PHARMACOVIGILANCE METRICS

Transcription

1 PHARMACOVIGILANCE METRICS Andy Stergachis, PhD, RPh Professor of Epidemiology and Global Health Director, Global Medicines Program University of Washington, Seattle, WA

2 MEASURING PERFORMANCE AND OUTCOMES OF PHARMACOVIGILANCE SYSTEMS

3 CONTENTS Why metrics? What are the available metrics? Sub Sahara Africa study experiences using the Indicator based Pharmacovigilance Assessment Tool (IPAT) Introduce framework for return on investment from strengthening pharmacovigilance systems

4 WHY METRICS? Lead to better decisions and better spending Tracks progress and performance Evaluates impact Improves accountability Can t manage what you don t measure IHICI

5 ACTIONS OF THE NATIONAL REGULATORY AUTHORITIES IN DEVELOPING COUNTRIES FOLLOWING US FDA AND EMA SAFETY ALERTS ON ROSIGLITAZONE (ICIUM 2012) Country Action Communicated Date Lag time (DAYS) Suspension of market authorization Enforcement of risk management practices Ghana Yes Safety alert Nov. 29, Kenya Yes Safety alert (e shot) Oct. 13, Namibia Yes Safety alert Nov 10, Nigeria Yes Safety alert and press release Oct. 9, Tanzania Yes Not available Nov. 5, Uganda Yes Not available Not available N/A Senegal Yes Safety alert Oct. 12, South Africa Yes Safety alert July 5,

6 DESIRED ATTRIBUTES OF METRICS Relevance Scientific Soundness Feasibility Comparability Risk based (?) Process: Evidence based, transparent, collaborative

7 METRICS FOR MONITORING & EVALUATION

8 AVAILABLE METRICS FOR PV Minimum Requirements for a Functional Pharmacovigilance System. The Global Fund and the WHO Indicator Based PV Assessment Tool (IPAT) Proposed Set of Indicators for Monitoring and Evaluation of Pharmacovigilance Activities (ICIUM 2011 Presentation) Miscellaneous Others pdf.usaid.gov/pdf_docs/pnads167.pdf

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10 MONITORING AND EVALUATION FRAMEWORK COMPREHENSIVE HIV AND AIDS CARE, MANAGEMENT AND TREATMENT PLAN FOR SOUTH AFRICA

11 INDICATOR-BASED PV ASSESSMENT TOOL (IPAT) IPAT has 43 indicators 25 core and 18 supplementary Five pharmacovigilance and medicine safety system components: policy, law, and regulation systems, structures, and stakeholder coordination signal generation/data management risk assessment and evaluation risk management and communication. Classified by structural, process, or outcome Modular; different segments of the health system can pull out indicators relevant to them to monitor different medicine safety issues IPAT used in more than 20 assessments of country PV systems

12 USE OF IPAT IN THE STUDY, SAFETY OF MEDICINES IN SUB-SAHARAN AFRICA Countries were classified into 4 groups depending on the current PV capacity. For example, group 4 countries present basic structures both passive and active surveillance activities the capacity to evaluate the risks outcomes of PV activities used for regulatory actions and communications with stakeholders. Result from SSA study should serve as a baseline Need to monitor countries performance over time

13 A FRAMEWORK FOR M & E: LOGIC MODEL Outcomes Inputs Processes Outputs Short term Long term Impacts DRAFT 13

14 CHALLENGES Defining evidence based metrics Producing data of sufficient quality to permit the regular tracking of progress and for evaluation Need for harmonized approaches Consensus on analytical and strategic frameworks among stakeholders

15 MODEL AND METHODS UNDER DEVELOPMENT We are developing a decision analytic return on investment (ROI) model The model compares the four PV classification groups in the report The investment represents an itemized costing of resources needed to set up & maintain different levels of PV activity The returns represent reductions in ADRrelated out patient visits and hospitalizations, reduction in mortality, and reduction in ADR related regimen switches

16 CONCLUSIONS Metrics are needed to assess PV systems performance and improvements Framework should address monitoring and evaluation needs of different users and multiple purposes, including: Monitoring of PV program inputs, processes and results PV systems investments Evaluating outcomes and impact