Pharmaco Vigilance Experience with development of PV systems

Pharmaco. Vigilance: Experience with development of PV systems and processes. Government perspective VICH Outreach Forum Auckland NZ, 2013 Anja Holm, EU

Different levels of PV systems Estimate the need and expectation depending on Existing PV system or starting new Financial and personel resources Size of country or region Husbandry production and medicinal use Cooperation with other authorities Legislation Pharmacovigilance, government perspective

Developing the PV system First, legislation for PV framework Plan PV-system in agency: responsibility, level of ambition, cooperation in region, practical work, … Make companies aware of their obligations Reporting form available on website, paper, by telephone, on conferences, … Spread the PV-understanding to vets/users/owners Filing system for reports: Paper small electronic system database Be VERY alert on tools for analysing data in the database. Aim for simple database with international compatibility Start analysing across substances, products, species, . . . Pharmacovigilance, government perspective

PV requirements in legislation Definitions of adverse reactions, surveillance, timelines ~ (VICH GLs) Obligation for companies to Possibility for authorities to ◦ receive PV-reports from vets/users, ◦ analyse the PV-reports and survey their products generally ◦ inform authorities. ◦ inspect or control that companies comply, ◦ analyse data from PV or other sources ◦ take necessary actions based on PV. Possibility for vets/users to report to authorities directly Pharmacovigilance, government perspective

Plan PV-system in agency Define PV-responsibility Realistic ambitions Aim for large regional cooperation, because ◦ large-scale PV-data are more useful and ◦ work-sharing between authorities is beneficial Company: main workload, responsibility, surveillance Agency : Control and corrective actions Pharmacovigilance, government perspective

Competent authority responsibility in EU 6 • Establish a PV system: • • collect information • evaluate scientifically • collate with data on use • monitoring compliance of companies • inspections • take action Initiate assessment of safety concerns • Implement conditions and restrictions • Encourage reporting Pharmacovigilance, government perspective

Spread the PV-understanding Encourage reporting: Receipt letter to vets, owners, (and MAHs). Personal response to a few reporters if additional information is needed. Annual PV-report in Vet magazine. PV-presentation for all graduating vets. Education: module on PV in vet university Ad-hoc presentations at vet conferences and Industry association meetings Reporting form easily available Pharmacovigilance, government perspective

Filing system for reports From paper small electronic system database Simple (vet-specific) database with international compatibility Benefit of smaller countries Tools for analysing data in the database! Hurdles for large regional/international database: �IT-compatibility for existing national databases �Product database (same product with different names must be ”linked”) �Who is responsible for analysing data �”Access to data”-agreements Pharmacovigilance, government perspective

EU experience Pharmacovigilance system based on Spontaneous reports PSURs – Periodic Safety Update Reports Signal detection Follow-up and changes to product information PV inspections Information to vets about safe use of products: ◦ what PV is really about! Pharmacovigilance, government perspective

EU-Pharmacovigilance scope Animal safety • serious and non-serious adverse reactions Lack of expected efficacy Off-label use / misuse Humans reacting after exposure Violations of residue levels Potential environmental problems Pharmacovigilance, government perspective

Practical approach in national agency: spontaneous reports Immediately after report is received: ◦ case-number and letter of receipt ◦ causality assessment by Agency-vet ◦ decision on action or request more information, etc ◦ PV-report forwarded --> Company NB: Protection of personal data of reporter/owner ◦ Filing in national and/or in EMAs database Pharmacovigilance, government perspective

Practical approach in national agency: PSURs Periodic safety update reports (PSURs): ◦ time-schedule or on request ◦ includes all reports and other information since last PSUR and ◦ a benefit-risk evaluation for the product ◦ Received and assessed for national products ◦ Workshare for EU-products Agreement on fixed data lock-points per substance ◦ Letter to MAH: OK, or occasionally changes in SPC or further investigation requested. Pharmacovigilance, government perspective

PRODUCTS DATABASE DATA WAREHOUSE CENTRAL DATABASE EVWEB Pharmacovigilance, government perspective GATEWAY

Minimal requirements of an AE report Ø Identifiable reporter Ø Animal (species) Ø Suspected product Ø Adverse event ØHowever, 14 many more details are desired and possible to fill in to the database/reporting form Pharmacovigilance, government perspective

Pharmacovigilance, government perspective

Pharmacovigilance, government perspective

20% 2. 5% 2. 3% 0. 4% 4% 1. 6% 46% 14% 17 0. 07% Pharmacovigilance, government perspective 17

18 Eudra. Vigilance Veterinary – Status Update Pharmacovigilance, government perspective 18

19 Eudra. Vigilance Veterinary – Status Update Pharmacovigilance, government perspective 19

Other PV information exchange Ø Rapid Alert (EUDRANET) Ø Non-Urgent Information System 20 Pharmacovigilance, government perspective 20

Reference documents • Regulation (EC) No 726/2004 (Title III Chapter 3) and • Directive 2011/82/EC (Title VII) • • 21 Volume 9 (b) – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. Guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal products Pharmacovigilance, government perspective

Goal of PV from government perspective ◦ Systematic surveillance of all products ◦ Ensure safe and effective products on the market ◦ Fast and proportional action towards triggered signals ◦ Active crisis management with good and open communication. Thank you for your attention! Pharmacovigilance, government perspective