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2.
AAPS PharmSciTech ; 21(2): 65, 2020 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-31933006

RESUMO

The application of the nanotechnology in medicine and pharmaceutics opens new horizons in therapeutics. Several nanomedicines are in the market and an increasing number is in clinical trials. But which is the advantage of the medicines in nanoscale? The scientists and the regulatory authorities agree that the size and consequently the physiochemical/biological properties of nanomaterials play a key role in their safety and effectiveness. Additionally, all of them agree that a new scientific-based regulatory landscape is required for the establishment of nanomedicines in the market. The aim of this review is to investigate the parameters that the scientists and the regulatory authorities should take into account in order to build up a dynamic regulatory landscape for nanomedicines. For this reason, we propose an "astrolabe-like system" as the guide for establishing the regulatory approval process. Its function is based on the different physicochemical/biological properties in comparison to low molecular weight drugs.


Assuntos
Medicamentos Biossimilares , Nanomedicina/legislação & jurisprudência , Aprovação de Drogas , Controle de Medicamentos e Entorpecentes , Humanos
5.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 627-632, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31810392

RESUMO

Introduction: There is significant difference in utilization of patented medicines in the EU, as pharmaceuticals at Western European price levels are usually not cost-effective in Central and Eastern European (CEE) countries. The article reviews options to solve the 'financing gap' posed by the challenge of covering patented medicines from more restricted resources in countries with greater unmet medical need.Areas covered: Hidden volume restrictions to patented pharmaceuticals implemented by payers to facilitate financial sustainability may increase European inequity in patient access. Confidential price discounts and financial risk-sharing agreements improve cost-effectiveness of pharmaceuticals with limited impact on the European floor price. Narrowing the eligible group of patients on the positive drug list can help to target the medicines to patients with potentially greater health benefit whilst reducing the budget impact. Pay-for-performance schemes can improve cost-effectiveness of pharmaceuticals with significant uncertainty or heterogeneity in the magnitude of added therapeutic value. Increased utilization of off-patent pharmaceuticals can increase patient access through re-investing the savings from generic or biosimilar price erosion.Expert opinion: Transparent and sustainable pharmaceutical policies aiming to improve the allocative efficiency of scarce resources should be implemented in CEE to reduce financing gap and improve patient access to high-cost medicines.


Assuntos
Custos de Medicamentos/estatística & dados numéricos , Acesso aos Serviços de Saúde/economia , Preparações Farmacêuticas/provisão & distribução , Reembolso de Incentivo/economia , Análise Custo-Benefício , Controle de Medicamentos e Entorpecentes , Farmacoeconomia , União Europeia , Humanos , Patentes como Assunto , Preparações Farmacêuticas/economia , Participação no Risco Financeiro/economia
6.
Lancet ; 394(10209): 1668-1684, 2019 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-31668410

RESUMO

The rapid emergence since the mid-2000s of a large and diverse range of substances originally designed as legal alternatives to more established illicit drugs (pragmatically clustered and termed new psychoactive substances; [NPS]) has challenged traditional approaches to drug monitoring, surveillance, control, and public health responses. In this section of the Series, we describe the emergence of NPS and consider opportunities for strengthening the detection, identification, and responses to future substances of concern. First, we explore the definitional complexity of the term NPS. Second, we describe the origins and drivers surrounding NPS, including motivations for use. Third, we summarise evidence on NPS availability, use, and associated harms. Finally, we use NPS as a case example to explore challenges and opportunities for future drug monitoring, surveillance, control, and public health responses. We posit that the current means of responding to emerging substances might no longer be fit for purpose in a world in which different substances can be rapidly introduced, and where people who use drugs can change preferences on the basis of market availability.


Assuntos
Monitoramento de Medicamentos/métodos , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Psicotrópicos/efeitos adversos , Saúde Pública/legislação & jurisprudência , Adolescente , Adulto , Comércio/legislação & jurisprudência , Coleta de Dados , Controle de Medicamentos e Entorpecentes/métodos , Feminino , Humanos , /legislação & jurisprudência , Masculino , Pessoa de Meia-Idade , Motivação , Psicotrópicos/classificação , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adulto Jovem
9.
S Afr Med J ; 109(9): 632-634, 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31635585

RESUMO

Amiloride is an antagonist of the renal tubular epithelial sodium channel (ENaC). As such, it is a diuretic that is both potassium and magnesium sparing. It is used for the treatment of potassium depletion and hypertension, and is the specific therapy for hypertension due to overactivity of the ENaC (Liddle syndrome and several additional genetic causes of the Liddle phenotype - low renin and low aldosterone). It is listed as a World Health Organization essential drug, but has never been registered in South Africa (SA) and can therefore only be prescribed under a Section 21 application to the SA Health Products Regulatory Authority (SAHPRA) on a case-by-case basis. In SA, >50% of patients treated for hypertension are not controlled. In the USA, the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study reported that African Americans are more likely to be diagnosed with hypertension, more likely to be treated, more likely to be treated intensively, and less likely to achieve blood pressure (BP) control. Although the reasons are complex, studies show that 10 - 20% of blacks may carry the Liddle phenotype. Observational data and a controlled clinical trial done in three African countries have shown that these patients respond to amiloride and not to conventional guideline-based antihypertensive treatment. The former is likely to result in a significant reduction in cardiovascular, stroke and kidney morbidity and mortality, because of improved BP control. Amiloride is very unlikely to ever be registered in SA, as it was first developed >50 years ago, and SAHPRA regulations prevent widespread prescription of this essential drug. This is a classic Gordian knot that requires a novel approach from authorities to sever the knot and improve the health of many South Africans.


Assuntos
Amilorida/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Hipertensão/tratamento farmacológico , Grupo com Ancestrais do Continente Africano/estatística & dados numéricos , Amilorida/farmacologia , Anti-Hipertensivos/farmacologia , Pressão Sanguínea/efeitos dos fármacos , Diuréticos/farmacologia , Diuréticos/uso terapêutico , Bloqueadores do Canal de Sódio Epitelial/farmacologia , Bloqueadores do Canal de Sódio Epitelial/uso terapêutico , Disparidades nos Níveis de Saúde , Humanos , Hipertensão/fisiopatologia , África do Sul
11.
Cien Saude Colet ; 24(10): 3783-3792, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31577009

RESUMO

In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in 2012. The reason for rejection was the lack of comparative effectiveness studies proving that LEN was more effective than thalidomide (THAL), a strictly controlled drug regulated by Federal law 10.651/2003 and dispensed to patients (at no costs) through public health system units and hospitals. ANVISA unexplained retreat on the LEN approval for marketing was an unquestionable triumph of the lobbying that ensued the denial, at the forefront of which were politicians, Congress members, patient organizations and medical societies. Two randomized (phase III) trials and three observational (case-control and population-based cohort) compared the effectiveness of THAL- versus LEN-based therapies in MM. Overall, these studies showed no difference in efficacy between LEN- and THAL-based therapies. LEN caused less neuropathy, and more severe hematologic adverse effects. It is much costlier than THAL, and substitution of THAL by LEN shall raise considerably public healthcare costs in Brazil.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Controle de Medicamentos e Entorpecentes , Lenalidomida/administração & dosagem , Talidomida/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/economia , Brasil , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Lenalidomida/efeitos adversos , Lenalidomida/economia , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/economia , Síndromes Mielodisplásicas/tratamento farmacológico , Síndromes Mielodisplásicas/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Talidomida/efeitos adversos , Talidomida/economia , Resultado do Tratamento
13.
JAMA Facial Plast Surg ; 21(6): 487-490, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31600382

RESUMO

Importance: Opioid prescriptions have increased substantially over the last 2 decades, contributing to the opioid epidemic. Physician practices and legislative changes play a key role in decreasing prescription opioid use. Objective: To evaluate changes in opioid prescribing habits for patients undergoing rhinoplasty and/or septoplasty before and after the adoption of new opioid legislation. Design, Setting, and Participants: This single-institution case-control study examined opioid prescribing habits for 80 patients who were undergoing rhinoplasty and septoplasty with or without turbinate reduction at the University of Vermont between March 2016 and May 2018. Patients were excluded if they underwent concomitant endoscopic sinus surgery or were younger than 14 years. Patients were divided by surgery date before or after legislative changes on July 1, 2017. Exposures: Rhinoplasty and septoplasty with or without turbinate reduction. Main Outcomes and Measures: Patient demographics and opioid prescriptions were recorded. Patients were evaluated if they reported pain during follow-up, called the office, or received a second prescription. The Vermont Prescription Monitoring System was queried to determine if opioid prescriptions were filled within 30 days of the procedure. The 2 groups were compared to test the hypothesis that opioid prescriptions had decreased after legislative changes. Results: Of a total of 80 participants, the mean (SD) age in the before (15 women [37.5%]) and after (16 women [40.0%]) groups were 41.4 years and 40.6 years, respectively. There was a statistically significant decrease in the number of pills prescribed to the after group (17.5 to 9.7; P < .001) as well as a decrease in the morphine milligram equivalents that were prescribed (130.9 to 73.2; P < .001). There was no statistical difference in the number of postoperative telephone calls for pain, second prescriptions, or increased complaints of pain at the postoperative visit. Conclusions and Relevance: Recent laws in Vermont regarding opioid prescribing were implemented in 2017 to curb the ongoing opioid epidemic. Our observations of patients undergoing septoplasties and rhinoplasties found a significant reduction in opioid prescriptions. This was not associated with an increase in patient complaints about postoperative pain or the need for a second prescription after surgery. This shows that we may safely be able to decrease the number of narcotic medications that we prescribe. Level of Evidence: 3.


Assuntos
Analgésicos Opioides/uso terapêutico , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Septo Nasal/cirurgia , Dor Pós-Operatória/tratamento farmacológico , Padrões de Prática Médica/legislação & jurisprudência , Rinoplastia , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Medição da Dor , Vermont
14.
Skin Therapy Lett ; 24(5): 7-13, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31584785

RESUMO

Dermatology supplements, often marketed as "skin, hair, and nail" supplements, are becoming increasingly popular. However, many consumers lack an understanding of the science of dietary supplements or the specifics of the supplement industry. While certain supplements at the right dose in the right population may prove beneficial, the evidence is sparse for many supplements. In addition, the use of some supplements has resulted in serious adverse effects. From a regulatory standpoint, the US FDA recognizes dietary supplements as foods. This distinction has multiple ramifications, including the fact that manufacturers do not need to prove efficacy, safety, or quality prior to sale. Therefore, physicians and consumers must evaluate each supplement ingredient and formulation individually. This article outlines an evidence-based approach to assess dermatology supplements. As a starting point, all supplements should be evaluated for PPIES: purity, potency, interactions, efficacy, and safety.


Assuntos
Suplementos Nutricionais , Cabelo/efeitos dos fármacos , Unhas/efeitos dos fármacos , Pele/efeitos dos fármacos , Suplementos Nutricionais/efeitos adversos , Suplementos Nutricionais/normas , Contaminação de Medicamentos , Interações de Medicamentos , Controle de Medicamentos e Entorpecentes , Medicina Baseada em Evidências , Humanos
16.
J Leg Med ; 39(2): 177-211, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31503531

RESUMO

The federal government subsidizes the research and development of prescription medications. Thus, a captivating critique of expensive medications is that prices are too high because of taxpayer co-financing. This critique is often framed in terms of "paying-twice"-first for the research and second through the above market pricing of resulting products. Reasonable pricing clauses-which place some kind of pricing limitation on the exercise of license or patent rights governing a federally funded medication-are one proposed policy tool for addressing the pay-twice critique. This article provides increased analytical clarity as well as historical context to present-day debates about the privatization of federally funded research and prescription drug pricing. It makes three arguments. First, despite its pervasiveness and intuitive plausibility, the pay-twice critique is subject to differing interpretations which has important implications for the appropriateness of proposed solutions. Second, despite their initial attractiveness, the costs, necessity, and effectiveness of reasonable pricing clauses render the wisdom of this policy tool uncertain. However, third, given continued interest in reasonable pricing clauses, the NIH's previous experience with such a policy offers some useful lessons.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/economia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Legislação de Medicamentos/economia , Medicamentos sob Prescrição/economia , Honorários por Prescrição de Medicamentos/legislação & jurisprudência , Custos e Análise de Custo/economia , Custos e Análise de Custo/legislação & jurisprudência , Governo Federal , Financiamento Governamental , National Institutes of Health (U.S.) , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/legislação & jurisprudência , Privatização/economia , Privatização/legislação & jurisprudência , Estados Unidos
19.
BMJ ; 366: l5221, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533922

RESUMO

OBJECTIVE: To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN: Cross sectional analysis. SETTING: European regulatory documents, clinical trial registry records, protocols, journal publications, and supplementary appendices. ELIGIBILITY CRITERIA: Pivotal randomised controlled trials of new cancer drugs approved by the EMA between 2014 and 2016. MAIN OUTCOME MEASURES: Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents). RESULTS: Between 2014 and 2016, the EMA approved 32 new cancer drugs on the basis of 54 pivotal studies. Of these, 41 (76%) were randomised controlled trials and 13 (24%) were either non-randomised studies or single arm studies. 39/41 randomised controlled trials had available publications and were included in our study. Only 10 randomised controlled trials (26%) measured overall survival as either a primary or coprimary endpoint, with the remaining trials evaluating surrogate measures such as progression free survival and response rates. Overall, 19 randomised controlled trials (49%) were judged to be at high risk of bias for their primary outcome. Concerns about missing outcome data (n=10) and measurement of the outcome (n=7) were the most common domains leading to high risk of bias judgments. Fewer randomised controlled trials that evaluated overall survival as the primary endpoint were at high risk of bias than those that evaluated surrogate efficacy endpoints (2/10 (20%) v 16/29 (55%), respectively). When information available in regulatory documents and the scientific literature was considered separately, overall risk of bias judgments differed for eight randomised controlled trials (21%), which reflects reporting inadequacies in both sources of information. Regulators identified additional deficits beyond the domains captured in risk of bias assessments for 10 drugs (31%). These deficits included magnitude of clinical benefit, inappropriate comparators, and non-preferred study endpoints, which were not disclosed as limitations in scientific publications. CONCLUSIONS: Most pivotal studies forming the basis of EMA approval of new cancer drugs between 2014 and 2016 were randomised controlled trials. However, almost half of these were judged to be at high risk of bias based on their design, conduct, or analysis, some of which might be unavoidable because of the complexity of cancer trials. Regulatory documents and the scientific literature had gaps in their reporting. Journal publications did not acknowledge the key limitations of the available evidence identified in regulatory documents.


Assuntos
Antineoplásicos/uso terapêutico , Aprovação de Drogas/métodos , Neoplasias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Viés , Estudos Transversais , Controle de Medicamentos e Entorpecentes , Humanos , Projetos de Pesquisa , Relatório de Pesquisa
20.
J Endod ; 45(11): 1314-1320.e1, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31522812

RESUMO

INTRODUCTION: Opioid prescriptions have the potential for misuse. In October 2014, the federal schedule II prescribing mandate reclassified hydrocodone combination products from schedule III to schedule II drugs that required a written prescription. The aim of this study was to evaluate the opioid-prescribing practices in a graduate endodontic clinic (GEC) before and after the mandate. METHODS: Electronic health records from all patients treated in the GEC from 2010 to 2018 were reviewed retrospectively for opioid prescribing, the date of prescription, and the Current Dental Terminology code. Where opioid prescribing was documented in the electronic health record, additional data were extracted about pulpal and periapical diagnosis, pain level, opioid type, and prescription details. Prescribing rates were calculated and analyzed by using chi-square, analysis of variance, logistic regression, and multivariable analysis. Significance was set at P < .05. RESULTS: Overall, 4851 patients underwent 7841 procedures; 92.2% of patients were never prescribed opioids. The remaining 380 patients underwent 420 procedures, and 509 prescriptions were provided. Prescribing rates were 7.5% (228/3021) before versus 4.0% (192/4820) after the mandate (P < .001). Hydrocodone combinations were the most prescribed opioid (77%, 392/509). Tramadol prescribing increased after the mandate (P = .023). Multivariable analysis showed significantly higher prescribing for apicoectomy procedures (P < .001). Preoperative pulpal and periapical diagnosis and pain level were not significantly associated with opioid prescribing. CONCLUSIONS: An overall reduction in opioid-prescribing rates occurred coincidentally with the 2014 federal mandate. The lack of correlation between prescribing and pain level highlighted the need for evidence-based rather than habitual prescribing protocols in the GEC.


Assuntos
Analgésicos Opioides , Controle de Medicamentos e Entorpecentes , Endodontia , Padrões de Prática Médica , Analgésicos Opioides/uso terapêutico , Substâncias Controladas , Endodontia/educação , Humanos , Hidrocodona/uso terapêutico , Dor , Estudos Retrospectivos
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