Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines

WHO Programme for International Drug Monitoring WHO HQ + 6 Regional offices WHO Collaborating Centre, Uppsala National Centres

Pharmacovigilance in WHO HQ Exchange of Information Policies, guidelines, normative activities Country support Collaborations Resource mobilisation

World Health Organization 21 September 2018 WHO Programme October 2008 At the moment there are 86 full member countries and 30 associate member countries. To become an associate member country, the government of a country needs to send an official application to the WHO HQ in Geneva. To become a full member the country also needs to send at least 20 ADR reports in a correct format. Few member countries in Africa. X became a member in CCYY.

World Health Organization Functions 21 September 2018 Receive and manage ADR data Develop tools; innovate Analyse: Signal detection :Identification of previously unknown drug reactions Communicate Support countries: train; search; technical assistance

What have we achieved in 40 years 118 National PV centres (89 full members +29 Associate members) Global ADR database: over 4 million reports In 2006: 37 Signals generated from database Some public health programs incorporating PV Gaining donor support

Juggling some questions….

Why is PV NOT getting the attention it deserves About 40 years later: less than 100 'full' members 4 million+ reports But from where? Most reports from developed countries. Why is PV still a non event globally?

2007 Thalidomide was the reason for the programme …..in the 60s Primary reason remains!!

World Health Organization 21 September 2018 125 Patients 24 Patients experienced ADRs (19%) Intro 2 (59%) were avoidable

Why do preventable errors occur

Where is the denominator? 4 million+ reports So What? Where is the denominator?

XX number of countries trained So What? Why don’t they report?

Can we use our database more effectively? What more can we do? Can we use our database more effectively?

Some ideas………

Consider traditional trends Adverse drug reaction Adverse drug event Medicine safety Medicine toxicity Benefit /harm profile of a medicine Product emphatic Where is the patient?

Need to humanize what we do Let's give pharmacovigilance a 'face' Let's talk about patient safety, not just medicine safety Ask the right question Instead of asking 'Is the medicine safe' Need to ask: Is the patient safe taking this medicine?

PV is about me !! Am I SAFE with this medicine?

Can we become more patient centred ? Yes, we can!!

Reports of medication errors in WHO ICSR database in 2005

Pharmacovigilance system Records medication related errors Analyses those errors Implements interventions Promotes patient safety Prevent 'preventable errors' Actionable learning system

WHO Patient Safety- Pharmacovigilance alliance Collaborative project for the development of pharmacovigilance centres for patient safety Building on medication related expertise of the WHO-PV programme Reporting and learning through Root Cause Analysis systems Improve patient safety Partners: WHO-PV, WAPS, UMC, Moroccan centre for poison control and pharmacovigilance

Safety of medicines in WHO HQ

Low presence of some countries in the programme Capacity building : multi regional, multilingual trainings, regional centres of excellence in PV Local evidence for the need for pharmacovigilance What gets measured, gets done (DG, WHO) Indicators for PV

Post-training: improving reporting The know–do gap: understanding it Reporting tools expensive Vigiflow : free when used only as a reporting tool Also discuss 'incentives' CME points Feedback Access to Information

Lack of denominator / exposure data Active surveillance to complement Cohort Event Monitoring Malaria, HIV Pregnancy registers To complement and NOT replace spontaneous reporting

What more with the database EML Dependence liability Counterfeit detection Support RUD programme with evidence

Optimising 'Donor' interest BMGF: HIV/AIDS proposal Malaria pregnancy registry Developing a global strategy EC: EC/ACP/WHO Partnership on Pharmaceutical Policies now in its 5th year Working with African countries to ensure a quality pharmaceutical response to malaria entering its second year Optimizing drug safety monitoring to enhance patient safety and achieve better health outcomes

What does the future look like Maintain as the cheapest, easiest, most sustainable method As before (global spontaneous reporting, training) Better than before (Active surveillance studies in some countries, multilingual, sentinel sites) As never before (ISMN, WAPS, EML, RUD, Indicators, capital) Cohort event monitoring Network, support, measure, fundraise

Major planned activities for 2009 Development of a global strategy for pharmacovigilance to increase awareness PV landscape assessment for ascertaining state of the art Expansion of the programme with a focus on China and India More Francophone countries supported in PV Cohort event monitoring method developed, piloted in 2 African countries (in malaria) Indicators for PV Expansion and development of database Pilot project on medication errors strengthened / expanded to other centres Strengthening PV in HIV/AIDS PV capacity in countries supported

Pharmacovigilance is about me !! Thank you Thank you