

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