50 results on '"Torre, Carla"'
Search Results
2. COVID-19 pandemic and the consumption of self-care products for pediculosis capitis in Portugal: an interrupted time-series analysis
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Almeida, Diogo, Rodrigues, Antonio Teixeira, Guerreiro, Jose Pedro, Bałkowiec-Iskra, Ewa, Vander Stichele, Robert, Sepodes, Bruno, and Torre, Carla
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- 2024
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3. Factors associated with underreporting of adverse drug reactions by patients: a systematic review
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Costa, Catarina, Abeijon, Patricia, Rodrigues, Daniela A., Figueiras, Adolfo, Herdeiro, Maria Teresa, and Torre, Carla
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- 2023
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4. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
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García-Abeijon, Patricia, Costa, Catarina, Taracido, Margarita, Herdeiro, Maria Teresa, Torre, Carla, and Figueiras, Adolfo
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- 2023
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5. Tumor mutational burden in colorectal cancer: Implications for treatment
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Marques, Adriana, Cavaco, Patrícia, Torre, Carla, Sepodes, Bruno, and Rocha, João
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- 2024
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6. Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults
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Denkinger, Michael, Knol, Wilma, Cherubini, Antonio, Simonds, Anita, Lionis, Christos, Lacombe, Denis, Petelos, Elena, McCarthy, Mary, Ouvrard, Patrick, Van Kerrebroeck, Philip, Szymański, Piotr, Cupelli, Amelia, Laslop, Andrea, Koch, Armin, Sepodes, Bruno, Torre, Carla, Rönnemaa, Elina, Bałkowiec-Iskra, Ewa, Herdeiro, Maria Teresa, Rosa, Mário Miguel, Trauffler, Martine, Mirošević Skvrce, Nikica, Mayrhofer, Sabine, Berntgen, Michael, Silva, Ivana, and Cerreta, Francesca
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- 2023
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7. A review of the continuous professional development system for pharmacists
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Batista, Jorge P. B., Torre, Carla, Sousa Lobo, José Manuel, and Sepodes, Bruno
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- 2022
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8. Medicines for an aging population: The EMA perspective and policies.
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Cerreta, Francesca, Iskra, Ewa Balkowiec, Cupelli, Amelia, Sepodes, Bruno, Rönnemaa, Elina, Rosa, Mário Miguel, Mayrhofer, Sabine, Trauffler, Martine, Torre, Carla, Berntgen, Michael, Vucic, Katarina, Bahri, Priya, Koch, Armin, Herdeiro, Maria Teresa, Mirošević Skvrce, Nikica, Pallos, Julia, and Laslop, Andrea
- Abstract
The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre‐ and post‐approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Pharmacist's role in influenza immunisation: a scoping review.
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Parracha, Edna Ribeiro, Rodrigues, António Teixeira, Oliveira‐Martins, Sofia, Romano, Sónia, Almeida, Diogo, Sepodes, Bruno, and Torre, Carla
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Background: Community pharmacists have become flu vaccine immunisers in several countries to increase vaccine uptake. Aim: This study aimed to perform a scoping review to evaluate the pharmacist's role and contribution to flu immunisation coverage, satisfaction and promotion as vaccine providers. Design: The framework proposed by Arksey and O'Malley and the PRISMA Extension for Scoping Reviews (PRISMA‐ScR) were considered for this analysis. Two electronic databases (PubMed and Cochrane Library) were used to search for relevant peer‐reviewed quantitative, qualitative and mixed‐method studies published between 1990 and 2022. Results: A total of 37 studies were included. These studies suggested that, over time, there was an increase in the rate of vaccine administration within community pharmacies across the various countries examined. Moreover, patients have consistently expressed their satisfaction with the convenience and accessibility of pharmacy‐based vaccine services, with some expressing a preference for pharmacies over traditional visits to their general practitioner′s office. Conclusion: Several initiatives aimed at promoting flu vaccination have been rolled out in pharmacy settings, and a number of these initiatives have demonstrated positive outcomes. The flu vaccination service provided by pharmacists has proven to be an asset in public health by improving accessibility to immunisation services. Pharmacists should continue to take part in yearly flu vaccination programs as flu vaccine providers as they contribute to an increased uptake of immunisations by the population. Extending these services to other vaccines should be further considered. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Ebola outbreaks: A stress test of the preparedness of medicines regulatory systems for public health crises
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Amaral, Rafael, Torre, Carla, Rocha, João, and Sepodes, Bruno
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- 2021
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11. Drug-drug interactions and inappropriate medicines impact on glycemic control and kidney function in older adults with diabetes-attending specialty care institution
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AL-Musawe, Labib, Torre, Carla, Guerreiro, Jose Pedro, Rodrigues, Antonio Teixeira, Raposo, Joao Filipe, Mota-Filipe, Helder, and Martins, Ana Paula
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- 2021
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12. Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU.
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Almeida, Diogo, Umuhire, Denise, Gonzalez-Quevedo, Rosa, António, Ana, Garcia Burgos, Juan, Verpillat, Patrice, Bere, Nathalie, Sepodes, Bruno, and Torre, Carla
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- 2024
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13. The association between polypharmacy and adverse health consequences in elderly type 2 diabetes mellitus patients; a systematic review and meta-analysis
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AL-Musawe, Labib, Martins, Ana Paula, Raposo, Joao Filipe, and Torre, Carla
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- 2019
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14. Health-related quality of life in adults with type 2 diabetes mellitus starting with new glucose lowering drugs: An inception cohort study
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Torre, Carla, Guerreiro, José, Longo, Patrícia, Raposo, João Filipe, Leufkens, Hubert, and Martins, Ana Paula
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- 2019
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15. Real-world prevalence of mild to moderate hypoglycemic episodes in type 2 diabetes in Portugal: Results from the HIPOS-PHARMA study
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Torre, Carla, Guerreiro, José Pedro, Romano, Sónia, Miranda, Ana, Longo, Patrícia, Alão, Sílvia, Conceição, João, and Laires, Pedro
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- 2018
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16. Patterns of glucose lowering drugs utilization in Portugal and in the Netherlands. Trends over time
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Torre, Carla, Guerreiro, José, de Oliveira Martins, Sofia, Raposo, João Filipe, Martins, Ana Paula, and Leufkens, Hubert
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- 2015
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17. Treatment Advances in Sepsis and Septic Shock: Modulating Pro- and Anti-Inflammatory Mechanisms.
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Marques, Adriana, Torre, Carla, Pinto, Rui, Sepodes, Bruno, and Rocha, João
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SEPTIC shock , *IMMUNOTHERAPY , *SEPSIS , *IMMUNE checkpoint inhibitors , *IMMUNITY , *HOSPITAL mortality - Abstract
Sepsis is currently defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection, and it affects over 25 million people every year. Even more severe, septic shock is a subset of sepsis defined by persistent hypotension, and hospital mortality rates are higher than 40%. Although early sepsis mortality has greatly improved in the past few years, sepsis patients who survive the hyperinflammation and subsequent organ damage often die from long-term complications, such as secondary infection, and despite decades of clinical trials targeting this stage of the disease, currently, no sepsis-specific therapies exist. As new pathophysiological mechanisms have been uncovered, immunostimulatory therapy has emerged as a promising path forward. Highly investigated treatment strategies include cytokines and growth factors, immune checkpoint inhibitors, and even cellular therapies. There is much to be learned from related illnesses, and immunotherapy trials in oncology, as well as the recent COVID-19 pandemic, have greatly informed sepsis research. Although the journey ahead is a long one, the stratification of patients according to their immune status and the employment of combination therapies represent a hopeful way forward. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Correlation of the conformational structure and catalytic activity of the highly thermostable xylanase of Thermomyces lanuginosus PC7S1T.
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Della Torre, Carla Lieko, Silva-Lucca, Rosemeire Aparecida, Ferreira, Rodrigo da Silva, Andrade Luz, Luciana, Oliva, Maria Luiza Vilela, and Kadowaki, Marina Kimiko
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XYLANASES , *CATALYTIC activity , *MOLECULAR weights , *TERTIARY structure , *CIRCULAR dichroism , *DENATURATION of proteins - Abstract
Thermomyces lanuginosus PC7S1T xylanase was purified after four chromatographic steps involving columns of ion exchange and molecular filtration. The purified xylanase revealed the molecular mass to be 21.3 kDa, high specificity for beechwood xylan and its main hydrolysis products were xylobiose and xylotriose. Xylanase exhibited increased activity at pH 6.5 and a temperature of 75 °C and was stable-over a wide range of pHs (100 hours) and temperatures (3 hours at 75 °C). Circular dichroism spectrum deconvolution showed a β-structure-rich secondary structure with a melting temperature of 73 °C. In addition, its secondary structure was preserved, even at extreme pHs and temperatures up to 70 °C in the presence of MnCl2 (1 mM), DTT (5 mM) and high concentrations of guanidine (6 M). On the other hand, changes in the tertiary structure of the enzyme, which was monitored using intrinsic and/or extrinsic fluorescence (ANS probe), in the presence of MnCl2, DTT and extreme values of pH may be related to variations in enzyme activity. Therefore, T. lanuginosus PC7S1T xylanase exhibited resistance to high temperatures, observed through its ability to remain active and demonstrate a high-degree of rigidity and resistance to denaturation; very extreme conditions were necessary in order to change the enzymes' secondary and/or tertiary structures. [ABSTRACT FROM AUTHOR]
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- 2023
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19. A cross-country utilization patterns comparison of high expenditure therapeutic groups between Portugal and six European countries: the two sides of the Portuguese coin.
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Martinho, Inês, Teixeira Rodrigues, António, Guerreiro, José, Rocha, João, Sepodes, Bruno, and Torre, Carla
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Understanding variability in prescribing patterns through comparative drug utilization studies can contribute to improve an efficient, effective and safe use of medicines. To perform a cross-country comparison of consumption patterns of ambulatory high expenditure therapeutic groups between Portugal and six European countries and simulate potential cost-saving scenarios through the adoption of the different prescribing patterns of studied countries. Cross-country comparison of 2019 drug consumption patterns between Portugal, Denmark, England, Finland, the Netherlands, Norway, and Spain. Analysis comprised antihypertensive drugs, glucose lowering drugs (GLD), insulins, lipid lowering drugs (LLD) and oral anticoagulants. Cost-saving analysis were performed using the Portugal average annual cost/daily defined dose and the potential reduction in expenditure simulating other European countries consumption pattern scenarios. Portugal had the lowest consumption uptake of metformin and the highest consumption of GLD (30.1%) and LLD (8.5% vs <3%) fixed-dose combinations. Annual cost-savings scenarios showed that Portugal would have saved between 53 M€ and 305 M€ if it had the same prescribing patterns than Norway or the Netherlands, respectively. Different utilization patterns across countries were found. Although Portugal has the lowest gross domestic product per capita among the countries studied, it had the highest uptake of newly and costly drugs. [ABSTRACT FROM AUTHOR]
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- 2023
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20. Predicting Resting Energy Expenditure in Healthy Puerto Rican Adults
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de la Torre, Carla L., Ramírez-Marrero, Farah A., Martínez, Lucía R., and Nevárez, Carmen
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- 2010
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21. Latino Parent Leadership: Through the Eyes of Latino Parent Leaders
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de la Torre, Carla
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Educational leadership ,Education ,Educational administration ,Latino parent engagement ,Latino parent leadership ,Latino parent participation - Abstract
The impact of parental involvement in a child’s academic success has been well-documented; however there is considerably less research that focuses specifically on Latino parent engagement and its potential to improve schools given the rising numbers of Latino students attending U.S. schools. Few studies have focused on the strengths that Latino families pass onto their children and how those strengths can be leveraged to better connect schools with Latino parents and develop schools where students feel their parents are respected (Rioja-Cortez & Bustos Flores, 2009). This research study set out to explore Latino parent engagement through the eyes of Latino parent leaders within one school district. The purpose of this research study was to identify and analyze how and why Latino parents become engaged within a school and district culture; in addition to learning what potential factors may exist that move Latino parents along a continuum of involvement and engagement into leadership and change agency. The researcher was interested in learning about Latino parent leadership, based on a hypothesis that Latino parent leadership may have the potential to impact the schooling experiences for Latino children and their families. A review of existing literature on parental engagement among Latinos, helped to develop a conceptual framework where four major themes emerge: 1.) Parent engagement produces more positive outcomes than traditional types of parent involvement; 2.) School personnel and Latino parents differ in their perceptions regarding what constitutes as parent involvement; 3.) Latino parents utilize culturally embedded strategies to promote their children’s education; and 4.) Home-based forms of engagement have been found to be more effective than school-based involvement. The four themes came together to shape a conceptual framework where whenever Latino parent backgrounds were valued and treated as legitimate sources of strength and when these Latino parents could identify with these strengths and use these strengths to connect with new forms of school information and knowledge, Latino parent leadership could be born and develop. In short, this study seeks to better understand Latino parent engagement and leadership as experienced by a group of Latino parent leaders in one school district.
- Published
- 2015
22. Low Persistence with Oral Bisphosphonate Treatment in Portuguese Women with Postmenopausal Osteoporosis: 993.
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Torre, Carla, Guerreiro, José, Mendes, Zilda, Miranda, Ana, Canhão, Helena, Branco, Jaime, Machado, Manuela, Ferreira, I, Feudjo-Tepie, M, and Cristino, Joaquim
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- 2013
23. Burnout in the Pharmaceutical Activity: The Impact of COVID-19.
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Santos, Pedro Machado dos, Silva, Claudia Ribeiro da, Costa, Diana, and Torre, Carla
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PSYCHOLOGICAL burnout ,PSYCHOLOGICAL distress ,MEDICAL personnel ,COVID-19 ,MASLACH Burnout Inventory ,SECONDARY traumatic stress - Abstract
Importance: Pharmacists are among the healthcare professionals involved in the response to the COVID-19 pandemic, maintaining essential services. In the context of restrictions and reorganization of human resources, as a result of policies recently applied to the health sector, following international guidelines, and given the scarcity of data on burnout in pharmaceutical activity, it was considered highly relevant to promote a nationwide survey aiming to collect more complete evidence on the burnout syndrome and to understand how pharmacists have viewed their work and the people they worked closely with. Objectives: The study aimed to assess the occurrence of pharmacist burnout and determine outcomes for each of its dimensions; identify potentially associated characteristics; and determine profiles and critical limits. Design: A cross-sectional observational study conducted by a multidisciplinary panel from the Portuguese Pharmaceutical Society (PPS). Professionals from community and hospital pharmacies who were at the forefront of the COVID-19 response were involved in (i) confirming the need and pertinence for conducting this research, (ii) identifying the main factors leading to pharmaceutical emotional distress ("burnout"), and (iii) disseminating the survey. The questionnaire was designed for digital voluntary, confidential, and anonymous participation and divided into four segments of data collection: (i) demographics, (ii) employment and workplace characterization, (iii) pandemic impact on labor activity, and (iv) burnout assessment (as described ahead). Setting: An electronic survey was addressed to all PPS members, and an account was created solely to manage the questionnaire data for the research team. The web-based and user-friendly platform Google Forms supported the data capture and provided an intuitive interface for validated data entry. Participants: In a population of 15,565 pharmacists (members of the PPS), the minimum recommended sample size (Epi Info software), with a 5% margin of error and a 99.9% confidence interval, should be 1,012 individuals. A total of 1,362 pharmacists participated in the study. Of these, 91.4% (n = 1,246) were involved in direct patient care activity and 7.7% (n = 106) in non-direct patient care activity. [ABSTRACT FROM AUTHOR]
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- 2022
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24. Levels And Determinants Of Physical Activity In Puerto Rican Adolescent Girls: 3023: Board #170 May 30 9:30 AM - 11:00 AM
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Alvarez, Amaury J., de la Torre, Carla L., and Ramirez-Marrero, Farah A.
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- 2009
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25. Overtreatment and undertreatment in a sample of elderly people with diabetes.
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AL‐Musawe, Labib, Torre, Carla, Guerreiro, Jose Pedro, Rodrigues, Antonio Teixeira, Raposo, Joao Filipe, Mota‐Filipe, Helder, and Martins, Ana Paula
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Aims: In older adults with type 2 diabetes (T2D), overtreatment remains prevalent and undertreatment ignored. The main objective is to estimate the prevalence and examine factors associated with potential overtreatment and undertreatment. Method: Observational study conducted within an administrative database of older adults with T2D who registered in 2018 at the Portuguese Diabetes Association. Participants were categorized either as potentially overtreated (HbA1c ≤ 7.5%), appropriately on target (HbA1c ≥7.5 to ≤9%), or potentially undertreated (HbA1c > 9%). Results: The study included 444 participants: potential overtreatment and undertreatment were found in 60.5% and 12.6% of the study population. Taking the patients on target as a comparator, the group of potentially overtreated showed to be more men (61.3% vs 52.2%), less‐obese (34.1% vs 39.2), higher cardiovascular diseases (13.7% vs 11%), peripheral vascular diseases (16.7% vs 12.8%), diabetic foot (10% vs 4.5%), and severe kidney disease (5.2% vs 4.5%). Conversely, the potentially undertreated participants were more women (64.2% vs 47.7%), obese (49% vs 39.2%), had more dyslipidemia (69% vs 63.1%), peripheral vascular disease (14.2% vs 12.8%), diabetic foot (8.9% vs 4.5%), and infections (14.2% vs 11.9%). The odds of potential overtreatment were mostly decreased by 59% of women, 73.5% in those with retinopathy, and 86.3% in insulin, 65.4% sulfonylureas, and 66.8% in SGLT2 inhibitors users. Contrariwise, an increase in the odds of potential undertreatment was more than 4.8 times higher in insulin, and more than 3.1 times higher in sulfonylureas users. Conclusion: Potential overtreatment and undertreatment in older adults with T2D in routine clinical practice should guide the clinicians to balance the use of newer oral antidiabetic agents considering its safety profile regarding hypoglycemia. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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26. VACCINATION SERVICE IN THE PORTUGUESE PHARMACIES
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Jacinto, Isabel Pimenta, Costa, Suzete, Horta, Maria Rute, Mendes, Zilda, Torre, Carla, Guerreiro, José Pedro, and Queirós, Sónia Isabel
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Pharmacies ,lcsh:Therapeutics. Pharmacology ,flu ,vaccines’ administration ,immunization coverage ,lcsh:RM1-950 - Abstract
Community Pharmacies’ legal framework (regulated by the decree-law nº 307/2007, 31st August) established the possibility of provision of pharmaceutical services to promote health and well-being by pharmacies. Due to its characteristics in terms of access and geographical distribution, pharmacies are health providers which can contribute to increase the immunization coverage with benefits in terms of public health. In this article, it is described the national and international framework of the implementation of vaccination services in pharmacies and the results of its implementation. It is also conducted a reflection on strengthening the role of pharmacies and its contribution to the national targets for immunization coverage and public health.
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- 2015
27. Intensive monitoring in Portugal : a pharmacy-based model to assess in real-life conditions : the example of new glucose lowering drugs
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Torre, Carla, Martins, Ana Paula, 1965, and Leufkens, Hubert
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Ciências Médicas::Medicina Básica [Domínio/Área Científica] ,Teses de doutoramento - 2018 - Abstract
Tese de doutoramento, Farmácia (Farmacoepidemiologia), Universidade de Lisboa, Faculdade de Farmácia, 2018 Submitted by Amelia Janeiro (ajaneiro@reitoria.ul.pt) on 2018-08-30T15:51:23Z No. of bitstreams: 1 ulsd731977_td_Carla_Torre.pdf: 9941838 bytes, checksum: 80c8c18f9f93ea9779855b57ee200013 (MD5) Made available in DSpace on 2018-09-06T11:17:39Z (GMT). No. of bitstreams: 1 ulsd731977_td_Carla_Torre.pdf: 9941838 bytes, checksum: 80c8c18f9f93ea9779855b57ee200013 (MD5) Previous issue date: 2018
- Published
- 2017
28. Polypharmacy, potentially serious clinically relevant drug-drug interactions, and inappropriate medicines in elderly people with type 2 diabetes and their impact on quality of life.
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AL-Musawe, Labib, Torre, Carla, Guerreiro, Jose Pedro, Rodrigues, Antonio Teixeira, Raposo, Joao Filipe, Mota-Filipe, Helder, and Martins, Ana Paula
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TYPE 2 diabetes , *ACE inhibitors , *OLDER people , *POLYPHARMACY , *BENZODIAZEPINES , *SEROTONIN uptake inhibitors , *QUALITY of life - Abstract
The aim of the study is to investigate the patterns of polypharmacy, clinical‐relevant drug‐drug interactions (DDIs), and potentially inappropriate medicines (PIMs), and whether polypharmacy, potential serious clinically‐relevant DDIs, or PIMs can be associated with low quality of life (QoL) index scores of older adults with type 2 diabetes (T2D). A cross‐sectional study was conducted using data of 670 elderly T2D sub‐cohort from a nationwide pharmacy‐based intensive monitoring study of inception cohort of T2D in Portugal. 72.09% were found on polypharmacy (≥5 medicines). Participants on polypharmacy were mostly females (P = .0115); more obese (P = .0131); have more comorbid conditions (P < .0001); more diabetes complications (P < .0001); and use more of glucose lowering drugs (P = .0326); insulin (P < .0001); chronic medicines (P < .0001); and have higher diabetes duration (P = .0088) than those without polypharmacy. 10.59% of the participants were found to have potential serious clinically relevant DDIs. The most frequent drug‐combinations were angiotensin‐converting enzyme (ACE) inhibitors with angiotensin‐receptor blockers (ARBs), aspirin with Selective serotonin reuptake inhibitors (SSRIs), and clopidogrel with calcium channel blockers. PIMs are found in 36.11% of the participants. The most common PIMs were benzodiazepines, long‐acting sulfonylureas, and iron overdose. The adjusted multivariate models show that Polypharmacy, PIMs, and potential serious clinically relevant DDIs were associated with lower QoL index scores (OR 1.80 95% CI 1.15‐2.82), (OR 1.57 95% CI 1.07‐2.28), and (OR 1.34 95% CI 0.73‐2.48) respectively. The study shows that polypharmacy, potential serious clinical‐relevant DDIs, and PIMs may correlate with risk of reduced health related QoL outcome of older adults with T2D. [ABSTRACT FROM AUTHOR]
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- 2020
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29. Epidemiologic Investigation of Foodborne Outbreaks in Pharmacies: A Pilot Study
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Torre, Carla, Brazão, Roberto, Guerreiro, José, Gomes, Marta, Costa, Suzete, Oliveira, Luisa, and Viegas, Silvia
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Segurança Alimentar ,Foodborne outbreaks ,Pharmacie ,PORTFIR - Abstract
Introduction: The analysis of Foodborne Outbreaks (FBO) investigation data provides knowledge on food vehicles and contributive factors of human infections allowing their risk management. However, FBO are commonly underreported and alternative sources of information may prove useful. Purpose: To test the adequacy of Pharmacies as an information source to identify foods involved in FBO, their confection type and acquisition place as well as the main symptoms and medicines taken. Methods: Application of a FBO epidemiologic investigation inquiry to individuals with FBD suggestive symptoms that went to 249 Pharmacies all over Portugal looking for treatment, between 18th August and 15th de November 2014. Descriptive statistical analysis of the results was performed and absolute and relative frequencies measures of location and dispersion were calculated in the program SAS version 9.1. Results: From 270 validated inquiries collected online until 29 October, 72.9% of the individuals went to the Pharmacy as the first health resort (average age 44.1 years), 56.3% individuals reported moderate symptoms, namely diarrhea and 58.0% of individuals took anti-diarrheal. The most frequent place of consumption of the suspect food was home (51.5 %), restaurants (22.9%) and parties (13.4%) and the food was meat (21.6%) and vegetables (18.3%), mostly cooked. About 67% of the individuals reported that an average of other 4.6 individuals has consumed the same food and 29.6% of them showed the same symptoms. Significance: The findings are consistent with the Portuguese FBO investigation data reported to EFSA and therefore indicate that Pharmacies can be a valuable source of information about FBO and also support consumer food safety education in order to prevent FBO. QREN
- Published
- 2015
30. Effect of different methods for estimating persistence and adherence to new glucose-lowering drugs: results of an observational, inception cohort study in Portugal.
- Author
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Torre, Carla, Guerreiro, José, Longo, Patrícia, Raposo, João Filipe, Leufkens, Hubert, and Martins, Ana Paula
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PEOPLE with diabetes , *ADVERSE health care events , *PATIENT compliance , *DISEASE prevalence , *GLYCEMIC control - Abstract
Purpose: Several methods have been developed for assessing medication-taking behavior; understanding the determinants and variability in estimates obtained is crucial in interpreting results. We estimated persistence and adherence levels to new glucose-lowering drugs (GLDs) in type 2 diabetes mellitus (T2DM) patients using different methods: through the collection of pharmacy records and combining pharmacy records with self-reported data.Methods: We conducted a prospective observational cohort study of T2DM patients initiating a new GLD. Data were collected at baseline through interviews (demographic and clinical data). Follow-up data included pharmacy records (refill dates and medication possession) and telephone questionnaires (self-declared monitored GLD refill in another pharmacy, reasons for drug withdrawal). The cohort was divided into incident and prevalent new users. Persistence and adherence (proportion of days covered) were estimated for patients using pharmacy records exclusively (Method 1) and ≥1 self-declared statement of being persistent (Method 2). Log-rank tests were used to compare Kaplan–Meier curves of time to nonpersistence.Results: A total of 1,328 patients were recruited. When considering Method 1, 38.7% (95% confidence interval [95% CI]: 36.0–41.5) of patients were persistent, whereas combining with self-reported information, this estimate increased to 65.6% (95% CI: 62.9–68.2). Using Method 1, the risk of persistence failure was associated with using an oral GLD, living alone and living in a suburban/urban setting. Three hundred and twenty-seven (24.8%) patients stopped to use the inception GLD.Conclusion: Regardless of the method used, results indicated low levels of persistence and adherence to a new GLD; however, when combining self-reported information, higher estimates were obtained. Considering pharmacy records exclusively, prevalent new users, who were more complex patients in terms of T2DM disease but more likely to be pharmacy-loyal patients, were significantly more adherent than the incident new users. Barriers and reasons leading to GLD withdrawal, namely adverse drug event management, should be addressed, since they represent half of the reasons for treatment switching or discontinuation. [ABSTRACT FROM AUTHOR]
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- 2018
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31. Overview of Pharmacoepidemiological Databases in the Assessment of Medicines Under Real-Life Conditions
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Torre, Carla
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Medical / Epidemiology - Abstract
Overview of Pharmacoepidemiological Databases in the Assessment of Medicines Under Real-Life Conditions
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- 2012
32. Os Programas de Troca de Seringas no Contexto da Redução de Danos
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Torre,Carla
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programa de troca de seringas ,redução de danos ,syringe exchange programme ,harm reduction ,utilizadores de drogas injectáveis ,injecting drug users - Abstract
Injecting drug users (IDU) are particularly vulnerable to hepatitis C virus (HCV), human immunodeficiency virus (HIV) and other bloodborne infections as result of sharing contaminated injecting equipment. Providing access and encouraging utilization of all sterile injection paraphernalia for IDU is considered a fundamental component of an effective harm reduction programme. Twenty-five years after the implementation of the first official syringe exchange programme (SEP) in the world, providing IDU with access to sterile injection equipment remains a serious challenge in both developed and developing countries. The capacity of any given SEP to reach IDU is dependent on its particular characteristics. SEP are extremely diverse in their modes of operation, injecting equipment dispensation policies and availability of other services provided. Different modalities for improving injecting equipment delivery, such as conventional SEP in fixed-sites, community pharmacy-based distribution, dispensing machines and outreach programmes, have been developed to improve access to and utilization of sterile injecting equipment and to increase IDU choice. Understanding barriers and preferences to SEP access of IDU is essential to providing services which meet their needs. Os utilizadores de drogas injectáveis (UDI) são particularmente vulneráveis à infecção por vírus da hepatite C (VHC), por vírus da imunodeficiência humana (VIH) e a outras infecções de transmissão sanguínea, como resultado da partilha de material de injecção contaminado. A promoção do acesso e da utilização de toda a parafernália de injecção aos utilizadores de drogas injectáveis é considerada uma componente fundamental de um programa efectivo de redução de danos. Vinte e cinco anos após a implementação do primeiro programa oficial de troca de seringas (PTS) no mundo, o acesso dos UDI ao equipamento estéril de injecção continua a ser um sério desafio, quer nos países desenvolvidos quer nos países em vias desenvolvimento. A capacidade de um determinado PTS em alcançar os UDI depende das suas características particulares. Os PTS são diversificados no que respeita aos modos de funcionamento, às políticas de dispensa do material de injecção e à disponibilidade de outros serviços prestados. Diferentes modalidades de programas, como os PTS convencionais em locais fixos, os PTS implementados pelas farmácias comunitárias, as máquinas de dispensa e os programas outreach, têm sido desenvolvidas com o intuito de promover o acesso e a utilização do material de injecção, e de aumentar as opções de escolha dos UDI. Compreender as barreiras e as preferências dos UDI relativas ao acesso aos PTS é essencial para a prestação de serviços que satisfaçam as suas necessidades.
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- 2009
33. Use of generic and essential medicines for prevention and treatment of cardiovascular diseases in Portugal.
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Gama, Helena, Torre, Carla, Pedro Guerreiro, José, Azevedo, Ana, Costa, Suzete, Lunet, Nuno, and Guerreiro, José Pedro
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CARDIOVASCULAR disease treatment , *GENERIC drugs , *GENERIC products , *CARDIOVASCULAR diseases , *ENDOTHELIUM diseases , *DIAGNOSIS , *MEDICAL care cost statistics , *ESSENTIAL drugs , *DRUG utilization , *MEDICAL care costs , *USER charges , *THERAPEUTICS - Abstract
Background: The successful control of cardiovascular diseases at the lowest possible cost requires the use of the most effective and affordable medicines. We aimed to describe the trends in the ambulatory use of medicines for prevention and treatment of cardiovascular diseases [Anatomic Therapeutic Chemical classification system (ATC): C and B01A] in Portugal, between 2004 and 2012, and to estimate the potential for expenditure reduction through changes in patterns of use.Methods: We analysed sell-out data, expressed as defined daily doses (DDD) and pharmacy retail price (€), from a nationwide database. We estimated potential reduction in expenditures through the increase, up to 90% of the volume of DDD, in the use of generic and essential medicines; the latter were defined according to guidelines from Portugal and another European country.Results: Overall consumption increased by approximately 50% from 2004 to 2012, reaching nearly 2400 million DDD, whereas expenditure decreased to 753 million € (-31.3% since 2006). Use of generics and essential medicines increased, representing 43.6 and 39.9% of DDD consumption in 2012, respectively. The 40 most used groups of medicines in 2012 accounted for just over 80% of overall consumption; among these, increase in use of generics and essential medicines would have contributed to a saving of 275 million €.Conclusions: Changes in patterns of consumption of medicines towards a more frequent use of generics, a preferential use of essential medicines and a more rational use of fixed-dose combinations may contribute to a more efficient use of health resources. [ABSTRACT FROM AUTHOR]- Published
- 2017
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34. Effectiveness of needle and syringe Programmes in people who inject drugs - An overview of systematic reviews.
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Fernandes, Ricardo M., Cary, Maria, Duarte, Gonçalo, Jesus, Gonçalo, Alarcão, Joana, Torre, Carla, Costa, Suzete, Costa, João, and Carneiro, António Vaz
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INTRAVENOUS drug abusers ,SOCIAL services ,SYRINGES ,BLOODBORNE infections ,HIV ,HEPATITIS C virus ,BACTEREMIA ,HEPATITIS B transmission ,HEPATITIS C transmission ,HIV infection transmission ,HIV infection epidemiology ,INTRAVENOUS drug abuse ,HEPATITIS B ,HEPATITIS C ,LONGITUDINAL method ,NEEDLE exchange programs ,RISK-taking behavior ,SYSTEMATIC reviews ,HARM reduction - Abstract
Background: Needle and syringe programmes (NSP) are a critical component of harm reduction interventions among people who inject drugs (PWID). Our primary objective was to summarize the evidence on the effectiveness of NSP for PWID in reducing blood-borne infection transmission and injecting risk behaviours (IRB).Methods: We conducted an overview of systematic reviews that included PWID (excluding prisons and consumption rooms), addressed community-based NSP, and provided estimates of the effect regarding incidence/prevalence of Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and bacteremia/sepsis, and/or measures of IRB. Systematic literature searches were undertaken on relevant databases, including EMBASE, MEDLINE, and PsychINFO (up to May 2015). For each review we identified relevant studies and extracted data on methods, and findings, including risk of bias and quality of evidence assessed by review authors. We evaluated the risk of bias of each systematic review using the ROBIS tool. We categorized reviews by reported outcomes and use of meta-analysis; no additional statistical analysis was performed.Results: We included thirteen systematic reviews with 133 relevant unique studies published between 1989 and 2012. Reported outcomes related to HIV (n = 9), HCV (n = 8) and IRB (n = 6). Methods used varied at all levels of design and conduct, with four reviews performing meta-analysis. Only two reviews were considered to have low risk of bias using the ROBIS tool, and most included studies were evaluated as having low methodological quality by review authors. We found that NSP was effective in reducing HIV transmission and IRB among PWID, while there were mixed results regarding a reduction of HCV infection. Full harm reduction interventions provided at structural level and in multi-component programmes, as well as high level of coverage, were more beneficial.Conclusions: The heterogeneity and the overall low quality of evidence highlights the need for future community-level studies of adequate design to support these results.Trial Registration: The protocol of this systematic review was registered in Prospective Register of Systematic Reviews (PROSPERO 2015: CRD42015026145 ). [ABSTRACT FROM AUTHOR]- Published
- 2017
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35. Syringe exchange in community pharmacies—The Portuguese experience
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Torre, Carla, Lucas, Raquel, and Barros, Henrique
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- 2010
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36. Practical's for Enhancing Conceptual Understanding in Inquiry Skills
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Torre, Carla B.
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education ,ComputingMilieux_COMPUTERSANDEDUCATION ,cellular respiration ,effectiveness of practicals - Abstract
This study attempted to determine the effectiveness of practicals in enhancing conceptual understanding about cellular respiration in relation to the functioning of six body systems and enhancing inquiry skills. The study was quasi-experimental in research design and involved forty First Year 1-A and 1-D BEED students enrolled in Natural Science 102 during the Second Semester of AY, 2000-2001 at West Visayas State University in Iloilo City. A pre-and post-instruction conceptions test, inquiry skills test, concept maps and interviews served as sources of data for the study. Ten case students from the experimental and control groups, respectively, were also selected for qualitative aspect of the study. The intervention consisted of seven practicals that dealt with cellular respiration, the functioning of six body systems in relation to cellular respiration and the changes that occur during vigorous activity or emergency. Students also analyzed the practicals requiring the use of eight inquiry skills, namely, identifying the problem, formulating hypothesis, designing a procedure to test the hypothesis, interpreting data, recording data in a form that facilities correct interpretation, seeing patterns and relationships in a set of data, judging adequacy of data and inferring. They also answered questions in relation to the procedure in the practical to enhance their conceptual understanding. To determine their conceptual understanding and inquiry skills, students gave reasons or explanations for their answers in the multiple-choice questions of the conceptions test on the topic covered in the practicals. They also made pre- and post-instruction concept maps and were interviewed on the same topic. To determine their inquiry skills, students were asked to answer a researcher-made inquiry skills test. Factors that influenced their conceptual understanding, and inquiry skills were also determined. The control group was taught using the traditional lecture method. For the enhancement of their inquiry skills, they analyzed articles on completed experiments, one of which was discussed in class. Findings show that students who performed the practicals were able to learn more scientific concepts than those taught using the traditional lecture method. However, the difference was not statistically significant. The two groups share similar alternative conceptions which they brought with them to school, and instructional methods used in both groups was not effective in changing several alternative conceptions. The bases and types of reasons of most students in both groups were precausal, macroscopic and incomplete, suggesting rote learning (Chin et al., 2000, p. 110). A few students in the experimental group were also able to relate more concepts and integrate them as shown in the number of correct propositions and cross-links in their concept maps. Students in the experimental group also performed better in the use of inquiry skills than the control group. The difference in their mean scores was significant. They improved greatly in their performance in the use of inquiry skills from pre- to post-test, specifically, in identifying the problem, formulating hypotheses and seeing patterns or relationships in the data. The difference was statistically significant for identifying the problem and seeing patterns or relationships in the data, and nearly so for formulating a hypothesis. The factors that facilitated the enhancement of students’ conceptual understanding in the experimental group were the demonstration with or without dissection and collaborative learning. The inhibiting factor was a lack of background knowledge about the topic. For the inquiry skills, the factors that enhanced their skills were the practicals and exposure to experiments in high school. Those with limited exposure tended to base their answers on a single, obvious factor and disregard relevant data. This study provided evidence that practicals are effective in enhancing students’ inquiry skills. It also identified tenacious alternative conceptions on cellular respiration in relation to the functioning of six body systems that urgently need to be addressed using conceptual change strategies. Lastly, it produced instructional materials (the practicals) which teachers can utilize in their natural science classes or use as a guide for developing their own practicals.
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- 2002
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37. Strategies and interventions on responsible and rational use of benzodiazepines and derivates in the treatment of anxiety and sleep disorders
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Rodrigues, Tiago, Sousa, Paulo, and Torre, Carla
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Benzodiazepines ,Adverse effects ,Drugs ,Ciências Sociais::Outras Ciências Sociais [Domínio/Área Científica] ,Rational use ,Anxiolytics ,Interventions - Abstract
Benzodiazepines and analogues (BDZ) are anxiolytics (also known as sedatives) and hypnotics commonly used world-wide. The use of BZD, especially long-term, can result in adverse effects and represents a complex problem for some healthcare systems. This systematic review aims to identify strategies aiming at the promotion of the rational use of benzodiazepines and analogues across Organization for Economic Co-operation and Development (OECD) countries from 2000 to 2020. We included randomized controlled trials (RCT), quasi-experimental studies, and non-randomized studies: cohort, case-control, cross-sectional, case series and reports. Government and conference reports on regulatory, administrative and educational strategies and interventions aiming at the rational use of benzodiazepines and targeted to consumers, healthcare professionals, healthcare organizations and healthcare systems were also included. A relevant literature search was conducted in PubMed, Scopus, Web of Science® (Web of Knowledge), DANS (Open Grey®), OECD iLibrary and GoogleSchoolar. Two reviewers performed duplicate and independent study selection, data extraction and assessment of the risk of bias. A total of 6,308 records were identified and screened in our search, from which twenty-eight studies were included. Professionals are the preferred target of different interventions. Interventions classified, exclusively or not, as administrative were reported the most in the studies included. Most interventions have demonstrated moderate to large improvements in the prescription, dispensing or utilization of benzodiazepines and analogues. Heterogeneity regarding the design, delivery, description and report of the strategies and interventions posed a challenge during this review and analysis. Because strategies and interventions on the rational use of medicines have uncertain effects proper methodological and evidenced-based approaches should be considered in the design, description, implementation and evaluation of these interventions.
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- 2023
38. Patterns of polypharmacy and potential overtreatment in elderly people with type 2 diabetes mellitus using real-world data
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Al-Musawe, Labib, Torre, Carla de Matos, Martins, Ana Paula, and Mota-Filipe, Helder
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Doenças cardiovasculares ,Hospitalização ,Ciências Médicas::Medicina Básica [Domínio/Área Científica] ,Overtreatment ,Polifarmácia ,Sobretratamento e subtratamento ,Função Renal ,Undertreatment ,Type 2 diabetes ,Glycemic Control Elderly ,Controle Glicêmico de Idosos ,Diabetes tipo 2 ,Kidney Function ,Hospitalization ,Cardiovascular diseases ,Mortalidade ,Polypharmacy ,Quality of Life ,Mortality ,Qualidade de Vida - Abstract
Submitted by Paula Guerreiro (passarinho@reitoria.ulisboa.pt) on 2021-04-20T12:04:04Z No. of bitstreams: 1 ulsd735645_td_Labib_AL-Musawe.pdf: 2523911 bytes, checksum: 16e96e49a63238a26b024379a0c578b3 (MD5) Made available in DSpace on 2021-06-14T14:47:38Z (GMT). No. of bitstreams: 1 ulsd735645_td_Labib_AL-Musawe.pdf: 2523911 bytes, checksum: 16e96e49a63238a26b024379a0c578b3 (MD5) Previous issue date: 2021-02
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- 2020
39. Patients contribution to the benefit/risk assessment of medicines in the post-marketing phase: the role of Portuguese patients’ associations in pharmacovigilance
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Nieto, Margarida Chinita and Torre, Carla de Matos
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Notificações espontâneas ,Ciências da Saúde ,Farmacovigilância ,Mestrado Integrado - 2019 ,Associações de doentes - Abstract
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2019 Made available in DSpace on 2020-05-04T22:58:09Z (GMT). No. of bitstreams: 0 Previous issue date: 2019-10-15 Farmácia Sália; Hospital de Egas Moniz
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- 2019
40. SGLT-2 inhibitors users profile recruited through a pharmacy-based intensive monitoring study: analysis of the pharmacotherapeutic profile, drug-drug interactions, and comparison with the population of the randomized controlled trials
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Crispim, Bernardo Manuel Ribeiro Pereira Simões, Martins, Ana Paula, and Torre, Carla
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Mestrado Integrado - 2017 ,Ciências da Saúde - Abstract
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2017 Submitted by Repositório FFUL (repositorio@ff.ul.pt) on 2018-12-17T18:18:39Z No. of bitstreams: 1 MICF_Bernardo_Crispim.pdf: 1598383 bytes, checksum: aba370335b89f4b05a788fac4a392af1 (MD5) Made available in DSpace on 2018-12-17T18:38:50Z (GMT). No. of bitstreams: 1 MICF_Bernardo_Crispim.pdf: 1598383 bytes, checksum: aba370335b89f4b05a788fac4a392af1 (MD5) Previous issue date: 2017-11-14
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- 2017
41. Comparative Analysis of Post-Authorization Measures for Advanced Medicinal Products Authorized in the European Union and in the United States of America Between 2009 and 2023.
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Mandslay D, Almeida D, Marques A, Rocha J, Drafi F, Sepodes B, and Torre C
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In the current landscape, regulatory agencies face the challenge of reconciling timely authorizations for novel medicines addressing life-threatening conditions with thorough evaluations of their benefits and risks. This challenge is pronounced with advanced therapy medicinal products (ATMPs), where expedited approval mechanisms and orphan drug designations are often applied, making post-authorization measures a crucial mechanism to address uncertainties. We compared post-authorization measures imposed by the U.S. Food and Drug Administration and the European Medicines Agency on ATMPs approvals, from 2009 to 2023. A systematic extraction of FDA postmarketing requirements (PMRs) and EMA-imposed post-authorization measures (PAMs) from publicly available regulatory documents was conducted. Descriptive analysis focused on post-authorization measure categories, objectives, study designs, and their status and registration rates. A total of 15 ATMPs were approved in both jurisdictions over the study period. For these products, the EMA imposed 53 PAMs (34 Annex II conditions and 19 Specific Obligations), whereas the FDA imposed 27 PMRs. As of December 2023, 15 EMA-imposed PAMs were fulfilled, with no explicit fulfilments indicated for FDA PMRs. Both agencies promoted real-world data use in around half of the imposed PAMs (23 by EMA vs. 15 by FDA), marking regulators' growing recognition of Real-World Evidence for decision-making. This study highlights disparities between imposed PAMs: EMA imposed more PAMs, covering efficacy, safety, and quality aspects, while the FDA required fewer measures focusing on specific safety concerns. These discrepancies primarily reflect distinct regulatory structures and approaches to further post-authorization data collection between the EMA and FDA, rather than disparities in initial benefit/risk assessments., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics © 2024 American Society for Clinical Pharmacology and Therapeutics.)
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- 2024
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42. Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.
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Prilla S, Groeneveld S, Pacurariu A, Restrepo-Méndez MC, Verpillat P, Torre C, Gartner C, Mol PGM, Naumann-Winter F, Breen KC, Gault N, Gross-Martirosyan L, Benchetrit S, Aylward B, Stoyanova-Beninska V, O'Donovan M, Straus S, Kjaer J, and Arlett P
- Abstract
Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology. A significant number of questions were related to the pediatric population and/or rare diseases. A total of 27 regulatory-led RWD studies have been conducted. Most studies were descriptive and aimed at estimating incidence and prevalence rates of clinical outcomes including adverse events or to evaluate medicines utilization. The review highlights key learnings to guide further efforts to enable the use and establish the value of real-world evidence (RWE) for regulatory decisions. For instance, there is a need to access additional fit-for-purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines. The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question is equally important. Finally, the review provides our perspective on the way forward to maximize the potential of regulatory-led RWE generation., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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- 2024
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43. COVID-19 pandemic and the quality of antibiotic use in primary care: an interrupted time-series study.
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Domingues M, Torre C, Guerreiro JP, Barata P, Correia-Neves M, Rocha J, Sepodes B, and Teixeira Rodrigues A
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- Humans, Anti-Bacterial Agents therapeutic use, Pandemics, Penicillins, Cephalosporins, Streptogramins, Lincosamides, Macrolides, Primary Health Care, COVID-19 epidemiology, Quinolones
- Abstract
The coronavirus disease-19 pandemic and the related public health mitigation measures have impacted the transmission of infectious diseases; however, their impact on the use of antibacterials has not yet been extensively evaluated. This study evaluated the impact of the pandemic on the consumption patterns of antibacterials for systemic use in primary care in Portugal. An interrupted time-series analysis was performed using the autoregressive integrated moving average model of the antibacterials dispensed in the community pharmacies in Portugal from 1 January 2016 to 30 June 2022. Monthly rates of absolute consumption (all antibacterials for systemic use, and specifically penicillins; cephalosporins; macrolides, lincosamides, and streptogramins; and quinolones) and the relative consumption of antibacterials (penicillins sensitive to β-lactamase, penicillin combinations including β-lactamase inhibitors, third- and fourth-generation cephalosporins, fluoroquinolones, and the ratio of broad- to narrow-spectrum antibacterials) were estimated. Antibiotic consumption was expressed in defined daily doses per 1000 inhabitants per day (DID). In Portugal, the consumption of antibacterials (J01) declined sharply immediately after the beginning of the pandemic, having a significant reduction of >5 DID (P < .0001). A similar, short-term impact was found for penicillins (-2.920 DID; P < .0001); cephalosporins (-0.428 DID; P < .0001); macrolides, lincosamides, and streptogramins (-0.681 DID; P = .0021); and quinolones (-0.320 DID; P < .0001). A long-term increase was found for cephalosporins (+0.019 DID per month; P < .0001). Relative consumption changes were only found for third- and fourth-generation cephalosporins (0.0734%). Our study suggests that the coronavirus disease-19 pandemic may have resulted in a decrease in antibiotic use, with no significant changes in the relative dispense. Uncertainties regarding the long-term effects of the pandemic and its impact on the rates of resistance remain., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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44. A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020.
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Teixeira MM, Borges FC, Ferreira PS, Rocha J, Sepodes B, and Torre C
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Introduction: Cancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical trials framework, PRO may provide evidence to support medicines approval, labeling and marketing claims. This study aims to analyze the existing evidence based on PRO as part of new oncology indications receiving positive opinions issued by the European Medicines Agency (EMA) between 2017 and 2020 and to identify PRO related label claims granted., Methodology: Oncology medicinal products and indications approved by the European Commission following a positive opinion from the EMA between 2017 and 2020 were identified. European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) were reviewed for each medicinal product to identify use of PRO and PRO label claims., Results: A total of 128 oncology indications, corresponding to 76 medicines, were approved; of those, 100 (78.1%) included PRO in the confirmatory clinical trials. Thirty-seven indications were supported by double-blind randomized trials and the remainder 63 by open-label trials. Out of the 104 confirmatory trials analyzed, PRO were defined as a secondary endpoint in 60 studies (57.7%), exploratory in 31 (29.8%) and as both in 13 (12.5%). In total, 54 different PRO measures (PROM) were used, of those 41 (75.9%) were disease-specific measures. Nevertheless, PROM selected relied on the EORTC (41.3%), FACIT (17.1%) and EQ-5D (29.2%) measures. A total of 76 indications (59.4%) had PRO reviewers comments included in the EPAR, however only 22 indications (17.8%) included label claims in the SmPC. The reasons identified in the EMA assessment supporting the exclusion of PRO claims were described for 34 indications (44.7%)., Conclusions: Despite growing recognition of the value of PRO data for the development of improved cancer therapies, PRO implementation remains challenging. The main reasons identified in our study are related with study design, missing data, study conduct and PROM selection., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Teixeira, Borges, Ferreira, Rocha, Sepodes and Torre.)
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- 2022
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45. Burnout in the Pharmaceutical Activity: The Impact of COVID-19.
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Dos Santos PM, da Silva CR, Costa D, and Torre C
- Abstract
Importance: Pharmacists are among the healthcare professionals involved in the response to the COVID-19 pandemic, maintaining essential services. In the context of restrictions and reorganization of human resources, as a result of policies recently applied to the health sector, following international guidelines, and given the scarcity of data on burnout in pharmaceutical activity, it was considered highly relevant to promote a nationwide survey aiming to collect more complete evidence on the burnout syndrome and to understand how pharmacists have viewed their work and the people they worked closely with., Objectives: The study aimed to assess the occurrence of pharmacist burnout and determine outcomes for each of its dimensions; identify potentially associated characteristics; and determine profiles and critical limits., Design: A cross-sectional observational study conducted by a multidisciplinary panel from the Portuguese Pharmaceutical Society (PPS). Professionals from community and hospital pharmacies who were at the forefront of the COVID-19 response were involved in (i) confirming the need and pertinence for conducting this research, (ii) identifying the main factors leading to pharmaceutical emotional distress ("burnout"), and (iii) disseminating the survey. The questionnaire was designed for digital voluntary, confidential, and anonymous participation and divided into four segments of data collection: (i) demographics, (ii) employment and workplace characterization, (iii) pandemic impact on labor activity, and (iv) burnout assessment (as described ahead)., Setting: An electronic survey was addressed to all PPS members, and an account was created solely to manage the questionnaire data for the research team. The web-based and user-friendly platform Google Forms supported the data capture and provided an intuitive interface for validated data entry., Participants: In a population of 15,565 pharmacists (members of the PPS), the minimum recommended sample size (Epi Info software), with a 5% margin of error and a 99.9% confidence interval, should be 1,012 individuals. A total of 1,362 pharmacists participated in the study. Of these, 91.4% ( n = 1,246) were involved in direct patient care activity and 7.7% ( n = 106) in non-direct patient care activity., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Santos, Silva, Costa and Torre.)
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- 2022
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46. Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe.
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Sepodes B, Rocha J, Batista J, Figueira ME, Dráfi F, and Torre C
- Abstract
Pre-exposure prophylaxis (PrEP) is a significant public health intervention with proven efficacy and safety in the prevention of human immunodeficiency virus (HIV) infection, which has taken a considerable amount of time to reach Europe in relation to their transatlantic counterparts, namely, the United States of America (USA). There, it is perceived as being an essential prevention tool to be integrated within existing medical, behavioral and structural interventions in place for the management and containment of HIV infection in men who have sex with men (MSM). In a region such as Europe, with approximately double the USA population, it is estimated that not even 10% have proper access to PrEP, and given the lack of coordination with healthcare, taking PrEP has to be at their own expense. Here, we identify the reasons behind the 4-year lag in the approval of PrEP in the European Union/European Economic Area (and Europe in general) and explore the efficacy and effectiveness of PrEP needed to be confirmed with some implementation or demonstration studies conducted in the region. Independent of the data gathered, access of MSM to PrEP is far from ideal in Europe and much still needs to be done. The demonstration of the cost-effectiveness of PrEP alongside other social and behavioral factors needs to be addressed, while the clear populations within MSM that will benefit from this intervention are properly identified and make use of the latest recommendations of the World Health Organization that consider not only daily PrEP but also event-driven PrEP. The momentum for the proper implementation of PrEP in the EU is not lost, and with the existence of generics and even new formulations, there is a renewed opportunity for unleashing the public health benefits arising from this pharmacological tool with other interventions in place (e.g., condoms, testing, and counseling)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Sepodes, Rocha, Batista, Figueira, Dráfi and Torre.)
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- 2021
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47. Scientific Advances in Diabetes: The Impact of the Innovative Medicines Initiative.
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Brito MF, Torre C, and Silva-Lima B
- Abstract
Diabetes Mellitus is one of the World Health Organization's priority diseases under research by the first and second programmes of Innovative Medicines Initiative, with the acronyms IMI1 and IMI2, respectively. Up to October of 2019, 13 projects were funded by IMI for Diabetes & Metabolic disorders, namely SUMMIT, IMIDIA, DIRECT, StemBANCC, EMIF, EBiSC, INNODIA, RHAPSODY, BEAT-DKD, LITMUS, Hypo-RESOLVE, IM2PACT, and CARDIATEAM. In general, a total of €447 249 438 was spent by IMI in the area of Diabetes. In order to prompt a better integration of achievements between the different projects, we perform a literature review and used three data sources, namely the official project's websites, the contact with the project's coordinators and co-coordinator, and the CORDIS database. From the 662 citations identified, 185 were included. The data collected were integrated into the objectives proposed for the four IMI2 program research axes: (1) target and biomarker identification, (2) innovative clinical trials paradigms, (3) innovative medicines, and (4) patient-tailored adherence programmes. The IMI funded projects identified new biomarkers, medical and research tools, determinants of inter-individual variability, relevant pathways, clinical trial designs, clinical endpoints, therapeutic targets and concepts, pharmacologic agents, large-scale production strategies, and patient-centered predictive models for diabetes and its complications. Taking into account the scientific data produced, we provided a joint vision with strategies for integrating personalized medicine into healthcare practice. The major limitations of this article were the large gap of data in the libraries on the official project websites and even the Cordis database was not complete and up to date., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Brito, Torre and Silva-Lima.)
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- 2021
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48. Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.
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Torre C, Cary M, Borges FC, Ferreira PS, Alarcão J, Leufkens HG, Costa J, and Martins AP
- Abstract
Introduction: Intensive monitoring (IM) is one of the methods of post-marketing active surveillance based upon event monitoring, which has received interest in the current medicines regulatory landscape. For a specific period of time, IM involves primary data collection and is actively focused on gathering longitudinal information, mainly safety, since the first day of drug use. Objectives: To describe IM systems and studies' data published over 11-years period (2006-2016). Specifically, we reviewed study population/event surveillance, methodological approaches, limitations, and its applications in the real-world evidence generation data. Methods: We completed a systematic search of MEDLINE and EMBASE to identify studies published from 2006 to 2016, that used IM methodology. We extracted data using a standardized form and results were analyzed descriptively. The methodological quality of selected studies was assessed using the modified Downs and Black checklist. Results: From 1,400 screened citations, we identified 86 papers, corresponding to 69 different studies. Seventy percent of reviewed studies corresponded to established IM systems, of which, more than half were prescription event monitoring (PEM) and modified-PEM. Among non-established IM systems, vaccines were the most common studied drugs ( n = 14). The median cohort size ranged from 488 (hospitals) to 10,479 (PEM) patients. Patients and caregivers were the event data source in 39.1% of studies. The mean overall quality score was similar between established and non-established IM. Conclusions: Over the study period, IM studies were implemented in 26 countries with different maturity levels of post-marketing surveillance systems. We identified two major limitations: only 20% of studies were conducted at hospital-level, which is a matter of concern, insofar as healthcare systems are facing a lack of access to new medicines at ambulatory care level. Additionally, IM access to data of drug exposure cohorts, either at identification or at follow-up stages, could somehow constitute a barrier, given the complexity of managerial, linkable, and privacy data issues.
- Published
- 2019
- Full Text
- View/download PDF
49. Low persistence with oral biphosphonate treatment in postmenopausal osteoporosis.
- Author
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Torre C, Guerreiro J, Mendes Z, Miranda A, Bragança F, Cristino J, Canhão H, and Branco JC
- Subjects
- Administration, Oral, Aged, Analysis of Variance, Cohort Studies, Databases, Pharmaceutical statistics & numerical data, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Middle Aged, Portugal, Prospective Studies, Self Report statistics & numerical data, Time Factors, Bone Density Conservation Agents administration & dosage, Diphosphonates administration & dosage, Medication Adherence statistics & numerical data, Osteoporosis, Postmenopausal drug therapy
- Abstract
Background: Osteoporotic fractures are a major cause of morbidity and mortality. It is recognized that persistence with medication is crucial to reach optimal clinical outcomes. We aimed to estimate the persistence level to weekly and monthly oral bisphosphonates (OBP) in women with postmenopausal osteoporosis (PMO) over 24 months from therapy initiation in a population-based setting., Methods: Prospective observational cohort study of PMO women ≥50 years initiating OBP recruited through community pharmacies. Data were collected at baseline during face-to-face interviews. Follow-up included pharmacy records (refill dates and medication possession; cohort 1) and telephone-surveys for patients who agreed to be interviewed (cohort 2). Patients were classified as persistent if they refilled their prescription within 30 days after exhausting the time covered by their previous supply. Log-rank tests were used to compare Kaplan-Meier curves of time to non-persistence., Results: Of 427 women recruited with a mean age of 65.0 years, 380 (89%) agreed to be interviewed (cohort 2). Over 24-months of follow-up, 3.4% (95% CI: [2.0%; 5.6%]) of all subjects were persistent to OBP based on pharmacy records. Analysis combining both self-reported information and pharmacy records (cohort 2) showed a persistence estimate of 20.0% (95% CI: [16.1%; 24.2%]). Lower persistence was associated with more frequent OBP dosing and living alone. The most common reason for treatment discontinuation was self-reported adverse events (27.6%)., Conclusions: Results indicate a low level of persistence with OBP. Barriers and reasons leading to discontinuation of anti-PMO therapies should be proactively addressed to promote persistence and improve fracture protection.
- Published
- 2019
50. High levels of β-xylosidase in Thermomyces lanuginosus: potential use for saccharification.
- Author
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Corrêa JM, Christi D, Torre CL, Henn C, da Conceição-Silva JL, Kadowaki MK, and Simão Rde C
- Subjects
- Biomass, Enzyme Activation, Hydrogen-Ion Concentration, Hydrolysis, Polysaccharides chemistry, Polysaccharides metabolism, Substrate Specificity, Temperature, Xylose metabolism, Zea mays chemistry, Ascomycota enzymology, Fermentation, Xylosidases metabolism
- Abstract
A new strain of Thermomyces lanuginosus was isolated from the Atlantic Forest biome, and its β-xylosidases optimization in response to agro-industrial residues was performed. Using statistical approach as a strategy for optimization, the induction of β-xylosidases activity was evaluated in residual corn straw, and improved so that the optimum condition achieved high β-xylosidases activities 1003U/mL. According our known, this study is the first to show so high levels of β-xylosidases activities induction. In addition, the application of an experimental design with this microorganism to induce β-xylosidases has not been reported until the present work. The optimal conditions for the crude enzyme extract were pH 5.5 and 60°C showing better thermostability at 55°C. The saccharification ability of β-xylosidase in the presence of hemicellulose obtained from corn straw raw and xylan from beechwood substrates showed a xylo-oligosaccharide to xylose conversion yield of 80 and 50%, respectively, at 50°C. Our data strongly indicated that the β-xylosidases activities was not subjected to the effects of potential enzyme inhibitors often produced during fermentation process. These data suggest the application of this enzyme studied for saccharification of hemicellulose, an abundant residue in the American continents, thus providing an interesting alternative for future tests for energy production., (Copyright © 2016 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
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