How to implement a "standard of care" regulatory model for pharmacists.

National pharmacy associations have increasingly explored regulation according to a "standard of care." In such a model, pharmacists can provide a wide range of clinical services aligned with their education and training. Based on Idaho's experience implementing this model, there are five critical steps states must take to enact a standard of care: 1) Adopt a broad definition of "practice of pharmacy;" 2) Allow elasticity for practice innovation over time; 3) Decide which limited instances still necessitate prescriptive regulation; 4) Eliminate all unnecessary regulations; and 5) Strengthen accountability for deviations from the standard of care. States wishing to adopt a standard of care approach can follow this five-step process to enhance patient care and mitigate the lag that is otherwise constant between laws and practice.

AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived Antibodies.

In May 2020, the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) published a recommendation report entitled "Recommendation on nonanimal-derived antibodies". In this report, the EURL ECVAM specifically states: "Therefore, taking into consideration the ESAC Opinion on the scientific validity of replacements for animal-derived antibodies, EURL ECVAM recommends that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. The provisions of Directive 2010/63/EU should be respected, and EU countries should no longer authorise the development and production of antibodies through animal immunisation, where robust, legitimate scientific justification is lacking." (1). Here, we are providing the American Association of Pharmaceutical Scientists (AAPS) opinion on the EURL ECVAM recommendation report. In brief, there has been a clear and strong progress in reduction of animal use in the drug discovery and development process, including significant reduction of animal use in production of antibody reagents. Yet, it is proposed that more data need to be generated, shared and discussed within the scientific community before a decision to implement the change to non-animal derived antibodies is made.

Creation and maintenance of a table for assessment of evolving evidence for COVID-19-related treatments.

PURPOSE: This report describes the development and maintenance of a table to present an assessment of evidence for treatments used in patients with coronavirus disease 2019 (COVID-19). SUMMARY: AHFS Drug Information (AHFS DI) (American Society of Health-System Pharmacists, Bethesda, MD) is ASHP's evidence-based drug compendium that contains drug monographs written for pharmacists and other healthcare professionals. The professional editorial and analytical staff of pharmacists critically evaluate published evidence to develop drug monographs for AHFS DI. In response to the global COVID-19 pandemic, these skills were applied to assess emerging evidence for COVID-19-related treatments, and the information was compiled into a new resource for pharmacists and other healthcare professionals to use at the point of care. A list of therapies was developed and prioritized based on review of scientific and public discussions on the use of these therapies in patients with COVID-19; certain therapies used for supportive care and therapies that might theoretically be harmful to patients with COVID-19 also were considered for inclusion. Potential treatments were identified, and the evidence for use in patients with COVID-19 was assessed and summarized in a table format. Information presented for each therapy included the rationale for use, summaries of clinical trials or experience, trial registry numbers, and dosage regimens. Comments on safety and efficacy, including limitations of available data, were presented along with recommendations from recognized authorities. The editorial team continued to add new therapies to the table and update existing entries as new evidence emerged. CONCLUSION: A comprehensive table that summarized available evidence for potential treatments for patients with COVID-19 was developed. The table format enabled the drug information editorial staff to provide ongoing updates as new information emerged during the pandemic.

Gestión integral de la nutrición artificial domiciliaria: humanización e innovación al servicio del paciente / Holistic management of home artificial nutrition: humanization and innovation at patient's service

La desnutrición relacionada con la enfermedad es una patología frecuente en el mundo desarrollado. Afecta a 30 millones de personas en Europa y tiene un coste asociado de ciento setenta mil millones de euros anuales. En España atañe en torno a 1,7 millones de adultos, lo que supone el 4,4% de la población. La desnutrición aqueja a uno de cada cuatro pacientes en el ingreso hospitalario. Se estima que los pacientes hospitalizados que se encuentran en estado de desnutrición a lo largo de su estancia oscilan entre un 23,7% y un 37%; agudizándose estas cifras en el caso de pacientes pluripatológicos mayores de 70 años, y casi un 10% se desnutre durante su estancia hospitalaria. Todo ello supone un aumento de las estancias hospitalarias y de los costes asociados; en concreto, los costes directos de la desnutrición hospitalaria se estimaron en 1,143 millones anuales en 2009, lo que supone el 1,8% del gasto sanitario del sistema nacional de salud. Los avances en tecnología e infraestructuras han facilitado la transferencia de servicios complejos de hospitales al hogar. Actualmente, la tendencia internacional apunta a un desarrollo cada vez mayor del domicilio como centro de cuidados. Un meta-análisis de 61 ensayos de asignación aleatoria y controlados, publicado en 2012, evidenció que los pacientes atendidos en el domicilio tenían una tasa de mortalidad a los seis meses entre un 19% y un 38% menor que los hospitalizados. La nutrición artificial domiciliaria (NAD) es la administración a domicilio de los nutrientes y demás agentes terapéuticos adjuntos a través de la vía digestiva -nutrición enteral domiciliaria (NED)- o intravenosa -nutrición parenteral domiciliaria (NPD)-, con la finalidad de mejorar o mantener, en el ámbito domiciliario, el estado de nutrición de un paciente. Esta modalidad de prestación facilita al paciente poder seguir con los compromisos familiares, sociales y laborales. El entorno en el que trabajan los profesionales sanitaros del siglo XXI está cambiando de manera significativa. Son múltiples las innovaciones en gestión por procesos, facilitadas por el creciente potencial que ofrecen las nuevas tecnologías en los cuidados a distancia. Todo ello favorece la permanencia del paciente en su casa, en su comunidad o en un entorno más familiar, es decir, en un ambiente más humanizado. Por último, se demuestra que la NPD es una alternativa coste-efectiva en relación con la atención hospitalaria clásica, lo que redunda en la adopción del criterio de eficiencia como elemento de priorización en sanidad

Disease-related malnutrition is a common pathology in the developed world. It affects 30 million people in Europe and it has an associated cost of one hundred and seventy billion euros per year. In Spain, around 1.7 million adults, 4.4% of total population, are negatively affected. Malnutrition affects one out of four patients on hospital admissions. It is estimated that hospitalized patients who are malnourished throughout their stay range from 23.7% to 37%; sharpening these figures for multi-patients over 70 years old, and almost 10% are disensuaded during their hospital stay. All this implies an increase in hospital stays and associated costs; in particular, the direct costs of hospital malnutrition were estimated at 1.143 million annually in 2009, representing 1.8% of health expenses within the national health system. Advances in technology and infrastructure have facilitated the transfer of complex hospital-to-home services. Nowadays, the international trend points to the increasing development of the domicile as a care center. A meta-analysis of 61 randomized and controlled trials, published in 2012, showed that patients treated at home had a six-month mortality rate between 19% and 38% lower than those who were hospitalized. Home artificial nutrition (HAN) is the nutrients home-administration, among other therapeutic agents, administered through the digestive tract -home enteral nutrition (HEN)- or intravenously -home parenteral nutrition (NPD-), with the objective of improving or maintaining, at home, the patient's nutritional status. That reports into a benefit for the patient as being able to continue the family, social and work commitments. The environment, in which 21st century health professionals work, is changing significantly. There are multiple innovations in process management, given by the growing potential offered by new technologies in remote care. It supports the patient's home stay, either in the community or in a more familiar environment, that is, in a more humanized environment. Finally, HAN is shown to be an effective-cost alternative in relation to classical hospital care, resulting in the adoption of the efficiency criterion as an element of prioritization in healthcare

Primary health care policy and vision for community pharmacy and pharmacists in Australia

There is evidence that the Australian Government is embracing a more integrated approach to health, with implementation of initiatives like primary health networks (PHNs) and the Government's Health Care Homes program. However, integration of community pharmacy into primary health care faces challenges, including the lack of realistic integration in PHNs, and in service and remuneration models from government. Ideally, coordinated multidisciplinary teams working collaboratively in the community setting are needed, where expanding skills are embraced rather than resisted. It appears that community pharmacy is not sufficiently represented at a local level. Current service remuneration models encourage a volume approach. While more complex services and clinical roles, with associated remuneration structures (such as, accredited pharmacists, pharmacists embedded in general practice and residential aged care facilities) promote follow up, collaboration and integration into primary health care, they potentially marginalize community pharmacies. Community pharmacists' roles have evolved and are being recognized as the medication management experts of the health care team at a less complex level with the delivery of MedChecks, clinical interventions and medication adherence services. More recently, vaccination services have greatly expanded through community pharmacy. Policy documents from professional bodies highlight the need to extend pharmacy services and enhance integration within primary care. The Pharmaceutical Society of Australia's Pharmacists in 2023 report envisages pharmacists practising to full scope, driving greater efficiencies in the health system. The Pharmacy Guild of Australia's future vision identifies community pharmacy as health hubs facilitating the provision of cost-effective and integrated health care services to patients. In 2019, the Australian Government announced the development of a Primary Health Care 10-Year Plan which will guide resource allocation for primary health care in Australia. At the same time, the Government has committed to conclude negotiations on the 7th Community Pharmacy Agreement (7CPA) with a focus on allowing pharmacists to practice to full scope and pledges to strengthen the role of primary care by better supporting pharmacists as primary health care providers. The 7CPA and the Government's 10-year plan will largely shape the practice and viability of community pharmacy. It is essential that both provide a philosophical direction and prioritize integration, remuneration and resources which recognize the professional contribution and competencies of community pharmacy and community pharmacists, the financial implications of service roles and the retention of medicines-supply roles

No disponible

Evolution of the AMCP Format for Formulary Submissions.

DISCLOSURES: No funding was required for this project. The authors are or have been members of the Format Executive Committee.

Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.

BACKGROUND: Improved knowledge of the molecular pathophysiology and immunopathogenesis of cholestatic liver diseases in recent years has led to an increased interest in developing novel therapies. Patients with cholestatic liver disease often require different approaches to assessment and management of suspected drug-induced liver injury (DILI) compared to those with healthy livers and those with parenchymal liver diseases. At present, there are no regulatory guidelines or society position papers, that systematically address best practices pertaining to detection of DILI in these patients. AIMS: To outline best practices for detection, assessment and management of suspected acute DILI during clinical trials in adults with the cholestatic liver diseases - Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). METHODS: This is one of the several papers developed by the IQ DILI Initiative, which is comprised of members from 16 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. The contents are the result of an extensive literature review, as well as in-depth discussions among industry, regulatory and academic DILI experts, to achieve consensus recommendations on DILI-related issues occurring during clinical trials for cholestatic liver diseases. RESULTS: Recommended best practices are outlined pertaining to hepatic eligibility criteria, monitoring of liver tests, approach to a suspected DILI signal, and hepatic discontinuation rules. CONCLUSIONS: This paper provides a framework for the approach to detection, assessment and management of suspected acute DILI occurring during clinical trials in adults with cholestatic liver disease.

Development of health-system inpatient pharmacy clinical metrics.

PURPOSE: To describe a process to identify metrics that represent the impact of inpatient pharmacy services on patient outcomes across a health system. SUMMARY: The authors describe a systematic process of identifying inpatient clinical outcome measures that could represent pharmacists' impact on patient outcomes and eventually be displayed in a dashboard within the electronic medical record (EMR). A list was generated through literature review, assessment of practices at other sites, evaluation of current pharmacy services, and collaboration with the quality department and System Pharmacy Clinical User Group. The project team narrowed the list through assessment against standardized criteria. An assessment tool was designed and distributed to stakeholders to prioritize clinical outcome measures for inclusion on the dashboard. The clinical outcome measures were transformed into metrics by determining measurement criteria, inclusion and exclusion parameters, and review time frame. After validation, the metrics are planned to be displayed on an inpatient pharmacy EMR dashboard. Exemption from institutional review board review was granted for this project. CONCLUSION: A systematic process was developed and used to identify inpatient clinical outcome metrics.

Indicadores del uso hospitalario de antimicrobianos basados en el consumo / Indicators of the hospital use of antimicrobial agents based on consumption

Objetivo: Identificar unos indicadores del uso hospitalario de antimicrobianos a partir del análisis comparativo de los datos de consumo entre hospitales del mismo nivel por medio del juicio colectivo de un grupo de expertos. Método: Un comité formado por miembros de la Sociedad Española de Farmacia Hospitalaria y de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica preparó una propuesta de indicadores que fue sometida a consenso por un panel de 21 expertos en enfermedades infecciosas, microbiología y terapéutica antimicrobiana mediante un método Delphi modificado. El panel se sometió a dos rondas de puntuaciones por correo electrónico. Los participantes puntuaron de 1 (completamente en desacuerdo) a 9 (completamente de acuerdo) la relevancia de cada indicador en cuatro dimensiones: evidencia científica, eficacia y seguridad, repercusión ecológica y coste. Las puntuaciones fueron procesadas según el método UCLA-RAND. Un indicador fue juzgado como relevante si al menos una dimensión distinta al coste obtenía una mediana de puntuación igual o superior a 7 sin haber desacuerdo entre el panel. Resultados: El comité planteó una propuesta inicial de 14 indicadores. Tras la primera ronda de puntuaciones del panel, un indicador fue desestimado y dos fueron modificados para el paso a la segunda ronda. finalmente, 13 indicadores fueron considerados relevantes. Conclusiones: El establecimiento de indicadores del uso hospitalario de antimicrobianos basados en el consumo puede permitir a los programas de optimización de antimicrobianos detectar cuáles son los problemas potenciales de uso de los antimicrobianos, y ayudar a orientar sus esfuerzos para emprender acciones de mejora, así como para valorar el impacto de las medidas efectuadas

Objective: To identify indicators of hospital use of antimicrobials from the benchmark analysis of consumption data between hospitals at the same level through the collective judgement of a group of experts. Method: A committee formed by members of the Spanish Societies of Hospital Pharmacy and Infectious Diseases and Clinical Microbiology prepared a proposal of indicators which was submitted to consensus by a panel of 21 experts on infectious diseases, microbiology and antimicrobial therapy, through a modified Delphi method. The panel underwent two rounds of scores by e-mail. Participants assigned a score from 1 (completely disagree) to 9 (completely agree) to the relevance of each indicator in four dimensions: scientific evidence, efficacy and safety, ecological impact and cost. Scores were processed according to the RAND-UCLA method. An indicator was considered to be relevant if at least one dimension other than cost obtained a median score equal to or higher than 7 without disagreement among the panel. Results: The committee submitted an initial proposal of 14 indicators. After the first round of panel scores, one indicator was ruled out and two were modified for moving on to the second round. finally, 13 indicators were considered relevant. Conclusions: Determining indicators of the hospital use of antimicrobial agents based on consumption can allow the antimicrobial stewardship programs to detect any potential problems with the use of antimicrobial agents, and to help guide their efforts in order to implement actions of improvement, as well as to assess the impact of the measures implemented

Incurred Sample Reanalysis: Time to Change the Sample Size Calculation?

Reliable results of pharmacokinetic and toxicokinetic studies are vital for correct decision making during drug discovery and development. Thus, ensuring high quality of bioanalytical methods is of critical importance. Incurred sample reanalysis (ISR)-one of the tools used to validate a method-is included in the bioanalytical regulatory recommendations. The methodology of this test is well established, but the estimation of the sample size is still commented on and contested. We have applied the hypergeometric distribution to evaluate ISR test passing rates in different clinical study sizes. We have tested both fixed rates of the clinical samples-as currently recommended by FDA and EMA-and a fixed number of ISRs. Our study revealed that the passing rate using the current sample size calculation is related to the clinical study size. However, the passing rate is much less dependent on the clinical study size when a fixed number of ISRs is used. Thus, we suggest using a fixed number of ISRs, e.g., 30 samples, for all studies. We found the hypergeometric distribution to be an adequate model for the assessment of similarities in original and repeated data. This model may be further used to optimize the sample size needed for the ISR test as well as to bridge data from different methods. This paper provides a basis to re-consider current ISR recommendations and implement a more statistically rationalized and risk-controlled approach.