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1.
Amino Acids ; 56(1): 27, 2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38564019

RESUMO

We investigated the bioavailability of the calcium salt (HMB-Ca) and the free acid (HMB-FA) forms of ß-hydroxy-ß-methylbutyrate (HMB). Sixteen young individuals received the following treatments on three different occasions in a counterbalanced crossover fashion: (1) HMB-FA in clear capsules; (2) HMB-Ca in gelatine capsules; (3) HMB-Ca dissolved in water. All treatments provided 1 g of HMB. Blood samples were taken before and on multiple time points following ingestion. The following parameters were calculated: peak plasma (Cmax), time to peak (Tmax), slope of HMB appearance in blood, area under the curve (AUC), half-life time (t1/2) and relative bioavailability (HMB-Ca in water set as reference). All treatments led to rapid and large increases in plasma HMB. HMB-Ca in capsules and in water showed similar plasma HMB values across time (p = 0.438). HMB-FA resulted in lower concentrations vs. the other treatments (both p < 0.001). AUC (HMB-Ca in capsules: 50,078 ± 10,507; HMB-Ca in water: 47,871 ± 10,783; HMB-FA: 29,130 ± 12,946 µmol L-1 × 720 min), Cmax (HMB-Ca in capsules: 229.2 ± 65.9; HMB-Ca in water: 249.7 ± 49.7; HMB-FA: 139.1 ± 67.2 µmol L-1) and relative bioavailability (HMB-Ca in capsules: 104.8 ± 14.9%; HMB-FA: 61.5 ± 17.0%) were lower in HMB-FA vs. HMB-Ca (all p < 0.001). HMB-Ca in water resulted in the fastest Tmax (43 ± 22 min) compared to HMB-Ca in capsules (79 ± 40 min) and HMB-FA (78 ± 21 min) (all p < 0.05), while t1/2 was similar between treatments. To conclude, HMB-Ca exhibited superior bioavailability compared to HMB-FA, with HMB-Ca in water showing faster absorption. Elimination kinetics were similar across all forms, suggesting that the pharmaceutical form of HMB affects the absorption rates, but not its distribution or elimination.


Assuntos
Cálcio , Valeratos , Água , Humanos , Disponibilidade Biológica , Preparações Farmacêuticas
2.
J Pharm Pharm Sci ; 27: 12434, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38571937

RESUMO

Microneedle (MN)-assisted drug delivery technology has gained increasing attention over the past two decades. Its advantages of self-management and being minimally invasive could allow this technology to be an alternative to hypodermic needles. MNs can penetrate the stratum corneum and deliver active ingredients to the body through the dermal tissue in a controlled and sustained release. Long-acting polymeric MNs can reduce administration frequency to improve patient compliance and therapeutic outcomes, especially in the management of chronic diseases. In addition, long-acting MNs could avoid gastrointestinal reactions and reduce side effects, which has potential value for clinical application. In this paper, advances in design strategies and applications of long-acting polymeric MNs are reviewed. We also discuss the challenges in scale manufacture and regulations of polymeric MN systems. These two aspects will accelerate the effective clinical translation of MN products.


Assuntos
Sistemas de Liberação de Medicamentos , Pele , Humanos , Microinjeções , Administração Cutânea , Preparações Farmacêuticas , Polímeros
3.
J Immunotoxicol ; 21(1): 2332177, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38578203

RESUMO

Drug-induced hepatotoxicity constitutes a major reason for non-approval and post-marketing withdrawal of pharmaceuticals. In many cases, preclinical models lack predictive capacity for hepatic damage in humans. A vital concern is the integration of immune system effects in preclinical safety assessment. The immune-related Adverse Outcome Pathway (irAOP) approach, which is applied within the Immune Safety Avatar (imSAVAR) consortium, presents a novel method to understand and predict immune-mediated adverse events elicited by pharmaceuticals and thus targets this issue. It aims to dissect the molecular mechanisms involved and identify key players in drug-induced side effects. As irAOPs are still in their infancy, there is a need for a model irAOP to validate the suitability of this tool. For this purpose, we developed a hepatotoxicity-based model irAOP for recombinant human IL-2 (aldesleukin). Besides producing durable therapeutic responses against renal cell carcinoma and metastatic melanoma, the boosted immune activation upon IL-2 treatment elicits liver damage. The availability of extensive data regarding IL-2 allows both the generation of a comprehensive putative irAOP and to validate the predictability of the irAOP with clinical data. Moreover, IL-2, as one of the first cancer immunotherapeutics on the market, is a blueprint for various biological and novel treatment regimens that are under investigation today. This review provides a guideline for further irAOP-directed research in immune-mediated hepatotoxicity.


Assuntos
Rotas de Resultados Adversos , Doença Hepática Induzida por Substâncias e Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hepatopatias , Humanos , Interleucina-2 , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Preparações Farmacêuticas
4.
JAMA Netw Open ; 7(4): e244246, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38578641

RESUMO

Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023. Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP). Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers). Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002). Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.


Assuntos
COVID-19 , Humanos , Estados Unidos/epidemiologia , COVID-19/epidemiologia , Pandemias , Estudos Transversais , Preparações Farmacêuticas , Medicamentos Genéricos
5.
JAMA Netw Open ; 7(4): e244777, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38568694

RESUMO

This cross-sectional study uses payment data publicly disclosed by pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association to describe their financial relationships with the subspecialty societies of the Japanese Society of Internal Medicine.


Assuntos
Preparações Farmacêuticas , Humanos
6.
Sci Rep ; 14(1): 7882, 2024 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-38570568

RESUMO

Pharmaceutical active compounds (PhACs) are some of the most recalcitrant water pollutants causing undesired environmental and human effects. In absence of adapted decontamination technologies, there is an urgent need to develop efficient and sustainable alternatives for water remediation. Metal-organic frameworks (MOFs) have recently emerged as promising candidates for adsorbing contaminants as well as providing photoactive sites, as they possess exceptional porosity and chemical versatility. To date, the reported studies using MOFs in water remediation have been mainly focused on the removal of a single type of PhACs and rarely on the combined elimination of PhACs mixtures. Herein, the eco-friendly bismuth-based MOF, SU-101, has been originally proposed as an efficient adsorbent-photocatalyst for the elimination of a mixture of three challenging persistent PhACs, frequently detected in wastewater and surface water in ng L-1 to mg·L-1 concentrations: the antibiotic sulfamethazine (SMT), the anti-inflammatory diclofenac (DCF), and the antihypertensive atenolol (At). Adsorption experiments of the mixture revealed that SU-101 exhibited a great adsorption capacity towards At, resulting in an almost complete removal (94.1 ± 0.8% for combined adsorption) in only 5 h. Also, SU-101 demonstrated a remarkable photocatalytic activity under visible light to simultaneously degrade DCF and SMT (99.6 ± 0.4% and 89.2 ± 1.4%, respectively). In addition, MOF-contaminant interactions, the photocatalytic mechanism and degradation pathways were investigated, also assessing the toxicity of the resulting degradation products. Even further, recycling and regeneration studies were performed, demonstrating its efficient reuse for 4 consecutive cycles without further treatment, and its subsequent successful regeneration by simply washing the material with a NaCl solution.


Assuntos
Estruturas Metalorgânicas , Poluentes Químicos da Água , Humanos , Adsorção , Poluentes Químicos da Água/análise , Águas Residuárias , Atenolol , Estruturas Metalorgânicas/química , Diclofenaco , Água , Preparações Farmacêuticas
7.
AAPS J ; 26(3): 43, 2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38575754

RESUMO

Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosage forms due to a medical condition or treatment that affects the ability to swallow or the function of the gastrointestinal tract. Off-label administration of oral drug products via EFT raises concerns for pharmaceutical sponsors, regulators, and healthcare practitioners (HCPs) because of the potential risks this practice introduces to both the patient and the caregiver. These risks can be mitigated by generating data-supported instructions that patients and HCPs can use to ensure safe and accurate administration of oral drug products via EFT. This commentary presents an industry perspective on the testing that should be conducted to enable development of product-specific instructions in the labeling to support or advise against administration of oral drug products via enteral feeding tube. The proposal outlined in this commentary takes a risk-based approach, addressing recommendations from both regulatory agencies as well as considerations for expanding this testing to address needs specific to neonatal and pediatric populations.


Assuntos
Nutrição Enteral , Intubação Gastrointestinal , Criança , Recém-Nascido , Humanos , Administração Oral , Preparações Farmacêuticas , Técnicas In Vitro
8.
AAPS PharmSciTech ; 25(4): 74, 2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38575778

RESUMO

Advancements in recombinant DNA technology have made proteins and peptides available for diagnostic and therapeutic applications, but their effectiveness when taken orally leads to poor patient compliance, requiring clinical administration. Among the alternative routes, transmucosal delivery has the advantage of being noninvasive and bypassing hepato-gastrointestinal clearance. Various mucosal routes-buccal, nasal, pulmonary, rectal, and vaginal-have been explored for delivering these macromolecules. Nanofibers, due to their unique properties like high surface-area-to-volume ratio, mechanical strength, and improved encapsulation efficiency, serve as promising carriers for proteins and peptides. These nanofibers can be tailored for quick dissolution, controlled release, enhanced encapsulation, targeted delivery, and improved bioavailability, offering superior pharmaceutical and pharmacokinetic performance compared to conventional methods. This leads to reduced dosages, fewer side effects, and enhanced patient compliance. Hence, nanofibers hold tremendous potential for protein/peptide delivery, especially through mucosal routes. This review focuses on the therapeutic application of proteins and peptides, challenges faced in their conventional delivery, techniques for fabricating different types of nanofibers and, various nanofiber-based dosage forms, and factors influencing nanofiber generation. Insights pertaining to the precise selection of materials used for fabricating nanofibers and regulatory aspects have been covered. Case studies wherein the use of specific protein/peptide-loaded nanofibers and delivered via oral/vaginal/nasal mucosa for diagnostic/therapeutic use and related preclinical and clinical studies conducted have been included in this review.


Assuntos
Sistemas de Liberação de Medicamentos , Nanofibras , Feminino , Humanos , Sistemas de Liberação de Medicamentos/métodos , Nanofibras/química , Proteínas , Peptídeos , Preparações Farmacêuticas
9.
BMJ Support Palliat Care ; 13(e3): e1390-e1397, 2024 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-38557352

RESUMO

OBJECTIVES: Most people say if they had a terminal illness, they would prefer to be cared for at home and, if possible, to die there. Often this is not possible without a carer to assist with on-going practical care and symptom management. If breakthrough symptoms are not treated in a timely manner, symptoms can escalate quickly causing increased suffering resulting in unwanted hospital transfers. Many carers report feeling motivated but uneducated for the task of medicine management, especially if it involves preparation and/or administration of subcutaneous medicines This study assesses the impact of an education and resource package, caring@home, on carers' confidence, knowledge, and skills in managing palliative symptoms at home using subcutaneous medicines. METHODS: Nurses trained volunteer carers on the use of the package. Carers were invited to complete a 10 min written evaluation survey and to consider consenting to a 30 min semistructure phone interview. RESULTS: Fifty carers returned surveys and 12 were interviewed. Most carers agreed or strongly agreed that the package provided them with the necessary knowledge, skills and confidence to safely and confidently manage breakthrough symptoms using subcutaneous medicines, further, they would recommend the package to others. Interview analysis revealed three main themes: (1) hesitation and motivation to adopt expanded carer role; (2) the importance of a layered approach to support; and (3) avoiding perceived unnecessary contact with nurses. CONCLUSION: The programme can be used by clinical services to empower carers to help enable a person to be cared for, and to die at home.


Assuntos
Cuidadores , Cuidados Paliativos , Humanos , Cuidadores/educação , Cuidados Paliativos/métodos , Atenção à Saúde , Preparações Farmacêuticas , Inquéritos e Questionários
10.
Artigo em Inglês | MEDLINE | ID: mdl-38558503

RESUMO

The blood-brain barrier presents a key limitation to the administration of therapeutic molecules for the treatment of brain disease. While drugs administered orally or intravenously must cross this barrier to reach brain targets, the unique anatomical structure of the olfactory system provides a route to deliver drugs directly to the brain. Entering the brain via receptor, carrier, and adsorption-mediated transcytosis in the nasal olfactory and trigeminal regions has the potential to increase drug delivery. In this review, we introduce the physiological and anatomical structures of the nasal cavity, and summarize the possible modes of transport and the relevant receptors and carriers in the nose-to-brain pathway. Additionally, we provide examples of nanotherapeutics developed for intranasal drug delivery to the brain. Further development of nanoparticles that can be applied to intranasal delivery systems promises to improve drug efficacy and reduce drug resistance and adverse effects by increasing molecular access to the brain. This article is categorized under: Therapeutic Approaches and Drug Discovery > Nanomedicine for Neurological Disease.


Assuntos
Encéfalo , Nanopartículas , Encéfalo/metabolismo , Barreira Hematoencefálica/metabolismo , Administração Intranasal , Preparações Farmacêuticas , Sistemas de Liberação de Medicamentos , Nanopartículas/química
11.
Hematol Oncol Stem Cell Ther ; 17(2): 88-94, 2024 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-38560970

RESUMO

This systematic review aimed to evaluate the proportion of primary and secondary endpoints in hematopoietic stem cell transplant (HSCT) phase III randomized clinical trials (RCTs) and analyze their trends in time and study sponsorship status. The Chi-square test and logistic regression analyses were performed using SPSS version 28. A total of 147 HSCT phase III RCTs from 2006 to 2021 reported 197 primary and 600 secondary endpoints. Overall survival (OS, 17 %), progression-free survival (PFS, 15 %), graft versus host disease (GVHD, 8 %), event-free survival (EFS, 8 %), and organ function (8 %) were the most common primary endpoints. GVHD (12.3 %, n = 74), safety/toxicity/adverse events (11.8 %, n = 71), OS (11.5 %, n = 69), PFS (9.3 %, n = 56), and relapse rate (RR; 7.5 %, n = 45) were the most common secondary endpoints during 2006-2021. After 2013, an increase was noted in the use of PFS as a primary endpoint (12 %-18 %, p = 0.196), while the use of OS as a primary endpoint declined (20 %-13 %, p = 0.170). An increase was observed in using the secondary endpoints RR (5 %-10 %, p = 0.047) and NRM (3 %-6 %, p = 0.047). EFS was used more (14 % vs. 4 %, p = 0.012) than ORR (11 % vs. 2 %, p = 0.003) as a primary endpoint in pharmaceutical-compared to non-pharmaceutical-sponsored studies. As secondary endpoints, the use of EFS (4 % vs. 1 %, p = 0.013) and ORR (4 % vs. 1 %, p = 0.028) was higher, whereas that of organ systems/functions (1.5 % vs. 5.5 %, p = 0.022) and GVHD (6.5 % vs. 15 %, p = 0.002) was lower in pharmaceutical-compared to non-pharmaceutical sponsored studies. GVHD-free relapse-free survival was reported as a primary endpoint in 2 % of studies, while only 5 % reported quality of life as a secondary endpoint. We described commonly used endpoints in HSCT phase III RCTs and patterns in their use over time by funding source and study intervention category.


Assuntos
Doença Enxerto-Hospedeiro , Transplante de Células-Tronco Hematopoéticas , Humanos , Ensaios Clínicos Fase III como Assunto , Doença Enxerto-Hospedeiro/etiologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Preparações Farmacêuticas , Ensaios Clínicos Controlados Aleatórios como Assunto , Transplante Homólogo
12.
AMA J Ethics ; 26(4): E289-294, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38564743

RESUMO

This commentary responds to a case about diethylene glycol-contaminated glycerin in cough syrup. Glycerin is a commonly used excipient in medicines to improve texture and taste. Excipients are typically pharmacologically inactive ingredients contained in prescription and over-the-counter drugs that play a critical role in the delivery, effectiveness, and stability of active drug substances. The commentary first canvasses how contaminants enter the excipient supply chains. One way is by misleading labeling or intentional adulteration by manufacturers or suppliers. Another way is by human or systemic error. This commentary then discusses quality control testing and suggests the ethical and clinical importance of increased transparency in excipient supply chains.


Assuntos
Excipientes , Glicerol , Criança , Humanos , Excipientes/efeitos adversos , Preparações Farmacêuticas , Contaminação de Medicamentos , Tosse/tratamento farmacológico
13.
AMA J Ethics ; 26(4): E327-333, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38564748

RESUMO

This article argues that drug shortages should be addressed as crises that exacerbate already compromised US health care infrastructure. Clinicians, especially pharmacists, can help limit threats that shortages pose to patients. For example, pharmacists can canvass procurement options, consolidate inventory, and prepare medications to prevent need for some clinical interventions. This article describes how pharmacists' preparation and training equip them to help clinical teams navigate shortages by equitably rationing limited medicines, suggesting appropriate therapeutic alternatives, modifying drug administration routes, or delaying interventions. Pharmacists' roles can be key, since good management of supplies during drug shortages can mitigate risk of worse-than-usual clinical outcomes, mitigate risk of medication errors, and reduce some financial burdens on the overall health care system.


Assuntos
Farmacêuticos , Serviço de Farmácia Hospitalar , Humanos , Preparações Farmacêuticas , Erros de Medicação/prevenção & controle , Hospitais
14.
J Pharm Pharm Sci ; 27: 12398, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38577255

RESUMO

Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug's pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2.


Assuntos
Medicamentos Genéricos , Projetos de Pesquisa , Humanos , Preparações Farmacêuticas , Equivalência Terapêutica
15.
Health Expect ; 27(2): e14043, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38590082

RESUMO

BACKGROUND: The emergence of proprotein convertase subtilisin/kexin type 9 inhibitors offered dyslipidemia patients an alternative to statins for lipid-lowering treatment. Understanding patient and physician preferences for lipid-lowering drugs may promote shared decision-making and improve treatment outcomes. METHODS: This study utilized an online discrete choice experiment (DCE) to assess the relative importance (RI) of six attributes related to lipid-lowering drugs, including frequency of administration, mode of administration, reduction of low-density lipoprotein cholesterol (LDL-C) level, risk of myopathy, risk of liver damage, and out-of-pocket monthly cost. Respondents were recruited from dyslipidemia patients and cardiovascular physicians in China. A mixed logit model and latent class analysis were employed to estimate the preference coefficient, marginal willingness to pay (mWTP), and RI of attributes. Ethical approval has been obtained for this study. RESULTS: A total of 708 patients and 507 physicians participated in the survey. Patients prioritized the 'risk of liver damage' (RI = 23.6%) with 'mode of administration' (RI = 19.2%) and 'frequency of administration' (RI = 18.8%) following closely. Contrarily, physicians prioritized the 'reduction of LDL-C level' (RI = 33.5%), followed by 'risk of liver damage' (RI = 26.0%) and 'risk of myopathy' (RI = 16.1%). Patients placed a higher value on 'frequency of administration' (p < .001) and 'mode of administration' (p < .001) compared to physicians, while physicians valued 'reduction of LDL-C level' (p < .001) and 'risk of myopathy' (p = .012) more than patients. Physicians exhibited higher mWTP than patients for all attributes except frequency and mode of administration. The LCA revealed three distinct patient classes: focus on oral administration, focus on hepatic safety and frequency and focus on hepatic safety and cost. Likewise, three physician classes were identified: frequency-insensitive, efficacy-focused and safety-focused. CONCLUSIONS: The preferences for lipid-lowering drug therapy differed between patients and physicians in China. Physicians should take into account patients' preferences and provide personalized treatment when they formulate lipid-lowering treatment plans. PATIENT OR PUBLIC CONTRIBUTION: Patients participated in the questionnaire design process. They engaged in a focus group discussion to determine attributes and levels and also participated in a pilot survey to assess the comprehensibility of the questionnaires. Additionally, patients were involved in the DCE survey to express their preferences. The findings of patient preference for lipid-lowering drug therapy will promote shared decision-making and optimize the treatment regimen.


Assuntos
Dislipidemias , Doenças Musculares , Médicos , Humanos , Preparações Farmacêuticas , LDL-Colesterol , Preferência do Paciente , Comportamento de Escolha
16.
Eur J Health Law ; 31(2): 129-152, 2024 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-38594021

RESUMO

Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) "regulatory silence"; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.


Assuntos
Uso Off-Label , Segurança do Paciente , Humanos , Europa (Continente) , Preparações Farmacêuticas
17.
BMJ Open ; 14(4): e083726, 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594185

RESUMO

INTRODUCTION: Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status. METHODS AND ANALYSIS: The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it. ETHICS AND DISSEMINATION: Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.


Assuntos
Serviço de Farmácia Hospitalar , Farmácia , Humanos , Farmacêuticos , Atenção Secundária à Saúde , Preparações Farmacêuticas , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Literatura de Revisão como Assunto
18.
Front Public Health ; 12: 1362716, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38596513

RESUMO

Introduction: Cardiovascular diseases are a multifaceted and complex problem in the health system that can change the priorities of the economic, social, and even political systems of countries. Therefore, as a grand challenge (GC), its management requires adopting a systematic, interdisciplinary, and innovative approach. In Iran, the most common causes of death, have changed from infectious and diarrheal diseases to cardiovascular diseases since 1960. Methods: In this study, the novel framework of the problem-oriented innovation system (PIS) has been used, and cardiovascular diseases in Iran have been selected as a case study. To this end, first, the main challenges related to cardiovascular diseases in Iran were identified in two layers of "governance-centered" (including legal and policy gaps, insufficient education, financing, lack and unbalanced distribution of medical personnel) and "society driven" (including unhealthy diet and lifestyle, uncontrolled and hard-to-regulate factors, and high costs) through a library research. Then, the functional-structural framework of the problem-oriented innovation system was used to analyze cardiovascular diseases and provide policy recommendations. Results: The findings indicate that based on the eight functions of the problem-oriented innovation system, an important part of cardiovascular diseases can be managed and controlled in three short-term, medium-term, and long-term periods. Conclusion: Increasing public awareness in the form of university courses, participation of the government with the private sector in building and equipping specialized cardiovascular centers, creating an electronic health record from birth, implementing a family health plan focusing on less developed areas, supporting agriculture and guaranteeing the purchase of agricultural products and healthy food, increasing the capacity of accepting students in medical and paramedical fields, and allocating pharmaceutical currency in the form of pharmaceutical subsidies directly to cardiovascular patients, are among the most important policy recommendations for this grand challenge.


Assuntos
Doenças Cardiovasculares , Humanos , Doenças Cardiovasculares/terapia , Governo , Preparações Farmacêuticas , Irã (Geográfico)
19.
Environ Geochem Health ; 46(4): 145, 2024 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-38568460

RESUMO

Frequent detection of sulfonamides (SAs) pharmaceuticals in wastewater has necessitated the discovery of suitable technology for their sustainable remediation. Adsorption has been widely investigated due to its effectiveness, simplicity, and availability of various adsorbent materials from natural and artificial sources. This review highlighted the potentials of carbon-based adsorbents derived from agricultural wastes such as lignocellulose, biochar, activated carbon, carbon nanotubes graphene materials as well as organic polymers such as chitosan, molecularly imprinted polymers, metal, and covalent frameworks for SAs removal from wastewater. The promising features of these materials including higher porosity, rich carbon-content, robustness, good stability as well as ease of modification have been emphasized. Thus, the materials have demonstrated excellent performance towards the SAs removal, attributed to their porous nature that provided sufficient active sites for the adsorption of SAs molecules. The modification of physico-chemical features of the materials have been discussed as efficient means for enhancing their adsorption and reusable performance. The article also proposed various interactive mechanisms for the SAs adsorption. Lastly, the prospects and challenges have been highlighted to expand the knowledge gap on the application of the materials for the sustainable removal of the SAs.


Assuntos
Nanotubos de Carbono , Águas Residuárias , Polímeros , Sulfonamidas , Sulfanilamida , Preparações Farmacêuticas
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