RESUMEN
The opioid crisis is a major public health challenge in the United States, killing about 70,000 people in 2020 alone. Long delays and feedbacks between policy actions and their effects on drug-use behavior create dynamic complexity, complicating policy decision-making. In 2017, the National Academies of Sciences, Engineering, and Medicine called for a quantitative systems model to help understand and address this complexity and guide policy decisions. Here, we present SOURCE (Simulation of Opioid Use, Response, Consequences, and Effects), a dynamic simulation model developed in response to that charge. SOURCE tracks the US population aged ≥12 y through the stages of prescription and illicit opioid (e.g., heroin, illicit fentanyl) misuse and use disorder, addiction treatment, remission, and overdose death. Using data spanning from 1999 to 2020, we highlight how risks of drug use initiation and overdose have evolved in response to essential endogenous feedback mechanisms, including: 1) social influence on drug use initiation and escalation among people who use opioids; 2) risk perception and response based on overdose mortality, influencing potential new initiates; and 3) capacity limits on treatment engagement; as well as other drivers, such as 4) supply-side changes in prescription opioid and heroin availability; and 5) the competing influences of illicit fentanyl and overdose death prevention efforts. Our estimates yield a more nuanced understanding of the historical trajectory of the crisis, providing a basis for projecting future scenarios and informing policy planning.
Asunto(s)
Sobredosis de Droga , Modelos Teóricos , Epidemia de Opioides , Trastornos Relacionados con Opioides , Formulación de Políticas , Sobredosis de Droga/epidemiología , Sobredosis de Droga/prevención & control , Política de Salud , Humanos , Trastornos Relacionados con Opioides/epidemiología , Salud Pública , Riesgo , Estados Unidos/epidemiologíaAsunto(s)
Trastornos Relacionados con Opioides/terapia , Farmacovigilancia , Trastornos Relacionados con Sustancias/prevención & control , United States Food and Drug Administration , Aminas/uso terapéutico , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/uso terapéutico , Ácidos Ciclohexanocarboxílicos/uso terapéutico , Quimioterapia Combinada/efectos adversos , Utilización de Medicamentos/tendencias , Gabapentina , Humanos , Loperamida/efectos adversos , Loperamida/uso terapéutico , Trastornos Relacionados con Opioides/prevención & control , Pautas de la Práctica en Medicina/tendencias , Medicamentos bajo Prescripción/uso terapéutico , Alcaloides de Triptamina Secologanina/uso terapéutico , Estados Unidos , Ácido gamma-Aminobutírico/uso terapéuticoRESUMEN
Significant changes have occurred in the policy landscape surrounding cannabis legalization, production, and use around the globe and across the United States. With widespread availability of novel cannabis and cannabis-based products, there is an urgent need to understand their safety and effectiveness for medical indications. Three primary barriers contribute to the difficulty in initiating research geared toward answering the most pressing public health questions: the US regulatory status of cannabis and cannabinoids, sources for cannabis and cannabinoid study medications, and limited funding and resources to support studies. Despite these hurdles, research is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Here, challenges and barriers to cannabis and cannabinoid research are described from the perspectives of the National Institute on Drug Abuse, National Institutes of Health; the US Food and Drug Administration; and 2 clinical researchers. Barriers specifically to studying cannabis, cannabinoids, and cancer are emphasized.
Asunto(s)
Cannabinoides , Cannabis , Alucinógenos , Analgésicos , Cannabinoides/efectos adversos , Humanos , Legislación de Medicamentos , Estados Unidos/epidemiologíaRESUMEN
Our nation's ongoing prescription opioid abuse crisis, amounting to over 78 billion dollars in health and social costs annually,1 is a critical priority for the US Food and Drug Administration (FDA). As a part of our mission to support the safe and effective use of prescription medicines, the FDA is taking a fresh look at potential scientific and regulatory actions we can take to address this crisis.
Asunto(s)
Analgésicos Opioides/uso terapéutico , Control de Medicamentos y Narcóticos/organización & administración , Trastornos Relacionados con Opioides/epidemiología , Dolor/tratamiento farmacológico , Medicamentos bajo Prescripción/normas , United States Food and Drug Administration/organización & administración , Descubrimiento de Drogas/organización & administración , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Humanos , Trastornos Relacionados con Opioides/prevención & control , Trastornos Relacionados con Opioides/terapia , Manejo del Dolor/métodos , Medición de Riesgo , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudencia , United States Food and Drug Administration/normasRESUMEN
The FDA's "abstinence" outcome measure for approval of new medications to treat opioid-use disorders has been difficult to achieve; developing and validating alternative meaningful outcomes could facilitate drug development.
Asunto(s)
Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/prevención & control , Aprobación de Drogas/estadística & datos numéricos , Desarrollo de Medicamentos/estadística & datos numéricos , Humanos , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Aprobación de Drogas , Naltrexona/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Trastornos Relacionados con Opioides/rehabilitación , Preparaciones de Acción Retardada , Humanos , Inyecciones , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Analgésicos Opioides/efectos adversos , Agencias Gubernamentales , Pulmón/efectos de los fármacos , Contramedidas Médicas , Naloxona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Epidemia de Opioides , Trastornos Relacionados con Opioides/complicaciones , Insuficiencia Respiratoria/terapia , Conducta Cooperativa , Humanos , Comunicación Interdisciplinaria , Pulmón/fisiopatología , Naloxona/efectos adversos , Antagonistas de Narcóticos/efectos adversos , Epidemia de Opioides/mortalidad , Trastornos Relacionados con Opioides/mortalidad , Pronóstico , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/mortalidad , Insuficiencia Respiratoria/fisiopatología , Medición de Riesgo , Factores de Riesgo , Estados UnidosRESUMEN
Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential.
Asunto(s)
Soluciones para Diálisis/provisión & distribución , Industria Farmacéutica/organización & administración , Accesibilidad a los Servicios de Salud/organización & administración , Diálisis Peritoneal/métodos , Reserva Estratégica/organización & administración , United States Food and Drug Administration , Conducta Cooperativa , Humanos , Comunicación Interdisciplinaria , Cooperación Internacional , Factores de Tiempo , Estados UnidosAsunto(s)
Analgésicos Opioides/uso terapéutico , Dolor en Cáncer/tratamiento farmacológico , Dolor en Cáncer/epidemiología , Accesibilidad a los Servicios de Salud , Manejo del Dolor , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Humanos , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Analgésicos Opioides , Combinación de Medicamentos , Prescripciones de Medicamentos/normas , Hidrocodona , Legislación de Medicamentos , Pautas de la Práctica en Medicina/tendencias , Medicamentos bajo Prescripción , Analgésicos Opioides/uso terapéutico , Humanos , Hidrocodona/uso terapéutico , Modelos Lineales , Pautas de la Práctica en Medicina/estadística & datos numéricos , Medicamentos bajo Prescripción/uso terapéutico , Atención Primaria de Salud/estadística & datos numéricos , Atención Primaria de Salud/tendencias , Estados UnidosRESUMEN
The requirement to establish safety of drugs prior to marketing has been in place since 1938 by the US Food, Drug and Cosmetic Act and is by no means a new concept. The efficacy regulations were enacted in 1962 via the Kefauver-Harris Amendment and the drug approval process has evolved thereafter. The assessment of safety and efficacy of drug products is made by pharmaceutical companies during drug development, which then goes through a regulatory review by the US FDA for the determination of market approval or nonapproval. The drug development and regulatory approval processes have endured close ongoing scrutiny by regulatory bodies, the public, US Congress and academic and private organizations and, as a result, have ensured continual refinement. Over the years, evidence has been emerging on varied drug responses in subgroup populations, and the underlying biology associated with age, race and sex as demographic variables have been examined. The resulting growing knowledge of disease burden, treatment response and disparate outcomes has generated opportunities to streamline and improve treatment outcomes in these populations. This article discusses the historical context of women's participation in clinical drug trials submitted to the FDA for regulatory review and approval purposes. The inadvertent consequences of women's exclusion or inadequate representation in past clinical trials and the evidentiary basis for understanding sex differences are also evaluated. Advances in the US regulatory processes to address treatment outcomes that are tied to the topic of this paper, specifically, adverse drug effects in women, are also discussed.