Implantação do serviço de farmácia clínica em hospitais públicos do Distrito Federal, Brasil

Dissertação (mestrado)—Universidade de Brasília, Faculdade de Ceilândia, Programa de Pós-Graduação em Ciências e Tecnologias em Saúde, 2020.Introdução: o paciente hospitalizado possui alto risco de sofrer eventos adversos relacionados à farmacoterapia. Para lidar com este cenário sugere-se a implantação de Serviços de Farmácia Clínica (SFCs), nos quais os farmacêuticos prestam cuidado ao paciente de forma a otimizar a farmacoterapia, promover saúde e bem-estar, e prevenir doenças . Objetivo: avaliar a implantação do SFC nos hospitais públicos da Secretaria de Estado de Saúde do Distrito Federal (SES/DF). Método: estudo observacional de Triangulação Metodológica, baseado em cinco etapas: (i) relato do processo de implantação do SFC; (ii) apresentação da sua estrutura e atividades; (iii) análise de um banco de dados com indicadores de intervenções farmacêuticas (IFs); (iv) percepção do serviço sob a ótica dos profissionais da equipe de saúde; e (v) identificação dos desafios e facilidades para seu desenvolvimento. Resultados: o SFC foi implantado nos 15 hospitais da SES/DF, em um processo coordenado pela Diretoria de Assistência Farmacêutica (DIASF). Nos três primeiros anos, considerando uma amostra de 12 hospitais, 36 farmacêuticos clínicos acompanharam 73.557 pacientes-dia e registraram 22.416 IFs, com uma taxa de aceitação de 82,4% na classe médica, e de 97,8% com outros profissionais de saúde. A maior parte das IFs (66,9%) ocorreu na etapa de prescrição, e a sinalização informativa foi a principal estratégia de intervenção (43,9%). A taxa de cobertura esteve fortemente associada à densidade de farmacêuticos clínicos por leito (rs=0,788; p=0,002). O SFC foi positivamente avaliado pelos profissionais da equipe de saúde, e se verificou melhora significativa da postura profissional do farmacêutico ao longo do tempo. A boa relação/apoio da equipe médica foi apontada como a principal facilidade para o desenvolvimento da atividade, e a escassez de recursos humanos, o principal desafio. Entre as limitações citam-se a falta de mensuração dos custos de implantação e manutenção do serviço, bem como a carência de indicadores que considerem resultados clínicos e econômicos. Conclusões: o estudo apresentou um processo de implantação do SFC bem sucedido. O serviço se mostrou relevante para a otimização da farmacoterapia, e foi favoravelmente avaliado pela equipe de saúde. Os achados reforçam a importância da participação do farmacêutico clínico na equipe de saúde, tanto para promover da racionalidade e segurança da farmacoterapia, assim como para contribuir com um processo de cuidado com melhores resultados clínicos, humanísticos e econômicos.Introduction: the hospitalized patient has a high risk of suffering adverse events related to pharmacotherapy. To deal with this scenario, it is suggested the implementation of Clinical Pharmacy Services (CPSs), in which pharmacists provide patient care in order to optimize pharmacotherapy, promote health and well-being, and prevent diseases. Objective: to evaluate the implementation of the SFC in public hospitals of the Department of Health of the Federal District (DH/FD). Method: observational study of Methodological Triangulation, based on five steps: (i) report of the CPS implementation process; (ii) presentation of its structure and activities; (iii) analysis of a database with pharmaceutical interventions (PIs) indicators; (iv) perception of the service from the perspective of health team professionals; and (v) identification of challenges and facilities for its development. Results: the CPS was implemented in the 15 hospitals of DH/FD, in a process coordinated by the Pharmaceutical Management Directory (PMD). In the first three years, considering a sample of 12 hospitals, 36 clinical pharmacists followed 73,557 patient-days and registered 22,416 PIs, with an acceptance rate of 82.4% in the medical class, and 97, 8% with other healthcare professionals. Most of the PIs (66.9%) ocurred at the prescription stage, and informational advice being the main intervention strategy (43.9%). The coverage rate was strongly associated with the ratio of clinical pharmacists per bed (rs = 0.788; p = 0.002). CPS was positively evaluated by health team professionals, and there was significant improvement in professional posture of the pharmacist over time. The good relationship/support of the medical team was identified as the main facility for the development of the activity, and the scarcity of human resources, the main challenge. Among the limitations are the lack of measurement of the costs of implementing and maintaining the service, as well as the lack of indicators that consider clinical and economic results. Conclusions: the study showed a successful CPS implantation process. The service proved to be relevant for the optimization of pharmacotherapy, and was favorably evaluated by the health team professionals. The findings reinforce the importance of the participation of the clinical pharmacist in the health team, both to promote the rationality and safety of pharmacotherapy, as well as to contribute to a care process with better clinical, humanistic and economic results

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

Clinical Pharmacy Key Performance Indicators in the Hospital: a Delphi consensus study

This is a Delphi study to define a core set of key performance indicators (KPIs) for evaluating clinical pharmacy services in hospital settings. The research will focus on outcome indicators, encompassing Economic, Clinical, and Humanistic dimensions. Stakeholders (health professionals, health service managers, patients, and representatives of patient associations) were recruited worldwide