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1.
Einstein (Sao Paulo) ; 18: eAO4745, 2019.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31664322

RESUMO

OBJECTIVE: To estimate the prevalence of and factors associated with the use of methylphenidate for cognitive enhancement among undergraduate students. METHODS: Simple random sample of students of the Universidade Federal de Minas Gerais (n=438), invited to answer an online questionnaire about the use of methylphenidate. Data collection occurred from September 2014 to January 2015. The sample was described by means of proportions, means and standard deviations. A multivariate analysis was performed using the Classification and Regression Tree algorithm to classify the cases of use of methylphenidate for cognitive enhancement in groups, based on the exposure variables. RESULTS: Out of 378 students included, 5.8% (n=22) reported using methylphenidate for cognitive enhancement; in that, 41% (9/22) in the 4 weeks prior to the survey. The housing situation was the variable most often associated with the use of methylphenidate for cognitive enhancement. Eleven students reported using methylphenidate for cognitive enhancement and other purposes 4 weeks prior to the survey, 27% of whom had no medical prescription to purchase it. CONCLUSION: The use of methylphenidate for cognitive enhancement is frequent among Brazilian undergraduate students and should be considered a serious public health problem, especially due to risks of harm and adverse effects associated with its use.


Assuntos
Estimulantes do Sistema Nervoso Central/administração & dosagem , Nootrópicos/administração & dosagem , Nootrópicos/uso terapêutico , Estudantes/estatística & dados numéricos , Universidades/estatística & dados numéricos , Adulto , Brasil/epidemiologia , Estudos Transversais , Árvores de Decisões , Exercício/psicologia , Feminino , Humanos , Masculino , Metilfenidato/administração & dosagem , Uso Off-Label/estatística & dados numéricos , Prevalência , Características de Residência/estatística & dados numéricos , Fatores de Risco , Fatores Socioeconômicos , Estudantes/psicologia , Inquéritos e Questionários , Adulto Jovem
2.
An. pediatr. (2003. Ed. impr.) ; 91(4): 237-243, oct. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-186744

RESUMO

Objetivo: Evaluar la prevalencia de prescripciones en condiciones no autorizadas (off-label y unlicensed) en una Unidad de Cuidados Intensivos Neonatales (UCIN) y definir qué características de los neonatos se asocian a un mayor uso de fármacos en estas condiciones. Material y métodos: Estudio observacional prospectivo en una UCIN nivel III-C durante un periodo de 6 meses. Se evaluó la condición de uso de cada fármaco, tomando como referencia su ficha técnica. Se utilizó un algoritmo secuencial para la clasificación de las prescripciones en: aprobadas, unlicensed u off-label (por edad, por indicación, por vía de administración, y por dosis). Resultados: Se incluyeron 84 pacientes y 564 prescripciones. Un total de 127 prescripciones fueron consideradas off-label y 45 unlicensed; lo cual supuso el 22,5% y el 8% del total, respectivamente. El 59,5% de los pacientes recibieron al menos un fármaco en una de estas condiciones, ascendiendo este porcentaje al 100% en los grandes prematuros y en los pacientes quirúrgicos (p < 0,001). Se encontró una correlación lineal positiva entre la estancia en UCIN y el número de prescripciones off-label (coeficiente de correlación 0,6 p < 0,001). Conclusiones: La prescripción de fármacos en condiciones no autorizadas es habitual en UCIN, siendo especialmente frecuente en los pacientes con mayor vulnerabilidad. Estos resultados ponen de manifiesto la necesidad de avanzar en la investigación y homogeneizar la información existente sobre los fármacos en neonatología, con el objetivo de realizar una prescripción eficaz y segura


Objective: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. Materials and methods: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). Results: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P < .001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P < .001). Conclusions: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Rotulagem de Medicamentos , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Terapia Intensiva Neonatal/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Algoritmos , Medicamentos sob Prescrição/administração & dosagem , Prevalência , Estudos Prospectivos , Tempo de Internação
3.
Pediatrics ; 144(4)2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31527173

RESUMO

BACKGROUND: Off-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings. METHODS: Using nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of systemic drugs for children age <18 based on US Food and Drug Administration-approved labeling for age, weight, and indication. We characterized the top classes and diagnoses with off-label orders and analyzed factors and trends of off-label orders using logistic regression. RESULTS: Physicians ordered ≥1 off-label systemic drug at 18.5% (95% confidence interval: 17.7%-19.3%) of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits). Off-label ordering was associated with female sex, subspecialists, polypharmacy, and chronic conditions. Rates and reasons for off-label orders varied considerably by age. Relative and absolute rates of off-label orders rose over time. Among common classes, off-label orders for antihistamines and several psychotropics increased over time, whereas off-label orders for several classes of antibiotics were stable or declined. CONCLUSIONS: US office-based physicians have ordered systemic drugs off label for children at increasing rates, most often for unapproved conditions, despite recent efforts to increase evidence and drug approvals for children. These findings can help inform education, research, and policies around effective, safe use of medications in children.


Assuntos
Instituições de Assistência Ambulatorial/tendências , Uso Off-Label/estatística & dados numéricos , Adolescente , Distribuição por Idade , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Intervalos de Confiança , Estudos Transversais , Feminino , Pesquisas sobre Serviços de Saúde/estatística & dados numéricos , Antagonistas dos Receptores Histamínicos/uso terapêutico , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Psicotrópicos/uso terapêutico , Estudos Retrospectivos , Estados Unidos
4.
Expert Opin Drug Saf ; 18(11): 1043-1053, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31498687

RESUMO

Introduction: Proton pump inhibitors (PPIs) are among the most commonly prescribed drugs worldwide. However, concerns are growing about the serious adverse events and mortality linked to their long-term use. Areas covered: The authors review the main approved clinical indications and adverse events associated with PPIs, including, among others, pneumonia, Clostridium difficile infection, cardiovascular diseases, bone fractures, kidney diseases, and several nutrient deficiencies. Recent studies have reported that patients taking PPIs displayed increased mortality, linked to cardiovascular diseases, gastrointestinal malignancies, and chronic kidney diseases. Expert opinion: PPIs represent an important advance in the medical treatment of acid-related diseases. PPIs have contributed to profound reductions in hospitalizations and mortality due to upper GI complications. However, concern is growing about the wide range of potentially serious adverse events and mortality linked to chronic PPI use. Nevertheless, the level of evidence on adverse events is low; it is based on observational studies, and most findings have not been confirmed in the limited number of clinical trials available. PPI overuse and off-label prescriptions must be eradicated, but long-term PPI use for clear indications must continue, until we have stronger evidence to support claims of serious adverse events and mortality.


Assuntos
Uso Off-Label/estatística & dados numéricos , Uso Excessivo de Medicamentos Prescritos/prevenção & controle , Inibidores da Bomba de Prótons/efeitos adversos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Neoplasias Gastrointestinais/epidemiologia , Neoplasias Gastrointestinais/etiologia , Neoplasias Gastrointestinais/mortalidade , Humanos , Inibidores da Bomba de Prótons/administração & dosagem , Insuficiência Renal Crônica/epidemiologia , Insuficiência Renal Crônica/etiologia , Insuficiência Renal Crônica/mortalidade
5.
Drugs Aging ; 36(11): 1035-1045, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31552597

RESUMO

BACKGROUND: Synthetic oral cannabinoids (nabilone and dronabinol) may have adverse respiratory effects. Our purpose was to describe the scope, pattern, and patient characteristics associated with incident off-label synthetic oral cannabinoid use among older adults with chronic obstructive pulmonary disease (COPD) compared to older adults without COPD. METHODS: This was a retrospective, population-based, cohort study using Ontario, Canada, heath administrative data. Individuals aged 66 years or older were included, and physician-diagnosed COPD was identified using a previously validated, highly specific algorithm. Incident off-label oral cannabinoid use was examined between April 1, 2005 and March 31, 2015. Descriptive statistics were used to describe drug use patterns. Multiple logistic regression was used to identify patient characteristics associated with incident drug use. RESULTS: There were 172,282 older adults with COPD and 1,068,256 older adults without COPD identified between April 1, 2005 and March 31, 2015. Incident synthetic oral cannabinoid use during this period occurred with significantly greater (p < 0.001) frequency among older adults with COPD (0.6%) versus older adults without COPD (0.3%). Compared to those without COPD, older adults with COPD used synthetic cannabinoids for significantly longer durations and more frequently at higher doses. CONCLUSIONS: Although incident off-label oral cannabinoid use was relatively low among all older Ontarian adults, this drug class was used with greater frequency and more often in potentially concerning ways among older adults with COPD. These findings raise possible safety concerns, but further research on the respiratory safety of oral cannabinoids among individuals with COPD is needed.


Assuntos
Dronabinol/análogos & derivados , Uso de Medicamentos/estatística & dados numéricos , Prescrição Inadequada/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Medicamentos sob Prescrição/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Idoso , Algoritmos , Estudos de Coortes , Dronabinol/administração & dosagem , Dronabinol/efeitos adversos , Dronabinol/uso terapêutico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Ontário , Medicamentos sob Prescrição/efeitos adversos , Medicamentos sob Prescrição/uso terapêutico , Estudos Retrospectivos
6.
J Dtsch Dermatol Ges ; 17(8): 856-870, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31437363

RESUMO

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part 1 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part 2 will be published in the next issue. It contains chapters on UV therapy, systemic treatment, tonsillectomy and antibiotics, vaccinations, guttate psoriasis, psoriatic arthritis, complementary medicine, as well as imaging studies and diagnostic workup to rule out tuberculosis prior to systemic treatment.


Assuntos
Guias de Prática Clínica como Assunto/normas , Psoríase/tratamento farmacológico , Psoríase/patologia , Administração Tópica , Adolescente , Artrite Psoriásica/diagnóstico , Criança , Pré-Escolar , Comorbidade , Consenso , Dermatologia , Humanos , Lactente , Recém-Nascido , Uso Off-Label/estatística & dados numéricos , Psoríase/psicologia , Psoríase/radioterapia , Qualidade de Vida/psicologia , Reumatologia , Índice de Gravidade de Doença , Raios Ultravioleta
7.
Int J Clin Pharm ; 41(4): 920-931, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31161497

RESUMO

Background Clinicians prescribe high-cost medicines for rare diseases and nonapproved indications when conventional therapies have failed. Objective To examine the use of non-formulary high-cost medicines at an Australian public hospital. Methods Retrospective audit of individual patient use applications for nonformulary medicines costing more than $5000 AUD per year at a large tertiary referral hospital in Adelaide, South Australia over a 12-month study period from January 2015 to December 2015. Main outcome measures Total cost of non-formulary high-cost medicines, medication class, indications for use, level of supporting evidence and proposed monitoring outcomes. Results Eighty-seven individual patient use applications were examined. All except one were approved, at a total cost of $1,339,203 AUD. The most common drug classes were anti-CD20 (n = 33, 38%), combined antiretrovirals (n = 10, 11%) and TNF-alpha antagonists (n = 10, 11%). There were 56 indications for these medicines with the majority being inflammatory conditions (n = 52, 60%), followed by infections (n = 14, 16%) and malignancies (n = 14, 16%). Of the first-time individual patient use applications (n = 63), there were 25 applications (40%) that provided a case series as supporting evidence. Approximately half of new individual patient use applications (n = 32) proposed an objective monitoring outcome, but few (n = 13, 21%) contained sufficient information to allow a third party to determine efficacy of the medication. Conclusions Non-formulary high-cost medicines are being used for a broad range of indications based largely on low levels of evidence. Prospective definition of an adequate response to treatment and reporting of these outcomes is required to improve the evidence-base and to aid decision-making for subsequent treatment courses.


Assuntos
Custos e Análise de Custo , Formulários de Hospitais como Assunto , Hospitais Públicos/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Medicamentos sob Prescrição/economia , Humanos , Estudos Retrospectivos , Austrália do Sul
8.
Eur J Clin Pharmacol ; 75(7): 985-994, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30834963

RESUMO

PURPOSE: Patients who suffer acquired brain injury (ABI) require a great variety of drugs. Furthermore, the lack of evidence on the medication effects in this type of patient increases off-label prescription. The aim of this study was to describe the pattern of medication use and the practice of prescribing off-label drugs in these patients. METHODS: A cross-sectional study was conducted in patients with ABI, of either traumatic or non-traumatic cause, admitted to a neurorehabilitation hospital for rehabilitation. Demographic and clinical data and prevalence of medication use and off-label prescription were collected. RESULTS: The majority of the studied patients (85.2%) were considered polymedicated since they were prescribed ≥ 6 drugs concomitantly. In traumatic brain injury (TBI) patients, antidepressants (81.5%) were the Anatomical Therapeutic Chemical (ATC) group's most prescribed versus antithrombotic agents (80.5%) in non-traumatic brain injury (N-TBI) patients. Up to 37.3% of all active substances prescribed in TBI patients were off-label compared with 24.9% in N-TBI patients. The most prescribed off-label active substances in both groups were those related to the Nervous System (N) ATC group to treat neurobehavioural problems. CONCLUSION: A multidisciplinary pharmacotherapeutic follow-up of these patients would be essential to address the high prescription rate of medications and the off-label prescription practice. In this way, medication problems related to polypharmacy could be minimised and the benefit-risk ratio of prescribed off-label drugs could be ensured according to the available medical evidence.


Assuntos
Lesões Encefálicas/tratamento farmacológico , Uso Off-Label/estatística & dados numéricos , Polimedicação , Adolescente , Adulto , Idoso , Criança , Uso de Medicamentos , Feminino , Hospitalização , Hospitais de Reabilitação/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Reabilitação Neurológica , Adulto Jovem
9.
Am J Med ; 132(7): 847-855.e3, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30776320

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation but may result in serious bleeding complications. Off-label dose-reduced use of DOACs to mitigate bleeding is common in routine clinical practice although data about its consequences on patient outcomes are limited. Therefore, our objective was to evaluate the effectiveness and safety of off-label dose-reduced vs per-label standard-dose DOAC treatment. METHODS: The study cohort included newly diagnosed patients with nonvalvular atrial fibrillation that had initiated DOAC therapy between 2011 and 2017 in Clalit Health Services (Tel Aviv, Israel). Effectiveness was defined as the composite outcome of all-cause mortality, stroke, or myocardial infarction. The safety outcome was defined as bleeding events requiring hospitalization. Patients were followed until March 30, 2018 or until occurrence of an outcome event. Hazard ratios (HR) were adjusted for 21 variables, including comorbidities, concomitant medications, and socioeconomic factors, using multivariate regression. RESULTS: A total of 8425 patients met the study criteria; 5140 (61%) patients were treated with DOACs at per-label dosing and 3285 (39%) patients were treated with off-label dose-reduced DOAC. Off-label dose-reduced treatment was associated with a higher rate of the composite effectiveness outcome: adjusted HR 1.57 (95% confidence interval, 1.34-1.83; P < .001) and a higher rate of bleeding: adjusted HR 1.63 (95% confidence interval, 1.14-2.34; P = .008). CONCLUSIONS: Almost 4 of 10 patients were treated with off-label dose-reduced DOAC, which was associated with reduced effectiveness without a safety benefit. Compliance with per-label dosage may significantly improve outcomes of this population.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Uso Off-Label/estatística & dados numéricos , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/mortalidade , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/mortalidade , Resultado do Tratamento
10.
JAMA ; 321(7): 676-685, 2019 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-30778596

RESUMO

Importance: Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. Objectives: To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. Design, Setting, and Participants: Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. Exposure: A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. Main Outcomes and Measures: (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. Results: Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. Conclusions and Relevance: In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program.


Assuntos
Dor Irruptiva/tratamento farmacológico , Competência Clínica , Fentanila/administração & dosagem , Conhecimentos, Atitudes e Prática em Saúde , Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Avaliação de Risco e Mitigação , United States Food and Drug Administration , Administração através da Mucosa , Dor do Câncer/tratamento farmacológico , Contraindicações de Medicamentos , Fentanila/efeitos adversos , Pesquisas sobre Serviços de Saúde , Humanos , Farmacêuticos , Vigilância de Produtos Comercializados , Estados Unidos
11.
An Pediatr (Barc) ; 91(4): 237-243, 2019 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-30772271

RESUMO

OBJECTIVE: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. MATERIALS AND METHODS: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). RESULTS: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P<.001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P<.001). CONCLUSIONS: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription.


Assuntos
Rotulagem de Medicamentos , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Terapia Intensiva Neonatal/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Algoritmos , Feminino , Humanos , Recém-Nascido , Tempo de Internação , Masculino , Medicamentos sob Prescrição/administração & dosagem , Prevalência , Estudos Prospectivos
12.
JAMA Dermatol ; 155(3): 315-320, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30673082

RESUMO

Importance: When making coverage determinations for off-label prescribing, Medicare Part D recognizes 2 compendia: the American Hospital Formulary Service (AHFS) Drug Information and the DRUGDEX Information System. Deficiencies in the accuracy and completeness of these compendia could result in coverage denials for necessary, effective, evidence-based treatments. Objective: To evaluate these compendia for dermatologic conditions, with a focus on less common conditions that often require systemic treatment. Design, Setting, and Participants: This cross-sectional study was conducted from July 1, 2018, through September 30, 2018. To identify diseases for which dermatologists may often need access to off-label systemic treatments, a list of 22 chronic, noninfectious, nonneoplastic diseases with at least 4 systemic therapies (including 1 in the first-line therapies and less than 25% approved by the US Food and Drug Administration) were selected for evaluation. With use of Treatment of Skin Disease, 5th Edition, a list of first-, second-, and third-line medications was created, including the level of evidence for each disease. A search of AHFS and DRUGDEX compendia was performed to evaluate for inclusion of the evidence-based therapies. In addition, the references cited in the compendia to justify inclusion of the therapy were examined qualitatively. Main Outcomes and Measures: Percentage of treatment options included in each compendium, stratified by level of evidence and position on the therapeutic ladder. Concordance between the 2 compendia was assessed using Cohen κ. Results: Overall, 73 of 238 treatments (30.7%) evaluated were included in either compendium. Among individual diseases, 10 of 22 (45%) had 1 or fewer treatments included in the DRUGDEX compendium and 15 of 22 (68%) had 1 or fewer treatments included in the AHFS compendium. Discrepancies in which a medication was included in one compendium but not in the other compendium occurred for 53 of the 238 medications (22.3%) evaluated. Literature use did not follow a discernible pattern and was often based on decades-old sources. Conclusions and Relevance: The findings suggest that treatment options listed in these compendia are incomplete, outdated, idiosyncratic, and unpredictable. To ensure that patients can access treatments for their disease, it appears that policies to reduce the reliance on these compendia for coverage determinations should be developed.


Assuntos
Fármacos Dermatológicos/economia , Prescrições de Medicamentos/economia , Medicare Part D/economia , Uso Off-Label/economia , Dermatopatias/tratamento farmacológico , Idoso , Estudos de Coortes , Estudos Transversais , Fármacos Dermatológicos/administração & dosagem , Feminino , Humanos , Masculino , Medicare Part D/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Dermatopatias/diagnóstico , Estados Unidos , United States Food and Drug Administration/normas
14.
PLoS One ; 14(1): e0210237, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30620749

RESUMO

OBJECTIVES: To evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing. METHODS: A retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code. RESULTS: There were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs. CONCLUSIONS: This study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.


Assuntos
Legislação de Medicamentos , Uso Off-Label/estatística & dados numéricos , Pediatria/educação , Austrália/epidemiologia , Criança , Pré-Escolar , Clonidina/uso terapêutico , Vias de Administração de Medicamentos , Prescrições de Medicamentos , Feminino , Humanos , Pacientes Internados , Isoxazóis/uso terapêutico , Masculino , Midazolam/uso terapêutico , Uso Off-Label/legislação & jurisprudência , Oxicodona/uso terapêutico , Pediatria/legislação & jurisprudência
15.
BMC Pediatr ; 19(1): 3, 2019 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-30609923

RESUMO

BACKGROUND: Many newborns may need to be hospitalized and receive drugs during the first days of their lives. These drugs are fundamentally prescribed as off-label and unlicensed. This study aimed to investigate the amount of these kinds of drugs administered in the Neonatal Intensive Care Units (NICUs) of Abuzar and Imam Khomeini Teaching Hospitals in Ahvaz, Iran. METHODS: This was a 3-month descriptive, cross-sectional study with retrospective nature in which 193 hospitalized newborns were studied. Demographic data were extracted from the patients' files. The drugs were classified as off-label, unlicensed or licensed according to the Pediatric & Neonatal Dosage Handbook (Lexicomp®, 22nd Edition). RESULTS: In total, 1049 prescriptions were registered for the 193 hospitalized newborns (term and preterm). For each newborn, the mean numbers of prescriptions and drugs received were 5.4 and 4.5, respectively. The mean numbers of prescriptions and drugs were greater for preterm newborns. Of the total 1049 prescriptions, 38.1% were off-label and 1.9% were unlicensed. Of the 193 newborns, 85% received at least one off-label or unlicensed prescription. Off-label prescriptions were mostly related to dose (44.8%) and dosing interval (36.5%). Most off-label drugs were antibiotics (mainly Gentamicin). Albuterol was used off-label in 100% of the cases. CONCLUSIONS: The results of the present study show that the prescription of off-label and unlicensed drugs in NICUs is as high in Iran as in other countries. This suggests that it is necessary to provide information to neonatologists to decrease the prescription of off-label and unlicensed drugs.


Assuntos
Uso de Medicamentos/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Estudos Transversais , Aprovação de Drogas , Feminino , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Irã (Geográfico) , Masculino , Estudos Retrospectivos
16.
Int J Clin Pharm ; 41(2): 555-562, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30680514

RESUMO

Background Tamoxifen is an estrogen receptor modulator used for the treatment of breast cancer; however, currently, it is used in many off-label indications. Objective To investigate the prevalence of tamoxifen off-label prescribing and explore available scientific evidence that supports those uses in outpatients. Setting Xiamen maternity and child health care hospital in Xiamen city of China. Method All the prescriptions of outpatients receiving tamoxifen were exported from an electronic prescribing system during a 1-year period. Tamoxifen use was then classified as either on- or off-label according to the criteria we established previously, and the details of the off-label prescriptions were collected. Logistic regression was applied to explore predictive variables. Evidence search was limited to Up-To-Date, the Micromedex database and PubMed. Main outcome measure The rate of off-label use, risk factors identified by logistic regression and evidence exhibition. Results A total of 75% of all the prescriptions available were classified as off-label use. Hyperplasia of the breast was the most frequently prescribed off-label indication. According to the analysis of logistic regression, male patients, patients less than 34 years old, and physicians with a higher professional title were more likely associated with off-label prescribing. After a search in Up-To-Date, the Micromedex database and PubMed, only male infertility, atypical hyperplasia, mastodynia, peripheral precocious puberty and gynecomastia were found to have strong evidence supporting the use of tamoxifen off-label (22.75%). Conclusion Although the off-label use of tamoxifen was common in our hospital, there was a relative shortage of evidence available supporting those uses.


Assuntos
Uso de Medicamentos/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Tamoxifeno/uso terapêutico , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Pré-Escolar , China , Estudos Transversais , Prescrição Eletrônica/estatística & dados numéricos , Antagonistas de Estrogênios/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Sexuais , Centros de Atenção Terciária/estatística & dados numéricos , Adulto Jovem
17.
Med Mal Infect ; 49(4): 275-280, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30527972

RESUMO

OBJECTIVES: Following the removal of temporary treatment protocol procedures, we developed a thesaurus for off-label indications for systemic antifungals at our facility to update clinical practices and to control off-label prescriptions. MATERIALS AND METHODS: Clinical practice guidelines and literature data were analyzed. This work was part of an antifungal stewardship program. RESULTS: Off-label wording (prophylaxis, preemptive, empirical, curative) and corresponding antifungals and references were validated by the multidisciplinary group for antifungal agents under the aegis of the Commission for the use of drugs and sterile medical devices and of the anti-infective committee. CONCLUSION: Considering the complexity of invasive fungal infection management, this thesaurus needs to be shared and used as a helping tool to review off-label situations.


Assuntos
Antifúngicos/uso terapêutico , Uso Off-Label , Padrões de Prática Médica/normas , Vocabulário Controlado , Antifúngicos/classificação , Gestão de Antimicrobianos/normas , Humanos , Uso Off-Label/classificação , Uso Off-Label/normas , Uso Off-Label/estatística & dados numéricos , Guias de Prática Clínica como Assunto/normas , Prescrições/normas , Prescrições/estatística & dados numéricos , Terminologia como Assunto
18.
Curr Pediatr Rev ; 15(1): 62-66, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30421680

RESUMO

BACKGROUND: Unlicensed (UL) and Off-label (OL) prescription of medications is common in paediatrics and does not constitute negligent practice since there is often no approved alternative according to FDA bulary. AIM: The study aimed to determine the current frequency of UL and OL prescriptions in children from one month to 12 years of age in a Paediatric Inpatient Unit (PIU). METHODS: This is an observational, prospective study, reviewing the prescriptions of all patients admitted to the PIU in a university hospital in a single week in August 2014 and a single week in January 2015. RESULTS: We included 157 patients of median age 18 months and median length of stay 24 days. There were 1,328 prescription items (average of 8.4 items/patient) and only two patients without UL/OL use. During the winter season (August), 27% of prescriptions were classified as UL and 44.6% as OL, and during summer (January), 29.6% as UL and 45.1% as OL. We identified 188 medications, of which the most prescribed were paracetamol (11%) and dipyrone (9.5%). The most frequent OL classification was regarding drug formulation (15.8%). In the winter week, the most frequent reasons for admission were respiratory (44%), followed by other clinical causes (CC) (17.3%), while in the summer week, they were CC (26.3%), followed by surgical and gastrohepatic (23.7%). CONCLUSION: The OL prescription of medicines for children in Brazil is in accordance with the international literature. The higher prevalence of OL due to formulation found in this study is related to the use of formulations other than those used by the FDA.


Assuntos
Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Prescrições/estatística & dados numéricos , Criança , Pré-Escolar , Estudos Transversais , Feminino , Hospitais Universitários , Humanos , Lactente , Pacientes Internados/estatística & dados numéricos , Masculino , Estudos Prospectivos
19.
World J Pediatr ; 15(1): 92-99, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30506238

RESUMO

BACKGROUND: Off-label use of psychotropic prescriptions for pediatric patients has been increasing in Japan. This study sought to clarify pediatric patients' off-label use of psychotropics approved only for adults in Japan. METHODS: This retrospective study on psychotropic utilization employed a pharmaceutical health insurance claims database supplied by a pharmacy for the fiscal year 2016. Seven psychotropic drugs were examined. For each drug, we calculated the proportion of patients aged < 16 years or who were under the approved age limit set in the United States out of all patients. The maximum daily dose of each drug within the study period was plotted by age. RESULTS: Data of 45,715 patients (female: 26,799, male: 18,916) with 331,920 prescriptions were examined in this study. For each drug, the proportion of pediatric patients aged < 16 years ranged from 0.15 to 1.1%, while the proportion of those under the approved age limit in the United States ranged from 0 to 0.27%. Olanzapine had the highest reported proportion. No drugs other than olanzapine were taken under the approved age limit in the United States. CONCLUSIONS: We identified the pediatric off-label use of psychotropics that were limited to adult use in Japan. The results indicated the possibility of referring to international guidelines or evidence in clinical practice, but these factors do not discount the existing problems with off-label use. More clinical trials within the pediatric population in Japan are needed to address the issue of off-label use and obtain useful and reliable information in the package inserts for rational use in future pediatric patients.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Psicotrópicos/uso terapêutico , Adolescente , Antidepressivos/uso terapêutico , Bases de Dados de Produtos Farmacêuticos , Feminino , Humanos , Japão , Masculino , Estudos Retrospectivos , Estados Unidos
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