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

Sultana, Janet; Fontana, Andrea; Giorgianni, Francesco; Pasqua, Alessandro; Cricelli, Claudio; Spina, Edoardo; Gambassi, Giovanni; Ivanović, Jelena; Ferrajolo, Carmen; Molokhia, Mariam; Ballard, Clive; Sharp, Samantha; Sturkenboom, Miriam; Trifirò, Gianluca

doi:10.1007/s40263-016-0366-z

Cited by 35 publications

(35 citation statements)

References 23 publications

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“…All of the 70 publications included are observational studies based on routinely collected health data, which included health insurance or hospital records. Thus, no RCTs were found for the defined search period.…”

Section: Resultsmentioning

confidence: 99%

“…Two publications examined safety warnings for two mutually independent substances each, that is, 70 publications reported 72 studies. If a study contained multiple characteristics, the characteristics of these studies were counted multiple times in the following analyses, for example, studies examining more than one safety warning on one substance or substance group (multiple counts for safety warnings per study) or where a safety warning included multiple recommendations, for example, indication limitations and new adverse reactions (multiple counts for the content of the safety warning) were also subject to multiple counting.…”

Section: Resultsmentioning

confidence: 99%

“…In 12 studies, the authors concluded that the content of the safety warnings investigated did not lead to a change in drug therapy . In 26 studies, a partial change in drug therapy was shown …”

Section: Resultsmentioning

confidence: 99%

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Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Georgi

Lämmel

Datzmann

et al. 2020

Pharmacoepidemiology and Drug

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Purpose The need for drug‐related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. Methods Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case‐control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. Results Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the “psychotropic drugs” group (23%) than in the “others” group (53%). Conclusion Drug‐related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Georgi

Lämmel

Datzmann

et al. 2020

Pharmacoepidemiology and Drug

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“…Some studies reported a decrease in AP prescribing [11, 40] while other studies showed an increase or stagnation in AP use [41, 42]. …”

Section: Discussionmentioning

confidence: 99%

Antipsychotic prescribing for Alzheimer’s disease and related disorders in specialized settings from 2010 to 2014 in France: a repeated cross-sectional study

Tifratene

Manera²,

Fabre

et al. 2017

Alz Res Therapy

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BackgroundSafety warnings from health authorities are currently intended to limit the use of antipsychotics (APs) in dementia-related conditions to treat neuropsychiatric symptoms, such as disturbing and/or delusional behaviors. The aim of this study is to investigate prevalence, correlates and trends of AP prescribing among people with dementia between 2010 and 2014 in the French population.MethodsAP prescribing and associated factors among individuals with AD, mixed dementia and vascular dementia in the French National Alzheimer Database between 2010 and 2014 were analyzed using multivariate generalized estimating equations models (n = 199,549).ResultsIn 2014, 7.7% of people with dementia were prescribed an AP. Compared with 2010 there was a 16% increase in AP use. Multivariate analysis showed a linear increase risk of prescription with an adjusted odds ratio (95% confidence interval) of 1.23 (1.17–1.30) in 2014 compared with 2010. Factors associated with AP prescribing were male gender, more severe cognitive decline and living in long-term care facilities. Older age and higher education were protective toward AP prescribing. The type of dementia did not have any influence on AP prescribing.ConclusionAn increase in AP prescribing among individuals with dementia in French specialized settings over the last 5 years occurred despite safety warnings. This phenomenon suggests that alternative solutions for the management of behavioral and psychiatric symptoms in these populations are still urgently needed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13195-017-0256-8) contains supplementary material, which is available to authorized users.

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“…18 A similar study looking at antipsychotic prescribing in the UK and Italy noted that safety warnings combined with proactive national initiatives in the UK may have contributed to a more sustained reduc tion in prescribing than occurred in Italy. 19 A 2005 study evaluated the quality of a group of direct healthcare profes sional communication letters sent during 2000 and 2001 that were intended to communicate important new drug safety information. 20 This study found a corre lation between the perceived quality of the letter and the extent to which physi cians regarded the new information as important.…”

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confidence: 99%

Perceptions of the Drug Safety Update newsletter

Wilcock¹,

Praed²

2017

Prescriber

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

Cited by 35 publications

References 23 publications

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Antipsychotic prescribing for Alzheimer’s disease and related disorders in specialized settings from 2010 to 2014 in France: a repeated cross-sectional study

Perceptions of the Drug Safety Update newsletter

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