1.
PHARMACOVIGILANCE and
PvPI

2.
PHARMACOVIGILANCE

3.
WHO-
The science & activities relating to the
Detection
Assessment
Understanding and
Prevention of adverse effects or any other drug related problems

4.
Historical Background
Thalidomide-
• In 1960 marketed in 46 countries
• Reports of fetal abnormalities
(20,000 cases )
• Phocomelia

5.
DIRECT RESULT- THALIDOMIDE INCIDENT
• USA - 1962 amendment to Federal Food, drug & Cosmetic Act -
required both safety & efficacy data
• UK - 1964 Yellow card scheme
• WHO - 1968 Program for International Drug Monitoring

6.
TERMINOLOGIES IN PHARMACOVIGILANCE
Adverse effect-
‘any undesirable or unintended consequence of drug
administration’.
Adverse drug event
‘any untoward medical occurrence that may present during
treatment with a medicine, but which does not necessarily have a
causal relationship with the treatment’.

7.
TERMINOLOGIES IN PHARMACOVIGILANCE
• Adverse drug reaction (ADR)
‘any noxious change which is suspected to be due to a drug,
occurs at doses normally used in man, requires treatment or decrease
in dose or indicates caution in the future use of the same drug’

8.
TERMINOLOGIES IN PHARMACOVIGILANCE
• Signal
-” Reported information on a possible causal relationship
between an adverse event and a drug, the relationship being unknown
or incompletely documented previously".
Medication error
any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in control of
the health care professional, patient or consumers

9.
Serious adverse drug reaction
• Death
• Life- threatening
• Hospitalization
• Disability (significant ,persistent, permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment/damage

10.
Need of pharmacovigilance?
1: Humanitarian concern
- Insufficient evidence of safety from clinical trials
- Tests in animals are insufficient to predict human safety
- Safety profile in special groups inadequate / Incomplete

11.
Need of pharmacovigilance?
2. Medicines are supposed to save lives
“Dying from a disease is sometimes unavoidable; dying from a
medicine is unacceptable”
3. ADRs are expensive
4. Promoting rational use of medicines and adherence

12.
AIMS-
• To improve patient care & safety
• To improve public health & safety
• To contribute to the assessment of benefit, harm, effectiveness and risk of
medicines
• To promote education and clinical training
• To promote rational and safe use of medicines

13.
• Who can report?
-Medical specialist
-Pharmacists
- Dentists
- Midwives
- patient
- patient’s relatives

14.
Reporting time frame
• Expedited reporting is required as soon as possible
• Day 0 - date when any of the MAH receive a case report
• Non –serious ADR
-not reported on an expedited basis
-included in the periodic safety update report

15.
• Serious unexpected – 15 calendar days
• Serious death/life threatening unexpected -7 calendar days

16.
Periodic safety update report
• MAH submit to regulatory authority to evaluate medicinal products
safety data for a particular interval of time
• PSUR- PREPARATION
-every 6 month from authorization until product placed on the
market
-every 6 month x first 2 years

17.
Periodic safety update report….
-annually for the next 2 years
-thereafter every 3 years

18.
INDIVIDUAL CASE SAFETY REPORT
• Adverse event report for an individual patient
• Source of data in pharmacovigilance
unsolicited solicited
Spontaneous reports Clinical trial
patients registries
Regulatory authorities Disease management programs
internet survey

19.
INDIVIDUAL CASE SAFETY REPORT
• Identifiable patient
• Identifiable reporter
• A suspected drug
• An adverse event

20.
VIGIFLOW
-WEB based individual case safety reports management system
-used by national pharmacovigilance centres
-supports collection ,processing , and sharing of ICSR data
VIGIBASE:
- WHO global individual case safety report database.

21.
PHARMACOVIGILANCE PROCESS
ICSR
NATIONAL CENTRE
UPPSALA MONITORING SYSTEM
SIGNAL DETECTION ACTION

22.
CAUSALITY ASSESSMENT
• assessment of relationship between a drug treatment and the
occurrence of an adverse event.
• It is used to evaluate and to check that the particular treatment is the
cause of an observed adverse event or not.
• It is an essential part of ADR report and important task, conducted by
National Pharmacovigilance Programme in each country.

23.
Causality is assessed on the basis of-
• Temporal relationship
• Previous knowledge
• Dechallenge
• Rechallenge

24.
WHO-UMC causality categories..

25.
WHO-UMC causality categories..

26.
Naranjo-algorithm

27.
Naranjo score
9 certain
 5-8 probable
1-4 possible
< 0 unlikely

28.
WHO - International drug monitoring
• Started 1978
• Located in Uppsala, Sweden
• Collaborating centre for maintaining global ADR database - Vigibase

29.
Roles of WHO Collaborating Centre
• • Identify early warning signals of serious adverse reactions to
medicines
• Evaluate the hazard
• Undertake research into the mechanisms of action to aid the
development of safer and more effective medicines

30.
THE PHARMACOVIGILANCE
PROGRAMME OF INDIA (PvPI)

31.
• 1997- WHO Programme for international drug monitoring.
• 2004- Central Drugs Standard Control Organization (CDSCO)
National Pharmacovigilance Programme (NPVP).
• 2010- PvPI Ministry of Health & Family Welfare of the
Government of India

32.
The Pharmacovigilance Programme of India
(PvPI)
1. Structure
2. Capacity building
3. Pharmacovigilance tools

33.
Structure

34.
Capacity building
• Four regional resource centers - training and technical support to AMCs of
their respective regions
• NCC -national and regional programms
(training, consumer awareness and Continuing Medical Education)
• 2014- A Guidance document for spontaneous ADR reporting
• January 2017 - skills development programme.

35.
Pharmacovigilance tools
• ADR reporting form
• Toll-free helpline (1800 180 3024) with SMS feedback facility
• 2015- Mobile application (ADR PvPI)
• WhatsApp (7042343309)
Facebook (NccPvPI Ipc)
Twitter (@IPCNCCPvPI).

36.
WORK FLOW

37.
Collaboration with public health programmes
• Universal Immunization Programme (UIP)
• HIV and tuberculosis programmes
• Vector-borne diseases programme
• Deworming programme

38.
Collaboration with medical organizations
• Aims : To synergize experience in pharmacovigilance and
pharmacoepidemiology to booster the country’s PvPI initiative.
• National AIDS Research Institution (NARI), Pune
• Institute of Research in Reproductive Health (IRRH), Mumbai
• National Institute of Cholera & Enteric Diseases (NICED), Kolkata
• National Institute of Nutrition (NIN), Hyderabad
• National Institute of Epidemiology (NIE), Chennai
• National Institute of Malaria Research (NIMR), New Delhi

39.
SUMMARY
• Pharmacovigilance
• Need of PV?
• Aims
• ICSR
• PCSR
• VIGIBASE
• VIGIFLOW
• PvPI

40.
THANK YOU