WHO Pharmacovigilance strategies of interest to IPC stakeholders

Transcription

1 WHO Pharmacovigilance strategies of interest to IPC stakeholders Shanthi Pal Medicines Safety Programme Manager Essential Medicines and Health Products WHO

2 WHO focus on building PV systems in LMIC Europe North America

3 Lack of harmonization limits data management and information exchange in LMIC Data do exist in LMIC But data management tools do not exist Existing tools not of international ICH/E2b standards Lack of harmonization Timely and accurate global exchange of PV information difficult Difficult to compare data across ICH and non ICH regions

4 Vigiflow: WHO solution for PV data management in LMIC WHO Solution for implementing ICH standards in non ICH countries Both a reporting tool as well as a national database The stored reports can be extracted as XML files can be transferred to other (E2b)databases A search and statistics module is built into the system

5 By using this tool 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 now have their own national database.

6 Impact of harmonized data management tools Data from African countries being pooled Part of global repository of ADRs First signal based on quality data of international standards from Africa Amodiaquine artesunate antimalarial medicine Signal of Extrapyramidal symptoms from African PV data Led to product information update by company Involves modest cost to countries: donors to consider funding

7 Vigiflow supports implementation of ICDRA recommendations ICDRA 2012 recommendations for pharmacovigilance in Member States Integration and cohesive systems Common nomenclature. Data standards and common reporting formats. Data sharing.

8 But need 'upstream' PV capacity building Focus on how data will be used Who will use the data: regulators How to build capacity of regulators for PV in LMIC Data assessment Decision making PV obligations of MAH. Medicines safety Advisory Committee Recommendation Develop a PV package for harmonized regulatory functions in LMIC Leverage AMRH consortium for deliverables

9 Global Fund: Access to large volumes of ARVs in these vulnerable settings but no PV Only 17 out of 430 proposals had any reference to PV 0 2,500 5,000 Kilometers

10 Global TB Drug Pipeline Discovery 1 Preclinical Development Clinical Development Lead Optimization Preclinical Development GLP Tox. Phase I Phase II Phase III Diarylquinoline DprE Inhibitors GyrB inhibitors InhA Inhibitors LeuRS Inhibitors MGyrX1 inhibitors Mycobacterial Gyrase Inhibitors Pyrazinamide Analogs Riminophenazines Ruthenium (II) complexes Spectinamides Translocase 1 Inhibitors CPZEN 45 DC 159a Q201 SQ609 SQ641 BTZ043 TBA Repurposed Drugs 6 New Drugs 3 New Classes AZD5847 Bedaquiline (TMC 207) Linezolid Novel Regimens 2 PA 824 Rifapentine SQ 109 Sutezolid (PNU ) Delamanid (OPC 67683) Gatifloxacin Moxifloxacin Rifapentine Drugs currently in the regulatory review process Updated: June 18, 2012

11 Dedicated resources for PV in PHPs 1. Minimum PV requirements identified together with Global Fund 2. Information notes etc: GF Round 10, 25 countries included PV in proposals 3. Various Handbooks: PV in HIV, TB, Malaria, NTDs 4. Level III indicators for PV 5. Implementing Active surveillance in malaria, HIV; TB to start soon

12 Other Innovations of interest for IPC partners Substandard medicinal products Global threat, but LMIC particularly vulnerable Impact on medicines procured through global health initiatives

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14 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 substandard medicinal products To be tested in national databases For prospective detection of substandard products