Safety and Vigilance (SAV)

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Presentation transcript:

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

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

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

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'.

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

Key SAV Priorities in 2014 - 2018 WHO Advisory Committees: Safety of Medicinal Products (ACSoMP), Global Advisory Committee on Vaccine Safety GACVS (GACVS)

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

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

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

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.

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

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.

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

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

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

www. who. int/medicines/areas/quality_safety/safety_efficacy/en/index www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.html email: pvsupport@who.int