1. Pharmacovigilance: New challenges for WHO Dr Shanthi Pal Group Lead, Medicines Safety

2. Safety and Vigilance (SAV)
Essential Medicines and Health Products (EMP)
Policy, Access and Use
(PAU)
Regulation of Medicines and other Health Technologies (RHT)
Public Health, Innovation and Intellectual Property
(PHI)
Director/EMP
K. De Joncheere
Prequalification Team (PQT)
Regulatory Systems Strengthening (RSS)
Safety and Vigilance (SAV)
Technologies Standard and Norms (TSN)
Coordinator PAU
G. Forte
Head/RHT
L.Rago
Coordinator/PHI
M Zafar
Medicines
Vaccines
SSFFC
Coordinator /PQT
Coordinator RSS
N Dellepiane
Coordinator /SAV
C Ondari
Coordinator /TSN
D Wood
Who are our partners
The SAV team works in close collaboration with the three other teams of Medical Products unit (Norms and Standards team, Prequalification team, and Regulatory Systems Strengthening team),
Group Lead
S Pal
Group Lead
P Zuber
Group Lead
M Deats

3. Scope of SAV work
Develop policies, norms, standards, and methods for medical product vigilance, post market surveillance and safe use
Support countries to adapt and implement policies, norms and standards
Build global capacity, esp, through NRA strengthening activities
Promote contribution to and effective use of the global safety data base
Facilitate exchange of information and global learning
Promote new approaches to medical product vigilance activities
Promote and collaborate on vigilance activities with public health programmes
Respond to safety concerns and crises of international importance
Encourage the systematic and structured reporting of incidents involving SSFFC medical products

4. Pharmacovigilance in WHO….
Establish PV systems and centres in every country in the world
Maintain the network of PV centres worldwide
Provide a platform for data sharing and exchange of information
Develop methods, norms and standards for PV in LMIC, PHPs
Bring capacity, resources
Provide 'PV service' to all programmes that use medicinal products in WHO
Mandate and Framework set by WHA Resolution 16.36: '….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'.

5. WHO Collaborating Centres
UMC
PV database
PV tools, training
Signal detection
Research
Oslo (ATC DDD, training)
Ghana (2009)
Toolkit
African outreach
PV in public health programmes
Morocco (2010)
Francophone/Arabic countries
PV for preventing ADRs: rational use of medicines
Cross cutting service across health interventions
Netherlands (2012)
Training: patient reporting & patient reporting systems
Integrate PV in curriculum

6. Key SAV Priorities in
WHO Advisory Committees: Safety of Medicinal Products (ACSoMP), Global Advisory Committee on Vaccine Safety GACVS (GACVS)

7. 20 years of growth of the WHO Pharmacovigilance Programme
2013
1993
Big surge in membership, with many countries joining the progamme these 10 – 12 years

8. PV in LMIC: Challenges Remain
WHO survey of PV systems in 55 countries
Lack of resources, political support
Lack of competence
Lack of PV systems and/
or inadequate function
Lack of communication and information exchange
Capacity to detect significant
vaccine safety issue
Various surveys by WHO and other groups have consistently highlighted the lack of PV infrastructure and resources in LMIC. The histogram depicts findings from a 55 country survey. These gaps in PV seriously affect the ability of countries to collect and respond to medicines safety information as illustrated by the pie chart where nearly all the safety reports in the WHO global database come from high-income countries. Countries also do not have harmonized systems that allow them to share and compare safety information with each other.
A recent landscape analysis of vaccine safety monitoring highlighted that with the exception of industrialized countries, a very small proportion of member states have the capacity to detect significant vaccine safety issues.
% 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 45 48
A. Industrialized 13 38 5 39
B. Upper middle income 9 29 17 57
C1.Lower middle income 4 12 2 49
C2.Low income
Europe
North America

9. The case of new drugs and MDR TB
Why is this a problem?
Ebola: 30 years later, still no capacity to develop, assess, manage treatments in these settings
The case of new drugs and MDR TB
new TB drugs in 40 years
accelerated approval; phase 2b data
Early introduction countries have no or limited PV and infrastructure
Through programmes such as Global Fund, large volumes of medicines are being brought into those very LMIC with little or no capacity to monitor the safety and quality of those products. This has serious implications for patient safety as well as the public health programmes where a rumour or a real adverse event can derail the entire treatment campaign and erode confidence in the system. Today, in all parts of the world, more attention is being given to patient safety. New products, many new drugs and vaccines, are available for poverty-related diseases that deserve WHO attention as a priority. There is a need for making available the improved technical solutions developed in the most advanced countries so all can benefit from pharmacovigilance standards of the 21st century.
Inadequate or no reference to PV

10. To be relevant: are we doing everything we can?
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)
By investing in PV, countries will benefit multifold:
Benefit harm assessment of medicines
Track quality issues
Track irrational use
Track medication errors
Do we have all the stakeholders: patients?
The WHO definition of Pharmacovigilance provides an opportunity to expand pharmacovigilance beyond the core business of detecting adverse reactions with medicines. The phrase 'any other drug-related problems' in the above WHO PV definition underscores this opportunity, to use PV systems to address other problems related to medicines, such as inappropriate use, harms due to substandard products, programmatic errors etc
Countries should have the capacity to detect the circulation of poor quality products in their markets and to monitor how these products are being used, all of which can be effectively implemented through functional PV systems.

11. WHO's strategy: When we need more
Denominator and numerator data:
ADR Frequencies
Patient reporting
Patient reporting
Medication errors
Targeted spontaneous reporting: to quantify a known ADR
Cohort Event Monitoring: to quantify all events with new medicines in a short period of time
Guidelines: Consumer reporting; preventable ADR detection

12. PV Training in Public Health Programme can improve overall PV awareness
Impact on Spontaneous reporting
CEM training
Not only can we get product specifc data through CEM and TSR, but also, by engaging the right stakeholders (NRA and PHPs), we can build infrastructure and overall capacity and awareness. In the 9 countries that received WHO training in CEM, overall reporting (also for non targeted products) improved as seen above by the overall number of reports coming from these countries in the global database.

13. POLICIES KNOWLEDGE PATIENTS DATA Health workers
Pharmacovigilance is effective / sustained if well integrated with Regulatory Function.
PV centres and PHPs need to collaborate better.
POLICIES
KNOWLEDGE
DRUG REGULATORY AUTHORITY
Expert Safety Review Panel
HIV / AIDS
PV Coordinator
National PV centre
T u b e r c u l o s i s
M a l a r i a
Immunization
PV activities need to operate within the framework of NRA functions. If not, they will remain academic and in perpetual 'project' mode.
1. By ensuring right capacity and infrastructure in the field, we will get quality data and good patient management
2. By sharing the data within PV centres, we will ensure evidence to support benefit harm assessment.
3. By providing data to NRA, we inform pharmaceutical policies and strategic choices in the country
4. While building capacity to collect data in the field, we need to ensure capacity 'upstream', in the NRA, to digest, and use the data for decisions.
DISTRICT INVESTIGATION TEAM
PATIENTS
DATA
Health workers
Ref: Safety monitoring in public health programmes:
pharmacovigilance an essential tool, WHO, 2002

14. Staircase Model for PV & NRA Programmes
Re-assess, improve, scale up
Twinning, mentorship, T3 for Advanced Capacity Building
Assessment, Guidelines, Education & Basic Capacity Building

15. SAV Programmes Vaccines PV centres in reporting network
Global vaccines Safety Initiative
Basic and advanced capacity for AEFI monitoring
Medicines
WHO Programme for International Drug Monitoring (PIDM)
Support to Global databases of Individual Case Safety Reports (ICSRs)
Drug Statistics Methodology (ATC DDD)
SSFFC
PV centres
in reporting
network
Interdependencies between the 3

16. www. who. int/medicines/areas/quality_safety/safety_efficacy/en/index