1 / 15

Pharmacovigilance: challenges facing WHO

Pharmacovigilance: challenges facing WHO . Shanthi Pal Leader, Medicines Safety Safety and Vigilance, WHO, Geneva. What is pharmacovigilance.

waneta
Download Presentation

Pharmacovigilance: challenges facing WHO

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 ProgrammeWhy?? 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? Capacity : Francophone & Arabic countries Capacity : Africa focused Public health focused WHO-CC Accra (2009) WHO-CC Rabat (2010) Technical support Capacity building Database, tools , Signals PV in academia Patient reporting UMC WHO-CC Uppsala > 40 years WHO-CC Oslo >30 years ATC DDD (2012) WHO-HQ Geneva > 50 years NationalCentres Policies, Norms, Guidance, Donor Liaison Resources Implement Collect ADRs Share with WHO database

  5. Challenges to PV in low and middle income countries (LMIC) WHO survey of PV systems in 55 countries • Lack of political support • Lack of resources • Lack of competence • Lack of PV systems and/ or inadequate function • Lack of communication and information exchange Capacity to detect significant vaccine safety issue Europe North America

  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. Global TB Drug Pipeline Discovery1 Preclinical Development Clinical Development Diarylquinoline DprE Inhibitors GyrB inhibitors InhAInhibitors LeuRSInhibitors MGyrX1 inhibitors Mycobacterial Gyrase Inhibitors Pyrazinamide Analogs Riminophenazines Ruthenium (II) complexes Spectinamides Translocase-1 Inhibitors BTZ043 TBA-354 CPZEN-45 DC-159a Q201 SQ609 SQ641 AZD5847 Bedaquiline (TMC-207) Linezolid Novel Regimens2 PA-824 Rifapentine SQ-109 Sutezolid(PNU-100480) Delamanid (OPC-67683) Gatifloxacin Moxifloxacin Rifapentine 4 Repurposed Drugs 6 New Drugs 3 New Classes Drugs currently in the regulatory review process www.newtbdrugs.org Updated: June 18, 2012

  8. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub/en/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 medication errors networks Links with SSFFC 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.

More Related