Protocolo del servicio para la realización, trazabilidad y seguimiento de los resultados obtenidos de test de diagnóstico y autodiagnóstico de antígenos de SA R S- CoV-2 / Protocol for the performance, traceability and monitoring of the results obtained from the SARS-CoV-2 antigen diagnostic and self-diagnostic test

Introducción: A través de un acuerdo de colabora-ción entre el Departamento de Sanidad del Gobier-no de Aragón y el Consejo de Colegios Oficiales de Farmacéuticos de Aragón, las oficinas de farmacia de Aragón tienen la posibilidad de adherirse volun-tariamente para su colaboración en la vigilancia epidemiológica, mediante la realización de test de antígenos, comunicación de los resultados y emi-sión de certificados.Método: Previamente a la adhesión, las farmacias han de cumplir una serie de requisitos, incluyen-do una declaración de responsabilidad. Ante la solicitud de un paciente asintomático que desea realizarse un test, el farmacéutico debe seguir un algoritmo de decisión.Resultados: A fecha 3 de octubre de 2021,303 far-macias en Aragón han participado. Se han emitido 6.021 Certificados COVID Digitales de la UE, tras la realización de un test de diagnóstico de antíge-nos en la oficina de farmacia, con 92 resultados positivos. Conclusiones: Las oficinas de farmacia han resul-tado esenciales en la realización de test de antí-genos, comunicación de resultados y emisión de Certificados COVID Digitales de la UE. (AU)

Introduction: Through a collaboration agreement between the Department of Health of the Govern-ment of Aragon and the Council of Official Associa-tions of Pharmacists of Aragon, those pharmacies that voluntarily wanted to register were incorporat-ed into the epidemiological surveillance system. In this way, they can carry out diagnostic and self-diagnosis tests on patients, issue certificates and communicate positive results directly to the Department of Health.Method: In order to accede to this agreement, some requirements must be met by the pharma-cies, including a statement of responsibility. At the request of an asymptomatic patient who wishes to undergo a test, the pharmacist must follow a decision algorithm.Results: As of October 3, 2021, 303 pharmacies in Aragón participated in this collaboration. 6.021 EU Digital COVID Certificates were issued, after having carried out an antigen diagnostic test at the phar-macy. 92 positive results were reported.Conclusions: Pharmacies have been essential in carrying out antigen tests, communicating results and issuing EU Digital COVID Certificates. (AU)

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.

Situación legal de la atención farmacéutica en residencias de ancianos en España / Legal Situation of Pharmaceutical Care in Nursing Homes in Spain

ntroducción: La mayor esperanza de vida está pro-duciendo un aumento de la población de personas mayores de 65 años. Este grupo de población se caracteriza por un elevado consumo de medica-mentos y de asistencia sanitaria, permaneciendo muchos de ellos en centros residenciales donde son cubiertas todas sus necesidades. El perfil farmacoterapéutico de estos pacientes suele ser complejo debido a la polimedicación y a las pato-logías crónicas que padecen. Es aquí donde entra en juego el papel del farmacéutico a través de servicios asistenciales. El objetivo de esta revisión es analizar la situación legal, a través del estudio de la normativa específica española que regula la atención farmacéutica en centros sociosanitarios.Método: Revisión de la situación legal de la aten-ción farmacéutica en centros sociosanitarios en EspañaResultados: En España, el marco legal básico se encuentra en el Real Decreto Ley 16/2012 que esta-blece la obligación de tener un servicio de farmacia para los centros sociosanitarios que tengan cien o más camas en régimen de asistidos, mientras que aquellos con menos camas tendrán que tener-lo vinculado a un hospital o a una farmacia. Sin embargo, cada Comunidad Autónoma establece un régimen propio de funcionamiento, a través de su normativa específica.Conclusiones: Existen diferencias en la regulación de los centros sociosanitarios en cuanto a presta-ciones, funciones y servicios farmacéuticos corres-pondiente a cada Comunidad Autónoma (AU)

Introduction: Longer life expectancy is producing an increase among the population of people over the age of 65. This population group is charac-terized by a high consumption of medicines and healthcare, living many of them in residential facili-ties where all their needs are covered.The pharmacotherapeutic profile of these patients is usually complex due to their polymedication and the chronic pathologies they suffer. Here is where the role of the pharmacist comes into play with healthcare services. The aim of this review is to analyze the legal situation by studying the specific Spanish regulations that rule the pharmaceutical care in social and health care centers.Method: Review of the legal situation of pharma-ceutical care in social-health centers in Spain.Results: In Spain, the basic legal framework is found in Royal Decree Law 16/2012, which estab-lishes the obligation to have a pharmacy service for social care centers with one hundred beds or more in assisted care, while those with fewer beds must be linked to a hospital or pharmacy. However, each Autonomous Community establishes its own oper-ating regime through its specific regulations.Conclusions: There are differences in the regula-tion of social and healthcare centers in terms of benefits, functions and pharmaceutical services corresponding to each Autonomous Community (AU)

O preço da vida

O premiado diretor Adam Wishart autorizou a Colabore com o Futuro a legendar e divulgar no Brasil o documentário "O Preço da Vida" (The Price of Life). Nesse filme patrocinado pela BBC Two, Adam mostra como foi feita a decisão sobre a incorporação do Lenalidomida (importante medicamento para mieloma múltiplo) pela NICE (Agência Sanitária do Reino Unido). Muito interessante assistir para entender melhor como funciona o processo de ATS - Avaliação de Novas Tecnologias - sob o aspecto do paciente que precisa do medicamento, do governo que tem um orçamento limitado, e do fabricante, que tem um custo alto para produzir a droga e por isso precisa cobrar caro pela mesma. Os conflitos muito humanos que surgem abrem para debate uma questão moral maior - quanto vale a vida e quanto deve pagar a sociedade?

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.

Oficina de farmacia. Atención farmacéutica. Servicio personalizado de dosificación / Pharmacy office. Pharmaceutical care. Personalized dosing service

Intento acercar la oficina de farmacia desde su legislación hasta su ejercicio profesional centrándonos en puntos menos conocido como la atención farmacéutica y calidad de vida el perfil psiquiátrico que acompaña a la no adherencia al tratamiento médico. Quisiera sacar la Conclusión de que he conseguido interesar para que se conozca la misión de los farmacéuticos y técnicos en farmacia que las integran

I try to bring the pharmacy office closer from its legislation to its professional practice, focusing on less known points such as pharmaceutical care and quality of life, the psychiatric profile that accompanies non-adherence to medical therapy. I would like to draw the conclusion that I have managed to interest so that the mission of the pharmacists and pharmacy technicians who are part of them is known

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.