Abstract This study aimed to characterize and compare medicines formularies (MFs) used in Long-Term Care (LTC) facilities in Portugal, and to identify the prevalence of Potentially Inappropriate Medicines (PIMs). A systematic contact with LTC facilities was undertaken in December 2021. MFs were systematized according to the Anatomical Therapeutical Chemical classification system (ATC), followed by descriptive content analysis. A structured comparison between MFs developed by public organizations and private LTC facilities was performed. After duplicate removal and exclusion of medicines not for systemic use, two explicit criteria - the Algorithm of medication review in frail older people and the EU(7)-PIM list - were employed for PIMs identification. Five MFs were obtained and assessed. The three MFs developed by private institutions covered 23% of the national LTC facilities and approximately 34% of the national total of beds. Heterogeneity was particularly high for the Alimentary tract and metabolism, Blood and blood-forming organs, Musculoskeletal system, and Respiratory system ATC groups. A PIM prevalence of 29,4% was identified. Medicines distribution between the MFs suggests the need to develop national guidelines towards harmonizing medicines usage in LTC. The prevalence of PIMs found highlights the importance of a particular optimized use of this health technology in aged sub-populations. (MFs LongTerm Long Term (LTC Portugal PIMs. . (PIMs) 2021 ATC, , (ATC) analysis performed EU7PIM EUPIM EU 7 identification assessed 23 34 beds metabolism bloodforming blood forming organs groups 294 29 4 29,4 identified subpopulations. subpopulations sub populations. populations sub-populations (PIMs 202 (ATC 2 3 29, 20

Background: Community pharmacy teams (CPTs) have an established role in assisting self-medication, contributing to the safe and effective use of non-prescription medicines. Objective: The study aimed to describe CPTs' performance in self-medication consultation, client-reported outcomes, and satisfaction. A secondary purpose was to develop an explanatory model for better understanding clients' satisfaction with this service. Methods: Descriptive, cross-sectional exploratory study. Data were collected in a purposive sample of pharmacy clients recruited in six community pharmacies in Portugal. CPTs adopted a structured approach to self-medication consultations, encompassing 11 quality criteria (five for case evaluation and six for counselling). An evaluation score, a counselling score and an overall quality score were estimated. Client-reported outcomes and satisfaction were ascertained via a follow-up telephone interview. Besides descriptive statistics, the association with several independent variables on the clients' overall satisfaction was explored, using linear regression. Results: Product-based dispensing was more frequent for lower educated clients. Reported compliance with the criteria by CPTs was overall high (93.95% of maximum compliance), mostly missing the ‘other medication' questioning. Most clients (93%) reported improvement after the consultation. Clients' satisfaction score was 4.70 out of 5. The variables that seem to better explain clients' overall satisfaction are pharmacy loyalty, the evaluation score, and the female gender. Conclusions: Clients' reported outcomes were favourable, as well as satisfaction with the service. Clients' satisfaction appears to be determined by consultation quality (evaluation score), suggesting the advancement of the pharmacists' clinical role. A larger study is warranted to confirm these findings.

Abstract Objective: To evaluate the training and standardization methods of multiple simulated patients (SPs) performing a single scenario in a multicenter study. Methods: A prospective quasi-experimental study, using a multicenter approach, evaluated the performance of five different individuals with the same biotype during a simulation session in a high-fidelity environment. The SPs training and standardization process consisted of four steps and six web or face-to-face mediated: Step 1: simulation scenario design and pilot test. Step 2: SPs selection, recruitment and beginning training (Session 1: performance instructions and memorization request.) Session 2: check the SPs’ performances and adjustments). Step 3 and session 3: training role-play and performance's evaluation. Step 4: SPs’ standardization and performances’ evaluation (Sessions 4 and 5: first and second rounds of SPs’ standardization assessment. Session 6: Global training and standardization evaluation. SPs performance consistency was estimated using Cronbach's alpha and ICC. Results: In the evaluation of training results, the Maastricht Simulated Patient Assessment dimensions of SPs performances “It seems authentic”, “Can be a real patient” and “Answered questions naturally”, presented “moderate or complete agreement” of all evaluators. The dimensions “Seems to retain information unnecessarily”, “Remains in his/her role all the time”, “Challenges/tests the student”, and “Simulates physical complaints in an unrealistic way” presented “moderate or complete disagreement” in all evaluations. The SPs “Appearance fits the role” showed “moderate or complete agreement” in most evaluations. In the second round of evaluations, the SPs had better performance than the first ones. This could indicate the training process's had good influence on SPs performances. The Cronbach's alpha in the second assessment was better than the first (varied from 0.699 to 0.978). The same improvement occurred in the second round of intraclass correlation coefficient that was between 0.424 and 0.978. The SPs were satisfied with the training method and standardization process. They could perceive improvement on their role-play authenticity. Conclusions: The SPs training and standardization process revealed good SPs reliability and simulation reproducibility, demonstrating to be a feasible method for SPs standardization in multicenter studies. The Maastricht Simulated Patient Assessment was regarded as missing the assessment of the information consistency between the simulation script and the SPs provision.

O ensino de habilidades de comunicação é indispensável aos profissionais de saúde. Este estudo objetivou identificar instrumentos validados no português do Brasil que avaliam habilidades de comunicação de estudantes ou profissionais da saúde. Para tanto, foi realizada uma revisão de escopo que incluiu estudos de validação de instrumentos para avaliação de habilidades de comunicação de estudantes/profissionais da área da Saúde. Foram identificados quatro instrumentos, traduzidos e validados para o português do Brasil. Validação de conteúdo, validação de construto e o teste de consistência interna foram realizados com maior frequência. Esta revisão identificou um número reduzido de instrumentos para avaliar habilidades de comunicação e dados limitados de validade e confiabilidade dos instrumentos.

Teaching communication skills to health professionals is extremely important. This study aimed to identify instruments validated for Brazilian Portuguese that assess communication skills of health students or professionals. We carried out a scoping review that included validation studies of instruments for assessing communication skills of students/professionals from the area of Health. Four instruments were identified, translated into Brazilian Portuguese and validated for this language. Content validation, construct validation and the internal consistency test were the most frequently performed ones. This review identified a reduced number of instruments to assess communication skills and limited data about the instruments’ validity and reliability.

La enseñanza de habilidades de comunicación es indispensable para los profesionales de la salud. El objetivo de este estudio fue identificar instrumentos validados en portugués de Brasil que evalúan habilidades de comunicación de estudiantes o profesionales de la salud. Para ello, se realizó una revisión de alcance que incluyó estudios de validación de instrumentos para evaluación de habilidades de comunicación de estudiantes/profesionales del área de la salud. Se identificaron cuatro instrumentos, traducidos y validados al portugués de Brasil. La validación de contenido, la validación del constructo y el test de consistencia interna se realizaron con mayor frecuencia. Esta revisión identificó un número reducido de instrumentos para evaluar habilidades de comunicación y datos limitados de validez y confiabilidad de los instrumentos.

O ensino de habilidades de comunicação é indispensável aos profissionais de saúde. Este estudo objetivou identificar instrumentos validados no português do Brasil que avaliam habilidades de comunicação de estudantes ou profissionais da saúde. Para tanto, foi realizada uma revisão de escopo que incluiu estudos de validação de instrumentos para avaliação de habilidades de comunicação de estudantes/profissionais da área da Saúde. Foram identificados quatro instrumentos, traduzidos e validados para o português do Brasil. Validação de conteúdo, validação de construto e o teste de consistência interna foram realizados com maior frequência. Esta revisão identificou um número reduzido de instrumentos para avaliar habilidades de comunicação e dados limitados de validade e confiabilidade dos instrumentos.

Teaching communication skills to health professionals is extremely important. This study aimed to identify instruments validated for Brazilian Portuguese that assess communication skills of health students or professionals. We carried out a scoping review that included validation studies of instruments for assessing communication skills of students/professionals from the area of Health. Four instruments were identified, translated into Brazilian Portuguese and validated for this language. Content validation, construct validation and the internal consistency test were the most frequently performed ones. This review identified a reduced number of instruments to assess communication skills and limited data about the instruments’ validity and reliability.

La enseñanza de habilidades de comunicación es indispensable para los profesionales de la salud. El objetivo de este estudio fue identificar instrumentos validados en portugués de Brasil que evalúan habilidades de comunicación de estudiantes o profesionales de la salud. Para ello, se realizó una revisión de alcance que incluyó estudios de validación de instrumentos para evaluación de habilidades de comunicación de estudiantes/profesionales del área de la salud. Se identificaron cuatro instrumentos, traducidos y validados al portugués de Brasil. La validación de contenido, la validación del constructo y el test de consistencia interna se realizaron con mayor frecuencia. Esta revisión identificó un número reducido de instrumentos para evaluar habilidades de comunicación y datos limitados de validez y confiabilidad de los instrumentos.

ABSTRACT BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects’ satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett’s sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler’s Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler’s Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects’ satisfaction with medicine package leaflets.

Abstract Objective: To characterize the inclusion of the teaching of communication skills in the curriculum of Pharmacy Schools of Federal Institutions of Higher Education. Methods: An exploratory study of documental analysis of curriculum of Pharmacy Schools was carried out. A convenience sample was selected from undergraduate pharmacy courses of Federal Institutions of Higher Education (IFES). The variables collected were related to the identification of the course, its nature (elective or mandatory), workload, semester, and program content. Results: Among the 49 undergraduate pharmacy courses of IFES, 35 (71.4%) had their curriculum available online. The teaching of communication in health was identified in 26 (74.3%) curriculum. In this study, three courses (7.2%) specifically aimed at teaching communication skills, while 39 (92.9%) had content related to this subject. Most courses (22; 52.4%) belonged to the field of Social, Behavioral, and Administrative Sciences. As for the course period, there was a concentration in the third (19%) and fourth (28.6%) years. The main content present in the curriculum was related to the principles and techniques of health communication (42.8%). Conclusions: Data obtained enabled the identification of gaps in the curricula of undergraduate courses in pharmacy concerning the inclusion of the teaching of communication skills. These results can be used to reflect the current models adopted in Brazil for the teaching of this skills, especially after the recent publication of the new curricular guidelines for undergraduate pharmacy courses.

O aparecimento de microrganismos multirresistentes, quer nos humanos quer nos animais, sugere a necessidade imperativa de intervenção no padrão de utilização dos antibióticos. O conhecimento do padrão de prescrição é imprescindível para fundamentar a revisão das práticas clínicas e de ensino no sentido de promover a prescrição racional dos antibióticos. Objetivo: Caracterização do perfil de prescrição de antibióticos de uso sistémico em consulta de medicina geral e familiar na região do Algarve. Material e métodos: Trata‐se de um estudo de prescrição‐indicação com desenho transversal. De um universo de 280 médicos a exercer nos centros de saúde do Algarve, foram selecionados 70 médicos de medicina geral e familiar, dos quais aceitaram participar 60. Os doentes foram incluídos no estudo de forma consecutiva até ao preenchimento da quota de doentes (20 doentes por médico), sempre que durante uma consulta de rotina ou de urgência básica fosse necessário prescrever um antibiótico de uso sistémico. Alguns médicos não preencheram esta quota. Resultados: Cerca de 80% dos médicos selecionados enviaram pelo menos uma ficha de registo de prescrição de antibióticos, dos quais 41,5% tinham 55 ou mais anos de idade e 52% eram mulheres. Foi avaliada uma amostra de 925 doentes em que 534 (59,6%) eram do género feminino. Verificou‐se que em todos os grupos etários as penicilinas foram os antibióticos mais prescritos atingindo um valor de quase 70% no grupo etário dos 0‐14. Apesar de serem também o grupo mais prescrito nos mais velhos, representam apenas cerca de 40%. Os macrólidos foram também frequentemente prescritos em todos os grupos etários. Quanto à distribuição da prescrição em função do género, verificou‐se que quer no género masculino quer no género feminino as penicilinas foram os antibióticos mais prescritos. No género masculino os macrólidos surgem em segundo lugar na prescrição, seguidos das quinolonas e das cefalosporinas, enquanto no género feminino são as quinolonas, seguidas dos macrólidos e das cefalosporinas. As infeções da pele foram as infeções com menor grau de dispersão da terapêutica quando se analisou simultaneamente DU50 e DU90. Conclusões: O padrão de prescrição dos antibióticos é semelhante a outros descritos na literatura. No entanto, realça‐se o alto nível de prescrição de quinolonas e de cefalosporinas de 3.ª geração e o baixo recurso a penicilinas sensíveis às betalactamases, a nitrofurantoína e a fosfomicina trometamol. As infeções da pele são as infeções com menor grau de dispersão da terapêutica quando se analisa simultaneamente DU50 e DU90.

The appearance of multi‐resistant micro‐organisms, whether in humans or animals, suggests an urgent need to intervene in the patterns of use of antibiotics. Knowledge of patterns of prescription is indispensable to support the review of clinical practices and teaching in order to promote rational prescription of antibiotics. Objective: Characterisation of the profile of prescription of antibiotics for systemic use in General and Family Practitioners' consultations in the region of the Algarve. Material and methods: This is a cross‐sectionally designed study of indicative prescription. 70 General and Family Practitioners were selected from a total of 280 doctors working at Health Centres in the Algarve, of whom 60 accepted the invitation to participate. The patients were included in the study in a consecutive way up to the patient quota (20 patients per doctor), whenever it was necessary to prescribe an antibiotic for systemic use during a routine or basic emergency consultation Results: Approximately 80% of the doctors selected sent at least a record of antibiotic prescription, of whom 41.5% were 55 years old or more and 52% were female. A sample of 925 patients was analysed, of whom 534 (59.6%) were female. It was noted that in all age groups, penicillin was the most prescribed antibiotic, reaching a level of nearly 70% in the 0‐14 age group. Although this was also the type of antibiotic most prescribed in older patients, it was only prescribed to about 40% of the sample. Macrolides were also often prescribed in all age groups. With regard to prescription in relation to gender, it was noted that penicillin was the most prescribed antibiotic, both for males and females. For prescriptions given to males, macrolides were in second place, followed by quinolones and cefalosporines, while for females it was quinolones, followed by macrolides and cefalosporines. Skin infections were the infections which occurred least often, when we analysed DU50 and DU90 simultaneously. Conclusions: The pattern of antibiotic prescription is similar to that described in other studies. However, we noted the high level of prescription of quinolones and 3 Rd generation cefalospirines and the low level of use of penicillins sensitive to beta lactamases, nitrofurantoin and fosfomycin trometol. Skin infections were the infections which occurred least often, when we analysed DU50 and DU90 simultaneously.

RESUMO Este ensaio destaca a importância das competências de comunicação clínica (CCC) nas ciências da saúde. Estas competências podem ser ensinadas, aprendidas e avaliadas, e vários estudos evidenciam para as vantagens de uma formação específica nesta área, potenciando a relação que os profissionais da área da saúde estabelecem com os pacientes, cuidadores informais e equipas de saúde, com resultados melhorados nos indicadores de saúde e cuidados mais humanizados. Confrontados com dificuldades na integração de programas específicos de comunicação nos curricula, assim como um défice no processo de avaliação e feedback estruturado, é crucial um investimento na formação pedagógica e no desenvolvimento curricular. Conscientes da escassez de trabalhos sistemáticos que apontam para um consenso sobre as competências e objetivos de ensino-aprendizagem das CCC, o sub-grupo Core Curriculum do comité de ensino (tEACH) da Associação Europeia de Comunicação em Saúde (EACH) desenvolveu e alcançou um consenso para um currículo nuclear nas diferentes áreas da saúde. Neste contexto, surgiu o Health Professions Core Communication Curriculum – HPCCC, que pode servir como referencial flexível de acordo com as necessidades específicas e contribuir para uma maior sistematização das iniciativas de CCC em saúde em língua portuguesa.

ABSTRACT This essay addresses the importance of clinical communication skills (CCC) in the health sciences. These skills can be taught, learned and assessed, and several studies have shown the advantages of specific training in this area, enhancing the relationship that healthcare professionals establish with patients, informal careers and health teams, with improved results in health indicators and more humanized care. Faced with difficulties in integrating specific communication programs in the curricula, as well as a deficit in the assessment process and structured feedback, an investment in teacher training and curriculum development is crucial. Aware of the lack of systematic studies that point to a consensus on the skills and CCC teaching-learning objectives, the Core Curriculum sub-group of the Teaching Committee (tEACH) of the European Association of Communication in Health (EACH) developed and achieved a consensus for a core curriculum in the different areas of healthcare. In this context, the Health Professions Core Curriculum Communication – HPCCC emerged, which can serve as a flexible framework in accordance with the specific needs and contribute to greater systematization of CCC initiatives in healthcare spoken in Portuguese.

Resumo Entre outros requisitos regulatórios, o nome dos medicamentos de marca deve ser composto por um único nome e não integrar abreviaturas para evitar erros de medicação. Os objetivos do estudo foram: investigar a adequação de um grupo de nomes de medicamentos de marca portugueses à regulação farmacêutica do mesmo País; identificar as suas características linguísticas básicas e comparar essas características e a sua frequência com valores de referência da língua corrente ou informal. Foi selecionada uma amostra de 474 nomes. Os nomes foram analisados com recurso a métodos manuais (análise visual) e automáticos (FreP - Frequency Patterns of Phonological Objects in Portuguese e o MS word). Um número significativo de nomes (61,3%) não estava em conformidade com o sistema fonológico (relacionado com a forma sonora das palavras) e ortográfico do Português (relacionado com a forma de escrita das palavras), tinha mais de uma palavra, continha uma alta proporção padrões silábicos e acentuais raros, e incluía abreviaturas. Os resultados sugerem que alguns dos nomes das marcas medicamentos portugueses devem ser reavaliadas e os aspetos regulatórios atualizados, tendo em consideração as características específicas do sistema linguístico e ortográfico português.

Abstract Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

ResumoEntre outros requisitos regulatórios, o nome dos medicamentos de marca deve ser composto por um único nome e não integrar abreviaturas para evitar erros de medicação. Os objetivos do estudo foram: investigar a adequação de um grupo de nomes de medicamentos de marca portugueses à regulação farmacêutica do mesmo País; identificar as suas características linguísticas básicas e comparar essas características e a sua frequência com valores de referência da língua corrente ou informal. Foi selecionada uma amostra de 474 nomes. Os nomes foram analisados com recurso a métodos manuais (análise visual) e automáticos (FreP - Frequency Patterns of Phonological Objects in Portuguese e o MS word). Um número significativo de nomes (61,3%) não estava em conformidade com o sistema fonológico (relacionado com a forma sonora das palavras) e ortográfico do Português (relacionado com a forma de escrita das palavras), tinha mais de uma palavra, continha uma alta proporção padrões silábicos e acentuais raros, e incluía abreviaturas. Os resultados sugerem que alguns dos nomes das marcas medicamentos portugueses devem ser reavaliadas e os aspetos regulatórios atualizados, tendo em consideração as características específicas do sistema linguístico e ortográfico português.

AbstractAmong other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

CONTEXTO E OBJETIVO: As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes.TIPO DE ESTUDO E LOCAL: Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa.MÉTODOS: Utilização de uma checklist para recolher os dados. A checklistfoi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem.RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos.CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos.

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients.DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon.METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose).RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety.CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

OBJECTIVO Analisar a literatura sobre legibilidade das bulas dos medicamentos para uso humano.MÉTODOS Estudo de revisão sistemática, utilizando as palavras-chave “Readability and Package Leaflet” e “Readability and Package Insert”e a ferramenta de busca académica b-on, que contém diferentes bases bibliográficas. O período analisado foi entre 2008 e 2013. Foram aplicados os critérios PRISMA para redigir o relatório da revisão. Foram incluídos artigos originais de pesquisa quantitativa ou qualitativa. Os critérios de exclusão foram: artigos de opinião ou de revisão, ou escritos numa língua diferente do inglês, português, italiano, francês ou espanhol.RESULTADOS Foram identificados 202 trabalhos, dos quais 180 foram excluídos e 22 selecionados para análise: dois com profissionais de saúde, 10 com pacientes, três sobre reações adversas e sete descritivos. As bulas apresentaram diversos problemas de legibilidade, entre os quais: textos insuficientemente claros e simples, utilização de tamanhos de letra pequenos e número reduzido de ilustrações. Os principais métodos utilizados para avaliar a legibilidade das bulas foram as fórmulas e os testes de legibilidade/usabilidade. Entre as limitações metodológicas, foram identificados aspetos como o recurso a amostras pequenas, a inexistência de fórmulas de legibilidade específicas para a língua em causa, e.g., português, e a realização de testes de compreensão em grupos de pacientes sem avaliação prévia da literacia, dos conhecimentos específicos na área da saúde, das capacidades cognitivas, ou do grau de satisfação dos participantes.CONCLUSÕES Em geral, as bulas apresentaram diversos problemas de legibilidade. Adicionalmente, nesta revisão foram identificadas algumas limitações metodológicas nos estudos revistos (e.g. a participação de um número reduzido de pacientes e profissionais de saúde, a ausência da avaliação prévia da literacia, do humor ou satisfação dos participantes ou o predomínio de estudos não baseados em encenações sobre o uso de medicamentos) que deverão ser consideradas na apreciação dos resultados e contornadas em estudos futuros.

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online,comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

OBJECTIVO Analisar a literatura sobre legibilidade das bulas dos medicamentos para uso humano.MÉTODOS Estudo de revisão sistemática, utilizando as palavras-chave “Readability and Package Leaflet” e “Readability and Package Insert”e a ferramenta de busca académica b-on, que contém diferentes bases bibliográficas. O período analisado foi entre 2008 e 2013. Foram aplicados os critérios PRISMA para redigir o relatório da revisão. Foram incluídos artigos originais de pesquisa quantitativa ou qualitativa. Os critérios de exclusão foram: artigos de opinião ou de revisão, ou escritos numa língua diferente do inglês, português, italiano, francês ou espanhol.RESULTADOS Foram identificados 202 trabalhos, dos quais 180 foram excluídos e 22 selecionados para análise: dois com profissionais de saúde, 10 com pacientes, três sobre reações adversas e sete descritivos. As bulas apresentaram diversos problemas de legibilidade, entre os quais: textos insuficientemente claros e simples, utilização de tamanhos de letra pequenos e número reduzido de ilustrações. Os principais métodos utilizados para avaliar a legibilidade das bulas foram as fórmulas e os testes de legibilidade/usabilidade. Entre as limitações metodológicas, foram identificados aspetos como o recurso a amostras pequenas, a inexistência de fórmulas de legibilidade específicas para a língua em causa, e.g., português, e a realização de testes de compreensão em grupos de pacientes sem avaliação prévia da literacia, dos conhecimentos específicos na área da saúde, das capacidades cognitivas, ou do grau de satisfação dos participantes.CONCLUSÕES Em geral, as bulas apresentaram diversos problemas de legibilidade. Adicionalmente, nesta revisão foram identificadas algumas limitações metodológicas nos estudos revistos (e.g. a participação de um número reduzido de pacientes e profissionais de saúde, a ausência da avaliação prévia da literacia, do humor ou satisfação dos participantes ou o predomínio de estudos não baseados em encenações sobre o uso de medicamentos) que deverão ser consideradas na apreciação dos resultados e contornadas em estudos futuros.

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online,comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

Objetivo: rever, de forma sistemática os estudos que investigaram a comunicação entre pacientes e profissionais de saúde através da aplicação da metodologia RIAS. Métodos: foram utilizados como expressão-chave Roter Interaction Analysis System e os recursos bibliográficos de: Academic Search Complete, Current Contents, ISI Proceedings, PubMed, Elsevier, SpringerLink, Web of Science, RCAAP, Solo e o site oficial do RIAS. Período de seleção: 2006 a 2011. Os estudos foram selecionados por análise dicotômica multicritério e organizados segundo os critérios PRISMA. Resultados: identificação de 1.262 artigos (455 não repetidos). Foram selecionados para análise 34 artigos, distribuídos pelas seguintes profissões de saúde: médicos de medicina geral e familiar (14), pediatras (5), enfermeiros (4), geneticistas (3), prestadores de cuidados a pacientes com Aids (2), oncologistas (2), cirurgiões (2), anestesistas (1) e especialistas de planejamento familiar (1). O RIAS é escassamente utilizado e divulgado no âmbito dos cuidados de saúde nos países de língua portuguesa. Discussão: os principais temas estudados incluíram a influência do cansaço, ansiedade e esgotamento profissional na comunicação e o impacto das ações específicas de formação no exercício profissional. A revisão permitiu identificar as principais forças e fraquezas na comunicação verbal, em díade e síncrona na prestação de cuidados de saúde. Conclusão: a investigação científica da comunicação entre profissionais de saúde e pacientes por meio do RIAS tem produzido resultados concretos. É esperada uma melhoria dos resultados em saúde decorrente da aplicação do RIAS.

Objective: Systematic review of studies that investigate the communication between patients and health professionals with the application of the RIAS methodology. Methods: Keyword Roter Interaction Analysis System was searched in the following bibliographic resources: Academic Search Complete, Current Contents, ISI Proceedings, PubMed, Elsevier, SpringerLink, Web of Science, RCAAP, Solo and the official RIAS site. Selection period: 2006 to 2011. Studies were selected using multicriteria dichotomous analysis and organized according to PRISMA. Results: Identification of 1,262 articles (455 unrepeated). 34 articles were selected for analysis, distributed by the following health professions: family medicine and general practitioners (14), pediatricians (5), nurses (4), geneticists (3), carers of patients with AIDS (2), oncologists (2), surgeons (2), anesthetists (1) and family planning specialists (1). The RIAS is scarcely used and publicized within the scope of healthcare in Portuguese speaking countries. Discussion: Main themes studied include the influence of tiredness, anxiety and professional burnout on communication and the impact of specific training actions on professional activities. The review enabled the identification of the main strengths and weaknesses of synchronous and dyadic verbal communication within the provision of healthcare. Conclusion: Scientific investigation of the communication between health professionals and patients using RIAS has produced concrete results. An improvement is expected in health outcomes through the application of the RIAS.