BACKGROUND & AIMS: OBJECTIVE:The present study sought to identify both the ingredients for success and the potential impediments to social marketing effectiveness for healthy eating behaviour, focusing on studies conducted over the last 10 years. DESIGN:A comprehensive literature review was undertaken examining seventeen databases to identify studies reporting the use of social marketing to address healthy eating. Thirty-four empirical studies were analysed to examine the effectiveness of social marketing interventions to improve healthy eating behaviour using Andreasen's (2002) social marketing benchmark criteria. Statistical analysis was undertaken to quantitatively evaluate whether effectiveness varied between study categories (subsets). SETTING:Healthy eating empirical studies published from 2000 onwards. SUBJECTS:Empirical studies that self-identified as social marketing. RESULTS:Sixteen social marketing studies (subset 1) were identified in the review. These were systematic studies which sought to change behaviour through tailored solutions (e.g. use of marketing tools beyond communication was clearly evident) that delivered value to the target audience. For these sixteen studies, the mean number of criteria identified was five. Six studies met all six criteria. Positive change to healthy eating behaviour was found in fourteen of sixteen studies. The sixteen studies that met the definition of social marketing used significantly more of Andreasen's (2002) criteria and were more effective in achieving behavioural change than the eighteen studies in subset 2. CONCLUSIONS:Social marketing is an involved process and it is important that studies identifying as social marketing adopt social marketing benchmark criteria. Social marketing when employed to its full extent offers the potential to change healthy eating.

背景与目标：

BACKGROUND & AIMS: :The levels of mycotoxins found were generally lower the more refined the maize products were. The highest levels of deoxynivalenol, nivalenol and fumonisins were found in maize bran and maize screenings. Ochratoxin A was found in a defatted germ meal sample at 50 μg/kg. Zearalenone was found randomly in samples at low levels (50 - 100 μg/kg). All other mycotoxins tested for, except in maize bran and maize screenings, were absent above the detection limits.

背景与目标： : 发现的霉菌毒素水平通常越低，玉米产品越精制。在玉米麸皮和玉米筛选中发现脱氧雪腐镰刀菌烯醇，雪腐镰刀菌烯醇和伏马菌素含量最高。在脱脂的胚芽粉样品中发现了曲霉毒素A，含量为50 μ g/kg。在样品中以低水平 (50-100 μ g/kg) 随机发现玉米赤菌烯酮。除玉米麸皮和玉米筛选外，所有其他测试的真菌毒素均高于检测限。

BACKGROUND & AIMS: :Although voluntary enrollment by abusive men in domestic violence perpetrator treatment programs occurs, most men enter treatment only after they have injured a partner or family member and have been arrested, convicted and sentenced. This leaves a serious gap for those who engage in abusive behavior but who have not been served by the legal or social service systems. To address this gap, the researchers applied social marketing principles to recruit abusive men to a telephone-delivered pre-treatment intervention (the Men's Domestic Abuse Check-Up-MDACU), designed to motivate non-adjudicated and untreated abusive men who are concurrently using alcohol and drugs to enter treatment voluntarily. This article discusses recruitment efforts in reaching perpetrators of intimate partner violence, an underserved population. Informed by McGuire's communication and persuasion matrix, the researchers describe three phases of the MDACU's marketing campaign: (1) planning, (2) early implementation, and (3) revision of marketing strategies based on initial results. The researchers' "lessons learned" conclude the paper.

背景与目标： : 尽管虐待男子自愿参加家庭暴力犯罪者治疗方案，但大多数男子只有在伤害伴侣或家庭成员并被逮捕，定罪和判刑后才接受治疗。这给那些从事虐待行为但没有得到法律或社会服务系统服务的人留下了严重的差距。为了解决这一差距，研究人员应用了社会营销原则，将虐待男性招募到电话提供的治疗前干预措施 (男性的家庭虐待检查-MDACU)，旨在激励未经裁决和未经治疗的虐待男性同时使用酒精和药物自愿接受治疗。本文讨论了招募工作，以帮助亲密伴侣暴力 (服务不足的人群) 的肇事者。根据McGuire的沟通和说服矩阵，研究人员描述了MDACU营销活动的三个阶段 :( 1) 计划，(2) 早期实施，以及 (3) 根据初步结果修订营销策略。研究人员的 “经验教训” 总结了这篇论文。

BACKGROUND & AIMS: :The National Association of EMS Physicians (NAEMSP), the American College of Emergency Physicians (ACEP), the Air Medical Physician Association (AMPA), the Association of Air Medical Services (AAMS), and the National Association of State EMS Officials (NASEMSO) believe that patient care and outcomes are optimized by using air medical transport services that are licensed air ambulance providers with robust physician medical director oversight and ongoing quality assessment and review. Only air ambulance medical transport services with these credentials should advertise/market themselves as air ambulance services.

背景与目标： : 全国EMS医师协会 (NAEMSP)，美国急诊医师协会 (ACEP)，航空医师协会 (AMPA)，航空医疗服务协会 (AAMS)，国家EMS官员协会 (NASEMSO) 认为，通过使用航空医疗运输服务来优化患者的护理和结果，这些服务是有执照的航空救护车提供者，并具有强大的医师医疗总监监督和持续的质量评估和审查。只有具有这些证书的空中救护车医疗运输服务才能将自己宣传/推销为空中救护车服务。

BACKGROUND & AIMS: AIMS:A sustained-release formulation (SRF) of tapentadol has been marketed in Australia since February 2013. This study examined tapentadol SRF extra-medical use, attractiveness for extra-medical use, and associated harms in Australia. METHODS:This post-marketing study comprises analyses of Australian community sales data (2011-2017) for eleven pharmaceutical opioids (prescription and over-the-counter codeine disaggregated); calls to three poisons information centres (covering five of the eight jurisdictions in Australia) related to pharmaceutical opioids and coded by the centres as 'misuse' or 'abuse' (2011-2017); and interviews with people who inject drugs (n = 888) recruited as part of the Illicit Drug Reporting System (IDRS) from all Australian capital cities (2017). RESULTS:Population-level availability of tapentadol SRF increased from market launch, comprising the sixth largest market share of all opioid unit sales, and third greatest share in oral morphine equivalent milligrams sold, in December 2017. Lifetime tapentadol SRF use among the IDRS sample (n = 888) was low (1.5%; 95%CI 0.9-2.5), with few reporting past-6 month non-prescribed use or injection. Non-fatal overdose following tapentadol use was self-reported by less than 1% (95%CI 0.1-0.8). Between 2013-2017, 1.1% (n = 25) of pharmaceutical opioid 'misuse/abuse' calls were related to tapentadol, and predominantly the SRF. CONCLUSIONS:Increasing utilisation of tapentadol sustained-release formulation was observed, along with indications of extra-medical use and harms associated with use, although on a smaller scale relative to other opioids. These findings need to be interpreted in the context of the low level of exposure to tapentadol sustained-release formulation among the sentinel population of people who inject drugs.

背景与目标：

BACKGROUND & AIMS: OBJECTIVE:To evaluate information contained within Internet sites that advertise and market dietary supplements containing ephedra. MATERIAL AND METHODS:We conducted an Internet search to identify Web sites advertising weight-loss supplements that contained ephedra. Between July 7 and July 18, 2002, 4 search engines were used by entering the term herbal weight loss. Outcome measures included disclosure of potential adverse effects of or contraindications to ephedra-containing supplements, disclosure of ephedra alkaloid dosage, and presence of misleading or incorrect information. RESULTS:Thirty-two products and advertisements were identified and systematically evaluated for deviance from truth-in-advertising standards. Of the 32 Web sites analyzed, 13 (41%) failed to disclose potential adverse effects or contraindications to supplement use. Seventeen (53%) did not reveal the dosage of ephedra alkaloids that was recommended. More importantly, 11 sites (34%) contained incorrect or misleading statements, some of which could directly result in serious harm to consumers. CONCLUSION:If dietary supplements containing ephedra are to continue to be marketed freely, substantial reform in advertising regulation and enforcement is warranted.

背景与目标：

BACKGROUND & AIMS: :The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation.

背景与目标： : 制药行业有义务在药物开发的所有阶段，包括上市后阶段，确定对药物产品的不良反应。估计人群对药品的暴露量对于药物上市后的监测很重要，并为评估与药物治疗相关的各种风险和收益 (包括药物安全性) 提供了背景。本文介绍了一种系统的方法来估计上市后的药物暴露，使用出厂装运数据来估计可用的药物数量，并使用剂量信息 (根据适应症或其他适当因素进行分层) 将药物数量转换为人的暴露时间。与通常用于估计暴露量的非标准化方法不同，这种方法提供的估算值是明确的，有文档记录的，并且在产品之间以及随着时间的推移是一致的。这些方法可以由专门从事此功能的个人或小组轻松执行，并有助于自动化。当前的估算方法是实用的，并且实施起来相对简单。我们认为这是一项有益的创新。

BACKGROUND & AIMS: OBJECTIVE:To evaluate the quality of information presented and claims made on websites offering bioidentical hormone therapy (BHT) products or services. METHODS:A quantitative content analysis was completed on 100 websites promoting or offering BHT products or services. Websites were identified through Google search engine from September to October 2013. Search terms included "bioidentical hormone therapy" or "bioidentical progesterone," accompanied by "purchase or buy," "service," or "doctors." The Brief DISCERN instrument was used to determine the quality of the health information. RESULTS:Websites were from Canada (59%), United States (38%), and other countries (3%). Almost half of the websites originated from medical clinics (47%), and healthcare professionals offering BHT services included physicians (50%), pharmacists (19%), and naturopaths (16%). Majority of websites promoted BHT as custom-compounded formulations (62%), with only 27% indicating that BHT is also commercially available. Websites overall claimed that BHT had less risk compared with conventional hormone therapy (62%). BHT was described as having less breast cancer risk (40%), whereas over a quarter of websites described BHT as "protective" for breast cancer. Websites mainly targeted women (99%), with males mentioned in 62% of websites. Product descriptors used to promote BHT included individualization (77%), natural (70%), hormone imbalance (56%), and antiaging (50%). The mean Brief DISCERN score was 15, indicating lower quality of information. CONCLUSIONS:Claims made about BHT on the internet are misleading and not consistent with current professional organizations' recommendations. Understanding how BHT may be promoted on the internet can help healthcare professionals when educating patients.

背景与目标：

BACKGROUND & AIMS: OBJECTIVE:To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. METHODS:A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). RESULTS:Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. CONCLUSION:This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors. It supports the safety of SFI for clinical, research,and production uses based on objective, reliable, and scientific information to provide safe medication.

背景与目标：

BACKGROUND & AIMS: :The Internet has allowed the expansion of food and beverage advertising in different media. The objective of this study was to identify the marketing strategies used in brand websites of foods and beverages consumed by children and adolescents, and classify them based on the Food Guidelines for the Argentinean Population. The foods and beverages most commonly consumed by the child and adolescent population as per the Survey on Nutritional Food Intake of the Autonomous City of Buenos Aires were selected. Brand websites were identified; marketing strategies were analyzed and marketed foods and beverages were classified based on the Guidelines. A total of 80 websites were found; the most common strategies were brand identity, benefits and claims, and links to websites and/or social media. Also, 30 % of sites were aimed at children and adolescents, and 75 % of marketed foods and beverages corresponded to the group of sweets and fats, including those of low nutritional value. :Internet permitió expandir la promoción de alimentos/bebidas a diferentes medios. El objetivo del estudio fue identificar las estrategias de marketing en sitios web de marcas de alimentos y bebidas consumidos por niños/as y adolescentes, y clasificarlos según las recomendaciones de las Guías Alimentarias para la Población Argentina. Se seleccionaron los alimentos/bebidas más consumidos por la población infantojuvenil según la Encuesta Alimentaria Nutricional de la Ciudad Autónoma de Buenos Aires. Se identificaron las páginas web de las marcas; se analizaron las estrategias de marketing y se clasificaron los alimentos/bebidas promocionados según las Guías. Se encontraron 80 páginas web, donde las estrategias más frecuentes fueron identificación de la marca, beneficios y declaraciones, y vínculos a páginas web y/o redes sociales. El 30 % de los sitios estaban dirigidos a niños/as/adolescentes, donde el 75 % de los alimentos/bebidas promocionados correspondieron al grupo de dulces y grasas, que incluye aquellos de bajo valor nutricional.

背景与目标：

BACKGROUND & AIMS: INTRODUCTION:Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. AIMS:A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. MATERIAL AND METHODS:A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. RESULTS:Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. CONCLUSION:Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

背景与目标：

BACKGROUND & AIMS: :Children's diets in their first 1000 days influence dietary preferences, eating habits, and long-term health. Yet the diets of most infants and toddlers in the United States do not conform to recommendations for optimal child nutrition. This narrative review examines whether marketing for infant formula and other commercial baby/toddler foods plays a role. The World Health Organization's International Code of Marketing Breast-milk Substitutes strongly encourages countries and manufacturers to prohibit marketing practices that discourage initiation of, and continued, breastfeeding. However, in the United States, widespread infant formula marketing negatively impacts breastfeeding. Research has also identified questionable marketing of toddler milks (formula/milk-based drinks for children aged 12-36 mo). The United States has relied exclusively on industry self-regulation, but US federal agencies and state and local governments could regulate problematic marketing of infant formula and toddler milks. Health providers and public health organizations should also provide guidance. However, further research is needed to better understand how marketing influences what and how caregivers feed their young children and inform potential interventions and regulatory solutions.

背景与目标： : 儿童在头1000日的饮食会影响饮食偏好，饮食习惯和长期健康。然而，美国大多数婴幼儿的饮食不符合最佳儿童营养的建议。本叙述性评论研究了婴儿配方奶粉和其他商业婴儿/幼儿食品的营销是否起作用。世界卫生组织的《母乳代用品国际销售守则》强烈鼓励各国和制造商禁止阻止开始和继续母乳喂养的销售做法。然而，在美国，广泛的婴儿配方奶粉营销对母乳喂养产生了负面影响。研究还发现了可疑的幼儿牛奶 (针对12-36岁儿童的配方奶粉/牛奶饮料) 的营销。美国完全依靠行业自律，但美国联邦机构以及州和地方政府可以监管有问题的婴儿配方奶粉和幼儿奶的营销。卫生提供者和公共卫生组织也应提供指导。然而，需要进一步的研究，以更好地了解营销如何影响什么，以及如何照顾者喂养他们的幼儿，并告知潜在的干预措施和监管解决方案。

BACKGROUND & AIMS: :Commercialization of genetic technologies is expanding the horizons for the marketing and sales of genetic tests direct-to-consumers (DTCs). This study assesses the information provision and access requirements that are in place for genetic tests that are being advertised DTC over the Internet. Sets of key words specific to DTC genetic testing were entered into popular Internet search engines to generate a list of 24 companies engaging in DTC advertising. Company requirements for physician mediation, genetic counseling arrangements, and information provision were coded to develop categories for quantitative analysis within each variable. Results showed that companies offering risk assessment and diagnostic testing were most likely to require that testing be mediated by a clinician, and to recommend physician-arranged counseling. Companies offering enhancement testing were less likely to require physician mediation of services and more likely to provide long-distance genetic counseling. DTC advertisements often provided information on disease etiology; this was most common in the case of multifactorial diseases. The majority of companies cited outside sources to support the validity of claims about clinical utility of the tests being advertised; companies offering risk assessment tests most frequently cited all information sources. DTC advertising for genetic tests that lack independent professional oversight raises troubling questions about appropriate use and interpretation of these tests by consumers and carries implications for the standards of patient care. These implications are discussed in the context of a public healthcare system.

背景与目标： : 基因技术的商业化正在扩大直接面向消费者的基因测试 (dtc) 的营销和销售的视野。这项研究评估了通过互联网宣传DTC的基因测试的信息提供和访问要求。特定于DTC基因测试的关键字集被输入到流行的Internet搜索引擎中，以生成24家从事DTC广告的公司的列表。公司对医生调解，遗传咨询安排和信息提供的要求进行了编码，以开发用于每个变量中定量分析的类别。结果表明，提供风险评估和诊断测试的公司最有可能要求由临床医生进行测试，并建议医生安排的咨询。提供增强测试的公司不太可能需要医生调解服务，而更有可能提供远程遗传咨询。DTC广告通常提供有关疾病病因的信息; 这在多因素疾病的情况下最常见。大多数公司引用外部来源来支持有关所宣传测试的临床实用性的主张的有效性; 提供风险评估测试的公司最常引用所有信息来源。缺乏独立专业监督的DTC基因测试广告引发了有关消费者对这些测试的适当使用和解释的令人困扰的问题，并对患者护理标准产生影响。这些含义将在公共医疗体系的背景下进行讨论。

BACKGROUND & AIMS: BACKGROUND:In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. METHODS:To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications (henceforth, application/s) of drugs submitted to the European Medicines Agency (EMA) from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study (issues related to informed consent, research ethics committees, and respect for persons). Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings (ERFs) reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. RESULTS:From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37 (56.9%). The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. CONCLUSION:None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes.

背景与目标：

BACKGROUND & AIMS: :The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/10(6) defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1-12.0) for aceclofenac, 24.8 (23.1-26.6) for meloxicam, and 52.6 (49.9-55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors.

背景与目标： : 目的是比较三种具有不同环加氧酶 (COX)-2选择性的非甾体抗炎药报告的不良反应发生率。世界卫生组织国际药物监测合作中心药物警戒数据库中的所有自发性不良反应通知均包括在上市第一年记录的醋氯芬酸，美洛昔康和罗非昔布。对于醋氯芬酸，总不良反应的发病率 (不良反应/10(6) 定义的每日剂量) 和95% 置信区间为8.7 (6.1-12.0)，美洛昔康为24.8 (23.1-26.6)，罗非昔布为52.6 (49.9-55.4)。与美洛昔康相比，醋氯芬酸的胃肠道出血，腹痛和动脉高血压的发生率较低，而胃肠道出血，腹痛，肝毒性，血栓栓塞心血管事件，动脉高血压和水肿的发生率低于罗非昔布。与美洛昔康或罗非昔布相比，醋氯芬酸的总和胃肠道不良反应发生率显着降低，因此对COX-2选择性抑制剂的假设优势产生了怀疑。