Results from a drug utilization study of extended release quetiapine fumarate prescribed by psychiatrists as treatment for major depressive disorder in selected countries in the European Union.

This multicenter, observational drug utilization (DU) study (NCT01594996) investigated the profile of patients and specialist providers who prescribed extended release quetiapine fumarate (quetiapine XR) for treatment of major depressive disorder (MDD) across five European countries (Germany, Italy, Romania, Spain, and Sweden). A DU data abstraction form captured information on the characteristics of physicians, patients, and drugs utilized in the medical management of depressive episodes in MDD, where the therapeutic regimen included quetiapine XR. Data were reported descriptively. This analysis included 811 patients. Psychiatric histories indicated a burden of severe MDD in these patients. Patient demographics were similar across countries; however, those in Sweden had a younger mean age. Physicians' ratings of the therapeutic effect of prior treatment with antidepressants suggested the need for an add-on treatment for most patients. Overall, 15.7% of patients initiated quetiapine XR treatment as monotherapy. Presence of psychotic symptoms during depressive episodes predicted treatment with higher than recommended doses of quetiapine XR (odds ratio=3.11; 95% confidence interval: 1.6-6.0). This analysis demonstrated similarities in DU across the countries analyzed, largely in accordance with the recommended dose of quetiapine XR as an adjunctive therapy to antidepressants in MDD (50-300 mg/day).

Incidence of live-attenuated influenza vaccine administration beyond expiry date in children and adolescents aged 2-17 years in the UK: a population-based cohort study.

OBJECTIVES: To estimate the proportion of live-attenuated influenza vaccine (LAIV) doses administered beyond expiry date in children and adolescents during influenza seasons 2013-2014 and 2014-2015 in the UK. DESIGN: This was a retrospective cohort study. Two cohorts of children and adolescents who received LAIV from 1 September 2013 to 31 March 2014 and from 1 September 2014 to 31 March 2015 and aged 2-17 years at time of LAIV administration were identified from the Clinical Practice Research Datalink (CPRD). SETTING: More than 500 primary care practices in the UK. POPULATION: Proportions of vaccine doses administered beyond expiry date were assessed among 47 396 and 67 099 LAIV recipients with a documented vaccine lot identifier in influenza seasons 2013-2014 and 2014-2015, respectively. INTERVENTION: None. MAIN OUTCOME MEASURE: Administrations of expired LAIV were ascertained by comparison of vaccination dates in CPRD records with expiration dates in AstraZeneca/MedImmune lot distribution data. RESULTS: Overall, 245 LAIV recipients, 80 in 2013-2014 and 165 in 2014-2015, received a dose after its expiration date, yielding proportion estimates of 1.7 per 1000 doses (95% CI 1.3 to 2.1) in season 2013-2014 and 2.5 per 1000 (95% CI 2.1 to 2.8) in season 2014-2015. This proportion increased above 1.0% after December during each season. Most (84% in influenza season 2013-2014 and 59% in influenza season 2014-2015) received an expired dose <30 days after its expiration date. The proportion was higher in London (relative risk 1.93 (95% CI 1.25 to 2.99)) and when the number of LAIV recipients registered in the practice was lower than the median number per practice (relative risk 2.69 (95% CI 1.99 to 3.62)). CONCLUSIONS: Administration of expired LAIV doses occurs infrequently.

Effectiveness of a risk-minimization activity involving physician education on metabolic monitoring of patients receiving quetiapine: results from two postauthorization safety studies.

Following Good Pharmacovigilance Practices Module XVI, two complementary studies were performed that included process and outcome measurements of the effectiveness of physician education on metabolic monitoring of patients receiving quetiapine. A multinational survey of 800 European Union physicians was utilized to assess the receipt of educational materials and also to assess the degree of monitoring as reported by physicians. Recall of receipt of educational materials ranged from 16.0 to 69.0% across the participating countries; however, physicians reported that 64.5% of patients were being monitored, with the majority reporting performance of three or more of four key metabolic-monitoring activities. Higher rates of monitoring were reported by those who reported receiving materials. Assessment of outcomes in a separate retrospective analysis of electronic medical record data showed lower levels of monitoring performed by specialist physicians. The monitoring activities observed were assessed as acceptable on the basis of the established performance of UK physicians, who are incentivized to deliver preventive screening.

Treatment patterns, healthcare resource utilization and costs in patients with bipolar disorder, newly treated with extended release or immediate release quetiapine fumarate using US healthcare administrative claims data.

BACKGROUND: Differences in treatment patterns, health care resource use, and costs are expected among patients newly treated with quetiapine extended release (XR) or quetiapine immediate release (IR). OBJECTIVE: To compare treatment patterns, health care resource use, and costs in patients with bipolar disorder newly treated with quetiapine XR or quetiapine IR. METHODS: This was an observational, retrospective cohort study that used HealthCore Integrated Research Database-identified patients (age range, 18-64 years) with an International Classification of Disease, Ninth Revision diagnosis of bipolar disorder and ≥1 pharmacy claim for quetiapine XR or quetiapine IR between October 2, 2008, and July 31, 2010. Outcomes were as follows: patient characteristics at the index date (first claim for quetiapine XR or quetiapine IR); 12-month preindex clinical characteristics, health care resource use, and costs; and 12-month postindex treatment patterns, health care resource use, and costs, assessed using generalized linear models (adjusted for index date and preindex patient demographic characteristics, clinical characteristics, health care resource use, and costs). RESULTS: In total, 3049 patients with bipolar disorder were analyzed (651 in the quetiapine XR group and 2398 in the quetiapine IR group). Of patients initiating treatment with quetiapine XR, 8.8% had no change in or discontinuation of their index therapy compared with 5.7% of patients treated with quetiapine IR (adjusted odds ratio, 1.44; 95% confidence interval, 1.03-2.00; P = 0.0317). The average daily dose (adjusted mean) of quetiapine XR was higher than quetiapine IR (225 vs 175 mg/d, P < 0.0001). An average daily dose of 300 to 800 mg was reached sooner (15.6 vs 30.8 days, P = 0.0049) and in more patients (44.2% vs 27.2%, P < 0.0001) who were taking quetiapine XR compared with patients taking quetiapine IR. No differences in total health care costs were found between the cohorts; however, patients taking quetiapine XR were less likely to be hospitalized for mental health-related reasons (12.1% vs 18.3%, P = 0.0022) and incurred lower mental health-related costs (US $6686 vs US $7577, P = 0.0063) compared with patients taking quetiapine IR. CONCLUSIONS: Treatment patterns and dosing differ in patients with bipolar disorder treated with quetiapine XR compared with those treated with quetiapine IR. Mental health-related hospitalizations and costs may be reduced in the 12 months after patients initiating treatment with quetiapine XR compared with initiating treatment with quetiapine IR.