The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study

Background Antipsychotic (AP) drugs are commonly used to manage the behavioural symptoms of dementia. Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulator...

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Veröffentlicht in:CNS drugs 2016-11, Vol.30 (11), p.1097-1109
Hauptverfasser: Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Pasqua, Alessandro, Cricelli, Claudio, Spina, Edoardo, Gambassi, Giovanni, Ivanovic, Jelena, Ferrajolo, Carmen, Molokhia, Mariam, Ballard, Clive, Sharp, Samantha, Sturkenboom, Miriam, Trifirò, Gianluca
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container_end_page 1109
container_issue 11
container_start_page 1097
container_title CNS drugs
container_volume 30
creator Sultana, Janet
Fontana, Andrea
Giorgianni, Francesco
Pasqua, Alessandro
Cricelli, Claudio
Spina, Edoardo
Gambassi, Giovanni
Ivanovic, Jelena
Ferrajolo, Carmen
Molokhia, Mariam
Ballard, Clive
Sharp, Samantha
Sturkenboom, Miriam
Trifirò, Gianluca
description Background Antipsychotic (AP) drugs are commonly used to manage the behavioural symptoms of dementia. Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009. Objective The aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy. Methods We calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings. Results We identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000–2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively). Conclusion The 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. Possible reasons for the difference in AP use between the two countries include a more proactive approach towards reducing the use of APs in the UK than in Italy.
doi_str_mv 10.1007/s40263-016-0366-z
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Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009. Objective The aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy. Methods We calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings. Results We identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000–2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively). Conclusion The 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. Possible reasons for the difference in AP use between the two countries include a more proactive approach towards reducing the use of APs in the UK than in Italy.</description><identifier>ISSN: 1172-7047</identifier><identifier>EISSN: 1179-1934</identifier><identifier>DOI: 10.1007/s40263-016-0366-z</identifier><identifier>PMID: 27423216</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Aged ; Antipsychotic Agents - adverse effects ; Antipsychotic Agents - therapeutic use ; Audits ; Benzodiazepines - adverse effects ; Benzodiazepines - therapeutic use ; Data analysis ; Databases, Factual ; Dementia ; Dementia - drug therapy ; Drug Prescriptions ; Female ; Funding ; Humans ; Initiatives ; Italy ; Male ; Medicine ; Medicine &amp; Public Health ; Mortality ; Neurology ; Neurosciences ; Older people ; Original Research Article ; Patients ; Pharmacotherapy ; Population ; Practice Patterns, Physicians ; Psychiatry ; Psychopharmacology ; Psychotropic drugs ; Retrospective Studies ; Risperidone - adverse effects ; Risperidone - therapeutic use ; Studies ; Trends ; United Kingdom</subject><ispartof>CNS drugs, 2016-11, Vol.30 (11), p.1097-1109</ispartof><rights>Springer International Publishing Switzerland 2016</rights><rights>Copyright Springer Science &amp; Business Media Nov 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-695c1c5330241542d2d3fd0957b2f0938a494e2dfe0620dd2c46074552e9e9ef3</citedby><cites>FETCH-LOGICAL-c448t-695c1c5330241542d2d3fd0957b2f0938a494e2dfe0620dd2c46074552e9e9ef3</cites><orcidid>0000-0001-9622-169X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40263-016-0366-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40263-016-0366-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27423216$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sultana, Janet</creatorcontrib><creatorcontrib>Fontana, Andrea</creatorcontrib><creatorcontrib>Giorgianni, Francesco</creatorcontrib><creatorcontrib>Pasqua, Alessandro</creatorcontrib><creatorcontrib>Cricelli, Claudio</creatorcontrib><creatorcontrib>Spina, Edoardo</creatorcontrib><creatorcontrib>Gambassi, Giovanni</creatorcontrib><creatorcontrib>Ivanovic, Jelena</creatorcontrib><creatorcontrib>Ferrajolo, Carmen</creatorcontrib><creatorcontrib>Molokhia, Mariam</creatorcontrib><creatorcontrib>Ballard, Clive</creatorcontrib><creatorcontrib>Sharp, Samantha</creatorcontrib><creatorcontrib>Sturkenboom, Miriam</creatorcontrib><creatorcontrib>Trifirò, Gianluca</creatorcontrib><title>The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study</title><title>CNS drugs</title><addtitle>CNS Drugs</addtitle><addtitle>CNS Drugs</addtitle><description>Background Antipsychotic (AP) drugs are commonly used to manage the behavioural symptoms of dementia. Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009. Objective The aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy. Methods We calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings. Results We identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000–2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively). Conclusion The 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. 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Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009. Objective The aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy. Methods We calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings. Results We identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000–2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively). Conclusion The 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. Possible reasons for the difference in AP use between the two countries include a more proactive approach towards reducing the use of APs in the UK than in Italy.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>27423216</pmid><doi>10.1007/s40263-016-0366-z</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0001-9622-169X</orcidid><oa>free_for_read</oa></addata></record>
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subjects Aged
Antipsychotic Agents - adverse effects
Antipsychotic Agents - therapeutic use
Audits
Benzodiazepines - adverse effects
Benzodiazepines - therapeutic use
Data analysis
Databases, Factual
Dementia
Dementia - drug therapy
Drug Prescriptions
Female
Funding
Humans
Initiatives
Italy
Male
Medicine
Medicine & Public Health
Mortality
Neurology
Neurosciences
Older people
Original Research Article
Patients
Pharmacotherapy
Population
Practice Patterns, Physicians
Psychiatry
Psychopharmacology
Psychotropic drugs
Retrospective Studies
Risperidone - adverse effects
Risperidone - therapeutic use
Studies
Trends
United Kingdom
title The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study
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