Transcript Challenges to PV in low and middle income countries

Addressing the innovation gap: strategies to inform
treatment policies in low and middle
income countries
Shanthi Pal, WHO, Switzerland
Sten Olsson, Uppsala Monitoring Centre, Sweden
WHO Global Programme for Safety
Monitoring of Medicinal Products
• 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.
The full scope of pharmacovigilance (PV)
• The science and
activities relating to the
detection, assessment,
understanding and
prevention of adverse
effects or any other
drug-related problems.
• By investing in PV,
countries will benefit
multifold:
– Benefit harm
assessment of medicines
– Track SSFFC
– Track irrational use
– Track medication errors
(The Importance of
Pharmacovigilance, WHO 2002)
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Challenges to PV in low and middle income countries (LMIC)
WHO survey of PV systems in 55 countries
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•
•
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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
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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
WHO Solutions:
First 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
Create a consortium
plus 9 other partners
Dedicated resources
Innovative/ intuitive software for data management
and information exchange
• ICH standards in ICH region
and individual countries
• Lack of harmonization in
other regions
• Data collected in LMIC not
compatible with ICH
standards
• Timely and accurate global
exchange of PV information
difficult
• Difficult to compare data
across ICH and non ICH
regions
• Vigiflow, E2b compatible
data management tool
• WHO Solution for
implementing ICH standards
in non-ICH countries
• Both a reporting tool as well
as a national database
• Can also support diverse
MAH in LMIC
Vigiflow user countries in the world
• 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.
Results of this innovative approach
• LMIC are able to collect reports in standard
format compatible with developed countries
• Information exchange between LMIC and global
database now possible
• The software update and management occurs
centrally, at Uppsala, Sweden
• Countries do not need to bother with self update
of their tools
• Countries now have their own nationla database
as well.
Impact of innovation
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Data from Africa pooled
Part of global repository of ADRs
Contribute to data mining
First signal based on quality data of
international standards
– Amodiaquine-artesunate antimalarial medicine
– Signal of Extrapyramidal symptoms from African
PV data
– Led to product information update by company
Innovations for broader use of PV data
• SSFFC: Substandard, Spurious, Falsified,
Falsely-labelled and Counterfeit medicinal
products (‘SSFFC’)
• Serious threat to patient safety and health
systems globally
• Global threat, but LMIC particularly
vulnerable
• Impact on medicines procured through global
health initiatives
A novel algorithm
• To detect clusters of reports within the WHO
Individual Case Safety Reports database VigiBase™
– for lack of effect
– based on geographic and temporal patterns
– may reflect cases of SSFFC medicinal products
• To be tested in national databases
– For prospective detection of SSFFC
Innovations to detect medication errors
Reports of medication errors in
WHO ICSR database
2%
Medication errors
Total reports
98%
PV system that :
Records errors
Analyses
Learns
Implements checks
Prevents errors
Innovations to bring in additional stakeholders
• Patients as partners in pharmacovigilance
– Faster identification of new medicine safety
problems
– Better understanding of impact of adverse drug
reactions (ADRs) on life
– More details of ADRs…
– The full picture
• Need simple systems, to support reporting by
patients
The ADR reporting tool for patients
• Developed by WHO and its partner, the UMC
• Complies with international standards (E2b
format data entry)
• Language, style sheets, logos can be adapted
to local preferences
• Can easily feed into the national database / PV
centre
www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.html
[email protected]
• Putting ideas to practice,
in LMIC