Digitale uitdagingen in de toekomst
Pharmacovigilantie/Geneesmiddelenbewaking wat is er (humaan) en wat zou kunnen CBG Collegedag 3 juni 2015 / WorkshopVET2
Baukje Schat / Anja van Haren (CBG)
Disclaimer
• The information contained in these slides is for general purposes only and presents the state of knowledge at June 2015 • No rights can be derived from this information • The Medicines Evaluation Board accepts no liability for direct or consequential damage resulting from the use of, reliance on or action taken on the basis of this information provided during this session
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HUMAAN
1. Introduction 2. Signal Management 3. Product database 4. Closure
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Implementation new PV legislation (human)
New pharmacovigilance legislation (human) entered into force in July 2012 Stepwise implementation Criteria for prioritisation: 1. public health activities 2. transparency and communication activities 3. simplification activities (many IT)
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ICT related changes (human)
PSUR Repository
Database of Medicinal Products (Article 57)
EudraVigilance
Pharmacovigilance Information system
Medical Literature Monitoring
Signal Management
Pharmacovigilance Fees
Status mid 2015: many systems still under development
Until now: pragmatic use of existing systems 5
1. Introduction 2. Signal Management 3. Product database 4. Closure
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Signal Management Vet proposal
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Signal Management Vet vs Human
Article 107h 1. Regarding medicinal products authorised in accordance with this Directive, national competent authorities in collaboration with the Agency, shall take the following measures: … (c) monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the riskbenefit balance. 8
Signal Management Vet vs Human
Signal Management not based on ‘groups’ of products but on substances Also applies the ‘worksharing’ principle: • EMA responsible for substances in centrally authorised procedures • Lead Member States have been appointed for ≈ 1000 substances (for ≈ 1700 substances still no Lead Member State yet) But: - Member States still responsible for monitoring data from their own territory - Industry also responsible for monitoring data in EudraVigilance (in addition to their own PV database) 9
Signal Management Human
EMA provides Lead Member States with monthly outputs from Eudravigilance for each substance: ‘Electronic Reaction Monitoring Reports’
Major workload for Lead Member States ongoing discussions on usability of this tool, tresholds used to detect signals, amending frequency, … From 2017 Marketing Authorisation Holders will also receive these outputs for their own substances and have to inform authorities of new signals 10
1. Introduction 2. Signal Management 3. Product database 4. Closure
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Product database
Art 57(2): EMA to create a list of all medicinal products authorized in the EU regardless of licensing procedure 12
Product database Vet proposal
Similar: also obligation on EMA to publish an electronic format that industry should use for submitting data
But: also refers to future use of
ISO IDMP (IDentification Med. Products…≠ op verpakking!) standards by all stakeholders
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Stepwise implementation
Phase 1 Notification of electronic submission format (July 2011, revised March 2012)
Phase 2
Electronic submission & data processing
Phase 3 Initiation of quality review and maintenance of Art 57(2) data
Phase 4 Update in compliance with ISO IDMP* standards
By 2 July 2012
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*ISO Standards for the Identification of Medicinal Products
1. Introduction 2. Signal Management 3. Product database 4. Closure
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Closure HUMAN Simplification as a goal of the human PV legislation has not fully been achieved yet (budget and technology limitations)
ICT-changes essential for efficient compliance with pharmacovigilance obligations Potential duplication of efforts for Signal Management Unclear responsibilities Hum Art 57: ‘list’ vs ‘database’, MAH vs NCA responsibilities. ONGOING activities (HUGE WORKLOAD!) to move to ISO IDMP standards.
3 years after human PV legislation entered into force there are still many challenges. 16
Uitdagingen-1- VET TIPs en UITDAGINGEN nav wetgeving en uitvoering humaan: - Wees duidelijk wie wat gaat doen, wat doet MAH, NCA en EMA?, met name gezien de product database: moet er “goed” inzitten. - Geen dubbel werk: PSURs of Signal Detection, niet beide! - Geen dubbel werk: wat doet NCA/EMA en wat MAH! - Let op frequentie van signal detectie doen! - Let op beoordelen signals, wie bepaald wat en wat leidt tot een verandering in risk/benefit? >>signal management optmaliseren! - Inventariseer wat wat oplevert, is het
Nice to Know or Need to Know. 17
Uitdagingen-2- VET Wat kan / zou mogelijk zijn?: - Identificatie verpakkingen>>via PraktijkManagmentSysteem invoer evt bijwerkingen naar EU farvigVet Database (EVVET)? - On line sales data naar database?>> incidentieberekening
- Dierhouders tevens toegang/ invoer evt bijwerkingen in EVVET? - Signaal Detectie (SD) door MAH, check door NCA/EMA? - PSURs nu niet meer genoemd in draft Verordening Diergeneesmiddelen: MAH ahv Signal Detection risk benefit analyse doen, product-breed of substance-breed?
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Uitdagingen-3- VET Wat kan / zou mogelijk zijn?
- Signal detectie op groepen substances bv monitoring resistentie-ontwikkeling en/of verminderde effectiviteit
(adhv
resultaat guidelines updaten)
- Continue-online Signal Detection mogelijk in de toekomst: voorwaarde serious en non serious “direct” in EVVET - VOORWAARDE: ICT-veranderingen en
ondersteuning
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Thank you for your attention
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Stellingen 1. Melden van evt bijwerking wordt eenvoudiger voor IEDEREEN door een centrale database!
2. De administratieve last voor de dierenarts neemt met de nieuwe verordening af. 3. De administratieve last voor de MAH neemt met de nieuwe verordening af. 4. Eén centraal Europees monitoringssysteem is de oplossing! 5. De industrie onder toezicht van de overheid beheert het centrale monitoringssysteem is een goed plan!!
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Tot SLOT Pas op voor de
Paarse krokodil!!
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Tot SLOT
Daarom
WHY
WHY
WHY (3x!)
(Ricardo Semler- The Seven-Day Weekend) 23
Abbreviations • • • • • • • • • • • • • • • • • • •
ADR = Adverse Drug Reaction EMA = European Medicines Agency EV = EudraVigilance GVP = Good Vigilance Practice HL7 = Health Level 7 ICSR = Individual Case Safety Report IDMP = Identification of Medicinal Products ISO = International Organization for Standardization MA = Marketing Authorisation MAH = Marketing Authorisation Holder MS = Member State NCA = National Competent Authority PASS = Post Authorisation Safety Study PBRER = Periodic Benefit Risk Evaluation Report PRAC = Pharmacovigilance Risk Assessment Committee PSUR = Periodic Safety Update Report RMP = Risk Management Plan XEVMPD = Extended EudraVigilance Medicinal Product Dictionary XEVPRM = Extended EudraVigilance Product Report Message 24
