Motivation and Knowledge of Portuguese Community Pharmacists Towards the Reporting of Suspected Adverse Reactions to Medicines: A Cross-Sectional Survey.

The close contact between patients and community pharmacists, along with the extensive geographical distribution of pharmacies in Portugal, offer exceptional conditions to detect and report adverse drug reactions (ADR). This study aimed to evaluate the motivation and knowledge of spontaneous reporting of ADR by community pharmacists of Porto, Portugal. Secondly, we aimed to generate real-world evidence on the main factors determining ADR report and at raising potential alternatives to the current reporting procedure in community pharmacy. We performed a descriptive, cross-sectional, observational, anonymous web survey-based study. Between April and July 2021, a web survey was implemented, targeting community pharmacists in the Porto district, Portugal. We validated 217 surveys from pharmacists. Regular notifiers seem to be more familiarised than non-regular notifiers with the Portuguese Pharmacovigilance System (PPS), with the Portal RAM for reporting suspected ADR, and with the update of the concept of ADR. Moreover, regular notifiers seem to be more proactive with their care in questioning patients about ADR and have more self-knowledge to identify suspected ADR. Conversely, non-regular notifiers, seem to be more reluctant to be judged by their ADR reporting activities. Respondents suggested to simplify and optimise the reporting process (31% of the suggestions), or to integrate a reporting platform into the pharmacy's software (27%). This study identified opportunities to promote the ADR reporting process by community pharmacists, namely receiving feedback from the PPS on the reported case and its regulatory implications, implementing training programs in pharmacovigilance, and creating solutions to simplify the reporting process.

A comprehensive review of adverse events to drugs used in COVID-19 patients: Recent clinical evidence.

BACKGROUND: Since the breakthrough of the pandemic, several drugs have been used to treat COVID-19 patients. This review aims to gather information on adverse events (AE) related to most drugs used in this context. METHODS: We performed a literature search to find articles that contained information about AE in COVID-19 patients. We analysed and reviewed the most relevant studies in the Medline (via PubMed), Scopus and Web of Science. The most frequent AE identified were grouped in our qualitative analysis by System Organ Class (SOC), the highest level of the MedDRA medical terminology for each of the drugs studied. RESULTS: The most frequent SOCs among the included drugs are investigations (n = 7 drugs); skin and subcutaneous tissue disorders (n = 5 drugs); and nervous system disorders, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, and metabolism and nutrition disorders (n = 4 drugs). Other SOCs also emerged, such as general disorders and administration site conditions, renal and urinary disorders, vascular disorders and cardiac disorders (n = 3 drugs). Less frequent SOC were eye disorders, respiratory, thoracic and mediastinal disorders, musculoskeletal and connective tissue disorders, and immune system disorders (n = 2 drugs). Psychiatric disorders, and injury, poisoning and procedural complications were also reported (n = 1 drug). CONCLUSIONS: Some SOCs seem to be more frequent than others among the COVID-19 drugs included, although neither of the studies included reported causality analysis. For that purpose, further clinical studies with robust methodologies, as randomised controlled trials, should be designed and performed.

Burnout among Portuguese healthcare workers during the COVID-19 pandemic.

BACKGROUND: During COVID-19 pandemic, healthcare workers (HCWs) have had high workload and have been exposed to multiple psychosocial stressors. The aim of this study was to evaluate HCWs in terms of the relative contributions of socio-demographic and mental health variables on three burnout dimensions: personal, work-related, and client-related burnout. METHODS: A cross-sectional study was performed using an online questionnaire spread via social networks. A snowball technique supported by health care institutions and professional organizations was applied. RESULTS: A total of 2008 subjects completed the survey. Gender, parental status, marriage status, and salary reduction were found to be significant factors for personal burnout. Health problems and direct contact with infected people were significantly associated with more susceptibility to high personal and work-related burnout. Frontline working positions were associated with all three dimensions. Higher levels of stress and depression in HCWs were significantly associated with increased levels of all burnout dimensions. Higher levels of satisfaction with life and resilience were significantly associated with lower levels of all burnout dimensions. CONCLUSIONS: All three burnout dimensions were associated with a specific set of covariates. Consideration of these three dimensions is important when designing future burnout prevention programs for HCWs.

Reducing Potentially Inappropriate Prescriptions for Older Patients Using Computerized Decision Support Tools: Systematic Review.

BACKGROUND: Older adults are more vulnerable to polypharmacy and prescriptions of potentially inappropriate medications. There are several ways to address polypharmacy to prevent its occurrence. We focused on computerized decision support tools. OBJECTIVE: The available literature was reviewed to understand whether computerized decision support tools reduce potentially inappropriate prescriptions or potentially inappropriate medications in older adult patients and affect health outcomes. METHODS: Our systematic review was conducted by searching the literature in the MEDLINE, CENTRAL, EMBASE, and Web of Science databases for interventional studies published through February 2018 to assess the impact of computerized decision support tools on potentially inappropriate medications and potentially inappropriate prescriptions in people aged 65 years and older. RESULTS: A total of 3756 articles were identified, and 16 were included. More than half (n=10) of the studies were randomized controlled trials, one was a crossover study, and five were pre-post intervention studies. A total of 266,562 participants were included; of those, 233,144 participants were included and assessed in randomized controlled trials. Intervention designs had several different features. Computerized decision support tools consistently reduced the number of potentially inappropriate prescriptions started and mean number of potentially inappropriate prescriptions per patient. Computerized decision support tools also increased potentially inappropriate prescriptions discontinuation and drug appropriateness. However, in several studies, statistical significance was not achieved. A meta-analysis was not possible due to the significant heterogeneity among the systems used and the definitions of outcomes. CONCLUSIONS: Computerized decision support tools may reduce potentially inappropriate prescriptions and potentially inappropriate medications. More randomized controlled trials assessing the impact of computerized decision support tools that could be used both in primary and secondary health care are needed to evaluate the use of medication targets defined by the Beers or STOPP (Screening Tool of Older People's Prescriptions) criteria, adverse drug reactions, quality of life measurements, patient satisfaction, and professional satisfaction with a reasonable follow-up, which could clarify the clinical usefulness of these tools. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42017067021; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42017067021.

How to promote adverse drug reaction reports using information systems - a systematic review and meta-analysis.

BACKGROUND: Adverse drug reactions (ADRs) are a well-recognized public health problem and a major cause of death and hospitalization in developed countries. The safety of a new drug cannot be established until it has been on the market for several years. Keeping drug reactions under surveillance through pharmacovigilance systems is indispensable. However, underreporting is a major issue that undermines the effectiveness of spontaneous reports. Our work presents a systematic review on the use of information systems for the promotion of ADR reporting. The aim of this work is to describe the state of the art information systems used to promote adverse drug reaction reporting. METHODS: A systematic review was performed with quantitative analysis of studies describing or evaluating the use of information systems to promote adverse drug reaction reporting. Studies with data related to the number of ADRs reported before and after each intervention and the follow-up period were included in the quantitative analysis. RESULTS: From a total of 3865 articles, 33 articles were included in the analysis; these articles described 29 different projects. Most of the projects were on a regional scale (62 %) and were performed in a hospital context (52 %). A total of 76 % performed passive promotion of ADR reporting and used web-based software (55 %). A total of 72 % targeted healthcare professionals and 24 % were oriented to patient ADR reporting. We performed a meta-analysis of 7 of the 29 projects to calculate the aggregated measure of the ADR reporting increase, which had an overall measure of 2.1 (indicating that the interventions doubled the number of ADRs reported). CONCLUSIONS: We found that most of the projects performed passive promotion of ADR reporting (i.e., facilitating the process). They were developed in hospitals and were tailored to healthcare professionals. These interventions doubled the number of ADR reports. We believe that it would be useful to develop systems to assist healthcare professionals with completing ADR reporting within electronic health records because this approach seems to be an efficient method to increase the ADR reporting rate. When this approach is not possible, it is essential to have a tool that is easily accessible on the web to report ADRs. This tool can be promoted by sending emails or through the inclusion of direct hyperlinks on healthcare professionals' desktops.

Unveiling the future: precision pharmacovigilance in the era of personalized medicine.

In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized treatments. We aim to provide a succinct reflection on the intersection of tailored therapeutic strategies and vigilant pharmacovigilance practices. We discuss the integration of pharmacogenetics in enhancing drug safety, illustrating how genetic profiling aids in predicting drug responses and adverse reactions. Emphasizing the importance of phase IV-post-marketing surveillance, we explore the limitations of pre-marketing trials and the necessity for a comprehensive approach to drug safety. The article discusses the pivotal role of pharmacogenetics in pre-exposure risk management and the redefinition of pharmacoepidemiological methods for post-exposure surveillance. We highlight the significance of integrating patient-specific genetic profiles in creating personalized medication leaflets and the use of advanced computational methods in data analysis. Additionally, we examine the ethical, privacy, and data security challenges inherent in precision medicine, emphasizing their implications for patient consent and data management.

Assessing medication use patterns by clinical outcomes severity among inpatients with COVID-19: A retrospective drug utilization study.

PURPOSE: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases. METHODS: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes. RESULTS: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes. CONCLUSIONS: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.

MedGAN: optimized generative adversarial network with graph convolutional networks for novel molecule design.

Generative Artificial Intelligence can be an important asset in the drug discovery process to meet the demand for novel medicines. This work outlines the optimization and fine-tuning steps of MedGAN, a deep learning model based on Wasserstein Generative Adversarial Networks and Graph Convolutional Networks, developed to generate new quinoline-scaffold molecules from complex molecular graphs, including hyperparameter adjustments and evaluations of drug-likeness attributes such as pharmacokinetics, toxicity, and synthetic accessibility. The best model was capable of generating 25% valid molecules, 62% fully connected, from which 92% were quinolines, 93% were novel, and 95% unique, preserving chirality, atom charge, and favorable drug-like properties while generating 4831 novel quinolines. These results provide valuable insights into how activation functions, optimizers, learning rates, neuron units, molecule size and constitution, and scaffold structure affect the performance of generative models and their potential to create new molecular structures, enhancing deep learning applications in computational drug design.

Public's perspective on COVID-19 adenovirus vector vaccines after thrombosis with thrombocytopenia syndrome (TTS) reports and associated regulatory actions - A cross-sectional study in six EU member states.

OBJECTIVE: In 2021, thrombosis with thrombocytopenia syndrome (TTS) was confirmed by the European Medicines Agency (EMA) as a rare side effect of the COVID-19 adenovirus vector vaccines Vaxzevria® and Jcovden®. This study aimed to describe the public's knowledge of TTS and how it affected the willingness to be vaccinated with COVID-19 vaccines and other vaccines in six European countries. METHODS: From June to October of 2022, a multi-country cross-sectional online survey was conducted in Denmark, Greece, Latvia, Netherlands, Portugal, and Slovenia. The minimum target of participants to be recruited was based on the size of the country's population. The results were analysed descriptively. RESULTS: In total, 3794 respondents were included in the analysis; across the six countries, 33.3 %-68.3 % reported being familiar with signs and symptoms of TTS, although 3.1-61.4 % of those were able to identify the symptoms correctly. The reported changes in willingness to be vaccinated against COVID-19 and with other vaccines varied per country. The largest reported change in the willingness to be vaccinated with Vaxzevria® and Jcovden® was observed in Denmark (61.2 %), while the willingness to be vaccinated with other COVID-19 vaccines changed most in Slovenia (30.4 %). The smallest decrease in willingness towards future vaccination against COVID-19 was reported in the Netherlands (20.9 %) contrasting with the largest decrease observed in Latvia (69.1 %). CONCLUSION: Knowledge about TTS seemed to have influenced the public's opinion in Europe resulting in less willingness to be vaccinated with Vaxzevria® and Jcovden®. Willingness for vaccination against COVID-19 with other vaccines and widespread use of vaccines to prevent other diseases also differed and seemed to be determined by the approaches taken by national health authorities when reacting to and communicating about COVID-19 vaccination risks. Further investigation of optimal risk communication strategies is warranted.

Drug-induced anaphylaxis: a decade review of reporting to the Portuguese Pharmacovigilance Authority.

PURPOSE: Anaphylaxis is a potentially fatal systemic adverse drug reaction (ADR). It is an unpredictable and mostly dose-independent event that occurs suddenly following exposure to the causative drug. Our objective was to characterize a case series of anaphylactic reactions reported to the Portuguese Pharmacovigilance authority during the past decade. Patients' demographic data and implicated drugs were analyzed as well as the severity of the ADR and time trends. METHODS: This study was a retrospective analysis of episodes of anaphylaxis, defined according to the Second Symposium on the Definition and Management of Anaphylaxis Criteria, reported to the Portuguese Pharmacovigilance System between 1 January 2000 and 1 November 2010 RESULTS: Amongst the 16,157 ADR reported to the Portuguese Pharmacovigilance System during the 10-year study period, we found 918 (6 %) cases of anaphylaxis that met the proposed criteria. The age of the patients varied from 7 days to 91 years, with 87 cases (9 %) of anaphylaxis involving patients under 18 years of age. There was an overall female predominance (67 %), but the majority of pediatric patients were male (56 %). There was a trend toward increased reporting as the decade progressed, and 31 % (284) of all anaphylaxis cases were reported during the last 2 years of the study period. Of the anaphylaxis episodes reported, 19 % led to hospitalization and 24 (3 %) had a fatal outcome. Antibiotics were responsible for most cases (17 %) followed by nonsteroidal anti-inflammatory drugs/acetaminophen (13 %), antineoplastic/cytotoxic drugs and immune-modulators. Vaccines and radiographic contrast media were also important contributors to an anaphylactic event. CONCLUSIONS: In this series of drug-related anaphylaxis, we found that most of the reported episodes were associated with widely used drugs, such as antibiotics and analgesics. Anaphylaxis can occur at any age. The female gender was more highly represented, with the exception of pediatric patients.

Trends in sales of antidepressants in Brazil from 2014 to 2020: A time trend analysis with joinpoint regression.

BACKGROUND: This study aimed to investigate the trends in antidepressants sales in Brazil. METHODS: We performed a joinpoint analysis of antidepressants sales in Brazil from 2014 to 2020, recorded in the Brazilian National Controlled Products Management System. The primary outcomes were the defined daily dose per 1000 inhabitants per day (DID) and the market shares for each antidepressant per year. We used joinpoint regression to assess the changes in antidepressant consumption in DID to obtain the average annual percent change (AAPC) and 95 % confidence intervals (95 % CI). Changes in market shares were tested by chi-square trend test (p < 0.05 as significant). RESULTS: From 2014 to 2020, 42,252,989 antidepressant sales were recorded in the system. Antidepressant sales increased from 13.7 to 33.6 DID in the period (AAPC: 15.7; 95 % CI: 13.0-18.4; p < 0.001); the largest increases were observed for serotonin reuptake inhibitors and 'other' antidepressants (including serotonin-norepinephrine reuptake inhibitors), whereas tricyclics remained steady. Escitalopram and sertraline were the most sold drugs. Market share of serotonin reuptake inhibitors decreased, particularly for paroxetine (13.1 % to 6.5 %; p = 0.016), while 'other' antidepressants' market share expanded from 21.9 % to 33.3 % (p = 0.027), especially for desvenlafaxine (2.9 % to 14.3 %; p < 0.001). LIMITATIONS: The dataset does not include antidepressants dispensed in hospitals, public services, and compounding pharmacies, neither their therapeutic indications. CONCLUSION: Sales of antidepressants significantly increased in Brazil from 2014 to 2020, which were mainly driven by higher prescriptions of serotonin reuptake inhibitors and 'other' antidepressants classes. Market share changes seem to be driven by novelty of products.

Prevalence of antidepressant use in Brazil: a systematic review with meta-analysis.

OBJECTIVE: To estimate the prevalence of antidepressant use in Brazil. METHODS: We conducted a systematic review with searches in MEDLINE, Embase, Scopus, LILACS, and SciELO up to May 2023. Two researchers independently selected studies, extracted data and assessed the methodological quality. We combined the prevalence of antidepressant use using meta-analyses of proportions by Freeman-Tukey and estimated heterogeneity by I². Odds ratio (OR) meta-analyses of antidepressant use by sex were calculated (men as reference) and between-study variation was explored by meta-regressions. RESULTS: Out of 3,299 records, 23 studies published in 28 reports were included. The overall prevalence of antidepressant use was 4.0% (95%CI 2.7-5.6%; I2=98.5%). Use of antidepressants in the previous 3 days was higher in women (12.0%; 95%CI 9.5-15.1%; I2=0.0%) than men (4.6%; 95%CI 3.1-6.8%; I2=0.0%), p<0.001; OR=2.82; 95%CI 1.72-4.62. Gender differences were particularly higher for antidepressant use in the previous year (women: 2.3%; 95%CI 1.6-3.1; I2=37.6% versus men: 0.5%; 95%CI 0.2-1.0%; I2=0.0%, p<0.001; OR=4.18; 95%CI 2.10-8.30). Between-study variation in the overall prevalence of antidepressant use significantly increased with participants' mean age (p=0.035; residual I²=0.0%; regression coefficient=0.003). CONCLUSIONS: Four in every 100 Brazilians use antidepressants; use increased with age and was higher in women compared to men.

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.

Trends in Brazilian market of antidepressants: A five-year dataset analysis.

Introduction: Depression is an emotional disorder associated with morbidities and disabilities worldwide. The growing use of antidepressants is a concern for health managers because there are still unanswered questions on the effectiveness and safety of these medicines. Drug sales have increased in Brazil in recent years, but investigations on antidepressants sales are not available. We aimed to describe the trends in the antidepressant commerce in Brazil in a five-year period. Materials and Methods: We performed an ecological study on antidepressant sales in Brazil, from November 2014 to October 2019, using data from IQVIA™, a data provider of pharmaceutical sales. Antidepressants were coded by the Anatomical Therapeutic Chemical classification system, and sales were presented in defined daily doses (DDDs) and DDDs per 1,000 inhabitants per day (DIDs). The results were expressed in absolute quantities and growth rates. Results: The analyzed dataset contained 23 active substances in 780 products. The total sales of antidepressants increased from 23.3 DIDs in November 2014 to 38.3 DIDs in October 2019 (p = 0.002). Selective serotonin reuptake inhibitors were the most sold category of drugs (+5.7 million DDDs) in the period. 'Other' antidepressants presented the largest growth rate (104.7%). Individually, the most sold active substance was escitalopram (+1.8 million DDDs), and vortioxetine had the largest growth rate (336.2%). Tricyclic sales remained unchanged, and monoamine oxidase inhibitors had low and even decreasing sales (-9.5%). Discussion: The total sales of antidepressants increased in Brazil from November 2014 to October 2019. The higher sale volumes of selective serotonin reuptake inhibitors and higher growth rate of 'other' antidepressants, with low sale volume of tricyclics and a decrease of monoamine oxidase inhibitors, suggest the replacement of older drugs by newer ones following a global trend. Therapeutic advances and commercial promotion efforts on new products might explain these findings.

Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections.

Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit-risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18-64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. "Skin and subcutaneous tissue connections" (15.9%), "general disorders and administrations site conditions" (12%), and "gastrointestinal disorders" (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR.

Adverse Drug Reactions and Potentially Inappropriate Medication in Older Patients: Analysis of the Portuguese Pharmacovigilance Database.

Criteria have been developed to identify potentially inappropriate medications that can enhance adverse reactions, highly prevalent in older patient's therapy. This study aimed to identify potentially inappropriate medications within the adverse drug reactions reported in the Portuguese pharmacovigilance system, characterizing the reports where inappropriate medications were identified. INFARMED, I.P. provided all adverse drug reactions reported from January to December 2019 in 65-year-old and older patients. Adverse drug reactions were characterized according to the System Organs Classes, seriousness, and medications with the Anatomical Therapeutical Classification. Potentially inappropriate medications were identified by applying the EU-(7)-PIM and the Beers criteria. A p value < 0.05 was considered statistically significant. From the 2337 reports considered for the analysis, PIMs were found in 12.8% of these, and 64.7% of all adverse reaction reports were classified as serious. Within the group of reports including at least one PIM, 71.4% were classified as serious, with hospitalization the most common criteria (35.1%). From the 3170 suspected medicines identified, 10.6% were classified as PIMs. Amiodarone was the most frequent PIM identified in the study (10.1%). Reports including at least one PIM were more associated with a higher number of ADRs (p = 0.025) reported in the same record, higher number of suspected medicines identified (p < 0.001), seriousness (p = 0.005), and hospitalization (p < 0.001). Potentially inappropriate medications are important enhancers of serious adverse drug reactions, increasing the likelihood of hospitalizations. This reinforces the importance of improving medication appropriateness in the older population.

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.

[Looking back on 20 years of work at the Porto Pharmacovigilance Centre, Portugal]. / Retrospectiva de 20 anos de atividade da Unidade de Farmacovigilância do Porto, Portugal.

Since 1963, the World Health Organization has acknowledged pharmacovigilance as a priority area in global public health, guaranteeing permanent monitoring of drug safety. This study aimed to characterize the reports of adverse drug reactions received by the Porto Pharmacovigilance Centre (UFPorto), Portugal, in the unit's two decades of work. The analysis included all reports of suspected adverse drug reactions received from January 2001 to December 2019. We calculated the annual reporting rates and distribution by origin, type of notifier and place of work, severity, prior knowledge, and causality of the reported adverse drug reactions. During the study period, UFPorto received 9,711 notifications of suspected adverse drug reactions. Hospital institutions reported the most suspected adverse drug reactions (n = 6,003; 64%), as did physicians among healthcare workers (n = 5,284; 54.4%). The most frequently reported adverse events were severe (n = 6,275; 72%) and are described in the respective Summary of Product Characteristics (n = 6,978; 72%). Most of the reports received by UFPorto were evaluated as having "probable" causality (n = 7,473; 77%), independently of the type of notifier. The results are consistent with other data previously reported in the international medical literature and official national reports. However, the underreporting rates are still higher than expected. In approximately 20 years, UFPorto has experienced an increase in its activity in various areas of drug safety.

Desde 1963 que a farmacovigilância foi reconhecida como uma área prioritária na saúde pública a nível global pela Organização Mundial da Saúde, garantindo a monitorização permanente da segurança dos medicamentos. O objetivo deste trabalho foi caracterizar as reações adversas a medicamentos recebidas pela Unidade de Farmacovigilância do Porto (UFPorto), Portugal, ao longo de duas décadas de atividade. Foram consideradas todas as notificações de suspeitas de reações adversas a medicamentos recebidas entre janeiro de 2001 e dezembro de 2019. Foram calculadas as taxas de notificação anuais, assim como a sua distribuição por origem, tipo de notificador e local de exercício da atividade, gravidade, conhecimento prévio e causalidade das reações adversas a medicamentos notificadas. No período em estudo, a UFPorto recebeu 9.711 notificações de suspeitas de reações adversas a medicamentos. As instituições hospitalares são aquelas que mais notificam (n = 6.003; 64%), assim como o médico entre os profissionais de saúde (n = 5.284; 54,4%). Os eventos adversos mais frequentemente reportados são graves (n = 6.275; 72%) e encontram-se descritos no respectivo Resumo das Características do Medicamento (n = 6.978; 72%). À maioria das notificações avaliadas pela UFPorto foi atribuído o grau de causalidade "provável" (n = 7.473; 77%), independentemente do tipo de notificador. Os resultados obtidos são concordantes com outros dados previamente reportados na literatura médica internacional e em relatórios oficiais nacionais. Contudo, continua-se a verificar taxas de subnotificação acentuadas, face ao esperado. Ao longo de aproximadamente 20 anos de atividade da UFPorto, tem-se verificado um aumento da sua atividade nas diversas vertentes da segurança do medicamento.

Desde 1963 la farmacovigilancia fue reconocida por la Organización Mundial de la Salud, como un área prioritaria en la salud pública a nivel global, garantizando la monitorización permanente de la seguridad de los medicamentos. El objetivo de este trabajo fue caracterizar las reacciones adversas a medicamentos recibidas por la Unidad de Farmacovigilancia de Oporto (UFPorto), Portugal, a lo largo de dos décadas de actividad. Se consideraron todas las notificaciones de sospechas de reacciones adversas a medicamentos, recibidas entre enero de 2001 y diciembre de 2019. Se calcularon las tasas de notificación anuales, así como su distribución por origen, tipo de notificador y lugar de ejercicio de la actividad, gravedad, conocimiento previo y causalidad de las reacciones adversas a medicamentos notificadas. En el período de estudio, la UFPorto recibió 9.711 notificaciones de sospechas reacciones adversas a medicamentos. Las instituciones hospitalarias son quienes más notifican (n = 6.003; 64%), así como el médico entre los profesionales de salud (n = 5.284; 54,4%). Los eventos adversos más frecuentemente reportados son graves (n = 6.275; 72%) y se encuentran descritos en lo respectivo Resumen de las Características del Medicamento (n = 6 978; 72%). A la mayoría de las notificaciones evaluadas por la UFPorto se le atribuyó el grado de causalidad "probable" (n = 7.473; 77%), independientemente del tipo de notificador. Los resultados obtenidos son concordantes con otros datos previamente reportados en la literatura médica internacional y en informes oficiales nacionales. No obstante, se continúa verificando tasas de subregistro acentuadas, frente a lo esperado. A lo largo de aproximadamente 20 años de actividad de la UFPorto, se ha verificado un aumento de su actividad en las diversas vertientes de la seguridad del medicamento.

Translation and adaptation of the STOPP-START screening tool to Portuguese for detecting inappropriate prescriptions in older people: a protocol.

INTRODUCTION: Rational prescribing for older adults is a challenge because they usually exhibit multimorbidity and multimedication. One available and reliable tool to tackle this issue consists of the Screening Tool of Older People's Prescriptions (STOPP) and the Screening Tool to Alert to Right Treatment (START), which has been associated with improvements in clinical outcomes. Our goal here is to translate and validate the STOPP-START screening tool for use with Portuguese general practitioners/family physicians. METHODS AND ANALYSIS: The study will be conducted in four phases: phase I-translation of the STOPP-START screening tool to Portuguese; phase II-data collection of patient data; phase III-intrarater reliability and agreement study; and phase IV-inter-rater reliability and agreement study. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the Central Health Region of Portugal (where the study will take place). Every participant will sign a written consent form. We intend to publish the full article in a related peer-reviewed journal, conference presentations, reports and in a PhD thesis.