Transcript Pharmacovigilance: challenges facing WHO Shanthi Pal Leader, Medicines Safety Safety and Vigilance, WHO, Geneva.

Pharmacovigilance: challenges facing WHO
Shanthi Pal
Leader, Medicines Safety
Safety and Vigilance,
WHO, Geneva
What is pharmacovigilance
• The science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
drug-related problems.
(The Importance of Pharmacovigilance, WHO
2002)
• A tool for generating evidence to influence
policies
WHO Global PV Programme
Why??
• World Health Assembly
Resolution 16.36
• INVITES Member States to
arrange for a systematic
collection of information on
serious adverse drug
reactions observed during
the development of a drug
and, in particular, after its
release for general use.
Who?
Capacity : Francophone &
Arabic countries
Capacity : Africa focused
Public health focused
WHO-CC
Rabat
(2010)
WHO-CC
Accra
(2009)
PV in academia
Patient reporting
ATC DDD
Policies,
Norms,
Guidance,
Donor Liaison
Resources
WHO-CC
Oslo
>30 years
WHO-HQ
Geneva
> 50 years
(2012)
UMC
WHO-CC
Uppsala
> 40 years
National
Centres
Technical support
Capacity building
Database, tools ,
Signals
Implement
Collect ADRs
Share with WHO
database
Challenges to PV in low and middle income countries (LMIC)
WHO survey of PV systems in 55 countries
•
•
•
•
Lack of political support
Lack of resources
Lack of competence
Lack of PV systems and/
or inadequate function
• Lack of communication and
information exchange
Capacity to detect significant
vaccine safety issue
Europe
North America
Group of
countries
Number
of
Countrie
s
Number of
Countries
with data
available
Number of
Countries
with Indicator
Implemented
%
Implemente
d (of those
with data
available)
%
Implemente
d out of the
total
countries in
the region
A. Industrialized
48
48
45
94
94
B. Upper middle
income
39
13
5
38
13
C1.Lower middle
income
57
17
5
29
9
C2.Low income
49
17
2
12
4
Why is this a problem?
• More than 300 products
in the pipeline for
neglected diseases, HIV
AIDS, TB and malaria
• At least half of them will
be launched in the
coming years in those
very settings where there
is little or no capacity for
post approval monitoring
Developer Analysis, BVGH, 2012
Global TB Drug Pipeline
Discovery1
Preclinical Development
Lead Optimization
Diarylquinoline
DprE Inhibitors
GyrB inhibitors
InhA Inhibitors
LeuRS Inhibitors
MGyrX1 inhibitors
Mycobacterial Gyrase
Inhibitors
Pyrazinamide Analogs
Riminophenazines
Ruthenium (II) complexes
Spectinamides
Translocase-1 Inhibitors
Preclinical
Development
CPZEN-45
DC-159a
Q201
SQ609
SQ641
Clinical Development
GLP
Tox.
Phase I
BTZ043
TBA-354
4 Repurposed Drugs
6 New Drugs
3 New Classes
Phase II
Phase III
AZD5847
Bedaquiline (TMC-207)
Linezolid
Novel Regimens2
PA-824
Rifapentine
SQ-109
Sutezolid (PNU-100480)
Delamanid (OPC-67683)
Gatifloxacin
Moxifloxacin
Rifapentine
Drugs currently in the regulatory
review process
www.newtbdrugs.org
Updated: June 18, 2012
What can we do about it?
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub
/en/
Build PV systems
Innovative solutions to support those
systems
Network of WHO Collaborating
Centres (CC) to support PV
systems in countries
• Uppsala Monitoring Centre,
Sweden
• WHO CC Accra, Ghana
• WHO CC Rabat, Morocco
• WHO CC Oslo, Norway
• WHO CC Netherlands
(Lareb)
PV consultants in Africa, for Africa
Dedicated resources
Overcome technical barriers to PV in
LMIC
Vigiflow
• for receiving and storing
ADR reports.
• The entered reports can
be extracted as XML files
• can be transferred to
other (E2b)databases
• A search and statistics
module is built into the
system
• Easy to use and errorchecking ensures
accuracy.
Task shifting: patients as partners
• Conventional models
can't work in some
settings
• All hands on board
– Task shifting
• Patient reporting (more
data, timely data,
additional information)
Forward looking strategies through broad
networks
Expanding and implementing the
full scope of PV
Links with medication errors networks
Links with SSFFC networks
Pharmacovigilance investments will
yield multiple benefits
• As an insurance for investments in public health
interventions:
– A comprehensive disease control approach must include quality
and safety as a component.
• By Investing in PV, countries will have data on medicines
– To assist decision making by regulators, improve treatment
strategies, health care practices, and treatment outcomes
•
Pharmacovigilance data can guide procurement of
effective medicines and reduce wastage
• Robust safety monitoring also provides a quality assurance
mechanism and helps monitor programmatic
implementation.