Regulatory barriers to dental anesthesia services for special populations.

AIMS: Sedation and general anesthesia are necessities for the treatment of many individuals within special populations such as those with physical and intellectual disabilities, fear/anxiety, or individuals requiring extensive procedures. This study aims to discover regulatory factors that may be contributing to the limited access to anesthesia services provided by dentist anesthesiologists. METHODS AND RESULTS: The study included an online survey completed by self-reported dentist anesthesiologists with 2 or more years of formal anesthesia training. The survey was distributed at the April 2019 American Society of Dentist Anesthesiologists national meeting in Chicago. Participants responded to questions regarding the effect of specific state regulations on decisions to practice in a particular state and how such regulations influenced patient safety and barriers to care. Rules and regulatory restrictions on the mobility of dentist anesthesiologist equipment/supplies and additional state narcotic transportation regulations were deemed statistically significant in failing to improve safety. Requiring airway and sedation training for a facility's provider and staff were not barriers to care. Rules and regulations were not a factor to establishing clinical practice in one state over another state. CONCLUSION: Individuals and organizations responsible for influencing the regulatory environment of anesthesia services should improve regulations to facilitate the mobility of dentist anesthesiologists.

Regulamentação e criminalização das drogas no Brasil / Drug regulation and criminalization in Brazil

O presente estudo visa avaliar, através de uma revisão narrativa da literatura, como o controle do Estado exerceu ao longo da história do Brasil a regulamentação do uso de drogas. Método Foram consultados livros, artigos de periódicos acadêmicos indexados, trabalhos completos apresentados em congressos e documentos históricos disponíveis na internet relativos ao tema. Resultados A primeira legislação penal em relação ao uso de drogas surge apenas no Brasil império. Nesse período começam a surgir também os primeiros problemas devido ao uso de drogas. A criação de cursos superiores nas áreas de saúde e de ciências naturais veio a formar profissionais capacitados na manipulação e fiscalização de produtos químicos e farmacêuticos. Com o tempo, observando-se os efeitos, algumas substâncias passam a ser proscritas. Conclusão Por toda história do país, o uso e a regulação das drogas, permearam todas as épocas influenciando na cultura, educação e no modo de vida da população. Atualmente há um grande debate acerca das políticas sobre drogas no Brasil, principalmente sobre a maconha e seus usos terapêuticos, mostrando novamente a influência do Estado sobre a saúde e a segurança da população.

The present study aims to evaluate, through a narrative review of the literature, how State's control has exercised regulation of drug use throughout the history of Brazil. Method Books, articles from indexed academic journals, complete works presented at conferences and historical documents available on the internet relating to the topic were consulted. Results The first criminal legislation related to drug use only appeared in Imperial Brazil. During this period, the first problems due to drug use also begin to appear. The creation of higher education courses in the areas of health and natural sciences resulted in the training of professionals capable of handling and supervising chemical and pharmaceutical products. Over time, observing the effects, some substances become proscribed. Conclusion Throughout the country's history, the use and regulation of drugs has permeated all eras, influencing culture, education and the population's way of life. There is currently a great debate about drug policies in Brazil, mainly regarding marijuana and its therapeutic uses, once again showing the influence of the State on the health and safety of the population.

Detección de drogas en saliva: aspectos metodológicos y legales / Detection of drugs in saliva: methodological and legal aspects

El análisis de drogas en saliva es una alternativa no invasiva para evidenciar su presencia en el organismo. La finalidad es amplia, pero se ha utilizado en medicina legal y forense, en especial para drogas ilícitas. La recolección de saliva no implica riesgo, ni personal especializado. El objetivo fue valorar diversos aspectos metodológicos y de validez del test de drogas en saliva para el diagnóstico de su consumo. Asimismo, se analizaron algunos aspectos relativos a la legislación de drogas. Las sustancias psicoactivas a evaluar fueron marihuana, cocaína, anfetaminas y opiáceos. Se realizó una búsqueda en las bases de Pubmed/MEDLINE, Embase, LILACS, Scopus, SciELO y de literatura gris. La identificación de drogas en fluidos biológicos incluye técnicas inmunoquímicas, cromatográficas y procedimientos espectrométricos. Resultados positivos obtenidos mediante una técnica deberían confirmarse con un segundo análisis basado en distintos principios químicos o físicos. Se han detectado en saliva marihuana, cocaína, opiáceos y anfetaminas, entre otras, mediante métodos analíticos, como inmunoensayo y cromatografía de gases / espectrometría de masas en tándem. En el fluido oral, se pueden detectar drogas de abuso durante 5-48 horas posteriores al consumo, a un nivel bajo de nanogramos por mililitro. Se concluyó que la detección de drogas en saliva es una opción indicada ante sospecha de su consumo, por signos o síntomas que sugieren abuso de drogas o para la vigilancia del usuario en un centro de tratamiento por dependencia. En el aspecto legal el uso de test de drogas en saliva es una posibilidad para determinadas circunstancias.

The analysis of drugs in saliva is a non-invasive alternative to demonstrate their presence in the body. The purpose is broad, but it has been used in forensic and legal medicine, especially for illicit drugs. The collection of saliva is not risky and does not require specialized personnel. The objective was to assess various methodological and validity aspects of the saliva drug test for the diagnosis of drug use. Likewise, some aspects related to drug legislation were analyzed. The psychoactive substances to be evaluated were marijuana, cocaine, amphetamines and opiates. A search was carried out in the Pubmed / MEDLINE, Embase, LILACS, Scopus, SciELO and gray literature databases. Identification of drugs in biological fluids was found to include immunochemical, chromatographic and spectrometric procedures. Positive results obtained by one technique must be confirmed with a second analysis based on different chemical or physical principles. Marijuana, cocaine, opiates and amphetamines, among other drugs, have been detected in saliva by various analytical methods, like immunoassay and gas chromatography / tandem mass spectrometry. In oral fluid, drugs of abuse can be detected for 5-48 hours post-consumption, at a low level of nanograms per milliliter. It was concluded that the detection of drugs in saliva is an option that is indicated in the event of suspected drug use, for signs or symptoms that suggest drug abuse, or for monitoring the user in a dependency treatment center. In the legal aspect, the use of drug tests in saliva is a possibility for certain circumstances.

Lung cancer mortality trends in Mexico, 1998-2018: the impact of the General Law on Tobacco Control / Tendências de mortalidade por câncer de pulmão no México, 1998-2018: o impacto da Lei Geral de Controle do Tabaco

ABSTRACT: Objective: The aim of this study was to describe trends in lung cancer (LC) mortality and trends in tobacco use. Methods: This is an ecological time-series study to determine mortality trends due to lung cancer resulting from tobacco consumption, based on secondary open-access sources, such as the National Surveys. Smoking prevalence, tobacco use trends, mortality rates, and percentage were determined by LC. The mortality trend from LC was calculated, and a linear regression analysis was performed to evaluate the impact of the General Law for Tobacco Control. Results: The prevalence of tobacco use decreased steadily between 1988 and 2015, particularly in men. Mortality rates and percentage decreased between 1998 and 2018. During this period, the mortality rate decreased from 6.3 to 5.4 per 100,000 population (−0.032/100,000 each year, p<0.001), with a net decrease of 0.9 per 100,000. We observe increases in mortality in women in the central and southeastern regions. Of 32 states, 18 showed a tendency to loss (p<0.005). The rate of change for men was −0.24, with a total reduction of 2.17 before the introduction of the laws and −0.32 after their introduction, a total reduction of 3.24 (p<0.005). Women showed no reduction. Conclusions: Mortality rates showed a limited decrease. Strategies need to be strengthened, mainly in the central and southeastern regions, and to focus on the control of tobacco use by women.

RESUMO: Objetivos: Descrever tendências na mortalidade por câncer de pulmão e no uso do tabaco. Métodos: Realizamos um estudo ecológico de séries temporais para determinar a tendência de mortalidade por câncer de pulmão de acordo com o consumo de tabaco, com base em fontes secundárias de acesso aberto, como as Pesquisas Nacionais. Prevalência de tabagismo, tendências de uso de tabaco, porcentagem e taxas de mortalidade foram determinadas pelo câncer de pulmão. A tendência de mortalidade por câncer de pulmão foi calculada e uma análise de regressão linear foi realizada para avaliar o impacto da lei geral para o controle do tabagismo. Resultados: A prevalência do uso de tabaco diminuiu continuamente entre 1988 e 2015, principalmente em homens. As taxas e percentuais de mortalidade diminuíram entre 1998 e 2018. Durante esse período, a taxa de mortalidade diminuiu de 6,3 para 5,4 por 100 mil habitantes (-0,032 por 100 mil a cada ano, p<0,001), com redução líquida de 0,9 por 100 mil. Observamos aumentos na mortalidade de mulheres nas regiões Centro e Sudeste. Dos 32 estados, 18 apresentaram tendência à perda (p<0,005). A taxa de mudança para os homens foi de -0,24, com redução total de 2,17 antes da introdução das leis e -0,32 após a sua introdução — redução total de 3,24 (p<0,005). As mulheres não apresentaram redução. Conclusões: As taxas de mortalidade mostraram redução limitada. Estratégias precisam ser fortalecidas, principalmente nas regiões Centro e Sudeste, e deve-se enfocar o controle do uso do tabaco pelas mulheres.

Forced degradation studies to identify organic impurities in pharmaceuticals: a Brazilian perspective

Objective: The aim of this study was to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products and to describe the Brazilian and international regulations associated with degradation studies of drugs and drug products. Methods: This review was conducted based on the Brazilian guidance tools as RDC 53/2015, Guide 4 and Question and Answer resource; references used as international guides; and articles in the field of degradation product analyses. Results: Characterization of the impurity profile for a substance, and development of indicative stability methods are essential criteria for compliance with current legislation, and address a legitimate health concern. As this matter falls under the purview of recently published regulation, many doubts remain regarding methods of conducting studies of forced degradation, and development of methods indicative of stability. Analytical conditions predict degradation after exposing them to thermal, humid, acidic, basic, oxidation, photolytic, and metal ion conditions. Conclusions: Although RDC 53/2015 outlines the parameters of degradation, the analytical conditions are not specified, as well as in other international standards. A well-designed forced degradation study is key to obtaining a good stability indicating method with peak purity and mass balance.

[Comparative analysis of policies regulating clinical trialsAnálisis comparativo de las políticas de reglamentación de los ensayos clínicos]. / Análise comparativa de políticas de regulamentação de ensaios clínicos.

The present article compares clinical trial regulations in Brazil, India, Canada, and the European Union with the aim of providing evidence for an evaluation of the Brazilian regulatory policy. For that, a document analysis approach was used, in four steps: preliminary exploratory analysis; descriptive study; categorization of information; contrasting contents. Noteworthy differences between the Brazilian regulatory framework as compared to the other regions studied include the existence of several laws and regulations in Brazil vs. a single rule in the other countries; the absence of requirements regarding drug traceability and collection and disposal of unused drugs if a study is interrupted or cancelled; and a higher time of 180 days for approval of clinical trials (vs. 30 days in the European Union or Canada, for example). This suggests opportunities for improvement and update of the Brazilian regulations vis-à-vis the international scenario.

En el presente trabajo se compararon los reglamentos sobre la realización de ensayos clínicos en Brasil, India, Canadá y la Unión Europea, con el objetivo de ofrecer subsidios para una evaluación de la política de reglamentación de Brasil. Para ello, se realizó un análisis documental en cuatro etapas, a saber, estudio preliminar exploratorio, estudio descriptivo, clasificación de la información y comparación de los contenidos. En cuanto a las diferencias entre la reglamentación brasileña y la de los demás casos, cabe destacar que en Brasil existen varias resoluciones sobre el tema, a diferencia de los demás países donde la información se concentró en una sola reglamentación nacional; no se exige que se rastreen los medicamentos ni que se recojan o se eliminen los no utilizados cuando se suspende o se cancela un estudio; y se requiere un tiempo de aprobación de 180 días para iniciar el ensayo (en comparación con 30 días en la Unión Europea y Canadá, por ejemplo). Eso indica que hay oportunidades para mejorar y actualizar la reglamentación brasileña tal como ocurre en el escenario internacional.

Nurse prescribing: Attitudes of medical doctors towards expanding professional competencies of nurses and midwives.

OBJECTIVE: To identify the attitudes of doctors regarding prescriptive competences of nurses and midwives since these have been recently regulated in several countries. . METHODS: The cross-sectional study was conducted at the Medical University of Warsaw from February 1to7, 2016 and comprised doctors working at the Prof. Jan Nielubowicz Regional Medical Chamber in Warsaw, Poland. A specially designed 36-item questionnaire that had 22 statements was used regarding the role of the reform in the healthcare system; the need of granting nurses and midwives particular competencies; and their preparation and readiness for these competencies. The respondents assessed the statements using a Likert scale (1=strongly disagree; 5=strongly agree). STATISTICA 13.2 was used for data analysis. . RESULTS: Of the 436 doctors, 245(56%) were women. The subjects presented different opinions about the reforms, especially about possible improvement in patient care with nurses prescribing, or the process getting simplified for the care-seekers. Most doctors believed that nurses and midwives were not yet equipped enough to prescribe certain medicines or issue prescriptions (1,79/5). Only in case of nurses and midwives being able to 're-order' medicines earlier prescribed by a doctor, the attitudes of primary care physicians was significantly different than those involved with hospital care (p=0.048). CONCLUSIONS: Doctors were sceptical about expanding professional competences of nurses and midwives regarding drug prescription.

Cannabis for paediatric epilepsy: challenges and conundrums.

Research is expanding for the use of cannabidiol as an anticonvulsant drug. The mechanism of cannabidiol in paediatric epilepsy is unclear but is thought to play a role in modulation of synaptic transmission. Evidence for its efficacy in treating epilepsy is limited but growing, with a single pharmaceutical company-funded randomised double-blind controlled trial in children with Dravet syndrome. Progress towards the use of medicinal cannabinoids incorporates a complex interplay of social influences and political and legal reform. Access to unregistered but available cannabidiol in Australia outside of clinical trials and compassionate access schemes is state dependent and will require Therapeutic Goods Administration approval, although the cost may be prohibitive. Further clinical trials are needed to clearly define efficacy and safety, particularly long term.

The effects of state rules on opioid prescribing in Indiana.

BACKGROUND: Prescription opioids have been linked to over half of the 28,000 opioid overdose deaths in 2014. High rates of prescription opioid non-medical use have continued despite nearly all states implementing large-scale prescription drug monitoring programs (PDMP), which points to the need to examine the impact of state PDMP's on curbing inappropriate opioid prescribing. In the short-term, PDMPs have been associated with short-term prescribing declines. Yet little is known about how such policies differentially impact patient subgroups or are interpreted by prescribing providers. Our objective was to compare volumes of prescribed opioids before and after Indiana implemented opioid prescribing emergency rules and stratify the changes in opioid prescribing by patient and provider subgroups. METHODS: An interrupted time series analysis was conducted using data obtained from the Indiana PDMP. Prescription level data was merged with census data to characterize patient socioeconomic status. Analyses were stratified by patients' gender, age, opioid dosage, and payer. The primary outcome indicator was the total morphine equivalent dose (MED) of dispensed opioids per day in the state of Indiana. Also considered were number of unique patients, unique providers, and prescriptions; MED per transaction and per day; and number of days supplied. RESULTS: After controlling for time trends, we found that total MED for opioids decreased after implementing the new emergency rules, differing by patient gender, age, and payer. The effect was larger for males than females and almost 10 times larger for 0-20 year olds as compared to the 60+ age range. Medicare and Medicaid patients experienced more decline in prescribing than patients with private insurance. Patients with prescriptions paid for by workers' comp experienced the most significant decline. The emergency rules were associated with decline in both the number of prescribers and the number of day supply. CONCLUSIONS: Although the Indiana opioid prescribing emergency rules impacted statewide prescribing behavior across all individual patient and provider characteristics, the emergency rules' effect was not consistent across patient characteristics. Further studies are needed to assess how individual patient characteristics influence the interpretation and application of state policies on opioid prescribing.

Adolescent Marijuana Use and Perceived Ease of Access Before and After Recreational Marijuana Implementation in Colorado.

BACKGROUND: As of January 1, 2017, eight states have approved laws for recreational marijuana use. While the social impacts of these changes remain under debate, the influence on adolescent marijuana use is a key policy and health issue across the U.S. OBJECTIVE: To examine changes in adolescent marijuana-use behaviors in the first year after recreational marijuana implementation in Colorado, and to analyze the effect of retail marijuana store proximity on youth use and perceptions. METHOD: Secondary analysis of Healthy Kids Colorado Survey data from 40 schools surveyed before and after recreational marijuana sales were implemented (2013 student n = 12,240; 2014 student n = 11,931). Self-reported marijuana use, ease of access, and perceived harms were compared between years and by proximity of recreational marijuana stores to surveyed schools. RESULTS: Adolescent marijuana use behaviors, wrongness of use, and perceptions of risk of harm were unchanged from baseline to one-year follow-up. Perceived ease of access to marijuana increased (from 46% to 52%). Proximity of recreational marijuana stores was not significantly associated with perceived ease of access to marijuana. Conclusions/Importance: In the first study of adolescent marijuana use and perceptions after state retail implementation of recreational marijuana, there was little change in adolescent marijuana use but a significant change in perception of ease of access. Public health workers and policymakers should continue to monitor these changes as essential for evaluating the impact of liberalization of marijuana policies.

[Attitudes of polish physicians towards extending competencies of nurses and midwives with respect to prescribing medicines].

INTRODUCTION: Due to the amendment of the Nurse and Midwife professions Act, since 1st of January 2016 Polish nurses and midwives with certain qualifications are able to prescribe medicines and referral for diagnostic tests. THE AIM: To analyse attitudes of physicians on new professional competencies of nurses and midwives regarding: prescribing medicines and referring patients for certain diagnostic tests. MATERIAL AND METHODS: In the study took part 436 physicians (245 women, 193 man). The average age was 36,6 years old (min.: 21; max.: 76; SD: 11,65; median: 31). 274 people lived in a city with over 500 thousand citizens, 70 people - city below 100 thousand citizens, 54 people - city between 100-500 thousands citizens and 14 people lived in a country. Most of people lived in masovian district. Authors prepared and validated own questionnaire, which contained statements assessed in Likert scale (1-strongly disagree, 5-stronlgy agree). It contained 22 questions about opinions of new abilities of nurses and midwives. The questionnaire was sent three times to Regional Medical Chamber in Warsaw via an online questionnaire: https://docs.google.com/forms/d/1cxiaJFPxDVphByhBTk4gDIBsm6bQsxGLVXDK-RtpGnk/ The reliability of the questionnaire used was tested in a pilot study by the coefficient α-Cronbach, which amounted to 0.937. Due to the fact that the study was performed in a group of doctors they did not require the consent of the Bioethics Committee, of Medical University of Warsaw to carry them out. The results are presented using descriptive statistics, which were obtained through statistical analysis using Microsoft Excel and StatSoft Statistica 12.0 (license Medical University of Warsaw). RESULTS: 53% of doctors claim that the new powers do not improve patient care. 35% of respondents disagreed with the opinion that the new powers will raise the prestige of professional nurses and midwives. At the same time 49% believe that prescriptions for nurses and midwives reduce the responsibilities of doctors. Only 9% agreed that the new abilities are needed in Poland. 65% of doctors have expressed the opinion that nurses and midwives should not have permission to prescriptions and 81% believe that they are not prepared for those abilities. CONCLUSION: Doctors have divided opinion about the benefits of the introduction of the nursing prescriptions for the patient. It is therefore, considered an information campaign through the mass media, or training in the workplace, where they will be presented in an objective manner the consequences of the introduction of new regulations.