Update on emergency contraception

pre-printEmergency contraception (EC) is any method used after sexual intercourse to prevent pregnancy. This article provides an overview of the history of EC methods and describes the current availability of oral and intrauterine EC. Oral forms include the Yuzpe regimen (combining ethinyl estradiol and levonorgestrel), levonorgestrel-only pills, and ulipristal acetate, which is a new emergency contraceptive drug recently approved by the US Food and Drug Administration. The copper T-380A intrauterine device can also be used for EC. Information about dosing, timing, access, and other considerations in the provision of EC is covered. Clinicians should be aware of all available options in order to counsel women in need of EC appropriately

Electronic cigarettes: a survey of users

<p>Abstract</p> <p>Background</p> <p>Little is known about users of electronic cigarettes, or their opinions, satisfaction or how and why they use such products.</p> <p>Methods</p> <p>An internet survey of 81 ever-users of ecigarettes in 2009. Participants answered open-ended questions on use of, and opinions about, ecigarettes.</p> <p>Results</p> <p>Respondents (73 current and 8 former users) lived in France, Canada, Belgium or Switzerland. Most respondents (77%) were men; 63% were former smokers and 37% were current smokers. They had used e-cigarettes for 100 days (median) and drew 175 puffs per day (median). Participants used the ecigarette either to quit smoking (53 comments), to reduce their cigarette consumption (14 comments), in order not to disturb other people with smoke (20 comments), or in smoke-free places (21 comments). Positive effects reported with ecigarettes included their usefulness to quit smoking, and the benefits of abstinence from smoking (less coughing, improved breathing, better physical fitness). Respondents also enjoyed the flavour of ecigarettes and the sensation of inhalation. Side effects included dryness of the mouth and throat. Respondents complained about the frequent technical failures of ecigarettes and had some concerns about the possible toxicity of the devices and about their future legal status.</p> <p>Conclusions</p> <p>Ecigarettes were used mainly to quit smoking, and may be helpful for this purpose, but several respondents were concerned about potential toxicity. There are very few published studies on ecigarettes and research is urgently required, particularly on the efficacy and toxicity of these devices.</p

Establishing What Constitutes a Healthy Human Gut Microbiome: State of the Science, Regulatory Considerations, and Future Directions.

On December 17, 2018, the North American branch of the International Life Sciences Institute (ILSI North America) convened a workshop "Can We Begin to Define a Healthy Gut Microbiome Through Quantifiable Characteristics?" with &gt;40 invited academic, government, and industry experts in Washington, DC. The workshop objectives were to 1) develop a collective expert assessment of the state of the evidence on the human gut microbiome and associated human health benefits, 2) see if there was sufficient evidence to establish measurable gut microbiome characteristics that could serve as indicators of "health," 3) identify short- and long-term research needs to fully characterize healthy gut microbiome-host relationships, and 4) publish the findings. Conclusions were as follows: 1) mechanistic links of specific changes in gut microbiome structure with function or markers of human health are not yet established; 2) it is not established if dysbiosis is a cause, consequence, or both of changes in human gut epithelial function and disease; 3) microbiome communities are highly individualized, show a high degree of interindividual variation to perturbation, and tend to be stable over years; 4) the complexity of microbiome-host interactions requires a comprehensive, multidisciplinary research agenda to elucidate relationships between gut microbiome and host health; 5) biomarkers and/or surrogate indicators of host function and pathogenic processes based on the microbiome need to be determined and validated, along with normal ranges, using approaches similar to those used to establish biomarkers and/or surrogate indicators based on host metabolic phenotypes; 6) future studies measuring responses to an exposure or intervention need to combine validated microbiome-related biomarkers and/or surrogate indicators with multiomics characterization of the microbiome; and 7) because static genetic sampling misses important short- and long-term microbiome-related dynamic changes to host health, future studies must be powered to account for inter- and intraindividual variation and should use repeated measures within individuals

Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC)

&lt;p&gt;Synthetic and naturally occurring substances present in food and feed, together with their possible breakdown or reaction products, represent a large number of substances, many of which require risk assessment. EFSA’s Scientific Committee was requested to evaluate the threshold of toxicological concern (TTC) approach as a tool for providing scientific advice about possible human health risks from low level exposures, its applicability to EFSA’s work, and to advise on any additional data that might be needed to strengthen the underlying basis of the TTC approach. The Scientific Committee examined the published literature on the TTC approach, undertook its own analyses and commissioned an &lt;em&gt;in silico &lt;/em&gt;investigation of the databases underpinning the TTC approach. The Scientific Committee concluded that the TTC approach can be recommended as a useful screening tool either for priority setting or for deciding whether exposure to a substance is so low that the probability of adverse health effects is low and that no further data are necessary. The following human exposure threshold values are sufficiently conservative to be used in EFSA’s work; 0.15 μg/person per day for substances with a structural alert for genotoxicity, 18 μg/person per day for organophosphate and carbamate substances with anti-cholinesterase activity, 90 μg/person per day for Cramer Class III and Cramer Class II substances, and 1800 μg/person per day for Cramer Class I substances, but for application to all groups in the population, these values should be expressed in terms of body weight, i.e. 0.0025, 0.3, 1.5 and 30 μg/kg body weight per day, respectively. Use of the TTC approach for infants under the age of 6 months, with immature metabolic and excretory systems, should be considered on a case-by-case basis. The Committee defined a number of exclusion categories of substances for which the TTC approach would not be used.&lt;/p&gt

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature.

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.Peer reviewedFinal Published versio

Sources of antibiotic resistance: zoonotic, human, environment

Antibiotic resistance is a global problem that must be managed under the One Health perspective. Retrospectively, it is assumed that microbial populations able to cope with compounds with antimicrobial activity and susceptible bacteria lived in equilibrium for a thousand years. This situation would change in the middle 1940s of the twentieth century when one of the most important revolutions of modern medicine started - the use of a natural antimicrobial compound, the penicillin, to treat infectious bacterial diseases. Over the years, the massive use of antibiotics in human and animal medicine, as well as in animal production for both growth promotion and infection prophylaxis/metaphylaxis, accelerated and shaped one of the most successful evolutionary case studies. As a result of an impressive combination of genome and community dynamics, bacteria with acquired antibiotic resistance are nowadays widespread across different environmental compartments (water, soil, wildlife) as well as in the human food chain (poultry, livestock, aquaculture, produce). Hence, the evolutionary success of these bacteria turned to represent a major threat to the human health. This review discusses some of the drivers and paths of antibiotic resistance dissemination across zoonotic, human, and environmental sources.info:eu-repo/semantics/acceptedVersio

Colorants in Cheese Manufacture: Production, Chemistry, Interactions, and Regulation

Colored Cheddar cheeses are prepared by adding an aqueous annatto extract (norbixin) to cheese milk; however, a considerable proportion (∼20%) of such colorant is transferred to whey, which can limit the end use applications of whey products. Different geographical regions have adopted various strategies for handling whey derived from colored cheeses production. For example, in the United States, whey products are treated with oxidizing agents such as hydrogen peroxide and benzoyl peroxide to obtain white and colorless spray‐dried products; however, chemical bleaching of whey is prohibited in Europe and China. Fundamental studies have focused on understanding the interactions between colorants molecules and various components of cheese. In addition, the selective delivery of colorants to the cheese curd through approaches such as encapsulated norbixin and microcapsules of bixin or use of alternative colorants, including fat‐soluble/emulsified versions of annatto or beta‐carotene, has been studied. This review provides a critical analysis of pertinent scientific and patent literature pertaining to colorant delivery in cheese and various types of colorant products on the market for cheese manufacture, and also considers interactions between colorant molecules and cheese components; various strategies for elimination of color transfer to whey during cheese manufacture are also discussed

Isolation and characterization of bacteriophages for avian pathogenic E. coli strains

Aims: To isolate and characterize bacteriophages, and to evaluate its lytic performance against avian pathogenic Escherichia coli (APEC) strains with high patterns of antibiotic resistance, in order to select phages for a therapeutic product to treat colibacillosis in chickens. Methods and Results: Bacteriophages were isolated from poultry sewage and tested against 148 O-serotyped APEC strains. The morphological characterization of the bacteriophages was made by transmission electronic microscopy (TEM) observations and the genetic comparison between bacteriophages DNA was performed by restriction fragment length polymorphism (RFLP) patterns. Results showed that 70·5% of the tested E. coli strains were sensitive to a combination of three of the five isolated phages, that seemed to be virulent and taxonomically belong to the Caudovirales order. Two of them look like 16–19, T4-like phages (Myoviridae) and the third is a T1-like phage and belongs to Syphoviridae family. All of them are genetically different. Conclusions: It was possible to obtain a combination of three different lytic bacteriophages with broad lytic spectra against the most prevalent O-serotypes of APEC. Significance and Impact of the Study: Data reported in this study, presents an in vitro well studied phage product to be used as antimicrobial agent to treat colibacillosis in poultry industry.Fundação para a Ciência e a Tecnologia (FCT

Acrylamide-forming potential of cereals, legumes and roots and tubers analyzed by UPLC-UV

For directing scientists, consumers, industry and stakeholders on mitigation strategies, there is a need to understand the acrylamide-forming potential of important Indian foods. Flour obtained from total 16 varieties of 9 Indian cereals, legumes and roots and tubers was heated at 160 °C for 20 min, acrylamide was extracted and quantified by UPLC-UV. Acrylamide level was above the European Commission indicative value in potato- and cereal-based food products, it ranged from 3436.13 to 5562.56 μg/kg in roots and tubers (potato and sweet potato). Among the cereals, maize (2195.31 μg/kg) and wheat (161.12 μg/kg) had the highest and lowest contents, respectively, whereas rice, sorghum and pearl millet showed intermediate values. Among the 2 legumes, soybean contained higher acrylamide (337.08–717.52 μg/kg) than chickpea (377.83–480.49 μg/kg). Analysis of variance revealed that roots and tubers acrylamide was highly significantly greater than the content in cereals (p < 0.0001) and in legumes (p < 0.0001) while there was no significant difference between cereals and legumes (p = 0.443). These results support the combination of pulses and minor cereals (chickpea, soybean, millets and sorghum) in cereal-based foods for improving the nutritional value and reducing acrylamide formation