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1.
Drug Saf ; 2024 May 07.
Article in English | MEDLINE | ID: mdl-38713347

ABSTRACT

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.

2.
Drug Saf ; 2024 May 07.
Article in English | MEDLINE | ID: mdl-38713346

ABSTRACT

BACKGROUND AND AIM: Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts. METHODS: We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting. RESULTS: Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts. CONCLUSIONS: The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.

3.
Int J Neuropsychopharmacol ; 27(4)2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38600711

ABSTRACT

BACKGROUND: The association between use of antipsychotics and COVID-19 outcomes is inconsistent, which may be linked to use of these drugs in age-related diseases. Furthermore, there is little evidence regarding their effect in the nongeriatric population. We aim to assess the association between antipsychotic use and risk of disease progression and hospitalization due to COVID-19 among the general population, stratifying by age. METHODS: We conducted a population-based, multiple case-control study to assess risk of hospitalization, with cases being patients with a PCR(+) test who required hospitalization and controls being individuals without a PCR(+) test; and risk of progression to hospitalization, with cases being the same as those used in the hospitalization substudy and controls being nonhospitalized PCR(+) patients. We calculated adjusted odds-ratios (aOR) and 95% confidence intervals (CI), both overall and stratified by age. RESULTS: Antipsychotic treatment in patients younger than 65 years was not associated with a higher risk of hospitalization due to COVID-19 (aOR 0.94 [95%CI = 0.69-1.27]) and disease progression among PCR(+) patients (aOR 0.96 [95%CI = 0.70-1.33]). For patients aged 65 years or older, however, there was a significant, increased risk of hospitalization (aOR 1.58 [95% CI = 1.38-1.80]) and disease progression (aOR 1.31 [95% CI = 1.12-1.55]). CONCLUSIONS: The results of our large-scale real-world data study suggest that antipsychotic use is not associated with a greater risk of hospitalization due to COVID-19 and progression to hospitalization among patients younger than 65 years. The effect found in the group aged 65 years or older might be associated with off-label use of antipsychotics.


Subject(s)
Antipsychotic Agents , COVID-19 , Hospitalization , Humans , Antipsychotic Agents/therapeutic use , Male , Female , Middle Aged , Aged , COVID-19/epidemiology , Case-Control Studies , Hospitalization/statistics & numerical data , Age Factors , Adult , Disease Progression , Aged, 80 and over , COVID-19 Drug Treatment , Outpatients
4.
Eur J Clin Pharmacol ; 80(4): 603-612, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38319349

ABSTRACT

PURPOSE: This study aims to identify PIM prevalence in older adults according to the 2019 Beers criteria, Screening Tool of Older Person's Prescriptions version 2 (STOPP v2) criteria, and the Portuguese EU(7)-PIM list and also to analyze the concordance between these criteria. METHODS: A retrospective study was conducted among 1200 Portuguese older adults (≥ 65 years old), users of primary health care. Demographic, clinical, and pharmacological data were collected concerning the period between April 2021 and August 2022. A comparative analysis was performed between the three PIM identification criteria, and the concordance was determined according to the Lin concordance correlation coefficient. RESULTS: The mean age was 76.3 (SD 7.7) years old and 57.6% of the older adults were females. Our findings indicate varying prevalence rates among these criteria with 63.8% (95% CI 61.0-66.6%), 66.8% (95% CI 64.1-69.5%), and 50.1% (95% CI 47.2-53.0%) of the older adults take at least one PIM according to the EU(7)-PIM list, Beers 2019, and STOPP v2 criteria, respectively. The highest prevalence observed was for proton pump inhibitors according to EU(7)-PIM list (30.1%, 95% CI 27.6-32.9) and Beers criteria (30.1%, 95% CI 27.6-32.9) and alprazolam according to STOPP v2 criteria (10.1%, 95% CI 8.4-11.9%). A poor concordance between criteria was observed (< 0.834). The highest concordance coefficient was found between the EU(7)-PIM list and the Beers criteria (0.833), and the lowest between the EU(7)-PIM list and STOPP criteria (0.735). CONCLUSION: This study reveals varying prevalence rates of PIM in older adults, as assessed by different criteria, and highlights the need for targeted interventions and improved prescribing practices. In the future, studies should focus on the occurrence of negative outcomes in older adults associated with PIM consumption.


Subject(s)
Inappropriate Prescribing , Potentially Inappropriate Medication List , Female , Humans , Aged , Child , Male , Retrospective Studies , Portugal , Primary Health Care
5.
Digit Health ; 10: 20552076231225133, 2024.
Article in English | MEDLINE | ID: mdl-38250145

ABSTRACT

Objective: Digital health is described as the use and development of all types of digital technologies to improve health outcomes. It could be used to prevent medication errors, a priority for health systems worldwide. However, the adoption of such tools remains slow. This study aims to identify factors (attitudes, knowledge and beliefs) acting as barriers and/or facilitators reported by healthcare professionals (HCPs) for the adoption of digital health-related tools for medication appropriateness. Methods: A systematic review was performed by searching the literature in the MEDLINE PubMed, and EMBASE scientific databases for original articles regarding qualitative and quantitative data. Results: Fifteen articles were included and a total of 125 barriers and 108 facilitators were identified, consolidated and categorized into technical (n = 48), organizational (n = 12), economical (n = 4), user-related (n = 34), and patient-related (n = 8) components. The most often reported barriers and facilitators were technical component-related ones concerning the need for additional training (n = 6), the time consumed (n = 6), and the easy way of using or learning how to use the tools (n = 9), respectively. Regarding setting analysis, agreement with clinical decision recommendations and impact on the doctor-patient relationship were more valued in primary care, while the user interface and system design were in the hospital. Conclusions: The barriers and facilitators identified in this study provide relevant information to developers and it can be used as a starting point for the designing of successful digital health-related tools, specifically related to medication appropriateness. Future research includes economic evaluation-focused studies and in-depth case studies of specific barriers and facilitators.

6.
Clin Ther ; 46(2): e54-e58, 2024 02.
Article in English | MEDLINE | ID: mdl-38061931

ABSTRACT

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.


Subject(s)
Gastrointestinal Diseases , Proton Pump Inhibitors , Humans , Aged , Proton Pump Inhibitors/adverse effects , Portugal , Retrospective Studies , Cross-Sectional Studies , Gastrointestinal Diseases/chemically induced , Primary Health Care
7.
Lancet Healthy Longev ; 4(12): e724-e729, 2023 12.
Article in English | MEDLINE | ID: mdl-37977177

ABSTRACT

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E7, the guidance for the conduct of clinical trials in people older than age 65 years, dates from 1994. Since then, the inclusion of older people in clinical trials has hardly improved, particularly for the oldest old age group (individuals older than age 75 years), which is the fastest growing demographic bracket in the EU. Even though most medications are taken by this group, relevant endpoints and safety outcomes for this cohort are rarely included and reported, both in clinical trials and regulatory approval documents. To improve the critical appraisal and the regulatory review of medicines taken by frail older adults, eight recommendations are presented and discussed in this Health Policy. These recommendations are brought together from different perspectives and experience of the treatment of older patients. On one side, the perspective of medical practitioners from various clinical disciplines, with their direct experience of clinical decision making; on the other, the perspective of regulators assessing the data submitted in medicine registration dossiers, their relevance to the risk-benefit balance for older patients, and the communication of the findings in the product information. Efforts to improve the participation of older people in clinical trials have been in place for more than a decade, with little success. The recommendations presented here are relevant for stakeholders, authorities, pharmaceutical companies, and researchers alike, as the implementation of these measures is not under the capacity of a single entity. Improving the inclusion of frail older adults requires awareness, focus, and action on the part of those who can effect a much needed change.


Subject(s)
Frailty , Aged, 80 and over , Aged , Humans , Frail Elderly , Communication
8.
Antioxidants (Basel) ; 12(10)2023 Oct 04.
Article in English | MEDLINE | ID: mdl-37891907

ABSTRACT

Male infertility is a prevalent concern affecting couples worldwide. While genetic factors, hormonal imbalances, and reproductive system defects play significant roles, emerging evidence suggests that lifestyle choices also profoundly impact male fertility. This study aimed to explore the effects of several lifestyle factors, including tobacco and alcohol consumption, physical activity, and dietary habits, on semen quality parameters and molecular biomarkers. Thirty healthy male volunteers were recruited in the Urology service at Hospital Infante D. Pedro, Aveiro, Portugal. Participants completed lifestyle questionnaires and provided semen samples, which were analyzed according to the World Health Organization criteria by experienced technicians. We also analyzed the expression levels of antioxidant enzymes and heat-shock response-related proteins to explore the activation of signaling pathways involved in stress response within sperm cells. Our results revealed that tobacco consumption reduced semen volume and total sperm count. Although the changes in the percentage of total motility and normal morphology in the smokers' group did not reach statistical significance, a slight decrease was observed. Moreover, we identified for the first time a significant association between tobacco consumption and increased levels of heat shock protein 27 (HSP27) and phosphorylated HSP27 (p-HSP27) in sperm cells, indicating the potential detrimental effects of tobacco on the reproductive system. This study highlights that lifestyle factors reduce semen quality, possibly by inducing stress in sperm, raising awareness about the effects of these risk factors among populations at risk of male infertility.

9.
Neurotoxicol Teratol ; 100: 107302, 2023.
Article in English | MEDLINE | ID: mdl-37739188

ABSTRACT

Mercury (Hg) is a global contaminant affecting aquatic ecosystems' health. Chronic exposure to Hg has shown that the normal development of zebrafish embryo-larvae is affected. However, the molecular mechanisms behind the toxicity of Hg on fish embryonic development are still poorly understood. This work aimed to investigate the effects of Hg exposure on zebrafish embryo-larvae using a combined approach at individual (mortality, embryo development and locomotor behavior) and biochemical (neurotoxicity and oxidative stress enzymatic activities and protein phosphatase expression) levels. The Fish Embryo Toxicity assay followed the Organization for Economic Cooperation and Development Guideline 236 and used a concentration range between 13 and 401 µg Hg/L. Lethal and developmental endpoints were examined at 24, 48, 72 and 96 hpf. Biochemical markers, including Acetylcholinesterase (AChE), Catalase (CAT), Glutathione Reductase (GR), and Glutathione-S-Transferase (GST) activities and, for the first time, the expression of the protein phosphatase 1 gamma (PP1γ) was assessed after 24, 48, 72 and 96 h of exposure to 10 and 100 µg Hg/L. The behavioral effects of a sublethal range of Hg (from 0.8 to 13 µg Hg/L) were assessed using an automated video tracking system at 120 hpf. Several developmental abnormalities on zebrafish embryos and larvae, including pericardial edema, spin and tail deformities and reduced rate of consumption of the yolk sac, were found after exposure to Hg (LC50 at 96 hpf of 139 µg Hg/L) with EC50 values for total malformations ranging from 22 to 264 µg Hg/L. After 96 hpf, no significant effects were observed in the CAT and GR activities. However, an increase in the GST activity in a concentration and time-dependent manner was found, denoting possible stress-related adaptation of zebrafish embryos to deleterious effects of Hg exposure. The AchE activity showed a response pattern in line with the behavioral responses. At the lowest concentration tested, no significant effects were found for the AChE activity, whereas a decrease in AChE activity was observed at 100 µg Hg/L, suggesting that exposure to Hg induced neurotoxic effects in zebrafish embryos which in turn may explain the lack of equilibrium found in this study (EC50 at 96 hpf of 83 µg Hg/L). Moreover, a decrease in the PP1γ expression was found after 96 h of exposure to 10 and 100 µg Hg/L. Thus, we suggest that Hg may be an inhibitor of PP1γ in zebrafish embryos-larvae and thus, along with the alterations in the enzymatic activity of GST, explain some of the developmental malformations observed, as well as the lack of equilibrium. Hence, in this study, we propose the use of PP1 expression, in combination with apical and biochemical endpoints, as a precursor for assessing Hg's toxic mechanism on embryonic development.


Subject(s)
Mercury , Water Pollutants, Chemical , Animals , Zebrafish , Acetylcholinesterase/metabolism , Larva , Ecosystem , Oxidative Stress , Embryo, Nonmammalian , Water Pollutants, Chemical/toxicity , Water Pollutants, Chemical/metabolism
10.
Int J Med Inform ; 177: 105124, 2023 09.
Article in English | MEDLINE | ID: mdl-37329766

ABSTRACT

INTRODUCTION: Differences in digital health literacy levels are associated with a lack of access to digital tools, usage patterns, and the ability to effectively use digital technologies. Although some studies have investigated the impact of sociodemographic factors on digital health literacy, a comprehensive evaluation of these factors has not been conducted. Therefore, this study sought to examine the sociodemographic determinants of digital health literacy by conducting a systematic review of the existing literature. METHODS: A search of four databases was conducted. Data extraction included information on study characteristics, sociodemographic factors, and the digital health literacy scales used. Meta-analyses for age and sex were conducted using RStudio software with the metaphor package. RESULTS: A total of 3922 articles were retrieved, of which 36 were included in this systematic review. Age had a negative effect on digital health literacy (B = -0.05, 95%CI [-0.06; -0.04]), particularly among older adults, whereas sex appeared to have no statistically significant influence among the included studies (B = - 0.17, 95%CI [-0.64; 0.30]). Educational level, higher income, and social support also appeared to have a positive influence on digital health literacy. DISCUSSION: This review highlighted the importance of addressing the digital health literacy needs of underprivileged populations, including immigrants and individuals with low socioeconomic status. It also emphasizes the need for more research to better understand the influence of sociodemographic, economic, and cultural differences on digital health literacy. CONCLUSIONS: Overall, this review suggests digital health literacy is dependent on sociodemographic, economic, and cultural factors, which may require tailored interventions that consider these nuances.


Subject(s)
Health Literacy , Humans , Aged , Health Status
11.
Drug Saf ; 46(7): 625-636, 2023 07.
Article in English | MEDLINE | ID: mdl-37277678

ABSTRACT

INTRODUCTION: Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic review showed the knowledge and attitudes of health professionals were strongly related with underreporting of ADRs. OBJECTIVE: Our aim was to update our previous systematic review to determine factors (sociodemographic, knowledge and attitudes) associated with the underreporting of ADRs by healthcare professionals. METHODS: We searched the MEDLINE and EMBASE databases for studies published between 2007 and 2021 that met the following inclusion criteria: (1) published in English, French, Portuguese or Spanish; (2) involving health professionals; and (3) the goal was to evaluate factors associated with underreporting of ADRs through spontaneous reporting. RESULTS: Overall, 65 papers were included. While health professional sociodemographic characteristics did not influence underreporting, knowledge and attitudes continue to show a significant effect: (1) ignorance (only serious ADRs need to be reported) in 86.2%; (2) lethargy (procrastination, lack of interest, and other excuses) in 84.6%; (3) complacency (the belief that only well tolerated drugs are allowed on the market) in 46.2%; (4) diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 44.6%; and (5) insecurity (it is nearly impossible to determine whether or not a drug is responsible for a specific adverse reaction) in 33.8%, and the absence of feedback in 9.2%. In this review, the non-obligation to reporting and confidentiality emerge as new reasons for underreporting. CONCLUSIONS: Attitudes regarding the reporting of adverse reactions continue to be the main determinants of underreporting. Even though these are potentially modifiable factors through educational interventions, minimal changes have been observed since 2009. CLINICAL TRIALS REGISTRATION: PROSPERO registration number CRD42021227944.


Subject(s)
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions , Humans , Health Personnel , Attitude of Health Personnel , Drug-Related Side Effects and Adverse Reactions/epidemiology , Health Knowledge, Attitudes, Practice , Pharmacovigilance
12.
Int J Clin Pharm ; 45(6): 1349-1358, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37247159

ABSTRACT

BACKGROUND: Spontaneous reporting is the most used method to monitor post-marketing safety information. Although patient involvement in spontaneous reporting has increased overtime, little is known about factors associated with patients' adverse drug reaction (ADR) reporting. AIM: To identify and assess the sociodemographic characteristics, attitudes and knowledge that influence spontaneous reporting and the reasons associated with ADR underreporting by patients. METHOD: A systematic review was conducted according to PRISMA guidelines. A search on the MEDLINE and EMBASE scientific databases was performed to retrieve studies published between 1 January 2006 and 1 November 2022. Studies were included if they addressed knowledge and attitudes associated with ADR underreporting. RESULTS: A total of 2512 citations were identified, of which 13 studies were included. Sociodemographic characteristics were frequently identified with ADR reporting in 6 studies, being age (3/13) and level of education (3/13) the most often reported. Older age groups (2/13) and individuals with higher level of education (3/13) were more likely to report ADRs. Underreporting was shown to be motivated by reasons related to knowledge, attitudes, and excuses. Ignorance (10/13), complacency (6/13), and lethargy (6/13) were the most frequent reasons for not reporting. CONCLUSION: This study highlighted the scarcity of research conducted with the aim of assessing ADR underreporting by patients. Knowledge, attitudes, and excuses were commonly observed in the decision to report ADRs. These motives are characteristics that can be changed; hence strategies must be designed to raise awareness, continually educate, and empower this population to change the paradigm of underreporting.


Subject(s)
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions , Humans , Aged , Surveys and Questionnaires , Health Knowledge, Attitudes, Practice , Pharmacovigilance , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology
13.
Curr Oncol ; 30(4): 4139-4152, 2023 04 11.
Article in English | MEDLINE | ID: mdl-37185428

ABSTRACT

Adverse drug reactions (ADRs) are responsible for almost 5% of hospital admissions, making it necessary to implement different pharmacovigilance strategies. The additional monitoring (AM) concept has been highlighted and intended to increase the number of suspected ADRs reported, namely in medicines with limited safety data. A prospective, descriptive study of active pharmacovigilance (AP) was conducted between 2019 and 2021 in the Local Health Unit of Matosinhos (LHUM) (Porto, Portugal). A model of AP for medicines under AM, namely oral antineoplastic agents, was designed. Follow-up consultations were performed, and adverse events (AEs) data were collected. The overall response to the treatment was evaluated through the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. A total of 52 patients were included in the study, and 14 antineoplastic drugs under AM were analyzed. Of the total number of patients included, only 29 developed at least one type of toxicity. Hematological disorders were the most reported suspected ADR. However, only four patients interrupted their treatment due to toxicity. After 12 months of treatment, most patients had disease progression, which was the main reason for therapy discontinuation. This AP model played an important role in the early detection of AEs and, consequently, contributed to better management of them. Increasing the number of suspected ADR reports is crucial for drugs with limited safety data.


Subject(s)
Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Humans , Pharmacovigilance , Prospective Studies , Follow-Up Studies , Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions/etiology , Antineoplastic Agents/adverse effects
14.
Clin Ther ; 45(7): e159-e166, 2023 07.
Article in English | MEDLINE | ID: mdl-37179194

ABSTRACT

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.


Subject(s)
Aspirin , Upper Gastrointestinal Tract , Humans , Case-Control Studies , Risk Factors , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antidepressive Agents/adverse effects , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/epidemiology
15.
Eur Neuropsychopharmacol ; 71: 96-108, 2023 06.
Article in English | MEDLINE | ID: mdl-37094487

ABSTRACT

The World Health Organization has proposed that a search be made for alternatives to vaccines for the prevention and treatment of COVID-19, with one such alternative being selective serotonin reuptake inhibitors (SSRIs). This study thus sought to assess: the impact of previous treatment with SSRI antidepressants on the severity of COVID-19 (risk of hospitalisation, admission to an intensive care unit [ICU], and mortality), its influence on susceptibility to SARS-CoV-2 and progression to severe COVID-19. We conducted a population-based multiple case-control study in a region in the north-west of Spain. Data were sourced from electronic health records. Adjusted odds ratios (aORs) and 95%CIs were calculated using multilevel logistic regression. We collected data from a total of 86,602 subjects: 3060 cases PCR+, 26,757 non-hospitalised cases PCR+ and 56,785 controls (without PCR+). Citalopram displayed a statistically significant decrease in the risk of hospitalisation (aOR=0.70; 95% CI 0.49-0.99, p = 0.049) and progression to severe COVID-19 (aOR=0.64; 95% CI 0.43-0.96, p = 0.032). Paroxetine was associated with a statistically significant decrease in risk of mortality (aOR=0.34; 95% CI 0.12 - 0.94, p = 0.039). No class effect was observed for SSRIs overall, nor was any other effect found for the remaining SSRIs. The results of this large-scale, real-world data study indicate that, citalopram, could be a candidate drug for being repurposed as preventive treatment aimed at reducing COVID-19 patients' risk of progressing to severe stages of the disease.


Subject(s)
COVID-19 , Selective Serotonin Reuptake Inhibitors , Humans , Selective Serotonin Reuptake Inhibitors/therapeutic use , Citalopram/therapeutic use , Case-Control Studies , Drug Repositioning , SARS-CoV-2
16.
Antibiotics (Basel) ; 12(3)2023 Feb 24.
Article in English | MEDLINE | ID: mdl-36978321

ABSTRACT

Antibiotic resistance is an issue of growing importance in the public health sphere. Medical interns are of great relevance when it comes to the source of this problem. This study therefore sought to ascertain which factors influence the management of antibiotic therapy by this population, in order to pinpoint the possible causes of misprescribing habits. We conducted a qualitative study based on focus group techniques, with groups consisting of medical interns from the Santiago de Compostela Clinical University Teaching Hospital. Our study identified factors which the participants considered to be determinants of antibiotic use and their relationship with the appearance of resistance. The single most repeated factor was the influence of the attending physician's judgement; other factors included a high healthcare burden or prescribing inertia. This stage is an opportunity to correct misprescribing habits, by implementing educational interventions aimed at modifying the identified factors.

17.
Article in English | MEDLINE | ID: mdl-36981864

ABSTRACT

Aging is associated with an increase in the prevalence of chronic diseases and polypharmacy, and with the prescription of potentially inappropriate medications (PIMs). This study aimed to analyze the variation in PIMs from hospital admission to discharge. A retrospective cohort study was conducted on inpatients of an internal medicine service. According to the Beers criteria, 80.7% of the patients had been prescribed at least one PIM at admission and 87.2% at discharge; metoclopramide was the most-prescribed PIM from admission to discharge, and acetylsalicylic acid was the most-deprescribed one. According to the STOPP criteria, 49.4% of patients had been prescribed at least one PIM at admission and 62.2% at discharge; quetiapine was the most-prescribed PIM from admission to discharge, and captopril was the most-deprescribed one. According to the EU(7)-PIM list, 51.3% of patients had been prescribed at least one PIM at admission and 70.3% at discharge, and bisacodyl was the most-prescribed PIM from admission to discharge and propranolol the most-deprescribed one. It was found that the number of PIMs at discharge was higher than at admission, suggesting the need to develop a guide with adapted criteria to be applied in an internal medicine service.


Subject(s)
Inappropriate Prescribing , Potentially Inappropriate Medication List , Humans , Aged , Retrospective Studies , Portugal , Hospitalization
18.
Antimicrob Resist Infect Control ; 12(1): 20, 2023 03 20.
Article in English | MEDLINE | ID: mdl-36941734

ABSTRACT

BACKGROUND: Dentist play an important role in misuse of antibiotics. Identification of the dental activities linked to the misuse of antibiotics is important for improving dentists' prescribing quality. The aim of the study was to quantify the magnitude of inappropriate antibiotic prescribing by dentists in Spain and identify the characteristics, knowledge and attitudes that influence prescribing quality. MATERIAL AND METHODS: We conducted a cross-sectional, questionnaire-based study on dentists in Spain, assessing prescribing quality (dependent variable) on the basis of their responses about the prescription of antibiotics in 14 clinical situations. As the independent variables, we assessed professional characteristics and attitudes (lack of knowledge, fear, complacency, scheduling problems, and economic benefit) measured on a Likert scale. Odds Ratios (OR) (95%CI) were calculated using logistic regression. RESULTS: A total of 878 participants were included in the analysis. Half of all dentists displayed inappropriate antibiotic prescribing habits in more than 28.6% (10/14) of the clinical situations posed (interquartile range 57-79%). Prescribing quality increased when resistance was perceived as a public health problem (OR 0.88, 95% CI: 0.79-0.97), and decreased in response to fear (OR 1.12, 95% CI:1.07-1.18) or the pursuit of economic benefit (OR 1.07, 95% CI 1.01-1.14). Having over 30 years' experience (OR 4.58, 95% CI:1.80-12.48) and/or practising in the field of prosthodontics as opposed to endodontics (OR 2.65, 95% CI:1.26-5.71) were associated with worse prescribing quality. CONCLUSIONS: Antibiotics are the most commonly prescribed drugs in dentistry, and in many cases this prescription is inappropriate. Our findings shows that modifiable factors influence prescribing quality among dentists in Spain. These may be use for designing educational and training programmes for dentists.


Subject(s)
Anti-Bacterial Agents , Dentists , Humans , Anti-Bacterial Agents/therapeutic use , Cross-Sectional Studies , Inappropriate Prescribing , Practice Patterns, Dentists' , Dentistry
19.
Clin Ther ; 45(2): e89-e99.e2, 2023 02.
Article in English | MEDLINE | ID: mdl-36775690

ABSTRACT

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.


Subject(s)
Anti-Asthmatic Agents , Asthma , COVID-19 , Humans , COVID-19/epidemiology , Anti-Asthmatic Agents/therapeutic use , Pandemics , Bronchodilator Agents/therapeutic use , Portugal/epidemiology , Asthma/drug therapy , Asthma/epidemiology , Anti-Inflammatory Agents/therapeutic use
20.
Arch. endocrinol. metab. (Online) ; 67(1): 136-142, Jan.-Feb. 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1420103

ABSTRACT

Abstract Objectives: The aim of this study is to develop and validate a novel clinical report form in the format of a structured interview to enable the characterization of the Portuguese population of the Baixo Vouga region with different subtypes of nodular thyroid pathologies (NTyPs). Materials and methods: A structured interview was developed and to the best of our knowledge, this is the first structured interview built and validated for that purpose in Portugal. Results: This structured interview enables the identification of possible correlations between each subtype of nodular lesions and sociodemographic data, consumption habits and lifestyle, endocrine history, and family predisposition. Conclusion: The novel structured interview will simultaneously, enable a detailed characterization of the group of patients with nodular thyroid lesions and will support future metabolomic studies.

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