3,879 research outputs found
Evolution of Self-Care Education
During the past 15 years, the curriculum content for nonprescription medication and self-care therapeutics has expanded significantly. Self-care courses ranging from stand-alone, required courses to therapeutic content and skills laboratories, have evolved in colleges and schools of pharmacy to accommodate rapid changes related to nonprescription medications and to meet the needs of students. The design of and content delivery methods used in self-care courses vary among institutions. Teaching innovations such as team-based learning, role playing/vignettes, videos, and social media, as well as interdisciplinary learning have enhanced delivery of this content. Given that faculty members train future pharmacists, they should be familiar with the new paradigms of Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative, nonprescription medications for chronic diseases, and the growing trends of health and wellness in advancing patient-care initiatives. This paper reviews the significant changes that may be impacting self-care curriculums in the United States
Exploring the Influence of Family on Adolescentsâ Seafood Consumption Choices
Seafood in the adolescent diet has many benefits, yet a number of adolescents do not consume the recommended levels. Despite this the consumption of seafood by younger consumers has received scant attention in the extant literature. Previous studies on adolescentsâ food-related behaviour tend to focus on general choice mechanisms or perceptions of food and mainly relate to fruit and vegetable intake. The present study seeks to address this gap through investigating the impact of family upon the consumption of seafood by younger consumers through exploring adolescentsâ attitudes and behaviour in regard to eating seafood. Utilising an exploratory qualitative methodology, seven focus groups of adolescents aged 13â19 years were conducted at two schools in South-West England. Discussions covered a range of issues related to adolescent seafood consumption. The use of thematic content analysis found that the family, and parents in particular, exert high levels of influence over adolescentsâ consumption of seafood both at home and when dining out. The parent who does the shopping and cooking has the greatest role. Sibling preferences and dietary choices also influence whether seafood is served in the home. Of value to researchers and management are the insights gleaned into the influences on adolescentsâ attitudes toward and behaviour in regard to eating seafood. In particular encouraging seafood consumption will rely upon interventions aimed at both parents and children and need to take into account adolescentsâ diet and lifestyle preferences, while also acknowledging the influence of peers and the school food environment
Approval of cancer drugs with uncertain therapeutic value: a comparison of regulatory decisions in Europe and the United States
Policy Points Regulatory agencies may have limited evidence on the clinical benefits and harms of new drugs when deciding whether new therapeutic agents are allowed to enter the market and under which conditions, including whether approval is granted under special regulatory pathways and obligations to address knowledge gaps through postmarketing studies are imposed. In a matched comparison of marketing applications for cancer drugs of uncertain therapeutic value reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we found frequent discordance between the two agencies on regulatory outcomes and the use of special regulatory pathways. Both agencies often granted regular approval, even when the other agency judged there to be substantial uncertainty about drug benefits and risks that needed to be resolved through additional studies in the postmarketing period. Postmarketing studies imposed by regulators under special approval pathways to address remaining questions of efficacy and safety may not be suited to deliver timely, confirmatory evidence due to shortcomings in study design and delays, raising questions over the suitability of the FDA's Accelerated Approval and the EMA's Conditional Marketing Authorization as tools for allowing early market access for cancer drugs while maintaining rigorous regulatory standards. Context: Regulatory agencies are increasingly required to make market approval decisions for new drugs on the basis of limited clinical evidence, a situation commonly encountered in cancer. We aimed to investigate how regulators manage uncertainty in the benefit-risk profiles of new cancer drugs by comparing decisions for the world's two largest regulatory bodiesâthe US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)âover a 5-year period. Methods: We systematically identified a set of cancer drug-indication pairs for which data on efficacy and safety was less complete than that required for regular approval at time of market entry from 2009 to 2013, as determined by the FDA's use of Accelerated Approval (AA) or the EMA's use of Conditional Marketing Authorization (CMA) pathways, and matched these across the two agencies. Using publicly available information, we compared regulatory pathways and outcomes, final approved indications, and postmarketing obligations imposed by the agencies. Findings: We identified 21 cancer drug-indication pairs that received FDA AA, EMAÂ CMA, or both. Although most applications relied on identical pivotal trials across the FDA and the EMA, regulatory pathways often differed; 57% of indications received either FDA AA or EMA CMA, and regular approval by the other agency. After approval, the EMA more often accepted single-arm studies to confirm clinical benefit compared to the FDA (75% vs. 29% of indications), and the FDA more commonly requested randomized controlled trials (85% vs. 50%). Forty-one percent of confirmatory trials after FDA AA were conducted in different populations than the approved indication, compared to 13% after EMA CMA. Both agencies relied primarily on surrogate measures of patient benefit for postmarketing obligations. After a median follow-up of 7.25 years, 40% of FDA and 61% of EMA postmarketing obligations after AA and CMA, respectively, were delayed. Conclusions: US and European regulators often deemed early and less complete evidence on benefit-risk profiles of cancer drugs sufficient to grant regular approval, raising questions over regulatory standards for the approval of new medicines. Even when imposing confirmatory studies in the postmarketing period through special approval pathways, meaningful evidence may not materialize due to shortcomings in study design and delays in conducting required studies with due diligence
Risk in CNS drug discovery: focus on treatment of Alzheimer's Disease
Despite rapid progress in our understanding of disease mechanisms and an exploding list of new targets for therapeutic intervention, drug discovery and development remains a highly risky business. Understanding the risk involved requires appreciation of the differing perspectives of risk held by the various stakeholders involved in drug research. Risk can be reduced by thoughtful management of drug candidate selection, careful planning and program execution by a team of engaged experts, and disciplined decision making. Drug development is particularly challenging for treatments of neurodegenerative diseases such as Alzheimer's disease, in which translation from animal models of efficacy to human success is poor or unknown, the timelines for clinical study are long, and the markers of efficacy are still evolving. Despite this there are several therapies in clinical development that hold the promise of influencing this disease through novel and possibly synergistic mechanisms
Thresholds of Toxicological Concern for Cosmetics-Related Substances: New Database, Thresholds, and Enrichment of Chemical Space
A new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-Adverse-Effect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 ÎŒg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 ÎŒg/kg-bw/day are broadly similar to those of the original Munro dataset
Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval
Problems and Prospects: Public Health Regulation of Dietary Supplements
Dietary supplements are a global business worth more than US$100 billion annually. These supplements are taken by up to 50% of adults and perhaps one-third of children in economically advanced economies. Definitions of dietary supplements differ from country to country, and regulation is generally lax and often seems to be directed more toward promoting commerce than protecting public health. Supplements may directly cause toxic reactions or may interact with other supplements or pharmaceuticals. Some supplements are found to have been contaminated with heavy metals, and others do not contain the expected quantities of active ingredients. In general, supplements are not needed except in cases of established deficiencies, and excess of some nutrients can increase cancer rates. There are important public health reasons for taking some supplements, including folate and iodine in pregnancy. This review discusses the public health concerns associated with dietary supplements and suggests directions for further regulation
Examining the Psychometric Properties of the CEAC (Comparing e-Cigarette and Cigarette) Questionnaire and Its Usefulness as a Predictor of e-Cigarette Use
Background: Electronic cigarette (e-cigarette) use continues to rise, while there is conflicting evidence about the health effects of its use. As such, research is needed to better determine risks factors for e-cigarette use. Accumulating evidence suggests that attitudes toward e-cigarette use could be a potential risk factor for e-cigarette use.
Objectives: This study sought to examine the psychometric properties of the Comparing E-cigarette And Cigarette questionnaire (CEAC), and to replicate a structural model of the relationship between impulsive-related personality traits and e-cigarette use mediated by positive attitudes toward e-cigarettes.
Methods: Participants were 525 adults (mean age = 33.42, SD = 11.27) who completed the CEAC and UPPS-P (trait impulsivity) questionnaires online.
Results: Confirmatory factor analysis of the CEAC replicated the a priori factor structure of the questionnaire reasonably well (Ï2(df = 32) =172.85, CFI = 0.94, TLI = 0.91, RMSEA = 0.09 (0.08â0.11, 90% Confidence Interval, SRMR = 0.06). Structural path analysis showed that deficits in conscientiousness was significantly negatively related to e-cigarette attitudes (ÎČ = â0.20, pâ=â.01), while urgency (ÎČ = 0.19, pâ=â.018) showed a significant positive relationship to e-cigarette attitudes. E-cigarette users showed significantly more positive attitudes toward e-cigarettes than nonusers (ÎČ = 0.59, pâ<â.001). No significant direct effects were found between impulsivity-related traits and e-cigarette use.
Conclusions: The present study suggests that impulsivity-related traits and attitudes toward e-cigarettes are likely to be important risk factors for e-cigarette use. Future prospective and experimental studies should test if the causal model described in this study predicts risk for e-cigarette use, and whether this model could therefore be used to guide strategies for reducing risk for e-cigarette use
International Frameworks Dealing with Human Risk Assessment of Combined Exposure to Multiple Chemicals
The development of harmonised terminology and frameworks for the human risk assessment of combined exposure to multiple chemicals (âchemical mixturesâ) is an important area for EFSA and a number of activities have already been undertaken, i.e. in the fields of pesticides and contaminants. The first step prior to a risk assessment of combined exposure to multiple chemicals is problem formulation defining the relevant exposure, hazard and population to be considered. In practice, risk assessment of multiple chemicals is conducted using a tiered approach for exposure assessment, hazard assessment and risk characterisation. Higher tiers require increasing knowledge about the group of chemicals under assessment and the tiers can range from tier 0 (default values, data poor situation) to tier 3 (full probabilistic models). This scientific report reviews the terminology, methodologies and frameworks developed by national and international agencies for the human risk assessment of combined exposure to multiple chemicals and provides recommendations for future activities at EFSA in this area
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