Implementing California Senate Bill 493 in an Outpatient Pharmacy Within an Integrated Health System: Evaluation of the Operational and Clinical Effect of Pharmacist-Ordered Laboratory Tests.

BACKGROUND: Under California Senate Bill 493, pharmacists can order patient laboratory tests (labs). Currently, it is unknown if this service affects patient outcomes or pharmacy operations. Does lab ordering by pharmacists improve access to care, improve quality outcomes, and/or affect pharmacy operational functions? PROGRAM DESCRIPTION: A 13-month pilot study was conducted at 2 Kaiser Permanente (KP) outpatient pharmacies where pharmacists provided extended adherence consultations and ordered hemoglobin A1c (HbA1c) labs for patients nonadherent to their oral diabetic medications with an HbA1c ≥ 8% or missing annual labs. Clinical outcomes of the pilot study were compared with a similar patient population at KP who concurrently received lab orders from their primary providers, defined here as the "usual care model." OBSERVATION: Of the 793 HbA1c lab orders, 87 (11.0%) were generated by a pharmacist, and 706 (89.0%) were generated by the usual care group. Forty-three (49.4%) patients in the pharmacist group completed their labs compared with 279 (39.5%) patients in the usual care group (P = 0.10). A significantly greater proportion of patients in the pharmacist group achieved an HbA1c < 8% within the follow-up period of 30-180 days (34.9%), compared with the usual care group (12.2%, P < 0.01). Of the patients who completed labs during the evaluation period, 38 (43.7%) patients in the pharmacist group and 111 (15.7%) patients in the usual care group had prelaboratory values ≥ 8% within the previous 12 months. The average pre-HbA1c value was 9.47% in the pharmacist group, and the average post-HbA1c value was 8.68% (P < 0.01). For the usual care group, the average pre-HbA1c value was 9.70%, and the average post-HbA1c value was 9.43% (P = 0.06). When comparing the difference in HbA1c reduction between the 2 groups, there was a larger decrease in HbA1c in the pharmacist group, but this difference was not significantly different (P = 0.06). The pilot study added an average of 5 minutes per patient encounter to the pharmacy workflow but did not affect overall patient wait times for receiving outpatient prescriptions. IMPLICATIONS: Laboratory ordering by pharmacists in the outpatient setting improved access to care, improved quality outcomes, and did not adversely affect pharmacy operations. DISCLOSURES: No outside funding supported this project. The authors have nothing to disclose.

[Interchangeability of biological products in the Brazilian Unified National Health System (SUS): the main regulatory challenges]. / Intercambialidade de produtos biológicos no Sistema Único de Saúde (SUS): principais desafios regulatórios.

Biological products have sparked a worldwide therapeutic revolution. However, the high cost of these products threatens health systems' sustainability. The development of copies is considered an economic alternative, but due to the products' complexity, many concepts used in generic drugs do not apply. Interchangeability between biologicals poses a regulatory challenge. This essay discusses the main regulatory challenges for establishing criteria for interchangeability between new biologicals and their copies in the scope of the Brazilian Unified National Health System (SUS), considering the guidelines adopted by the world's main drug regulatory agencies concerning interchangeability and the prevailing Brazilian regulatory framework on this issue. Concerns related to the interchangeability of biologicals include automatic substitution, nomenclature, pharmacovigilance, immunogenicity, and extrapolation of therapeutic indications and clinical data from new biologicals to their copies. While the clinical success and economic benefits of switching from new biologicals to their biosimilars have already been observed, the heterogeneity between countries in the regulatory barriers to the approval of copies of biologicals should be taken into consideration during the regulation of interchangeability of biologicals in Brazil.

Produtos biológicos revolucionaram a terapêutica mundial. O alto custo desses medicamentos, no entanto, ameaça a sustentabilidade dos sistemas de saúde. O desenvolvimento de cópias é tido como uma alternativa econômica, mas devido à complexidade desses produtos, muitos conceitos utilizados para os medicamentos genéricos não se aplicam. A intercambialidade entre produtos biológicos representa um desafio regulatório a ser superado. Este ensaio discute os principais desafios regulatórios relacionados ao estabelecimento de critérios para intercambialidade entre produtos biológicos novos e suas cópias no âmbito do Sistema Único de Saúde (SUS), considerando as diretrizes adotadas pelas principais agências reguladoras de medicamentos do mundo sobre a intercambialidade e o arcabouço regulatório vigente no Brasil para esta questão. Preocupações relacionadas à intercambialidade de produtos biológicos incluem substituição automática, nomenclatura, farmacovigilância, imunogenicidade e extrapolação das indicações terapêuticas e dos dados clínicos de produtos biológicos novos para suas cópias. Embora o sucesso clínico e os benefícios econômicos da alternância entre alguns produtos biológicos novos e seus biossimilares já tenham sido observados, a heterogeneidade das barreiras regulatórias para aprovação das cópias de produtos biológicos entre diferentes países deve ser considerada para a regulamentação da intercambialidade de produtos biológicos no Brasil.

Los productos biológicos revolucionaron la terapéutica mundial. El alto coste de estos medicamentos, no obstante, amenaza la sostenibilidad de los sistemas de salud. El desarrollo de copias se considera como una alternativa económica, pero debido a la complejidad de estos productos, muchos conceptos utilizados para los medicamentos genéricos no se aplican a los mismos. La intercambiabilidad entre productos biológicos representa un desafío regulatorio que se debe superar. Este trabajo discute los principales desafíos regulatorios, relacionados con el establecimiento de criterios para la intercambiabilidad entre productos biológicos nuevos y sus copias en el ámbito del Sistema Único de Salud (SUS), considerando las directrices adoptadas por las principales agencias regulatorias de medicamentos del mundo sobre la intercambiabilidad y el armazón regulatorio vigente en Brasil para esta cuestión. Las preocupaciones relacionadas con la intercambiabilidad de productos biológicos incluyen la sustitución automática, nomenclatura, farmacovigilancia, inmunogenicidad y extrapolación de las indicaciones terapéuticas, así como de los datos clínicos de productos biológicos nuevos para sus copias. A pesar de que el éxito clínico y los beneficios económicos de la alternancia entre algunos productos biológicos nuevos y sus biosimilares, ya se han observados, la heterogeneidad de las barreras regulatorias para la aprobación de las copias de productos biológicos entre los diferentes países debe ser considerada para la regulación de la intercambiabilidad de productos biológicos en Brasil.

Intercambialidade de produtos biológicos no Sistema Único de Saúde (SUS): principais desafios regulatórios / Interchangeability of biological products in the Brazilian Unified National Health System (SUS): the main regulatory challenges / Intercambiabilidad de productos biológicos en el Sistema Único de Salud (SUS): principales desafíos regulatorios

Resumo: Produtos biológicos revolucionaram a terapêutica mundial. O alto custo desses medicamentos, no entanto, ameaça a sustentabilidade dos sistemas de saúde. O desenvolvimento de cópias é tido como uma alternativa econômica, mas devido à complexidade desses produtos, muitos conceitos utilizados para os medicamentos genéricos não se aplicam. A intercambialidade entre produtos biológicos representa um desafio regulatório a ser superado. Este ensaio discute os principais desafios regulatórios relacionados ao estabelecimento de critérios para intercambialidade entre produtos biológicos novos e suas cópias no âmbito do Sistema Único de Saúde (SUS), considerando as diretrizes adotadas pelas principais agências reguladoras de medicamentos do mundo sobre a intercambialidade e o arcabouço regulatório vigente no Brasil para esta questão. Preocupações relacionadas à intercambialidade de produtos biológicos incluem substituição automática, nomenclatura, farmacovigilância, imunogenicidade e extrapolação das indicações terapêuticas e dos dados clínicos de produtos biológicos novos para suas cópias. Embora o sucesso clínico e os benefícios econômicos da alternância entre alguns produtos biológicos novos e seus biossimilares já tenham sido observados, a heterogeneidade das barreiras regulatórias para aprovação das cópias de produtos biológicos entre diferentes países deve ser considerada para a regulamentação da intercambialidade de produtos biológicos no Brasil.

Abstract: Biological products have sparked a worldwide therapeutic revolution. However, the high cost of these products threatens health systems' sustainability. The development of copies is considered an economic alternative, but due to the products' complexity, many concepts used in generic drugs do not apply. Interchangeability between biologicals poses a regulatory challenge. This essay discusses the main regulatory challenges for establishing criteria for interchangeability between new biologicals and their copies in the scope of the Brazilian Unified National Health System (SUS), considering the guidelines adopted by the world's main drug regulatory agencies concerning interchangeability and the prevailing Brazilian regulatory framework on this issue. Concerns related to the interchangeability of biologicals include automatic substitution, nomenclature, pharmacovigilance, immunogenicity, and extrapolation of therapeutic indications and clinical data from new biologicals to their copies. While the clinical success and economic benefits of switching from new biologicals to their biosimilars have already been observed, the heterogeneity between countries in the regulatory barriers to the approval of copies of biologicals should be taken into consideration during the regulation of interchangeability of biologicals in Brazil.

Resumen: Los productos biológicos revolucionaron la terapéutica mundial. El alto coste de estos medicamentos, no obstante, amenaza la sostenibilidad de los sistemas de salud. El desarrollo de copias se considera como una alternativa económica, pero debido a la complejidad de estos productos, muchos conceptos utilizados para los medicamentos genéricos no se aplican a los mismos. La intercambiabilidad entre productos biológicos representa un desafío regulatorio que se debe superar. Este trabajo discute los principales desafíos regulatorios, relacionados con el establecimiento de criterios para la intercambiabilidad entre productos biológicos nuevos y sus copias en el ámbito del Sistema Único de Salud (SUS), considerando las directrices adoptadas por las principales agencias regulatorias de medicamentos del mundo sobre la intercambiabilidad y el armazón regulatorio vigente en Brasil para esta cuestión. Las preocupaciones relacionadas con la intercambiabilidad de productos biológicos incluyen la sustitución automática, nomenclatura, farmacovigilancia, inmunogenicidad y extrapolación de las indicaciones terapéuticas, así como de los datos clínicos de productos biológicos nuevos para sus copias. A pesar de que el éxito clínico y los beneficios económicos de la alternancia entre algunos productos biológicos nuevos y sus biosimilares, ya se han observados, la heterogeneidad de las barreras regulatorias para la aprobación de las copias de productos biológicos entre los diferentes países debe ser considerada para la regulación de la intercambiabilidad de productos biológicos en Brasil.

Contribution of Arabic Medicine and Pharmacy to the Development of Health Care Protection in Bosnia and Herzegovina - the First Part.

The time interval from the 9th to the 13th century remained known as the "Golden period of the Arab science", and a significant place among the taught sciences are occupied by Medicine and Pharmacy. In the history of medicine, Islamic medicine, also known as Arabic medicine, refers to the science of medicine developed in the Islamic Golden Age, and written in Arabic Arabs were able to use their cultural and natural resources and trade links to contribute to the strong development of pharmacy. After the collapse of the Arab rule, the Arab territorial expanses and cultural heritage were taken over by the Turks. Although scientific progress in the Turkish period slowed down due to numerous unfavorable political-economic and other circumstances, thanks to the Turks, Arab culture and useful Islamic principles expanded to the territory of our homeland of Bosnia and Herzegovina. Significant role in the transfer of Arabic medical and pharmaceutical knowledge was also attributed to the Sephardic Jews who, with their arrival, continued to perform their attar activities, which were largely based on Arab achievements. However, insufficiently elaborated, rich funds of oriental medical and pharmaceutical handwriting testify that Oriental science has nurtured in these areas as well, and that the Arab component in a specific way was intertwined with other cultures and traditions of Bosnia and Herzegovina.

¿Puedo seguir aplicando plasma rico en plaquetas a mis pacientes?, ¿cómo hacerlo legalmente? / Can I continue to use platelet-rich-plasma on my patients?, How do I use it legally?

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Lo que debe saber el dermatólogo sobre los medicamentos biológicos y los biosimilares / What dermatologists should know about biologics and biosimilars

Los medicamentos biológicos se han convertido en los últimos años en una de las principales alternativas para el tratamiento de diversas enfermedades graves y su uso futuro en otras enfermedades es aún más prometedor. A pesar de que estos productos son un arsenal terapéutico importante y novedoso, su costo de producción y desarrollo ha limitado su acceso a los pacientes, especialmente en los países en desarrollo. Por tal motivo, en la última década, y en respuesta a la caducidad de las patentes de diferentes biológicos en el mundo, se ha propiciado la introducción al mercado farmacéutico de lo que hoy se denominan biosimilares. Teniendo en consideración que cada vez es mayor la introducción de los fármacos biosimilares en el arsenal terapéutico dermatológico, en este artículo de revisión se describe el proceso de producción de un producto biológico y las características que lo diferencian de uno biosimilar; además, se exponen algunos aspectos de la reglamentación mundial y local de estos productos.

Multiple organ failure - death of consumer protection?

The enormously profitable complementary medicines, dietary supplements and traditional medicines markets are largely unregulated internationally and South Africa. Attempts to ensure that consumers are not exposed to harmful or ineffective products have met with varying success around the world.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de mise au point d'un code de la pharmacie au Mali: partie legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

Labor analgesia for the parturient with herbal medicines use: what does an obstetrician need to know?

The use of herbal medicines in the developed world is widespread, and increasing. Herbal medicines, which include a wide spectrum of substances ranging from home-made teas to the national regulatory bodies-approved medicinal substances, are defined as plant-derived products that are used for medicinal and/or nutritional purposes. The use of herbal self-therapy is common in pregnancy, with many parturients consuming more than one agent at a time. Despite widespread use there has been surprisingly little research into the outcomes or the potential risks of using herbal therapies during pregnancy. As epidural analgesia is the most popular form of pain relief in labor, the potential for herbal remedies-related alterations in maternal hemodynamics (e.g., hypertension, tachycardia), and increased bleeding tendencies (e.g., spinal-epidural hematoma) remain a significant concern. Obstetricians and obstetric anesthesiologists must be familiar with the effects of herbal medicines and should specifically inquire about the use of herbal medicines during prenatal/preanesthetic assessment. This review article attempts to summarize current data on special considerations for labor analgesia in parturients with herbal medicines use.

Estudio jurisprudencial de la responsabilidad legal del personal sanitario en la reformulación de medicamentos / common law study of the legal responsability of health care staff related to drug reformulation

Objetivo: Analizar la responsabilidad del personal sanitario alelaborar reformulaciones (modificación de la dosis, forma farmacéuticao vía de administración de especialidades farmacéuticas)desde la jurisprudencia del Tribunal Supremo y la AudienciaNacional.Método: Búsqueda y análisis de jurisprudencia y estudios jurídicosen las bases de datos “El Derecho”, “Difusión Jurídica” e“Indret”.Resultados: El personal sanitario tiene una obligación demedios –no de resultados– aplicando unas normas de cuidadoque constituyen la “Lex Artis”, y que pueden ir más allá de lasmeras normas jurídicas. La falta a estas normas de cuidado, ladenegación de auxilio o la falta de respeto a la autonomía delpaciente pueden ser comportamientos negligentes. Se encontraron4 casos en la jurisprudencia. En los dos casos en que secumplieron las normas de cuidado, incluyendo la reformulación,los profesionales sanitarios fueron absueltos, mientras queen otros dos casos en que no se aplicaron reformulaciones,cuando las “Lex Artis” así lo imponía, los profesionales fueroncondenados.Conclusiones: La reformulación de especialidades farmacéuticas,incluidas en la Lex Artis, es una práctica aceptada por elTribunal Supremo y la Audiencia Nacional, siendo causa de condenael no recurrir a las mismas cuando los conocimientos científicosdel momento así lo aconsejen

Objective: To analyze the responsibility of health care staff indrug reformulation (change of dose, pharmaceutical form or routeof administration of medicinal products) based on the commonlaw of the High Court and the National Court.Method: Search and analysis of common law and legal studiesincluded in databases “El Derecho”, “Difusión Jurídica” and“Indret”.Results: Health care staff has means –not outcomes– obligationsaccording to the care standards included in the “Lex Artis”that can go beyond the mere legal standards. Failure to apply thiscare standards, denial of assistance or disrespect to the autonomyof the patient can be negligent behaviors. We found 4 cases incommon law. In the two cases in which care standards were compliedwith, including reformulation, health care professionals wereacquitted, whereas in the other two cases in which reformulationswere not used even though the “Lex Artis” required them, theprofessionals were condemned.Conclusions: Reformulation of medicinal products, as setforth in the Lex Artis, is a practice accepted by the High Courtand the National Court and failure to use it when the scientificknowledge advises so is a cause for conviction

Marco Jurídico de la homeopatía en Venezuela / Homeopathic legislation in Venezuela

Se realiza un análisis desde el punto de vista social, enfocado en el ciudadano, desde los inicios legales en 1881, hasta nuestra actual legislación. Se tocan aspectos de los derechos de los médicos y farmacéuticos y el conflicto que existe con los gremios que los asocian

Portable medicine chests in Serbia during the 19th and the first half of the 20th century.

Portable medicine chests could be considered as the oldest type of pharmacy in the 19th century Serbia. Historically their emergence could be associated with the appearance of the first physicians who kept post in Serbia. They were foreigners engaged on a contract to work during the reign of Prince Milos Obrenovic. According to the data preserved at the State Archive of Serbia (Chancellery of the principality, State Council, Home Office - Medical Department), medicine chests existed as late as the middle of the last century. They were an important source for health protection of the Serbian people as well as for distribution of drugs during the course of the 19th century. This article aims to analyse the content of these chests, based on the archive data records referring to the regular supervision of the medicine chests conducted every fourth year by the district physician. The legal aspect of keeping the portable medicine chest will be discussed as well.

Lessons from Korea's pharmaceutical policy reform: the separation of medical institutions and pharmacies for outpatient care.

In Korea, until recently, both physicians and pharmacists were allowed to prescribe and dispense drugs for outpatient care. Along with other deep-rooted structural problems, this worked against the quality and efficiency of the health care system. To rectify this problem, the Korean government launched a drug policy reform in July 2000. However, the drug policy reform was more drastic than initially intended--driven by political factors, the reform ended up bringing about complete separation of medical institutions and pharmacies. Also, unlike in many other countries, Korea did not take a gradual approach, but instead, it implemented the reform all at once and nation-wide. As a result, the reform has faced criticism and protests, thereby generating unprecedented social turmoil and even strikes by physicians. Still, it is not clear what benefits Korea gained from this reform, when we look at the price which has had to be paid, including greater inconvenience, worsened access to medical care, increased drug spending, increased market share for multinational drug producers, and a greater deficit in the budget of the Korea's national health insurance system. Based on Korea's costly experience, we attempt to draw some policy implications for the future development of a better health care system.

Normas farmacológicas cubanas: desarrollo e impacto / Cuban pharmacological standards: development and impact

Se describió la importancia como instrumento de consulta, del compendio nacional de sustancias activas y asociaciones de uso farmacéutico industrial aceptadas y rechazadas en Cuba. Se identificó la información de seguridad para el uso racional que incorpora la clasificación terapéutica adoptada y la estructura organizativa de estas Normas Farmacológicas Cubanas (NFC). Se cuantificó su aplicación por el Centro para el Control de la Calidad de los Medicamentos (CECMED), usuarios cubanos y extranjeros durante el período 1996 al 2000, para determinar grados de novedad y caracterización terapéutica, mediante el análisis de Ensayos Clínicos Autorizados y Registros de Medicamentos otorgados. Se dimensionó el impacto en la Reglamentación Farmacéutica Nacional y la interacción con otras regulaciones. Se identificaron las perspectivas de desarrollo en su alcance y contenido. Se concluyó la utilidad de las NFC en la adecuada clasificación del grado de novedad de los productos, el ágil y preciso manejo y evaluación de trámites, así como en la caracterización del enfoque terapéutico