1 Raquel Gopal EMA - De Briyne N, Gopal R, Diesel G, et al. Veterinary pharmacovigilance in Europe:...

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

Adverse event reporting

How and where to report

Evaluation

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

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)

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

What if you observe an adverse event?

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…

Report it!Report it!Report it!Report it!

Where to report AEs

Pharmaceutical company

Ministero della Salute Centri regionali

European Medicines Agency(EVVet)

Reporting

Feedback

How to report (vets)

15 2010

25 18 12

203040

506070

Category 1 Category 2 Category 3 Category 4 Category 5 Category 6

X-axis title

Chart title

Series 1 Series 2 Series 3

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: farmacovigilanzavet@sanita.it

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

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

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

12 EU Veterinary Pharmacovigilance Overview: Workshop – Farmacovigilanza veterinaria, Rome

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

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

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

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

Lack of efficacy

Adverse reaction(off-label)

Adverse reaction(recommended use)

Adverse event reporting is the foundation

Frequency of observing adverse events

Adverse events for CAPs reported to EVVet in 2016

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

Conclusions (1)

• Safe and effective VMPs

• Surveillance of AE reports

• adverse reactions (animals & humans)

• lack of efficacy

• Veterinarians are key!

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

Report it!

Any questions?

Further information

Follow us on @EMA_News

raquel.gopal@ema.europa.eu or VetPhV@ema.europa.eu

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

1 Raquel Gopal EMA - De Briyne N, Gopal R, Diesel G, et al. Veterinary pharmacovigilance in Europe:...

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