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Changes in antipsychotic use among patients with severe mental illness after a Food and Drug Administration advisory.

ABSTRACT: A 2003 Food and Drug Administration advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). After the advisory, a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness.We created a retrospective cohort using Florida Medicaid's claims from 2001 to 2006. We included non-Medicare eligible adults with bipolar disorder or schizophrenia who filled an SGA prescription. We assessed changes in overall and agent-specific use, discontinuations, interruptions, and therapeutic alternative use among prevalent users and agent-specific use among incident users. Pre-advisory utilization was compared with utilization initially after the advisory and two subsequent periods.Among prevalent users, overall SGA use decreased slightly, and no increases in treatment interruptions or discontinuations were observed after the advisory and consensus statement publication. Compared with the pre-advisory period, in the months immediately after the advisory, the use of the highest metabolic-risk agent, olanzapine, decreased by 34% among prevalent users with bipolar disorder (adjusted risk ratio [aRR]?=?0.66, 95%CI?=?0.59-0.74) and 26% among prevalent users with schizophrenia (aRR?=?0.74, 95%CI?=?0.72-0.76). A greater decrease was estimated among incident users with bipolar disorder (aRR?=?0.37, 95%CI?=?0.29-0.47) and schizophrenia (aRR?=?0.42, 95%CI?=?0.35-0.51) during this period. During each subsequent post-advisory period, olanzapine use continued to decrease whereas quetiapine, ziprasidone, and aripiprazole use increased.The metabolic risk advisory and the published consensus statement were associated with a selective reduction in olanzapine use without evidence of treatment disruptions among this population.

SUBMITTER: Dusetzina SB

PROVIDER: S-EPMC3431449 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Changes in antipsychotic use among patients with severe mental illness after a Food and Drug Administration advisory.

Dusetzina Stacie B SB Busch Alisa B AB Conti Rena M RM Donohue Julie M JM Alexander G Caleb GC Huskamp Haiden A HA

Pharmacoepidemiology and drug safety 20120503 12

<h4>Purpose</h4>A 2003 Food and Drug Administration advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). After the advisory, a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness.<h4>Methods</h4>We created a retrospective cohort ...[more]

PMID: 22553074

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Project description:Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns.ContextThe Food and Drug Administration (FDA) convenes advisory committees to provide external scientific counsel on potential agency actions and to inform regulatory decision making. The degree to which advisory committees and their respective agency divisions disagree on recommendations has not been well characterized across product and action types.MethodsWe examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015. We classified the 376 voting meetings in that period by medical product, regulatory, and advisory committee meeting characteristics. We used multivariable logistic regression to determine the associations between these characteristics and discordance between the advisory committee's recommendations and the FDA's final actions.FindingsTwenty-two percent of the FDA's final actions were discordant with the advisory committee's recommendations. Of these, 75% resulted in the FDA making more restrictive decisions after favorable committee recommendations, and 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations. Discordance was associated with lower degrees of advisory committee consensus and was more likely for agency actions focused on medical product safety than for novel approvals or supplemental indications. Statements by public speakers, advisory committee conflicts of interest, and media coverage were not associated with discordance between the committee and the agency.ConclusionsThe FDA disagrees with the recommendation of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions. Deviations from recommendations thus offer an opportunity to understand the factors influencing decisions made by both the agency and its expert advisory groups.

Project description:Background: Schizophrenia (SCZ) and bipolar disorder (BD) are severe mental illnesses (SMI) associated with elevated cardiovascular disease (CVD) risk, including obesity. Leptin and adiponectin are secreted by adipose tissue, with pro- and anti-inflammatory properties, respectively. The second generation antipsychotics (AP) olanzapine, clozapine, and quetiapine have been associated with high leptin levels in SMI. However, the link between inflammatory dysregulation of leptin and adiponectin and CVD risk in SMI, and how this risk is influenced by body mass and AP medication, is still not completely understood. We investigated herein if leptin, adiponectin or their ratio (L/A ratio) could predict increased CVD risk in SCZ, BD, and in subgroups according to use of antipsychotic (AP) treatment, independent of other cardio-metabolic risk factors. Methods: We measured fasting plasma levels of leptin and adiponectin, and calculated the L/A ratio in n = 1,092 patients with SCZ and BD, in subgroups according to AP treatment, and in n = 176 healthy controls (HC). Differences in the levels of adipokines and L/A between groups were examined in multivariate analysis of covariance, and the correlations between adipokines and body mass index (BMI) with linear regression. CVD risk was defined by total cholesterol/high-density lipoprotein (TC/HDL) and triglyceride/HDL (TG/HDL) ratios. The adipokines and L/A ratios ability to discriminate individuals with TG/HDL and TC/HDL ratios above threshold levels was explored by ROC analysis, and we investigated the possible influence of other cardio-metabolic risk factors on the association in logistic regression analyses. Results: We observed higher leptin levels and L/A ratios in SMI compared with HC but found no differences in adiponectin. Both adipokines were highly correlated with BMI. The low adiponectin levels showed a fair discrimination in ROC analysis of individuals with CVD risk, with AUC between 0.7 and 0.8 for both TC/HDL and TG/HDL, in all groups examined regardless of diagnosis or AP treatment. Adiponectin remained significantly associated with an elevated TC/HDL and TG/HDL ratio in SMI, also after further adjustment with other cardio-metabolic risk factors. Conclusions: Adiponectin is not dysregulated in SMI but is associated with CVD risk regardless of AP treatment regime.

Project description:Importance:Atypical antipsychotics (AAPs) are often used off-label to manage dementia-associated neuropsychiatric symptoms. In 2005, the US Food and Drug Administration (FDA) issued a boxed warning for the use of AAPs in elderly patients. The long-term association of this warning with health outcomes is unknown to date. Objective:To assess the long-term association of the 2005 FDA boxed warning on AAPs with psychiatric medication and opioid use, health events, and quality of life among elderly individuals with dementia. Design, Setting, and Participants:For this cross-sectional study, data were analyzed from the household component of the Medical Expenditure Panel Survey (MEPS), the National Ambulatory Medical Care Survey (NAMCS), and the National Hospital Ambulatory Medical Care Survey (NHAMCS) fielded between January 1, 1996, and December 31, 2014. This interrupted time-series analysis applied to 3-year moving means derived from the 1996-2014 MEPS, NAMCS, and NHAMCS. All survey respondents included in this analysis were 65 years or older and had dementia. Data analysis was performed from December 1, 2017, to March 15, 2018. Exposures:The 2005 FDA boxed warning on AAPs. Main Outcomes and Measures:Use of psychiatric medications and opioids, prevalence of cerebrovascular and cardiovascular events, prevalence of falls and/or fractures, 2-year mortality, and health-related quality of life assessed by the Medical Outcomes Study 12-Item Short-Form Health Survey scores. Results:A total of 2430 (MEPS) and 5490 (NAMCS and NHAMCS) respondents were identified, corresponding to weighted populations of 22 996 526 (MEPS) and 65 502 344 (NAMCS and NHAMCS) noninstitutionalized elderly individuals with dementia (mean [SD] age, 81.06 [1.13] years; 63.1% female). In the MEPS sample, compared with before 2005, AAP use (from an annual slope of 0.99 to -0.18 percentage points), cerebrovascular events (0.75 to -0.50 percentage points), and falls and/or fractures (-1.72 to -0.40 percentage points) decreased and opioid use (0.04 to 1.29 percentage points), antiepileptic use (-0.42 to 1.21 percentage points), cardiovascular events (-0.13 to 1.30 percentage points), and 2-year mortality risk (-0.68 to 0.18 percentage points) increased. Health-related quality of life remained relatively unchanged. The NAMCS and NHAMCS sample yielded similar findings. Conclusions and Relevance:These data suggest that the 2005 FDA boxed warning was associated with some unintended negative patient outcomes.

Project description:BACKGROUND:Severe mental illness (SMI) is associated with increased risk for type 2 diabetes, partly due to adverse metabolic effects of antipsychotic medications. In public health care settings, annual screening rates are 30%. We measured adherence to national diabetes screening guidelines for patients taking antipsychotic medications. OBJECTIVE:To estimate diabetes screening prevalence among patients with SMI within an integrated health care system, and to assess characteristics associated with lack of screening. DESIGN:Retrospective cohort study. PARTICIPANTS:Antipsychotic-treated adults with SMI. We excluded participants with known diabetes. MAIN MEASURES:Primary outcome was screening via fasting glucose test or hemoglobin A1c during a 1-year period. KEY RESULTS:In 2014, 16,754 patients with SMI diagnoses were receiving antipsychotics. Seventy-four percent of these patients' providers ordered diabetes screening tests that year, but only 55% (9247/16,754) received screening. When the observation time frame was extended to 2 years, 73% (12,250/16,754) were screened. Adjusting for sex and race/ethnicity, young adults (aged 18-29 years) were less likely to receive screening than older age groups [adjusted RR (aRR) 1.23-1.57, p < 0.0001]. Compared to whites, screening was more common for Asians (aRR 1.141, 95% CI 1.089-1.195, p < 0.0001), less common for blacks (aRR 0.946, 95% CI 0.898-0.997, p < 0.0375), and no different for Hispanics (aRR 1.030, 95% CI 0.988-1.074, p = 0.165). Smokers were less likely to be screened than non-smokers (aRR 0.93, 95% CI 0.89-0.97, p < 0.0008). Utilization of either mental health or primary care services increased the likelihood of screening. CONCLUSIONS:While almost three-fourths of adults with SMI taking antipsychotic medications received a lab order for diabetes screening, only 55% received screening within a 12-month period. Young adults and smokers were less likely to be screened, despite their disproportionate metabolic risk. Future studies should assess the barriers and facilitators with regard to diabetes screening in this vulnerable population at the patient, provider, and system levels.

Project description:Interventions: We are assessing the impact of the National Bowel Cancer Screening Program (NBCSP) by comparing participation rates of people with and without Severe Mental Illness (SMI) and looking at health outcomes. We will be using data collected from Aug 2006 - latest available. We are linking data using Commonwealth data (NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database & the National Death Index) to compare bowel cancer screening participation in people with SMI to those from the general population. We will additionally link these to the NSW cancer registry and hospital data to examine care pathways from diagnosis through treatment and end-of-life care. We will also conduct a consultation with people with experience of SMI and Colorectal cancer and people with SMI in peer support roles who can provide their perspective on the barriers faced by people with SMI to gaining timely screening, diagnosis and optimal care. These participants will be recruited from New South Wales consumer organisations and organisations with a strong focus on provision of peer support and advocacy. We will use a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5). We will use this qualitative arm of the study to further develop our understanding of the quantitative findings. The consultation will also develop ideas on how to improve access to care. Primary outcome(s): Participation rates in the National Bowel Cancer Screening Program assessed using data from the NBCSP.[Person-years will be calculated from entry into the study (2006) (the date of commencement of the NBCSP) or from the year that people become eligible for screening (i.e. age 50), whichever occurs later.. This is a retrospective cohort study, so all of the outcomes have already occurred and were recorded in the administrative data. This will be assessed when we receive the data.];Colonoscopy rates assessed using data from the NBCSP [Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until colonoscopy. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.];Cancer diagnosis using data from the Australian Cancer Database[Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until cancer diagnosis. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Case control;Timing: Both

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Changes in antipsychotic use among patients with severe mental illness after a Food and Drug Administration advisory.

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Changes in antipsychotic use among patients with severe mental illness after a Food and Drug Administration advisory.

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