1 raquel gopal ema - de briyne n, gopal r, diesel g, et al. veterinary pharmacovigilance in europe:...
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An agency of the European Union
Veterinary pharmacovigilanceEuropean Union (EU) overview
Workshop – Farmacovigilanza veterinaria, Rome
Presented by Raquel Gopal on 16 November 2017Scientific Administrator, European Medicines Agency
Overview Veterinary pharmacovigilance
Adverse event
Scope
Adverse event reporting
How and where to report
Evaluation
Roles
European Medicines Agency
Veterinarians
Challenges
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome1
What is veterinary pharmacovigilance?
Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other veterinary medicine-related problem
monitoring adverse events (AEs)safe effectiveveterinary medicinal products (VMPs)
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome2Legal basis: Regulation (EC) 726/2004; Directive 2001/82/EC
Adverse event: definition
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome3
Adverse drug
reaction (ADR)
Lack of efficacy
Adverse event
Vaccine failure
Adverse effect
Treatment failure
Side effect
Adverse event: definition
• Unfavourable, unintended observation occurs after any use of VMP
• Whether or not considered to be product-related
• Off-label or recommended use
• Adverse reactions (ARs): serious or non-serious
• Lack of expected efficacy (LEE)
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome4
Adverse event: examples
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome5Photo from Animal and Plant Health Agency, UK
Injection site reaction Bovine neonatal pancytopenia
Adverse event: scope
Adverse reactions (serious/non serious)
Lack of expected efficacy
Adverse reactions in humans
Suspected transmission of infectious agent
Environmental problems
Investigations into validity of withdrawal periods
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome6
What if you observe an adverse event?
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Veterinarians are key! What can you do?
• If it’s an adverse event
• If it’s lack of effect
• If you’ve seen it before
• If you don’t want to see more…
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome8
Report it!Report it!Report it!Report it!
Where to report AEs
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome9
Pharmaceutical company
Ministero della Salute Centri regionali
European Medicines Agency(EVVet)
Reporting
Feedback
How to report (vets)
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome10
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http://www.salute.gov.it/FarmacoVigilanzaVetModule/FarmacoVigVetServlet
Scheda da inviare per posta, via fax o tramite mail a:
1) Ministero della Salute Direzione Generale della Sanità Animale e dei Farmaci veterinari Ufficio 4 – Medicinali veterinari Via Giorgio Ribotta, 5 - 00144 Roma 2) Centri Regionali di Farmacovigilanza di competenza N. fax: 06 59946949 N. tel.: 06 59946255 Casella di posta elettronica: [email protected]
RISERVATO Solo ad uso dell’ufficio
Numero di riferimento della segnalazione
IDENTIFICAZIONE NOME ED INDIRIZZO DEL MITTENTE NOME & INDIRIZZO DEL PAZIENTE e/o DETENTORE DELL’ANIMALE
Argomenti attinenti la sicurezza
negli animali negli esseri umani
Assenza di efficacia attesa Argomenti attinenti i tempi di attesa Problemi di impatto ambientale
Veterinario Farmacista Altro n° di telefono: n° di Fax :
PAZIENTE (I) Animale(i) Uomo (per l’uomo riempire solo l’età e il sesso sotto riportati)
Specie Razza Sesso: Status Età Peso Motivo del trattamento
Femminile Maschile
Sterilizzato/castrato In gravidanza
MEDICINALI VETERINARI SOMMINISTRATI PRIMA DELLA SOSPETTA REAZIONE AVVERSA
( se il numero di prodotti somministrati contemporaneamente eccede il numero di colonne della tabella disponibili, si prega di duplicare questa scheda)
Nome del medicinale veterinario somministrato
1 2 3
Forma farmaceutica e dosaggio (es.: compresse da 100 mg)
Numero di autorizzazione
all’immissione in commercio
Numero del lotto
Via/sito di somministrazione
Posologia / Frequenza
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How to report (marketing authorisation holders (MAHs)) (1)
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome
How to report (MAHs) (2)
• 15-days (‘expedited’) via EudraVigilance Veterinary (EVVet) database
serious AEs (EU) or serious unexpected AEs (non-EU)
all human adverse reactions
suspected transmission of any infectious agent via VMP
• All AEs at defined intervals via Periodic Safety Update Reports• non-serious• clinical studies• literature
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What happens next?
• Continuous surveillance of EVVet data and PSURs by regulators
• Ongoing evaluation of data at defined intervals
• If necessary take regulatory action:
• increase reporting frequency or targeted monitoring
• change product information
• new adverse reactions/warnings/contraindications
• post-authorisation safety study
• batch recall
• suspension of marketing authorisation
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Example: Velactis and recumbency in cattle (2016)
• Cabergoline: aid abrupt drying-off
• Authorised (Dec 15) marketed (March 16) DK, NL
• Adverse events: recumbency and death
• March - July 2016
• 12 Member States affected (N.B. mostly DK)
• Aetiology unknown, multi-factorial risk factors?
MA suspended and product recalled
14 EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome
Role of European Medicines Agency (EMA)
• Committee for Medicinal Products for Veterinary Use (CVMP)
• responsible for VMP authorisation/surveillance (CAPs) • arbitration/urgent PhV issues any VMP
• CVMP Pharmacovigilance Working Party (PhVWP-V)
• meets 6x per year• recommendations to CVMP and MSs for surveillance of VMPs• develops guidance for veterinary pharmacovigilance
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome15
Pharmacovigilance activities
• Vaccines against bluetongue disease (2008)
• Collection of reports from a mass vaccination campaign
• EMA Veterinary pharmacovigilance public bulletins
• EVVet• IT tools, training, implementation• Contains reports from EU and outside
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome16
Lack of efficacy
Adverse reaction(off-label)
Adverse reaction(recommended use)
Adverse event reporting is the foundation
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome17
Frequency of observing adverse events
Adverse events for CAPs reported to EVVet in 2016
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome18
n=17,859
Reasons for not reporting
• Unsure if reaction/lack of efficacy?
• Adverse reaction is not serious enough
• Adverse event everyone is aware of
• Resources: time/‘paper’ work
• Liability concerns
• Fear loss of available VMPs
• Lack of feedbackEU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome19
Initiatives
• Access to EVVet for veterinarians & MAHs
• Electronic reporting system
• Promoting pharmacovigilance awareness
• Publications: EMA public bulletin, news items
• Engaging with stakeholders
• PhVWP-V focus group: food production veterinarians
EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome20
Conclusions (1)
• Safe and effective VMPs
• Surveillance of AE reports
• adverse reactions (animals & humans)
• lack of efficacy
• Veterinarians are key!
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Conclusions (2)
• If it’s an adverse event..
• If it’s lack of effect..
• If you’ve seen it before..
• If you don’t want to see more..
We need your support to report adverse events
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Report it!
Any questions?
Further information
Follow us on @EMA_News
[email protected] or [email protected]
European Medicines Agency30 Churchill Place • Canary Wharf • London E14 5EU • United KingdomTelephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555Send a question via our website www.ema.europa.eu/contact
References (hyperlinks)• Adverse event EU reporting forms for veterinarians
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000176.jsp&mid=WC0b01ac058002ddcb
• EU veterinary pharmacovigilance guidance (EMA website) http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000190.jsp&mid=WC0b01ac058002d89c
• EudraVigilance Veterinary (EVVet)
http://eudravigilance.ema.europa.eu/veterinary/index.html
• Veterinary pharmacovigilance in Europe: a survey of veterinary practitioners
• De Briyne N, Gopal R, Diesel G, et al. Veterinary pharmacovigilance in Europe: a survey of veterinary practitioners. Veterinary Record Open 2017;4:e000224. doi:10.1136/ vetreco-2017-000224
• WikiVet
http://en.wikivet.net/Pharmacovigilance ; http://en.wikivet.net/Drug_Legislation; http://en.wikivet.net/Adverse_Drug_Reactions; http://en.wikivet.net/Vaccines#Vaccine_Failure
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