Understanding pharmaceutical care and nurse prescribing in Spain: A grounded theory approach through healthcare professionals' views and expectations.

BACKGROUND: Pharmaceutical care has been implemented and regulated differently across Europe with no consensus among countries in relation with professional competencies and especially on nurse prescribing. Demophac Project funded by the European Commission aims to develop a Pan-European Pharmaceutical Care Model with collaboration of 14 partner teams across Europe including Spain where nurse prescribing is starting its implementation at regional level. The aim of the study was to increase understanding of the role of nurses in Pharmaceutical care in Spain after the Nurse Prescribing Regulation approved in 2018 throughout exploring the views and expectations of health professionals involved in the representative settings. METHODS AND FINDINGS: In depth interviews were conducted in a structure previously agreed by the European Demophac partnership around four topics associated with the Nursing ideal role in pharmaceutical care and the ideal interaction with other healthcare professionals. A grounded-theory approach based on Corbin & Strauss was conducted to interpret collected data from the Spanish most representative settings (primary care, specialized care and residential care for older population). Participants were health professionals involved in pharmaceutical care that accepted to participate (nurses (n = 7), physicians (n = 8) and pharmacists (n = 9)). A pharmaceutical care comprehensive model for the Spanish context considering the recently approved Nurse Prescribing role and the interprofessional collaboration and communication was developed towards facilitating the understanding in such context and the contribution to the unified European Demophac Framework. CONCLUSIONS: Nurses are primarily responsible for population's Pharmaceutical Care while other professionals pivot on them to provide quality healthcare on a multidisciplinary level. Nurse prescribing may contribute efficiently to the Spanish Health System though more consensus in terms of nurses' training nationwide and enhancement in communication among different professionals within healthcare organizations is required to achieve adequate integrated care into practice.

Accessibility of Pharmacist-Prescribed Contraceptives in Utah.

OBJECTIVE: To assess pharmacy participation in and accessibility of pharmacist-prescribed contraception after legislation effective in the state of Utah in 2019. METHODS: A secret-shopper telephone survey was used to assess participation in pharmacist-prescribed contraception. Geospatial analysis was used to map the distribution of participating pharmacies by population characteristics. RESULTS: Of all operating Class A retail pharmacies in Utah, 127 (27%) were providing pharmacist-prescribed contraception 1 year after implementation of the Utah standing order. Oral contraceptive pills were widely accessible (100%); however, other allowed methods were not (vaginal ring 14%; contraceptive patch 2%). Consultation fees and medication costs varied widely. Participating pharmacies were mainly concentrated in population centers. Assuming access to a personal vehicle, urban areas with a high percentage of Hispanic people (Utah's largest minority race or ethnicity group) have access to a participating pharmacy within a 20-minute driving distance. However, access in rural areas with a high percentage Hispanic or other minority were limited. We identified 235 (40%) census tracts with a high proportion of Utah's residents living below the poverty line or of minority race or ethnicity who also had low access to pharmacist-prescribed contraception. CONCLUSIONS: Although the pharmacy-based model is intended to increase access to contraception, practical availability 1 year after the authorization of pharmacist-prescribed contraception in Utah suggests that this service does not adequately serve rural areas, particularly rural areas with a high proportion of minorities and those living below the federal poverty line.

Indication or diagnosis should be required on prescriptions.

Although prospective drug utilization review and patient counseling have long been recognized as professional and ethical responsibilities of pharmacists, the implementation of the Omnibus Budget Reconciliation Act of 1990 made them legal responsibilities. Ensuring the safety and effectiveness of prescription pharmaceutical care requires that all members of the prescriber-patient-pharmacist triad are equally informed about the therapeutic plan for which the pharmacist is professionally, ethically, and legally responsible for properly implementing. Providing pharmacists with the clinical indication or diagnosis is an important and long overdue first step. DISCLOSURES: No funding was received for the writing of this article. Warholak has received grant funding through the University of Arizona from Sinfonia Rx, Pharmacy Quality Alliance, and the Arizona Department of Health Services, unrelated to this work. The other authors have nothing to disclose.

COVID-19 related regulatory change for pharmacists - The case for its retention post the pandemic.

The delivery of healthcare including the provision of pharmacy services globally is highly regulated internationally in order to protect public health and welfare. However, the onset of the COVID-19 pandemic has precipitated the need internationally to amend the model of regulation in order to ensure that people were able to continue to access a range of healthcare services in a timely and effective manner. Many of the changes introduced to the regulation of pharmacy services in Ireland have been replicated in other countries. These include the introduction of electronic means to transmit prescriptions and other orders for medications, relaxing the legal restrictions in place controlling the emergency supply of prescription only medicines and more fully utilizing the professional competency of pharmacists by empowering them to use their expertise and judgment to support their patients accessing the healthcare services that they need. Many of the regulatory changes that have been introduced to support the COVID-19 public health emergency effort are ones that pharmacists have previously sought to enable them provide a more effective and expanded model of pharmaceutical care to their patients. Accordingly, many pharmacists will want these regulatory changes to be retained and further expanded in the aftermath of the COVID-19 public health emergency in order to extend their scope of practice and support them in the care of their patients.

Pharmacists' Patient Care Process: State "Scope of Practice" Priorities for Action.

To fully engage in the Pharmacists' Patient Care Process, pharmacists must be able to (1) participate in a Collaborative Practice Agreement, (2) order and interpret laboratory tests, (3) prescribe certain medications, (4) adapt medications, (5) administer medications, and (6) effectively delegate tasks to support staff. Each of these activities is dependent on state scope of practice laws, but these laws are not binary. Various state-level restrictions allow us to view these activities on a continuum from more restrictive to less restrictive. This continuum will allow pharmacy and public health stakeholders to identify priorities for action in their states.

[Regulation of drug prices in nineteenth-century Bazilian pharmacy]. / O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista.

On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

A comparison of trends in opioid dispensing patterns between Medicaid pharmacy claims and prescription drug monitoring program data.

PURPOSE: Public and private payers have implemented benefit limitations to reduce high-risk opioid prescriptions. The effect of these policies on the increase of out-pocket payment is unclear. To understand this gap, we compared the discrepancies in trends between opioid prescription fills vs claims among Medicaid beneficiaries. METHODS: Data from the Oregon Prescription Drug Monitoring Program (PDMP) and Oregon Medicaid administrative claims were used to identify Medicaid beneficiaries 18 years and older enrolled at least one full month from 2015 to 2017. Generalized linear models assessed the trends in the monthly rates of opioid PDMP prescription fills and pharmacy claims per 1000 eligible members. Rates by morphine equivalent dose (MED) tier (<50, 50-89, 90-120, >120 MED) and co-prescribed opioid and benzodiazepine were also assessed. RESULTS: During the study period, an average of 495 355 Medicaid members had 2 797 054 opioid PDMP fills and 2 472 155 opioid Medicaid pharmacy claims. Study participants had 15.4 (95% confidence interval [CI] 13.6 to 17.0; P < .001) more prescriptions per 1000 member per month in the PDMP data (114.1 [SD 7.4]) compared with the Medicaid claims data (98.7 [SD 7.9]). Similarly, there were 1.9 more co-occurring opioid/benzodiazepine prescriptions per 1000 members per month observed in the PDMP data than the Medicaid claims data (95% CI 1.7 to 2.1; P < .001). At each MED tier, the PDMP fills were consistently higher than the claims (P < .001). CONCLUSIONS: Higher rate of fills in the PDMP compared to pharmacy claims suggests that there may be an increasing trend of out-of-pocket payment among Medicaid beneficiaries.

O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista / Regulation of drug prices in nineteenth-century Bazilian pharmacy

Resumo Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

Abstract On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Moving Pharmacy Benefits from Nice to Have to Essential Benefits.

DISCLOSURES: No funding supported the writing of this commentary. The authors have nothing to disclose.

The Reemergence of Specialty Pharmacy.

Twenty years ago, the Journal of Managed Care & Specialty Pharmacy published an article titled "The Emergence of Specialty Pharmacy." While the industry was in its relative infancy at the time, the specialty pharmacy model has since grown, expanded, and matured, largely following some of the trends outlined at the time. Now, with changes in legislation, a progressive approach within the FDA, a second coming of novel therapies and supplemental indications, along with an involvement in cell and gene therapy, a reemergence of the specialty model is taking place, and the market must adapt to the new challenges associated with this era of modern medicine. DISCLOSURES: No funding contributed to the writing of this article. Ogurchak reports speaker fees from MJH Live Events and WellSky, unrelated to this work. The other authors have nothing to disclose with respect to research, authorship, and/or publication of this article.

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.

Institutional strategies as a mechanism to rationalize the negative effects of the judicialization of access to medicine in Brazil.

BACKGROUND: Recently, the Executive Branch and Judiciary in Brazil increased spending due to larger numbers of lawsuits that forced the State to provide health goods and services. This phenomenon, known as health judicialization, has created challenges and required the Executive Branch and Judiciary to create institutional strategies such as technical chambers and departments to reduce the social, economic and political distortions caused by this phenomenon. This study aims to evaluate the effects of two institutional strategies deployed by a Brazilian municipality in order to cope with the economic, social and political distortions caused by the phenomenon of health judicialization regarding access to medicines. METHODS: A longitudinal study was carried out in a capital in the Central-West Region of Brazil. A sample of 511 lawsuits was analyzed. The variables were placed into three groups: the sociodemographic characteristics and the plaintiffs' disease, the characteristics of the claimed medical products and the institutional strategies. To analyze the effect of the interventions on the total cost of the medicines in the lawsuits, bivariate and multivariate linear regressions with variance were performed. For the categorical outcomes, Poisson regressions were performed with robust variance, using a significance level of 5%. RESULTS: A reduction in the costs of medicines in the lawsuits and of the requests for medicines within the SUS formulary was verified after the deployment of the Department of Assessment of Nonstandardized Medicines (DAMNP) and the Technical Chamber of Health Assessment (CATS); an increase in processed prescriptions from the Brazilian Universal Health System was observed after the deployment of the CATS; and an increase in medicines outside the SUS formulary without a therapeutic alternative was verified after the CATS. CONCLUSION: The institutional strategies deployed were important tools to reduce the high costs of the medicines in the lawsuits. In addition, they represented a step forward for the State, provided a benefit to society and indicated a potential path for the health and justice systems of other countries that also face problems caused by the judicialization of health.

Examining Misaligned Incentives for Payers and Manufacturers in Value-Based Pharmaceutical Contracts.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between health care payers and pharmaceutical manufacturers in which the price, quantity, or nature of reimbursement is tied to value-based outcomes. As value-based payment models have permeated through much of the health care payment landscape via reimbursement to payers and providers, VBPCs offer opportunities for manufacturers to similarly engage in performance-based models. This article compares 2 VBPC schemes: "pay-for-failure" schemes, in which manufacturers offer rebates or discounts to payers for treatment failure, and "pay-for-success" schemes, in which manufacturers offer rebates or discounts to payers for treatment success. Each method has its own short-term and long-term trade-offs, and both lead to some degree of misaligned incentives between payers and manufacturers. These incentive differences have important downstream effects, influencing patient selection, provision of wraparound services, and nature of reimbursements. This analysis contrasts potential benefits and disadvantages for each of these approaches and offers potential solutions to address misalignment. For example, although pay-for-success models may be more aligned between payers and manufacturers, pay-for-failure contracts can be innovative and effective in controlling costs and/or improving outcomes. To illustrate, VBPCs aimed to reduce costs could incorporate total cost of care reduction as a value-based outcome. The authors encourage payers and manufacturers to consider a blended alternative where pay-for-failure and pay-for-success outcomes could be incorporated as VBPC outcomes. Since little is known about the effect of each scheme on outcomes, further research on VBPCs is necessary to fully understand how differing incentives ultimately affect clinical outcomes and costs. DISCLOSURES: No outside funding supported the writing of this article. Good and Kelly are employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care, and Parekh was employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care at the time of this study. The authors have no other disclosures to report.

Policy Recommendations for Pharmacy Benefit Managers to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians.

Recent discussions about the increasing prices of prescription drugs have focused on pharmacy benefit managers (PBMs), third-party intermediaries for various types of employers and government purchasers who negotiate drug prices in health plans and thus play a crucial role in determining the amount millions of Americans pay for medications. In this position paper, the American College of Physicians expands on its position paper from 2016 by offering additional recommendations to improve transparency in the PBM industry and highlighting the need for reliable, timely, and relevant information on prescription drug pricing for physicians and patients.

O Tema 793 do STF e o direcionamento do cumprimento das prestações na área de saúde conforme as regras de repartição de competências estabelecidas no SUS / The Item 793 of the Supreme Court and the compliance for health benefits according to the rules for the division of competences established for Brazilian SUS / Tema 793 de la Corte Suprema y la dirección del cumplimiento de los beneficios de salud de acuerdo con las reglas para la división de competencias establecidas en el SUS de Brasil

Objetivo: analisar o Tema 793 do STF, que trata da responsabilidade solidária dos entes federados pelo dever de prestar assistência à saúde, e que exigiu do magistrado que direcione o cumprimento da obrigação conforme as regras de repartição de competências. Metodologia: o trabalho utilizou o método dedutivo para compreender os diversos aspectos insertos no voto do relator Ministro Edson Fachin sobre o tema da repartição de competência no SUS, que culminou com a Tese 793 do STF. Resultados: o artigo apresenta as regras básicas de financiamento da assistência farmacêutica; fornece parâmetros para identificar o ente responsável pela prestação da saúde; indica formas de diminuir os custos da judicialização e aponta a União Federal como a maior responsável pelo financiamento da assistência farmacêutica. Conclusão: o Tema 793 não conseguiu ainda trazer uma unicidade das decisões judiciais, e não é claro sobre qual ente federado deva compor o polo passivo e ser condenado nas prestações da saúde. A identificação do devedor da prestação deve ser uma preocupação dos litigantes e dos operadores do direito, inclusive para assunção das eventuais penalidades por descumprimento

Objective: To overview the Item 793 of the Federal Supreme Court, which deals with the joint liability of federated entities for the duty to provide health care, and which required the magistrate to direct the fulfillment of the obligation according to the rules for the division of competences. Methodology: the the deductive method was applied to understand the various aspects inserted in the vote of the rapporteur Minister Edson Fachin on the subject of the division of competences in the Brazilian public health care system, SUS, which culminated in the Item 793 of the Federal Supreme Court. Results: this paper presents the basic rules for financing pharmaceutical assistance; providing parameters for identifying the provider of health care; it also indicates ways to reduce the costs of judicialization and points to the Federal Union as the main responsible for financing pharmaceutical assistance Conclusion: Item 793 has not yet been able to bring a single court decision, and it is not clear about which federated entity should male part of the factual matter and be condemned in health benefits. The identification of the debtor of the benefit should be a concern of the litigants and the legal operators, including the assumption of possible penalties for noncompliance

Objetivo: analizar el Tema 793 de la Corte Suprema, que se ocupa de la responsabilidad conjunta y solidaria de las entidades federadas por el deber de brindar atención médica, y que requiere que el magistrado dirija el cumplimiento de la obligación de acuerdo con las reglas para la división de competencias. Metodología: el trabajo utilizó el método deductivo para comprender los diversos aspectos insertados en la votación del relator Ministro Edson Fachin sobre el tema de la división de competencias en el SUS, que culminó con el Tema 793 del STF. Resultados: el artículo presenta las reglas básicas para financiar la asistencia farmacéutica; proporciona parámetros para identificar al proveedor de atención médica; Indica formas de reducir los costos de la judicialización y señala a la Unión Federal como el principal responsable de financiar la asistencia farmacéutica. Conclusión: el Tema 793 aún no ha sido capaz de presentar una decisión judicial única, y no está claro qué entidad federada debería conformar el polo pasivo y ser condenado en beneficios para la salud. La identificación del deudor del beneficio debe ser una preocupación de los litigantes y los operadores legales, incluida la asunción de posibles sanciones por incumplimiento.

A Judicialização de medicamentos no estado da Bahia: os números no período de 2014 a 2017 / The judicialization of medications in the state of Bahia, Brazil: the numbers from 2014 to 2017 / La judicialización de los medicamentos en el estado de Bahía, Brasil: las cifras en el período de 2014 a 2017

Objetivo: o trabalho é dedicado ao tema da judicialização no estado da Bahia, visando analisar sua dimensão e trajetória entre 2014 e 2017, com destaque para os números relacionados à assistência farmacêutica. Metodologia: estudo de caso em que se utilizou a base de dados do Núcleo de Atendimento à Judicialização da Saúde (NAJS) do estado da Bahia. Resultados: curva crescente da judicialização no âmbito da assistência farmacêutica; predomínio de ações individuais; incremento de gastos com a judicialização no componente especializado. Conclusão: a judicialização no estado da Bahia segue a tendência nacional de aumento, sem que se vislumbre uma adequada discussão entre o Poder Público, o Judiciário e a sociedade.

Objective: the work is devoted to the subject of judicialization in the state of Bahia, aiming to analyze its size and trajectory between 2014 and 2017, with emphasis on the numbers related to pharmaceutical care. Methodology: a case study in which the database of the nucleus of care for the judicialization of the state of Bahia was used. Results: increasing curve of judicialization in the scope of pharmaceutical care; predominance of individual actions; reduction of costs with judicialization in the specialized component. Conclusion: the judicialization in the state of Bahia follows the national trend of increase, without a glimpse of an adequate discussion between the public power, the Judiciary and the society. Keyword: Health's judicialization. Public policy. Pharmaceutical assistance

Objetivo: el trabajo se dedica al tema de la judicialización en el estado de Bahía, con el objetivo de analizar su tamaño y trayectoria entre 2014 y 2017, con énfasis en las cifras relacionadas con la atención farmacéutica. Metodología: un estudio de caso en el que se utilizó la base de datos del núcleo de atención para la judicialización del estado de Bahía. Resultados: aumento de la curva de judicialization en el ámbito de la atención farmacéutica; predominio de acciones individuales; reducción de costes con judicialización en el componente especializado. Conclusión: la judicialización en el estado de Bahía sigue la tendencia nacional de aumento, sin vislumbrar una discusión adecuada entre el poder público, el poder judicial y la sociedad

Judicialização do acesso a medicamentos no município de Ivinhema, Mato Grosso do Sul / Judicialization of access to medicines in the municipality of Ivinhema, Mato Grosso do Sul, Brazil / Judicialización del acceso a medicamentos en la ciudad de Ivinhema, Mato Grosso do Sul, Brasil

Objetivo: conhecer o perfil das requisições de medicamentos na esfera administrativa, recebidas pela Secretaria de Saúde do Município de Ivinhema, Mato Grosso do Sul, no ano de 2017. Métodos: estudo descritivo, retrospectivo, com foco em base documental. Definiuse como universo da pesquisa os ofícios recebidos pelo departamento jurídico da Secretaria de Saúde no Município de Ivinhema/MS, no período de primeiro de janeiro a 31 de dezembro de 2017. As variáveis concatenadas foram: quantificação das requisições de medicamentos no período supracitado; classificação da autoria dos ofícios recebidos; características dos medicamentos requeridos: pertinência à rede de assistência farmacêutica do SUS e classificação pela Anatomical Therapeutic Chemical Classification (ATC), de acordo com a recomendação da Organização Mundial de Saúde. Resultados: foram recebidos 59 ofícios, requisitando um total de 169 medicamentos. Desse total, 118 (69,8%) não faziam parte da rede de assistência farmacêutica do SUS. Dos 51 (30,2%) medicamentos listados na rede pública de saúde, 38 (74,5%) estavam elencados na Relação Estadual de Medicamentos Essenciais (Resme) e 13 (25,5%), na lista do componente especializado. Os fármacos solicitados com maior frequência foram: ácido acetilsalicílico (3,5%), metoprolol e cilostazol (2,4%). A maioria das requisições recebidas veio da Defensoria Pública (93,2%). Além disso, segundo a classificação terapêutica dos medicamentos solicitados, verificou-se que os grupos anatômicos mais frequentes foram: sistema nervoso central (31,9%), sistema cardiovascular (26,0%) e sangue e órgãos hematopoiéticos (10,6%). Conclusão: a maioria dos ofícios era de autoria da Defensoria Pública e requisitavam medicamentos que não faziam parte da rede de assistência farmacêutica do SUS

Objective: to know the profile of medicines requests in the administrative level, received by the Secretary of Health of Ivinhema, Mato Grosso do Sul, Brazil, in 2017. Methodology: descriptive, retrospective study, focusing on documentary basis. The universe of research was defined as the documents received by the law department of Secretary of Health of Ivinhema, Mato Grosso do Sul, from January 1 to December 31, 2017. The variables studied were: quantification of medicines requests; authorship classification of the received documents; characteristics of the required medicines: relevance to the SUS pharmaceutical assistance network and classification by the Anatomical Therapeutic Chemical Classification (ATC), according to the recommendation of the World Health Organization. Results: 59 documents were received, requesting a total of 169 medicines. Of this total, 118 (69.8%) were not part of SUS's pharmaceutical assistance network. Of the 51 (30.2%) medicines listed in the public health network, 38 (74.5%) were listed in the State List of Essential Medicines (Resme), and 13 (25.5%) in the specialized component list. The most frequently requested medicines were acetylsalicylic acid (3.5%), metoprolol and cilostazol (2.4%).Most of the documents received came from the Public Defender's Office (93.2%). In addition, according to the therapeutic classification of the medicine requested, it was found that the most frequent anatomical groups were: central nervous system (31.9%), cardiovascular system (26.0%) and blood and hematopoietic organs (10.6%). Conclusion: Most of the documents were from the Public Defender's and requested medicines that were not part of SUS's pharmaceutical assistance network.

Objetivo: conocer el perfil de las requisiciones de medicamentos en la esfera administrativa, recibidas por la Secretaría de Salud del Municipio de Ivinhema, Mato Grosso do Sul, en el año 2017. Metodología: estudio descriptivo, retrospectivo con foco en base documental. Se definió como universo de la investigación los oficios recibidos por el departamento jurídico de la Secretaría de Salud en el Municipio de Ivinhema/MS, en el período del primero de enero al 31 de diciembre de 2017. Las variables concatenadas fueron: cuantificación de las solicitudes de drogas en el período mencionado; clasificación de autoría de los oficios recibidas; características de los medicamentos requeridos: relevancia para la red de atención farmacéutica del SUS y clasificación según la Clasificación Química Terapéutica Anatómica (ATC), según la recomendación de la Organización Mundial de la Salud. Resultados: recibieron 59 oficios, solicitando un total de 169 medicamentos. De este total, 118 (69,8%) no formaban parte de La red de Asistencia Farmacéutica del SUS. De los 51 (30,2%) medicamentos listados en la red pública de salud, 38 (74,5%) estaban enumerados en la Lista Estatal de Medicamentos Esenciales (Resme) y 13 (25,5%) en la lista del componente especializado. Los fármacos solicitados com mayor frecuencia fueron: ácido acetilsalicílico (3,5%), metoprolol y cilostazol (2,4%). La mayoría de las acciones recibidas vinieron de La Defensoría Pública (93,2%). Además, según La clasificación terapéutica de los medicamentos solicitados, se verificó que los grupos anatómicos más frecuentes fueron: sistema nervioso central (31,9%), sistema cardiovascular (26,0%) y sangre y órganos hematopoyéticos (10,6%). Conclusion: La mayoría de los documentos provenían de la Oficina del Defensor Público y solicitaban medicamentos que no formaban parte de la red de asistencia farmacéutica del SUS.

Reflections on the ISPOR Special Task Force on U.S. Value Frameworks: Implications of a Health Economics Approach for Managed Care Pharmacy.

In 2016, The Professional Society for Health Economics and Outcomes Research (ISPOR) formed a special task force (STF) to review approaches and methods to support the definition and use of high-quality U.S. value frameworks. As the leadership group of that initiative, we present our perspective, focusing on implications for the managed care pharmacy community. Our reflections are organized by 9 key observations and conclude with a summary recommendation. We begin by emphasizing the importance of distinguishing among "perspectives" and "decision contexts." Possible perspectives include patient, payer, provider, health care sector, and societal. Decision contexts range from formulary inclusion to guideline development to clinical shared decision making, and multiple perspectives can be taken on each of these decisions. The STF focused on value in the context of including a new medicine in a formulary and, thus, health plan, using a health economics approach that compares marginal benefit (gross value) and marginal (opportunity) cost, yielding the net value. Health care is unique compared with other markets. While economists often use market purchases as indicators of value, they also recognize that this does not work well in health care, since most patent-protected drugs are covered by insurance. To assess the likely health and economic impact, health economists often employ cost-effectiveness analysis, using the quality-adjusted life-year (QALY), a metric that combines mortality and morbidity into a single preference-based index. We strongly endorse the STF's recommendation that payers should use the cost-per-QALY metric as a starting point. However, like the STF, and many of those stakeholders who provided input, we recognize that this metric has some limitations in theory and in practice. Nonetheless, the cost-per-QALY metric is a pragmatic tool that can be augmented to address some of its limitations by integrating other elements of value, particularly those related to uncertainty, such as financial risk protection, health risk protection, the value of hope, real option value, and the value of knowing. The resulting adjusted ratio can be compared with a willingness-to-pay threshold or combined in a measure of net monetary benefit. Alternatively, the array of elements can be valued using multi-criteria decision analysis. We end with the key recommendation that further development and testing of these promising approaches is needed to improve the deliberative process of health technology assessment. DISCLOSURES: No outside funding supported the writing of this article. The authors are leaders of the ISPOR Special Task Force on U.S. Value Frameworks. Willke is employed by ISPOR. Garrison and Neumann have nothing to disclose. The opinions expressed in this article should be considered as belonging only to the authors.