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1.
Psychiatry Res ; 285: 112810, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-32062326

RESUMO

This study sought to: 1. determine the frequency of rehospitalization with diagnosis of suicidal ideation or suicide attempt (SI/SA) within a year and how often patients had multiple rehospitalizations; 2. identify the time period for which the risk of rehospitalization is highest; and 3. determine the characteristics of patients with multiple rehospitalizations. We conducted a retrospective cohort study of adults with depression using 4 US health claims databases. We defined hospitalization as an inpatient or emergency room visit with codes indicating a suicide attempt or suicidal thoughts using a validated algorithm. Rates of rehospitalization with SI or SA were analyzed together and separately, including multiple re-hospitalizations with SI/SA. Across all databases 121,065 patients were hospitalized with a diagnosis of SI/SA. Rates of rehospitalization within a year ranged from 7.96% to 11.24%. The risk of rehospitalization with SI/SA is highest during the first month. Nearly 50% of rehospitalizations occurred within 3 months after initial hospitalization. Patients with rehospitalization(s) had more anxiety disorders, sleep disorders and substance use disorders than patients without. Among patients with depression hospitalized for SI/SA, rehospitalization for SI/SA within a year is not uncommon. Risk of rehospitalization with a diagnosis of SI/SA is highest during the first month.

2.
PLoS One ; 15(2): e0228632, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32053653

RESUMO

OBJECTIVE: Some patients who are given opioids for pain could develop opioid use disorder. If it was possible to identify patients who are at a higher risk of opioid use disorder, then clinicians could spend more time educating these patients about the risks. We develop and validate a model to predict a person's future risk of opioid use disorder at the point before being dispensed their first opioid. METHODS: A cohort study patient-level prediction using four US claims databases with target populations ranging between 343,552 and 384,424 patients. The outcome was recorded diagnosis of opioid abuse, dependency or unspecified drug abuse as a proxy for opioid use disorder from 1 day until 365 days after the first opioid is dispensed. We trained a regularized logistic regression using candidate predictors consisting of demographics and any conditions, drugs, procedures or visits prior to the first opioid. We then selected the top predictors and created a simple 8 variable score model. RESULTS: We estimated the percentage of new users of opioids with reported opioid use disorder within a year to range between 0.04%-0.26% across US claims data. We developed an 8 variable Calculator of Risk for Opioid Use Disorder (CROUD) score, derived from the prediction models to stratify patients into higher and lower risk groups. The 8 baseline variables were age 15-29, medical history of substance abuse, mood disorder, anxiety disorder, low back pain, renal impairment, painful neuropathy and recent ER visit. 1.8% of people were in the high risk group for opioid use disorder and had a score > = 23 with the model obtaining a sensitivity of 13%, specificity of 98% and PPV of 1.14% for predicting opioid use disorder. CONCLUSIONS: CROUD could be used by clinicians to obtain personalized risk scores. CROUD could be used to further educate those at higher risk and to personalize new opioid dispensing guidelines such as urine testing. Due to the high false positive rate, it should not be used for contraindication or to restrict utilization.


Assuntos
Coleta de Dados/métodos , Informática Médica/métodos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adolescente , Adulto , Idoso , Algoritmos , Analgésicos Opioides/uso terapêutico , Área Sob a Curva , Dor Crônica/tratamento farmacológico , Estudos de Coortes , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Anamnese , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Dor , Doenças do Sistema Nervoso Periférico , Análise de Regressão , Medição de Risco , Fatores de Risco , Inquéritos e Questionários , Estados Unidos , Adulto Jovem
3.
JMIR Public Health Surveill ; 6(1): e13018, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31913130

RESUMO

BACKGROUND: Identifying the medical conditions that are associated with poor health is crucial to prioritize decisions for future research and organizing care. However, assessing the burden of disease in the general population is complex, lengthy, and expensive. Claims databases that include self-reported health status can be used to assess the impact of medical conditions on the health in a population. OBJECTIVE: This study aimed to identify medical conditions that are highly predictive of poor health status using claims databases. METHODS: To determine the medical conditions most highly predictive of poor health status, we used a retrospective cohort study using 2 US claims databases. Subjects were commercially insured patients. Health status was measured using a self-report health status response. All medical conditions were included in a least absolute shrinkage and selection operator regression model to assess which conditions were associated with poor versus excellent health. RESULTS: A total of 1,186,871 subjects were included; 61.64% (731,587/1,186,871) reported having excellent or very good health. The leading medical conditions associated with poor health were cancer-related conditions, demyelinating disorders, diabetes, diabetic complications, psychiatric illnesses (mood disorders and schizophrenia), sleep disorders, seizures, male reproductive tract infections, chronic obstructive pulmonary disease, cardiomyopathy, dementia, and headaches. CONCLUSIONS: Understanding the impact of disease in a commercially insured population is critical to identify subjects who may be at risk for reduced productivity and job loss. Claims database studies can measure the impact of medical conditions on the health status in a population and to assess changes overtime and could limit the need to collect prospective collection of information, which is slow and expensive, to assess disease burden. Leading medical conditions associated with poor health in a commercially insured population were the ones associated with high burden of disease such as cancer-related conditions, demyelinating disorders, diabetes, diabetic complications, psychiatric illnesses (mood disorders and schizophrenia), infections, chronic obstructive pulmonary disease, cardiomyopathy, and dementia. However, sleep disorders, seizures, male reproductive tract infections, and headaches were also part of the leading medical conditions associated with poor health that had not been identified before as being associated with poor health and deserve more attention.

4.
BMC Psychiatry ; 20(1): 4, 2020 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-31900133

RESUMO

BACKGROUND: Understanding how patients are treated in the real-world is vital to identifying potential gaps in care. We describe the current pharmacologic treatment patterns for the treatment of depression. METHODS: Patients with depression were identified from four large national claims databases during 1/1/2014-1/31/2019. Patients had ≥2 diagnoses for depression or an inpatient hospitalization with a diagnosis of depression. Patients were required to have enrollment in the database ≥1 year prior to and 3 years following their first depression diagnosis. Treatment patterns were captured at the class level and included selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, other antidepressants, anxiolytics, hypnotics/sedatives, and antipsychotics. Treatment patterns were captured during all available follow-up. RESULTS: We identified 269,668 patients diagnosed with depression. The proportion not receiving any pharmacological treatment during follow-up ranged from 29 to 52%. Of the treated, approximately half received ≥2 different classes of therapy, a quarter received ≥3 classes and more than 10% received 4 or more. SSRIs were the most common first-line treatment; however, many patients received an anxiolytic, hypnotic/sedative, or antipsychotic prior to any antidepressive treatment. Treatment with a combination of classes ranged from approximately 20% of first-line therapies to 40% of fourth-line. CONCLUSIONS: Many patients diagnosed with depression go untreated and many others receive a non-antidepressant medication class as their first treatment. More than half of patients received more than one type of treatment class during the study follow up, suggesting that the first treatment received may not be optimal for most patients.

5.
Pain Med ; 21(1): 92-100, 2020 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30877807

RESUMO

OBJECTIVE: To assess changes in mortality rates in extended-release and long-acting (ER/LA) opioid analgesics after the implementation of the Risk Evaluation and Mitigation Strategy (REMS). SETTING: All drug poisoning deaths in three states: Florida, Oregon, and Washington. Data were obtained through state vital records offices and the Researched Abuse, Diversion and Addiction-Related Surveillance System Medical Examiner Program. METHODS: Using cause-of-death literal text from death certificates, individual opioid active pharmaceutical ingredients (APIs) involved in each death were identified using rules-based natural language processing. Population-adjusted and prescriptions dispensed-adjusted mortality rates were calculated for all ER/LA opioid analgesic and individual opioid APIs. Rates before and after implementation of the REMS were compared. Rate changes were compared with rates from two APIs with little or no inclusion in the REMS: benzodiazepines and hydrocodone. RESULTS: The mean ER/LA opioid analgesic population-adjusted mortality rate significantly decreased in all three states (FL: P = 0.003; OR: P = 0.003; WA: P < 0.001). Mortality rates for benzodiazepines and hydrocodone also decreased and were not statistically different. Significant heterogeneity in mortality rates of individual opioids was observed between the three states. When adjusted for prescription volume, the ER/LA opioid analgesic mortality rate decreased in all three states, but was significant only for Washington (P < 0.001). CONCLUSIONS: The population-adjusted mortality rate of ER/LA opioid analgesics has decreased in three states. Notably, the contributions to mortality rates by individual opioid analgesics were not uniform across the three states in this study. However, these changes were not generally distinct from changes in mortality rates where comparator substances were involved.

6.
Postgrad Med ; 132(1): 44-51, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31721609

RESUMO

Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose).Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies.Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful.


Assuntos
Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Preparações de Ação Retardada/uso terapêutico , Vigilância de Produtos Comercializados , Medição de Risco/métodos , Gestão de Riscos/organização & administração , Overdose de Drogas/epidemiologia , Humanos , Estudos Observacionais como Assunto , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Projetos de Pesquisa , Estados Unidos/epidemiologia , United States Food and Drug Administration
7.
Subst Abuse Rehabil ; 10: 47-55, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31534380

RESUMO

Background: Doctor and pharmacy shopping ("Shopping") for opioids is related to opioid abuse and is associated with opioid overdose and death. Lacking identifiers for prescribers and pharmacies, many data resources (notably the US FDA's Sentinel System) cannot evaluate Shopping. We used data in which presumptive Shopping could be identified. We investigated whether US health insurance claims data could perform as well as Shopping to identify people with evidence for opioid abuse. Methods: In this cross-sectional study, we examined health insurance claims from 164,923 persons with at least two dispensing of opioids in 18 months, the first occurring in 2012. Evidence for the presence of a possible opioid abuse disorder was drawn from predictive patterns of drug fills, diagnoses and care-seeking identified in a companion research project, and Shopping was determined using a published index. The prevalence of presumptive opioid abuse was examined across levels of Shopping. The comparison between Shopping and insurance-claims-derived covariates in the detection of apparent opioid abuse was examined in multiple regression analyses. Results: Despite a strong correlation between presumptive opioid abuse and Shopping, most persons with extensive Shopping did not manifest presumptive opioid abuse, and half of the population with presumptive opioid abuse did not exhibit Shopping. As Shopping ranged from "None" to "Extensive," the prevalence of presumptive opioid abuse increased from 0.28 to 5.0 per 100. The discriminating power of Shopping for identifying opioid abuse could be replaced using insurance claims data. Conclusion: The results suggest that patient characteristics that can be inferred from insurance claims data provide as complete discrimination of persons with presumptive opioid abuse as does a full assessment of doctor and pharmacy shopping. The inference rests on patterns of health services and drug dispensing that are indicative of doctor-pharmacy shopping and of opioid abuse. There was no direct evaluation of patients. The extent to which the conclusions are generalizable beyond the study population - Americans with health insurance coverage in the early part of this decade - is uncertain in a quantitative sense. The qualitative conclusion is that diagnostic data in health insurance databases can be predictive of behaviors consistent with opioid abuse and that more elaborate indices such as doctor and pharmacy shopping may add little.Registration: ClinicalTrials.gov study number: NCT02668549.

8.
BMC Pregnancy Childbirth ; 19(1): 323, 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31477032

RESUMO

BACKGROUND: Peripartum depression is a leading cause of disease burden for women and yet there is little evidence as to how often peripartum depression does not respond to treatment and becomes treatment resistant depression. We sought to determine the incidence of treatment resistant depression (TRD) in women with peripartum depression. METHODS: Population based retrospective cohort study using a large US claims database. Peripartum depression was defined as having a depression diagnosis during pregnancy or up to 6 months after the end of pregnancy. We included women with prevalent or incident depression. The outcome was the development of TRD within 1 year after the diagnosis of peripartum depression. TRD was defined as having 3 distinct antidepressants or 1 antidepressant and 1 antipsychotic in 1 year. Women with peripartum depression may not be exposed to pharmacological treatments early in pregnancy, therefore we created two groups: 1. women with peripartum depression, and 2. women with peripartum depression diagnosed 3 months before a live birth delivery or within 6 months after that delivery. RESULTS: There were 3,207,684 pregnant women, of whom 2.5% had peripartum depression. Of these women half had incident depression during pregnancy. Five percent of women with peripartum depression developed TRD within 1 year of the depression diagnosis. The risk of developing TRD was 50% higher in women with prevalent depression than in women with incident peripartum depression (P < 0.0001). Results were similar in women with peripartum depression diagnosed later in their pregnancy. Women who went on to develop TRD had more substance use disorders, anxiety, insomnia and painful conditions. CONCLUSIONS: TRD occurs in approximately 5% of women with peripartum depression. The risk of TRD is higher in pregnant women with a history of depression. Women who went on to develop TRD had more psychiatric comorbidities and painful conditions than women who did not.


Assuntos
Depressão Pós-Parto/epidemiologia , Transtorno Depressivo Resistente a Tratamento/epidemiologia , Complicações na Gravidez/epidemiologia , Adolescente , Adulto , Antidepressivos/uso terapêutico , Antipsicóticos/uso terapêutico , Transtornos de Ansiedade/epidemiologia , Estudos de Coortes , Comorbidade , Depressão Pós-Parto/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Dor/epidemiologia , Período Periparto , Gravidez , Complicações na Gravidez/tratamento farmacológico , Prevalência , Estudos Retrospectivos , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Estados Unidos/epidemiologia , Adulto Jovem
9.
J Pain Res ; 12: 2291-2303, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31413626

RESUMO

Objectives: Doctor/pharmacy shopping, the practice of seeking prescriptions from multiple healthcare sources without their coordination, may be a measure of prescription medicine abuse. This cross-sectional study examined the relationship between a claims-based doctor/pharmacy shopping definition and medical record documented behaviors suggestive of misuse, diversion, abuse and/or addiction. Methods: Patients with ≥2 opioid dispensings starting in 2012 in a US administrative claims database were grouped into doctor/pharmacy shopping categories by number of providers and pharmacies used over 18 months: no shopping, minimal shopping, moderate shopping and severe shopping. Medical charts of opioid prescribers were reviewed to identify behaviors suggestive of misuse, diversion, abuse and/or addiction. Results: Among 581,940 opioid users, 78% were classified as no shopping, 11% minimal shopping, 8% moderate shopping and 3% severe shopping. Almost 40% of severe shopping patients had no medical record documented behaviors (positive predictive value: 24.3%). Compared with no shopping, the odds ratio [OR] of ≥3 behaviors was 1.70 (95% confidence interval [CI] 0.50-5.78) for minimal shopping, 1.81 (95% CI 0.54-6.03) for moderate shopping, and 8.93 (95% CI 3.12-25.54) for severe shopping. Conclusions: Claims-identified severe doctor/pharmacy shopping was strongly associated with behaviors suggestive of misuse, diversion, abuse and/or addiction, but the proportion of medical records documenting these was low.

10.
Clin Drug Investig ; 39(11): 1067-1075, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31327127

RESUMO

BACKGROUND: Parkinson's disease is a disorder growing in prevalence, disability, and deaths. Healthcare databases provide a 'real-world' perspective for millions of individuals. We envisioned helping accelerate drug discovery by using these databases. OBJECTIVES: The objectives of this study were to assess the association of marketed medications with the risk of parkinsonism in four US claims databases and to evaluate the consistency of the association of ß-adrenoreceptor modulation with parkinsonism. METHODS: The study was conducted using a self-controlled cohort design in which subjects served as their own control. The time from treatment initiation until discontinuation or end of observation was the exposed period and a similar time preceding medication was the unexposed period. Medications were studied at ingredient and class level. The incidence rate ratio (IRR) and combined IRR were calculated. RESULTS: We assessed 2181 drugs and 117,015,066 people. Diphenhydramine, isradipine, methylphenidate, armodafinil, and modafinil were associated with reduced risk for parkinsonism in at least two databases. Armodafinil, modafinil, methylphenidate, and the ß-agonist albuterol were associated with a 56%, 54%, 39%, and 17% reduction in the risk of having parkinsonism, respectively. Isradipine results were heterogeneous and no significant association was found. Propranolol was associated with a 32% increased risk, the only ß-adrenoceptor antagonist (ß-blocker) associated with an increased risk. CONCLUSIONS: Armodafinil, modafinil, and methylphenidate were associated with a decreased risk of parkinsonism, as were ß-agonists. Of the ß-blockers, only propranolol was associated with increased risk. Healthcare database analyses that incorporate scientific rigor provide insight and direction for drug discovery efforts. These findings show association not causality; however, they offer considerable support to the association between ß-adrenergic receptor modulation and risk of Parkinson's disease.


Assuntos
Antiparkinsonianos/uso terapêutico , Descoberta de Drogas/métodos , Doença de Parkinson Secundária/induzido quimicamente , Doença de Parkinson Secundária/diagnóstico , Vigilância de Produtos Comercializados/métodos , Antagonistas Adrenérgicos beta/efeitos adversos , Adulto , Estudos de Coortes , Bases de Dados Factuais/normas , Feminino , Humanos , Masculino , Metilfenidato/efeitos adversos , Modafinila/efeitos adversos , Doença de Parkinson Secundária/prevenção & controle
11.
Int Neurourol J ; 23(1): 40-45, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30943693

RESUMO

PURPOSE: To identify risk factors for interstitial cystitis (IC), a chronic bladder disorder that may have a significant detrimental impact on quality of life, in the general population and in individuals with depression. METHODS: This was a comparative study using a US claims database. Adults who had records of a visit to the health system in 2010 or later were included. The outcome was the development of IC within 2 years after the index date. The index date for the general population was the first outpatient visit, and for individuals with depression, it was the date of the diagnosis of depression. IC was defined using the concepts of ulcerative and IC. We included all medical conditions present any time prior to the index visit as potential risk factors. RESULTS: The incidence of IC was higher in individuals with depression than in the general population. Of the 3,973,000 subjects from the general population, 2,293 (0.06%) developed IC within 2 years. Of the 249,200 individuals with depression, 320 (0.13%) developed IC. The characteristics of the individuals who developed IC were similar in both populations. Those who developed IC were slightly older, more likely to be women, and had more chronic pain conditions, malaise, and inflammatory disorders than patients without IC. In the general population, subjects who developed IC were more likely to have mood disorders, anxiety, and hypothyroidism. CONCLUSION: The incidence of IC was higher in individuals with depression. Subjects who developed IC had more chronic pain conditions, depression, malaise, and inflammatory disorders.

13.
Heliyon ; 4(7): e00707, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30094377

RESUMO

Background: Health services databases provide population-based data that have been used to describe the epidemiology and costs of treatment resistant depression (TRD). This retrospective cohort study estimated TRD incidence and, via sensitivity analyses, assessed the variation of TRD incidence within the range of implementation choices. Methods: In three US databases widely used for observational studies, we defined TRD as failure of two medications as evidenced by their replacement or supplementation by other medications, and set maximum durations (caps) for how long a medication regimen could remain in use and still be eligible to fail. Results: TRD incidence estimates varied approximately 2-fold between the two databases (CCAE, Medicaid) that described socioeconomically different non-elderly populations; for a given cap varied 2-fold to 4-fold within each database across the other implementation choices; and if the cap was also allowed to vary, varied 6-fold or 7-fold within each database. Limitations: The main limitations were typical of studies from health services databases and included the lack of complete -rather than recent - medical histories, the limited amount of clinical information, and the assumption that medication dispensed was consumed as directed. Conclusion: In retrospective cohort studies from health services databases, TRD incidence estimates vary widely depending on the implementation choices. Unless a firm basis for narrowing the range of these choices can be found, or a different analytic approach not dependent on such choices is adopted, TRD incidence and prevalence estimates from such databases will be difficult to compare or interpret.

14.
Depress Anxiety ; 35(7): 668-673, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29786922

RESUMO

BACKGROUND: Treatment for depressive disorders often requires subsequent interventions. Patients who do not respond to antidepressants have treatment-resistant depression (TRD). Predicting who will develop TRD may help healthcare providers make more effective treatment decisions. We sought to identify factors that predict TRD in a real-world setting using claims databases. METHODS: A retrospective cohort study was conducted in a US claims database of adult subjects with newly diagnosed and treated depression with no mania, dementia, and psychosis. The index date was the date of antidepressant dispensing. The outcome was TRD, defined as having at least three distinct antidepressants or one antidepressant and one antipsychotic within 1 year after the index date. Predictors were age, gender, medical conditions, medications, and procedures 1 year before the index date. RESULTS: Of 230,801 included patients, 10.4% developed TRD within 1 year. TRD patients at baseline were younger; 10.87% were between 18 and 19 years old versus 7.64% in the no-TRD group, risk ratio (RR) = 1.42 (95% confidence interval [CI] 1.37-1.48). TRD patients were more likely to have an anxiety disorder at baseline than non-TRD patients, RR = 1.38 (95% CI 1.35-1.14). At 3.68, fatigue had the highest RR (95% CI 3.18-4.25). TRD patients had substance use disorders, psychiatric conditions, insomnia, and pain more often at baseline than non-TRD patients. CONCLUSION: Ten percent of subjects newly diagnosed and treated for depression developed TRD within a year. They were younger and suffered more frequently from fatigue, substance use disorders, anxiety, psychiatric conditions, insomnia, and pain than non-TRD patients.


Assuntos
Transtornos de Ansiedade/epidemiologia , Transtorno Depressivo Resistente a Tratamento/epidemiologia , Fadiga/epidemiologia , Dor/epidemiologia , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adolescente , Adulto , Fatores Etários , Antidepressivos/uso terapêutico , Antipsicóticos/uso terapêutico , Transtornos de Ansiedade/psicologia , Estudos de Coortes , Comorbidade , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/psicologia , Fadiga/psicologia , Feminino , Humanos , Masculino , Razão de Chances , Dor/psicologia , Estudos Retrospectivos , Fatores de Risco , Distúrbios do Início e da Manutenção do Sono/psicologia , Transtornos Relacionados ao Uso de Substâncias/psicologia , Adulto Jovem
15.
PLoS One ; 13(2): e0193453, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29489906

RESUMO

BACKGROUND: Observational studies of switching from branded to generic formulations of the same drug substance often lack appropriate comparators for the subjects who switched. Three generic formulations were deemed equivalent to Concerta: an authorized generic (AG) identical except for external packaging, and two other generics (EG). OBJECTIVE: Compare the incidence of a combined endpoint (switching back to Concerta, changing the use of immediate release methylphenidate (MPH), stopping all long-acting methylphenidate, or starting a new medication) among people switched from Concerta to the AG versus the EG. METHODS: Cohort study from the Truven CCAE database of people aged 6 to 65 diagnosed with ADHD, treated with Concerta, and switched to the EG or to the AG formulation. RESULTS: In the EG arm 24.6% and in the AG arm 19.7% of subjects switched back to Concerta. The proportion of subjects meeting the combined endpoint was 39.5% in the EG arm, 32.9% in the AG arm, a crude risk ratio of 1.20 (95% CI 0.94, 1.54). After adjustment by propensity score stratification, the adjusted odds ratio (OR) was 1.23 (95% CI 0.90, 1.70). In an unplanned analysis using a different method of adjustment, the adjusted OR was 1.00 (95% CI 0.69, 1.44). DISCUSSION: This study did not detect a difference between the proportion of people who met the study endpoint in the two study arms, i.e. between those who switched to a generic formulation that was identical to Concerta except for external packaging and those who switched to the comparison generics. The high incidence of the combined endpoint in the AG arm demonstrates the need for an appropriate comparator in studies of this type. TRIAL REGISTRATION: ClinicalTrials.gov NCT02730572.


Assuntos
Bases de Dados Factuais , Medicamentos Genéricos/uso terapêutico , Metilfenidato/uso terapêutico , Adulto , Estudos de Coortes , Preparações de Ação Retardada , Composição de Medicamentos , Medicamentos Genéricos/administração & dosagem , Feminino , Humanos , Masculino , Metilfenidato/administração & dosagem , Estudos Retrospectivos , Adulto Jovem
16.
Depress Anxiety ; 35(3): 220-228, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29244906

RESUMO

BACKGROUND: Depression that does not respond to antidepressants is treatment-resistant depression (TRD). TRD definitions include assessments of treatment response, dose and duration, and implementing these definitions in claims databases can be challenging. We built a data-driven TRD definition and evaluated its performance. METHODS: We included adults with depression, ≥1 antidepressant, and no diagnosis of mania, dementia, or psychosis. Subjects were stratified into those with and without proxy for TRD. Proxies for TRD were electroconvulsive therapy, deep brain, or vagus nerve stimulation. The index date for subjects with proxy for TRD was the procedure date, and for subjects without, the date of a randomly selected visit. We used three databases. We fit decision tree predictive models. We included number of distinct antidepressants, with and without adequate doses and duration, number of antipsychotics and psychotherapies, and expert-based definitions, 3, 6, and 12 months before index date. To assess performance, we calculated area under the curve (AUC) and transportability. RESULTS: We analyzed 33,336 subjects with no proxy for TRD, and 3,566 with the proxy. Number of antidepressants and antipsychotics were selected in all periods. The best model was at 12 months with an AUC = 0.81. The rule transported well and states that a subject with ≥1 antipsychotic or ≥3 antidepressants in the last year has TRD. Applying this rule, 15.8% of subjects treated for depression had TRD. CONCLUSION: The definition that best discriminates between subjects with and without TRD considers number of distinct antidepressants (≥3) or antipsychotics (≥1) in the last year.


Assuntos
Antidepressivos/uso terapêutico , Antipsicóticos/uso terapêutico , Transtorno Depressivo Resistente a Tratamento/diagnóstico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Heurística , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
17.
J Opioid Manag ; 13(3): 157-168, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28829517

RESUMO

OBJECTIVE: The Food and Drug Administration approved the extended-release/long-acting (ER/LA) opioid analgesics risk evaluation and mitigation strategies (REMS) in July 2012 to educate healthcare providers and patients about safe and appropriate opioid analgesic use. The authors evaluated the impact of the REMS on ER/LA opioid analgesic utilization, overall and stratified by patient characteristics and prescriber type associated with greater expected need for analgesia. DESIGN: Retrospective repeated cross-sectional study. QuintilesIMS's National Prescription Audit™ and LifeLink™ patient-level longitudinal prescription databases measured prescription volumes, projected to national estimates. MAIN OUTCOME MEASURES: Changes were assessed in ER/LA opioid analgesic prescriptions dispensed from the 2-year pre-REMS implementation (July 2010 to June 2012) to the 18-month post-REMS implementation (July 2013 to December 2014) periods (with 12-month transitional implementation period in between). RESULTS: Average quarterly ER/LA opioid prescription volume significantly decreased by 4.3 percent from Preimple-mentation to the Active Period (5.58 vs 5.34 million, p < 0.001). Differences in prescription volume change were observed between age, gender, and payer types. Prescription volume either significantly decreased or remained stable from Preimplementation to the Active Period among most provider specialties evaluated. The largest volume decreases were observed for dentists (-48.5 percent) and emergency medicine specialists (-25.5 percent) (both p < 0.001). The largest increases were observed for nurse practitioners (+33.7 percent) and physician assistants (+31.2 percent; both p < 0.001), whose overall prescribing of nonopioid medications also increased. CONCLUSIONS: A significant decrease in dispensed ER/LA opioid prescriptions was observed following REMS implementation compared to Preimplementation. The impact on volume varied by patient characteristics and prescriber specialty. The REMS program, in conjunction with other healthcare policies and initiatives, likely influenced these observations.


Assuntos
Analgésicos Opioides/efeitos adversos , Controle de Medicamentos e Entorpecentes/tendências , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Medicamentos sob Prescrição/efeitos adversos , Avaliação de Risco e Mitigação , Adolescente , Adulto , Idoso , Analgésicos Opioides/química , Criança , Pré-Escolar , Estudos Transversais , Preparações de Ação Retardada , Composição de Medicamentos , Prescrições de Medicamentos , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Medicina de Emergência/tendências , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Profissionais de Enfermagem/tendências , Assistentes Médicos/tendências , Padrões de Prática Odontológica/tendências , Padrões de Prática em Enfermagem/tendências , Padrões de Prática Médica/tendências , Medicamentos sob Prescrição/química , Avaliação de Programas e Projetos de Saúde , Estudos Retrospectivos , Avaliação de Risco e Mitigação/legislação & jurisprudência , Fatores de Risco , Estados Unidos , Adulto Jovem
18.
Pharmacoepidemiol Drug Saf ; 26(9): 1061-1070, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28758289

RESUMO

PURPOSE: An unintended consequence of extended-release (ER) and long-acting (LA) prescription opioids is that these formulations can be more attractive to abusers than immediate-release (IR) formulations. The US Food and Drug Administration recognized these risks and approved the ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (ER/LA REMS), which has a goal of reducing opioid misuse and abuse and their associated consequences. The primary objective of this analysis is to determine whether ER/LA REMS implementation was associated with decreased reports of misuse and abuse. METHODS: Data from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS(R)) System Poison Center Program were utilized. Poison center cases are assigned a reason for exposure, a medical outcome, and a level of health care received. Rates adjusted for population and drug utilization were analyzed over time. RESULTS: RADARS System Poison Center Program data indicate a notable decrease in ER/LA opioid rates of intentional abuse and misuse as well as major medical outcomes or hospitalizations following implementation of the ER/LA REMS. CONCLUSIONS: While similar decreases were observed for the IR prescription opioid group, the decreasing rate for the ER/LA opioids exceeded the decreasing rates for the IR prescription opioids and was distinctly different than that for the prescription stimulants, indicating that the ER/LA REMS program may have had an additional effect on decreases in opioid abuse and intentional misuse beyond secular trends.


Assuntos
Analgésicos Opioides/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Uso Indevido de Medicamentos sob Prescrição/tendências , Avaliação de Risco e Mitigação , Adolescente , Adulto , Analgésicos Opioides/química , Criança , Preparações de Ação Retardada/efeitos adversos , Preparações de Ação Retardada/química , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Adulto Jovem
19.
J Clin Periodontol ; 44(9): 866-871, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28644512

RESUMO

AIM: Assess the association of flossing with periodontitis. MATERIALS AND METHODS: This was a cross-sectional study using the National Health and Nutrition Examination Survey (NHANES) years 2011-2014. We used three categories of flossing: 0-1, 2-4 and ≥5 days in the past week and the CDC definition of periodontitis. We calculated odds ratios controlling for age, gender, smoking, drinking, income and dentist visits. RESULTS: A total of 6939 adult subjects were included, 35% flossed ≤1 time a week, and 40% had periodontitis. After adjustment, the odds of periodontitis were 17% lower for subjects who flossed >1 time a week than for subjects who flossed less often (odds ratio=0.83, 95% CI 0.72-0.97). A dose response was not observed. Men were twice as likely as women to have periodontitis. Younger subjects, non-smokers and subjects with the highest incomes had lower odds of having periodontitis. CONCLUSIONS: Flossing was associated with a modestly lower prevalence of periodontitis. Older age, being male, smoking, low income and less frequent dental visits were associated with a higher prevalence of periodontitis. Flossing 2-4 days a week could be as beneficial as flossing more frequently. This is a cross-sectional study so a causal relation between flossing and periodontitis cannot be established.


Assuntos
Dispositivos para o Cuidado Bucal Domiciliar/estatística & dados numéricos , Periodontite/prevenção & controle , Adulto , Idoso , Estudos Transversais , Demografia , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Periodontite/epidemiologia , Prevalência , Fatores Sexuais , Estados Unidos/epidemiologia
20.
Clin J Pain ; 33(11): 976-982, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28145912

RESUMO

BACKGROUND: We created an operational definition of possible opioid shopping in US commercial health insurance data and examined its correlates. METHODS: The population consisted of 264,204 treatment courses in persons with a fill for an opioid or diuretic prescription in 2012 and a second within 18 months. We examined counts of prescribers and pharmacies and the numbers of fills and overlaps for ability to discriminate courses of opioids from diuretics, which were a negative control. The most discriminatory measure, indicating possible shopping behavior, was cross-tabulated against other prescriptions filled and diagnoses as found in insurance claims. The associations between claims characteristics and shopping behavior were assessed in a logistic regression. RESULTS: A definition that classified possible "moderate" or "extensive" shopping when a person obtained drug through at least 3 practices and at least 3 pharmacies over 18 months was highly discriminatory between opioid and diuretic treatment. Overlaps between fills and number of fills did not improve the discrimination. Data from insurance claims strongly predicted moderate-to-extensive levels of possible shopping (c=0.82). Prominent among 20 significant predictors were: state of residence; amount of opioid dispensed; self-payment; use of nonspecialist prescribers; high use of anxiolytics, hypnotics, psychostimulants, and antipsychotics; and use of both immediate release and extended-release or long-acting opioids. CONCLUSIONS: The use of ≥3 prescribing practices and ≥3 dispensing pharmacies over 18 months sharply discriminated courses of opioid treatment from courses of diuretics. This pattern of fills was additionally associated with the numbers of nonspecialist and self-paid fills, the total morphine milligram equivalents dispensed, and heavier use of drugs for anxiety, sleep, attention, and psychosis.


Assuntos
Analgésicos Opioides/uso terapêutico , Comportamento de Procura de Droga , Transtornos Relacionados ao Uso de Opioides , Fatores Etários , Comportamento Aditivo , Estudos de Coortes , Estudos Transversais , Diuréticos/uso terapêutico , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Análise Multivariada , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Farmácias , Análise de Regressão , Estados Unidos
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