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1.
Semina cienc. biol. saude ; 45(2): 183-198, jul./dez. 2024. ilus; tab.
Artigo em Português | LILACS | ID: biblio-1554828

RESUMO

O câncer, frequentemente relacionado ao envelhecimento, impulsiona pacientes a buscarem tratamento hospitalar ou métodos alternativos, como plantas medicinais. Este estudo visou avaliar os perfis sociodemográfico e clínico e o consumo de plantas para fins medicinais entre pacientes idosos em tratamento oncológico no Hospital Araújo Jorge (HAJ). Dados de 55 pacientes foram analisados, abrangendo informações sociodemográficas, tipos de câncer, tratamento, a utilização de plantas medicinais, o objetivo de uso, as fontes de informações sobre plantas e se notaram alguma reação adversa após o consumo. A faixa etária mais encontrada foi 61 a 70 anos (67,27%), a maioria dos pacientes eram homens (63,64%), com ensino fundamental incompleto (32,73%), casados (56,36%) e que moram no interior de Goiás (43,64%). Quanto ao tratamento, a maioria realizava quimioterapia (40,00%) e o câncer gástrico foi mais relatado (14,54%). Sobre o uso de plantas medicinais, a maioria relatou simpatizar com o consumo (58,18%), e acredita em sua segurança devido à origem natural (59,37%). Informações sobre o uso de plantas medicinais eram obtidas com amigos, vizinhos e familiares (21,81%). Ao relatar sobre o consumo de plantas medicinais durante a quimioterapia, a maioria não percebeu nenhum efeito (40,63%). Foram citadas 17 plantas, que eram utilizadas no tratamento anticâncer (29,00%) e preparadas como infusões (18,75%) pelo uso das folhas frescas (60,00%), principalmente para uso interno (46,87%). Diante disso, a atenção farmacêutica se mostra vital para guiar pacientes nas práticas seguras e eficazes de consumo. Isso inclui direcionar sobre doses adequadas, efeitos colaterais e interações, garantindo bem-estar e prevenindo riscos à saúde.


Cancer, which is often related to ageing, drives patients to seek hospital treatment or alternative methods such as medicinal plants. This study aimed to evaluate the sociodemographic and clinical profile and the consumption of plants for medicinal purposes among elderly patients undergoing cancer treatment at the Araújo Jorge Hospital (AJH). Data from 55 patients was analyzed, covering sociodemographic information, types of cancer, treatment, the use of medicinal plants, the purpose of use, the source of information about plants and whether they noticed any adverse reactions after consumption. The most common age group was 61 to 70 years (67.27%), the majority of patients were men (63.64%), had incomplete primary education (32.73%), were married (56.36%) and lived in the interior of Goiás (43.63%). With regard to treatment, the majority were undergoing chemotherapy (40,00%) and gastric cancer was the most frequently reported (14.54%). With regard to the use of medicinal plants, the majority were sympathetic to their consumption (58.18%) and believed them to be safe due to their natural origin (59.37%). Information on the use of medicinal plants was obtained from friends, neighbors and family members (21.81%). When reporting on the consumption of medicinal plants during chemotherapy, the majority did not notice any effect (40.63%). Seventeen plants were mentioned, which were used for anticancer treatment (29,00%) and prepared as infusions (18.75%) with fresh leaves (60,00%), mainly for internal use (46.87%). In view of this, pharmaceutical care is vital to guide patients in safe and effective consumption practices. This includes guidance on appropriate doses, side effects and interactions, ensuring well-being and preventing health risks.


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais
2.
Curr Pharm Des ; 2024 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-39385419

RESUMO

Aspirin, an analgesic, antipyretic and non-steroidal anti-inflammatory drug, was a fascinating discovery that became the precursor to one of the oldest pharmaceutical success stories. It was discovered in 1899 by Felix Hoffman and patented in 1900. In 2024, Aspirin turns 125 years old and is still one of the bestselling medicines today. This review aims to celebrate 125 years of Aspirin and show the status of analytical methods available in the literature to evaluate pharmaceutical products based on Acetylsalicylic Acid (ASA). In addition, it contextualizes them with the current needs of green and clean analytical chemistry. ASA, despite being consolidated in the consumer market, embraces continuous improvement as it is a fundamental part of studies for other new purposes and studies with associations with other active ingredients. In the manuscripts available in the literature, ASA is predominantly evaluated by HPLC (41%) and UV-Vis (41%) methods, which use methanol (21.82%) and acetonitrile (18.18%), followed by buffer (16.36%). The most evaluated pharmaceutical matrix is ASA tablets (40%), followed by ASA tablets in combination with other drugs (26%). While ASA continues to innovate in the market through new forms of delivery and combinations, as well as intended purposes, the analytical methods for evaluating its pharmaceutical products do not. They continue with non-eco-efficient analytical options, which can significantly improve and meet the current demand for green and sustainable analytical chemistry.

3.
Int J Pharm Pract ; 2024 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-39404080

RESUMO

BACKGROUND: Cancer treatment has become a significant health challenge, with notable changes in recent years due to increasing knowledge of cancer biology. The use of immune checkpoint inhibitors (ICIs) has shown promising results, but they can induce adverse events (AEs), resulting in serious consequences for patients. Pharmaceutical care aims to prevent, identify, and address issues related to medications, such as AEs. AIM: The objective of this scoping review was to assess the contribution of pharmacists to the intervention and care of cancer patients undergoing treatment with ICIs. METHODS: The PubMed, Scopus, Embase, and Web of Science databases were searched for studies on the treatment of cancer patients treated with ICIs in which pharmacists participated. No time frame or language restriction was applied. Article screening was performed independently by two authors, with any discrepancies resolved by a third author. The studies were analyzed and included in this review following the inclusion and exclusion criteria. RESULTS: Nine studies fulfilled the inclusion criteria. Pharmaceutical care encompasses a variety of interventions, including providing guidance to patients and to the multidisciplinary team, monitoring and managing AEs, conducting pharmaceutical consultations, and recommending over-the-counter medications and laboratory tests, among other actions. Pharmaceutical recommendations led to better outcomes regarding AEs. CONCLUSIONS: Pharmaceutical care has a positive impact on oncological immunotherapy with ICIs, contributing to both health institutions through cost reduction and, most importantly, patients by improving treatment outcomes and enhancing the quality of life.

4.
Data Brief ; 56: 110844, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39281013

RESUMO

This dataset includes spectra obtained through Raman spectroscopy of acetylsalicylic acid, paracetamol, and ibuprofen commercialized in San Lorenzo, Central Department of Paraguay. The pharmaceuticals were randomly purchased from pharmacies, official sales points, and street vendors, simulating purchases for self-consumption. These drugs were selected due to their high demand and consumption by the population, aiming to document and facilitate the identification of adulterations or alterations in their original structures caused by poor storage conditions. Additionally, this database will support multivariate studies for clustering using various techniques, both supervised and unsupervised, and will allow for signal processing and spectroscopic data handling.

5.
Environ Sci Pollut Res Int ; 31(43): 55119-55131, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39245671

RESUMO

In this work, the photo-, electro-, and photo-electro-oxidation of chloramphenicol was investigated. The photo-experiments were carried out with different irradiation sources (an ultraviolet and a simulated solar source) using self-doped titanium nanotubes (SDTNT), a very promising and innovative material that deserves further investigations in the degradation of different pollutants. The photo-electrooxidation (j = 15 mA cm-2) under simulated solar irradiation presented the best efficiency, with ca. 100% degradation and kinetic constant of k = 0.04427 min-1. The FTIR analysis demonstrated a structural modification of the standard molecule occurred for all conditions used, suggesting a modification in functional groups responsible for the biological activity. Furthermore, the TOC analysis showed a significant mineralization of the pollutant (66% from the initial concentration). In addition, both photo-electrooxidation approaches have demonstrated a positive value of S, where the simulated solar irradiation reached the highest value S = 0.6960. The experimental results pointed out evidence that the methodology employed herein for chloramphenicol degradation is greatly interesting and the photo-electrooxidation under simulated solar irradiation is a promising approach for this purpose.


Assuntos
Cloranfenicol , Nanotubos , Titânio , Cloranfenicol/química , Titânio/química , Nanotubos/química , Oxirredução , Cinética
6.
Vaccines (Basel) ; 12(9)2024 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-39339999

RESUMO

The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), began in 2019. One of the strategies for pandemic control was mass vaccination. In Brazil, the recombinant COVID-19 vaccine (RCV) was produced on a large scale and offered at no charge to the population. The specifications for quality control analyses of RCV included identity and infectivity determination. To validate the results, a reference material (RM) must be analyzed in parallel with the sample vaccine. This research aimed to establish the RM for use in the identity and infectivity assay for RCV. The candidate RM was analyzed using homogeneity and stability studies. The RM was considered homogeneous for identity (cycle threshold (Ct) ≤ 25.19) and infectivity (average x- was 9.25 log10 infectious units/mL). The RM was considered adequately stable for identity during the total period in all studies, being stable at -70, 5, and 22.5 °C for 380, 313, and 14 days, respectively (Ct ≤ 21.81). For infectivity, the RM was stable at -70, 5, and 22.5 °C for 380, 97, and three days, respectively. Since the property identity and infectivity values of the RM were established, the new RM could be used in quality control analysis.

7.
Int J Health Policy Manag ; 13: 8516, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39099496

RESUMO

This paper discusses the potential of an international agreement to ensure equitable vaccine distribution, addressing the failures witnessed during the COVID-19 pandemic. COVAX was unable to prevent vaccine monopolization and unequal distribution, which led to significant disparities in vaccination rates and avoidable deaths. Any future agreement on equitable vaccine distribution must address ethical and practical issues to ensure global health equity and access. The proposed agreement should recognize healthcare as a human right and consider vaccines beyond mere commodities, emphasizing the social responsibility of pharmaceutical companies to prioritize affordability, availability, and accessibility, particularly for low-income countries (LICs). Voluntary licensing agreements are suggested as a means to enhance access to essential medicines. The paper also outlines the necessity of international cooperation, with robust compliance mechanisms, to effectively enforce such an agreement and mitigate future health crises.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Indústria Farmacêutica , Acessibilidade aos Serviços de Saúde , Humanos , Indústria Farmacêutica/ética , COVID-19/prevenção & controle , COVID-19/epidemiologia , Cooperação Internacional , Equidade em Saúde , SARS-CoV-2 , Saúde Global , Países em Desenvolvimento
8.
J Oncol Pharm Pract ; : 10781552241269690, 2024 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-39106361

RESUMO

INTRODUCTION: Veterinary oncology is constituted mainly by human-use drugs with hazardous agents. Occupational risks are present in all stages of handling. Many studies highlighted that veterinarians and pharmacists staff present a lack of knowledge and insufficient structure for promoting safety practices. This study investigated the professional profile and structure of veterinary antineoplastic chemotherapy in Brazilian services. METHODS: A nationwide survey was carried out through digital platforms by a self-applicable from 2020 to 2021. The characteristics of the structure, facilities, professional profiles, practices related to antineoplastic chemotherapy services, and inspections provided by regulatory companies were investigated. Frequency and ranges were used to examine and describe data. RESULTS: This study analyzed 108 respondents from all Brazilian regions where 36 participants worked in veterinary oncology. Dogs and cats comprised more than 90% of animals assisted. Vincristine, doxorubicin, carboplatin, vinblastine, and cyclophosphamide were the most commonly used drugs. Considering pharmacists-led (n = 4) vs veterinarians-led (n = 18) services, structure with safety for handling hazardous drugs (4 vs 9), correct PPE usage (3 vs 0), and occurrence of occupational accident (0 vs 5) were registered. Almost 60% were dissatisfied with the structure and the managerial unwillingness to promote facility improvements. The majority of participants reported an absence of service inspection. CONCLUSION: The results demonstrated worrying concerning the inadequacy of the physical structure of the facilities, human resources, and handling hazardous drugs increased occupational health risk. The lack of competent authority standards and supervision corroborates practices that expose professionals, the population, and the environment to hazardous agents.

9.
Int J Clin Pharm ; 2024 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-39110341

RESUMO

BACKGROUND: Treating multiple myeloma is complex, and providing supportive care through an interdisciplinary approach is essential. AIM: To report and synthesize pharmacists' clinical activities and impact on the care of patients with multiple myeloma. METHOD: This was a scoping review that followed the PRISMA-ScR reporting recommendations. A search was conducted in PubMed, Embase, Web of Science, Scopus, and LILACS from the inception of the database until January 10th, 2024. Papers that reported pharmacists' clinical activities in the care of patients with multiple myeloma were included. Descriptive Elements of Pharmacist Intervention Characterization Tool (DEPICT) version 2 was used to characterize the pharmacists' clinical activities. The results are presented as a narrative and tabular synthesis. RESULTS: A total of 2885 records were identified, 10 of which met the inclusion criteria. Pharmacists' clinical activities related to 'direct patient care' (n = 8) and 'medication counseling, education, and training' (n = 7) were the most cited. Most were provided for patients (n = 8), by one-on-one contact (n = 9), and through face-to-face communication method (n = 8), with patient counseling being the main action taken by pharmacists (n = 7). Materials that supported pharmacists' actions were cited in five studies. Integrating pharmacists into interdisciplinary teams led to improved process, clinical, humanistic, and economic outcomes. CONCLUSION: This scoping review emphasizes pharmacists' clinical activities in improving the care of patients with multiple myeloma. There is a need to develop studies with patient-reported outcomes and comprehensive reporting of pharmacists' clinical activities to ensure reproducibility and effective implementation in clinical practice.

10.
Anal Bioanal Chem ; 2024 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-39126504

RESUMO

Water, renowned for its sustainability and minimal toxicity, is an ideal candidate for environmentally friendly solvent-based microextraction. However, its potential as an extractant solvent in miniaturized sample preparation remains largely unexplored. This paper pioneers using water as the extraction solvent in headspace single-drop microextraction (HS-SDME) for N-nitrosamines from losartan tablets. Autonomous HS-SDME is executed by an Arduino-controlled, lab-made Cartesian robot, using water for the online preconcentration of enriched extracts through direct injection into a column-switching system. Critical experimental parameters influencing HS-SDME performance are systematically explored through univariate and multivariate experiments. While most previously reported methods for determining N-nitrosamines in pharmaceutical formulations rely on highly selective mass spectrometry detection techniques to handle the strong matrix effects typical of pharmaceutical samples, the water-based HS-SDME method efficiently eliminates the interfering effects of a large amount of the pharmaceutical active ingredient and tablet excipients, allowing straightforward analysis using high-performance liquid chromatography with ultraviolet detection (HPLC-UV-Vis). Under optimized conditions, the developed method exhibits linear responses from 100 to 2400 ng g-1, demonstrating appropriate detectability, precision, and accuracy for the proposed application. Additionally, the environmental sustainability of the method is assessed using the AGREEprep methodology, positioning it as an outstanding green alternative for determining hazardous contaminants in pharmaceutical products.

11.
Dement Neuropsychol ; 18: e20230049, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39193464

RESUMO

It is estimated that 45% of individuals with cognitive impairment experience sleep disturbances prior to the onset of cognitive symptoms. Assessing sleeping problems and enhancing sleep quality are critical first steps to reduce the risk of cognitive impairment. Objective: To review existing literature based on predefined eligibility criteria to understand the connection between sleep disturbance and Alzheimer's disease. Methods: A thorough and systematic evaluation of numerous studies was carried out to assess one or more of the following epidemiological factors: (1) sleep disorders, (2) cognitive impairment, and (3) risk estimates for cognitive impairment due to sleep. Results: Studies suggest that individuals who experience memory loss may encounter sleep disturbances before noticing other symptoms. Numerous sleep disorders, such as excessive and inadequate sleep duration, poor sleep quality, circadian rhythm abnormalities, insomnia, and obstructive sleep apnea were found to increase the risk of cognitive dysfunction and dementia. Additionally, lower sleep quality and shorter sleep duration have been linked to higher cerebral-ß-amyloid levels. Objective evidence for the development of cognitive impairment is provided by the architecture of sleep stages. Patients experiencing sleep problems may benefit from specific types of sleep medicine as a preventative measure against cognitive decline. Conclusion: Sleep disorders can have adverse effects on cognitive health. The duration and quality of sleep are fundamental factors for maintaining a healthy brain as we age. Proper sleep can aid prevent cognitive impairment, particularly Alzheimer's disease and dementia.


Acredita-se que 45% dos indivíduos com comprometimento cognitivo experimentem distúrbios do sono antes do início dos sintomas cognitivos. Avaliar problemas de sono e melhorar a qualidade do sono são passos críticos iniciais para reduzir o risco de comprometimento cognitivo. Objetivo: Revisar a literatura existente com base em critérios de elegibilidade predefinidos para entender a conexão entre distúrbios do sono e a Doença de Alzheimer. Métodos: Uma avaliação completa e sistemática de vários estudos foi realizada para avaliar um ou mais dos seguintes fatores epidemiológicos: (1) distúrbios do sono, (2) comprometimento cognitivo e (3) estimativas de risco de comprometimento cognitivo decorrente do sono. Resultados: Os estudos sugerem que indivíduos que experimentam perda de memória podem enfrentar distúrbios do sono antes de notarem outros sintomas. Foi constatado que vários distúrbios do sono, como duração excessiva e inadequada do sono, má qualidade do sono, anormalidades no ritmo circadiano, insônia e apneia obstrutiva do sono, podem aumentar o risco de disfunção cognitiva e demência. Além disso, menor qualidade do sono e duração mais curta do sono têm sido associadas a níveis mais altos de ß-amiloide cerebral. Evidências objetivas para o desenvolvimento de comprometimento cognitivo são fornecidas pela arquitetura dos estágios do sono. Pacientes que experimentam problemas de sono podem se beneficiar de tipos específicos de medicamentos para o sono como medida preventiva contra o declínio cognitivo. Conclusão: Os distúrbios do sono podem ter efeitos adversos na saúde cognitiva. A duração e a qualidade do sono são fatores fundamentais para manter um cérebro saudável à medida que envelhecemos. Um sono adequado pode ajudar a prevenir o comprometimento cognitivo, especialmente a Doença de Alzheimer e a demência.

12.
Curr Med Chem ; 2024 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-39129289

RESUMO

INTRODUCTION: Human Immunodeficiency Virus (HIV) infection is still a major global problem, whose drug treatment consists of prophylactic prevention and antiretroviral combination therapy for better pharmacological efficacy and control of the circulating virus. However, there are still pharmacological problems that need to be overcome, such as low aqueous solubility of drugs, toxicity, and low patient adherence. Drug delivery technologies can be used to overcome these barriers. OBJECTIVE: This review summarized the latest drug delivery systems for HIV treatment. Initially, an overview of the current therapy was presented, along with the problems it presents. Then, the latest drug delivery systems used to overcome the challenges imposed in conventional HIV therapy were discussed. CONCLUSION: This review examines innovative approaches for HIV treatment, where various drug delivery systems have shown significant advantages, such as high drug encapsulation, improved solubility, and enhanced bioavailability both in vitro and in vivo. Strategies like cyclodextrins, solid dispersions, microneedles, and nanoparticles are explored to address challenges in drug solubility, bioavailability, and administration routes. Despite progress, obstacles like limited clinical trials and industrial scalability hinder the widespread adoption of these formulations, emphasizing the need for further research and collaboration to optimize and ensure accessibility of innovative HIV therapies, mainly in regions where access to HIV treatment is scarce and remains a challenge.

13.
Pharmacy (Basel) ; 12(4)2024 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-39051384

RESUMO

Although preliminary evidence suggests Cannabis's efficacy in symptom control for anxiety and depression-psychiatric disorders that significantly impact mental health-much remains to be understood about its effects on the central nervous system (CNS) and how to optimize treatment for these disorders. This study aims to conduct a narrative review to evaluate pharmaceutical care in treating symptoms of anxiety and depression alongside Cannabis use, focusing on safety and therapeutic efficacy optimization. We seek to conceptualize anxiety and depression disorders, review evidence on Cannabis use, evaluate the evidence quality, and identify knowledge gaps. Twelve articles were identified, revealing a significant gap in the literature regarding the integration of pharmaceutical care with Cannabis-based therapies, specifically for anxiety and depression. Despite a growing interest in the relationship between Cannabis and mental health, current research is insufficient for a comprehensive understanding. The relationship between Cannabis use and anxiety and depression disorders requires further, more targeted investigations. This study underscores the importance of future research to fill existing gaps, providing informed insights and robust guidelines for the safe and effective use of Cannabis as part of the treatment for anxiety and depression. It is crucial that pharmaceutical care integrates these therapies responsibly to improve the overall well-being of patients.

14.
Farm Hosp ; 48(5): T198-T203, 2024.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38890067

RESUMO

Hospital pharmacy worldwide has proven to be a crucial element in healthcare. In Latin America, it draws inspiration from 2 main models: United States, which promoted clinical pharmacy and later pharmaceutical care, and Spain, which shares similar healthcare practices and the added advantage of a common language. Both models influenced the implementation of hospital pharmacy residencies in Argentina since the 1980s. Hospital pharmacy residencies in Argentina constitute a paid system of intensive postgraduate training on a full-time basis with exclusive dedication. They are carried out in 11 provinces across Argentina in services with recognized teaching experience. Currently, there are 46 locations with a total of 75 annual vacancies for applicants. The objective of hospital pharmacy residencies is to train pharmaceutical professionals with the necessary competencies to ensure the care of patients through the optimization of the safe, effective, and efficient use of medications and healthcare products tailored to each patient's individual therapy. Hospital pharmacy residencies have demonstrated that pharmacists acquire specialized training that can be decisive in influencing healthcare policies related to the safe use of medications and healthcare products. Therefore, actions to promote and encourage interest in this field among pharmaceutical professionals are necessary, involving scientific societies, universities, pharmaceutical associations, and the political sphere.


Assuntos
Farmacêuticos , Residências em Farmácia , Serviço de Farmácia Hospitalar , Argentina , Serviço de Farmácia Hospitalar/organização & administração , Humanos
15.
J Toxicol Environ Health A ; 87(17): 687-700, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38836411

RESUMO

The increasing use of UV filters, such as benzophenone-3 (BP-3) and titanium dioxide nanoparticles (TiO2 NPs), has raised concerns regarding their ecotoxicological effects on the aquatic environment. The aim of the present study was to examine the embryo-larval toxicity attributed to BP-3 or TiO2 NPs, either alone or in a mixture, utilizing zebrafish (Danio rerio) as a model after exposure to environmentally relevant concentrations of these compounds. Zebrafish embryos were exposed to BP-3 (10, 100, or 1000 ng/L) or TiO2 NPs (1000 ng/L) alone or in a mixture (BP-3 10, 100, or 1000 ng/L plus 1000 ng/L of TiO2 NPs) under static conditions for 144 hr. After exposure, BP-3 levels were determined by high-performance liquid chromatography (HPLC). BP-3 levels increased in the presence of TiO2 NPs, indicating that the BP-3 degradation decreased in the presence of the NPs. In addition, in the presence of zebrafish, BP-3 levels in water decreased, indicating that zebrafish embryos and larvae might absorb BP-3. Data demonstrated that, in general, environmentally relevant concentrations of BP-3 and TiO2 NPs, either alone or in a mixture, did not significantly induce changes in heart and spontaneous contractions frequencies, levels of reactive oxygen species (ROS), morphological and morphometric parameters as well as mortality rates during 144 hr exposure. However, the groups exposed to TiO2 NPs alone and in a mixture with BP-3 at 10 ng/L exhibited an earlier significant hatching rate than the controls. Altogether, the data indicates that a potential ecotoxicological impact on the aquatic environment exists.


Assuntos
Benzofenonas , Embrião não Mamífero , Protetores Solares , Titânio , Poluentes Químicos da Água , Peixe-Zebra , Animais , Titânio/toxicidade , Titânio/química , Benzofenonas/toxicidade , Protetores Solares/toxicidade , Protetores Solares/química , Embrião não Mamífero/efeitos dos fármacos , Poluentes Químicos da Água/toxicidade , Nanopartículas/toxicidade , Nanopartículas Metálicas/toxicidade , Ecotoxicologia , Larva/efeitos dos fármacos
16.
Artigo em Inglês | MEDLINE | ID: mdl-38942484

RESUMO

Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification results and product disposal. This is one of the major concerns of the regulatory health agencies. Microbiological load (bioburden) may represent a potential risk for patients if the sterilization process is not effective and/or due to the production of toxins. Although bioburden can be eliminated by terminal sterilization or filtration processes, it is important to monitor the amount and determine the identity and characteristics of the microorganisms present prior to final processing. The application of microorganism identification systems is crucial for identifying the type of contamination, which can be extremely useful for investigating. The aim of this study was to evaluate the profiles of microorganisms identified in bioburden assays from solutions, culture medias, and products (SCP) from a pharmaceutical industry facility. From 2018-2020, a total of 1,078 samples from 857 different lots of SCP were analyzed and isolated microorganisms were identified. A prefiltering step was included after March 2020, in order to reduce the bioburden before sterilizing filtration. Criteria for the definition and management of microorganisms identified were evaluated after an integrative bibliographic review, and three groups were proposed (critical, objectionable, and nonobjectionable microorganisms). For the samples that did not include prefiltering (n=636), 227 (35.7%) presented microbial growth. For those that included prefiltering, before prefiltering (n=221), 60.6% presented microbial growth, and after prefiltering, this value was reduced to 4.1%, which can be attributed to a contamination during the sampling or a wrong filtering. From the samples that presented microbial growth, 678 microorganisms were identified as bacteria and 59 as molds and yeasts. A total of 120 microorganisms (56 and 27 Gram-positive and negative bacteria, respectively, 31 yeasts, and six filamentous molds) could not be identified, and the remaining microorganisms were classified as objectionable (n=507; 82.2%), nonobjectionable (n=103; 16.7%) and critical (n=7; 1.1%). Most of the bioburden species (>80.0%) were considered objectionable microorganisms. A process for classification and management of bioburden analysis results based on a literature review of pathogenic and physiological characteristics of the microorganisms was proposed.

17.
Regul Toxicol Pharmacol ; 151: 105669, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38936796

RESUMO

Potentially mutagenic impurities are likely to be formed in any drug substance, since their synthesis requires reactive intermediates which may also react with DNA. The ICH M7 guideline, which defines how to risk assess and control mutagenic impurities, was first published in 2014 and is not to be applied retrospectively; however, some impurities have been found above the permitted limits in drug products which were already on the market. This study assessed the implications of applying ICH M7 retrospectively to anti-hypertensive drugs marketed in Brazil by performing a risk assessment and establishing control strategies. The manufacturing processes of 15 drug substances were evaluated and 262 impurities were identified, from which 21% were classified as potentially mutagenic. Most of the impurities were identified below ICH M7 acceptable limits, except for impurities described in a pharmacopoeial monograph. Compendial specifications are defined based on scientific evidence and play an important role in setting quality and safety standards for pharmaceuticals, however there are opportunities for further alignment with ICH guidelines, aiming for a holistic assessment of the impurities profile to ensure the safety of medicines.


Assuntos
Anti-Hipertensivos , Contaminação de Medicamentos , Mutagênicos , Brasil , Medição de Risco , Anti-Hipertensivos/toxicidade , Mutagênicos/toxicidade , Mutagênicos/análise , Estudos Retrospectivos , Humanos , Guias como Assunto
18.
Acta Odontol Latinoam ; 37(1): 13-24, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38920122

RESUMO

Cold sores require Healthcare professionals to employ specific approaches for prevention and management, with the need for effective therapeutic guidelines and ongoing improvement in patient care. AIM: To evalúate the methodological quality of Clinical Guidelines (CG), clinical guides and manuals for care of the population affected by herpes labialis, to verify their compliance with evidence-based health standards. MATERIALS AND METHOD: A search was conducted for CG on labial herpes in the MedicalLiteratureAnalysis andRetrieval System Online (Medline) database, Google Scholar, Brazilian Virtual Health Library (BVS), and sites of institutions/professional categories, using the descriptors "herpes labialis" or "oral herpes". Document quality was assessed using the Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II). The Kappa test was used to avoid randomness or poor agreement between results. RESULTS: Analysis of the 12 selected publications on the management of labial herpes revealed flaws in quality, as the publications did not follow a quality standard. The main quality flaws identified were in "rigor in development" and "applicability. ". CONCLUSIONS: Priorities need to be redefined in the development of CG for clinical practice related to fever blisters to reduce the variability of the quality standard, and generate reliable, applicable recommendations.


A Herpes labial requer dos profissionais abordagens específicas para prevenido e manejo, com a ne-cessidade de diretrizes terapéuticas eficazes e continuo aprimoramento do cuidado ao paciente. OBJETIVO: avaliar a qualidade metodológica de documentos que abordaram Diretrizes Clínicas (DC), guias clínicos e manuais para o cuidado da populando afetada pelo herpes labial, verificando sua conformidade com padroes de saúde baseados em evidencias. MATERIAIS E MÉTODO: As DC sobre herpes labial foram pesquisadas na base de dados Medical Literature Analysis and Retrieval System Online (Medline), Google Académico, Biblioteca Virtual em Saúde (BVS) e em sites de instituigoes/categorias profissionais, utilizando os descritores "herpes labial" ou "herpes oral". Utilizamos aferramenta The Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II) para a avaliagdo da qualidade. O teste Kappa também foi utilizado para evitar aleatoriedade ou baixa concordáncia entre os resultados. RESULTADOS: Na análise das 12 publicagoes selecionadas sobre o manejo do herpes labial, foram identificadas falhas na qualidade dos documentos, que ndo seguiram um padrdo de qualidade. As principais falhas de qualidade identificadas foram em "rigor no desenvolvimento" e "aplicabilida-de". CONCLUSÃO: é necessário um reenfoque para definir prioridades no desenvolvimento de DC para a prática clínica do herpes labial, a fim de reduzir a variabilidade do padrdo de qualidade e gerar recomendagoes que possam ser confiáveis e aplicáveis.


Assuntos
Herpes Labial , Guias de Prática Clínica como Assunto , Humanos
19.
Int J Pharm Pract ; 32(4): 332-335, 2024 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-38842060

RESUMO

OBJECTIVE: To describe the resident pharmacist's participation in Shared Medical Appointments (SMA) in palliative care. METHODS: The resident pharmacist participated in face-to-face SMA with the attending physician, medical and gerontology students, and a nurse. KEY FINDINGS: The resident pharmacist supported interdisciplinary discussions and performed pharmaceutical interventions. He helped raise awareness about the effective, safe, and convenient use of medicines, helping improve the quality of life of patients and caregivers. CONCLUSIONS: Providing pharmaceutical care to patients in palliative care helped to improve the quality of clinical services offered to these patients, as well as adding value to resident pharmacists' interprofessional practice.


Assuntos
Cuidados Paliativos , Farmacêuticos , Papel Profissional , Consultas Médicas Compartilhadas , Humanos , Cuidados Paliativos/organização & administração , Farmacêuticos/organização & administração , Brasil , Qualidade de Vida , Residências em Farmácia/organização & administração , Equipe de Assistência ao Paciente/organização & administração , Assistência Farmacêutica/organização & administração
20.
Expert Rev Pharmacoecon Outcomes Res ; 24(8): 977-986, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38859799

RESUMO

BACKGROUND: We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. RESEARCH DESIGN AND METHODS: The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. RESULTS: The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions - Therapeutic Need and Added Therapeutic Value - and other two about methodological features - Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. CONCLUSION: This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors' weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.


Assuntos
Algoritmos , Antineoplásicos , Projetos de Pesquisa , Avaliação da Tecnologia Biomédica , Humanos , Avaliação da Tecnologia Biomédica/métodos , Antineoplásicos/administração & dosagem , Neoplasias/tratamento farmacológico , Necessidades e Demandas de Serviços de Saúde , Viés
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