Pharmacovigilance. Maia Uusküla

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1 Pharmacovigilance Maia Uusküla

2 PhV activities - Local ADR reports (collection, assessment) - Encouragement of HCPs to report ADRs - Increase knowledge about ADRs - benefit-risk assessment -Assessment of PSURs, risk managements plans, signal management (detection, assessment, communication) - PhV inspections (in EU as supervisory authority, local affiliates)

3 ADR reports from Estonia HCPs, patients MAH

4 Number of adverse drug reaction reports Estonian Database Number of reports I HY

5 Database Simple Excel database (around 1000 reports) - Local statistics, duplicate detection - In Estonian language - Transmission of cases to EMA database, WHO database translation into English

6 Education of doctors Lectures Suspect and recognise ADRs How to report Web-based form and guidance on our webpage

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11 MAH Risk-benefit assessment ADR (ICSR) PSUR Signal detection

12 Estonia Population 1,3 million State Agency of Medicines 77 Pharmacovigilance staff 3 Small country same responsibilities in EU

13 Human resour ourses Estonia Agency (total) 77 PhV staff 3 Products 5740 human medicines 1637 nationally authorized 890 MRP 1419 DC 1794 CAP 1193 different active ingredients Estonia RMS 140 MRP and DC product Estonia Rapporteur/Co-Rapp 14 CAP products 36 different active ingredients

14 EU work sharing Decreased workload, more effective work Harmonised information in the product information across EU Complex approach to benefit-risk assessment

15 EU work sharing PSURs 1 active ingredient = 1 Reference Member State assessor (P-RMS) - Assessment is done by P-RMS, other member states comment/accept active ingredients covered by WS - Centrally auth. products PRAC Rapporteur

16 EU PSUR Work Sharing UK FR NL SE DK DE IE IT CZ AT ES HU FI NO BE EE PT SK LV PL SI LT GR MT BG CY IS LI LU RO

17 Estonia P-RMS rabbit anti-t IgG ciclosporin lacidipine celiprolol nortriptylline clonazepam cefuroxime axetile cefuroxime sodium amikacin sultamicillin testosterone

18 PSUR PSUR - Periodic safety update report a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product submitted by marketing authorisation holders at defined time points during the post-authorisation phase. assessed by regulatory authority

19 EU work sharing - PSURs Assessment - whether there are new risks/risks have changed/changes to the risk-benefit balance of medicinal products Core Safety Profile (CSP) SPC sections (4.2) harmonised safety information in SPCs all over EU After finalisation MAH has to submit variation in Member States where SPC differs from CSP

20 Exchange of information Assessment reports and comments Eudramail created by EMA Repository - EPITT European Pharmacovigilance Tracking Tool PSURs assessment reports, signals, issues discussed at Pharmacovigilance Risk Assessment Committee (PRAC)

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26 More information about PSUR WS Heads of Medicines Agencies website PSUR Work Sharing List PSUR Synchronisation EURD list - EMA website

27 Signal management EU Work sharing Estonia 11 active ingredients (same as in PSUR WS)

28 Signal management set of activities performed to determine - whether there are new risks associated with an active substance or a medicinal product or - whether known risks have changed. based on an examination of - individual case safety reports (ICSRs), - aggregated data from studies, - literature information or - other data sources

29 Signal management - initial signal detection, - validation/confirmation, - analysis and prioritisation, - assessment, action MS PRAC (all MSs) EMA CHMP/CMD

30 Signal detection in EVDAS Statistical tool - Signal of Disproportionate Reporting (SDR) - statistical associations between medicinal products and adverse events i.e. drug-event pairs. - The proportional reporting ratio (PRR) - a measure of disproportionality of reporting is used to detect SDRs When a SDR is identified for a medicinal product, this adverse event is reported relatively more frequently in association with this medicinal product than with other medicinal products.

31 Signal detection in EVDAS The following criteria are applied in the queries of the EVDAS: The lower bound of the 95% confidence interval greater or equal to 1 The number of individual cases greater or equal to 3 Statistical association does not imply any kind of causal relationship Always investigate, taking into account the clinical context

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35 More information about PhV legislation Good Pharmacovigilance Practice (GVP) modules European Commission website

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37 Conclusion Small countries/ small authorities - Set up your priorities - Rely on others as much as possible - Take part in work sharing, but only after careful consideration of how much you can do - At national level -communicate risks -educate HCPs (suspect, recognise, report ADRs)