Skip to main content Accessibility help
×
Home

Utilisation of extended release quetiapine (Seroquel XL™): Results from an observational cohort study in England

  • V. Osborne (a1), M. Davies (a1), D. Layton (a1) and S.A.W. Shakir (a1)

Abstract

Background

A post-authorisation safety study was carried out as part of the EU Risk Management Plan to examine the long-term (up to 12 months) use of quetiapine XL as prescribed in general practice in England.

Aim

To present a description of the drug utilisation characteristics of quetiapine XL.

Methods

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 months 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.

Results

The final M-PEM cohort consisted of 13,276 patients; median age 43 years (IQR: 33, 55) and 59.0% females. Indications for prescribing included bipolar disorder (n = 3820), MDD (n = 2844), schizophrenia (n = 2373) and other (non-licensed) indications (n = 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 patients 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]).

Conclusions

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.

Copyright

Corresponding author

Corresponding author. Tel./fax: +44 0 23 8040 8600. E-mail address:vicki.osborne@dsru.org (V. Osborne).

References

Hide All
[1]European Medicines Agency, Guideline on good pharmacovigilance practices (GVP): module V – risk management systems (Rev 1) 2014
[2]European Medicines Agency, Guideline on good pharmacovigilance practices (GVP): module VIII – post-authorisation safety studies (Rev 1) 2013
[3]AstraZeneca UK Limited, Seroquel XL 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets: summary of product characteristics 2014 [Ref type: pamphlet]
[4]AstraZeneca UK Limited, SEROQUEL 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets 2014 [Ref type: pamphlet]
[5]Peuskens, J.Trivedi, J.Malyarov, S.Brecher, M.Svensson, O.Miller, F., et al.Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients Psychiatry 2007; 4(11): 3450
[6]Bui, K.Earley, W.Nyberg, S.Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications. Curr Med Res Opin 2013; 29(7): 813825
[7]Hallinen, T.Soini, E.Granstrom, O.Leinonen, E.Koponen, H.Hanninen, K.Differential use of extended and immediate release quetiapine: a retrospective registry study of Finnish inpatients with schizophrenia spectrum and bipolar disorders. BMJ Open 2012; 2:e000915
[8]Layton, D.Hazell, L.Shakir, S.A.Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management. Drug Saf 2011; 34:e1e9
[9]CIOMS/WHO, International guidelines for biomedical research involving human subjects Geneva: CIOMS; 2002 [Available from: URL: http://www.cioms.ch/publications/layout_guide2002.pdf]
[10]Royal College of Physicians Guidelines on the practice of ethics committees in medical research involving human subjects 3rd ed 1996 Royal College of Physicians of London London
[11]Health Research Authority, Advisory Group advice and approval decisions. Prescription-event monitoring, CAG ref: ECC 5-07(b)/2009 2013 HRA [Available from: URL: http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/cag-advice-and-approval-decisions/]
[12]Yood, M.U.DeLorenze, G.Quesenberry, C.P. Jr.Oliveria, S.A.Tsai, A.L.Willey, V.J., et al.The incidence of diabetes in atypical antipsychotic users differs according to agent–results from a multisite epidemiologic study Pharmacoepidemiol Drug Saf 2009; 18(9): 791799
[13]NICE, Schizophrenia – core interventions in the treatment and management of schizophrenia in adults in primary and secondary care 2009 [Report no.: clinical guideline 82]
[14]NICE, Bipolar disorder – the management of bipolar disorder in adults, children and adolescents in primary and secondary care 2006 [Report no.: clinical guideline 38]
[15]Royal College of Psychiatrists Consensus statement on high-dose antipsychotic medication 2006 [Report no.: council report CR138]
[16]AstraZeneca, Seroquel XL: UK summary of product characteristics 2010
[17]Banerjee, S.Good news on dementia prevalence – we can make a difference. Lancet 2013; 382: 13841386
[18]Health, I.M.S.The use of medicines in dementia care London: IMS; 2009
[19]Child, A.Clarke, A.Fox, C.Maidment, I.A pharmacy led program to review antipsychotic prescribing for people with dementia. BMC Psychiatry 2012; 12:155
[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]
[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]
[22]Joint Formulary Committee, British National Formulary (BNF) 69 2015 Pharmaceutical Press
[23]McAvoy, B.Kaner, E.General practice postal surveys: a questionnaire too far?. BMJ 1996; 313(7059): 732733
[24]Heeley, E.Riley, J.Layton, D.Wilton, L.Shakir, S.Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358(9296): 18721873
[25]Martin, R.Kapoor, K.Wilton, L.Mann, R.Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study. BMJ 1998; 317(7151): 119120

Keywords

Utilisation of extended release quetiapine (Seroquel XL™): Results from an observational cohort study in England

  • V. Osborne (a1), M. Davies (a1), D. Layton (a1) and S.A.W. Shakir (a1)

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed.

Utilisation of extended release quetiapine (Seroquel XL™): Results from an observational cohort study in England

  • V. Osborne (a1), M. Davies (a1), D. Layton (a1) and S.A.W. Shakir (a1)
Submit a response

Comments

No Comments have been published for this article.

×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *