Läkemedelsverkets farmakovigilansdag
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1 PRAC : Pharmacovigilance Risk Assessment Committee Kommittén för säkerhetsövervakning & riskbedömning av läkemedel Farmakovigilansdagen maj 2017 Ulla Wändel Liminga, PhD Ämnesområdesansvarig farmakologi/toxikologi; PRAC delegat 1 Summary of presentation The PRAC Structure, responsibilities and tasks Transparency Five year of PRAC work some figures Recent referral procedures examples PRAC Workplan information som fanns tillgänglig vid presentationstillfället. 1
2 4 days meetings, 11 times / year The PRAC Chairperson: Vice Chair: June Raine (UK) Almath Spooner (Ireland) 1 Member/Member State (n=28) 1 Alternate/MS 1 Member fr Iceland, Norway 6 Independent experts nominated by EC Health care professional (EC & EP) Patient organisation (EC & EP) SE: Ulla Wändel Liminga Qun Ying Yue (alternate) Charlotte Backman (co ordinator) Nominated by EC European Commission; EP European Parlament PRAC responsibilities and tasks All aspects of safety and risk management Detection, assessment, minimisation, communication risk for adverse reactions, while taking therapeutic effect into account Union procedures (referral) related to safety (Art. 20, 31, 107) PSUR (Periodic Safety Update Report); EURD Signal assessment; Additional monitoring list Risk management plans Non interventional safety studies (PASS; design, report) Pharmacovigilance audit; PhV inspections Recommendation/advice on safety to CHMP, CMDh, EMA, European Commission e.g. renewals, selected Type II variations Functionalities of Eudravigilance, PSUR repository All centrally authorised products; selected issues for non centrally 4 authorised products information som fanns tillgänglig vid presentationstillfället. 2
3 PRAC transparency Publication of PRAC documents Agenda Highlights Minutes Questions to MAHs, time tables for referral procedures Referral assessment reports Monthly list of signals discussed etc; MAH to monitor Stake holders can submit information in some procedures Possibility for public hearings first one planned in valproate referral; autumn Five years of PRAC some figures 44 referrals from e.g. Combined oral contraceptives risk for VTE, ATE Diclofenac cardiovascular safety HES hydroxy ethyl starch serious risks in sepsis/critically ill patients Retinoids risks use in pregnancy, psychiatric events Valproate (twice) risks use in pregnancy Gadolinium contrast agents brain deposition Paracetamol modified release handling of overdose Gardasil POTS and CRPS Many PSURs, RMPs, renewals.in 2016 PSUSA : 796 (205 plenary) RMP : 550 (159 plenary) ~ 340 signals, 574 signal discussions (~12 / month) information som fanns tillgänglig vid presentationstillfället. 3
4 PRAC Workload Referral procedures started at PRAC by triggering party per article from July 2012 End 2016 Total 44 R/CoR SE : 3/ 8 UK: 9/7 DE: 6/6 NL 6/5 8 information som fanns tillgänglig vid presentationstillfället. 4
5 Signals at PRAC Ongoing within PSUSA/PSUR procedure 3% Ongoing within signal procedure 6% Referral evaluation 5% Update of RMP 1.8 % PASS 0.6% Routine PhV / monitor within PSUR 35% Update of PI 49% Recent referrals Tysabri (natalizumab) : PML and Risk management February 2016 Inhaled corticosteroids : no difference in risk for pneumonia between products March 2016 Fusafungine withdrawn due to serious allergic reactions & limited evidence of benefit Feb 2016 SGLT2 minimise the risk of diabetic ketoacidosis May 2016 toe amputations revised product information Feb 2017 Direct acting antivirals for hepatitis C Screen for hepatitis B to address risk for reactivation + further studies in relation to potential risk for early recurrence of hepatic cancer December 2016 Zydelig risk management of serious infections October 2016 Factor VIII plasma derived and recombinant products Inhibitor development updated product information May information som fanns tillgänglig vid presentationstillfället. 5
6 Valproate referral 2014 Intra uterine exposure to valproate associated with increased risk of developmental disorders in offspring; known risk of congenital anomalies confirmed. Valproate not be used in female children, women of childbearing potential & pregnant women unless alternative treatments ineffective or not tolerated in various epileptic seizure indications, manic episode in bipolar disorders, while contraindicated as prophylaxis of migraine attacks Further changes to product information Educational materials to better inform patients & healthcare professionals DHPC neurologists, psychiatrists, general practitioners, obstetricians/ gynaecologists, family planning centres, pharmacists, health visitors, midwife, school nurses Drug utilisation study 11 Valproate thereafter Drug utilisation surveys shown that knowledge about these risks not communicated Further actions taken by some NCAs (e.g. France, UK) DHPC sent again in SE 2016 New referral started 2017 How get messages across?? General question for all communication on safety of medicines. 12 information som fanns tillgänglig vid presentationstillfället. 6
7 Retinoids referral 2016/2017 EU review started in July 2016 following review of data on effectiveness of pregnancy prevention programmes (PPP) for oral isotretinoin Data raised concerns on how PPP followed in practice; and inconsistencies between products Same challenges how can messages get across?? 13 Paracetamol modified release 2016/2017 Review B/R of paracetamol modified & prolonged release tablets [MR]; immediate release [IR] not included in review Standard procedures for handling paracetamol overdose & poisoning designed for IR products Case reports & retrospective PK & clinical analysis* indicate that recommended risk assessment of suspected poisonings and standard treatment protocol with antidote N Acetylcysteine, insufficient to manage overdoses with Alvedon 665 mg MR exposure profile following overdose and subsequent clinical course unpredictable absorption prolonged, maximal plasma concentrations observed later than expected from overdoses IR paracetamol Cases of overdose with Alvedon 665 mg modified release tablets causing hepatic injuries, despite timely treatment, have been identified Review is ongoing. BE PRAC Rapp, SE PRAC CoRapp. * Salmonson H, et al. Clin Toxicol 2016;54:424 (Abstract 124) 14 information som fanns tillgänglig vid presentationstillfället. 7
8 Gadolinium contrast agents for MRI (GdCA) Mar 2016 : Start of referral on Gd contrast agents for MRI to review risk of Gd deposition in brain tissue Mars 2017 : PRAC recommends regulatory actions: Suspension of four linear Gd contrast agents Primovist(for hepatic MRI) remains with SmPC updates Product information for other (macrocyclic agents) to be updated April 2017: Some MAHs have requested a re examination Re examination started in May; expected to conclude in July 2017 SE (UWL) PRAC rapp; DE PRAC CoR 15 Gd: Summary grounds for PRAC recommendation Mar 2017 Data (stability, in vitro, non clinical) suggest more Gd released from linear than macrocyclic agents Gdmeasured in brain indirectly and directly. Non clinical data show linear agents persist up to one year / longer. Macrocyclic transient No adverse neurological effects demonstrated; long term safety data limited Harmful effects plausible (dechelation and known toxicity of unchelated Gd). Linear GdCAs associated with risk of NSF, Gd associated skin plaque Studies to fully address serious concerns not feasible Risk minimisation measures not effective B/R negative for gadobenic acid, gadodiamide, gadopentetic acid, and gadoversetamide B/R positive for Primovist (gadoxetic acid) due to substantial hepatic uptake, low dose, clinical utility for some imaging Magnevist (gadopentetic acid) for intra articular injection All macrocyclic GdCAs with SmPC changes 16 information som fanns tillgänglig vid presentationstillfället. 8
9 PRAC Work plan activities 17 PRAC Work plan 2017 MPA involved in Expert input to GVP P.III on pregnancy release public consultation Optimise RMP GVP V on Risk management systems Task force patients registries Various activities on signal detection incl Develop strategic approach on signal validation activities by industry Impact f PhV Regulatory science (pharmacogenomics) 2.5 Process improvements Content & process of PSURs/PSUSA; Initiate revision of GVP VII on PSUR Better guidance for assessors to facilitate publication of PSUR AR Support GPAG (reviews EURD list on dates for PSUR submission) Implement & operate new format of GVP V on RMP Review quarterly workload & performance measures Support established PRAC WG on efficiency & effectiveness plenary meetings Expert advice on optimal role of PRAC for safety related variations 18 information som fanns tillgänglig vid presentationstillfället. 9
10 PRAC Work plan 2017 examples 19 PRAC Work plan 2017 examples 20 information som fanns tillgänglig vid presentationstillfället. 10
11 PRAC Work plan 2017 examples 21 PRAC Work plan 2017 examples 22 information som fanns tillgänglig vid presentationstillfället. 11
12 Wrap up and? Variety of issues handled by PRAC Risk management and risk communication Impact of pharmacovigilance Work load and capacity Brexit 23 information som fanns tillgänglig vid presentationstillfället. 12
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