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1.
JAMA ; 323(2): 164-176, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935033

RESUMO

Importance: US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks. Objective: To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018. Evidence: Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018). Findings: From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period. Conclusions and Relevance: Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Regulamentação Governamental , Legislação de Medicamentos/tendências , Preparações Farmacêuticas/normas , United States Food and Drug Administration , Aprovação de Drogas/economia , Aprovação de Drogas/estatística & dados numéricos , História do Século XX , Legislação de Medicamentos/história , Estados Unidos
2.
Aten. prim. (Barc., Ed. impr.) ; 51(4): 245-251, abr. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-180865

RESUMO

Objetivo: Examinar críticamente el concepto de prescripción enfermera mediante el estudio de los antecedentes y una revisión de la literatura científica con el fin de desarrollar una concepción precisa de esta actuación enfermera e identificar los elementos esenciales que envuelven este concepto. Método: Aplicación del procedimiento de análisis de concepto descrito por Wilson y adaptado por Avant. Resultados: El concepto de prescripción enfermera implica prescribir por parte de la enfermera el mejor régimen terapéutico frente a un problema de salud. Esta prescripción estará guiada por la valoración del problema de salud, por el criterio de la buena práctica clínica del profesional enfermero y estará dirigida a satisfacer las necesidades de salud del usuario y la población. Conclusiones: Los resultados aclaran el significado del concepto de estudio para ayudar a los profesionales a comprender y abordar esta actuación en todas sus dimensiones y promover el reconocimiento social de la profesión enfermera


Objective: To critically analyse the concept of nursing prescription through the study of its background and a review of the scientific literature, in order to develop an accurate conception of this nursing activity and to identify the essential elements surrounding this concept. Method: Application of the concept analysis method described by Wilson, and adapted by Avant. Results: The concept of nurse prescription implies prescribing, by the nurse, the best therapeutic regimen for a health problem. This prescription will be guided by the assessment of the health problem, by the criterion of the good clinical practice of the nurse, and will be focused to satisfy the health needs of the patient and the population. Conclusions: The results clarify the meaning of the study's concept to help professionals understand and address this nursing activity in all its dimensions, and promote social recognition of the nursing profession


Assuntos
Humanos , Prescrições de Medicamentos/enfermagem , Competência Profissional , Processo de Enfermagem/legislação & jurisprudência , Modelos de Enfermagem , Papel Profissional , Legislação de Medicamentos/tendências
5.
Drug Alcohol Depend ; 194: 13-19, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30390550

RESUMO

OBJECTIVES: Medical marijuana use may substitute prescription opioid use, whereas nonmedical marijuana use may be a risk factor of prescription opioid misuse. This study examined the associations between recreational marijuana legalization and prescription opioids received by Medicaid enrollees. METHODS: State-level quarterly prescription drug utilization records for Medicaid enrollees during 2010-2017 were obtained from Medicaid State Drug Utilization Data. The primary outcome, opioid prescriptions received, was measured in three population-adjusted variables: number of opioid prescriptions, total doses of opioid prescriptions in morphine milligram equivalents, and related Medicaid spending, per quarter per 100 enrollees. Two difference-in-difference models were used to test the associations: eight states and DC that legalized recreational marijuana during the study period were first compared among themselves, then compared to six states with medical marijuana legalized before the study period. Schedule II and III opioids were analyzed separately. RESULTS: In models comparing eight states and DC, legalization was not associated with Schedule II opioid outcomes; having recreational marijuana legalization effective in 2015 was associated with reductions in number of prescriptions, total doses, and spending of Schedule III opioids by 32% (95% CI: (-49%, -15%), p = 0.003), 30% ((-55%, -4.4%), p = 0.027), and 31% ((-59%, -3.6%), p = 0.031), respectively. In models comparing eight states and DC to six states with medical marijuana legalization, recreational marijuana legalization was not associated with any opioid outcome. CONCLUSIONS: No evidence suggested that recreational marijuana legalization increased prescription opioids received by Medicaid enrollees. There was some evidence in some states for reduced Schedule III opioids following the legalization.


Assuntos
Analgésicos Opioides/administração & dosagem , Legislação de Medicamentos/tendências , Uso da Maconha/tendências , Medicaid/tendências , Maconha Medicinal/administração & dosagem , Medicamentos sob Prescrição/administração & dosagem , Analgésicos Opioides/economia , Uso de Medicamentos/economia , Uso de Medicamentos/tendências , Feminino , Humanos , Legislação de Medicamentos/economia , Masculino , Uso da Maconha/economia , Medicaid/economia , Maconha Medicinal/economia , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/economia , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Medicamentos sob Prescrição/economia , Fatores de Risco , Estados Unidos/epidemiologia
6.
Drug Alcohol Depend ; 194: 178-183, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30447509

RESUMO

BACKGROUND: This study compared young adults with and without a medical marijuana (MM) recommendation from a provider ("MM card") on their developmental trajectories of frequent marijuana use and marijuana-related problems in young adulthood. METHODS: The analytic sample consists of young adult past month marijuana users (N = 671) who were part of a larger, diverse, and predominantly California cohort. Analyses are based on data from seven surveys completed from ages 13-19. RESULTS: At age 19, 28% of participants reported having an MM card to legally purchase marijuana from an MM dispensary. A multiple group latent growth model indicated that young adults who had an MM card showed steeper increases in frequent marijuana use (i.e., 20-30 days of use in the past month) from ages 13-19 compared to young adults who did not have an MM card. Logistic regression models that matched MM cardholders and non-MM cardholders on individual sociodemographic characteristics found that MM cardholders were more likely to report marijuana negative consequences, selling marijuana/hashish, and driving under the influence of marijuana in the past year. In addition, MM cardholders were more likely to have tried cutting down or quitting in the past 3-months. CONCLUSIONS: Among young adult marijuana users, those with an MM card had a higher risk profile for marijuana use and related problems compared to those without an MM card. Given expanding state legalization of MM, this issue warrants further attention.


Assuntos
Dirigir sob a Influência/tendências , Legislação de Medicamentos/tendências , Uso da Maconha/tendências , Maconha Medicinal/efeitos adversos , Adolescente , Adulto , Condução de Veículo/psicologia , California/epidemiologia , Estudos de Coortes , Dirigir sob a Influência/psicologia , Feminino , Humanos , Masculino , Abuso de Maconha/diagnóstico , Abuso de Maconha/epidemiologia , Abuso de Maconha/psicologia , Uso da Maconha/efeitos adversos , Uso da Maconha/epidemiologia , Uso da Maconha/psicologia , Maconha Medicinal/uso terapêutico , Fatores de Risco , Inquéritos e Questionários , Adulto Jovem
7.
Clin Pharmacol Ther ; 105(2): 329-337, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30471089

RESUMO

The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter the market, but the past decade has witnessed rising costs and shortages of generic drugs. We describe the strategies used by brand-name manufacturers to undermine generic competition and the reasons underlying the price increases of off-patent drugs, some of which continue to lack any competition from generic versions, and others that have increased in price despite having generic versions. We discuss the FDA's role in addressing drug prices and promoting competition, including recent agency policies to modify its process of reviewing generic drug applications and to prioritize applications for off-patent drugs with few competitors. We also examine proposed policy solutions and research areas that could help address the price increases of off-patent drugs.


Assuntos
Custos e Análise de Custo/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Medicamentos Genéricos/economia , Medicamentos Genéricos/normas , Competição Econômica/legislação & jurisprudência , Legislação de Medicamentos/tendências , Aprovação de Drogas/legislação & jurisprudência , Custos de Medicamentos/normas , Indústria Farmacêutica , Competição Econômica/normas , Humanos , Políticas , Medicamentos sob Prescrição/economia , Estados Unidos , United States Food and Drug Administration
8.
Int Rev Psychiatry ; 30(5): 91-106, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30522342

RESUMO

Pre-clinical research supports that cannabinoids reduce opioid dose requirements, but few studies have tested this in humans. This review evaluates ecological and epidemiological studies that have been cited as evidence that medical cannabis use may reduce opioid use and opioid-related harms. Medline and Embase were searched for relevant articles. Data were extracted on study setting, analyses approach, covariates, and outcomes. Eleven ecological and 14 epidemiological studies were found. In ecological studies, states that allow medical cannabis laws have reported a slower rate of increase in opioid overdose deaths compared with states without such laws. These differences have increased over time and persisted after controlling for state sociodemographic characteristics and use of prescription monitoring programmes. Few studies have controlled for other potential confounders such as opioid dependence treatment and imprisonment rates. Some epidemiological studies provide evidence that cannabis availability may reduce opioid use, but are limited by selection bias, cross-sectional designs, and self-reported assessments of the opioid-sparing effects of cannabis. Some epidemiological and ecological studies suggest that cannabis may reduce opioid use and harms, although important methodological weaknesses were identified. Well-designed clinical studies may provide more conclusive evidence on whether cannabinoids can reduce opioid use and related harm.


Assuntos
Analgésicos Opioides/efeitos adversos , Overdose de Drogas/epidemiologia , Overdose de Drogas/prevenção & controle , Redução do Dano , Maconha Medicinal/administração & dosagem , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Canabinoides , Overdose de Drogas/mortalidade , Humanos , Legislação de Medicamentos/tendências
9.
Curr Pharm Teach Learn ; 10(11): 1512-1517, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30514543

RESUMO

BACKGROUND AND PURPOSE: The purpose of this project was to impact pharmacy students' personal and professional development through simulation of a board of pharmacy disciplinary hearing regarding addiction. EDUCATIONAL ACTIVITY AND SETTING: The mock board hearing was conducted as part of the required curriculum. Faculty obtained materials from a prior board hearing. The actual respondent, lawyer, former executive director, and a board agent participated. Students served as board members and president, asked questions of the witnesses, and deliberated per board procedure. After the event, student learning and perceptions were assessed through knowledge-based, opinion-based questions, and open-ended questions. FINDINGS: Of the 141 students who attended the event, 97% completed the assessment. The average score on the knowledge-based questions was 95%. Ratings of perceptions and reflections of the experience were used in tandem to understand the experience. In general, students indicated the experience was positive and impactful towards their education. Students indicated they felt that the experience allowed them to better understand addiction and empathize with someone called before the board. In fact, there were fundamental differences in perceptions regarding the "addicted person," going from a penalizing and stigmatized perspective to one of caring and compassion. SUMMARY: Students were knowledgeable about the board and its regulatory process after the event. More than knowledge, students indicated fundamental changes in their views of addiction. Other institutions may consider implementing similar exercises to engender empathy and professionalism regarding drug addiction and regulatory compliance.


Assuntos
Empatia , Disciplina no Trabalho/métodos , Legislação de Medicamentos/tendências , Profissionalismo/educação , Estudantes de Farmácia/psicologia , Atitude do Pessoal de Saúde , Currículo/tendências , Educação em Farmácia/métodos , Avaliação Educacional/métodos , Humanos , Organização e Administração , Estudantes de Farmácia/estatística & dados numéricos
10.
BMC Int Health Hum Rights ; 18(1): 43, 2018 11 29.
Artigo em Inglês | MEDLINE | ID: mdl-30497476

RESUMO

BACKGROUND: As of May 2017, the United States federal government renewed its prioritization for the enforcement of mandatory minimum sentences for illicit drug offenses. While the effect of such policies on racial disparities in incarceration is well-documented, less is known about the extent to which these laws are associated with decreased drug use. This study aims to identify changes in cocaine use associated with mandatory minimum sentencing policies by examining differential sentences for powder and crack cocaine set by the Anti-Drug Abuse Act (ADAA) (100:1) and the Fair Sentencing Act (FSA), which reduced the disparate sentencing to 18:1. METHODS: Using data from National Survey on Drug Use and Health, we examined past-year cocaine use before and after implementation of the ADAA (1985-1990, N = 21,296) and FSA (2009-2013, N = 130,574). We used weighted logistic regressions and Z-tests across models to identify differential change in use between crack and powder cocaine. Prescription drug misuse, or use outside prescribed indication or dose, was modeled as a negative control to identify underlying drug trends not related to sentencing policies. RESULTS: Despite harsher ADAA penalties for crack compared to powder cocaine, there was no decrease in crack use following implementation of sentencing policies (odds ratio (OR): 0.72, p = 0.13), although both powder cocaine use and misuse of prescription drugs (the negative control) decreased (OR: 0.59, p < 0.01; OR: 0.42, p < 0.01 respectively). Furthermore, there was no change in crack use following the FSA, but powder cocaine use decreased, despite no changes to powder cocaine sentences (OR: 0.81, p = 0.02), suggesting that drug use is driven by factors not associated with sentencing policy. CONCLUSIONS: Despite harsher penalties for crack versus powder cocaine, crack use declined less than powder cocaine and even less than drugs not included in sentencing policies. These findings suggest that mandatory minimum sentencing may not be an effective method of deterring cocaine use.


Assuntos
Transtornos Relacionados ao Uso de Cocaína , Cocaína Crack , Legislação de Medicamentos/tendências , Transtornos Relacionados ao Uso de Substâncias , Humanos , Pós , Prisões , Política Pública , Estados Unidos
11.
Mo Med ; 115(5): 398-404, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30385981

RESUMO

We review recent findings on medical aspects of marijuana use in order to identify those who are at greatest risk of marijuana-related medical problems. We analyze the impact of medical marijuana laws on health, in particular the disproportionate effects on adolescents and children. Chronic marijuana use predominantly affects certain areas of the brain that overlap the default mode network, linked hubs in the brain that play a supervisory role in critical thought processes such as attention, memory, and social interactions. Disruption of the default mode network areas has been documented in schizophrenia and Alzheimer's disease, illnesses with symptoms and brain changes that parallel findings in marijuana abusers. These findings counter the claim that marijuana is a harmless drug and are a cause for alarm in persons with cannabis dependence.


Assuntos
Legislação de Medicamentos/tendências , Uso da Maconha/legislação & jurisprudência , Maconha Medicinal/uso terapêutico , Humanos
12.
Rev. Rol enferm ; 41(10): 648-656, oct. 2018. ilus
Artigo em Espanhol | IBECS | ID: ibc-179756

RESUMO

La prescripción enfermera es un tema que ha generado controversia en los últimos años. Desde hace tiempo, se viene reclamando un apoyo legal para esta tarea que las enfermeras asumen de manera habitual en su práctica clínica. Las enfermeras realizan tareas asistenciales relacionadas con pacientes crónicos, cuidados paliativos, de atención domiciliaria o de otros procesos y, en muchas ocasiones, deben tomar decisiones sin ningún respaldo legal. La primera regulación en España que hace referencia a la capacidad de las enfermeras para indicar, usar y dispensar determinados medicamentos y productos sanitarios de forma autónoma aparece en la Ley 28/2009, que modificaba la ley de garantías y uso racional de los medicamentos. En ella, también se hacía referencia a que el gobierno regularía esta competencia. El desarrollo de esta normativa no se produjo hasta el año 2015 con el Real Decreto 954/2015, que niega la posibilidad de la prescripción enfermera autónoma y genera de nuevo controversia. En los últimos meses se ha llegado a un acuerdo para modificar este real decreto, de manera que, una vez que se publique en el BOE, las enfermeras podrán prescribir en el ámbito de sus competencias, lo que supondrá el reconocimiento de sus competencias en la práctica profesional y un beneficio tanto para los pacientes como para el sistema sanitario


The nursing prescription is a subject that has generated controversy in recent years. For some time now, legal support has been demanded for this task which nurses usually assume in their clinical practice. The nurses perform care tasks related to chronic patients, palliative care, home care or other processes, and in many cases, they must make decisions without any legal backing. The first regulation in Spain that refers to the ability of nurses to indicate, use and dispense certain medicines and health products autonomously appears in Law 28/2009, which modified the law on guarantees and rational use of medicines. In it, reference was also made to the fact that the government would regulate this competence. The development of this regulation does not occur until 2015 with Royal Decree 954/2015, which denies the possibility of autonomous nurse prescription and generates new controversy. In recent months, an agreement has been reached to modify this royal decree so that, once it is published in the BOE, nurses may prescribe within the scope of their competences, which will mean the recognition of their skills in professional practice and a benefit for both patients and the health system


Assuntos
Humanos , Prescrições de Medicamentos/enfermagem , Tomada de Decisão Clínica/ética , Cuidados de Enfermagem/tendências , Legislação de Medicamentos/tendências , Processo de Enfermagem/legislação & jurisprudência , Acreditação/tendências
14.
Drug Saf ; 41(12): 1285-1302, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30128638

RESUMO

In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network. The project was divided into eight separate work streams, five of which concentrated on pharmacovigilance topics-collecting information on suspected adverse drug reactions, identifying and managing safety issues (signals), communicating risk and assessing risk minimisation measures, supported by effective quality management systems. The other three work streams focused on the functional aspects-coordination, communication and evaluation of the project. Through the project, SCOPE delivered guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. The deliverables provide practical guidance that those working in the European national competent authorities can take to strengthen their national systems. The SCOPE outputs can be useful for other stakeholders involved in pharmacovigilance activities, including the pharmaceutical industry, healthcare professionals, patient and consumer organisations, and academia.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , União Europeia , Colaboração Intersetorial , Legislação de Medicamentos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Legislação de Medicamentos/tendências
15.
Drug Alcohol Depend ; 188: 385-391, 2018 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-29779761

RESUMO

BACKGROUND: Marijuana use during adolescence is associated with neurocognitive deficits and poorer functioning across several domains. It is likely that more states will pass both medical and recreational marijuana legalization laws in the coming elections; therefore, we must begin to look more closely at the longitudinal effects of medical marijuana (MM) advertising on marijuana use among adolescents so that we can better understand effects that this advertising may have on their subsequent marijuana use and related outcomes. METHODS: We followed two cohorts of 7th and 8th graders (mean age 13) recruited from school districts in Southern California from 2010 until 2017 (mean age 19) to examine effects of MM advertising on adolescents' marijuana use, cognitions, and consequences over seven years. Latent growth models examined trajectories of self-reported exposure to medical marijuana ads in the past three months and trajectories of use, cognitions, and consequences. RESULTS: Higher average exposure to MM advertising was associated with higher average use, intentions to use, positive expectancies, and negative consequences. Similarly, higher rates of change in MM advertising exposure were associated with higher rates of change in use, intentions, expectancies, and consequences over seven years. CONCLUSIONS: Results suggest that exposure to MM advertising may not only play a significant role in shaping attitudes about marijuana, but may also contribute to increased marijuana use and related negative consequences throughout adolescence. This highlights the importance of considering regulations for marijuana advertising, similar to regulations in place for the promotion of tobacco and alcohol in the U.S.


Assuntos
/tendências , Cognição , Legislação de Medicamentos/tendências , Uso da Maconha/tendências , Maconha Medicinal , Adolescente , California/epidemiologia , Criança , Feminino , Humanos , Intenção , Masculino , Abuso de Maconha/epidemiologia , Abuso de Maconha/prevenção & controle , Uso da Maconha/epidemiologia , Uso da Maconha/legislação & jurisprudência , Maconha Medicinal/administração & dosagem , Instituições Acadêmicas/tendências , Fatores de Tempo , Adulto Jovem
16.
J Trauma Acute Care Surg ; 85(3): 566-571, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29787529

RESUMO

BACKGROUND: Half of the US states have legalized medical cannabis (marijuana), some allow recreational use. The economic and public health effects of these policies are still being evaluated. We hypothesized that cannabis legalization was associated with an increase in the proportion of motor vehicle crash fatalities involving cannabis-positive drivers, and that cannabis use is associated with high-risk behavior and poor insurance status. METHODS: Hawaii legalized cannabis in 2000. Fatality Analysis Reporting System data were analyzed before (1993-2000) and after (2001-2015) legalization. The presence of cannabis (THC), methamphetamine, and alcohol in fatally injured drivers was compared. Data from the state's highest level trauma center were reviewed for THC status from 1997 to 2013. State Trauma Registry data from 2011 to 2015 were reviewed to evaluate association between cannabis, helmet/seatbelt use, and payor mix. RESULTS: THC positivity among driver fatalities increased since legalization, with a threefold increase from 1993-2000 to 2001-2015. Methamphetamine, which has remained illegal, and alcohol positivity were not significantly different before versus after 2000. THC-positive fatalities were younger, and more likely, single-vehicle accidents, nighttime crashes, and speeding. They were less likely to have used a seatbelt or helmet. THC positivity among all injured patients tested at our highest level trauma center increased from 11% before to 20% after legalization. From 2011 to 2015, THC-positive patients were significantly less likely to wear a seatbelt or helmet (33% vs 56%). They were twice as likely to have Medicaid insurance (28% vs 14%). CONCLUSION: Since the legalization of cannabis, THC positivity among MVC fatalities has tripled statewide, and THC positivity among patients presenting to the highest level trauma center has doubled. THC-positive patients are less likely to use protective devices and more likely to rely on publically funded medical insurance. These findings have implications nationally and underscore the need for further research and policy development to address the public health effects and the costs of cannabis-related trauma. LEVEL OF EVIDENCE: Prognostic, level III.


Assuntos
Acidentes de Trânsito/mortalidade , Fumar Maconha/efeitos adversos , Fumar Maconha/legislação & jurisprudência , Veículos Automotores/estatística & dados numéricos , Acidentes de Trânsito/estatística & dados numéricos , Adulto , Cannabis/efeitos adversos , Feminino , Hawaii/epidemiologia , Humanos , Reembolso de Seguro de Saúde/economia , Legislação de Medicamentos/estatística & dados numéricos , Legislação de Medicamentos/tendências , Masculino , Medicaid/economia , Medicaid/estatística & dados numéricos , Metanfetamina/efeitos adversos , Pessoa de Meia-Idade , Centros de Traumatologia/estatística & dados numéricos , Estados Unidos/epidemiologia
17.
Curr Opin Psychiatry ; 31(4): 300-305, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29746420

RESUMO

PURPOSE OF REVIEW: To review the literature on decriminalization of drug use from 2016 to 2017 and suggest the way forward. RECENT FINDINGS: The systematic review of the literature on decriminalization resulted in seven articles that discuss decriminalization as compared with 57 published articles on legalization. Decriminalization of drug use did not have an effect on the age of onset of drug use and the prices of drugs did not decrease after the implementation of drug decriminalization. Policy-based studies on decriminalization suggest shifting from criminal sanctions to a public health approach, which was endorsed by the United Nations (UN) that viewed drug addiction as a preventable and treatable health disorder. One study preferred decriminalization only for cannabis and cautioned against regulating cannabis like alcohol. Another study indicated that general medical practitioners in Ireland did not favour the decriminalization of cannabis. SUMMARY: Scientific evidence supporting drug addiction as a health disorder and the endorsement by the UN strengthen the case for decriminalization. However, studies reporting on the positive outcomes of decriminalization remain scarce. The evidence needs to be more widespread in order to support the case for decriminalization. Furthermore, the endorsement by the UN needs to be acted upon by individual member states.


Assuntos
Cannabis , Direito Penal , Legislação de Medicamentos , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Direito Penal/métodos , Direito Penal/tendências , Humanos , Legislação de Medicamentos/organização & administração , Legislação de Medicamentos/tendências , Opinião Pública
18.
Chimia (Aarau) ; 72(3): 146-150, 2018 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-29631666

RESUMO

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.


Assuntos
Contaminação de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos/tendências , Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Regulamentação Governamental , Guias como Assunto , Controle de Qualidade , Suíça
19.
Value Health ; 21(3): 252-257, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29566830

RESUMO

OBJECTIVES: To analyze how value-based pricing (VBP), which grounds the price paid for pharmaceuticals in their value, can manage "affordability" challenges, defined as drugs that meet cost-effectiveness thresholds but are "unaffordable" within the short-run budget. METHODS: Three specific contexts are examined, drawing on recent experience. First, an effective new treatment for a chronic, progressive disease, such as hepatitis C, creates a budget spike that is transitory because initial prevalence is high, relative to current incidence. Second, "cures" that potentially provide lifetime benefits may claim abnormally high VBP prices, with high immediate budget impact potentially/partially offset by deferred cost savings. Third, although orphan drugs in principle target rare diseases, in aggregate they pose affordability concerns because of the growing number of orphan indications and increasingly high prices. RESULTS: For mass diseases, the transitory budget impact of treating the accumulated patient stock can be managed by stratified rollout that delays treatment of stable patients and prioritizes patients at high risk of deterioration. Delay spreads the budget impact and permits potential savings from launch of competing treatments. For cures, installment payments contingent on outcomes could align payment flows and appropriately shift risk to producers. This approach, however, entails high administrative and incentive costs, especially if applied across multiple payers in the United States. For orphan drugs, the available evidence on research and development trends and returns argues against the need for a higher VBP threshold to incentivize research and development in orphan drugs, given existing statutory benefits under orphan drug legislation.


Assuntos
Doença Crônica/tratamento farmacológico , Produção de Droga sem Interesse Comercial/economia , Doenças Raras/tratamento farmacológico , Orçamentos , Análise Custo-Benefício , Aprovação de Drogas/economia , Aprovação de Drogas/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Custos de Medicamentos/tendências , Política de Saúde/legislação & jurisprudência , Política de Saúde/tendências , Humanos , Legislação de Medicamentos/economia , Legislação de Medicamentos/tendências
20.
Eur Rev Med Pharmacol Sci ; 22(4): 1161-1167, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29509270

RESUMO

This review illustrates some brief considerations of the medical use of cannabis recently issued in Italy. History and uses of cannabis throughout centuries and different countries are illustrated together with a description of botany and active phytocannabinoids. Then, medical use of cannabis anti-pain treatment for patients resistant to conventional therapies is described in case of chronic neuropathic pain, spasticity, for anticinetosic and antiemetic effect in nausea and vomiting caused by chemotherapy, for appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, hypotensive effect in glaucoma resistant to conventional therapies and for reduction of involuntary body and facial movements in Gilles de la Tourette syndrome. Italian most recent legislation on medical cannabis is detailed with some law proposals, also showing the inconsistent legislation within European Union. Some final considerations of future studies are also reported.


Assuntos
Legislação de Medicamentos/tendências , Maconha Medicinal/uso terapêutico , Manejo da Dor/tendências , Antieméticos/uso terapêutico , Caquexia/tratamento farmacológico , Caquexia/epidemiologia , Europa (Continente)/epidemiologia , Humanos , Itália/epidemiologia , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/epidemiologia , Náusea/tratamento farmacológico , Náusea/epidemiologia , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Neuralgia/tratamento farmacológico , Neuralgia/epidemiologia , Manejo da Dor/métodos , Síndrome de Tourette/tratamento farmacológico , Vômito/tratamento farmacológico , Vômito/epidemiologia
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