<p dir="ltr"><b>Background</b></p><p dir="ltr">Recent developments in cancer therapeutics have allowed increased use of Oral Anticancer Medications (OAMs), including in the treatment of breast cancer. Breast cancer is the most common cancer among women in the United States. Patients with breast cancer may face key barriers in managing their OAMs at home. These challenges can lead to sub-optimal adherence and lower the overall quality of life. Designing interventions that enhance the patient experience with use of OAMs requires a deeper understanding of barriers faced by patients as they navigate their cancer care journey. The objective of this study was to identify the unmet medication management needs of patients with breast cancer who are receiving OAMs and co-design an early prototype intervention with patients to support medication management needs of patients with breast cancer.</p><p dir="ltr"><b>Methods</b></p><p dir="ltr">Two phases comprise this study. Phase 1 involved patient-journey mapping to characterize the longitudinal experience of OAMs use among patients diagnosed with breast cancer. In phase 2, we conducted participatory design (PD) workshops to develop a prototype tool to address OAM needs identified in phase 1. All participants were recruited from an outpatient breast cancer clinic in Indianapolis. Eligible participants were: 18 years of age or older, diagnosed with breast cancer, and currently receiving an OAM. All participants completed a brief sociodemographic and health information questionnaire. In phase 1, enrolled persons participated in a journey mapping exercise through semi-structured interviews. Interviews were conducted either in-person or remotely via Zoom, based on participant preference. For each interview, two researchers and the participant collaborated to create individual patient journey maps to generate a concise visual storyboard focused on medication use experiences related to OAMs. The journey maps helped capture treatment timelines, key markers of medication use, and specific barriers faced by patients. Individual journey maps were consolidated to generate personas representing groups of patients with related characteristics, treatment types, goals, and unmet needs. In phase 2, three rounds of PD workshops were conducted using the focus group format to develop an early prototype intervention. In round one (inspiration stage), participants defined the problem space and prioritized a list of challenges amenable to solutions; in round two (ideation stage), participants generated multiple possible solutions and design ideas; and in round three (convergence stage), two design concepts were selected and evaluated by participants.</p><p dir="ltr"><b>Results</b></p><p dir="ltr">In phase 1, 12 interviews (11 females and 1 male) were completed. The median age of participants was 65.5 years (range, 37-75). Participants were divided into two groups based on their prescribed medication types: (1) specialty medication (palbociclib or ribociclib; n=4 patients) and (2) traditional medication (tamoxifen, anastrozole, or exemestane; n=8 patients). We defined ‘Specialty’ medications as those that require specialty pharmacies and ‘traditional’ medications as those obtainable in local community pharmacies. To represent participants across these two broad categories of medications, two personas were created. Participants who had been prescribed specialty medication reported difficulty navigating the insurance process during medication fills, while participants who prescribed traditional medication did not. Notably, the word “prior authorization” was not used by participants to explain the issues they experienced. While all participants reported having side effects from their medications, sub-optimal adherence (n=2) was reported among the traditional medication group only. Other participants taking traditional medications either found their own ways to manage side effects or simply reported: “dealing with side effects as I don’t want cancer.” Participants expressed coping with side effects by enduring them. Participants had few strategies to manage their side effects, often stating that “they didn’t think of reaching out to the doctor,” when asked. Additionally, participants mentioned needing more financial and emotional support during their treatment journey. In phase 2, each PD session was conducted with 4-5 participants and 2 researchers (the design panel). Participants identified key challenges including difficulties navigating resources and information as well as managing medication side effects. The design panel prioritized two design concepts, which were subsequently developed into two prototypes: 1) a physical breast cancer handbook; and 2) an interactive treatment navigation app for use on tablet and smartphone devices. Our team plans to consolidate, further develop, and evaluate these prototypes in subsequent work as a follow up to this pilot study.</p><p dir="ltr"><b>Conclusion</b></p><p dir="ltr">This study provides insight into the patient experience with OAMs. The personas created can be applied in designing interventions tailored to breast cancer patients’ needs and goals, while the consolidated journey maps identify potential areas for improvement. Adequate patient education and enhanced tools and processes are necessary to manage medication side effects effectively, ultimately leading to improved medication outcomes and assisting patients in navigating their treatment. The two design concepts require further revision prior to implementation and pilot testing.</p>

Overweight and obesity are enormous problems, causing both reduced life expectancy as well as socioeconomic consequences. In 2016, almost 40 % of the global population was classified as obese. Obesity is a major risk factor to numerous serious health issues, including high blood pressure, stroke, diabetes and it is connected to an increased risk of certain types of cancer.    Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved by the European Union in 2022 for treatment of obesity and some types of overweight. Semaglutide supports the regulation of blood sugar, hunger and satiety, similar to the hormone glucagon-like peptid-1 (GLP-1).   This review examined research related to expected length of treatment for weight loss with semaglutide. Specifically, it considered whether it is an option to end treatment with semaglutide once the patient reached the target weight and improved health, or if continuous treatment with semaglutide is necessary to prevent weight regain.    The studies reviewed were connected to the clinical trials “Semaglutide Treatment Effect in People with obesity” (STEP), that studied change of weight. The basic design of these trials combined once weekly injections of Semaglutide 2.4 mg or placebo with 150 minutes weekly exercise, 500 calories reduction in daily intake and ongoing supportive counselling. The trial objective, length and population varied, still all trials resulted in about 15 % mean weight loss with semaglutide treatment compared to 2-6 % with placebo treatment.    Investigation in changes in weight and cardiometabolic endpoints up to one year after discontinued 68 weeks of treatment, found that only -5% weight loss from base line remained, even with on-going lifestyle changes. Neither intensive behavioural therapy and 8 weeks of initial low-carb diet nor a prolonged 104 weeks study showed additional weight loss.    A questionnaire regarding the control of food cravings, hunger and satiety found that the semaglutide group had in average less cravings for savoury food and an increased control of general food craving than placebo.    It is not possible, based on examined trials of subcutaneous semaglutide 2.4 mg, to conclude that ending treatment will result in a permanent stable weight loss, even with continued lifestyle changes and supportive follow ups. Additional research, especially on long-term treatment with semaglutide 2.4 mg, is needed to investigate results as weight loss, other improved parameters and reported side effects. Still the reported side effects have not raised any alarm and parameters connected to some of the serious risk factors that are increased when obese or over-weight were indicated as improved compared to placebo.    Despite the need for more research, the absence of severe adverse effects, above positive indications related to reduced risk factors, and the fact that nearly 70 % of participants in average lost at least -10 % of their weight at base line, and closer to 35 % lost at least 20 %, all support a positive view of semaglutide 2.4 mg as a potential lifelong treatment option. / Fetma är ett globalt hälsoproblem, med flera allvarliga följdsjukdomar som kan leda till både förkortad förväntad livslängd och socioekonomiska konsekvenser. Semaglutid är en glukagonliknande peptid-1 receptoragonist (GLP-1RA) som godkändes för behandling av fetma och viss övervikt av Europeiska unionen år 2022. Precis som kroppsegen glukagonliknande peptid-1 (GLP-1) stödjer semaglutid glukoshomeostas genom att både stimulera insulinproduktionen och hämma glukagonutsöndring. Semaglutid bidrar även till minskade hungerkänslor och ökad mättnadskänsla. Denna litteraturstudie har undersökt forskningsresultat gällande förväntad behandlingstid vid behandling av övervikt och fetma med veckovis subkutan semaglutid 2,4 mg; en kortare kur med semaglutid som följs av fortsatta livsstilsförändringar för att bibehålla önskad vikt, eller livslång farmakologisk behandling. Utvalda studier har varit kopplade till de randomiserade, dubbelblinda kliniska studierna ”Semaglutide Treatment Effect in People with obesity” (STEP) som undersökte procentuell viktnedgång och där livsstilsförändring i form av 150 min rörelse per vecka, 500 kalorier minskat dagligt kaloriintag samt uppföljningssamtal kombinerades med behandling med veckovis subkutan 2,4 mg semaglutid.  Samtliga studier, som undersökte förändring av vikt, gav trots skillnader i studiernas längd och andra parametrar likvärdiga effektkurvor som planade ut runt 15 % jämfört med omkring 2-6 % genomsnittlig viktreduktion för placebo. Efter 20 veckor sågs 10,6 % genomsnittlig viktnedgång, efter 68 veckor cirka 15 % och 104 veckors behandling med semaglutid gav inte ytterligare procentuell viktnedgång. Inte heller intensiv beteendeterapi eller inledande lågkalorikost bidrog till ökad viktnedgång. Däremot visade en av studierna en statistiskt signifikant förbättrad upplevd kontroll av begär efter mat och begär efter salta livsmedel för den grupp som behandlades med semaglutid.  Vid avbruten behandling återgick vikten till ungefär – 5% av ursprungsvikten efter 48-52 veckor utan semaglutid, oavsett om livsstilsförändringar bibehölls eller ej. Utifrån undersökta studier av subkutan semaglutid 2,4 mg går det inte att dra slutsatsen att en kortare behandlingskur åtföljs av en bestående viktminskning, inte ens i de fall där semaglutid ersätts med fortsatt icke-farmakologisk behandling i form av ökad rörelse, minskat kaloriintag samt kontinuerliga stödsamtal.  Fler långtidsstudier kring effekt och biverkan behövs, men rapporterad biverkan är framför allt lindrig och övergående, kardiometabola parametrar indikerar en förbättring jämfört med placebo men försämring vid avbruten behandling. Detta och en bibehållen viktnedgång där det för nästan 70 % leder det till minst 10 % viktminskning och närmare 35 % får minst 20 % bestående viktminskning är en anledning till att se positivt till möjlig livslång behandling med subkutan semaglutid 2.4 mg.

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.

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.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / In hospitals, when the pharmaceutical incorporates in your routine the clinical practice, several barriers and facilitators influencing the establishment of Clinical Pharmacy Services. One of the criteria that favor the successful implementation of innovative practices is to understand the perceptions of professionals involved in the practice as well as environmental analysis and qualification of these professionals. Objectives: Understand the perception of a group of pharmacists and key informants on the implementation of clinical pharmacy services in a public hospital of high complexity; analyze the structure (physical and pharmaceutical communication abilities) exists for the development of Clinical Pharmacy services in this institution. Methodology: The first stage corresponds to a qualitative study, which was conducted a focus group with 16 pharmaceutical and interviews with professional managers of pharmaceutical classes (2), nursing (1) and health (1). The data analysis was performed by the content analysis technique. In the second stage was carried the evaluation of the structure to the provision of clinical pharmacy services at the hospital. To analyze the physical structure was used an instrument elaborated based on the ordinance 4,283 / 10 from the Ministry of Health and the Canadian accreditation quality indicators. The pharmaceutical communication abilities were evaluated using the adapted instrument "Assessment of pharmaceutical care process." Results: Stage 1- The perception of pharmacists and other professionals brought topics such as the outdating of the pharmaceutical profession, the resistance of some professionals and difficulties in communicating the multidisciplinary team. Also listed were facilitators for the service and the experience of some professionals in the Clinical Pharmacy services as well as the expectations were related to the improvement in the rational drug use process. Stage 2 - The evaluation of the physical structure was considered inadequate for Clinical Pharmacy services in most of the items evaluated. Inadequacies were found in the location of pharmacies in the hospital and private environment to the pharmaceutical care service, as well as in normative and organizational instruments of pharmacies. In relation to communication abilities, the overall impression of the pharmacist's responsibilities to the Clinical Pharmacy Services was considered regular (3) on a scale of 1-5 the instrument used. Conclusion: The analysis of the perception of participants allow the knowledge of factors such as barriers and facilitators that may influence the implementation of Clinical Pharmacy Services. In the evaluation of the structure important indicators for the development of pharmaceutical services were considered non-conforming to the instrument, which can hamper the clinical practice of pharmacists. Regarding pharmaceutical communication skills, the results indicate difficulties of interaction with the patient as well as other professionals. In this perspective, these results can guide planning for implementation of Clinical Pharmacy in hospitals. / Em hospitais, no momento em que o farmacêutico incorpora a prática clínica em sua rotina, várias barreiras e facilitadores influenciam a implantação dos serviços de Farmácia Clínica. Um dos critérios que favorecem o sucesso da implantação de práticas inovadoras é a compreensão da percepção dos profissionais envolvidos na prática, bem como a análise do ambiente e a qualificação destes profissionais. Objetivos: Compreender a percepção de um grupo de farmacêuticos e de informantes-chave sobre a implantação dos serviços de farmácia clínica em um hospital público de alta complexidade; analisar a Estrutura (física e habilidades de comunicação dos farmacêuticos) existente para o desenvolvimento dos serviços de Farmácia Clínica nesta instituição. Metodologia: A primeira etapa correspondeu a um estudo qualitativo, no qual foram realizados um grupo focal com 16 farmacêuticos e entrevistas com profissionais gestores das classes farmacêutica (2), enfermagem (1) e médica (1). A análise dos dados foi feita por meio da técnica de análise de conteúdo. Na segunda etapa foi realizada a avaliação da Estrutura para a prestação dos serviços de Farmácia Clínica no hospital. Para análise da estrutura física foi utilizado um instrumento elaborado com base na portaria 4.283/10 do Ministério da Saúde e nos indicadores de qualidade da acreditação canadense. As habilidades de comunicação dos farmacêuticos foram avaliadas por meio do instrumento adaptado “Avaliação do processo de atendimento farmacêutico”. Resultados: Etapa 1- A percepção dos farmacêuticos e outros profissionais trouxe temas como a desatualização da profissão farmacêutica, resistência de alguns profissionais e dificuldades na comunicação da equipe multiprofissional. Além disso foram elencados facilitadores para o serviço como a experiência de alguns profissionais com os serviços de Farmácia Clínica, bem como expectativas que estavam relacionadas à melhora no processo de uso racional do medicamento. Etapa 2 – A avaliação da estrutura física foi considerada inadequada para os serviços de Farmácia Clínica na maioria dos itens avaliados. Foram verificadas inadequações na localização das farmácias no hospital e no ambiente reservado ao serviço de assistência farmacêutica, bem como nos instrumentos normativos e organizacionais das farmácias. Em relação às habilidades de comunicação, a impressão geral sobre as competências do farmacêutico para os serviços de Farmácia Clínica foi considerada regular (3) em uma escala de 1-5 do instrumento utilizado. Conclusão: A análise da percepção dos participantes do estudo qualitativo permitiu o conhecimento de fatores, como barreiras e facilitadores, que poderão influenciar a implantação dos serviços de Farmácia Clínica. Na avaliação da estrutura indicadores importantes para o desenvolvimento da Assistência Farmacêutica foram considerados em não conformidade no instrumento, o que podem dificultar a prática clínica dos farmacêuticos. Em relação às habilidades de comunicação dos farmacêuticos, os resultados indicam dificuldades de interação com o paciente e também como outros profissionais. Nesta perspectiva, estes resultados podem direcionar planejamentos para implantação da Farmácia Clínica em hospitais.

Background: There is a widespread and increasing use of psychoactive prescription drugs, such as opioid analgesics, anxiolytics, hypnotics and anti-epileptics, but their use is associated with a risk of drug use disorder, misuse and abuse. Today, these are globally recognized and emerging public health concerns. Aim: The aim of this thesis is to estimate the prevalence of psychoactive prescription drug (PPD) use disorders, misuse and abuse, and to investigate the association with some potential risk factors. Methods: A study using register data from forensic cause of death investigations investigated and described cases of fatal unintentional intoxication with tramadol (Study I). Based on register data on spontaneously reported adverse drug reactions (ADRs) reported cases of tramadol dependence were investigated and summarised (Study II). In a study in suspected drug-impaired drivers with a toxicology analysis confirming the intake of one out of five pre-specified PPDs, the prevalence of non-prescribed use was assessed and associated factors were investigated (Study III). From a cohort of patients initiating prescribed treatment with pregabalin, using data on prescription fills, a study investigated longitudinal utilisation patterns during five years with regards to use of the drug above the maximum approved daily dose (MAD), and factors associated with the utilisation patterns (Study IV). Results: In the first study, 17 cases of unintentional intoxications were identified, of which more concerned men, the median age was 44 years and the majority used multiple psychoactive substances (alcohol, illicit drugs and prescription drugs). The second study identified 104 spontaneously reported cases of tramadol dependence, in which more concerned women, the median age was 45 years, and a third reported a history of substance abuse and 40% of past psychoactive medication use. In the third study, more than half of the individuals suspected of drug-impaired driving used the drug without a recent prescription. Non prescribed use was most frequent in users of benzodiazepines and tramadol, and was more likely in younger individuals and in multiple-substance users. In the last paper five longitudinal utilisation patterns were found in pregabalin users, with two patterns associated with a particularly high risk of doses above the maximum approved dosing recommendation. This pattern of use was associated with male sex, younger age, non-urban residency and a recent prescribed treatment with an antiepileptic or opioid analgesic drug. Conclusions: This thesis shows that psychoactive prescription drug use disorders, misuse and abuse occur and may have serious and even fatal consequences. The prevalence varies between different drugs and populations. Abuse and misuse seem to be more common in young people. Fatal intoxications and misuse of prescribed drugs may be more common in men, while drug use disorders following prescribed treatment may be more common in women and non-prescribed use equally distributed between women and men. Individuals with a history of mental illness, substance use disorder or abuse, or of past use of psychoactive medications are likely important risk groups. In summary, the findings suggest a potential for improvements in the utilisation of psychoactive prescription drugs. The results may be useful in the planning of clinical and regulatory preventive interventions to promote the rational, individualised and safe use of such drugs.

Sammanfattning Sedan sjukdomen Covid-19s uppdykande i början av 2020 har forskning pågått för att karaktärisera sjukdomen ur alla tänkbara vinklar för att på kortast möjliga tid bereda väg för ett fungerande botemedel. Effektiva läkemedel som kan minska risken för allvarligt sjuka patienter att avlida i sjukdomen behövs; många preparat har föreslagits och testats och i Sverige har hittills två läkemedel godkänts för Covid-19. Ett av dessa är kortikosteroiden dexametason som godkänts för Covid-19-patienter i behov av syrgas eller respirator. Syftet med detta arbete var att undersöka hur effektiv kortikosteroidbehandling av svårt sjuka Covid-19-patienter var i jämförelse med standardbehandling utan kortikosteroider. En litteratursökning gjordes i PubMed och i covid-nma efter randomiserade kliniska studier av kortikosteroider jämfört med standardbehandling till patienter med Covid-19. Ur resultatet som inkluderade 7 kontrollerade studier med 7784 svårt sjuka patienter från 11 länder och fem kontinenter, gjordes en sammanvägning av den primära utfallsvariabeln mortalitet 28 dagar efter randomisering varpå relativ risk (RR) räknades ut individuellt per studie och sammanvägt för alla studier. Analysen gjordes också med den mest dominanta studien borträknad. Vidare utforskades möjliga samband mellan sjukdomsgrad och effektstorlek, dels genom ett försök till metaregression av studiemortalitet och andningshjälpsnivå mot RR som var inkonklusivt, men också genom att leta efter speciellt sjuka undergrupper i studierna. 3 studier rapporterade mortalitet efter 28 dagar, 1 studie rapporterade mortalitet efter 21 dagar, 2 studier rapporterade död på sjukhus och en studie rapporterade död efter 15 dagar. Testade preparat var dexametason, hydrokortison och metylprednisolon. Av 2885 patienter som randomiserats till någon kortikosteroid, dog 739, medan det av de 4899 som randomiserats till standardbehandling dog 1347 patienter vilket gav en icke signifikant RR på 0,93 (95% CI 0,86–1,01). Vid borträkning av den största studien som bestod av relativt friskare patienter erhölls en starkare och signifikant effekt med RR 0,80 (95% CI 0,70–0,92) baserat på 257 av 781 döda i steroidgrupperna jämfört med 237av 578 döda i någon kontrollgrupp med standardbehandling. Resultatet var även i linje med analysen av olika sjuka undergrupper från största studien som visade bäst effekt hos de med invasiv mekanisk andningshjälp (absolut riskreduktion 12,1%) samt en icke signifikant försämring hos de friskaste patienterna utan syrgasbehov. Sammantaget tyder dessa resultat på att behandling av svårt sjuka Covid-19-patienter med kortikosteroider minskar mortaliteten efter 28 dagar. Dessutom ger studien en stark indikation på att bästa effekten fås om kortikosteroiderna ges till patienter där den systemiska inflammationen i lungorna nått en gasutbyteshämmande nivå / ABSTRACT Since the emergence of the new corona virus disease, Covid-19, much research effort has gone into characterising every possible angle of the disease to pave the way for a possible cure in the shortest possible time. Effective therapies are needed that will reduce the risk of dying for severely to critically ill Covid-19 patients. Many existing therapies have been suggested, tested and repurposed for the treatment of Covid-19 but so far only two drugs have been approved in Sweden for this indication, namely the antiviral drug remdesivir and the corticosteroid dexamethasone. Corticosteroids are both immunosuppressive and anti-inflammatory and when they were administered previously for severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and influenza they were found to increase the time to rid the body of virus. The purpose of this study was to investigate evidence found in the research literature of how effective corticosteroids are in reducing the risk of dying as compared to standard treatment with no corticosteroids when administered to hospitalised patients with severe Covid-19. A literature search was made in the PubMed and covid-nma databases for randomized clinical studies of corticosteroids versus standard treatment to patients with Covid-19. The result included 7 studies with 7784 patients from 11 countries and 5 continents which all reported death as an outcome in groups that were receiving corticosteroids compared to groups that were receiving standard care. The studies used one of the following corticosteroids as intervention: dexamethasone, methylprednisolone and hydrocortisone in different doses. In the groups receiving standard care, 1347 patients out of 4899 died while in the corticosteroid groups 739 of 2885 patients died. When doing a statistical calculation these figures indicated that the risk of dying when getting corticosteroids was 93% of the risk when not getting corticosteroids, however the difference was not statistically significant. After omitting the largest study from the material, that contributed the absolute majority of total participants, who were deemed relatively healthy or well taken care of, the results were instead that 257 out of 781 died in the steroid groups and 237 of 578 died in the control groups. This later comparison among supposedly sicker patients, gave a statistically significant 8,1% lower absolute risk of dying in the corticosteroid groups; an effect that could also be expressed as for every 25 patients treated, 2 more lives would be saved. A further control of a more severely sick subgroup of patients from the largest study, in need of invasive mechanical ventilation, revealed an absolute reduction of the risk of dying when given corticosteroids of 12,1%. This group showed the most effectful response to the administered corticosteroids in this study which could also be expressed as 1 more life saved for every 8 patients treated. Another sub group analysis of the patients from the largest study that were not in need of any type of oxygen support, indicated on the other hand a possible harm of corticosteroids. This potentially harmful effect was however not statistically significant. In summary, the results of this study imply that administration of corticosteroids to patients with severe Covid-19 will reduce the risk of dying. The greatest effect is seen in those patients that has reached a level of illness were the gas exchange in the lungs is impaired by the inflammation. Furthermore, caution must be taken not to introduce harm by giving corticosteroids to patients with milder disease in which the immunosuppressive properties of the drug could lead to unintended worsening of the illness.

La transition du patient entre les secteurs de soins est une période à haut risque de discontinuité de la prise en charge médicamenteuse. Les problèmes liés aux médicaments spécifiquement rencontrés résultent principalement de différences non expliquées entre les traitements médicamenteux documentés aux niveaux des différents sites de soins et/ou des différents professionnels de la santé, également appelés discordances médicamenteuses médicalement non justifiées. Leur survenue peut entrainer des préjudices pour le patient mais aussi une utilisation accrue des services de soins de santé et par conséquent une augmentation des coûts. <p><p>Dans ce contexte, la première partie de ce travail est consacrée à la mise au point d’un instrument valide et fiable permettant de caractériser les discordances médicamenteuses médicalement non justifiées lors de la sortie de l’hôpital. Il s’avère particulièrement bien approprié pour la recherche ou pour la familiarisation à la problématique. La deuxième partie de ce travail a permis de mettre en œuvre cet outil dans une situation clinique réelle. Une étude prospective d’observation incluant des patients recevant les soins usuels (groupe contrôle) et des patients pris en charge par des pharmaciens cliniciens (groupe intervention) a été réalisée. L’intervention des pharmaciens cliniciens comportait la réalisation d’une conciliation médicamenteuse à l’admission et à la sortie de l’hôpital. La conciliation médicamenteuse est un processus structuré pendant lequel le professionnel de santé collabore avec le patient, la famille et les proches pour s’assurer qu’une information correcte et exhaustive sur les médicaments est communiquée lors de la transition du patient entre les secteurs de soins. Elle consiste en la vérification (collecte d’un historique médicamenteux correct et l’identification des discordances médicamenteuses), la clarification (s’assurer que les médicaments et la posologie sont appropriés), la conciliation (documentation de chaque changement de médicament et éducation du patient à ce sujet) et finalement le transfert d’information aux autres professionnels de santé. Les résultats montrent que l’intervention des pharmaciens cliniciens diminue le risque de discordances médicamenteuses médicalement non justifiées après la sortie de l’hôpital. De plus, la satisfaction des patients vis à vis de l’information sur les médicaments prescrits à la sortie est significativement plus élevée dans le groupe pris en charge par le pharmacien clinicien. Cependant, aucun impact n’a été montré sur l’utilisation des services de soins (visites aux urgences et réadmission à l’hôpital) dans le mois après la sortie. Finalement, la dernière partie de ce travail a permis de développer une information sur les médicaments destinée aux pharmaciens d’officine à la sortie de l’hôpital du patient. Une étude prospective a évalué l’effet de la remise de cette information, dénommée feuille de transfert, par le pharmacien clinicien au patient. Une enquête en ligne ouverte à tous les pharmaciens d’officine a par ailleurs évalué leurs besoins en information. Il a été observé que la communication d’une feuille de transfert contenant des informations sur le traitement médicamenteux à la sortie de l’hôpital présente un réel intérêt pour le pharmacien d’officine. Ces informations vont en effet au-delà des informations retrouvées sur une prescription médicale. Néanmoins, la feuille de transfert devrait inclure davantage d'informations nécessaires pour la réalisation des soins pharmaceutiques. <p><p>En conclusion, ce travail a permis de développer, d’une part, un nouvel outil de détection et de classification des discordances médicamenteuses médicalement non justifiées et d’autre part, un modèle de pratique qui a montré son efficacité sur la continuité des traitements médicamenteux lors de la sortie des patients de l’hôpital à leur domicile, en maison de repos et en revalidation. Toutefois, des perspectives d’amélioration de ce modèle ont été mises en évidence et mériteraient une attention particulière dans le futur. / Doctorat en Sciences biomédicales et pharmaceutiques / info:eu-repo/semantics/nonPublished

Introduction: Incident reporting systems have been implemented in health care for over a decade and contain reports of critical incidents (CI). These must be analyzed in order to suggest, implement and evaluate solutions for minimizing the risk of future CIs to occur, thereby increasing patient safety. Drug-related CIs (DRCI) are one type of CI which may represent up to 1/3rd of all CIs, therefore this CI-type is characterized in this study. Aim: To categorize and characterize DRCIs reported in the Critical Incident Reporting System North Rhine-Westphalia (CIRS-NRW). Materials &amp; Methods: In this explorative, retrospective, descriptive study, 553 reports from the CIRS-NRW, reported between the 1st of January 2019 and the 15th of September 2021, were analyzed. These were categorized by setting, medication use process stage, ATC-code, patient age and look-alike, sound-alike (LASA), and then analyzed via descriptive statistics. Various subgroup analyses were also conducted. Results: DRCIs occurred mostly in the hospital (48,5%) and pharmacy (40,7%) settings, during the prescribing (33,8%) and administration (33,5%) of drugs and the ATC-codes N02 (9,4%), B01 (6,9%) and N05 (5,4%) were commonly involved. Patient age contained &gt;50% missing data and LASA was involved in 16,5% of DRCIs. Subgroups were often small, likely resulting in low statistical power. Conclusion: By successfully characterizing the DRCIs, some potential areas of improvement for reducing future DRCIs were highlighted, however there are many more variables of relevance for patient safety than those analyzed in this study, underlining the need for further studies characterizing more DRCIs including additional variables.