veterinary pharmacovigilance in spain ......rome - november 2017 spanish medicines and medical...
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ROME - November 2017
SPANISH MEDICINES AND MEDICAL DEVICES AGENCY
VETERINARY
PHARMACOVIGILANCE IN SPAIN:
EVOLUTION AND FUTURE
CHALLENGES
Ramiro Casimiro Elena
Technical Adviser 1
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SPANISH MEDICINES AND MEDICAL DEVICES AGENCY
INDEX
• AEMPS: STRUCTURE AND FUNCTIONS.
• STARTING POINT OF VETERINARY PHARMACOVIGILANCE (VPH) IN SPAIN.
• MAJOR ACHIEVEMENTS.
• DATA EVOLUTION IN THESE YEARS.
• FUTURE CHALLENGES.
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AEMPS:
STRUCTURE AND FUNTIONS
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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.
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Veterinary medicinal products
Human medicines
Medical devices
Cosmetics & higyenic products
Inspection & Control
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SCOPE OF ACTIVITIES
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Structure of the AEMPS
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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
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VETERINARY MEDICINES DEPARTMENT (DMV)
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Personal of the DMV
• 95 people
• 31 permanent staff.
• 64 temporal staff.
• Support from horizontal Services (IT, Lawyers,
Economical-Financial unit, etc.).
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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.
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External Experts
• Universities and other scientific centers.
• Declaration of Conflict of Interests.
• 63 are designated as EMA´s experts.
• Training courses and regular meetings.
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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
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SARTING POINT OF
VETERINARY
PHARMACOVIGILANCE
IN SPAIN
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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.
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Starting point of Vet. Pharmacov. in Spain
Limited legislation on Veterinary Pharmacovigilance
(VPH).
Scarce resources working on VPH.
No VPH national database.
No committees specialized in VPH.
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Starting point of Vet. Pharmacov. in Spain
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.
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Starting point of Vet. Pharmacov. in Spain
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.
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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.
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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)
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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).
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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.
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DATA EVOLUTION
IN
THESE YEARS
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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
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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
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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
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SAEs notified by others than MAHs -
5,46 %
SAEs notified by the MAHs - 94,54 %
Origen of the AEs in 2016
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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)
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FUTURE
CHALLENGES
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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).
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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.
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SPANISH MEDICINES AND MEDICAL DEVICES AGENCY
¡GRACIAS
!
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THANK YOU VERY MUCH
FOR YOUR ATTENTION
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GRAZIE TANTO PER
LA SUA ATTENZIONE