[Use of antibiotics in Spain and regulatory framework for clinical development in the European Union].
Identifieur interne : 000445 ( Main/Exploration ); précédent : 000444; suivant : 000446[Use of antibiotics in Spain and regulatory framework for clinical development in the European Union].
Auteurs : Edurne Lázaro-Bengoa [Espagne] ; Francisco José De Abajo Iglesias ; Antonio L Pez-Navas ; María Jesús Fernández-CortizoSource :
- Enfermedades infecciosas y microbiologia clinica [ 1578-1852 ] ; 2010.
Descripteurs français
- KwdFr :
- MESH :
- normes : Utilisation médicament.
- statistiques et données numériques : Utilisation médicament.
- usage thérapeutique : Antibactériens.
- Espagne, Humains, Résistance bactérienne aux médicaments, Union européenne.
- Wicri :
- geographic : Espagne.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Anti-Bacterial Agents.
- geographic : Spain.
- standards : Drug Utilization.
- statistics & numerical data : Drug Utilization.
- Drug Resistance, Bacterial, European Union, Humans.
Abstract
The high use of antibiotics in the community is closely related to the increase in resistance to antibiotics. Monitoring antibiotic use is a key step to understanding whether trends are changing, and in this way efforts towards more prudent use can be implemented. Over the last 9 years, available active ingredients have decreased in Spain while at the same time the number of antibiotic offerings has increased. Presentations of generic pharmaceutical specialties account for almost 50% of the most frequently used subgroups. The use of antibiotics remains stable or shows a slight decrease depending on the unit of measure (DID or PIM) used. These differences are explained mainly by amoxicillin-clavulanate, since in recent years packages with greater concentrations and greater number of pharmaceutical formulations per package have been used. Ten active ingredients constitute 80% of antibiotic use. Throughout the study period, more than 50% of total antibiotic use was due to amoxicillin-clavulanate and amoxicillin. There is significant seasonal variation in the use of antibiotics. Peaks in influenza incidence are correlated with the maximum consumption of antibiotics. The criteria on which the marketing authorization for medication, including antibiotics, is based are quality, safety and effectiveness, regardless of the registration procedure used. The criteria that dictate the use of these antibiotics in clinical practice go beyond the purely regulatory framework. For this reason, it would be useful to have clinical practice guidelines based on broad consensus that incorporate criteria for a more rational use of antibiotics, such as the local prevalence of resistance.
DOI: 10.1016/S0213-005X(10)70036-7
PubMed: 21458694
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Iglesias</name></author><author><name sortKey="L Pez Navas, Antonio" sort="L Pez Navas, Antonio" uniqKey="L Pez Navas A" first="Antonio" last="L Pez-Navas">Antonio L Pez-Navas</name></author><author><name sortKey="Fernandez Cortizo, Maria Jesus" sort="Fernandez Cortizo, Maria Jesus" uniqKey="Fernandez Cortizo M" first="María Jesús" last="Fernández-Cortizo">María Jesús Fernández-Cortizo</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="RBID">pubmed:21458694</idno><idno type="pmid">21458694</idno><idno type="doi">10.1016/S0213-005X(10)70036-7</idno><idno type="wicri:Area/Main/Corpus">00385</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">00385</idno><idno type="wicri:Area/Main/Curation">000385</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000385</idno><idno 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données numériques" xml:lang="fr"><term>Utilisation médicament</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antibactériens</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Resistance, Bacterial</term><term>European Union</term><term>Humans</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Espagne</term><term>Humains</term><term>Résistance bactérienne aux médicaments</term><term>Union européenne</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Espagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The high use of antibiotics in the community is closely related to the increase in resistance to antibiotics. Monitoring antibiotic use is a key step to understanding whether trends are changing, and in this way efforts towards more prudent use can be implemented. Over the last 9 years, available active ingredients have decreased in Spain while at the same time the number of antibiotic offerings has increased. Presentations of generic pharmaceutical specialties account for almost 50% of the most frequently used subgroups. The use of antibiotics remains stable or shows a slight decrease depending on the unit of measure (DID or PIM) used. These differences are explained mainly by amoxicillin-clavulanate, since in recent years packages with greater concentrations and greater number of pharmaceutical formulations per package have been used. Ten active ingredients constitute 80% of antibiotic use. Throughout the study period, more than 50% of total antibiotic use was due to amoxicillin-clavulanate and amoxicillin. There is significant seasonal variation in the use of antibiotics. Peaks in influenza incidence are correlated with the maximum consumption of antibiotics. The criteria on which the marketing authorization for medication, including antibiotics, is based are quality, safety and effectiveness, regardless of the registration procedure used. The criteria that dictate the use of these antibiotics in clinical practice go beyond the purely regulatory framework. For this reason, it would be useful to have clinical practice guidelines based on broad consensus that incorporate criteria for a more rational use of antibiotics, such as the local prevalence of resistance.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21458694</PMID><DateCompleted><Year>2011</Year><Month>08</Month><Day>17</Day></DateCompleted><DateRevised><Year>2011</Year><Month>04</Month><Day>04</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1578-1852</ISSN><JournalIssue CitedMedium="Internet"><Volume>28 Suppl 4</Volume><PubDate><Year>2010</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Enfermedades infecciosas y microbiologia clinica</Title><ISOAbbreviation>Enferm. Infecc. Microbiol. Clin.</ISOAbbreviation></Journal><ArticleTitle>[Use of antibiotics in Spain and regulatory framework for clinical development in the European Union].</ArticleTitle><Pagination><MedlinePgn>10-6</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0213-005X(10)70036-7</ELocationID><Abstract><AbstractText>The high use of antibiotics in the community is closely related to the increase in resistance to antibiotics. Monitoring antibiotic use is a key step to understanding whether trends are changing, and in this way efforts towards more prudent use can be implemented. Over the last 9 years, available active ingredients have decreased in Spain while at the same time the number of antibiotic offerings has increased. Presentations of generic pharmaceutical specialties account for almost 50% of the most frequently used subgroups. The use of antibiotics remains stable or shows a slight decrease depending on the unit of measure (DID or PIM) used. These differences are explained mainly by amoxicillin-clavulanate, since in recent years packages with greater concentrations and greater number of pharmaceutical formulations per package have been used. Ten active ingredients constitute 80% of antibiotic use. Throughout the study period, more than 50% of total antibiotic use was due to amoxicillin-clavulanate and amoxicillin. There is significant seasonal variation in the use of antibiotics. Peaks in influenza incidence are correlated with the maximum consumption of antibiotics. The criteria on which the marketing authorization for medication, including antibiotics, is based are quality, safety and effectiveness, regardless of the registration procedure used. The criteria that dictate the use of these antibiotics in clinical practice go beyond the purely regulatory framework. For this reason, it would be useful to have clinical practice guidelines based on broad consensus that incorporate criteria for a more rational use of antibiotics, such as the local prevalence of resistance.</AbstractText><CopyrightInformation>Copyright © 2010 Elsevier España S.L. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lázaro-Bengoa</LastName><ForeName>Edurne</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España. elazaro@aemps.es</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Iglesias</LastName><ForeName>Francisco José de Abajo</ForeName><Initials>FJ</Initials></Author><Author ValidYN="Y"><LastName>López-Navas</LastName><ForeName>Antonio</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Fernández-Cortizo</LastName><ForeName>María Jesús</ForeName><Initials>MJ</Initials></Author></AuthorList><Language>spa</Language><PublicationTypeList><PublicationType UI="D004740">English Abstract</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><VernacularTitle>Uso de antibióticos en España y marco regulador para su desarrollo clínico en la Unión Europea.</VernacularTitle></Article><MedlineJournalInfo><Country>Spain</Country><MedlineTA>Enferm Infecc Microbiol Clin</MedlineTA><NlmUniqueID>9104081</NlmUniqueID><ISSNLinking>0213-005X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D024881" MajorTopicYN="N">Drug Resistance, Bacterial</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004363" MajorTopicYN="N">Drug Utilization</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005062" MajorTopicYN="N">European Union</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N" Type="Geographic">Spain</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2011</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>4</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>8</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">21458694</ArticleId><ArticleId IdType="pii">S0213-005X(10)70036-7</ArticleId><ArticleId IdType="doi">10.1016/S0213-005X(10)70036-7</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li></country><region><li>Communauté de Madrid</li></region><settlement><li>Madrid</li></settlement></list><tree><noCountry><name sortKey="Fernandez Cortizo, Maria Jesus" sort="Fernandez Cortizo, Maria Jesus" uniqKey="Fernandez Cortizo M" first="María Jesús" last="Fernández-Cortizo">María Jesús Fernández-Cortizo</name><name sortKey="Iglesias, Francisco Jose De Abajo" sort="Iglesias, Francisco Jose De Abajo" uniqKey="Iglesias F" first="Francisco José De Abajo" last="Iglesias">Francisco José De Abajo Iglesias</name><name sortKey="L Pez Navas, Antonio" sort="L Pez Navas, Antonio" uniqKey="L Pez Navas A" first="Antonio" last="L Pez-Navas">Antonio L Pez-Navas</name></noCountry><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Lazaro Bengoa, Edurne" sort="Lazaro Bengoa, Edurne" uniqKey="Lazaro Bengoa E" first="Edurne" last="Lázaro-Bengoa">Edurne Lázaro-Bengoa</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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