Monitorizao da

literatura mdica pela

Agncia Europeia do
Medicamento (EMA)
Ftima Hergy
Direo de Gesto do Risco de Medicamentos

15 outubro 2015

22 anos de servio pblico com valores e tica

 Sumrio
Monitorizao da Literatura Mdica pela
EMA
1.Introduo
2.Regras gerais: GVP, Mod. VI
3.Enquadramento jurdico
4.Substncias ativas
5.Literatura mdica e cientfica
6.Requisitos de notificao
7.Vantagens do MLM service
 Sumrio
Monitorizao da Literatura Mdica pela
EMA
8.Objetivos da pesquisa
9.Identificao de ICSR vlido e prazos
previstos
10.Critrios de incluso/excluso
11.Critrios para follow-up de ICSR
12.Medical Literature Monitoring
13.Documentos de suporte
14. Concluso
1. Introduo
TAIM deve pesquisar casos de RAM em publicaes mdicas e
cientficas

TAIM
GVP VI

1 de setembro
de 2015

MLM service
2. Regras gerais: GVP, Mod. VI (1)

Pesquisa com periodicidade no superior a semanal

Um ICSR para cada doente

Dia zero

Informao de segurana que no ter critrio de

notificao como ICSR, tambm deve ser avaliada e
discutida no RPS
2. Regras gerais: GVP, Mod. VI (2)

Referncia de literatura (A.2.2) estilo Vancouver

Resumo do caso Narrativa (B.5.1)

Casos relacionados (A.1.12)

Cpia do artigo e traduo completa em ingls EMA

3.Enquadramento Jurdico
Article 107, paragraph 3 of Directive 2001/83/EC

For medicinal products containing the active substances

referred to in the list of publications monitored by the
Agency pursuant to Article 27 of Regulation (EC) No
726/2004, marketing authorisation holders shall not be
required to report to the Eudravigilance database the
suspected adverse reactions recorded in the listed medical
literature, but they shall monitor all other medical
literature and report any suspected adverse reactions.
4. Substncias ativas

As substncias ativas presentes nos medicamentos para

os quais um grande nmero de autorizaes de
mercado foram concedidas para vrios TAIM na EEE
esto includas no servio

400 grupos de substncias ativas

300 grupos de substncias ativas + 100 grupos de

substncias base de plantas

Medical literature monitoring: substance and herbal

substance groups
5. Literatura Mdica e Cientfica (1)
Feature Embase

Frequency of searching Daily

Description Embase is a biological and pharmacological database containing over 28 million indexed citations from over
8400 currently published journals from over 90 countries, and in addition to screening medical journals provides
abstracts from over 1000 conferences, generating over 300000 fully indexed abstracts each year. The indexing
of Embase allows full searching of all trade names, generic names and chemical designations allowing for
exhaustive literature searching ability.

Thesaurus Each search term within Embase is automatically matched to corresponding terms using the Emtree thesaurus
to promote accuracy and consistency in retrieval. This hierarchically structured, controlled vocabulary is applied
at both the Disease Index Term and Drug Index Term level and results in increased confidence in search results
irrespective of how a disease or drug is referenced within the article.

Further information http://www.elsevier.com/online-tools/embase/about.

http://www.elsevier.com/__data/assets/excel_doc/0015/201804/Embase-journals-titles-2014.xlsx
http://www.elsevier.com/__data/assets/excel_doc/0004/234769/Embase_Conference_Coverage_301014.xlsx

Fonte: Kinapse, EV-EWG, maio 2015

Medical literature monitoring: description of the journal/reference databases

used
5. Literatura Mdica e Cientfica (2)
Feature EBSCO

Frequency of searching Monthly

Description EBSCO is an information technology community which has developed a customizable service to provide access to
multiple databases. BESCO deliver global quality research content, powerful search technologies and intuitive delivery
platforms. Through the platform EBSCO provide the most comprehensive source of full text for medical journals,
providing full text for over 2,000 journals indexed. EBSCO covers the entire spectrum of drug therapy and
pharmaceutical information. Using MESH (Medical Subject Headings) EBSCO has indexed over 5,600 current biomedical
journals. Many of these journals are not indexed in any other biomedical database.
Within the platform, systems are offered with unique features such as the full text for many of the most used journals
and clinical abstracts including the study design, number of patients, dosage, dosage forms, and dosage schedule.

Thesaurus EBSCO uses MeSH which is the National Library of Medicine's controlled vocabulary thesaurus. Each bibliographic
reference is associated with a set of MeSH terms that are assigned to describe the content of an article. There are more
than 26,000 main headings in MeSH, as well as thousands of cross-references that assist in finding the most appropriate
MeSH heading.
MeSH terms are arranged in a hierarchy, or "tree structure," that permits searching at various levels of detail from the
most general level to more narrow levels to find the most precise terms. MeSH is updated annually by subject specialists
at the NLM. The thesaurus contains approx. 3,000 descriptors in English language- many of these terms are derived from
the MeSH.
Further information http://health.ebsco.com/products/international-pharmaceutical-abstracts
http://www.ebscohost.com/academic/medline-with-full-text
http://www.ebscohost.com/academic/AMED-The-Allied-and-Complementary-Medicine-Database

Fonte: Kinapse, EV-EWG, maio 2015

6. Requisitos de notificao (1)

1. Substncias ativas e literatura que no esto sujeitas

monitorizao de literatura conduzida pela Agncia

2. Substncias ativas sujeitas monitorizao de literatura

conduzida pela Agncia mas quando a publicao
contendo as informaes relevantes no est includa na
lista de publicaes monitorizadas pela Agncia
6. Requisitos de notificao (2)
3. Substncias ativas sujeitas monitorizao de literatura
mdica conduzida pela Agncia e quando a publicao
contendo a informao relevante est includa na lista de
publicaes monitorizadas pela Agncia nos termos do artigo
27 do Regulamento (EC) No 726/2004
7.Vantagens do MLM service

Aumentar a eficincia da notificao de reaes adversas

Simplificar o trabalho da indstria farmacutica (IF)

Melhorar a qualidade dos dados ao reduzir o nmero de

duplicados

Contribuir para a poupana de recursos por parte da IF

Apoiar atividades de deteo de sinal realizadas pelas AC e

TAIM
8.Objetivos da pesquisa (1)
Analisar, avaliar e identificar ICSR vlidos relacionados com:

Reaes adversas a medicamentos provenientes de

notificaes espontneas e solicitadas

Situaes especiais de ocorrncia de RAM:

gravidez ou amamentao,

na populao peditrica e idosos,

uso off-label, mau uso, abuso, overdose, erros de

medicao e exposio ocupacional
8.Objetivos da pesquisa (2)

Falta de eficcia teraputica

Suspeita de RAM relacionada com defeitos de qualidade

ou falsificao de medicamentos

Suspeita de transmisso de um agente infecioso via

medicamento
9.Identificao de ICSR vlido e
prazos previstos

Casos de RAM grave ocorridos no EEE e pases terceiros

7 dias

Casos de RAM no grave ocorridos no EEE

21 dias
10.Critrios de Incluso/Excluso (1)
Tipo de relatrio

Fonte: www.ema.europa.eu
10.Critrios de Incluso/Excluso (2)

Notificador Identificvel

Fonte: www.ema.europa.eu
10.Critrios de Incluso/Excluso (3)

Doente Identificvel

Fonte: www.ema.europa.eu
10.Critrios de Incluso/Excluso (4)
Medicamento suspeito/interao

Fonte: www.ema.europa.eu
10.Critrios de Incluso/Excluso (5)
Doente

RAM

Fonte:
Fonte: www.ema.europa.eu
www.ema.europa.eu
10.Critrios de Incluso/Excluso (6)
Causalidade

Fonte: www.ema.europa.eu
10.Critrios de Incluso/Excluso (7)

Gravidade

Fonte: www.ema.europa.eu
11.Critrios para follow-up de ICSR

Autor da publicao

Avaliao cientfica

Evoluo desconhecida

Ausncia de informao clnica

12.Medical Literature Monitoring

Fonte: www.eudravigilance.ema.europa.eu
13.Documentos de suporte (1)

Fonte: www.ema.europa.eu
13.Documentos de suporte (2)

Detailed guide

Inclusion/exclusion criteria for processing Individual Case

Safety Reports

Process description for managing duplicates in the context of

the medical literature monitoring service

Questions and answers on medical literature monitoring

service desk

MLM@ema.europa.eu
14.Concluso (1)
AC no retransmite MLM case para TAIM

TAIM no deve reenviar MLM case ocorrido no EEE para AC ou

para EudraVigilance

TAIM no deve reenviar MLM case ocorrido fora do EEE para

EudraVigilance
14.Concluso (2)

Fonte: www.ema.europa.eu
 fatima.hergy@infarmed.pt
farmacovigilancia@infarmed.pt

www.infarmed.pt https://twitter.com/INFARMED_IP

http://m.infarmed.pt http://www.linkedin.com/company/infarmed

22 anos de servio pblico com valores e tica