veterinary pharmacovigilance in spain ......rome - november 2017 spanish medicines and medical...

ROME - November 2017

SPANISH MEDICINES AND MEDICAL DEVICES AGENCY

VETERINARY

PHARMACOVIGILANCE IN SPAIN:

EVOLUTION AND FUTURE

CHALLENGES

Ramiro Casimiro Elena

Technical Adviser 1



INDEX

• AEMPS: STRUCTURE AND FUNCTIONS.

• STARTING POINT OF VETERINARY PHARMACOVIGILANCE (VPH) IN SPAIN.

• MAJOR ACHIEVEMENTS.

• DATA EVOLUTION IN THESE YEARS.

• FUTURE CHALLENGES.



AEMPS:

STRUCTURE AND FUNTIONS



AEMPS is a national Agency responsable for guaranteen the quality, safety, efficacy and correct information of medicines (human and veterinary) and medical devices from their investigation to their use, in the interest of the protection and promotion of health of people and animals.

4



Veterinary medicinal products

Human medicines

Medical devices

Cosmetics & higyenic products

Inspection & Control

5

SCOPE OF ACTIVITIES



Structure of the AEMPS

6



Jefe de Unidad

JEFE DE DEPARTAMENTO

SECRETARIAS

SECRETARÍAS DE LOS COMITÉS

GESTIÓN DE CALIDAD

CONSEJERO TÉCNICO COMITÉ DE MEDICAMENTOS

VETERINARIOS (CODEMVET)

COMITÉ de SEGURIDAD

GRUPOS de TRABAJO

GESTIÓN Y

PROCEDIMIENTOS

Jefe de Unidad

Personal técnico-

administrativo

FARMACOVIGILANCIA,

DEFECTOS de CALIDAD

Y

COMERCIO EXTERIOR

Jefe de Unidad

Evaluadores

CALIDAD

Jefe de Unidad

Evaluadores

BIOLÓGICOS

Jefe de Unidad

Evaluadores

DESCENTRALIZADOS

y

RECONOCIMIENTO MUTUO

CENTRALIZADO, PRAN

Y

EFICACIA

Jefe de Unidad Jefe de Unidad

Evaluadores

COMITÉ TÉCNICO DEL SEF-VET

COMITÉ de DISPONIBILIDAD

Evaluadores

SEGURIDAD

Jefe de Unidad

Evaluadores

7

VETERINARY MEDICINES DEPARTMENT (DMV)



8

Personal of the DMV

• 95 people

• 31 permanent staff.

• 64 temporal staff.

• Support from horizontal Services (IT, Lawyers,

Economical-Financial unit, etc.).



9

Technical commitees

Veterinary medicines committee (CODEMVET) – Evaluation of VMP.

Safety committee (CSMV) – Pharmacovigilance (PSURs).

Veterinary Pharmacovigilance Technical committee – 17 (+ 2) CCAA.

Availability committee – Identify therapeutic gaps and try to help to

resolve technical problems.

• External experts (Universities, Research centres, etc.).

• Opinions are compulsory but not binding, except for Public or Animal health.

• Guarantee a better drgree of objectivity and give the technical and cientific support.



10

External Experts

• Universities and other scientific centers.

• Declaration of Conflict of Interests.

• 63 are designated as EMA´s experts.

• Training courses and regular meetings.



Veterindustria, ADIPREM , CESFAC, Homeopáticos

Ministry of Health

EMA

Ministry of Agriculture

Ministry of Industry

European Commission

Organizations

Health Professionals

Citizens

Sociedades

Health / Agriculture units of the Autonomous Communities

(regional administration)

Ministry of Economy Experts

Our environment (stakeholders)

National Agencies network

11



SARTING POINT OF

VETERINARY

PHARMACOVIGILANCE

IN SPAIN



13

Starting point of Vet. Pharmacov. in Spain

AEMPS was created in May 1999. Healthcare professionals had no tradition to notify

Suspected Adverse Events (SAEs) to AEMPS and not so much to Marketing Authorisation Holders (MAHs).

MAHs rarely notify AEs nor Periodic Safety Update

Reports (PSURs) to AEMPS. Consequently, very few SAEs and PSURs were

received in AEMPS.



14


Limited legislation on Veterinary Pharmacovigilance

(VPH).

Scarce resources working on VPH.

No VPH national database.

No committees specialized in VPH.



15


Some healthcare professionals are reluctant to

communicate SAEs. They think that their daily

work will be examine by AEMPS.

Little information of the Benefit / Risk balance of the

veterinary medicines in real conditions of use.

Obligation to implement european legislation on VPH

Necessity to create a real national system.



16


Healthcare professionals considerer that not

real impact of VPH in their daily work.

Some MAHs are reluctant to notify SAEs and/or

PSURs because think that a regulatory action

will be adopted.

Some farmers/owners thought that VPH is a tool

designed to compensate for damages. They do not

think about to improved the knowledge of veterinary

medicinal products.



MAJOR

ACHIEVEMENTS



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Major Achievements

A team for VPH issues was created. Currently, 8

veterinarians and pharmacits and 2 administrative

people work full or part time in VPH scientific and

administrative aspects.

Great efforts had been made on:

• Obtaining resources, selecting and training

people.

• Growing the group and improving the expertise

available.



19

Major Achievements

Promotion of VPH to vets and other professionals:

• Lectures at Universities, Veterinary Colleges, etc. • Courses at Autonomous Communities (regional

administration). • Articles in professional publications. • Leaflets.



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Major Achievements

• Adoption of a simple forms for notification of AEs for healthcare professionals (Green card).

FECHA DE LA

SUPUESTA REACCIÓN

ADVERSA

/ /

Tiempo transcurrido entre la

administración del medicamento y

la reacción en minutos, horas o días

Nº animales tratados

Nº animales con signos

Nº animales muertos

Duración de la reacción adversa

en minutos, horas o días

DESCRIPCIÓN DE LA REACCIÓN (Problemas de Seguridad en animales o en personas / Presunta Falta de la Eficacia esperada /

Problemas con el Tiempo de Espera / Problemas Medioambientales) – Por favor, descríbalos:

Indicar también si la reacción ha sido tratada. ¿Cómo y con qué y cuál fue el resultado?

OTRA INFORMACIÓN RELEVANTE (adjuntar la documentación oportuna, pe. Estudios realizados o en marcha, Informes

médicos, informes de necropsias).

REACCIONES EN PERSONAS

Si el caso se refiere a personas, por favor complete los datos que figuran más abajo.

Contacto con el animal tratado

Ingestión oral

Exposición tópica

Exposición ocular

Exposición por inyección dedo mano articulación otro

Otro (deliberado ….)

Dosis recibida:

Si no desea que su nombre y dirección se envíe al Laboratorio para recabar más información, por favor indíquelo en este cuadro

Fecha: Lugar: Nombre y firma del notificador:

Punto de contacto ( teléfono) (si difiere del número indicado en la primera página)



21

Major Achievements

Information had been provided to the MAHs about

their responsabilities, obligations, etc.

A list of Infranctions and corresponding Sanctions

had been implemented in the national legislation.

Modification/Improvement of national legislation

(R.D. 2000 / 37, Law 29 / 2006, R.D. 1246 / 2008,

Instructions and Recommendations on VPH).



22

Major Achievements

Adoption of the simplified forms for notification of

SAEs for MAHs.

Creation of specific Assessor Committees:

- Veterinary Safety Committee.

- Technical Committee of the Spanish Veterinary

Pharmacovigilance System.



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Major Achievements

National database for SAEs enter into operation in

2004 (“VIGÍA-VET”). VIGÍA-VET allows healthcare

professionals and MAHs to notify electronically AEs

and PSURs. It is connected with EVVET through

Gateway.

VIGÍA-IPS is a national database to control the

submission of the PSURs by MAHs.



DATA EVOLUTION

IN

THESE YEARS



2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

55

300

447

220 268 251

373

462

1484

905

429

729

875

1148

1341

1538

SAEs NOTIFIED IN SPAIN



ROME – November 2017

2009 2010 2011 2012 2013 2014 2015 2016 SPECIES

15 5 5 4 4 1 3 12 Poultry

183 568 38 75 54 49 52 75 Bovine

894 263 70 68 141 150 181 156 Ovine/

Caprine

33 7 17 40 63 66 55 138 Porcine

422 288 265 442 578 759 843 910 Dog

6 3 - 7 2 - - 5 Equine



498

335

230

182

52 48 44 42 27 24 12 10 9 8 7 3 2 2 1 1 1

TIPO DE MEDICAMENTO 2016



ROME – November 2017

SAEs notified by others than MAHs -

5,46 %

SAEs notified by the MAHs - 94,54 %

Origen of the AEs in 2016



18 56

233

699

855

935

738

1001 1044

1145

1429

1214

1336

1453

1561

1701

1787 1751

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

PERIODIC SAFETY UPDATE REPORTS (PSURs)



FUTURE

CHALLENGES



31

Future Challenges

Improve the expertise of the AEMPS in VPH.

Increase active international participation.

Increase the number of P-RMS of the PSURs

assessed.

Increase the notification of SAEs specially in certain

species (food producing species and horses).



32

Future Challeges

Increase notification from healthcare professionals

other than veterinarians.

Increase direct notification of SAEs from healthcare

professionals (when necessary, it will allows direct

contact with them).

An electronic application developed by the Spanish

Royal Colleage of Veterinarians will be operational

at the end of 2017 with the aim to simplify the direct

notification from veterinarians to AEMPS.



¡GRACIAS

!



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THANK YOU VERY MUCH

FOR YOUR ATTENTION



35

GRAZIE TANTO PER

LA SUA ATTENZIONE

veterinary pharmacovigilance in spain ......rome - november 2017 spanish medicines and medical...

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