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 ID: 752787
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Slide1
Pharmacovigilance: challenges facing WHO
Shanthi Pal
Leader, Medicines Safety
Safety
and Vigilance,
WHO, GenevaSlide2
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 Slide3
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.Slide4
Who?
WHO-HQ
Geneva
> 50 years
UMC
WHO-CC
Uppsala
> 40 years
National
Centres
WHO-CC
Accra
(2009)
WHO-CC
Rabat
(2010)
(2012)
WHO-CC
Oslo>30 years
Policies,
Norms, Guidance,Donor LiaisonResources
Technical support
Capacity buildingDatabase, tools , Signals
Capacity : Africa focused
Public health focused
Capacity : Francophone & Arabic countries
ATC DDD
PV in academia
Patient reporting
Implement
Collect ADRs
Share with WHO databaseSlide5
Challenges to PV in low and middle income countries (LMIC)
Lack of political support
Lack of resources
Lack of competence
Lack of PV systems and/
or inadequate function
Lack of communication and information exchange
% Implemented out of the total countries in the region
% Implemented (of those with data available)
Number of Countries with Indicator Implemented
Number of Countries with data available
Number of Countries
Group of countries
94
94
45
48
48
A. Industrialized
13
38
5
13
39
B. Upper middle income
9
29
5
17
57
C1.Lower middle income
4
12
2
17
49
C2.Low income
Capacity to detect significant vaccine safety issue
WHO survey of PV systems in 55 countries
North America
EuropeSlide6
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, 2012Slide7
Delamanid
(
OPC-67683
)
Gatifloxacin
Moxifloxacin
Rifapentine
AZD5847
Bedaquiline
(TMC-207)
Linezolid
Novel Regimens
2PA-824Rifapentine
SQ-109Sutezolid (PNU-100480)
CPZEN-45DC-159aQ201SQ609SQ641
Preclinical DevelopmentDiscovery1Clinical Development
Diarylquinoline
DprE
InhibitorsGyrB inhibitorsInhA
Inhibitors
LeuRS Inhibitors
MGyrX1 inhibitors
Mycobacterial Gyrase
Inhibitors
Pyrazinamide Analogs
Riminophenazines
Ruthenium (II) complexes
Spectinamides
Translocase-1 Inhibitors
Global TB Drug Pipeline
Updated:
June 18, 2012
BTZ043
TBA-354
www.newtbdrugs.org
4 Repurposed Drugs
6 New Drugs3 New Classes Drugs currently in the regulatory review processSlide8
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub/en/
What can we do about it?Slide9
Build PV systemsSlide10
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 AfricaSlide11
Dedicated resourcesSlide12
Overcome technical barriers to PV in LMIC
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 error-checking ensures accuracy. VigiflowSlide13
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)Slide14
Forward looking strategies through broad networks
Expanding and implementing the
full scope of PV
Links with SSFFC networks
Links with medication errors networks Slide15
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 medicinesTo assist decision making by regulators, improve treatment
strategies, health
care
practices, and treatment outcomes
Pharmacovigilance data can guide procurement of effective medicines and reduce wastageRobust safety monitoring also provides a quality assurance mechanism and helps monitor programmatic implementation.