“WHO Medicines Safety Programme: Pharmacovigilance and risk minimization programs for biological products”
Illustrates the WHO work program on pharmacovigilance, with a focus on both small molecule chemically-synthesized medicines and biotherapeutics
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20. Dr. Shanthi Pal - World Health Organization
1. WHO Medicines Safety Programme:
Pharmacovigilance and risk minimization programs
for biological products
Dr Shanthi Pal
Medicines Safety Programme Manager
Essential Medicines and Health Products, WHO
pals@who.int
pvsupport@who.int
2. Birth of modern pharmacovigilance
Thalidomide – Phocomelia 1961
3. 16th World Health Assembly 1963
Assembly Resolution 16.36 - Clinical and
Pharmacological Evaluation of Drugs
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.
4. WHO Programme for International
Drug Monitoring
WHO-HQ
Geneva
WHO-HQ
Geneva
UMC
WHO-CC
Uppsala
UMC
WHO-CC
Uppsala
National
Centres
UMC-A
WHO-CC
Accra
UMC-A
WHO-CC
Accra
WHO-CC
Rabat
WHO-CC
Rabat
WHO-CC
Oslo
ATC DDD
WHO-CC
Oslo
ATC DDD
5. Pharmacovigilance in WHO
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Resource mobilisation
6. Advisory Committee on Safety of Medicinal
Products (ACSoMP)
The Advisory Committee on Safety of Medicinal Products shall
provide advice on pharmacovigilance policy and issues
related to the safety and effectiveness of medicinal products
to the relevant Assistant Director-General in WHO and
through him / her
to the Collaborating Centres for the Medicines Safety
Programme, and
to the Member States of WHO
14. Concept of generics
Patent expiry of medicines enables
Generics
Cost savings because no need to invest in further
human trials for safety and efficacy
Can use data from investigations with innovator
products
More patients receive treatment
Further investment in new medicines
15. Global Fund HIV/AIDS Coverage
After 9 Rounds of proposals
0 5,0002,500
Kilometers
´
16. Traditional chemical medicines
relatively small
Stable molecules
No need to repeat large-scale human trials
Safety monitoring is needed nevertheless
Used in 'other' environments & populations: LMIC
Comorbidities, nutritional effects, genetic differences
Long-term effects
17. Pharmacovigilance in Global Fund grants
A 2010 analysis of Grant applications in the Global FundA 2010 analysis of Grant applications in the Global Fund
database (R4 to R9)database (R4 to R9)
Is PV mentioned?
Does it set out to establish min PV requirements?
431 individual Global Fund Proposals
31% had “acceptable reference to PV''
Interviews: even if mentioned, PV not implemented in
practice
(Ref: Unpublished data, Pal, Xueref et al; 2010)
18. Joint WHO/Global Fund
pharmacovigilance strategy
Establish basic functions and minimum requirements of
national pharmacovigilance system
Minimum PV requirements
pharmacovigilance toolkit to support training and
development
www.PVToolkit.org
Strong wording in Round 10 requesting countries to include
PV
19. Biotherapeutics
Generally large, complex molecules
produced from living cells using biotechnology
can pose rare but serious risks of unwanted immune
responses
Require extensive testing and risk management
planning
20. Similar biotherapeutic products (SBPs)
Copies or 'generic' versions of biotherapeutic
products (SBP)
Are not exact copies of innovator products
Due to manufacturing process
Unlike other generics, can't rely on data for / from
innovator products
Need sufficient proof of similarity to innovator
product (both preclinical laboratory testing and
clinical trials
Risk management plans are also essential
22. Pharmacovigilance of SBPs
Manufacturer required to submit
Safety specification and PV plan at the time of
submission for approval
Safety specification should describe important
identified or potential safety risks for RBP, the
substance class and / or any that are specifc for the SBP
Risk minimization activities may be needed : education
material for patients / HCP etc
23. Post approval activities for SBPs
Due to potential of SBPs to provoke immune
reactions
manufacturers to undertake post marketing
surveillance to the same standards as RBP MAH
Pharmacovigilance plan should include
Safety monitoring as required of corresponding RBP
Safety monitoring for additional risks identified
SBP manufacturers required to have
PV systems in place at approval
Qualified PV personnel
means to report to NRAs where the reactions occur
24. Traceability of Adverse events
AEs may be product specific
Critical information to assign AEs with specific BPs
ADR report for any BP to include
INN
Proprietary or brand name
Manufacturer's name
Lot number
Country of origin
26. Reports on Monoclonal antibodies (MABs) in
WHO database (out of 8 million Individual Case
Safety Reports, ICSRs)
Total
ICSR 356787
ICSRs with INN, trade
names, indications
285327
28. Top 5 ADRs with MAB in WHO
database
MedDRA_PT_name Number_of_Reports
Fatigue 18208
Drug ineffective 15879
Headache 13543
Dyspnoea 13100
Pyrexia 13031
30. SBPs provide
An opportunity to engage in PPP for PV in LMIC
MAH of generic and innovator biotherapeutics are
obliged to invest in PV
Generics are often used in LMIC
Through PV of SBPs, possible to create PV systems in
LMIC
That will be used also for other medicines (not only SBP)
Governments and Pvt industry should work out a
model
Data on products (MAH & Regulator)
PV System and PV capacity in country
32. But we do need to build structures and best
practices because…
Dying from a disease is sometimes unavoidable. But
dying from an adverse drug event is unacceptable
Dr Vladimir Lepakhin, ex Assistant Director General, World
Health Organization
Hinweis der Redaktion
Article published 1961 in The Lancet. Resulted in the birth of pharmacovigilance. Before this catastrophy the general opinion about drug use was only positive. No negative effects were expected. Phocomelia means ’limbs like a seal’.
National Information officers, WHO Pharmaceuticals Newsletter, ICDRA conference The Importance of pharmacovigilance, PV Toolkit, Public reporting of ADRs Training courses – in cooperation with others Collaboration with public health programmes to make PV a part of them e.g. Malaria, Chagas disease, Vaccines Make them interested in PV e.g Global Fund (sponsored the PV Toolkit), Gates foundation etc