ABSTRACT
El derecho a la protección de la salud impulsa al poder ejecutivo a establecer una política sanitaria conducente, dentro de los principios de equidad, calidad y participación ciudadana, a la promoción del uso racional del medicamento y a adoptar medidas dirigidas a que la prestación farmacéutica, por el Sistema Nacional de Salud, se realice a precios razonables y con un gasto publico ajustado, dentro de la necesidad de optimizar los recursos disponibles. En la actualidad el Estado de Bienestar alcanzado en nuestro país se hace cada día más gravoso, de aquí que para garantizar la sostenibilidad del Sistema Nacional de Salud el Estado español haya promovido una reforma sanitaria a través de normas, entre otras, el Real Decreto Ley 16/ 2012 del cual analizamos el impacto y consecuencias más destacables en el sector farmacéutico
The right to health protection encourages the Executive to establish a leading health policy according to the principles of equity, quality and citizen participation, to promote a responsible use of drugs and to adopt measures in order to make the provision of pharmaceutical care affordable and with reasonable public health expenditure by the Spanish National Health System as part of the need of optimizing the available resources. Nowadays, the welfare state achieved in our V country is progressively more expensive. Hence, in order to guarantee the sustainability of the Spanish National Health System, the Spanish government has promoted a health reform through standards, among others the Royal Decree-]Law16/ 2012, of April 20, 2012. From this Royal Decree-] Law we analyze the impact and the most noteworthy consequences in the pharmaceutical sector
Subject(s)
Drugs, Investigational/economics , Drugs, Investigational/therapeutic use , Chemistry, Pharmaceutical/ethics , Chemistry, Pharmaceutical/methods , Drug Monitoring/ethics , Drug Monitoring/methods , Drug and Narcotic Control/legislation & jurisprudence , Drug and Narcotic Control/methods , Legislation, Drug/ethics , Legislation, Drug/standards , Drug Evaluation/legislation & jurisprudence , Drug Evaluation/methods , Drug Evaluation, Preclinical/ethics , Drug Evaluation, Preclinical/methods , Medication Therapy Management/ethics , Medication Therapy Management/legislation & jurisprudence , Legislation, Drug/trends , Legislation, DrugABSTRACT
Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL), and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market. Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6%) followed by unsubstantiated efficacy claims (18.6%). Warning letters were primarily directed to manufacturers of cardiovascular (14.6%), anti-microbial (14.6%), and CNS (12.5%) drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%). Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health(AU)
Objetivo: Evaluar el número y el tipo de cartas de advertencia enviadas por la US Food and Drug Admisnitration (FDA) a industrias farmacéuticas por violaciones promocionales. Métodos: Dos revisores descargaron, imprimieron y evaluaron independientemente las cartas de advertencia enviadas por la FDA a industrias farmacéuticas entre os años 2003-2008. Las propagandas engañosas se clasificaron como propagandas clínicas, de calidad de vida (QoL) y económicas. Las propagandas clínicas incluían propagandas de eficacia, seguridad y tolerabilidad, superioridad, amplitud de indicación no sustanciadas, y/u omisión de información de riesgos. Las propagandas de QoL incluían propagandas de calidad de vida o de calidad de vida relacionada con la salud no sustanciadas. Las propagandas económicas incluían cualquier forma de propaganda de las compañías farmacéuticas relacionada con superioridad de costes o ahorro de costes del medicamento comparado con otros en el mercado. Resultados: En los 6 años de estudio, la FDA envió 65 cartas de advertencia que contenían 144 propagandas clínicas, 3 de QoL, y una económica. De media, se enviaron 11 cartas de advertencia por año. La violación más frecuentemente encontrada fue la omisión de la información de riesgo (30,6%), seguida de propagandas de eficacia insustanciadas (18,6%). Las cartas de advertencia fueron dirigidas principalmente a medicamentos cardiovasculares (14,6%), antimicrobianos (14,6%) y del SNC (12,5%). La mayoría de las propagandas referidas en las cartas contenía materiales promocionales dirigidos a los médicos (57%). Conclusión: El estudio encontró que las propagandas engañosas de resultados clínicos consituian la mayoría de las violaciones promocionales, y la mayoría de estas propagandas estaban dirigidas a médicos. Como la promoción inadecuada puede llevar a una prescripción irracional, este estudio enfatiza la importancia de diseminar información fiable, creíble y científica a los pacientes, y más importante a los médicos para así proteger la salud pública(AU)
Subject(s)
Humans , Male , Female , United States Food and Drug Administration/ethics , United States Food and Drug Administration/standards , Propaganda , Products Publicity Control , Chemistry, Pharmaceutical/ethics , Drug and Narcotic Control/legislation & jurisprudence , Drug Industry/ethics , Public Health/ethics , Advertising/ethics , Advertising/legislation & jurisprudence , Ethics, Pharmacy , Drug and Narcotic Control/methods , Drug and Narcotic Control/organization & administration , Legislation, Pharmacy/ethics , Drug Industry/standards , Evaluation of the Efficacy-Effectiveness of Interventions , Drug Publicity , Marketing of Health Services/ethics , Marketing of Health Services/legislation & jurisprudence , Marketing/legislation & jurisprudenceABSTRACT
The use of generic drugs has increased significantly in recent years. Since generic drugs are available at a lower cost, they provide an opportunity for savings in drug expenditure. Thus, use of generic drugs is encouraged especially in developing countries. There are only a few studies concerning the perceptions and attitudes of the healthcare providers and patients towards generic drug use. Methods: The present study was conducted by a face to face questionnaire in the Kadikoy district of Istanbul in April 2010. From randomly chosen respondents, 68 pharmacists, 56 prescribers and 101 patients consented to participate in the study. Results: Thirty one and 32 % of the pharmacists and prescribers, respectively, expressed that they believed that the generics did not differ from the original drugs, whereas only 24% of the patients believed so. Forty percent of the pharmacists and 82% of the prescribers told that they were unsure about the bioequivalence of the generics. Ten percent of the patients claimed that they immediately accept generic substitution by the pharmacist, while 26% accepted it if it was substituted by the prescriber. Cost was the most important factor taken into consideration about generic substitution (92% for prescribers; 83% for patients and 82% for pharmacists). Conclusion: Our findings demonstrated that healthcare providers as well as the drug consumers have insufficient knowledge about generic drugs. Therefore, they should be better educated with respect to generic substitution(AU)
El uso de medicamentos genéricos ha aumentado significativamente en los últimos años. Como los genéricos están disponibles a menor coste, proporcionan una oportunidad para ahorrar en el gasto en medicamentos. Así que en los países en desarrollo se estimula el uso de medicamentos genéricos. Hay pocos estudios sobre las percepciones y actitudes de los profesionales de la salud y los pacientes hacia el uso de medicamentos genéricos. Métodos: El presente estudio se realizó con una entrevista presencial en el distrito de Kadikoy de Estambul en abril de 2010. Una muestra aleatoriamente seleccionada de 68 farmacéuticos, 56 prescriptores y 101 pacientes aceptó participar en el estudio. Resultados: El 315 y 32% de farmacéuticos y prescriptores respectivamente expresaron que creían que los genéricos no se diferenciaban de los medicamentos originales, mientras que sólo el 24% de los pacientes pensaba así. El 40% de los farmacéuticos y el 82% de los prescriptores dijo que no estaba seguro sobre la bioequivalencia de los genéricos. Un 10% de los pacientes afirmó que aceptaban de inmediato la sustitución genérica por el farmacéutico, mientras que un 26% la aceptaba si era sustituida por el prescriptor. El coste era el factor más importante tomado en consideración en la sustitución genérica (92% de los prescriptores, 83% de los pacientes, y 82% de los farmacéuticos). Conclusión: Nuestros hallazgos demuestran que tanto los profesionales de la salud como los consumidores de medicamentos tienen conocimientos insuficientes sobre medicamentos genéricos. Por tanto, deberían educarse mejor en relación a la sustitución genérica(AU)
Subject(s)
Humans , Male , Female , Health Knowledge, Attitudes, Practice , Pharmacists/ethics , Pharmacists/psychology , Pharmaceutical Services/ethics , Drugs, Generic/therapeutic use , Generic Drug Policy , Chemistry, Pharmaceutical/ethics , Drug Industry/ethics , Ethics, Pharmacy/educationABSTRACT
There are numerous medicinal chemistry reports in the literature describing the pharmacological properties of thousands of narcotics, stimulants, hallucinogens, sedative-hypnotic drugs, cannabinoids, and other psychoactive substances as well as synthetic methods for their preparations. This information, while essential for the advancement of science, has been used by clandestine chemists to manufacture and market an endless variety of analogs of so-called designer drugs. In this review, we describe how clandestine chemists used the principles of medicinal chemistry to design molecules, referred to as designer drugs, that elicit the effects of opioids, amphetamine and analogs, cannabinoids, and phencyclidine analogs while circumventing the law.
Subject(s)
Designer Drugs/chemistry , Drug Design , Illicit Drugs/chemistry , Amphetamines/chemistry , Amphetamines/pharmacology , Analgesics, Opioid/chemistry , Analgesics, Opioid/pharmacology , Animals , Cannabinoids/chemistry , Cannabinoids/pharmacology , Chemistry, Pharmaceutical/ethics , Designer Drugs/pharmacology , Drug and Narcotic Control/legislation & jurisprudence , Humans , Illicit Drugs/legislation & jurisprudence , Illicit Drugs/pharmacology , Phencyclidine/analogs & derivatives , Phencyclidine/chemistry , Phencyclidine/pharmacology , Scientific Misconduct , United StatesABSTRACT
Curso de acesso aberto oferecido pela Johns Hopkins Bloomberg School of Public Health. Apresenta princípios subjacentes ao desenvolvimento pré-clínicos e clínicos de novas drogas terapêuticas e procedimentos. discute as normas legais e éticas que se aplicam ao desenvolvimento de medicamentos.
Subject(s)
Health Education , Education, Distance , Education, Pharmacy , Chemistry, Pharmaceutical/ethics , Legislation, Drug , Schools, Public HealthABSTRACT
The parenteral administration of insoluble drugs leads to the use of biologically active solvents inducing effects associated with ethical cause of concern including pain and pharmacological interactions. Selected vehicles currently used were ethically and scientifically reviewed. Our investigations allowed reinforcing the formulation decision tree with an ethical point of view. The last generation of cyclodextrin appears to be the safest solvent. Second choice could be lipidic emulsions, third choice being co-solvents, and finally non-ionic surfactants because of their hypersensitivity reactions. Screening tests including pH, osmolality measurements, cytotoxicity, and hemotoxicity, should allow to check the formulation tolerance before the animals' administration.
