WORKING OF WHO PHARMACOVIGILANCE PROGRAMME. UPPSALA MONITORING CENTER

1. CONEPT OF SAFTEY REPORTING
SERVICES
MADE BY:
SOMYA
PHARMACOVIGILANCE
ORGANISATION:

2. PHARMACOVIGILANCE
Pharmacovigilance as the science and activities
relating to the detection, assessment,
understanding and prevention of adverse
effects or any other medicine-related problem.
PV heavily focuses on:
 adverse drug reactions, or ADRs
 Medication errors such as overdose, and
misuse and abuse of a drug
 drug exposure during pregnancy and
breastfeeding

3. WHY PV ID NEEDED?
 Most medicines will only have been tested for short-
term safety
 Efficacy on a limited number of carefully selected
individuals
 Treatments are monitored for their effectiveness and
safety under real-life conditions post release
 More information is generally needed about use in
specific population group

4. HOW IS PV DONE?
 Since 1978 , WHO International Drug Monitoring
Programme, through which over 130 member nations
have systems in place
 encourage healthcare personnel to record and report
adverse effects of drugs in their patients,
 Member countries send their reports to the Uppsala
Monitoring Centre where they are processed,
evaluated and entered into the WHO International
Database
 if similar reports are being made elsewhere lead to
the detection of a signal, and an alert about a possible
hazard communicated to members countries after
detailed evaluation and expert review.

5.  Monitoring the safety of medicines: key
partners
 • Government
• Industry
• Hospitals and academia
• Medical and pharmaceutical associations
• Poisons and medicines centres information
• Health professionals
• Patients
• Consumers
• The media
• World Health Organization

6. SIGNAL DETECTION
 Identification and analysis of new adverse
reaction signals from the case report information
submitted to the National Centres
 sent from them to the WHO ICSR( Individual
Case Safety Report) database
 data-mining approach (IC analysis) is used at the
UMC to support the clinical analysis made by a
panel of signal reviewers

7. SIGNAL STRENTHNING
 The signal generation is followed by preliminary
assesment of available data
 Preliminary data can be qualitative derived from
clinical observation or quantitative derived from
epidemiological studies, CRF,experimets
 Most of cases of data supportive evidence is
required to measure ther the relative risk
 Higher is the relative risk higher stronger is the
signal
 Periodic analysis of VigiBase™ data is
performed, in accordance with UMC’s current
routine signal detection process, to find
previously unrecognised ADRs

8. SIGNAL EVALUATION
To qualify as a signal through the current routine signal
detection process, a drug-ADR combination has to go
through and meet the criteria in the following
procedure:
 relative reporting rates for all drug-ADR combinations
reported in VigiBase are calculated. The IC value
highlights the drug-ADR combination as being
reported “unexpectedly” more frequently relative to
the database background.
 drug-ADR combinations the triage algorithms (filtering
methods) select combinations for which the ICSRs
derive from at least two countries and meet one of the
following criteria:
• new drug and serious reaction (drug first entered

9.  Drug-ADR combinations filtered out by the triage
algorithms are subsequently checked by UMC staff
for occurrence in available product information and
literature. If the reaction is not found or not described
well enough, the individual case reports are retrieved
from VigiBase.
 A thorough clinical assessment of the individual case
reports is then done either internally by UMC staff or
externally by members of the UMC Signal Review
Panel.
 Thus UMC signals are found by a combination of
data-mining methodology, together with expert
clinical evaluation.

10. FACTORS AFFECTING IN SIGNAL STRENGTHNING
 Quantitative strength of the association
Number of individual case reports
Statistical disproportionality
 Consistency of the data (pattern)
 Exposure-response relationship
Site, timing, dose, reversibility
 Biological plausibility of hypothesis
Pharmacological, pathological
 Experimental findings
e.g. dechallenge, rechallange, blood levels,
metabolites, drug-dependent antibodies
 Nature and quality of the data
Objectivity, documentation, causality assessment

11. SOURCES AND METHODS OF
SIGNAL DETECTION
1. SPONTANEOUS REPORTING SYSTEM(SRS):
Spontaneous reports are termed spontaneous as
they take place during the clinician’s normal
diagnostic appraisal of a patient, when the clinician
is drawing the conclusion that the drug may be
implicated in the causality of the event. Voluntary
participation by health
profession,pharamcists,nurses ad pateints.
2. INTENSIVE HOSPITAL –BASED DRUG
SURVELLIENCE SYSTEM
hospital based survellience involves use of in-
pateint record records that are maintained with
details drug used ,indication, dose,roue of

12. 3. PRESCRIPTION- EVENT MONITORING:
Large scale PMS method in UK. All NHS
prescriptions issued by general practitioners are
analyzed centrally. Sytem identified the pateint
reciving particular drugs and doctor who prescribed
the drug and follow up questionnaire is sent.
4. EPIDEMIOLOGICAL STUDIES:
Carefully designed studies specifically directed to
study adverse effect related to use of a particular
drug.
5. CASE REPORT IN LITERATURE:
The case report forms by observant physicians
contribute significantly in signal detection. Although
a single report by itself do not generate a signal it
can stimulate others to be watchful for same.

13. ROLE OF NATIONAL PV CENTER
IN SIGNAL DETECTION
Regional centers
National PV
center
SIGNAL
STRENGTHNING
SIGNAL ANALYSIS
COMMUNICATION
ACTIONFOLLOW UP
CASE REPORT
VIGIBASE
SIGNAL
GENERATION

14. National pharmacovigilance centers are the
organisation designated by the ministeries of health
of member countries responsible for collecting and
processing of ADR reports.
National pharmacovigilance centers of member
countries works in coorperation with UMC and send
ADR reports, which is source of database in WHO
data base.
The pharmacovigilance data from national center is
communicated to WHO-ADR database(vigibase)
where further analysis is done either confirm or
disprove the signal and decide accordingly for
necessary action

15. UMC monitoring reports
The number of countries has raised to 130 from 10
since 1968

16. THE WHO PROGRAMME
Members of the WHO Programme for International
Drug Monitoring, 1968 - 2014
2014-05-06

17. PV PROGRAMME IN INDIA
 Pharmacovigilance in India was conceived way
back in 1986 when 12 regional centers were
proposed
 India then joined the WHO-Adverse Drug
Reaction (ADR) monitoring program, based in
Uppsala, Sweden.
 Three centers were assigned the task of ADR
monitoring of marketed medicines - All India
Institute of Medical Sciences (AIIMS) New Delhi,
King Edward Memorial (KEM) Hospital Mumbai,
JLN Hospital Aligarh Muslim University.

18.  the WHO sponsored and World Bank funded
National Pharmacovigilance Program (NPP) was
launched, which is overseen by National
Pharmacovigilance Advisory Committee. There
are 24 PV centers at present under this program.
 the Drug Controller General of India (DCGI) has
announced the CDSCO's "VISION 2020" which
proposes to create a PV center in every medical
college in the country which is an ambitious task
keeping in view the fact that it is still at low ebb in
many government medical colleges and the
condition is the same or may be worse in the
private institutes

19. REFRENCES
 http://apps.who.int/medicinedocs/en/d/Js6164e/1.
html
 http://www.who-
umc.org/DynPage.aspx?id=98081&mn1=7347&m
n2=7252&mn3=7322&mn4=7325
 https://en.wikipedia.org/wiki/Pharmacovigilance
 http://www.jpharmacol.com/article.asp?issn=0976
-
500X;year=2011;volume=2;issue=4;spage=295;e
page=299;aulast=Chakrabarty