This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.

1. PRESENTED TO:
Prof. S.P. AGARWAL
By :
POLISHETTY
NAVALIKA
M.PHARMACY
(PHARMACEUTICS)
A10647016015
PHARMACOVIGILANCE

2. PHARMACOVIGILANCE
Pharmacovigilance (PV) also known as drug safety.
Pharmakon Drug
Vigilare To keep watch

3. •Pharmacovigilance(PV) is the pharmacological
science relating to the detection, evaluation,
understanding and prevention of adverse drug
reactions or any other drug-related problems .
•As such, pharmacovigilance heavily focuses
on adverse drug reactions, or ADRs.
PHARMACOVIGILANCE

4. •To role pharmacovigilance they receiving
information data from patients and health care
providers via pharmacovigilance agreements
(PVAs), as well as other sources such as the medical
literature.
•Ultimately, pharmacovigilance is concerned with
identifying the hazards associated with
pharmaceutical products and with minimizing the
risk of any harm that may come to patients.
PHARMACOVIGILANCE

5. Pharmacovigilance
Major Aims
• early detection of unknown safety problems
• identification of risk factors
• quantifying risks
• preventing patients from being affected
unnecessarily
Rational and Safe use of Medicines
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6. Cycle for New Drug Approval

7. Why Pharmacovigilance?
Pre-marketing safety data
• Animal Experiments: Relevant?
• Clinical Trials: Complete?
7

8. Why Pharmacovigilance?
Post Marketing Topics
• Unexpected adverse reactions
• Interactions
• Risk factors
• Quality of life
• Long-term efficacy
• Cost assessment
8

9. Why Pharmacovigilance?
10% of people of the some countries is admitted
in hospital due to ADR events .
Adverse Drug Reactions are among the top ten
causes of mortality.
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10. Work flow

11. GOVERNING BODIES
•The pharmaceutical industry.
•Regulatory authorities.
•WHO collaborating centre for international drug
monitoring.
•CIOMS(Council for International Organisation of
Medical Science).

12. WHO Programme for International Drug
Monitoring
12
WHO
HQ
WHO
Collaborating
Centre, Uppsala
National
Centres
•Policy.
•Exchange of Information.
•Technical support to
countries .
•Advisory Committee on
Safety of Medicinal Products.
ADR Reports
•Analysis
•Output
Feedback to National
Centres.
Signal documents.

13. Adverse event
•Any adverse change in health or side effect that occurs
while the patient is receiving the treatment.
Serious adverse event(SAE)
It is defined as any adverse event occurrence that at any
dose results.
•In death
•Is life threatening
•Requries inpatient hospitalization
•Birth defect
•Permanent damage

14. ADVERSE DRUG REACTION (ADR)
•An adverse drug reaction (ADR) is an injury caused
by taking a medication. ADRs may occur following a
single dose or prolonged administration of a drug or
result from the combination of two or more drugs.
•The study of ADRs is the concern of the field known
as pharmacovigilance.

15. ADVERSE DRUG REACTION (ADR)
REPORTING PROCEDURES
•Every country with a
developed pharmacovigilance
system has its own form.
National reporting Form

16. Yellow card scheme
•The Yellow Card Scheme is the UK system for
collecting information on suspected adverse
drug reactions (ADRs) to medicines.
•ADRs can be reported by anyone; this is usually
done by healthcare professionals – including
doctors, pharmacists and nurses – but patients
and carers can also make reports.

17. Yellow card scheme
It contains patient details , suspected drug and suspected reaction

18. Periodic safety update Report(PSURs)
Periodic Safety Update Reports (PSURs) is a
pharmacovigilance document intended to provide an
evaluation of the risk-benefit balance of a medicinal
product at defined time points post- authorization.
First 2 years: every 6 months.
Next 2 years: every year.
After that every 3 years.
But this (PSURs) now changes to PBRER (periodic
benefit risk evaluation report, on 21st Jul in 2012).

19. Pharmacovigilance program of
india (PVPI)
•Officially started on 23 November 2004 at new
Delhi.
PVPI is under control of-
1. CDSCO(Centarl Drugs Standard Control
Organization).
2. Directorate general of health services.
3. Indian pharmacopeia commission (Ghaziabad).
4. The programme is conducting by NCC(National
Coordinatinating Center)

20. Objectives :-
•To monitor the ADRs.
•To create awareness among health care
professionals about ADRs.
•To monitor benefits-rifts of the drug.
•Supports CDSCO.
•Communicate findings with all stake holders.
•Create a national centre.

21. PVPI will be administered and monitored by
the following committees.
1. Steering committee.
2. Strategic advisory committee.
Technical support by-
1. Signal review panel
2. Core training panel
3. Quality review panel

22. Program communications