Validated medication deprescribing instruments for patients with palliative care needs: a systematic review / Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática / Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Cost-effectiveness analysis of epidural morphine/ropivacaine treatment in patients with cancer pain.

BACKGROUND: Cancer pain is one of the main causes of human suffering, which can generate disabilities and compromise quality of life, giving rise to several psychosocial and economic consequences. AIMS: This quantitative study sought to perform a cost-effectiveness pharmacoeconomic analysis to assess the impact of implanting epidural morphine associated with ropivacaine treatment in gastrointestinal cancer patients with pain that is difficult clinical control, compared with conventional oral treatment. MATERIALS AND METHODS: The study population consisted of 24 patients with gastrointestinal neoplasia who underwent treatment for cancer pain that was difficult to clinically control. 12 patients each were recruited into the control and intervention groups, respectively. While patients in the control group were administered drug treatment orally, patients in the intervention group underwent a surgical procedure for subcutaneous implantation of a catheter that allowed epidural administration of morphine and ropivacaine. For pain assessment, the Visual Analogue Scale was applied. Data analysis had a descriptive character of costs, taking into account the costs for the year 2021. The study perspective was the Brazilian public healthcare provider, referred to as the Unified Health System (Sistema Único de-SUS in Portuguese). Costs were computed over the time horizon corresponding to the duration of treatment, from the first medical consultation (when the treatment was defined) to the end (end of treatment, disease progression, or death). Treatment duration was divided into three phases (first 60 days, support with palliative care, and end-of-life care). To assess the robustness of the economic analysis, sensitivity analyses were performed, considering the effectiveness of pain reduction on the Visual Analogue Scale, and a comparison of results using the median prices of pharmaceutical components used in the study. RESULTS: The mean age of patients was 59.3 years. The results from the cost-effectiveness analysis showed the epidural morphine/ropivacaine treatment to be more effective with regard to pain reduction on the pain scale, particularly for end-of-life care, when compared to the conventional oral treatment, however, at a significantly higher cost. DISCUSSION: From the accomplishment of this research, it was observed that the application of the pain assessment scale is a way to better interpret and understand the patient's pain, facilitating care planning and decision-making by health professionals, as well as monitoring the effectiveness of the proposed new treatment. CONCLUSION: To present a better cost-effectiveness ratio, a reduction in the cost of the new epidural technology or an increase in the value of the existing oral intervention would be required. However, the latter is not feasible and unlikely to occur. A value judgement to decide whether the incremental benefit associated with the use of the new intervention is worth the extra cost will have to be made by the healthcare provider. Interventions that can relieve cancer pain symptoms should be investigated continuously, in search of evidence to support clinical practice and promote better quality of life for patients.

A Scoping Review of Pharmacists' and Pharmacy Students' Knowledge, Skills, and Attitudes in Medical Emergencies.

OBJECTIVES: Competence can be defined as a set of knowledge, skills, and attitudes. In a medical emergency scenario, competent pharmacists are increasingly required, mainly as a result of the expansion of professional functions in this context. Therefore, the objective of this study was to map the scientific evidence that shows the development of knowledge and/or skills, and/or attitudes in the training of pharmacists and pharmacy students to work in emergency care. FINDINGS: The scoping review was conducted in the PubMed, Embase, Latin American and Caribbean Health Sciences Literature, Scopus, Web of Science, and Cumulative Index to Nursing and Allied Health Literature databases in January 2021, as recommended by the Joanna Briggs Institute. Our study retrieved 6276 files, and 31 articles met the inclusion criteria. It was observed that the studies were developed mainly in the United States of America and addressed the development and/or assessment of knowledge and skills, and training in cardiac emergencies. The most used teaching strategy was simulation, and the most used assessment strategy was feedback and/or debriefing. SUMMARY: Publications involving the development of at least 1 domain of clinical competence have increased in the last decade. Thus, the mapping of studies has provided subsidies for identifying gaps in the teaching-learning process, as well as the identification of methodologies applied in the development and assessment of clinical competence for the referred population.

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

Clinical pharmacy in hospital palliative medicine: non-randomised clinical trial.

OBJECTIVE: To assess the impact of pharmaceutical care on hospital indicators and clinical outcomes of palliative care (PC) patients admitted to a secondary hospital. METHODS: A non-randomised clinical trial was carried out in the PC ward of a secondary hospital in São Paulo, Brazil. Pharmaceutical care for all patients aged 18 and above, admitted between October 2021 and March 2022, with stays exceeding 48 hours, was provided. The interventions required were performed in collaboration with healthcare teams, patients and caregivers. Assessments occurred at admission and discharge, using PC performance scales and pharmacotherapy tools, with Research Ethics Committee approval. RESULTS: Over 6 months, 120 hospitalisations were analysed, primarily involving women (58.9%), averaging 71.0 years, with neoplasm diagnoses (20.5%). A total of 170 drug-related problems were identified in 68.3% of patients. Following assessment, 361 interventions were performed, with a 78.1% acceptance rate, including medication dose adjustments, additions and discontinuations. Addressing unintentional pharmacotherapy discrepancies at admission led to reduced hospital stays (p<0.05). Pharmaceutical interventions also decreased pharmacotherapy complexity (p<0.001), inappropriate medications for the older people (p<0.001) and improved symptom management, such as pain (p<0.05). CONCLUSIONS: Pharmaceutical care services integrated within the multiprofessional health team contributed to reducing drug-related problems associated with polypharmacy as well as improved the management PC symptoms in end-of-life patients, which reduced hospitalisation time.

Validated medication deprescribing instruments for patients with palliative care needs a systematic review.

OBJECTIVES: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. METHODS: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. RESULTS: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. CONCLUSIONS: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

Critical Factors Associated with Morbimortality in COVID-19 Patients Attended at a Brazilian Public Hospital: a Cross-Sectional Study / Fatores Críticos Associados à Morbimortalidade em Pacientes com COVID-19 Atendidos em um Hospital Público Brasileiro: um Estudo Transversal

The association between death from Covid-19 and case management, especially in small and medium-sized municipalities, is still uncertain. To analyze sociodemographic, clinical, and pharmacological factors associated with death in patients with Coronavirus Disease 2019 (COVID-19), from a Brazilian referral public hospital. This is a cross-sectional study, with data from the hospital records of patients (≥ 18 years old) diagnosed with COVID-19, from March 2020 to March 2021. The sample was classified according to the clinical outcome into two groups (death and discharge), among which statistical associations were performed with the variables of interest, with a 5% significance level. Factors such as need for intensive care, use of mechanical ventilation, and total length of hospital stay was related to higher hospital mortality, as well as the permanence of changes in clinical laboratory testing, including lactic acid, D-dimer, markers of hepatic and renal function, C-Reactive protein, anemia, leukocytosis, lymphopenia, thrombocytopenia, pH, and blood oxygen saturation (SpO2) (P < 0.05). Medications used most frequently in the studied hospital for the treatment of COVID-19, such as enoxaparin, dexamethasone, ivermectin, acetylcysteine, chloroquine, and clarithromycin were correlated with morbimortality (P < 0.05). Clinical outcome was influenced by patient-related factors, such as age and comorbidities, however, therapeutic interventions and the choice of medication also impacted morbimortality. These results reinforce the need for preventive actions and adequate clinical protocols in the treatment of hospitalized COVID-19 patients.(AU)

A associação entre o óbito pela Covid-19 e o manejo dos casos, principalmente em municípios de pequeno e médio porte, ainda é incerta. Analisar os fatores sociodemográficos, clínicos e farmacológicos associados à morte em pacientes com a doença do Coronavírus 2019 (COVID-19) em um hospital público brasileiro de referência. Trata-se de um estudo transversal realizado com dados dos prontuários de pacientes (≥ 18 anos) diagnosticados com COVID-19 no período de março de 2020 a março de 2021. A amostra foi classificada de acordo com o desfecho clínico em dois grupos (óbito e alta) e foram realizados testes de associação estatística com as variáveis de interesse com nível de significância de 5%. Fatores como necessidade de terapia intensiva, uso de ventilação mecânica e tempo total de internação estiveram relacionados com maior mortalidade hospitalar, assim como a permanência de alterações nos exames laboratoriais clínicos, incluindo ácido lático, D-dímero, marcadores de função hepática e renal, proteína C reativa, anemia, leucocitose, linfopenia, trombocitopenia, pH e saturação de oxigênio no sangue (SpO2) (P < 0,05). Os medicamentos utilizados com maior frequência no hospital para o tratamento de COVID-19, como enoxaparina, dexametasona, ivermectina, acetilcisteína, cloroquina e claritromicina, foram correlacionados com morbimortalidade (P < 0,05). O desfecho clínico foi influenciado por fatores relacionados ao paciente, como idade e comorbidades, porém as intervenções terapêuticas e a escolha dos medicamentos também impactaram na morbimortalidade. Esses resultados reforçam a necessidade de ações preventivas e protocolos clínicos adequados no tratamento de pacientes hospitalizados com COVID-19.(AU)

Experiences and strategies adopted for the implementation of pharmaceutical services in hospital geriatric units: A scoping review protocol.

Background: Pharmaceutical care is considered an important pillar for promoting the rational and safe use of medicines. Consequently, it constitutes actions of practices capable of reducing morbidity and mortality induced by pharmacotherapy. On the other hand, pharmaceutical services may face several barriers related to the implementation of these practices. These difficulties are associated with management, availability of an appropriate physical environment, integration with the multidisciplinary team, and acceptance of pharmaceutical interventions by health professionals. Objectives: This study aims to map and summarize the scientific evidence on the experiences and strategies used to implement pharmaceutical services in hospital geriatric units. Methods: The scoping review will be based on three electronic databases (PubMed, EMBASE, and Web of Science). Studies that met the inclusion criteria and are published by December 2022 will be selected. The screening, eligibility, extraction, and assessment of studies will be carried out by two independent researchers. Experimental and observational studies will be eligible for inclusion. Discussion: The experiences of incorporating pharmaceutical care into geriatric hospital units need to be better disseminated. Our review could support the performance of pharmaceutical care in other geriatric wards and has the potential to be a reference for multidisciplinary training. In addition, the study is related to the global challenge of the World Alliance for Patient Safety as it is a survey that will demonstrate strategies for safety in the use of medicines.

Impact of the insertion of the clinical pharmacist in the Allogeneic Hematopoietic Stem Cells Transplantation team.

INTRODUCTION: Allogeneic Hematopoietic Stem Cells Transplantation (allo-HSCT) is capable of curing patients with neoplastic or non-neoplastic hematologic disorders or of prolonging their survival. This study assessed if the insertion of the clinical pharmacist in the allo-HSCT team modified the outcomes: transplantation-related mortality, grafting failure, incidence of Graft versus Host Disease, hospitalization time, time for grafting, number of readmissions, number of drug-related problems (DRPs), adherence and knowledge about pharmacotherapy. METHODS: Interventional study with historical control carried out in an allo-HSCT unit, in which the intervention group (IG) included 33 individuals who received pharmacotherapy follow-up. Control Group (CG) consisted of 28 individuals. RESULTS: A total of 250 DRPs were identified, 59 team's doubts were clarified, and 309 interventions were conducted in the IG. The DRPs mainly arose from safety (51.60%) and effectiveness (38.40%) problems. A mean of 9.36 (SD = 6.97) interventions per patient was obtained, mainly including dose reductions (19.09%), adjustments in administration time (18.12%), educational activities (15.21%) and drug removal (10.68%). Clinical significance of the interventions was considered high (75.7% extremely significant, very significant or significant), as well as their acceptability (89.7% accepted). Each patient attended a mean of 4.68 pharmaceutical consultations (SD = 1.91) after hospital discharge, presenting increase in knowledge (p = 0.0001) and in adherence (p = 0.0115). There was no evidence of differences between the groups in the other outcomes analyzed. CONCLUSIONS: The pharmacotherapy follow-up allowed detecting several DRPs and performing interventions of high clinical relevance and acceptability, in addition to improving adherence and individualizing the pharmacotherapy.

Can pharmacotherapeutic follow-up after allogeneic hematopoietic stem cell transplantation improve medication compliance?

BACKGROUND: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) is currently one of the most effective therapies in onco-hematology. For the treatment of the disease and prevention of such complications, a complex pharmacotherapeutic regimen is employed. Non-compliance is prevalent among adolescents and young adults with chronic hematological diseases, being reported by up to 50% of the patients. OBJECTIVE: To evaluate the results of pharmacotherapeutic follow-up on medication compliance and on the knowledge about pharmacotherapy of patients who underwent allo-HSCT. METHODS: A single-arm, open-label and non-randomized intervention study developed in an allo-HSCT outpatient clinic. The participants attended pharmaceutical consultations and had their knowledge about pharmacotherapy and medication compliance measured by MedTake and Brief Medication Questionnaire (BMQ), respectively. RESULTS: A total of 27 patients attended pharmaceutical consultations (4.81 consultations/patient; SD = 1.80). There was an improvement in medication compliance and in knowledge between the first and last consultations (p < 0.05). In the final consultation, 70.37% of the patients showed compliance, with a knowledge rate of 98.35% (SD = 3.63). Non-compliant individuals presented a greater tendency to hospital readmissions. There was no relationship between medication compliance and sociodemographic variables, graft-versus-host disease, and knowledge about pharmacotherapy. CONCLUSIONS: Pharmacotherapeutic follow-up contributed to improving medication compliance. Knowledge about pharmacotherapy alone does not translate into behaviors, which corroborates the complexity of the biopsychosocial factors associated with medication compliance.

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

Avaliação econômica de uma estratégia individual de empoderamento farmacoterapêutico: um modelo em longo prazo aplicado do diabetes mellitus tipo II / Economic evaluation of an individual pharmacotherapeutic empowerment strategy: an applied long-term model for type II diabetes mellitus

Objetivos: contribuir para a geração de dados de avaliação econômica de estratégias de empoderamento farmacoterapêutico para pacientes com Diabetes Mellitus tipo 2 (DM tipo 2). Métodos: este estudo farmacoeconômico é aninhado a um ensaio clínico com controle não randomizado que incluiu pacientes ≥18 anos de idade, cadastrados no HIPERDIA. Os pacientes foram alocados em um modelo de Markov conforme valores de hemoglobina glicada do acompanhamento. As probabilidades do surgimento de complicações relativas ao DM, incluindo-se óbito, foram estimadas por dez anos. Cada complicação do DM tipo 2 teve seu custo estabelecido para determinação do custo anual. Resultados: entre os participantes da intervenção, não ocorrem óbitos ocasionados por DM tipo 2, e a progressão de complicações mantém-se estável durante os anos simulados, enquanto, no grupo controle, 60% dos pacientes podem evoluir para óbito nos dez anos, e a probabilidade de serem acometidos por complicações relacionadas ao DM tipo 2 é crescente. Com relação aos custos, ao final de dez anos, os pacientes que participaram da Estratégia Individual de Empoderamento Farmacoterapêutico (EIEF) tiveram um custo médio de UU$134,45 poupando a vida de 100% dos pacientes, e os pacientes do atendimento convencional um custo médio de UU$237,12 e 40% dos pacientes acompanhados chegariam ao final do ciclo com vida. Conclusão: a EIEF parece ser uma alternativa economicamente viável em longo prazo, bem como para a promoção do controle glicêmico.

Objectives: contribute to the data generation for the economic evaluation of pharmacotherapeutic empowerment strategies for type 2 diabetes mellitus patients (type 2 DM). Method: This pharmacoeconomic study is nested in a clinical trial with non-randomized control that included patients ≥18 years old, registered in HIPERDIA. The patients were allocated to a Markov model according to the follow-up glycated hemoglobin values. The probabilities of the appearance of complications related to DM, including death, have been estimated for ten years. Each complication of type 2 DM had its cost established to determine the annual cost. Results: Among the participants in the intervention, there are no deaths caused by type 2 DM, and the progression of complications remains stable during the simulated years, whereas in the control group, 60% of the patients can progress to death in ten years and the probability of being affected by complications related to type 2 DM is increasing. Regarding costs, at the end of ten years, patients who participated in Individual Pharmacotherapeutic Empowerment Strategy (IPES) had an average cost of US$ 134.45, saving 100% of patient's lives, and conventional care patients cost an average of US$ 237.12 and 40% of the patients followed would reach the end of the life cycle. Conclusion: The IPES seems like an economically viable and long-term economic alternative and promotes glycemic control.

[Central nervous system adverse events potentially associated with drugs used for COVID-19: scoping reviewEventos adversos en el sistema nervioso central potencialmente relacionados con los medicamentos para tratar la COVID-19: revisión exploratoria]. / Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo.

Objective: To identify central nervous system (CNS) adverse events potentially associated with prophylaxis or drug treatment for COVID-19, and to describe the characteristic of the individuals affected. Methods: A scoping review was performed using a search strategy to retrieve articles from PubMed, EMBASE, SciELO, Scopus, CINAHL and BVS databases. Studies reporting on individuals receiving prophylactic or curative drugs for COVID-19 with at least one CNS adverse event were included. Articles reporting on CNS adverse events associated with medication for other health conditions were excluded. Results: The search retrieved 1 547 articles, eight of which met the inclusion criteria. Seven studies had an observational design. A total of 3 035 individuals were assessed, of whom 1 701 were health care professionals and 1 978 were women. Curative treatment with hydroxychloroquine, chloroquine, lopinavir/ritonavir, and azithromycin was the most frequent (n = 5). The most common adverse events were headache, dizziness, mood disturbances, and drowsiness. Suicide was the most frequent severe event. Six adverse events were unexpected for hydroxychloroquine, chloroquine, and doxycycline. Conclusion: Potential CNS adverse events were unspecific and in general potentially associated with the use of hydroxychloroquine (monotherapy or associated with antibiotics). The data confirm the unfavorable risk/benefit profile of these drugs for the prevention and management of signs and symptoms of SARS-CoV-2 infection.

Objetivo: Identificar los eventos adversos en el sistema nervioso central (SNC) potencialmente relacionados con el uso de medicamentos empleados para profilaxis o tratamiento de la COVID-19, y caracterizar a las personas afectadas. Métodos: Se realizó una revisión exploratoria a partir de una estrategia de búsqueda en las bases de datos PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) y la Biblioteca Virtual de Salud (BVS). Se incluyeron estudios de personas que emplearon medicamentos con fines profilácticos o curativos para la COVID-19 y presentaron al menos un evento adverso en el SNC. Se excluyeron los artículos en los cuales se notificaron eventos adversos en el SNC potencialmente relacionados con medicamentos para tratar otros problemas de salud. Resultados: Se recuperaron 1 547 artículos, de los cuales ocho cumplieron con los criterios de admisibilidad. Siete estudios tuvieron un diseño observacional. Se analizaron 3 035 personas, de las cuales 1 701 eran profesionales de salud y 1 978, mujeres. El tratamiento más utilizado fue el curativo (n = 5), con hidroxicloroquina, cloroquina, lopinavir/ritonavir y azitromicina. Los eventos adversos comúnmente citados fueron dolor de cabeza, mareos, trastornos del estado de ánimo y somnolencia. El suicidio fue el evento grave más frecuente. Seis eventos inesperados (mioclonías, temblor, trastorno de la marcha, disgeusia, hiperhidrosis y desasosiego) guardaron relación con el empleo de hidroxicloroquina, cloroquina y doxiciclina. Conclusión: Los eventos adversos del SNC fueron inespecíficos y, en general, posiblemente estuvieron relacionados con el uso de hidroxicloroquina (sola o combinada) para el tratamiento curativo de la COVID-19. Los datos corroboran la relación desfavorable de riesgo/beneficio de esos medicamentos en la prevención y el manejo de los signos y síntomas de la infección por el SARS-CoV-2.

Selection dynamics of HCV genotype 3 resistance-associated substitutions under direct-acting antiviral therapy pressure.

The chronic hepatitis C (CHC) treatment is currently based on the use of direct-acting antivirals (DAAs), and patients infected with hepatitis C virus genotype 3 (GT3) have emerged as a more difficult-to-cure population. The NS5A inhibitor daclatasvir (DCV) and sofosbuvir (SOF), an NS5B viral polymerase inhibitor, are among the drugs that compose more effective and safer treatment regimens. The virus genetic variability is related to resistance-associated substitutions (RASs) that adversely impact DAAs effectiveness. The aims of this study were to analyze the association of NS5A and NS5B RASs and other clinical factors with DAAs regimens effectiveness in patients with GT3 CHC infection. This was a prospective cohort study performed in a Brazilian university hospital. Individuals older than 18 years with GT3 CHC treated with SOF + DCV ± ribavirin (RBV) or SOF + peginterferon (PEG) + RBV were included. Blood samples were collected at baseline and post-treatment. A total of 121 patients were included. Sustained virological response rates were 87.6% for the SOF + DCV ± RBV group and 80.0% for the SOF + PEG + RBV arm. Cirrhosis, prior treatment with interferon/PEG + RBV, and baseline NS5A RAS were associated with higher risk of treatment failure. The NS5A analysis suggested that A30K, Y93H, and RAS at site 62 were related to failure. Interestingly, a likely compensatory effect was shown between A30K and A62T. Emergence of Y93H was always associated with RAS at position 62. The RASs dynamics comprehension is an important tool to indicate more effective treatment for GT3 patients.

Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo

[RESUMO]. Objetivo. Identificar eventos adversos no sistema nervoso central (SNC) potencialmente associados ao uso de medicamentos para profilaxia ou tratamento da COVID-19, bem como caracterizar os indivíduos acometidos. Métodos. Desenvolveu-se uma revisão de escopo a partir de estratégia de busca nas bases de dados PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) e Biblioteca Virtual em Saúde (BVS). Foram incluídos estudos com indivíduos que utilizaram medicamentos como medida profilática ou curativa para COVID-19 e que apresentaram ao menos um evento adverso no SNC. Foram excluídos os artigos que reportaram eventos adversos no SNC potencialmente associados a medicamentos para outras condições de saúde. Resultados. Recuperaram-se 1 547 artigos, dos quais oito atenderam aos critérios de elegibilidade. Em sete estudos, o desenho foi do tipo observacional. Foram analisados 3 035 indivíduos, dos quais 1 701 eram pro- fissionais da saúde e 1 978, mulheres. A terapia mais utilizada foi a curativa (n = 5), com hidroxicloroquina, cloroquina, lopinavir/ritonavir e azitromicina. Os eventos adversos comumente descritos foram dor de cabeça, tontura, distúrbios de humor e sonolência. Suicídio foi o evento grave mais frequente. Seis eventos foram ines- perados para hidroxicloroquina, cloroquina e doxiciclina (mioclonias, tremor, distúrbio de marcha, disgeusia, hiperidrose e inquietação). Conclusão. Os eventos adversos no SNC foram inespecíficos e, geralmente, potencialmente associados ao uso de hidroxicloroquina em monoterapia ou em associação para tratamento curativo da COVID-19. Os dados corroboram a relação desfavorável de risco/benefício desses medicamentos na prevenção e no manejo dos sinais e sintomas da infecção por SARS-CoV-2.

[ABSTRACT]. Objective. To identify central nervous system (CNS) adverse events potentially associated with prophylaxis or drug treatment for COVID-19, and to describe the characteristic of the individuals affected. Methods. A scoping review was performed using a search strategy to retrieve articles from PubMed, EMBASE, SciELO, Scopus, CINAHL and BVS databases. Studies reporting on individuals receiving prophylactic or cura- tive drugs for COVID-19 with at least one CNS adverse event were included. Articles reporting on CNS adverse events associated with medication for other health conditions were excluded. Results. The search retrieved 1 547 articles, eight of which met the inclusion criteria. Seven studies had an observational design. A total of 3 035 individuals were assessed, of whom 1 701 were health care professio- nals and 1 978 were women. Curative treatment with hydroxychloroquine, chloroquine, lopinavir/ritonavir, and azithromycin was the most frequent (n = 5). The most common adverse events were headache, dizziness, mood disturbances, and drowsiness. Suicide was the most frequent severe event. Six adverse events were unexpected for hydroxychloroquine, chloroquine, and doxycycline. Conclusion. Potential CNS adverse events were unspecific and in general potentially associated with the use of hydroxychloroquine (monotherapy or associated with antibiotics). The data confirm the unfavorable risk/benefit profile of these drugs for the prevention and management of signs and symptoms of SARS-CoV-2 infection.

[RESUMEN]. Objetivo. Identificar los eventos adversos en el sistema nervioso central (SNC) potencialmente relacionados con el uso de medicamentos empleados para profilaxis o tratamiento de la COVID-19, y caracterizar a las personas afectadas. Métodos. Se realizó una revisión exploratoria a partir de una estrategia de búsqueda en las bases de datos PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) y la Biblioteca Virtual de Salud (BVS). Se incluyeron estudios de personas que emplearon medicamentos con fines profilácticos o curativos para la COVID-19 y presentaron al menos un evento adverso en el SNC. Se excluyeron los artículos en los cuales se notificaron eventos adversos en el SNC potencialmente relacionados con medicamentos para tratar otros problemas de salud. Resultados. Se recuperaron 1 547 artículos, de los cuales ocho cumplieron con los criterios de admisibi- lidad. Siete estudios tuvieron un diseño observacional. Se analizaron 3 035 personas, de las cuales 1 701 eran profesionales de salud y 1 978, mujeres. El tratamiento más utilizado fue el curativo (n = 5), con hidro- xicloroquina, cloroquina, lopinavir/ritonavir y azitromicina. Los eventos adversos comúnmente citados fueron dolor de cabeza, mareos, trastornos del estado de ánimo y somnolencia. El suicidio fue el evento grave más frecuente. Seis eventos inesperados (mioclonías, temblor, trastorno de la marcha, disgeusia, hiperhidrosis y desasosiego) guardaron relación con el empleo de hidroxicloroquina, cloroquina y doxiciclina. Conclusión. Los eventos adversos del SNC fueron inespecíficos y, en general, posiblemente estuvieron rela- cionados con el uso de hidroxicloroquina (sola o combinada) para el tratamiento curativo de la COVID-19. Los datos corroboran la relación desfavorable de riesgo/beneficio de esos medicamentos en la prevención y el manejo de los signos y síntomas de la infección por el SARS-CoV-2.

Protocol for the implementation of pharmaceutical care in geriatrics: strategy for safety in health care.

OBJECTIVE: To describe the experience of the implementation of pharmaceutical care in a geriatric hospital unit and to propose an instructional protocol for the practice. METHODS: Experience report that became the practice manual of pharmaceutical care in geriatrics (MaP-CFarmaGeri) of a Brazilian hospital and was structured in three topics (1. Situational diagnosis; 2. Adequacy of the procedure and service provision; 3. Practice exercise). RESULTS: The situational diagnosis comprised the collection of data on the structure of the ward and the epidemiological profile. The pharmaceutical services provided included pharmacotherapeutic follow-up, medication reconciliation and pharmacotherapy review. The certification of the content of this procedure was attested by specialists from a multiprofessional team and the technique served more than 60 patients in practice, with good acceptance by the participants. FINAL CONSIDERATIONS: The MaP-CFarmaGeri proved to be a satisfactory strategy in the implementation of pharmaceutical care in geriatrics and can support this insertion in similar locations.

High-risk pregnancy: characterization of medication use profile and association with clinical and sociodemographic factors / Gestação de alto risco: caracterização do perfil de utilização de medicamentos e associação com fatores clínicos e sociodemográficos

Abstract Objectives: describe the profile of medication use and adherence, and the association with clinical and sociodemographic characteristics of high-risk pregnant women attended at a university hospital. Methods: cross-sectional study with data collected through a questionnaire applied on 386 pregnant women. Results: most participants were seen only by the gynecologist (75.1%), started prenatal in the first gestational trimester (86.8%), did not plan the pregnancy (61.9%), and performed an average of 8.2 (SD=4.4) prenatal consultations. The most frequent diagnoses were arterial hypertension (20.5%) and diabetes mellitus (19.7%). Prevalence of medication use was 99.7%, with an average of 5.1 (SD=2.1) medication per woman and 12.7% self-medication. Antianemics (88.9%) and analgesics (63.2%) were the most prevalent classes and 17.9% of the women reported the use of medication with significant gestational risk. Only 36.5% were considered adherent, 32.9% declared they were unaware of the indication of the medication in use and 42% did not receive guidance on the use of the medication during pregnancy. There is no evidence of association between the number of the medication used and clinical and sociodemographic aspects. Conclusions: there is a need to develop strategies to improve the care of this population, with emphasis on strengthening multi-professional care.

Resumo Objetivos: descrever o perfil de utilização de medicamentos e de adesão, e a associação com as características clínicas e sociodemográficas de gestantes de alto risco atendidas em um hospital universitário. Métodos: trata-se de um estudo transversal com dados coletados mediante um questionário estruturado aplicado à 386 gestantes. Resultados: a maior parte das participantes era acompanhada apenas pelo ginecologista (75,1%), iniciou o pré-natal no primeiro trimestre gestacional (86,8%), não planejou a gravidez (61,9%) e realizou em média 8,2 (DP=4,4) consultas de pré-natal. Os diagnósticos mais frequentes foram hipertensão arterial (20,5%) e diabetes mellitus (19,7%). A prevalência de uso de medicamentos foi 99,7%, com média de 5,1 (DP=2,1) medicamentos por mulher e 12,7% de automedicação. Os antianêmicos (88,9%) e analgésicos (63,2%) foram as classes farmacológicas mais prevalentes e 17,9% das gestantes referiram uso de fármacos com risco gestacional relevante. Apenas 36,5% das gestantes foram consideradas aderentes ao tratamento, 32,9% declararam desconhecer a indicação dos medicamentos em uso e 42% não receberam orientações sobre o uso de medicamentos durante a gestação. Não há evidências de associação entre o número de medicamentos utilizados e os aspectos clínicos e sociodemográficos. Conclusão: é necessário desenvolver estratégias para melhorar o atendimento desta população e o uso racional de medicamentos, com ênfase no fortalecimento do cuidado multiprofssional.