{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T04:25:24Z","timestamp":1781497524324,"version":"3.54.1"},"reference-count":25,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2020,3,23]],"date-time":"2020-03-23T00:00:00Z","timestamp":1584921600000},"content-version":"unspecified","delay-in-days":1543,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2016,1,1]],"date-time":"2016-01-01T00:00:00Z","timestamp":1451606400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":["europsy-journal.com","clinicalkey.jp","clinicalkey.com","clinicalkey.es","clinicalkey.com.au","clinicalkey.fr","em-consulte.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Eur. psychiatr."],"published-print":{"date-parts":[[2016]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S0924933800066360_abs1\" sec-type=\"other\"><jats:title>Background<\/jats:title><jats:p>A post-authorisation safety study was carried out as part of the EU Risk Management Plan to examine the long-term (up to 12\u00a0months) use of quetiapine XL as prescribed in general practice in England.<\/jats:p><\/jats:sec><jats:sec id=\"S0924933800066360_abs2\" sec-type=\"other\"><jats:title>Aim<\/jats:title><jats:p>To present a description of the drug utilisation characteristics of quetiapine XL.<\/jats:p><\/jats:sec><jats:sec id=\"S0924933800066360_abs3\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>An observational, population-based cohort design using the technique of Modified Prescription-Event Monitoring (M-PEM). Patients were identified from dispensed prescriptions issued by general practitioners (GPs) for quetiapine XL between September 2008 and February 2013. Questionnaires were sent to GPs 12\u00a0months following the 1st prescription for each individual patient, requesting drug utilisation information. Cohort accrual was extended to recruit additional elderly patients (special population of interest). Summary descriptive statistics were calculated.<\/jats:p><\/jats:sec><jats:sec id=\"S0924933800066360_abs4\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>The final M-PEM cohort consisted of 13,276\u00a0patients; median age 43\u00a0years (IQR: 33, 55) and 59.0% females. Indications for prescribing included bipolar disorder (<jats:italic>n<\/jats:italic> = 3820), MDD (<jats:italic>n<\/jats:italic> = 2844), schizophrenia (<jats:italic>n<\/jats:italic> = 2373) and other (non-licensed) indications (<jats:italic>n<\/jats:italic> = 3750). Where specified, 59.3% (7869\/13,276) were reported to have used quetiapine IR (immediate release formulation) previously at any time. The median start dose was highest for patients with schizophrenia (300 mg\/day [IQR 150, 450]). The final elderly cohort consisted of 3127\u00a0patients and 28.5% had indications associated with dementia. The median start dose for elderly patients was highest for patients with schizophrenia or BD (both 100 mg\/day [IQR 50, 300]).<\/jats:p><\/jats:sec><jats:sec id=\"S0924933800066360_abs5\" sec-type=\"conclusions\"><jats:title>Conclusions<\/jats:title><jats:p>The prevalence of off-label prescribing in terms of indication and high doses was common, as was use in special populations such as the very elderly. Whilst off-label use may be unavoidable in certain situations, GPs may need to re-evaluate prescribing in circumstances where there may be safety concerns. This study demonstrates the ongoing importance of observational studies such as M-PEM to gather real-world clinical data to support the post-marketing benefit:risk management of new medications, or existing medications for which license extensions have been approved.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.eurpsy.2015.12.004","type":"journal-article","created":{"date-parts":[[2016,2,10]],"date-time":"2016-02-10T00:31:09Z","timestamp":1455064269000},"page":"61-67","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":9,"title":["Utilisation of extended release quetiapine (Seroquel XL\u2122): Results from an observational cohort study in England"],"prefix":"10.1017","volume":"33","author":[{"given":"V.","family":"Osborne","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Davies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Layton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.A.W.","family":"Shakir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2020,3,23]]},"reference":[{"key":"S0924933800066360_bib0024","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06898-2"},{"key":"S0924933800066360_bib0022","volume-title":"British National Formulary (BNF) 69","author":"Joint Formulary Committee","year":"2015"},{"key":"S0924933800066360_bib0021","unstructured":"[21] National Institute for health and Care Excellence Dementia: supporting people with dementia and their carers in health and social care 2015 NICE [Available from: URL: http:\/\/www.nice.org.uk\/guidance\/cg42\/resources\/guidance-dementia-pdf]"},{"key":"S0924933800066360_bib0020","unstructured":"[20] National Institute for health and Care Excellence Low-dose antipsychotics in people with dementia 2015 NICE [Available from: URL: http:\/\/www.nice.org.uk\/advice\/ktt7\/resources\/lowdose-antipsychotics-in-people-with-dementia-1632175200709]"},{"key":"S0924933800066360_bib0017","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)61579-2"},{"key":"S0924933800066360_bib0016","volume-title":"Seroquel XL: UK summary of product characteristics","author":"AstraZeneca","year":"2010"},{"key":"S0924933800066360_bib0015","volume-title":"Consensus statement on high-dose antipsychotic medication","year":"2006"},{"key":"S0924933800066360_bib0019","doi-asserted-by":"publisher","DOI":"10.1186\/1471-244X-12-155"},{"key":"S0924933800066360_bib0001","volume-title":"Guideline on good pharmacovigilance practices (GVP): module V \u2013\u00a0risk management systems (Rev 1)","author":"European Medicines Agency","year":"2014"},{"key":"S0924933800066360_bib0014","volume-title":"Bipolar disorder \u2013\u00a0the management of bipolar disorder in adults, children and adolescents in primary and secondary care","author":"NICE","year":"2006"},{"key":"S0924933800066360_bib0018","volume-title":"The use of medicines in dementia care","author":"Health","year":"2009"},{"key":"S0924933800066360_bib0012","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1781"},{"key":"S0924933800066360_bib0006","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2013.794774"},{"key":"S0924933800066360_bib0004","volume-title":"SEROQUEL 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets","author":"AstraZeneca UK Limited","year":"2014"},{"key":"S0924933800066360_bib0023","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.313.7059.732"},{"key":"S0924933800066360_bib0007","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2012-000915"},{"key":"S0924933800066360_bib0011","volume-title":"Advisory Group advice and approval decisions. 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