Background: The increasing consumption of dietary supplements (DS) has drawn the attention of regulatory agencies, researchers and healthcare professionals. The US Food and Drug Administration (FDA) does not require premarketing assessment of DS considering them safe unless proven otherwise. However, the reporting rate of DS adverse events (DS-AE) is low. Objective: To describe pharmacists’ attitudes and knowledge of DS and DS information resources, and to determine the importance of selected attributes in pharmacists’ decisions to report a DS-AE. Methods: A convenience sample of practicing pharmacists in Virginia was surveyed using a web-based self-administered questionnaire. A conjoint analysis exercise was developed using several scenarios based on a set of five attributes: patient’s age, initiation of DS, last modification in drug therapy, evidence supporting the AE, and outcome of the AE. Participants were asked to indicate their decision to report the AE in each scenario to prescriber, drug manufacturer, DS manufacturer and FDA on a 6-point ordered scale. Participants’ attitude, knowledge of DS, demographic information, and DS information resources were also requested. Linear regression models were used to determine the relative importance of the profile attributes on a pharmacist’s decision to report the AE. The effects of other characteristics on the importance of the attributes were assessed. Results: Participants’ overall attitudes were relatively positive for the clinical use of DS but negative for safe of DS. Formal training on DS was associated with better knowledge of DS regulation. The average knowledge score of DS identification was relatively good but was low for DS regulation. Lexi-Comp® was the most widely used and available information resource and the Natural Medicines Comprehensive Database was the most useful once. The most important attribute that a pharmacist considered in the decision to report a DS-AE to DS manufacturer, drug manufacturer and FDA was the outcome of the AE followed by the evidence supporting the AE. Ranking of these two factors was the reversed in reporting to prescriber. Conclusions: Outcome and evidence of the AE are the most important factors participants considered when reporting. Other characteristics do not have an impact on the relative importance of the attributes.

O objetivo desse estudo foi avaliar o impacto da atenção farmacêutica em desfechos clínicos e na qualidade de vida de pacientes portadores de diabete melito tipo 2 (DM2) atendidos em um hospital de nível terciário de atenção à saúde. O estudo foi clínico controlado randomizado com 70 pacientes portadores de DM2, com mais de 45 anos, em uso de insulina e hemoglobina glicada (HbA1c) 8%. Os pacientes do grupo controle (GC) (n=36) receberam tratamento usual e os do grupo intervenção (GI) (n=34) receberam acompanhamento farmacoterapêutico individualizado e educação para o DM2. A amostra total foi composta principalmente por mulheres (61,4%), com uma média de idade aproximada de 61 anos e tempo de DM2 de cerca de 14 anos, sendo que os grupos eram homogêneos quanto a essas características (p>0,05). Após seis meses de intervenção, os conhecimentos sobre o diabetes e sobre os medicamentos aumentaram significativamente no GI, de 9,91±2,69 para 15,74±3,03 e de 4,47±0,84 para 6,58±1,29, respectivamente, ambos permanecendo inalterados no GC. A adesão ao tratamento farmacológico, para o GI, segundo o questionário Morisky-Green e o Questionário de Adesão a Medicamentos passou de 17,6% para 70,6% e de 29,4% para 52,9%, respectivamente (p<0,05), permanecendo inalterada no GC. Houve aumentos significativos na realização correta das técnicas de aplicação de insulina e de monitorização de glicemia capilar ao final após a intervenção. No início do estudo, a média de HbA1c era para o GC 9,61±1,38 e, para o GI 9,78±1,55 (p>0,05). Após a intervenção, a média de HbA1c do GI diminuiu significativamente para 9,21±1,41, o que não ocorreu para o GC (9,53±1,68) (p>0,05). Ao final do estudo houve melhora significativa da qualidade de vida relacionada ao diabete no GI enquanto que para o GC esse desfecho piorou significativamente. A atenção farmacêutica resultou em melhora significativa de desfechos clínicos e humanísticos dos pacientes com DM2 após seis meses de intervenção / The aim of this study was to evaluate the impact of a pharmaceutical care program on health outcomes and quality of life in patients with type 2 diabetes mellitus (T2DM) attending in a tertiary care center. The study was a randomized controlled, parallel-group trial with a 6-month follow-up carried out with 70 adults (45 years of age) with T2DM, taking insulin, with an HbA1c 8%. Patients in control group (CG) (n=36) received usual care and for those patients in intervention group (IG) (n=34) an individualized pharmacotherapeutic care plan and diabetes education were provided. Total sample was composed primarily of women (61,4%), with mean age of 61 years and duration of T2DM of 14 years and these characteristics were similar in the groups (p>0,05). After a 6-month follow-up, diabetes knowledge and medication knowledge significantly improved in IG, from 9,75±2,69 to 15,74±3,03 and from 4,47±0,84 to 6,58±1,29, respectively, and both outcomes remained unchanged in the CG. Adherence to medication for the IG according to the Morisky-Green questionnaire and to the Questionário de Adesão a Medicamentos varied, respectively, from 17,6% in baseline to 70,6% at end of the study and from 29,4% to 52,9% (p<0,05), with no changes in CG. There were significant improvements in the correct execution of insulin injections and home blood glucose monitoring techniques in the IG at the end of the study. At the beginning of the study HbA1c mean values were 9,61±1,38 in the CG and 9,78±1,55 in the IG (p>0,05). After the intervention, HbA1c mean values was reduced significantly to 9,21±1,41 in the IG and remained unchanged in the CG (9,53±1,68) (p>0,05). After the intervention the diabetes related quality of life significantly improved in IG while it worsened significantly in the CG. Pharmaceutical care resulted in significant improvement in health outcomes in patients with T2DM after 6-month follow-up

Face aux problématiques d’accès, de désertification médicale et de qualité des soins, la loi « Hôpital, Patients, Santé, Territoires » (HPST), votée en 2009, représente un socle pour la réorganisation des soins primaires en France. L’accent est mis sur la collaboration entre les professionnels de santé et l’optimisation des compétences de chacun. Le pharmacien d’officine se trouve au coeur de cette loi. Grâce à son accessibilité, sa formation et sa proximité avec les patients sains comme malades, il voit l’opportunité d’étendre ses pratiques au-delà de la simple dispensation des médicaments en fournissant directement des soins au patient. Cette proposition n’est pas une exception française mais s’inspire des expériences internationales et du concept de « soins pharmaceutiques ». Le pharmacien écossais peut désormais être payé à la capitation pour délivrer des consultations pharmaceutiques lors du renouvellement d’ordonnance au patient atteint de maladie chronique; le pharmacien anglais peut prescrire des médicaments dans le cadre d’un plan de gestion clinique et recevoir un honoraire de dispensation; le pharmacien suisse peut organiser des réunions de discussion avec les médecins; et le pharmacien portugais peut vacciner son patient au sein de l’officine. Les illustrations de la diversification des pratiques du pharmacien d’officine sont donc variées et se replacent dans leur contexte national. L’enjeu est aujourd’hui de comprendre les conditions et les effets d’un ensemble d’innovations techniques, organisationnelles et sociales qui pourraient être en faveur du développement des soins pharmaceutiques en France. Ce travail de thèse a pour objectif de nourrir les débats autour de cette problématique. Un état des lieux de la profession en France et une enquête d’opinion auprès des futurs pharmaciens montrent que le contexte sanitaire, professionnel, économique est propice au développement des pratiques du pharmacien et que l’avenir des soins pharmaceutiques trouve un écho favorable auprès des pharmaciens de demain. Cependant, nombreux sont les facteurs qui peuvent constituer des obstacles à leur diffusion (Chapitres 1 et 2). D’un point de vue économique, d’après une revue de littérature systématique sur l’efficience des soins pharmaceutiques en Europe, les services de surveillance médicamenteuse, de médication officinale, de collaboration entre les professionnels de santé et de promotion de la santé pourraient être, dans certaines conditions, des interventions coût-efficaces d’un point de vue collectif (Chapitre 3). Mais qu’en est-il en France ? On ne dispose pas de travaux sur le sujet. Deux travaux originaux - une étude de cohorte (exposés/non exposés) et une analyse coût-efficacité -, que nous avons menés, se focalisant sur l’implication du pharmacien d’officine dans le dépistage d’une maladie chronique (le syndrome d’apnées du sommeil) montrent que les coûts engendrés par la mise en place d’une telle intervention sont sous certaines conditions compensés par les gains générés, et les résultats sont en faveur de l’implantation du service en pratique de routine (Chapitre 4). / Facing the issues of access, quality and proximity, the "Hospital, Patients, Health and Territories" (HPST) law, passed in 2009, constitutes a basis for the reorganization of primary care in France. The healthcare reform emphasizes on the collaboration between healthcare professionals and the optimization of their skills. The community pharmacist is on the forefront of this reform. Through its accessibility, its training and its proximity with healthy and sick patients, community pharmacists have the opportunity to broaden the scope of their practices beyond the merely dispensing of medication by delivering patient care. This proposal is not a French exception but takes inspiration from international experiences and the concept of "pharmaceutical care." The Scottish pharmacist can now be paid by capitation to renew a prescription for a patient with chronic illness; the English pharmacist can prescribe medication as part of a clinical management plan and receive a dispensing fee, the Swiss pharmacist can organize meetings with general practitioners and in Portugal, pharmacists can vaccinate a patient in the pharmacy. Pharmaceutical care practices are diversified and depend on national context. The challenge today is to understand the conditions and consequences of technical, organizational and social innovations that could be in favor of the development of pharmaceutical care in France. The objective of the thesis is to feed into the debates around this problematic. An overview of profession in France and an original opinion survey of future pharmacists show that the healthcare, professional and economic contexts are suitable to develop pharmaceutical care and future pharmacists are in favor of it. However, there are many barriers to their spread in routine practice (Chapters 1 and 2). From an economical perspective, a systematic review of the literature on the efficiency of pharmaceutical care in Europe show that drug monitoring services, prescription for minor ailments, collaboration between health professionals and health promotion interventions could be cost-effective from a collective point of view under certain conditions (Chapter 3). What about France? There is no study on this topic. We conducted two original studies - a cohort study (exposed / unexposed), and a cost-effectiveness analysis which focused on the involvement of the pharmacist in screening for chronic disease (sleep apnea syndrome). We show that the costs of implementing such an intervention are offset by the gains under certain conditions, and the results are in favor of the implementation of the service in routine practice (Chapter 4).

Erros de medicação e eventos adversos relacionados a medicamentos são comuns em pacientes hospitalizados. O risco de ocorrer problemas com a população pediátrica é cerca de três vezes maior do que com a população adulta, especialmente em unidades de terapia intensiva, onde os pacientes são submetidos a grande número de prescrições de medicamentos intravenosos, com baixo índice terapêutico e formas farmacêuticas adaptadas. A farmácia clínica tem como objetivo introduzir o farmacêutico clínico junto à equipe multidisciplinar de saúde no sentido de intervir, prevenindo problemas relacionados a medicamentos à farmacoterapia (PRF), otimizando-a e contribuindo para a segurança do paciente. O presente estudo teve como objetivo avaliar a implantação e o impacto das intervenções da farmácia clínica no Centro de Terapia Intensiva-Pediátrico (CTIP) do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP). Trata-se de estudo prospectivo, observacional e descritivo que incluiu crianças de zero a dezoito anos, no período de um ano. Foi aplicada a ferramenta Failure Mode and Effects Analysis (FMEA - Análise dos Modos de Falha e seus Efeitos) no início do estudo para avaliar os riscos relacionados aos medicamentos no CTIP e orientar a atuação da farmácia clínica, em que o farmacêutico avaliou as prescrições diárias e realizou intervenções junto à equipe multidisciplinar. Foram acompanhadas 162 crianças e avaliadas 1586 prescrições com uma taxa de PRF de 12,42% (IC95% 10,50-14,04). Foram realizadas 197 intervenções com custo salvo de R$15.118,73. Os principais tipos de intervenções foram relacionados à indicação e necessidade do medicamento. A partir destas, os grupos foram divididos em pacientes com PRF e sem PRF. Foram detectadas diferenças significativas nas seguintes variáveis: peso, idade, tempo de internação, tempo de acompanhamento, custo total, custo salvo pelas intervenções, gravidade dos pacientes avaliada pelo escore PRISM e PELOD, quantidade total de medicamentos utilizados e quantidade de medicamentos potencialmente perigosos e endovenosos contínuos. Além disso, houve diferenças significativas na taxa de óbito e nas categorias diagnósticas entre os grupos. A implantação do serviço de farmácia clínica no CTIP mostrou impacto positivo na redução de riscos relacionados a todo o processo de utilização de medicamentos. As intervenções do farmacêutico clínico identificaram e preveniram PRF, promovendo o uso racional de medicamentos e contribuindo para a redução de custos associados à prescrição médica. / Medication errors and adverse events related to drugs are common in hospitalized patients. The potential risk for medication errors in pediatric patients is about three times higher than in adults, especially in intensive care units, where patients are subjected to a large number of intravenous drug prescriptions, with low therapeutic index and adapted pharmaceutical forms. Clinical pharmacy aims to introduce the clinical pharmacist in a multidisciplinary health team in order to intervene, preventing drug-related problems (DRPs) and optimize pharmacotherapy, contributing to patient safety. This study aimed to assess the implementation and the impact of clinical pharmacy interventions in the Pediatric Intensive Care Unit (PICU) of Hospital das Clinicas of Ribeirao Preto Medical School, University of São Paulo (HCFMRP-USP). This was a prospective, observational and descriptive study which included children from zero to eighteen years of age, over a one year period. Failure Mode and Effects Analysis Tool (FMEA) was applied at the beginning of the study to assess the risks related to medicines in the PICU and to guide clinical pharmacy work, where the pharmacist evaluated daily prescriptions and made interventions along with a multidisciplinary team. One thousand five hundred and eighty-six prescriptions of 162 children were assessed, and a DRPs rate of 12.42% (95% CI - 10.50 to 14.04) was found. One hundred ninety-seven interventions were performed, with a cost saving of R$ 15,118.73. The main types of interventions were related to indication and necessity of the drug. From these, the groups were divided in patients with DRPs and without DRPs. Significant differences were found in weight, age, time of hospitalization, time of follow-up, total cost, costs saved by interventions, severity of patients assessed by PRISM and PELOD scores, total amount of medications used, and number of potentially dangerous and continuous intravenous medications. In addition, there were significant differences in mortality rate and diagnostic categories between groups. The implementation of clinical pharmacy service in the PICU showed a positive impact on patients\' treatment. The clinical pharmacist interventions identified and prevented DRPs, promoting the rational use of medications and contributing to the reduction of costs associated with medical prescription.

Erros de medicação e eventos adversos relacionados a medicamentos são comuns em pacientes hospitalizados. O risco de ocorrer problemas com a população pediátrica é cerca de três vezes maior do que com a população adulta, especialmente em unidades de terapia intensiva, onde os pacientes são submetidos a grande número de prescrições de medicamentos intravenosos, com baixo índice terapêutico e formas farmacêuticas adaptadas. A farmácia clínica tem como objetivo introduzir o farmacêutico clínico junto à equipe multidisciplinar de saúde no sentido de intervir, prevenindo problemas relacionados a medicamentos à farmacoterapia (PRF), otimizando-a e contribuindo para a segurança do paciente. O presente estudo teve como objetivo avaliar a implantação e o impacto das intervenções da farmácia clínica no Centro de Terapia Intensiva-Pediátrico (CTIP) do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP). Trata-se de estudo prospectivo, observacional e descritivo que incluiu crianças de zero a dezoito anos, no período de um ano. Foi aplicada a ferramenta Failure Mode and Effects Analysis (FMEA - Análise dos Modos de Falha e seus Efeitos) no início do estudo para avaliar os riscos relacionados aos medicamentos no CTIP e orientar a atuação da farmácia clínica, em que o farmacêutico avaliou as prescrições diárias e realizou intervenções junto à equipe multidisciplinar. Foram acompanhadas 162 crianças e avaliadas 1586 prescrições com uma taxa de PRF de 12,42% (IC95% 10,50-14,04). Foram realizadas 197 intervenções com custo salvo de R$15.118,73. Os principais tipos de intervenções foram relacionados à indicação e necessidade do medicamento. A partir destas, os grupos foram divididos em pacientes com PRF e sem PRF. Foram detectadas diferenças significativas nas seguintes variáveis: peso, idade, tempo de internação, tempo de acompanhamento, custo total, custo salvo pelas intervenções, gravidade dos pacientes avaliada pelo escore PRISM e PELOD, quantidade total de medicamentos utilizados e quantidade de medicamentos potencialmente perigosos e endovenosos contínuos. Além disso, houve diferenças significativas na taxa de óbito e nas categorias diagnósticas entre os grupos. A implantação do serviço de farmácia clínica no CTIP mostrou impacto positivo na redução de riscos relacionados a todo o processo de utilização de medicamentos. As intervenções do farmacêutico clínico identificaram e preveniram PRF, promovendo o uso racional de medicamentos e contribuindo para a redução de custos associados à prescrição médica. / Medication errors and adverse events related to drugs are common in hospitalized patients. The potential risk for medication errors in pediatric patients is about three times higher than in adults, especially in intensive care units, where patients are subjected to a large number of intravenous drug prescriptions, with low therapeutic index and adapted pharmaceutical forms. Clinical pharmacy aims to introduce the clinical pharmacist in a multidisciplinary health team in order to intervene, preventing drug-related problems (DRPs) and optimize pharmacotherapy, contributing to patient safety. This study aimed to assess the implementation and the impact of clinical pharmacy interventions in the Pediatric Intensive Care Unit (PICU) of Hospital das Clinicas of Ribeirao Preto Medical School, University of São Paulo (HCFMRP-USP). This was a prospective, observational and descriptive study which included children from zero to eighteen years of age, over a one year period. Failure Mode and Effects Analysis Tool (FMEA) was applied at the beginning of the study to assess the risks related to medicines in the PICU and to guide clinical pharmacy work, where the pharmacist evaluated daily prescriptions and made interventions along with a multidisciplinary team. One thousand five hundred and eighty-six prescriptions of 162 children were assessed, and a DRPs rate of 12.42% (95% CI - 10.50 to 14.04) was found. One hundred ninety-seven interventions were performed, with a cost saving of R$ 15,118.73. The main types of interventions were related to indication and necessity of the drug. From these, the groups were divided in patients with DRPs and without DRPs. Significant differences were found in weight, age, time of hospitalization, time of follow-up, total cost, costs saved by interventions, severity of patients assessed by PRISM and PELOD scores, total amount of medications used, and number of potentially dangerous and continuous intravenous medications. In addition, there were significant differences in mortality rate and diagnostic categories between groups. The implementation of clinical pharmacy service in the PICU showed a positive impact on patients\' treatment. The clinical pharmacist interventions identified and prevented DRPs, promoting the rational use of medications and contributing to the reduction of costs associated with medical prescription.

Die Arzneimitteldistribution in Deutschland ist maßgeblich vom historischen Leitbild "des Apothekers in seiner Apotheke" geprägt und unterlag nur geringfügigen Änderungen. Die regulativen Bestimmungen, insbesondere das Fremdbesitzverbot, die eingeschränkte Mehrbesitzerlaubnis und die Apothekenbetriebsordnung, werden auf ihre Effektivität hinsichtlich einer ordnungsgemäßen Arzneimittelversorgung der Bevölkerung und ihre Effizienz untersucht. Hierbei werden alle relevanten Kräfte in der Arzneimitteldistribution kritisch untersucht und deren Verhandlungsposition dargestellt. Im nächsten Schritt wird ein Konzept zur optimalen Arzneimitteldistribution aus volkswirtschaftlicher Sicht entwickelt. Hierbei werden eine Abschaffung des Fremdbesitzverbotes, die Aufhebung der eingeschränkten Mehrbesitzerlaubnis und tiefgreifende Änderungen an der Apothekenbetriebsordnung vorgeschlagen. Diese Schritte sind aus volkswirtschaftlicher Sicht notwendig, um eine effektive und effiziente Arzneimitteldistribution zu gewährleisten.

Η μελέτη είναι μια προσπάθεια ανίχνευσης της καταναλωτικής συμπεριφοράς των πελατών των Ελληνικών φαρμακείων και του βαθμού ικανοποίησης τους από τις αγορές, τις υπηρεσίες και την ατμόσφαιρα του φαρμακείου με τη χρήση ερωτηματολογίου και τη μέθοδο της βολικής δειγματοληψίας σε δείγμα εκατό ατόμων. Σημαντική παράμετρος αποτέλεσε η εμπιστοσύνη των πελατών στο φαρμακοποιό. Για την εξαγωγή συμπερασμάτων αναζητήθηκαν στατιστικά σημαντικές συσχετίσεις ανάμεσα στα δημογραφικά στοιχεία, τα καταναλωτικά πρότυπα και τις μεταβλητές ατμόσφαιρα φαρμακείου, εμπιστοσύνη στο φαρμακοποιό και ικανοποίηση από τις φαρμακευτικές υπηρεσίες. / This study is a survey of customers shopping behavior in Greek pharmacies, and their satisfaction from purchases, pharmaceutical services and store atmosphere using a questionnaire among a hundred customers sample. An important factor was trust upon the pharmacist. Conclusions made out of statistically significant correlations among demographics, consumers shopping styles and variables such as satisfaction from pharmaceutical services, trust upon the pharmacist and pharmacies atmosphere.

L’hypothèse de cette thèse est qu’une pratique collaborative médecins de famille-pharmaciens communautaires (PCMP) où le pharmacien fournit des soins pharmaceutiques avancés avec ajustement posologique d’une statine permettrait aux patients avec une dyslipidémie une réduction plus importante de leur LDL et augmenterait le nombre de patients atteignant leurs cibles lipidiques. Dans une étude clinique contrôlée et randomisée en grappe visant à évaluer une PCMP pour des patients ayant une dyslipidémie (l’étude TEAM), une journée de formation basée sur un protocole de traitement et des outils cliniques a été offerte aux pharmaciens PCMP pour les préparer à fournir des soins pharmaceutiques avancés. Les connaissances des pharmaciens sur les dyslipidémies étaient faibles avant la formation mais se sont améliorées après (moyenne de 45,8% à 88,2%; p < 0,0001). Après la formation, les pharmaciens avaient un haut niveau d’habiletés cliniques théoriques et pratiques. Bref, une journée de formation basée sur un protocole de traitement et des outils cliniques était nécessaire et adéquate pour préparer les pharmaciens à fournir des soins pharmaceutiques avancés à des patients ayant une dyslipidémie dans le contexte d’une étude clinique. Dans l’étude TEAM, 15 grappes de médecins et de pharmaciens (PCMP : 8; soins habituels (SH) : 7) ont suivi pendant un an, 225 patients (PCMP : 108; SH : 117) à risque modéré ou élevé de maladie coronarienne qui débutaient ou étaient déjà traités par une monothérapie avec une statine mais qui n’avaient pas atteint les cibles lipidiques. Au départ, par rapport aux patients SH, les patients PCMP avaient un niveau de LDL plus élevé (3,5 mmol/L vs 3,2 mmol/L) et recevaient moins de statine à puissance élevée (11,1 % vs 39,7 %). Après 12 mois, la différence moyenne du changement de LDL entre les groupes était égale à -0,2 mmol/L (IC95%: -0,3 à -0,1) et -0,04 (IC95%: -0,3 à 0,2), sans ajustement et avec ajustement, respectivement. Le risque relatif d’atteindre les cibles lipidiques était 1,10 (IC95%: 0,95 à 1,26) et 1,16 (1,01 à 1,32), sans ajustement et avec ajustement, respectivement. Les patients PCMP ont eu plus de visites avec un professionnel de la santé et d’analyses de laboratoire et étaient plus enclins à rapporter des changements de style de vie. La PCMP a amélioré l’adhésion aux lignes directrices en augmentant la proportion de patients aux cibles lipidiques. Les données intérimaires de l’étude TEAM (PCMP : 100 patients; SH : 67 patients) ont permis d’évaluer les coûts directs annuels du suivi du pharmacien du groupe PCMP (formation, visites, laboratoire), du médecin (visites, laboratoire) et du traitement hypolipémiant. Le suivi du pharmacien a coûté 404,07$/patient, incluant 320,67$ pour former les pharmaciens. Le coût global incrémental était 421,01$/patient. Une pratique collaborative pour des patients ayant une dyslipidémie engendre un coût raisonnable. / The hypothesis was that a family physician-community pharmacist collaborative care (PPCC) model where the pharmacist provides advanced pharmaceutical care including statin dosage adjustment would provide a greater LDL reduction to dyslipidemia patients and increase the number of patients reaching their target lipid levels. . In a cluster randomised controlled trial to evaluate a PPCC model for patients with dyslipidemia (TEAM study), a one-day workshop based on a treatment protocol and specific clinical tools was offered to prepare PPCC pharmacists to provide advanced pharmaceutical care to dyslipidemia patients. Pharmacists knowledge on dyslipidemia was low before the workshop but significantly improved thereafter (overall score from 45,8% to 88,2%; p < 0,0001). After the workshop, pharmacists showed a high level of theoretical and practical skills. Finally, a one-day workshop based on a treatment protocol and clinical tools was necessary and adequate to prepare pharmacists to provide advanced pharmaceutical care to patients with dyslipidemia in the context of a clinical trial. In the TEAM study, 15 clusters of physicians and pharmacists (PPCC: 8; usual care (UC) : 7) followed for 1 year, 225 patients (PPCC: 108; UC:117) at moderate or high risk of coronary heart disease who initiated or were already treated with a statin monotherapy but who did not achieved target lipid levels. At baseline, compared to UC patients, PPCC patients had a higher level of LDL (3.54 mmol/L vs 3.22 mmol/L) and were prescribed less high-potency statin (11,1% vs 39,7%). At 12 months, the crude and adjusted between group-differences in the mean change in LDL-C were equal to -0.2 mmol/L (95%CI: -0.3 to -0.1) and -0.04 (95%CI: -0.3 to 0.2), respectively. The crude and the adjusted relative risk of achieving lipid targets were equal to 1.10 (95%CI: 0.95 to 1.26) and 1.16 (1.01 to 1.32), respectively. PPCC patients had more health-professional visits and laboratory tests, were more likely to have their lipid-lowering treatment changed, and to report lifestyle changes. PPCC improved adherence to treatment-guideline recommendations with higher proportion of patients achieving their target lipid levels. From an interim analysis of the TEAM study (PPCC: 100 patients; UC: 67 patients) the annual direct costs for the pharmacist follow-up in the PPCC group (training, visits, laboratories), physician follow-up (visits, laboratories) and lipid-lowering treatment were evaluated. The cost for the pharmacist follow-up was $404.07/patient, including $320.67 to train pharmacists. The incremental overall cost was $421.01/patient. Finally, a PPCC for patients with dyslipidemia entails a reasonable cost.

O objetivo desse estudo foi avaliar o impacto da atenção farmacêutica em desfechos clínicos e na qualidade de vida de pacientes portadores de diabete melito tipo 2 (DM2) atendidos em um hospital de nível terciário de atenção à saúde. O estudo foi clínico controlado randomizado com 70 pacientes portadores de DM2, com mais de 45 anos, em uso de insulina e hemoglobina glicada (HbA1c) 8%. Os pacientes do grupo controle (GC) (n=36) receberam tratamento usual e os do grupo intervenção (GI) (n=34) receberam acompanhamento farmacoterapêutico individualizado e educação para o DM2. A amostra total foi composta principalmente por mulheres (61,4%), com uma média de idade aproximada de 61 anos e tempo de DM2 de cerca de 14 anos, sendo que os grupos eram homogêneos quanto a essas características (p>0,05). Após seis meses de intervenção, os conhecimentos sobre o diabetes e sobre os medicamentos aumentaram significativamente no GI, de 9,91±2,69 para 15,74±3,03 e de 4,47±0,84 para 6,58±1,29, respectivamente, ambos permanecendo inalterados no GC. A adesão ao tratamento farmacológico, para o GI, segundo o questionário Morisky-Green e o Questionário de Adesão a Medicamentos passou de 17,6% para 70,6% e de 29,4% para 52,9%, respectivamente (p<0,05), permanecendo inalterada no GC. Houve aumentos significativos na realização correta das técnicas de aplicação de insulina e de monitorização de glicemia capilar ao final após a intervenção. No início do estudo, a média de HbA1c era para o GC 9,61±1,38 e, para o GI 9,78±1,55 (p>0,05). Após a intervenção, a média de HbA1c do GI diminuiu significativamente para 9,21±1,41, o que não ocorreu para o GC (9,53±1,68) (p>0,05). Ao final do estudo houve melhora significativa da qualidade de vida relacionada ao diabete no GI enquanto que para o GC esse desfecho piorou significativamente. A atenção farmacêutica resultou em melhora significativa de desfechos clínicos e humanísticos dos pacientes com DM2 após seis meses de intervenção / The aim of this study was to evaluate the impact of a pharmaceutical care program on health outcomes and quality of life in patients with type 2 diabetes mellitus (T2DM) attending in a tertiary care center. The study was a randomized controlled, parallel-group trial with a 6-month follow-up carried out with 70 adults (45 years of age) with T2DM, taking insulin, with an HbA1c 8%. Patients in control group (CG) (n=36) received usual care and for those patients in intervention group (IG) (n=34) an individualized pharmacotherapeutic care plan and diabetes education were provided. Total sample was composed primarily of women (61,4%), with mean age of 61 years and duration of T2DM of 14 years and these characteristics were similar in the groups (p>0,05). After a 6-month follow-up, diabetes knowledge and medication knowledge significantly improved in IG, from 9,75±2,69 to 15,74±3,03 and from 4,47±0,84 to 6,58±1,29, respectively, and both outcomes remained unchanged in the CG. Adherence to medication for the IG according to the Morisky-Green questionnaire and to the Questionário de Adesão a Medicamentos varied, respectively, from 17,6% in baseline to 70,6% at end of the study and from 29,4% to 52,9% (p<0,05), with no changes in CG. There were significant improvements in the correct execution of insulin injections and home blood glucose monitoring techniques in the IG at the end of the study. At the beginning of the study HbA1c mean values were 9,61±1,38 in the CG and 9,78±1,55 in the IG (p>0,05). After the intervention, HbA1c mean values was reduced significantly to 9,21±1,41 in the IG and remained unchanged in the CG (9,53±1,68) (p>0,05). After the intervention the diabetes related quality of life significantly improved in IG while it worsened significantly in the CG. Pharmaceutical care resulted in significant improvement in health outcomes in patients with T2DM after 6-month follow-up

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / In community pharmacies, at the time the pharmacist incorporates clinical practice into their routine, several barriers and facilitators influencing the implementation of patient care services. Objectives: To learn and understand the perception of a group of pharmacists on the process of implementation of Clinical Pharmacy Services in community pharmacies; Understand through a Scoping Review of literature, pharmacist perception about Clinical Pharmacy Services in community pharmacy. Methods: The study was structured in two stages. The first step corresponded to Scoping Review held in the Lilacs, PubMed, Scopus, Scielo and Web of Knowledge database. Studies should be of the pharmacist perception, and the pharmaceutical services should be patient-focused. The second stage corresponded to a qualitative study in which three focus groups were conducted with a group of 11 pharmacists. Data analysis was done using the technique of content analysis. Results: Step 1 - The literature search resulted in 29 articles that met the inclusion criteria. The studies were performed in eight different countries, had qualitative methods (focus groups, interviews, diaries and questionnaires) and quantitative (questionnaires) and 12 different classifications of pharmaceutical services were found. In most studies, pharmacists believed that their role in community pharmacies was positive for patients, barriers and facilitators for service were reported. Step 2 - The audio recording of the focus groups were fully transcribed and analyzed. The perception of pharmacists brought issues such as access to medication, barriers and facilitators to service, expectations, changes generated during the implementation of services, results achieved and consolidation of services. Conclusion: The Scoping Review made recommendations for implementation of Clinical Services Pharmacists in community pharmacies, making it easier to service delivery and enhancing practices in community pharmacies. The dissemination of positive experiences in implementations of services through perception studies have shown that it is possible to develop a model of clinical services in community pharmacies. / Em farmácias comunitárias, no momento em que o farmacêutico incorpora a prática clínica em sua rotina, várias barreiras e facilitadores influenciam a implantação de serviços de cuidado aos pacientes. Objetivos: Conhecer e compreender a percepção de um grupo de farmacêuticos sobre o processo de implementação dos Serviços Clínicos Farmacêuticos em farmácias comunitárias; Conhecer e compreender por meio de uma Revisão de Escopo da literatura, a percepção farmacêutico na provisão de Serviços Clínicos Farmacêuticos em farmácia comunitária. Metodologia: O estudo foi estruturado em duas etapas. A primeira etapa correspondeu a Revisão de Escopo realizada nas bases de dados Lilacs, PubMed, Scopus, Scielo e Web of Knowledge. Os estudos deveriam ser e se declarar de percepção de farmacêutico e os Serviços Farmacêuticos deveriam ser centrados no paciente. A segunda etapa correspondeu a um estudo qualitativo, no qual foram realizados três Grupos Focais com um grupo de 11 farmacêuticos. A análise dos dados foi feita por meio da técnica de análise de conteúdo. Resultados: Etapa 1 - A pesquisa bibliográfica resultou em 29 artigos que cumpriram os critérios de inclusão. Os estudos foram realizados em oito países diferentes, possuíam metodologias qualitativas (grupos focais, entrevistas, diários e questionários) e quantitativas (questionários), e foram encontradas 12 diferentes classificações de serviços farmacêuticos. Na maioria dos estudos, os farmacêuticos acreditavam que seu papel em farmácias comunitárias era positivo para os pacientes, barreiras e facilitadores para os serviços foram relatados. Etapa 2 - A gravação dos áudios dos grupos focais foi integralmente transcrita e analisada. A percepção dos farmacêuticos trouxe temas como acesso ao medicamento, barreiras e facilitadores para o serviço, expectativas, mudanças geradas ao longo da implementação dos serviços, resultados atingidos e a consolidação dos serviços. Conclusão: A Revisão de escopo apresentou recomendações para a implementação de serviços clínicos farmacêuticos em farmácias comunitárias, tornando mais fácil a provisão de serviços e valorizando as práticas em farmácias comunitárias. A divulgação de experiências positivas em implementações de serviços por meio de estudos de percepção têm mostrado que é possível desenvolver um modelo de serviços clínicos em farmácias comunitárias.