Recent updates in the therapeutic uses of Pembrolizumab: a brief narrative review.

INTRODUCTION: Treatment of cancer has been improved with the discovery of biological drugs that act as immune checkpoint inhibitors. In 2017, FDA designated pembrolizumab, an immune checkpoint inhibitor employed in immunotherapy, as the first tissue-agnostic cancer treatment. OBJECTIVES: To review pembrolizumab's use in oncology, gather and examine the latest discoveries regarding the effectiveness of pembrolizumab in cancer treatment. METHODOLOGY: A literature review was conducted through PubMed(Medline) from January 2015 to December 2023 using "pembrolizumab", "cancer" and "treatment" as search terms. RESULTS: Pembrolizumab demonstrated effectiveness as primary treatment for metastatic nonsmall cell lung cancer, unresectable esophageal cancer, head and neck squamous cell carcinoma and alternative treatment for notable triple-negative breast cancer, biliary, colorectal, endometrial, renal cell, cervical carcinoma, and high microsatellite instability or mismatch repair deficiencies tumors. Pediatric applications include treatment for refractory Hodgkin lymphoma. CONCLUSION: Evolving research on pembrolizumab allows a deeper clinical understanding, despite challenges as variable patient responses. Pembrolizumab has emerged as a pivotal breakthrough in cancer treatment, improving patient outcomes and safety.

Implementation and impact of integrated health and social care services: an umbrella review.

Governments in many European countries have been working towards integrating health and social care services to eliminate the fragmentation that leads to poor care coordination for patients. We conducted a systematic review to identify and synthesize knowledge about the integration of health and social care services in Europe. We identified 490 records, in 14 systematic reviews that reported on 1148 primary studies and assessed outcomes of integration of health care and social care. We categorized records according to three purposes: health outcomes, service quality and integration procedures outcomes. Health outcomes include improved clinical outcomes, enhanced quality of life, and positive effects on quality of care. Service quality improvements encompass better access to services, reduced waiting times, and increased patient satisfaction. Integration procedure outcomes involve cost reduction, enhanced collaboration, and improved staff perceptions; however, some findings rely on limited evidence. This umbrella review provides a quality-appraised overview of existing systematic reviews.

Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database.

INTRODUCTION: Opioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice. OBJECTIVE: This study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes. METHODS: Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2021 with an opioid drug as the suspected/interacting medicine were analyzed. Reporting odds ratios (RORs) for drug-ADR combinations were calculated, analyzed, and corrected for sex and drug utilization (expenditure) for the Dutch population. RESULTS: A total of 8769 reports were analyzed. Tramadol was the opioid with the most reports during the period (n = 2746), while oxycodone or tramadol had the highest number of reports per year in the study period. The most reported ADRs from opioid use were nausea, followed by dizziness and vomiting, independent of sex, and all of them were more often reported in women. Vomiting associated with tramadol (ROR females/males = 2.17) was significantly higher in women. Buprenorphine was responsible for most ADRs when corrected for expenditure, with high RORs observed with application site hypersensitivity, application site reaction, and application site rash. Fentanyl gave rise to most of the reports of ADRs concerning abuse, misuse, and medication errors. CONCLUSION: Patients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS.

Iopromide safety assessment in a radiology department: A seven-year retrospective characterization of adverse events.

BACKGROUND: Since the mid-20th century, contrast agents have been widely used in radiology due to their ability to provide high-definition radiographic images and greater precision in diagnostic exams. Different types of contrast agents are used in image diagnosis, namely radiological media. Despite being considered safe, there are still uncertainties about their safety profile, interactions, and incidence of adverse drug reactions in real-world settings. OBJECTIVE: To characterise the pattern of adverse events, during 7 years, in a radiology unit. METHODS: We performed a retrospective observational and descriptive study at an Image Center in Portugal between August 2012 and October 2019. A total of 77,449 computed tomography (CT) were registered, and from those 15,640 cases of iopromide were used as a contrast agent. The authors have accessed, under the authorization, the data of adverse events and procedures after the event. RESULTS: Most of the hypersensitivity events were immediate or with a short time of onset, with the majority of cases developing events with skin involvement and mild degree, where the most common events were papules (n = 60), pruritus (n = 42), erythema (n = 27) and urticaria (n = 14). Severe events, including hypersensitivity, were mainly represented by vomiting (n = 11), stridor (n = 8), breathing difficulties (n = 7) and syncope (n = 3). Abdominal-pelvic CT exam presented a higher frequency of adverse events. CONCLUSION: Despite all the current information about iopromide usage, the utilization of this agent is not abstent of risks and its safety profile not fully established. Most frequent symptoms were local, as skin adverse events, including papules, pruritus and erythema. Common medications used to treat or control adverse events were frequently hydrocortisone, clemastine and methylprednisolone.

Towards a consensus for nurse education of methotrexate for people with rheumatic and musculoskeletal diseases: A scoping review.

INTRODUCTION: Patient education (PE) is a key role of nurses, which includes providing information, training, and support about methotrexate (MTX), an anchor drug in rheumatology. However, there is a wide variation in the access to rheumatology nurse consultations in Europe, and there is a lack of consensus regarding the delivery, context and timing of PE in these cases. This study aimed to provide a comprehensive overview of the existing research on nurse education of MTX for children/youth and adults with Rheumatic and Musculoskeletal Diseases (RMDs). METHODS: This scoping review was conducted in accordance with Arksey and O'Malley's framework. A search on PubMed (MEDLINE), Scopus and Cochrane Database, and CINAHL, from inception until March 2022 was conducted. Articles on PE with a focus on MTX exclusively were included. Published and unpublished studies, from any world region, conducted with a qualitative, quantitative, or mixed-methods design and focused on defined research questions, were eligible for inclusion. Broad inclusion criteria were used if a research paper on PE focused on MTX for people with RMDs (PE or patient engagement, self-management, medication knowledge, or health literacy in patients). The reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Extension for Scoping Reviews (PRISMA-ScR) checklist. Two independent reviewers performed standardized data extraction and synthesis. RESULTS: From 292 references identified, the total number of studies which met the inclusion criteria was relatively small (n = 14). The results identified that knowledge of MTX improves when education by nurses is provided. CONCLUSION: This scoping review showed that there is no universal worldwide strategy for MTX education of children/youths and adults with RMDs. However, PE regarding MTX can be delivered in different forms, resulting in better satisfaction and adherence. More randomized controlled trials with powered samples are required.

Translation and cultural adaptation of MedStopper®-A web-based decision aid for deprescribing in older adults: A protocol.

BACKGROUND: Older patients are more likely to have medication-related problems, which are associated with changes in pharmacokinetics and pharmacodynamics, multimorbidity, and polypharmacy. Polypharmacy and inappropriate prescribing are well-known risk factors which commonly cause adverse clinical outcomes in older people. Prescribers struggle to identify potentially inappropriate medications and to choose an adequate tapering approach. METHODS/DESIGN: The goal of the study is to translate and culturally adapt MedStopper®, an original English language web-based decision aid system in deprescribing medication, to the Portuguese population. A translation-back translation method, with validation of the obtained Portuguese version of MedStopper® will be used, followed by a comprehension test. DISCUSSION: This is the first research in the Portuguese primary care setting that aims to provide a useful online tool for the appropriate prescription of older patients. The translated version in Portuguese version of the MedStopper® tool will represent an advance that seeks to continue improving the management of medications in the elderly. The adaptation into Portuguese of the educational tool provides clinicians with a screening tool to detect potentially inappropriate prescribing in patients older than 65 that reliable and easier to use. TRIAL REGISTRATION: Retrospectively registered.

Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.

INTRODUCTION: Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV. OBJECTIVE: The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe. METHODS: A literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO® software and employing reflective thematic analysis. RESULTS: A total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process. CONCLUSION: In this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.

Inappropriate Prescriptions in Older People-Translation and Adaptation to Portuguese of the STOPP/START Screening Tool.

Inappropriate prescribing, which encompasses the prescription of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), is a common problem for older people. The STOPP/START tool enables general practitioners, who are the main prescribers, to identify and reduce the incidence of PIMs and PPOs and appraise an older patient's prescribed drugs during the diagnosis process to improve the clinical care quality. This study aimed to translate and validate the STOPP/START screening tool to enable its use by Portuguese physicians. A translation-back translation method including the validation of the obtained Portuguese version was used. Intra- and inter-rater reliability and agreement analyses were used in the validation process. A dataset containing the information of 334 patients was analyzed by one GP twice within a 2-week interval, while a dataset containing the information of 205 patients was independently analyzed by three GPs. Intra-rater reliability assessment led to a Kappa coefficient (κ) of 0.70 (0.65−0.74) for the STOPP criteria and 0.60 (0.52−0.68) for the START criteria, considered to be substantial and moderate values, respectively. The results of the inter-rater reliability rating were almost perfect for all combinations of raters (κ > 0.93). The version of the STOPP/START criteria translated into Portuguese represents an improvement in managing the medications prescribed to the elderly. It provides clinicians with a screening tool for detecting potentially inappropriate prescribing in patients older than 65 years old that is reliable and easy to use.

Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database.

INTRODUCTION: Sexual dysfunction (SD) is a problem that can affect any phase of the sexual response cycle (such as sexual desire, arousal and orgasm) and individuals of any age. SD can be caused by physical reasons, such as medical conditions, alcoholism or drug abuse; psychological factors, such as stress and anxiety; and different medicines, such as selective serotonin reuptake inhibitors (SSRIs), and their associated adverse effects. AIM: The aim of this study was to characterise drugs suspected to have caused SD adverse drug reactions (ADRs) in patients, by conducting a descriptive study based on pharmacovigilance reports. METHODS: Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2019 were used to investigate drug-induced sexual disorders. Selected reports had at least one ADR reported in the Medical Dictionary for Regulatory Activities (MedDRA®) System Organ Class (SOC) 'Reproductive system and breast disorders' and the SOC 'Psychiatric disorders' relating to sexual disorders and corrected for drug utilisation (expenditure) for the Dutch population. RESULTS: A total of 2815 SD ADRs were reported in the observed period. Data were divided according to three variables: pharmacotherapeutic group, the drug itself, and sex. A total of 722 different SD/pharmacotherapeutic group pairs were observed. The pharmacotherapeutic groups with the highest frequency of SD reports were SSRIs (n = 488, 17.58%), other antidepressants (n = 172, 6.20%) and HMG-CoA reductase inhibitors (n = 149, 5.37%). Distinguishing ADRs by sex, men suffered more from erectile dysfunction, decreased libido and ejaculation disorders, while among women, libido disorders, dyspareunia and SD were the most common ADRs. CONCLUSION: Different reactions and disproportionality of reactions were detected between the sexes. Antidepressants, antihypertensives, oral contraceptives, α-blockers, and anti-androgens were the pharmacotherapeutic groups with the highest number of SD reports and corresponding high odds ratios.

Patient Organizations' Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation.

INTRODUCTION: European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. AIM: The aim of this study was to understand patient organizations' perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. METHODS: A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. RESULTS: The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. CONCLUSION: Both study phases show congruent results regarding patients' involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.

Diabetes patient's pharmacovigilance knowledge and risk perception: the influence of being part of a patient organisation.

OBJECTIVE: The aim was to assess the perception of risk for developing adverse drug reaction (ADRs) and knowledge, attitudes and opinions regarding pharmacovigilance in diabetic patients, and to investigate the effect of being a member of a patient organisation for diabetes on these factors, in comparison with other patients. METHODS: A cross-sectional study looking for patients' risk perception of experiencing ADRs. Diabetes patients followed at the Portuguese Diabetes Association (APDP) were included, together with two comparison groups (patients with and without diabetes). Kruskal-Wallis followed by post hoc Dunn's multiple-comparison test were used to compare patients' groups. RESULTS: A total of 314 patients participated in the survey (104 followed at APDP, 106 with diabetes not followed at APDP and 104 without diabetes diagnosis that used chronic medication). APDP patients presented higher risk perception scores for medicines related to their disease compared with two groups. Those patients affirmed that doctors explained possible ADRs on medication to them, and showed higher intention to report ADRs in the future if serious or unexpected. CONCLUSIONS: Patients with diabetes showed greater understanding of ADRs and higher need to report them than patients without diabetes. They would like to have more information about general ADRs related to anti-diabetic medication and present higher intention to acquire information on how and when to report compared with non-diabetic patients. Patients followed in APDP presented higher score of risk perception, which could be influenced by the presence of the diabetes disease in the patients' life, by their previous experiences using medicines, but also by information received from the patient organisation. The two groups of patients with diabetes have different experiences of the disease, but both present higher perception of side effects related with medicines they use respectively in their diabetes type. Hence, patient organisations are well positioned to be a source where patients can obtain reliable information, changing their attitudes and perceptions about the disease and drug treatments.

The Role of European Patient Organizations in Pharmacovigilance.

INTRODUCTION: Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance. AIM: The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. METHODS: A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018. RESULTS: A total of 1898 patient organizations were invited to participate in the survey, including 89 pan-European organizations. In total, 337 questionnaires (17.76%) were collected from 31 countries, including 297 complete answers (88.31%). A large number of organizations stated that they would like to increase the awareness of patients regarding specific adverse drug reactions (ADRs) related to their medicines (43.19%, n  = 130); however, 38.54% (n  = 116) declared they do not have any pharmacovigilance goals. Barriers to supporting pharmacovigilance activities include low budget to promote pharmacovigilance among members (45.45%, n  = 135), lack of resources to participate in pharmacovigilance activities (43.77%, n  = 130), or lack of support from the National Competent Authorities (33.33%, n  = 99). Organizations inform patients to report ADRs (40.40%; n  = 120), information regarding new ADRs related to their medicines (40.07%; n  = 119), or when a new drug is marketed (30.98%; n  = 92); however, more than one-third indicated that they never had any involvement in pharmacovigilance (34.68%; n  = 103). CONCLUSION: Bringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness.

Cinemática do nado crawl em velocidade sustentada até a exaustão / Kinematics of the front crawl in sustained speed to exhaustion

O objetivo deste estudo foi verificar as respostas da frequência média de ciclos de braçadas (FB) e da distância média percorrida por ciclo de braçada (DC) no nado crawl ao longo de série de natação na intensidade de 95% da velocidade média dos 400 m (V400), até a exaustão. Onze nadadores realizaram 400 m em máxima intensidade para determinação da V400, e, posteriormente, uma série a 95% da V400 (95v) com média de 2,88 ± 1,37 repetições de 400 m e intervalos de 40 s de repouso passivo, quarenta e oito horas após a V400. A duração da série a 95% da V400 foi normalizada a 100%, de modo individual, e posteriormente, foi dividida em cinco momentos (0, 25, 50, 75 e 100%) para a análise de FB e DC, que foram comparadas ao longo da série. Resultados: houve manutenção dos parâmetros cinemáticos apenas entre os momentos 0 e 25%. Ocorreram aumento da FB e diminuição da DC nos últimos momentos (75 e 100%) em comparação aos demais momentos da série 95v. Ao nadar nesta intensidade, que está situada o domínio de intensidade severa, nadadores não são capazes de manter a técnica constante ao longo da duração total da série...(AU)

The objective of this study was to investigate the stroke rate (SR) and the stroke length (SL) responses in front crawl along swimming training series in the intensity of 95% of the average velocity of 400 m (V400) until exhaustion. Eleven swimmers performed 400 m at maximum intensity for determining V400, and subsequently, a series of 95% the V400 (95v) with average 2.88 ± 1.37 trials of 400 m and intervals of 40 s of passive rest, 48 hours after the V400. The duration of the 95V was normalized to 100%, individually, and, later, it was divided into five moments (0, 25, 50, 75, and 100%) for the SR and SL analysis, which were compared over the series. Results: there was maintenance of kinematic parameters only between moments 0 and 25%, The SR increased and the SL decreased in the end of the series (75 and 100%) compared to other moments. When swimming at this intensity, which is situated in severe intensity domain, swimmers are not able to keep constant the technique over the entire duration of the series...(AU)

Influence of hand paddles and fins on blood lactate, heart rate and perceived exertion behavior / Influência do uso de palmares e nadadeiras no comportamento do lactato sanguíneo, da frequência cardíaca e do esforço percebido

Abstract - One of the great challenges for swim coaches is proper control of the training intensity. This issue is more complex when using equipment such as paddles and fins. Among intensity control parameters, blood lactate concentration is the standard for monitoring metabolic responses, and heart rate and perceived effort are practical and inexpensive methods. The aim of this study was to compare blood lactate concentration ([LA]), heart rate (HR) and rate of perceived exertion (RPE) in swimming training series without equipment and with paddles and fins. We evaluated 11 swimmers on three different days during sessions in a series of 12 repetitions of 50 m in front crawl. The first session was performed without equipment, maintaining perception exertion at 15 (15 points) of the 6-20 point Borg scale. In the second and third sessions, athletes should swim in the series with: (i) paddles and (ii) fins, at the same swimming speed of the series without equipment, in random order. [LA], HR and RPE at rest (after warm-up and before swimming series) and after the sixth and 12th repetitions were measured and compared. The mean speed for all series was 1.30 ± 0.13 m.s-1; fins and paddles presented lower final [LA] (respectively, 5.9 ± 0.3 and 8.1 ± 0.4 mmol.l-1) and HR values (respectively, 161.1 ± 15, 5 161.1 and 170.3 ± 13.3 170.3 bpm) in comparison to series without equipment (respectively, 10.8 ± 0.7 mmol.l-1 and 178.2 ± 4.3 bpm). Fins had lower final RPE values (12.5 ± 0.6 points) in relation to series without equipment (15.8 ± 0.2 points) and similar values in relation to swimming with paddles. Swimming series with equipment produced lower physiological demands in relation to swimming without equipment if performed at the same swimming speed as swimming without equipment.

Resumo Um dos grandes desafios para treinadores de natação é o adequado controle da intensidade de treino. Essa questão é mais complexa quando utilizados equipamentos como palmares e nadadeiras. Dentre os parâmetros de controle de intensidade, a concentração sanguínea de lactato [LA] é padrão para acompanhamento de respostas metabólicas, e a frequência cardíaca (FC) e o esforço percebido (EP) são métodos práticos e baratos. Esse estudo teve como objetivo comparar a concentração sanguínea de lactato, a frequência cardíaca e o esforço percebido em série de treinamento de natação sem equipamentos, com palmares ou com nadadeiras. Foram avaliados 11 nadadores em três diferentes dias durante série de 12 repetições de 50 m nado crawl. A primeira foi realizada sem equipamentos mantendo a percepção relativa ao escore 15 da escala de 6 a 20 pontos de Borg. A segunda e terceira séries os atletas realizavam (i) utilizando palmares e (ii) utilizando nadadeiras, na mesma velocidade de nado da série sem equipamentos, em ordem aleatória. Foram mensuradas e comparadas [LA], FC e EP nos momentos repouso (pós-aquecimento e antes da série), após a sexta e a 12ª repetições. A velocidade média para todas as séries foi de 1,30 ± 0,13 m.s-1; nadadeiras e palmares apresentaram menores valores finais de [LA] (respectivamente, 5,9 ± 0,3 e 8,1 ± 0,4 mmol.l-1) e de FC (respectivamente, 161,1 ± 15,5 e 170,3 ± 13,3 bpm) em relação ao nado sem equipamentos (respectivamente, 10,8 ± 0,7 mmol.l-1 e 178,2 ± 4,3 bpm). O nado com nadadeiras apresentou menores valores finais de EP (12,5 ± 0,6 pontos) em relação ao nado sem equipamentos (15,8 ± 0,2 pontos) e similares valores em relação ao nado com palmares. Séries de natação com equipamentos produzem menores demandas fisiológicas em relação ao nado sem equipamentos se realizadas na mesma velocidade de nado que o nado sem equipamentos.

Patient Reporting of Adverse Drug Reactions: An International Survey of National Competent Authorities' Views and Needs.

INTRODUCTION: Patient reporting of adverse drug reactions (ADRs) to spontaneous reporting systems can make a valuable contribution to pharmacovigilance. However, the implementation and promotion of patient reporting systems (PRSs) differ worldwide. OBJECTIVE: The objective of the study was to describe attitudes toward PRSs, and progress toward implementing such systems among national competent authorities participating in the World Health Organization Programme for International Drug Monitoring. METHODS: A web-based questionnaire was constructed based on qualitative interviews, and distributed through SurveyMonkey ® to all countries listed on the World Health Organization Programme for International Drug Monitoring (n = 178) during November and December of 2015. Data were analyzed using descriptive statistics and Chi-square tests. RESULTS: A total of 143 valid questionnaires were received from 141 countries (79.2 %). A spontaneous reporting system for both healthcare professionals and patients was present in 58 countries (41.1 %). An official PRS to report ADRs directly was implemented in 44 countries (31.2 %) and in a pilot stage in five countries (3.5 %). Patients were not allowed to report in 34 countries (24.1 %). The reasons for not having an official PRS were mainly a lack of resources/budget (56.5 %) or a lack of information/education for patients (56.5 %). When analyzing the attitudes among the respondents toward a PRS, most acknowledge that the general public contributes to the detection or strength of drug safety signals (82.2 % agree or strongly agree) and with information that is not present in healthcare professional reports (80.7 % agree or strongly agree). For respondents, giving feedback to patients could be an incentive for patients to report more (80.8 % agree or strongly agree). To be able to further PRSs, guidelines on promoting a PRS efficiently to the general public (87.4 % agree or strongly agree), training courses/conferences (86.7 % agree or strongly agree), or a public list of Lareb's scientific publications (86.7 % agree or strongly agree) were the support measures most well accepted by the respondents. CONCLUSIONS: Most countries accept ADR reports from patients by an official reporting system designed for patients or through the existing system for healthcare professionals. The main reasons for not having a PRS is financial restraints and a lack of information/education of patients. Attitudes toward a PRS are positive, but some countries fear that they will not be able to handle an increase in reports.

Are consumers ready to take part in the Pharmacovigilance System?--a Portuguese preliminary study concerning ADR reporting.

BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.

The use of hand paddles and fins in front crawl: biomechanical and physiological responses / Utilização de palmares e nadadeiras no nado crawl: respostas biomecânicas e fisiológicas

Paddles and fins are used during swim training and practice as tools for improving performance. The use of these equipment can alter physiological and kinematic parameters of swimming. The purpose of this literature review was to present and discuss the effects of paddles and fins on kinematic and physiological variables in front crawl, and provide update on the topic for teachers, researchers, coaches and swimmers. Thirty articles were reviewed. To crawl, paddles can change the averages of stroke length and stroke rate, the average swimming speed, the absolute duration of the stroke phases and the index of coordination. Fins can modify the average stroke rate, the average swimming speed, the kick frequency and deep, and the energy cost. We found no studies that verified the longitudinal effects of the use of paddles and fins on these parameters.

Palmares e nadadeiras são utilizados durante a prática e o treinamento da natação como ferramentas para a melhora do desempenho. A utilização desses equipamentos pode alterar parâmetros cinemáticos e fisiológicos do nado. Os objetivos dessa revisão de literatura foram apresentar e discutir os efeitos dos palmares e nadadeiras sobre variáveis cinemáticas e fisiológicas no nado crawl e fornecer atualização sobre o tema a professores, pesquisadores, treinadores e nadadores. Trinta artigos foram revisados. Para o nado crawl, palmares podem alterar o comprimento e a frequência média de braçadas, velocidade média de nado, duração absoluta das fases da braçada e índice de coordenação. Nadadeiras podem modificar a frequência média de braçadas, velocidade média de nado, frequência de pernada e profundidade da pernada e custo energético. Não foram encontrados estudos que verificaram os efeitos longitudinais da utilização de nadadeiras e palmares nesses parâmetros.

Variabilidade do lactato sanguíneo em resposta a nados de aquecimento e de máxima intensidade / Variability of blood lactate in response on heating and maximum intensity swim

Os objetivos do presente estudo foram (1) verificar as concentrações de lactato no sangue e sua variabilidade em resposta à intensidade característica de aquecimento e em resposta à máxima intensidade de nado; (2) verificar o comportamento das concentrações de lactato ao longo do tempo, e (3) testar a correlação entre valores de pico de concentração de lactato com o desempenho em 200 m nado crawl. Participaram 13 nadadores competitivos, com experiência de, no mínimo, 4 anos na modalidade. Foram obtidas amostras de sangue arterializado que foram analisadas com aparelho portátil para mensuração de lactato Accusport (Roche) em quatro momentos distintos: após 15 min de repouso em decúbito dorsal (M1), após 800 m nadados em intensidade de aquecimento (M2), um (M3) e três minutos (M4) após 200 m nadados em máxima intensidade no estilo crawl. O desempenho na distância de 200 m foi transformado em unidades pontuais (DESP) a fim de comparação com outros estudos. Os resultados apontaram para maiores concentrações de lactato em M3 e M4 em comparação à M1 e M2). Alta variabilidade inter e intra-indivíduos foi verificada. Nenhuma correlação entre desempenho e concentração de lactato sanguíneo foi encontrada. As diferenças inter individuais devem ser levadas em consideração quando se busca estudar o metabolismo energético em natação.

The objectives of this study were (1) to verify the concentrations of lactate in the blood and its variability in response to the characteristic intensity of warming up and response to maximum intensity in swim, (2) to verify the behavior of lactate concentrations over time, and (3) to test the correlation between peak values of lactate concentration and performance in 200 m crawl. Subjects were 13 competitive swimmers, with experience of at least four years in the sport. Samples of arterial blood were obtained and analyzed through a portable device for lactate measurement Accusport (Roche) from four different times: after 15 min rest in the supine position (M1), after 800 m intensity heating swimming(M2), one (M3) and three minutes (M4) after a 200 m at maximum intensity swimming in front crawl stroke. The performance at the distance of 200 m was transformed on units (DESP) to compare to other studies. The results pointed to higher lactate concentration values in M3 and M4 when compared to M1 and M2. High variability within and between individuals were found. None correlation between performance and blood lactate concentration was found. The inter-individual differences should be taken into consideration when seeking to study energy metabolism in swimming.