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Purpose: Proton Pump Inhibitors (PPIs) have been associated with several adverse effects of particular concern in older populations. Their use for a period longer than 8 weeks is not recommended for older adults. Strategies to discontinue PPIs have been offered; however, their use remains high. This study aims to characterize PPI use in Portuguese older people and to identify the factors associated with potentially inappropriate use., Methods: A cross-sectional study was conducted on 1200 randomly selected older adults (≥65 years of age), users of primary health care facilities in the Regional Health Administration (Administração Regional de Saúde of Centro [ARSC]) of Portugal between April 2021 and August 2022. Data concerning their characteristics and PPI use were provided by the Shared Services of the Health Ministry (Serviços Partilhados do Ministério da Saúde) and collected retrospectively. Associations between independent variables and PPI use were investigated by logistic regression analysis., Findings: Of the older adults, 37.92% were receiving PPIs and 78.68% of them were taking them for a longer period than recommended; 49.79% were taking PPIs without having any digestive system-related disease. Multivariate analysis showed that the prolonged use of PPIs was not associated with any specific pattern, although inappropriate PPI use is high among Portuguese older adults., Implications: Long-term PPI use in older adults is widespread and does not fit any particular patient profile; therefore, cross-cutting educational interventions should be designed independently of the patient's pathologic condition or treatment., Competing Interests: Declaration of Competing Interest Daniela A. Rodrigues reports financial support was provided by Fundação para a Ciência e a Tecnologia. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate the association between the use of antidepressants and the risk of upper gastrointestinal tract bleeding (UGIB)., Methods: A Case-control study was conducted in a Brazilian hospital complex. Cases were defined as patients with a diagnosis of UGIB and controls as patients admitted for reasons unrelated to gastrointestinal bleeding, gastric concerns, or complications associated with low-dose aspirin (LDA) or nonsteroidal anti-inflammatory drugs (NSAIDs) use. Sociodemographic and clinical data, comorbidities, drug therapy in use (long-term use and self-medication), and lifestyle habits were recorded through face-to-face interviews. Two groups were defined: use of antidepressants in general and use of antidepressants according to their affinity for serotonin transporters. The presence of synergism between the concomitant use of antidepressants and LDA or NSAIDs on the risk of UGIB was also explored., Findings: A total of 906 participants were recruited (200 in the case group and 706 in the control group). The use of antidepressants was not associated with the risk of UGIB (odds ratio [OR] = 1.503; 95% CI, 0.78-2.88) or the use of antidepressants with high affinity for serotonin receptors (OR = 1.983; 95% CI, 0.81-4.85). An increased risk of UGIB was observed in concomitant users of antidepressants and LDA (OR = 5.489; 95% CI, 1.60-18.81) or NSAIDs (OR = 18.286; 95% CI, 3.18-105.29). Despite the lack of significance, the use of antidepressants appears to be a positive modifier of UGIB risk in LDA and NSAID users., Implications: These findings indicate an increased risk of UGIB in concomitant users of antidepressants and LDA or NSAIDs, suggesting the need to monitor antidepressant users, especially those most likely to develop UGIB. In addition, further studies with larger sample sizes are needed to confirm these findings., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose: The coronavirus disease 2019 (COVID-19) pandemic has had a profound impact on everyday life, the environment, and health care services. A shift from in-person medical appointments to telemedicine was a main adjustment. Such changes can have repercussions on the control and management of chronic respiratory diseases, such as asthma. The available data suggest that there was an overall decrease in asthma-related morbidities during the first year of the pandemic. Therefore, the goal of this study was to quantify the effects of the pandemic on the prescribing of antiasthmatic treatments in outpatient care (public and private health care)., Methods: This before-after study used a time series approach based on data from monthly prescriptions of antiasthmatic drugs (anti-inflammatory drugs and bronchodilators) dated between April 2018 and March 2021. An interrupted time series (ITS) design was used for assessing changes in antiasthmatic prescribing patterns in the short and long terms after COVID-19 was recognized as a pandemic. The results are complemented with seasonal autoregressive integrated moving average (sARIMA) models., Findings: The ITS analysis showed a non-significant increase in antiasthmatic prescribing in the short term. In the long term, after the pandemic was declared, a statistically significant decrease was observed in the prescribing of antiasthmatics (in anti-inflammatory drugs and, more pronounced, in bronchodilators). In the sARIMA model, the mean monthly volume of antiasthmatic prescriptions was 18.1% lower than predicted. The numbers of months outside of the 95% CIs were different between anti-inflammatory drugs (1 month) and bronchodilators (7 months)., Implications: The prescribing of antiasthmatic drugs in the long term was significantly decreased with the COVID-19 pandemic, with a greater effect in the case of bronchodilators., Competing Interests: Declaration of Interest The authors have indicated that they have no conflicts of interest with regard to the content of this article., (Copyright © 2023. Published by Elsevier Inc.)

Background: Portugal has among the highest rates of dependency among older adults in Europe. Older adults with aging-related comorbidities are prone to the use of potentially inappropriate medication (PIM)., Objective: The aim of this study was to analyze PIM prescriptions in older Portuguese adults, as well as the change rate of PIM prescriptions over time, and assess the geographical variability between the different regions of mainland Portugal., Methods: Using a national database, PIM prescriptions were analyzed for older adults (aged 65 years and older) between 2019 and 2021 from 2 perspectives: PIM-defined daily dose (DDD) frequency (%) and DDD per 1000 inhabitants per day (DID)., Results: Overall, mainland Portugal presented a PIM DDD frequency of 9.20%, which was relatively higher in Alentejo and Centro and lower in the North. Alprazolam, fluoxetine, and rivaroxaban were PIM with higher DDD frequency values. Over the years, the DID change rates for these three PIM were -3.80%, -14.86%, and +18.54%, respectively, depending on the geographic region. Alprazolam and fluoxetine were mostly prescribed to older women, whereas rivaroxaban was mostly prescribed to older men., Conclusions: These results emphasize the need to implement initiatives and interventions to decrease PIM prescriptions in older adults., (© 2022 The Author(s).)

Purpose: The complex combination of medicines associated with age-related physiological alterations leads older adults to experience drug-related problems (DRPs). The goal of this study was to review the frequency and type of DRPs and DRP risk factors in home-dwelling older adults., Methods: A MEDLINE PubMed and EMBASE scientific databases search was performed. Articles published from January 2000 through December 2018 reporting DRPs in home-dwelling older adults were included., Findings: From 668 articles screened, 13 met the inclusion criteria and were included in this study. Overall, the studies included 8935 home-dwelling patients. The mean number of DRPs per patient observed was 4.16 (1.37-10). The main causes of DRPs were "drug selection" (51.41%), "dose selection" (11.62%), and "patient related" (10.70%) problems. The drug classes more frequently associated with DRPs were "cardiovascular system," "alimentary tract and metabolism," and "nervous system," and they represented 32.1%, 29.4%, and 16.5% of all drug selection problems, respectively. Respiratory system medicines accounted for 6.65% of all DRPs, of which "patient related" problems accounted for 97.28%., Implications: Despite the heterogeneity of methodology of the included studies and the heterogeneity of tools used to identify DRPs, this analysis clearly shows the high prevalence of DRPs in home-dwelling older adults and highlights the need for interventions to improve medicine use in this population. This work also provides useful information for the development of strategies to improve medication use in home-dwelling older adults., (Copyright © 2020. Published by Elsevier Inc.)

Purpose: The aim of this study was to perform a systematic review and meta-analysis of studies performed in primary care centers and hospital facilities that evaluated the effectiveness of computerized clinical decision support systems (CDSSs) in decision making on the prescription of any given antibiotic., Methods: We conducted a search of the MEDLINE and EMBASE databases. A meta-analysis was then conducted of all variables with results reported in >2 studies., Findings: A total of 42 of the 46 studies included in the review identified a statistically significant advantage for CDSSs in ≥1 study variables. The effect of CDSSs on the percentage accuracy of the antibiotic spectrum prescribed empirically with respect to the microbial agent's susceptibility, which is one of the most frequently studied outcome variables, was examined in 7 studies, all undertaken in hospital settings. In all these studies but one, CDSSs resulted in a statistically significant increase in percentage accuracy. The other study variables present in >2 studies had more inconsistent results. Although the results of the meta-analysis of the variables percentage accuracy, antibiotic prescription rate in hospital, percentage adherence to antibiotic prescription guidelines in primary care or hospital, and percentage of inappropriate prescriptions for antibiotics in primary care were statistically significantly favorable to CDSSs; in the case of hospital length of stay and mortality, they were favorable although not statistically significantly., Implications: CDSSs appear to be useful for variables such as the percentage of appropriate empirical treatment in the hospital setting or to induce changes in antibiotics prescription rate. Even so, more better quality studies are required to draw clearer conclusions in respect of morbidity and mortality outcome variables and other settings., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Brazilian pharmacovigilance regulations involve 3 spheres: health services, Marketing Authorization Holders (MAHs), and sanitary agency. Drug tolerability began to be effectively assessed in Brazil after the founding of the National Agency of Sanitary Surveillance, which developed the Sentinel Network Project. The objective of the Sentinel Network Project is to increase the adverse drug reaction (ADR) reporting rate by health care professionals in the hospital setting. Pharmacovigilance practices became mandatory for MAHs, and patient tolerability issues were considered in drug policy in Brazil only as recently as 2000. However, despite recent events, the regulatory advancements in pharmacovigilance in Brazil are only equivalent to international practices (ie, those of the European Union). The pharmacovigilance system in the European Union integrates the national authorities, the European Commission, and the European Medicines Agency, which is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the European Union. Furthermore, ADR patient reporting is included in the new EU pharmacovigilance regulations. Numerous possible ways are available to improve the Brazilian pharmacovigilance system, mainly through regulations of biosimilar, nanotechnology, and veterinary medicines or by training health care professionals and patients to report nonserious cases and quality deviations. It is necessary to encourage and develop strategies for decentralizing pharmacovigilance actions in the whole country, as is common practice in several EU countries. Motivating and considering ADR reports by patients and improving feedback and audit practices in health care services and MAHs are also necessary measures. With the inclusion of Brazil as a member of the International Conference of Harmonization, significant changes in pharmacovigilance regulation are expected; these updates, which will consider international standards, will improve signal detection and risk communication., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: This study explored the performance of trigger in detecting adverse drug reactions (ADRs), the confounding variables impairing the causal association of the ADRs, and the underreporting rate by hospital health professionals., Methods: A 6-month cross-sectional study was conducted in a public general hospital. Data collection was conducted in 2 stages: (1) screening of patient hospitalizations to identify suspected ADRs with 9 triggers developed by the Institute of Healthcare Improvement; and (2) chart review to perform the causality assessment of the suspected ADRs identified, to describe the confounding variables associated with detection of suspected ADRs that were not drug induced, and to analyze the positive predictive value of triggers in recognizing ADRs. To estimate the underreporting rate, ADRs detected by using the tool were compared with ADRs reported by health professionals during the same period., Findings: During the study period, 3318 hospitalizations were analyzed. A total of 837 suspected ADRs were identified. However, after causality assessment, 356 were definite ADRs. Confounding variables associated with the detection-suspected ADRs were related to the clinical conditions of inpatients. The use of triggers contributed to increased ADR detection by 10.5%. The performance ranged from 0.00 to 0.75, with an overall positive predictive value of 0.43. Six ADRs were spontaneously reported, of which just 1 was also detected by using the trigger tool. Only 1 of 356 potential ADRs was reported by health professionals., Implications: Findings show that the use of triggers contributes to detecting ADRs underreported by health professionals. However, confounding variables impaired the performance of the tool because they underestimated the causal association. Furthermore, both methods are complementary to early recognition of drug-induced harm and should be applied together in health institutions to contribute to policies of risk management, drug safety, and optimization of pharmacotherapy., (Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.)

Purpose: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED)., Methods: From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required., Findings: In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety., Implications: The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances., (Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.)

Purpose: The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED)., Methods: We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code., Findings: A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked., Implications: The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches., (Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.)

Purpose: The emergence of microbial resistance is widely associated with inappropriate antibiotic use. Self-medication with antibiotics acquired directly from pharmacies without a medical prescription has been reported by several European countries as being an important cause of such inappropriate use. The goal of this study was to identify and evaluate community pharmacists׳ attitudes toward and knowledge of antibiotics and microbial resistance and to assess what influence, if any, these attitudes might have on their propensity to dispense unprescribed antibiotics., Methods: We conducted a cross-sectional study covering all community pharmacists registered with the Official College of Pharmacists in Portugal׳s Central Region. A self-administered questionnaire on attitudes toward microbial resistance and antibiotic use was mailed to 1197 pharmacists. Responses ranged from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to model the association between respondents׳ attitudes and their propensity to dispense antibiotics without an earlier medical prescription., Findings: The overall response rate was 64.8%. Agreement with the dispensing of unprescribed antibiotics was highest in the case of dental diseases and ailments, followed by urinary tract infections. Although none of the sociodemographic data were associated with a propensity to dispense antibiotics without a medical prescription, the attitudes shown to be significantly associated with this propensity were complacency about patients, responsibility of others, and precaution or fear., Implications: Because the attitudes of community pharmacists can influence their readiness to dispense unprescribed antibiotics, educational interventions addressing such attitudes should be implemented to improve antibiotic use., (Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.)