1. Pharmacovigilance: challenges facing WHO Shanthi Pal Leader, Medicines Safety Safety and Vigilance, WHO, Geneva

2. What is pharmacovigilance 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) A tool for generating evidence to influence policies

3. WHO Global PV Programme Why?? 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.

4. Who? WHO-HQGeneva > 50 years WHO-HQGeneva UMCWHO-CCUppsala > 40 years UMCWHO-CCUppsala National Centres WHO-CCAccra(2009)WHO-CCAccra(2009)WHO-CCRabat(2010)WHO-CCRabat(2010) (2012) WHO-CCOslo >30 years WHO-CCOslo Policies, Norms, Guidance, Donor Liaison Resources Technical support Capacity building Database, tools, Signals Capacity : Africa focused Public health focused Capacity : Francophone & Arabic countries ATC DDD PV in academia Patient reporting Implement Collect ADRs Share with WHO database

5. Challenges to PV in low and middle income countries (LMIC) Lack of political support Lack of resources Lack of competence Lack of PV systems and/ or inadequate function Lack of communication and information exchange % Implemente d out of the total countries in the region % Implemente d (of those with data available) Number of Countries with Indicator Implemented Number of Countries with data available Number of Countrie s Group of countries 94 4548 A. Industrialized 133851339 B. Upper middle income 92951757 C1.Lower middle income 41221749C2.Low income Capacity to detect significant vaccine safety issue WHO survey of PV systems in 55 countries North America Europe

6. 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

7. Lead Optimization Preclinical Development GLP Tox. Phase IPhase IIPhase III Delamanid (OPC-67683) Gatifloxacin Moxifloxacin Rifapentine AZD5847 Bedaquiline (TMC-207) Linezolid Novel Regimens 2 PA-824 Rifapentine SQ-109 Sutezolid (PNU-100480) CPZEN-45 DC-159a Q201 SQ609 SQ641 Preclinical Development Discovery 1 Clinical Development Diarylquinoline DprE Inhibitors GyrB inhibitors InhA Inhibitors LeuRS Inhibitors MGyrX1 inhibitors Mycobacterial Gyrase Inhibitors Pyrazinamide Analogs Riminophenazines Ruthenium (II) complexes Spectinamides Translocase-1 Inhibitors Global TB Drug Pipeline Updated: June 18, 2012 BTZ043 TBA-354 www.newtbdrugs.org 4 Repurposed Drugs 6 New Drugs 3 New Classes Drugs currently in the regulatory review process

8. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub /en/ What can we do about it?

9. Build PV systems

10. 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

11. Dedicated resources

12. Overcome technical barriers to PV in LMIC 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 error- checking ensures accuracy. Vigiflow

13. Task shifting: patients as partners Conventional models can't work in some settings All hands on board – Task shifting Patient reporting (more data, timely data, additional information)

14. Forward looking strategies through broad networks Expanding and implementing the full scope of PV Links with SSFFC networks Links with medication errors networks

15. Pharmacovigilance investments will yield multiple benefits As an insurance for investments in public health interventions: – A comprehensive disease control approach must include quality and safety as a component. By Investing in PV, countries will have data on medicines – To assist decision making by regulators, improve treatment strategies, health care practices, and treatment outcomes Pharmacovigilance data can guide procurement of effective medicines and reduce wastage Robust safety monitoring also provides a quality assurance mechanism and helps monitor programmatic implementation.