Transcript Rapid Pharmacovigilance Implementation in Developing Countries

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Rapid Pharmacovigilance Implementation in Developing Countries
“Some remedies are worse than the disease”
Publilius Syrus, Roman writer, 1st century BC.
OSI Public Health Program Seminar
Safety of Medicines
Presentation by
Paul Lalvani, Pharmacist, MBA
Executive Director, RaPID
March 6, 2007
Implementing Drug Safety in 90 days
O r g a n iz a t io n
f o r In n o v a t io n
Impl emen t a t io n
a n d Impa c t
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“Primum non nocere” (First do no harm)
Hippocrates 500BC
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Overview of Presentation
What is
P’vigilance
(PV)
Why
P’vigilance
is Important
Current
Status of
P’vigilance
P’vigilance
and Public
Health
Programs
The RaPID™
Approach
Conclusions
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Pharmacovigilance
Pharmacovigilance is defined as
“the science and activities
relating to the detection,
assessment, understanding and
prevention of adverse effects or
any other possible drug-related
problems”
The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool, World
Health Organization, 2006
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Objectives of
Pharmacovigilance
• improve patient care and
safety
• improve public health and
safety
• encourage safe, rational and
appropriate use of drugs
• promote understanding,
education and clinical training
in pharmacovigilance
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Pharmacovigilance
Reporting Process
(movement of information)
Pulmonary/
Chest
Surgery
Hematology
Endocrinology
HIV/AIDS,
TB, Malaria
All other
RaPID’s Focus
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Illustrative Representation of National
Pharmacovigilance Programs
National Pharmacovigilance Program
Pulmonary/
Surgery
Chest
HIV/AIDS Other
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
HIV/AIDS Other
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
HIV/AIDS Other
HIV/AIDS
Other
Surgery
Hematology
Endocrinology
Hematology
Endocrinology
HIV/AIDS
Other
HIV/AIDS
Other
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
HIV/AIDS Other
HIV/AIDS Other
Endocrinology
Pulmonary/
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
HIV/AIDS Other
Hematology
Endocrinology
Hematology
Surgery
Hematology
Endocrinology
Pulmonary/
Surgery
Chest
Surgery
Pulmonary/
Chest
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
Pulmonary/
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
Hematology
Endocrinology
Hematology
Endocrinology
HIV/AIDS Other
HIV/AIDS Other
HIV/AIDS Other
Hematology
Endocrinology
HIV/AIDS Other
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
Hematology
Endocrinology
Hematology
Endocrinology
HIV/AIDS Other
HIV/AIDS Other
HIV/AIDS Other
Hematology
Endocrinology
HIV/AIDS Other
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Pulmonary/
Surgery
Chest
Hematology
Endocrinology
Hematology
Endocrinology
Hematology
Endocrinology
HIV/AIDS Other
HIV/AIDS Other
HIV/AIDS Other
Hematology
Endocrinology
HIV/AIDS Other
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Illustrative Representation of National
Pharmacovigilance Programs
Policy Recommendations and
Fine tuning of Public Health Programs
Data Entry &
Report
Generation
Vigiflow®
Data Mining
Signal Analysis
Triage
Review by Experts
Department of
Pharmacovigilance
National Pharmacovigilance Program
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Overview of Presentation
Why
P’vigilance
Is Important
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Impact of ADRs in USA
• 1.2 million hospitalized patients in
20041
• Cost of drug-related morbidity and
mortality >$177.4 billion2
• ADRs are the 4th - 6th leading
cause of death3
1 Exilhauser, Owen AHRQ 2007
2 Ref. Ernst & Grizzle J Am Pharm Assoc. 41: 192(2001)
3 Lazarou et al JAMA 1998;279: 1200 - 1205
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Examples of Product Recalls
and Product Safety Concerns
• Even developed countries with stringent regulatory
authorities, have withdrawn several drugs from the
market in the past few years
• Experience/data shows 4% to 5% of drugs on the
market are withdrawn and about 20% receive ‘black
box’ warnings (safety concerns not previously
identified)
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Importance of
pharmacovigilance
• Complete safety data (especially for
unexpected and serious adverse
events) can only be captured
through pharmacovigilance
• It cannot be captured through
clinical trials which are conducted in
an “artificial environment.”
– In clincial trials patients
• are not taking any other medications
• do not have concomitant infections
• are taking the drug short-term (during the
duration of the trials only) and
• are not part of vulnerable groups (e.g.,
children, pregnant women, elderly, etc.)
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Safety concerns with
Anti-Retrovirals
Product
Potential ADRs and Risks
Abacavir
Hypersensitivity, potentially fatal,
up to 5%
Didanosine
• Pancreatitis – often fatal, very
difficult to manage
• Neuropathy
Indinavir
Ritonavir
Saquinavir
• Lipodystrophy--disfiguring change
of fat distribution identifies HIV+
patients on ARV treatment
• Leads to discontinuation
• Severe skin reactions – potentially
fatal
Safety of ARVs in pediatrics is
largely a ’black box’
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Adverse effects associated with
antiretroviral medicines have been
reported to occur in up to 30% of HIVinfected children on antiretroviral
therapy. [Examples of ADR’s included]:
hepatotoxicity, raised serum amylase
without symptomatic pancreatitis,
zidovudine-(AZT-) induced anaemia,
nevirapine- (NVP-) induced
rash, didanosine- (ddI-) induced pain in
the abdomen, stavudine- (d4T-) induced
angioedema.
Most of the adverse effects are
reversible by modifying the dosage
or omitting the offending medicine.
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Importance and
URGENCY of
pharmacovigilance
We are accelerating the use of new drugs
in new environments, which are mostly
devoid of pharmacovigilance activites
• Faster scale up of public health programs due
to availability of new funding from major
donors such as the Global Fund, World Bank,
PEPFAR, UNITAID, etc
• New drugs are reaching developing countries
in greater numbers and more quickly because
of new funding from several donors, including
the Bill and Melinda Gates Foundation
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“All things are a poison and none is without poison;
it is the dose that determines it is a poison.”
Paracelsus "father" of toxicology (1500AD)
The RaPID™
Approach
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RaPID Overview
Current situation in country
RaPID’s Approach
Mission
Principles
Process
Activities
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Mission
• To conduct pharmacovigilance on
behalf of public health programs
and
• To strengthen national
pharmacovigilance capacity in
developing countries
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Guiding Principles
• Establish complementarity with National
Programs
• Strengthen local capacity
• Focus on the big three killers (AIDS, TB,
Malaria)
• Focus on the most vulnerable
populations
• Implement quickly using a ‘RaPID™
Force’—in months, not years
• Leverage IT to connect global specialists
• Use the findings to formulate policies
for patient safety
• Ensure sustainability
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RaPID Overview
Current situation in country
RaPID’s Approach
Mission
Principles
Process
Activities
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3 Key Activities of the
RaPID™ Program
Data Analysis
3
Data Sharing
2
1
Data Gathering
In-country
partners
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Overall Architecture of RaPID™ Program
RaPID Office
Department of
Information
System
Department of
Pharmacovigilance
Data Analysis
Data Entry &
Report
Generation
Vigiflow®
Data Mining
Signal Analysis
Triage
Review by Experts
Data
Sharing
Data Gathering
Focus of RaPID™
HIV
TB
Program
Program
ART
Centers
TB
Centers
ART
Centers
TB
Centers
ART
Centers
TB
Centers
ART
Centers
TB
Centers
Malaria
+ Other
Pulmonology
Hematology
Other
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National Pharmacovigilance Program
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RaPID™ Process Flow
RaPID Office
Data Analysis
Department of
Information
System
Department of
Pharmacovigilance
Data Entry &
Report
Generation
Vigiflow®
Daily
transmission
Data Mining
Signal Analysis
Triage
Review by Experts
Weekly
Reporting
2
5
3
Focus of RaPID™
HIV
TB
Program
Program
ART
Centers
1
TB
Centers
ART
Centers
TB
Centers
ART
Centers
TB
Centers
ART
Centers
TB
Centers
PV
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activities
Data
Sharing
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Malaria
+ Other
Pulmonology
Hematology
Other
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National Pharmacovigilance Program
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Key activities and roles of partners
Implementing Org
Analyze Pharmacovigilance Capacity In-Country
Assess
Pharmacovigilance
Capacity of Country
Assess Public
Health
Programs
for
HIV/TB/Malari
a
Assess Donor
And Partner
Support
for
Pharmacovigil
ance
In-country PV
Dept, WHO,
RaPID team
Develop a Customized RaPID Pharmacovigilance Approach for Program
Co-Develop RaPID
Pharmacovigilance
Approach
for Country
Establish
a
Protocol
For
Implemen
ting
RaPID
Customize
ADR
forms
Establish
RaPID
Infrastruct
ure
In-Country
In-country PV
Dept, WHO,
RaPID team
Gather Data and Ensure
Quality
WHO/UM
WHO/UMC to
Train New
In-Country
RaPID Staff
C
to Train
Country
Program
Officers
and
PV team
Dedicate
d ‘RaPID
Force’ to
Gather
ADR
Data
Data
Screened
for
Accuracy
and Quality
Data
Transferred
to
RaPID’s
Data
Entry Office
UMC, WHO,
Swissmedic,
In-country PV
Dept,
RaPID team
Analyze Data
Enter ADR
Data into
National Vigiflow®
Database
Conduct
Causality
Assessm
ents and
Produce
Reports
Share
Reports
with
Global
Experts
for
Review
RaPID Data
entry team,
In-country PV
Dept, UMC,
WHO
Provide Support for Policy Change
Present Analysis
and Findings
to the Country
Program
Provide
Support
in Policy
Generati
on
In-country PV
Dept, WHO,
UMC,
Swissmedic,
RaPID team
Share
Data
Globally
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Ongoing Pharmacovigilance Activities
Pharmacovigilance Capacity Assessment:
Development of Protocol for Assessing
antimalarials
Assessment of ADR/AE Reports
Data Gathering and Assessment of
Pharmacovigilance data in ART Centers:
•
In collaboration with UNAIDS, CHAI, WHO and various
donors for providing support to National AIDS Control
Organization in India
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Current Consortia Partners
Uppsala Monitoring Centre (UMC)
An independent centre of scientific excellence, the Uppsala Monitoring
Centre is responsible for the collection of data about adverse drug reactions
from WHO member states from around the world, and the generation of
signals of drugs which might possibly have problematic side-effects.
Currently 82 countries are actively contributing to the database.
Ecumenical Pharmaceutical Network (EPN)
Swissmedic will collaborate with RaPID on a project basis with a focus
on Vigiflow®
In discussions with: MSF, CHAI, PSI, IDA, MC,
among others
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Contacts
RaPID™ Program, O3i
11 West 42nd Street,
3rd Floor, New York, NY 10036;
Tel: +1-212-208-2447
The Uppsala Monitoring Centre,
Stora Torget 3, S-753 20 Uppsala;
Sweden;
Tel:+46-18-656060
Email: [email protected]
Website: www.rapidpharmacovigilance.org
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