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OBJECTIVE: The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. METHODS: Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs' relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). RESULTS: Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. CONCLUSION: This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.
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Asma , Consenso , Técnica Delphi , Medidas de Resultados Relatados pelo Paciente , Humanos , Asma/terapia , Asma/tratamento farmacológico , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Índice de Gravidade de Doença , Inquéritos e Questionários , Qualidade de Vida , IdosoRESUMO
Atopic dermatitis is a cutaneous inflammatory disease characterized by intense pruritus, which is often underestimated despite its direct impact on patients' health-related quality of life and the high burden it poses. The authors' goal was to design a qualitative tool to guide patients and healthcare professionals in their assessment and interpretation of pruritus intensity using a numerical rating scale. The draft of this tool, henceforth "guideline", was developed based on a systematic literature review and focus groups comprising patients and a scientific committee. This draft was validated with an independent group of patients and the final version was designed following their feedback. According to the results of the systematic review, pruritus impacts 6 health-related quality of life domains: sleep quality; emotional status; overall health-related quality of life; physical function; social/sexual activity; productivity, particularly affecting sleep quality and the emotional domain. Patients considered that physical function was the most strongly affected domain, followed by sleep quality and emotional well-being, establishing that a minimum pruritus intensity of 4 and 7 points impacts moderately and severely, respectively, on the different domains of patients' health- related quality of life. The guideline may help patients and healthcare professionals to interpret and assess pruritus intensity using a numerical rating scale and to understand the impact of pruritus on patients' health-related quality of life.
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Dermatite Atópica , Prurido , Qualidade de Vida , Índice de Gravidade de Doença , Humanos , Prurido/psicologia , Prurido/diagnóstico , Prurido/etiologia , Prurido/fisiopatologia , Dermatite Atópica/psicologia , Dermatite Atópica/complicações , Dermatite Atópica/diagnóstico , Sono , Emoções , Feminino , Masculino , Reprodutibilidade dos Testes , Adulto , Grupos Focais , Valor Preditivo dos Testes , Pesquisa Qualitativa , Efeitos Psicossociais da Doença , Inquéritos e Questionários , Pessoa de Meia-IdadeRESUMO
The introduction of direct-acting antivirals (DAA) and the implementation of the National Strategic Plan has extended the spectrum of patients suitable for treatment to include practically all affected individuals. There has been a change in patient profile. Most patients are previously untreated, with lesser awareness of the disease, and taking polymedication, and are often under treatment with opioid replacement therapy, are active drug users or have psychiatric comorbidities. This article reviews the most important factors determining the degree of treatment adherence, in particular, drug therapy complexity, the adverse effects of DAA, demographic factors (age, ethnic group, sex, educational level, marital status) and psychosocial factors (beliefs, motivation to take therapy and negative attitude to therapy), as well as the doctor-patient relationship, knowledge/awareness of the disease, and finally comorbidities and drug abuse or abuse of other substances such as alcohol. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier España, S.L.U. All rights reserved.
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Antivirais/uso terapêutico , Hepatite C/tratamento farmacológico , Adesão à Medicação , Antipsicóticos/uso terapêutico , Antivirais/efeitos adversos , Ensaios Clínicos como Assunto , Comorbidade , Usuários de Drogas , Humanos , Tratamento de Substituição de Opiáceos , PolimedicaçãoRESUMO
OBJECTIVE: The aim of this study was to establish guidelines for the optimization of biologic therapies for health professionals involved in the management of patients with RA, AS and PsA. METHODS: Recommendations were established via consensus by a panel of experts in rheumatology and hospital pharmacy, based on analysis of available scientific evidence obtained from four systematic reviews and on the clinical experience of panellists. The Delphi method was used to evaluate these recommendations, both between panellists and among a wider group of rheumatologists. RESULTS: Previous concepts concerning better management of RA, AS and PsA were reviewed and, more specifically, guidelines for the optimization of biologic therapies used to treat these diseases were formulated. Recommendations were made with the aim of establishing a plan for when and how to taper biologic treatment in patients with these diseases. CONCLUSION: The recommendations established herein aim not only to provide advice on how to improve the risk:benefit ratio and efficiency of such treatments, but also to reduce variability in daily clinical practice in the use of biologic therapies for rheumatic diseases.
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Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Produtos Biológicos/efeitos adversos , Relação Dose-Resposta a Droga , HumanosAssuntos
Fator VIII/farmacologia , Fator VIII/farmacocinética , Hemofilia A/complicações , Hemorragia/complicações , Hemorragia/prevenção & controle , Sacarose/química , Adolescente , Adulto , Criança , Estudos Transversais , Composição de Medicamentos , Fator VIII/química , Feminino , Hemofilia A/metabolismo , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Psoriatic arthritis (PsA) is a complex, progressive, and often debilitating disease. Despite recent advances in treatment, numerous unmet needs in patient care persist. Rheumacensus is a multistakeholder, pan-European initiative designed to identify ways to elevate the standard of care (SoC) and treatment ambition for patients with PsA, using the perspectives of three key stakeholder groups: patients, healthcare professionals (HCPs) and payors. METHODS: Rheumacensus followed three phases: an insights-gathering workshop to identify current unmet needs in PsA and an area of focus for the project, a modified Delphi process to gain consensus on improvements within the agreed area of focus, and a Consensus Council (CC) meeting which used consensus statements as inspiration to generate 'Calls to Action' (CTA)-practical measures which, if implemented, could elevate the SoC for patients with PsA. RESULTS: The Rheumacensus CC consisted of four patient representatives, four HCPs and four payors. All 12 members completed all three Delphi e-consultations. The shared area of focus that informed the Delphi process was "patient empowerment through education on the disease and treatment options available, to enable patient involvement in management". Four key themes emerged from the Delphi process: patient empowerment, patient knowledge and sources of education, patient-HCP consultations, and optimal initial treatment. Statements within these themes informed 12 overarching CTA, which focus on the need for a multistakeholder approach to implementing a paradigm shift towards patient-centred care and improved outcomes for patients with PsA. CONCLUSION: Rheumacensus has identified shortcomings in the current SoC for patients with PsA and provides a foundation for change through practical CTA. It is hoped that all stakeholders will now take practical steps towards implementing these CTA across Europe to elevate the SoC for patients with PsA.
Inequalities in the care patients with psoriatic arthritis (PsA) receive can be mainly explained by poorly coordinated management due to a lack of disease and treatment knowledge. This report is about a programme called Rheumacensus which has the overall aim of improving the standard of care (SoC) for patients with PsA. Rheumacensus brings together the points of view of three key groups involved in the care of people with PsA: patients, payors and healthcare professionals (HCPs) from across Europe. Together, these three groups agreed to focus on patient empowerment through education on the disease and treatment options as a way to raise the SoC. Through a series of exercisesto agree on the current SoC and what needs to be improvedand group discussions, four themes were established which were used by the groups to help them suggest 'Calls to action' (CTA). The CTAs were ideas of how improvements could be made or what needs to be done to improve the care patients receive. The four themes were (1) patient empowerment, (2) patient knowledge, (3) patientHCP consultation and (4) optimal initial treatment. In total, 12 CTAs were developed across these themes that provide direction and practical next steps which patients, payors and HCPs could take to drive change and make a real difference to patients by improving their care.
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Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, "Guía de entrevista telemática en atención farmacéutica," as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews. The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment. Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.
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Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Entrevistas como Assunto , Consenso , Monitoramento de Medicamentos/métodos , Sistemas de Liberação de Medicamentos , FarmacêuticosRESUMO
Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, Guía de entrevista telemática en atención farmacéutica, as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews. The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment. Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.
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Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Entrevistas como Assunto , Sistemas de Liberação de Medicamentos , FarmacêuticosRESUMO
OBJECTIVE: To describe, analyze and compare the situation of pharmaceutical care consultations for outpatients with immune-mediated inflammatory diseases of the Pharmacy Services of Spain at two different times. METHOD: Longitudinal, multicenter and unidisciplinary descriptive observational study, carried out by the Immune-mediated Inflammatory Diseases Working Group of the Spanish Society of Hospital Pharmacy through a virtual survey in 2019 and 2021. Variables were collected regarding coordination, resources, biosimilars, unmet needs and telepharmacy. Numerical results were presented in absolute value and percentage and free text responses were grouped by topic areas. To compare the results between the two collection times, the Chi-Square test was used with a significance level of p<0.05. RESULTS: The level of participation was 70 pharmacists in 2019 and 53 in 2021. The main significant findings obtained were an increase in participation in asthma biologic committees (p=0.044) and care coordination in dermatology (p=0.003) and digestive system (p=0.022). The wide use of biosimilar biological medicines stood out, with a 15% increase in the exchange of the reference biological to the biosimilar. The lack of research in the field and insufficient human resources, among other unmet needs, were revealed. In the outpatient units, the use of the stratification model of the MAPEX project was a minority and an increase in the use of information and communication technologies was promoted. Motivated by the pandemic derived from COVID-19, telepharmacy was established for the first time in 85% of the centers, maintaining the service at 66% at the time of the second survey. CONCLUSIONS: Outpatient units are undergoing constant change to adapt to new times, for which institutional support is needed to invest more resources to promote the development of strategies to reduce unmet needs. We must continue working to achieve a pharmaceutical practice that provides efficiency, safety, quality of life and access to innovative drugs in patients with immune-mediated inflammatory diseases.
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BACKGROUND: Hereditary angioedema due to C1 inhibitor deficiency (HAE-C1INH) is a genetic rare disease characterized by recurrent, transient and unpredictable episodes of cold, non-pruriginous oedema without associated urticaria. The characteristics of the disease have a considerable impact on the quality of life of patients. The aim of this study was to increase understanding of the patient journey of HAE in Spain. METHODS: A multidisciplinary committee of 16 HAE experts (allergy, immunology, emergency department, hospital pharmacy and nursing) and 3 representatives of the Spanish Hereditary Angioedema Patient Association (AEDAF) who were patients or caregivers participated in the study. A review of the publications on HAE treatment was performed. Semi-structured interviews were performed to HAE experts, patients, or caregivers. Three meetings with the experts, patients and caregivers were held to share, discuss, and validate data obtained from literature and interviews and to build the model. RESULTS: Throughout the project, the patient journey has been drawn up, dividing it into the stages of pre-diagnosis, diagnosis and treatment/follow-up. Some areas for improvement have been identified. Firstly, there is a need to enhance awareness and training on HAE among healthcare professionals, with a particular emphasis on primary care and emergency department personnel. Secondly, efforts should be made to minimize patient referral times to allergy/immunology specialists, ensuring timely access to appropriate care. Thirdly, it is crucial to encourage the study of the relatives of diagnosed patients to early identify potential cases. Fourthly, equitable access to self-administered treatments should be ensured, facilitated by systems that enable medication delivery at home and proper education and training for patients. Equitable access to long-term prophylactic treatment should also be prioritized for all patients in need. To standardize HAE management, the development of consensus guidelines that reduce variability in clinical practice is essential. Lastly, promoting research studies to enhance knowledge of the disease and align its treatment with new developments in the healthcare field should be encouraged. CONCLUSIONS: The knowledge of the patient journey in HAE allowed us to identify improvement areas with the final aim to optimize the disease management.
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Angioedemas Hereditários , Humanos , Angioedemas Hereditários/diagnóstico , Angioedemas Hereditários/terapia , Espanha , Qualidade de Vida , Feminino , MasculinoRESUMO
OBJECTIVE: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use. METHODS: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. RESULTS: The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. CONCLUSIONS: Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability.
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Medicamentos Biossimilares , Humanos , Espanha , Medicamentos Biossimilares/uso terapêuticoRESUMO
OBJECTIVE: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. METHOD: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: (1) First visit, which included general patient data and data from the first treatment; (2) follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; (3) telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; (4) non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, 2 rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability". RESULTS: Forty-eight hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi, the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the 2 rounds of the Delphi, there were 2 that, based on utility, the participants did not reach consensus for inclusion in the checklist: the one referring to "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on "Relaxation". No consensus was reached on their applicability for 2 of the items: "Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model" and "Collection of Results Reported by the Patient". CONCLUSIONS: The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach where the hospital pharmacist plays a key role, especially, although not only, in monitoring drug treatment. We believe that this checklist can contribute from pharmaceutical care to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotic drugs.
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Doenças Pulmonares Intersticiais , Assistência Farmacêutica , Humanos , Consenso , Lista de Checagem/métodos , Doenças Pulmonares Intersticiais/tratamento farmacológico , Farmacêuticos , Técnica DelphiRESUMO
BACKGROUND: Inhaled antibiotics have achieved or stabilised the clinical condition of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. We aimed to determine the effectiveness of aztreonam lysine inhaled solution (AZLI) in patients with CF and chronic P. aeruginosa infection. METHODS: A retrospective observational study was conducted on patients with CF and chronic P. aeruginosa infection who received AZLI between July 2012 and September 2018 inclusive in three Spanish hospitals in a routine clinical practice setting. The primary endpoint was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) compared with the previous 12 months, at the start of AZLI treatment and 12 months after starting the drug. Other variables analysed were exacerbations, hospitalisations, type and route of antibiotics prescribed, weight and body mass index (BMI) and adverse drug reactions. RESULTS: In a cohort of 52 patients, AZLI treatment led to stabilisation of FEV1, changing from a mean (SD) value of 55.60 (21.3)% at the start of treatment to 56.8 (20.4)% after 12 months of treatment (p=0.5296) in patients who had not previously received the drug. In addition, it significantly reduced exacerbations from a median (P25; P75) of 2.0 (1.0; 3.0) in the 12 months prior to AZLI to 1.0 (1.0; 2.0) in the 12 months after treatment initiation (p=0.0350). AZLI also reduced the need for other antibiotics and prevented a decrease in BMI, with an adequate safety profile. CONCLUSIONS: AZLI achieved stabilisation of lung function measured by FEV1 in patients with CF and chronic P. aeruginosa infection, along with an adequate safety profile.
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OBJECTIVE: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. METHOD: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: 1) First visit, which included general patient data and data from the first treatment; 2) Follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; 3) Telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; 4) Non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, two rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability". RESULTS: 48 hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the two rounds of the Delphi, there were two that, based on utility, the participants did not reach consensus for inclusion in the checklist: The one referring to "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on "Relaxation". No consensus was reached on their applicability for two of the items: "Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model" and "Collection of Results Reported by the Patient". CONCLUSIONS: The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach where the hospital pharmacist plays a key role, especially, although not only, in monitoring drug treatment. We believe that this checklist can contribute from pharmaceutical care to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotic drugs.
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Doenças Pulmonares Intersticiais , Assistência Farmacêutica , Humanos , Consenso , Lista de Checagem , Doenças Pulmonares Intersticiais/tratamento farmacológico , Farmacêuticos , Técnica DelphiRESUMO
OBJECTIVE: To update and define indicators for improving the quality of care and Pharmaceutical Care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of Pharmaceutical Care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.
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Infecções por HIV , Serviço de Farmácia Hospitalar , Humanos , Infecções por HIV/tratamento farmacológico , HIV , Consenso , Qualidade da Assistência à Saúde , Indicadores de Qualidade em Assistência à Saúde , Técnica DelphiRESUMO
OBJECTIVE: To update and define indicators for improving the quality of care and pharmaceutical care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of pharmaceutical care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.
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Infecções por HIV , Serviço de Farmácia Hospitalar , Humanos , Infecções por HIV/tratamento farmacológico , HIV , Consenso , Qualidade da Assistência à Saúde , Indicadores de Qualidade em Assistência à Saúde , Técnica DelphiRESUMO
To evaluate the reasons for changing to monotherapy with protease inhibitors, together with the proportion and reasons for the interruption to treatment, in patients who have been treated at some point with cobicistat-boosted darunavir (DRV/c). Outpatients in a tertiary hospital. Observational retrospective study to evaluate monotherapy with DRV/c (800 mg/150 mg) in adult patients with human immunodeficiency virus infection, from December 2014 to July 2022. Demographic variables, viral load, cluster of differentiation 4 lymphocyte lymphocyte count, and antiretroviral therapy were assessed. 42 patients were included. 36% of the patients were undergoing monotherapy at the time of the analysis. The main reason for discontinuation was poor adherence. At time of analysis, 80% of the patients in monotherapy had an undetectable viral load. Antiretroviral therapy recommendations advise against exposing the patient to functional monotherapy with a single drug due to the high risk of virological failure and the onset of resistance to a single drug. Following the analysis of the results, DRV/c in monotherapy is not an effective strategy in the medium and long term due to factors such as lack of adherence or virological failure, although it can be maintained in specific circumstances. Therefore, patients undergoing monotherapy require close monitoring.
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Fármacos Anti-HIV , Infecções por HIV , Inibidores da Protease de HIV , HIV-1 , Adulto , Humanos , Darunavir/uso terapêutico , Darunavir/efeitos adversos , Inibidores da Protease de HIV/uso terapêutico , Inibidores da Protease de HIV/efeitos adversos , Estudos Retrospectivos , Ritonavir/uso terapêutico , Cobicistat/uso terapêutico , Cobicistat/efeitos adversos , Infecções por HIV/tratamento farmacológico , Carga ViralRESUMO
OBJECTIVE: Telepharmacy, as a complementary activity to face-to-face pharmaceutical care in a Hospital pharmacy service, must have specific activity, effectiveness and quality indicators. The objectives of the project were to design a scorecard of activity, effectiveness and quality indicators that will make it possible to assess the situation and progress of Telepharmacy and enable continuous improvement. A tool is also provided to measure the indicators, and some recommendations are given for its implementation. METHOD: The project, led by a panel of expert pharmacists, was developed in 2021 in four phases: a literature review, preliminary identification of quality criteria and indicators, evaluation of indicators, adjustment of the proposal and definition of priority indicators, and drafting of descriptive files, as well as the development and validation of a scorecard. The indicators were prioritized based on their appropriateness, usefulness, relevance and feasibility. Finally, the scorecard was submitted for evaluation by the members and Patient Committee of the Spanish Hospital Pharmacy Society. RESULTS: The resulting scorecard consists of 50 indicators grouped into five areas: General aspects (18); pharmacotherapeutic follow-up (12); home drug delivery (15); patient information and education (2); and coordination with the care team (3). A total of 31 were considered priority or essential indicators, which are initially recommended for the implementation of a Telepharmacy program. In contrast, 15 are general indicators, including measurement of patient and professional satisfaction; 6 indicators refer to pharmacotherapeutic follow-up; 1 is related to patient information and education, and 2 correspond to care team coordination. CONCLUSIONS: The scorecard developed is a management tool for the implementation and evaluation of Telepharmacy in the Hospital pharmacy service. This tool enables assessing the initial situation, monitoring implementation progress, measuring quality and performance, facilitating decision-making and establishing an improvement plan.
OBJETIVO: La Telefarmacia, como actividad complementaria de la atención farmacéutica presencial en un servicio de farmacia de hospital, debe disponer de indicadores de calidad, actividad y efectividad específicos. Los objetivos del proyecto fueron definir los indicadores de calidad, actividad y efectividad de un cuadro de mando que permitan conocer la situación y evolución de la Telefarmacia y ayuden a la toma de decisiones de mejora continua, además de diseñar una herramienta que permita medir los indicadores y establecer recomendaciones para su implantación.Método: El proyecto liderado por un grupo de expertos farmacéuticos se desarrolló durante el año 2021 en cuatro fases: revisión bibliográfica, elaboración preliminar de criterios de calidad e indicadores, valoración de los indicadores y definición de indicadores prioritarios, la elaboración de fichas descriptivas, y el desarrollo y validación de una herramienta de cuadro de mando. Los indicadores se priorizaron en función de su adecuación, utilidad, pertinencia y factibilidad. Finalmente, el cuadro de mando fue sometido a la evaluación de los socios y del Comité de Pacientes de la Sociedad Española de Farmacia Hospitalaria. RESULTADOS: El cuadro de mando consta de 50 indicadores agrupados en cinco ámbitos: 18 de ellos sobre aspectos generales, 12 en el ámbito del seguimiento farmacoterapéutico, 15 relacionados con la dispensación y entrega informada de medicamentos a distancia, 2 sobre formación e información a los pacientes y 3 en relación con la coordinación con el equipo asistencial. Se consideraron 31 de ellos prioritarios, siendo los recomendados inicialmente en la implantación de un programa de Telefarmacia. De ellos, 15 son generales (incluyendo la medida de satisfacción del paciente y el profesional), 6 son indicadores de seguimiento, 1 de formación e información y 2 de coordinación asistencial. CONCLUSIONES: El cuadro de mando desarrollado es una herramienta de gestión para implantar y evaluar la Telefarmacia en los servicios de farmacia hospitalaria, que permite conocer la situación inicial, monitorizar la implantación, medir la calidad y el desempeño, facilitar la toma de decisiones y establecer un plan de mejora.
Assuntos
Serviço de Farmácia Hospitalar , Humanos , Indicadores de Qualidade em Assistência à Saúde , HospitaisRESUMO
The Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy states that the inclusion of patients should take into account ethical considerations and, therefore, be based on the concept of equity. Thus, it establishes that Telepharmacy should not be limited to specific pathologies or medicines, but should be based on the individual needs of each patient: it also highlights the need to rely on selection or prioritisation models to help identify patients who can benefit from Telepharmacy. The aim of this article is to present the Spanish Society of Hospital Pharmacy Telepharmacy Patient Prioritisation Model, which establishes key recommendations and a reference prioritisation model to guide hospital pharmacists in the identification and prioritisation of patients who are candidates for inclusion in Telepharmacy programmes. This model was developed based on the experience of a group of experts in their clinical practice as well as on a review of the main reference documents available in this field. It comprises 25 criteria, grouped into 8 minimum inclusion criteria, 5 continuity criteria, and 12 recommended criteria. The latter criteria are divided into high, medium, and low priority criteria. Patients are prioritised according to their scores on meeting the recommended criteria, such that those with the highest scores are given the highest priority. As stated in the Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy, pharmacotherapeutic monitoring can be conducted via remote consultation without sending medication, but not vice versa; thus, the 25 criteria defined apply to Telepharmacy programmes in the area of the remote dispensing and informed delivery of medicines, but only 19 of them apply to pharmacotherapeutic monitoring programmes. The model presented is intended to be a reference guide and should be adapted to the particular characteristics and circumstances of each pharmacy service, depending on demand and available resources.
La Sociedad Española de Farmacia Hospitalaria, en su Documento de osicionamiento sobre Telefarmacia, establece que la inclusión de pacientes debe tener en cuenta consideraciones éticas y, por tanto, estar basada en el concepto de equidad. Por ello, establece que la Telefarmacia no debe restringirse por patologías ni medicamentos, sino en función de las necesidades individuales de cada paciente, y destaca la necesidad de apoyarse en modelos de selección o priorización que ayuden en la identificación de los pacientes que puedan beneficiarse de la Telefarmacia. El objetivo de este artículo es presentar el "Modelo de priorización de pacientes en Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", que pretende establecer recomendaciones clave y un modelo de priorización de referencia que sirva de orientación a los farmacéuticos especialistas en farmacia hospitalaria para la identificación y priorización de pacientes candidatos a ser incluidos en programas de Telefarmacia. El modelo a sido desarrollado en base a la experiencia de un grupo de expertos en su práctica clínica y a la revisión de los principales documentos de referencia disponibles en este ámbito y está conformado por un total de 25 criterios, agrupados en 8 criterios mínimos de inclusión, 5 criterios de continuidad y 12 criterios recomendables. Estos últimos se dividen en criterios de alta, media y baja prioridad. En función de las puntuaciones obtenidas del cumplimiento de los criterios recomendables, se establece el orden de prioridad de pacientes, de modo que aquellos que mayor puntuación obtengan serán los más prioritarios. Tal como recoge el "Documento de Posicionamiento sobre Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", puede haber seguimiento farmacoterapéutico por teleconsulta sin envío de medicación, pero no al contrario, por lo que los 25 criterios definidos aplican a programas de Telefarmacia en el ámbito de la dispensación y entrega informada de medicamentos a distancia, pero solamente 19 de ellos aplican para los programas de seguimiento farmacoterapéutico. El modelo que se presenta ha sido concebido como un marco de referencia y deberá adaptarse a las características y circunstancias particulares de cada servicio de farmacia, en función de la demanda y de los recursos disponibles.
Assuntos
Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Farmacêuticos , Pacientes InternadosRESUMO
OBJECTIVE: To analyze knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake across physicians managing immune diseases and hospital pharmacists. METHOD: Two structured and closed anonymous online surveys were designed and sent to 41 physicians (rheumatologists, dermatologists, gastroenterologists) and 32 hospital pharmacists. Sociodemographic and clinical practice related variables were collected. We also gathered information about biosimilars knowledge and importance, access, attitude in clinical practice and perceptions, barriers and facilitators to biosimilars uptake. A descriptive analysis was performed. RESULTS: Surveys response rate was 100% (hospital pharmacists) and 96% (physicians). We found certain lack of biosimilars knowledge about key aspects including switching, extrapolation, interchangeability or substitution. There was a great variability in the types and brands of biosimilars depending on the hospital. We observed several organization preferences, policies, and practices regarding biosimilars. General perception and attitude to biosimilars was positive. If used, biosimilars were predominantly prescribed in biologic treatment-naive patients (this indication was considered adequate and participants felt comfortable with it). Reluctance to switch in clinical practice was common. The main barriers to biosimilars uptake were the lack of confidence and knowledge. The main facilitators were the development of recommendations from professional associations and societies and the demonstration of interchangeability efficacy. We gathered concerns about biosimilar long term efficacy and safety, lack of real-life data, lack of biosimilars traceability or the risk of biologic reference medicines stock shortages. CONCLUSIONS: Biosimilar education and more evidence filling current gaps might help increase prescriber knowledge, comfort and use of biosimilars.
Objetivo: Analizar el conocimiento, las percepciones, la actitud, las barreras y los facilitadores sobre el uso de los biosimilares entre los médicos que manejan enfermedades inmunológicas y los farmacéuticos de hospital.Método: Se diseñaron dos encuestas online anónimas, estructuradas y cerradas que se enviaron a 41 médicos (reumatólogos, dermatólogos y gastroenterólogos) y 32 farmacéuticos de hospital. Se recogieron variables sociodemográficas y relacionadas con la práctica clínica. También información sobre el nivel de conocimiento e importancia de los biosimilares, el acceso a los mismos, la actitud en la práctica clínica, y las percepciones, barreras y facilitadores con el uso de los mismos. Se realizó un análisis descriptivo.Resultados: La tasa de respuesta fue del 100% (farmacéuticos de hospital) y del 96% (médicos). Encontramos cierta falta de conocimiento sobre los biosimilares en aspectos clave como el cambio de un biológico de referencia a un biosimilar, la extrapolación de indicaciones, la intercambiabilidad o la sustitución. Hubo una gran variabilidad en los tipos y marcas comerciales de biosimilares entre hospitales. Observamos distintas preferencias, políticas y prácticas en los hospitales en relación con el uso de biosimilares. La percepción y actitud general hacia los biosimilares fue positiva. Los biosimilares se prescribían predominantemente en pacientes sin tratamiento bioló gico previo (esta indicación se consideraba adecuada y los participantes se sentían cómodos con ella). La reticencia al cambio en la práctica clínica fue común. Los principales obstáculos para el uso de biosimilares fueron la falta de confianza y de conocimientos. Los principales facilitadores el desarrollo de recomendaciones de asociaciones y sociedades científicas y la demostración de la eficacia de la intercambiabilidad. Se recogieron preocupaciones sobre la eficacia y seguridad a largo plazo de los biosimilares, la falta de datos en vida real, la falta de trazabilidad de los biosimilares o el riesgo de escasez de existencias de medicamentos biológicos de referencia.Conclusiones: Actividades formativas en biosimilares y una mayor evidencia podrían ayudar a aumentar el conocimiento, comodidad y el uso de los biosimilares por parte de los prescriptores.