Pharmacovigilance in Spain

Supervisor Rowa Al Ramahi

Presented by Reem Al-zawahreh
 CONTENT

• Introduction

• Risk identification

• A specific program for risk identification and

quantification.
•4 Primary Healthcare Records Database (BIFAP).

• Risk Evaluation.

4• Risk Management.

• Risk Communication.

• Evaluation of the effectiveness of the measures taken.

• Noninterventional Post-Authorization studies.

1
Pharmacovigilance

U P

L C
AEMPS

S P

A I
Responsible for the evaluation of the risks that emerge after the authorization of
medicinal products for human use.
Obligations on
pharmacovigilanc
e are included in
Royal Decree
577/2013
(available on the
Spanish Agency
website
www.aemps.gob.e
s)
2
FEDRA
 Reports facts

Percentage of reports sent directly

to the regional centers of the
Spanish pharmacovigilance system.
80% Percentage of reports received
by the system through
marketing authorization
holders.
20%

The number of reports received yearly is in the range of 10 000–15000,

with medical doctors from primary healthcare being the ones that
contribute most
CONT….

Coordination by the Spanish

Medicines Agency is performed

A D
through a Technical Committee

M E This committee meets regularly

and its aim is to analyze the
signals identified by the centers
 P O

D G
FEDRA enables the electronic exchange of spontaneous reports with marketing
authorization holders and the European Medicines Agency (EudraVigilance database)
according to agreed international standards.
2
o The Spanish Medicines Agency is well aware of the importance of performing studies to further
characterize and quantify risks. Therefore, it contributes to the financial support of independent
data sources for pharmacoepidemiology research.

o These registries are run by researchers from the public healthcare system or scientific societies.
o The registries that are currently financially supported by the Spanish Medicines Agency are registries of
diagnosis that not infrequently are involved in adverse drug reactions.

Financial support basically depends on

P O
the relevance of the

D G
topic from a regulatory the scientific quality of
perspective the project.
2
 BIFAP

o The BIFAP database is a computerized, population-based

database of anonymized longitudinal medical records of
general practitioners in Spain.
 The objective of BIFAP

• is the performance of independent

research on pharmacoepidemiology

1883 1150 11 526 376

GPS

General currently anonymized

practitioners active information
2
RISK EVALUATION
 CONT….

o When advice is given on safety-related issues identified after a drug is

authorized, members appointed by the Spanish Medicines Agency in the
EMA's Pharmacovigilance Risk Assessment Committee are supported by the
scientific advice of clinical experts.
2
 Risk Management

The Division of Pharmacoepidemiology and Pharmacovigilance implements the necessary

 The Division
measures of Pharmacoepidemiology
for mitigating risks. and Pharmacovigilance implements the necessary
measures for mitigating risks.

 Changes in product information in the sections of indications, warnings, contraindications,

and adverse reactions are managed by the Division of Pharmacoepidemiology and
Pharmacovigilance.

 specific programs aimed at managing risks are also supervised.

2
Risk Communication

02 These communications
are available on the
website of the Spanish
Medicines Agency,

the Division of 01
Pharmacoepidemiology
and Pharmacovigilance
elaborates on specific
communications

0404 It sent electronically to autonomous

the message is amplified through 04 communities, scientific societies, and
different channels. other strategic organizations
2
EVALUATION OF THE EFFECTIVENESS OF The Measures taken

 Although not systematically performed, there have been some instances where drug
utilization data from the National Health Service, data from BIFAP, and data from the registries
supported by the Spanish Medicines Agency.
2
NIS

a specific regulation was set up in

2002 with the aim of promoting
good-quality research.

The procedure is simplified for studies performed

at the request of the European network of
regulatory authorities and for independent studies

protocols of studies classified by the Division of

Pharmacoepidemiology and Pharmacovigilance as
prospective observational studies.
From methodological and ethical points of view,
these measures have contributed to the
improvement of the quality of noninterventional
post-authorization studies in Spain
Gracias