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BACKGROUND: During the COVID-19 pandemic, access to in-person care was limited, and regulations requiring in-person dispensing of mifepristone for medical abortions were relaxed. The effect of the pandemic and accompanying regulatory changes on abortion use is unknown. OBJECTIVE: To estimate changes in the incidence rate of induced medical and procedural abortions. DESIGN: Serial cross-sectional study with interrupted time-series analyses. SETTING: Commercially insured persons in the United States. PARTICIPANTS: Reproductive-aged women. INTERVENTION: Onset of the COVID-19 pandemic in March 2020 and subsequent regulatory changes affecting the in-person dispensing requirement for mifepristone. MEASUREMENTS: Monthly age-adjusted incidence rates of medical and procedural abortions were measured among women aged 15 to 44 years from January 2018 to June 2022. Medical abortions were classified as in-person or telehealth. Linear segmented time-series regression was used to calculate changes in abortion rates after March 2020. RESULTS: In January 2018, the estimated age-adjusted monthly incidence rate of abortions was 151 per million women (95% CI, 142 to 161 per million women), with equal rates of medical and procedural abortions. After March 2020, there was an immediate 14% decrease in the monthly incidence rate of abortions (21 per million women [CI, 7 to 35 per million women]; P = 0.004), driven by a 31% decline in procedural abortions (22 per million women [CI, 16 to 28 per million women]; P < 0.001). Fewer than 4% of medical abortions each month were administered via telehealth. LIMITATION: Only abortions reimbursed by commercial insurance were measured. CONCLUSION: The incidence rate of procedural abortions declined during the COVID-19 pandemic, and this lower rate persisted after other elective procedures rebounded to prepandemic rates. Despite removal of the in-person dispensing requirement for mifepristone, the use of telehealth for insurance-covered medical abortions remained rare. Amid increasing state restrictions, commercial insurers have the opportunity to increase access to abortion care, particularly via telehealth. PRIMARY FUNDING SOURCE: Health Resources and Services Administration.
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Aborto Induzido , COVID-19 , Gravidez , Feminino , Humanos , Estados Unidos/epidemiologia , Adulto , Mifepristona/uso terapêutico , Estudos Transversais , Pandemias , COVID-19/epidemiologiaRESUMO
The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Some of these approved applications were initially rejected because of manufacturing concerns (four of 36 [11%] with the EMA, seven of 16 [44%] with the FDA, none of ten for the PMDA). Median times from initial regulatory submission before approval of oncology biosimilars were 1·5 years (EMA), 1·3 years (FDA), and 0·9 years (PMDA). Pharmacists can substitute biosimilars for reference biologics in some EU countries, but not in the USA or Japan. US regulation prohibits substitution, unless the biosimilar has been approved as interchangeable, a designation not yet achieved for any biosimilar in the USA. Japan does not permit biosimilar substitution, as prescribers must include the product name on each prescription and that specific product must be given to the patient. Policy Reviews published in 2014 and 2016 in The Lancet Oncology focused on premarket and postmarket policies for oncology biosimilars before most of these drugs received regulatory approval. In this Policy Review from the Southern Network on Adverse Reactions, we identify factors preventing the effective launch of oncology biosimilars. Introduction to the market has been more challenging with therapeutic than for supportive care oncology biosimilars. Addressing region-specific competition barriers and educational needs would improve the regulatory approval process and market launches for these biologics, therefore expanding patient access to these products in the EU, the USA, and Japan.
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Antineoplásicos Imunológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Hematínicos/uso terapêutico , Neoplasias/tratamento farmacológico , United States Food and Drug Administration , Antineoplásicos Imunológicos/efeitos adversos , Bevacizumab/uso terapêutico , Medicamentos Biossimilares/efeitos adversos , Aprovação de Drogas/legislação & jurisprudência , Substituição de Medicamentos , Eritropoetina/análogos & derivados , Eritropoetina/uso terapêutico , Europa (Continente) , Filgrastim/uso terapêutico , Hematínicos/efeitos adversos , Humanos , Japão , Neoplasias/imunologia , Neoplasias/mortalidade , Segurança do Paciente , Formulação de Políticas , Polietilenoglicóis/uso terapêutico , Medição de Risco , Rituximab/uso terapêutico , Trastuzumab/uso terapêutico , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community. Utilizing data from various surveillance systems, some recent post-market studies suggest a decline in abuse of extended-release oxycodone after reformulation with abuse-deterrent properties. We discuss challenges stemming from the use of such data. METHODS: We quantify the relationship between the sample, the population, and the underlying sampling mechanism and identify the necessary conditions if valid statements about the population are to be made. The presence of other interventions in the community necessitates the use of comparators. We discuss the principles under which the use of comparators can be meaningful. CONCLUSIONS: Results based on surveillance data need to be interpreted with caution as the underlying sampling mechanisms can bias the results in unpredictable ways. The use of comparators has the potential to disentangle the effect due to the abuse-deterrence properties from those due to other interventions. However, identifying a comparator that is meaningful can be very difficult.
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Analgésicos Opioides/efeitos adversos , Composição de Medicamentos/métodos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Vigilância de Produtos Comercializados/métodos , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/farmacocinética , Interpretação Estatística de Dados , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/efeitos adversos , Preparações de Ação Retardada/farmacocinética , Humanos , Transtornos Relacionados ao Uso de Opioides/etiologia , Oxicodona/administração & dosagem , Oxicodona/efeitos adversos , Oxicodona/farmacocinética , Dor/tratamento farmacológico , PrescriçõesRESUMO
PURPOSE: To compare doses to organs at risk (OARs) for left-sided whole-breast radiation therapy with comparable planning target volume (PTV) coverage using three techniques: free breathing in a supine position (SFB), deep inspirational breath-hold in a supine position (SDIBH), and free breathing in prone position (PFB). MATERIALS AND METHODS: Thirty-three patients with left-sided early-stage breast cancer underwent CT simulation following SFB, SDIBH, and PFB protocols for whole-breast radiation therapy. One radiation oncologist contoured the breast PTV, heart, left ventricle (LV), and left anterior descending artery (LAD). Treatment plans were optimized using field-in-field technique with the AAA algorithm. Each plan was optimized to provide identical coverage to the PTV such that a reasonable comparison for OAR dosimetry could be evaluated. All plans were prescribed 42.56 Gy in 16 fractions to the left-breast PTV. RESULTS: The mean dose in SFB for the heart, LV, and LAD was 1.92, 3.19, and 21.73 Gy, respectively, which were significantly higher than the mean dose in SDIBH for the heart (1.08 Gy, P ≤ 0.0001), LV (1.50 Gy, P ≤ 0.0001), and LAD (6.3 Gy, P ≤ 0.0001) and in PFB for the heart (0.98 Gy, P ≤ 0.0001), LV (1.34 Gy, P ≤ 0.0001), and LAD (6.57 Gy, P ≤ 0.0001). Similar findings were noted for the cardiac components in SFB for V2.5, V5, V10, V20, and V30 compared with values in SDIBH and PFB. The mean dose for the left lung in PFB was 0.61 Gy that was significantly lower than in SFB (5.63 Gy, P ≤ 0.0001) and SDIBH (5.54 Gy, P ≤ 0.0001). Mean dose and dosimetric values for each OAR increased in SFB and SDIBH for patients with a large breast volume compared with values for patients with a small breast volume. CONCLUSIONS: SFB results in higher heart, LAD, and LV doses than the other techniques. Both PFB and SDIBH are more advantageous for these OARs irrespective of breast volume. PFB results in significantly lower lung doses than SFB and SDIBH. PFB always provided better results than SFB for the heart, LV, LAD, and lung. This conclusion contrasts with some published studies concluding that the prone position has no benefit for heart sparing.
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Órgãos em Risco , Neoplasias da Mama , Suspensão da Respiração , Coração , Humanos , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Estudos Retrospectivos , Neoplasias Unilaterais da MamaRESUMO
Public health authorities have described, with growing alarm, an unprecedented increase in morbidity and mortality associated with use of opioid pain relievers (OPRs). Efforts to address the opioid crisis have focused mainly on reducing nonmedical OPR use. Too often overlooked, however, is the need for preventing and treating opioid addiction, which occurs in both medical and nonmedical OPR users. Overprescribing of OPRs has led to a sharp increase in the prevalence of opioid addiction, which in turn has been associated with a rise in overdose deaths and heroin use. A multifaceted public health approach that utilizes primary, secondary, and tertiary opioid addiction prevention strategies is required to effectively reduce opioid-related morbidity and mortality. We describe the scope of this public health crisis, its historical context, contributing factors, and lines of evidence indicating the role of addiction in exacerbating morbidity and mortality, and we provide a framework for interventions to address the epidemic of opioid addiction.
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Epidemias/prevenção & controle , Dependência de Heroína/prevenção & controle , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Saúde Pública/métodos , Epidemias/estatística & dados numéricos , Dependência de Heroína/epidemiologia , Humanos , Prescrição Inadequada/prevenção & controle , Prescrição Inadequada/estatística & dados numéricos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Uso Indevido de Medicamentos sob Prescrição/estatística & dados numéricos , Prevenção Primária/métodos , Prevenção Secundária/métodos , Prevenção Terciária/métodos , Estados Unidos/epidemiologiaRESUMO
PURPOSE: We quantified the degree to which the August 2010 reformulation of abuse-deterrent OxyContin affected its use, as well as the use of alternative extended-release and immediate-release opioids. METHODS: We used the IMS Health National Prescription Audit, a nationally representative source of prescription activity in the USA, to conduct a segmented time-series analysis of the use of OxyContin and other prescription opioids. Our primary time period of interest was 12 months prior to and following August 2010. We performed model checks and sensitivity analyses, such as adjusting for marketing and promotion, using alternative lag periods, and adding extra observation points. RESULTS: OxyContin sales were similar before and after the August 2010 reformulation, with approximately 550 000 monthly prescriptions. After adjusting for declines in the generic extended-release oxycodone market, the formulation change was associated with a reduction of approximately 18 000 OxyContin prescription sales per month (p = 0.02). This decline corresponded to a change in the annual growth rate of OxyContin use, from 4.9% prior to the reformulation to -23.8% during the year after the reformulation. There were no statistically significant changes associated with the sales of alternative extended-release (p = 0.42) or immediate-release (p = 0.70) opioids. Multiple sensitivity analyses supported these findings and their substantive interpretation. CONCLUSIONS: The market debut of abuse-deterrent OxyContin was associated with declines in its use after accounting for the simultaneous contraction of the generic extended-release oxycodone market. Further scrutiny into the effect of abuse-deterrent formulations on medication use and health outcomes is vital given their popularity in opioid drug development.
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Analgésicos Opioides/administração & dosagem , Oxicodona/uso terapêutico , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Comércio , Preparações de Ação Retardada , Humanos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Prescrições/economia , Fatores de Tempo , Estados Unidos/epidemiologiaRESUMO
Glucagon-like peptide-1 receptor agonists are effective for treating obesity, but the high cost of these medications endangers the financial viability of our health care system. To ensure that these drugs are available to Medicare beneficiaries, pharmaceutical manufacturers must lower their prices.
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Fármacos Antiobesidade , Custos de Medicamentos , Medicare , Estados Unidos , Humanos , Fármacos Antiobesidade/economia , Fármacos Antiobesidade/uso terapêutico , Medicare/economia , Obesidade/tratamento farmacológico , Obesidade/economia , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Cobertura do Seguro/economiaRESUMO
INTRODUCTION: Tramadol has been associated with chronic opioid use and emergency room (ER) visits. However, little is known about trends in prescription tramadol use in the U.S. METHODS: Optum's de-identified Clinformatics® Data Mart Database was used to assess trends in monthly incident and prevalent tramadol use from 2005 to 2021, stratified by sex and age (18-64 vs. ≥65 years). State-specific trends following scheduling of tramadol as Class IV controlled substance in August 2014 were analyzed with random effects regression models. Demographics, comorbidities, initiation setting, dose, and co-dispensing with other opioids and central nervous system (CNS) agents were assessed in people initiating tramadol, stratified by age and initiation year (2005-2010, 2011-2015, 2016-2021). Analyses were performed in 2023 and 2024. RESULTS: During 2005-2021, the mean percentage using tramadol in a given month was 0.88% of younger females, 0.55% of younger males, 1.97% of older females, and 1.14% of older males; 5,729,652 initiations were identified. Since 2014, estimated relative yearly decrease was 4% (95% CI 3%; 5%) in use and 5% (95% CI 4%; 5%) in initiation, with variation across states. Primary care percentage of tramadol initiations declined from 49.2% in 2005-2010 to 37.2% in 2016-2021. During 2016-2021, co-dispensing with other CNS agents occurred in 37.8% of younger and 32.1% of older adults initiating tramadol. CONCLUSIONS: Tramadol use was higher in females and older adults, exhibited heterogeneous trends across states, and shifted from primary care to ER and specialist settings over time. Co-dispensing with other CNS agents was common and warrants further monitoring.
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Importance: Endothelin receptor antagonists are first-line therapy for pulmonary arterial hypertension (PAH). The first 2 agents approved in the class, bosentan and ambrisentan, initially carried boxed warnings for hepatotoxicity and required monthly liver function tests (LFTs) as part of a risk evaluation and mitigation strategy (REMS); however, in 2011, as further safety data emerged on ambrisentan, the boxed hepatotoxicity warning and LFT requirements were removed. Objective: To analyze changes in the use of and LFT monitoring for ambrisentan and bosentan after changes to the ambrisentan labeling and REMS. Design, Setting, and Participants: This serial cross-sectional study used data from 3 longitudinal health care insurance claims databases-Medicaid, Optum's deidentified Clinformatics Data Mart, and Merative Marketscan-to perform an interrupted time series analysis of prescription fills and LFTs for patients taking ambrisentan and bosentan. Participants were patients filling prescriptions for ambrisentan and bosentan from July 1, 2007, to December 31, 2018. Data analysis was performed from April 2021 to August 2023. Exposure: Removal of the boxed warning for hepatotoxicity and the REMS LFT monitoring requirements on ambrisentan in March 2011. Main Outcomes and Measures: The primary outcomes were use of ambrisentan (ie, individuals with at least 1 dispensing per 1â¯000â¯000 individuals enrolled in the 3 datasets) vs bosentan and LFT monitoring (ie, proportion of initiators with at least 1 ordered test) before initiation and before the first refill. Results: A total of 10â¯261 patients received a prescription for ambrisentan during the study period (7442 women [72.5%]; mean [SD] age, 52.6 [17.6] years), and 11â¯159 patients received a prescription for bosentan (7931 women [71.1%]; mean [SD] age, 47.7 [23.7] years). Removal of the ambrisentan boxed hepatotoxicity warning and LFT monitoring requirement was associated with an immediate increase in the use of ambrisentan (1.50 patients per million enrollees; 95% CI, 1.08 to 1.92 patients per million enrollees) but no significant change in the use of bosentan. There were reductions in recorded LFTs before drug initiation (13.1% absolute decrease; 95% CI, -18.2% to -8.0%) and before the first refill (26.4% absolute decrease; 95% CI, -34.4% to -18.5%) of ambrisentan but not bosentan. Conclusions and Relevance: In this serial cross-sectional study of ambrisentan, labeling changes and removal of the REMS-related LFT requirement were associated with shifts in prescribing and testing behavior for ambrisentan but not bosentan. Further clinician education may be needed to maximize the benefits of REMS programs and labeling warnings designed to ensure the safe administration of high-risk medications.
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Bosentana , Doença Hepática Induzida por Substâncias e Drogas , Testes de Função Hepática , Fenilpropionatos , Piridazinas , Humanos , Fenilpropionatos/uso terapêutico , Fenilpropionatos/efeitos adversos , Piridazinas/efeitos adversos , Piridazinas/uso terapêutico , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Transversais , Testes de Função Hepática/métodos , Testes de Função Hepática/estatística & dados numéricos , Estados Unidos , Bosentana/uso terapêutico , Adulto , Rotulagem de Medicamentos/normas , United States Food and Drug Administration , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Idoso , Antagonistas dos Receptores de Endotelina/uso terapêutico , Hipertensão Pulmonar/tratamento farmacológicoRESUMO
Introduction: Pseudomonas citronellolis is an unusual pathogen in humans and has not been extensively described in the scientific literature. Herein, we present a case of bacteremia and septic shock due to Pseudomonas citronellolis following Campylobacter species gastroenteritis in a patient with immunosuppression. Case Presentation: An 80-year-old man with myeloproliferative disorder on ruxolitinib presented with several days of worsening abdominal pain, which rapidly developed into septic shock with multi-organ failure and explosive diarrhea. Gram-negative bacilli observed on Gram staining of his blood culture broth were later identified as Pseudomonas citronellolis and Bacteroides thetaiotaomicron . Repeated abdominal imaging revealed no evidence of intestinal perforation or megacolon. In addition, stool PCR was positive for Campylobacter species. His clinical course improved after 14 days of meropenem with complete resolution of his symptoms and organ failure. Conclusion: P. citronellolis is a rare infection in humans. We postulate that Janus Associated Kinase (JAK) inhibition in myeloproliferative disorders heightened this patient's risk of bacterial translocation and severe illness in the setting of Campylobacter gastroenteritis. P. citronellolis may be identified more frequently as a pathogen in humans as more advanced diagnostic technologies become increasingly available in clinical microbiology.
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BACKGROUND: Brachytherapy is an integral component of the curative treatment of locally advanced cervical cancer. Optimal applicator placement is associated with improvements in local control and treatment-related toxicity. Uterine perforation by the tandem is common and often undetected by orthogonal radiographs. The role of ultrasound in guiding tandem placement remains controversial. METHODS: A 55-year-old woman with International Federation of Gynecology and Obstetrics stage IIB cervix cancer underwent placement of a Fletcher-Suit-Delcos tandem and ovoids applicator. Postoperative computed tomography was used for treatment planning. RESULTS: The applicator appeared to be appropriately placed on clinical exam and orthogonal radiographs. Postoperative computed tomography revealed the tandem had perforated the anterior uterine wall. In a second procedure, the tandem was placed correctly under intraoperative ultrasonography. CONCLUSIONS: A review of the literature finds a relatively high rate of uterine perforation of the uterus that is undetected by orthogonal radiographs or clinical examination. Multiple reports support the use of real-time ultrasound for patients with especially challenging anatomy. As this report illustrates, uterine perforation is possible in any patient. Therefore, routine real-time ultrasonography should be considered for all uterine tandem insertions.
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Braquiterapia/efeitos adversos , Braquiterapia/instrumentação , Carcinoma de Células Escamosas/radioterapia , Radioterapia Guiada por Imagem/métodos , Neoplasias do Colo do Útero/radioterapia , Útero/diagnóstico por imagem , Braquiterapia/métodos , Carcinoma de Células Escamosas/diagnóstico por imagem , Feminino , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/prevenção & controle , Humanos , Doença Iatrogênica/prevenção & controle , Pessoa de Meia-Idade , Radioterapia Guiada por Imagem/instrumentação , Ultrassonografia , Neoplasias do Colo do Útero/diagnóstico por imagem , Perfuração Uterina/etiologia , Perfuração Uterina/prevenção & controleRESUMO
Despite representing 30% to 40% of newly diagnosed cases of adult non-Hodgkin lymphoma, diffuse large B-cell lymphoma (DLBCL) rarely presents (1) in the leukemic phase (2) with dysregulation of the TP53 tumor suppressor gene and (3) an elevated serum lactic acid level. In this case report and literature review, we highlight this unfortunate triad of poor prognostic features associated with an aggressive and fatal clinical course in a 53-year-old man with recrudescent DLBCL. A leukemic presentation of de novo or relapsed DLBCL is rare and may be related to differential expressions of adhesion molecules on cell surfaces. In addition, TP53 gene mutations are present in approximately 20% to 25% of DLBCL cases and foreshadow worse clinical outcomes. Finally, an elevated serum lactic acid level in DLBCL that is not clearly associated with sepsis syndrome is a poor prognostic factor for survival and manifests as type B lactic acidosis through the Warburg effect.
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PURPOSE: To determine how the skin dose varies in patients receiving radiation treatment for breast cancer in the prone and supine positions. METHODS: Fifty patients were scanned in the prone and supine positions. A radiation treatment plan was created for the left breast using a 6-MV beam for a prescribed dose of 42.66 Gy in 16 fractions. The dose was calculated using 1- and 2.5-mm calculation grid sizes and the surface dose was compared in both techniques. RESULTS: The median gantry angles relative to the skin surface at the central axis were 8 and 52 degrees for treatment in the prone and supine positions, respectively. The mean dose difference between the prone and supine techniques was statistically significant from 3- to 5-mm depth for both grid sizes. For the 1-mm calculation grid size, the doses at 3-, 4-, and 5-mm depths in the prone and supine techniques were 87.80% and 89.10% (P < 0.003), 91.92% and 94.50% (P < 0.00), and 95.30% and 98.20% (P < 0.00), respectively; for the 2.5-mm grid size, the respective doses were 87.10% and 88.59% (P < 0.00), 91.60% and 94.63% (P < 0.00), and 95.10% and 97.80% (P < 0.00), respectively. CONCLUSIONS: This study demonstrates that the prone technique facilitates a relatively lower skin dose than the supine technique. This observation is probably due to the beam angle. The beam is more perpendicular to the skin surface in the prone technique, whereas it is more tangential in the supine technique, which may deliver a higher skin dose. Thus, the dose to the skin should be evaluated in the prone technique, and if desired, the skin dose could be carefully augmented via a bolus or beam spoiler.
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Neoplasias da Mama , Neoplasias da Mama/radioterapia , Feminino , Humanos , Decúbito Ventral , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Decúbito DorsalRESUMO
Transitional care management (TCM) and chronic care management (CCM) fee-for-service billing codes can serve as bridges to help organizations build care management capabilities and effectively transition from volume- to value-based care. TCM codes encourage providers to build capabilities for managing hospital discharge transitions. CCM codes encourage physician and nonphysician staff to build capabilities for longitudinally managing patients with multiple chronic conditions. Implementation challenges include achieving return on investment in health information technology and securing stakeholder commitment and engagement. Nonetheless, policy makers have reinforced their commitment to these codes, offering an encouraging signal for organizations seeking more gradual ways to build competencies and bridge toward value-based payment and care delivery.
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Múltiplas Afecções Crônicas , Cuidado Transicional , Atenção à Saúde , Planos de Pagamento por Serviço Prestado , Humanos , Alta do PacienteRESUMO
This Viewpoint discusses the limitations of state prescription drug spending targets for lowering medication costs.
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Medicamentos sob Prescrição , Humanos , Medicamentos sob Prescrição/economia , Estados Unidos , Gastos em Saúde , Governo Estadual , Custos de Medicamentos/tendênciasRESUMO
PURPOSE: To compare dose to organs at risk (OARs) and biological evaluation using normal tissue complication probability (NTCP) for left-sided breast radiation therapy in 4 techniques: supine free breathing (SFB), supine deep inspiration breath hold (SDIBH), prone free breathing (PFB), and prone deep inspiration breath hold (PDIBH). METHODS AND MATERIALS: Twenty-five patients with left-sided breast cancer suitable for this study underwent a computed tomography scan using SFB, SDIBH, PFB, and PDIBH. One radiation oncologist contoured the planning target volume and OAR (cardiac components). Dose-volume histograms and NTCPs for the heart, left ventricle (LV), left anterior descending artery (LAD), and left lung were calculated for all 4 techniques. RESULTS: The mean heart dose in PDIBH is 0.77 Gy, which is statistically significantly lower than in SFB (1.88 Gy, P < .0001), SDIBH (0.97 Gy, P < .001), and PFB (0.85 Gy, P < .001). The mean left lung dose is 0.69 Gy in PFB and 0.88 Gy in PDIBH. PFB and PDIBH have statistically significantly lower doses compared with SFB (6.09 Gy, P < .0001) and SDIBH (5.41 Gy, P < .0001). The mean NTCP in SFB for the heart, LV, and LAD is 0.27%, 0.62%, and 4.23%, respectively, and it is negligible for other techniques. CONCLUSIONS: We found that PDIBH had a dosimetrically lower mean dose for the heart and LV compared with the other 3 techniques. In addition, SDIBH, PFB and PDIBH had statistically significantly lower NTCP for the heart, LV, and LAD compared with SFB. NTCP for the left lung was statistically significantly lower for prone techniques compared with supine techniques. Therefore we concluded that, compared with SDIBH, PDIBH provides the added benefit of sparing the heart while keeping the benefit of sparing the lung as in the prone technique.
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Neoplasias Unilaterais da Mama/radioterapia , Feminino , Humanos , Estudos RetrospectivosRESUMO
Importance: Many stakeholders are working to improve the safe use of immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics. However, little information exists regarding the relative use of these 2 formulations in chronic pain management. Objectives: To describe the distribution of IR and ER/LA opioid analgesic therapy duration and examine adding and switching patterns among patients receiving long-term IR opioid analgesic therapy, defined as at least 90 consecutive days of IR formulation use. Design, Setting, and Participants: A retrospective cohort study of 169 million individuals receiving opioid analgesics from across 90% of outpatient retail pharmacies in the United States from January 1, 2003, to December 31, 2014, using the IQVIA Health Vector One: Data Extract Tool. Analyses were conducted from March 2015 to June 2017. Exposures: Receipt of dispensed IR or ER/LA opioid analgesic prescription. Main Outcomes and Measures: Distribution of therapy frequency and duration of IR and ER/LA opioid analgesic use, and annual proportions of patients receiving long-term IR opioid analgesic therapy who added an ER/LA formulation while continuing to use an IR formulation, switched to an ER/LA formulation, or continued receiving IR opioid analgesic therapy only. Results: Among the 169â¯280â¯456 patients included in this analysis, 168â¯315â¯458 patients filled IR formulations and 10â¯216â¯570 patients filled ER/LA formulations. A similar percentage of women received ER/LA (55%) and IR (56%) formulations, although those receiving ER/LA formulations (72%) were more likely to be aged 45 years or older compared with those receiving IR formulations (46%). The longest opioid analgesic episode duration was 90 days or longer for 11â¯563â¯089 patients (7%) filling IR formulations and 3â¯103â¯777 patients (30%) filling ER/LA formulations. The median episode duration was 5 days (interquartile range, 3-10 days) for patients using IR formulations and 30 days (interquartile range, 21-74 days) for patients using ER/LA formulations. From January 1, 2003, to December 31, 2014, a small and decreasing proportion of patients with long-term IR opioid analgesic therapy added (3.8% in 2003 to 1.8% in 2014) or switched to (1.0% in 2003 to 0.5% in 2014) an ER/LA formulation. Conclusions and Relevance: Most patients receiving opioid analgesics, whether for short or extended periods, use IR formulations. Once receiving long-term IR opioid analgesic therapy, patients are unlikely to add or switch to an ER/LA formulation.