Adverse reactions to sulfites

Sulfites are widely used as preservatives in the food and pharmaceutical industries. In the United States more than 250 cases of sulfite-related adverse reactions, including anaphylactic shock, asthmatic attacks, urticaria and angioedema, nausea, abdominal pain and diarrhea, seizures and death, have been reported, including 6 deaths allegedly associated with restaurant food containing sulfites. In Canada 10 sulfite-related adverse reactions have been documented, and 1 death suspected to be sulfite-related has occurred. The exact mechanism of sulfite-induced reactions is unknown. Practising physicians should be aware of the clinical manifestations of sulfite-related adverse reactions as well as which foods and pharmaceuticals contain sulfites. Cases should be reported to health officials and proper advice given to the victims to prevent further exposure to sulfites. The food industry, including beer and wine manufacturers, and the pharmaceutical industry should consider using alternative preservatives. In the interim, they should list any sulfites in their products.     

The performance and problems of the Turkish pharmaceutical industry: is there a need to develop a national drug policy?

Turkey has a big pharmaceutical industry—of the drugs consumed there, 90% are manufactured domestically. Eighty percent of this manufacturing is run by foreign companies. In this study, the performance of the Turkish pharmaceutical industry in terms of the technology and production is examined and compared with that of some other countries, and the importance of the essential drugs list and national drug policy is discussed. At the end of the study, strategies are suggested toward meeting the main current challenges in the Turkish pharmaceutical industry.     

浅析当前浙江省医药企业社会责任的现状——以公司网站内容为视角

目的探讨目前医药企业对企业社会责任（CSR）的概念认知及其发展水平,针对现状作出相应的分析使其深化认识,提高履行企业社会责任的理性自觉。方法通过对五家医药企业网站的内容分析,一个小组制定一张关键词列表,包括10个使命关键词和10个核心价值观关键词,然后分析并分配到Lerbinger的CSR金字塔模式中。结果使命关键词主要体现经济职能;价值关键词支持减少社会成本。结论医药企业在全面深刻剖析企业社会责任之后,在履行其基本经济职能的同时,必须沿着LerbingerCSR金字塔模型逐级向上发展。     

Commercialism, choice and consumer protection: regulation of complementary medicines in Australia

Controls on the supply and promotion of complementary medicines in Australia are weak. We used weight-loss products as an example to compare the regulation in Australia of listed complementary medicines and registered pharmaceutical products. Complementary medicines are listed without evaluation for efficacy, while conventional pharmaceutical products are registered after evaluation for quality, safety and efficacy. From 1996 to 2006, over 1000 "weight-loss" products were listed on the Australian Register of Therapeutic Goods; most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy. Over the same period, 10 conventional medicines were registered; each contained one evaluated ingredient of proven efficacy. The number of listed weight-loss products (and complaints about their promotion) is increasing. These appear to be a direct consequence of the decision not to evaluate listed products for efficacy and the lower fees for listing a product, compared with registration. Complaint procedures (now overloaded) are no substitute for adequate regulation at the time of market entry. Regulatory reform of listed and homoeopathic products is required.     

The dearth of new antibiotic development: why we should be worried and what we can do about it

The emergence and spread of multidrug-resistant pathogens has increased substantially over the past 20 years. Over the same period, the development of new antibiotics has decreased alarmingly, with many pharmaceutical companies pulling out of antibiotic research in favour of developing "lifestyle" drugs. Reasons given for withdrawing from antibiotic development include poor "net present value" status of antibiotics, changes in regulations requiring larger drug trials and prolonged post-marketing surveillance, clinical preference for narrow-spectrum rather than broad-spectrum agents, and high new-drug purchase costs. Major improvements in infection control in Australia are needed to prevent further spread of resistant clones, buying some time to develop urgently needed new antibiotic agents. Perpetuating a culture of "pharma bashing" will simply lead to more pharmaceutical companies withdrawing from the market. A change in the health and research culture is needed to improve cooperation between public, academic and private sectors.     

Will the Australia-United States Free Trade Agreement undermine the Pharmaceutical Benefits Scheme?

The Australia-United States Free Trade Agreement (AUSFTA) contains major concessions to the US pharmaceutical industry that may undermine the egalitarian principles and operation of the Pharmaceutical Benefits Scheme (PBS) and substantially increase the costs of medicinal drugs to Australian consumers. AUSFTA's approach to the PBS excessively emphasises the need to reward manufacturers of "innovative" new pharmaceuticals, instead of emphasising consumers' need for equitable and affordable access to necessary medicines (the first principle of our National Medicines Policy). Several features of AUSFTA may bring pressure to bear on the Pharmaceutical Benefits Advisory Committee (PBAC) to list "innovative" drugs that the committee initially rejected because the evidence for cost-effectiveness was not compelling. Intellectual property provisions of AUSFTA are likely to delay the entry of PBS cost-reducing generic products when pharmaceutical patents expire. We support the many concerned health and consumer organisations who have asked the Senate either not to pass the enabling legislation, or to delay its passage until a fairer deal in terms of public health can be obtained.     

阿奇霉素分散片的人体相对生物利用度及生物等效性

目的 评价阿奇霉素分散片受试制剂与参比制剂人体相对生物利用度及生物等效性.方法 18名男性健康自愿者随机交叉口服A厂阿奇霉素分散片和B厂阿奇霉素分散片以及C厂阿奇霉片分散片各500 mg,采用液相色谱-质谱/质谱联用法测定血浆药物浓度.结果 A厂分散片、B厂分散片和C厂参比分散片的Tmax分别为(2.30±1.10)、(3.00±1.10)和(2.90±0.80)h;Cmax分别为(319.20±176.70)、(303.10±144.60)和(313.70±165.00)ng/ml,AUC0-144分别为(5073.60±2933.00)、(4296.80±1896.20)和(4797.80±3234.00)ng·h·ml,AUC0-∞分别为(5461.60±3236.00)、(4804.40±2162.90)和(5163.20±3497.50)ng·h/ml.结论 A厂阿奇霉素分散片受试制剂、B厂阿奇霉素分散片受试制剂与C厂阿奇霉素分散片参比制剂在吸收程度和吸收速度方面生物等效.     

符合新版GSP要求的计算机系统验证

《药品经营质量管理规范》(2012年修订版)已经于2013年6月1日开始实施。新版GSP对中国药品生产企业和药品经营企业都提出了很高的要求。药品经营企业的计算机系统验证问题,尽管在某些中国药品经营企业已有涉及,但是很多企业理解不全面或者不深刻。笔者汇集并分析了关于计算机系统验证相关法规和指南,进行系统研究,撰写此文希望为中国药品企业提供借鉴和帮助。     

Attitudes and practices of medical graduates in Delhi towards gifts from the pharmaceutical industry

Pharmaceutical companies use a variety of strategies, including gifts, to influence physicians. In December 2009, the Medical Council of India amended the Code of Medical Ethics to ban medical professionals from accepting gifts from pharmaceutical companies. In view of this ban, it is important to find out the magnitude and contours of the problem amongst Indian medical professionals. We aimed to study, through an e-mail based survey, the attitudes and practices of young resident doctors and interns from two medical colleges of New Delhi regarding acceptance of gifts from the pharmaceutical industry. We e-mailed the questionnaire to 150 fresh graduates. We found that the majority of graduates agreed with existing guidelines: they accepted low cost gifts but considered expensive gifts unrelated to patient welfare unethical. Despite the low response rate, this study is important because data from India on attitudes and practices of medical professionals regarding gifts from the pharmaceutical industry are virtually non-existent.     

Mining MEDLINE for the Treatment of Osteoporosis

In this paper, we consider the importance of osteoporosis disease in terms of medical research and pharmaceutical industry and we introduce a knowledge discovery approach regarding the treatment of osteoporosis from a historical perspective. Osteoporosis is a systemic skeletal disease in which osteoporotic fractures are associated with substantial morbidity and mortality and impaired quality of life. Osteoporosis has also higher costs, for example, longer hospital stays than many other diseases such as diabetes and heart attack and it is an attractive market for pharmaceutical companies. We use a freely available biomedical search engine leveraging text-mining technology to extract the drug names used in the treatment of osteoporosis from MEDLINE articles. We conclude that alendronate (Fosamax) and raloxifene (Evista) have the highest number of articles in MEDLINE and seem the dominating drugs for the treatment of osteoporosis in the last decade.     

美国生物制药研究进展与国家生物经济蓝图

生物技术和生物制药已经极大地改变了制药工业的格局。由于生物技术和生物制药在促进经济增长和产生社会效益方面存在的巨大潜力，使得生物经济的发展已成为美国政府优先考虑的民生问题。目前，美国制药和生物制药公司止在研发900多种生物制剂和疫苗，适用范围包括抗肿瘤、自身免疫性疾病，心血管疾病和感染性疾病等100多种疾病。本文综述当前美国生物制药领域的进展，并对美国政府的《国家生物经济蓝图》进行探讨。     

Child-Resistant Packaging

The CMA recommends that sulfites be banned as food preservatives when satisfactory and safe alternatives are available. When there is no suitable substitute strict labelling requirements on foods should be imposed for sulfite additives. The association supports the efforts of the Health Protection Branch of the Department of National Health and Welfare to regulate sulfites in the food and drug industry to prevent adverse reactions in people sensitive to sulfites. The CMA recommends that the Department of National Health and Welfare establish a federal-provincial liaison group that has the authority to introduce additive standards for food producers, distributors and restaurants and to monitor foods at the consumer level for the presence of allergenic additives.     

Tartrazine-containing drugs.

Pharmaceutical manufacturers producing or distributing drugs in Canada were surveyed between December 1974 and March 1975 to determine which of their products contained tartrazine, a pyrazole aniline dye. A list of some 580 drug products of the 156 manufacturers who responded is presented for aid in managing the tartrazine-sensitive patients.     

Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.

The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada.     

Tartrazine: a potentially hazardous dye in Canadian drugs.

The literature was reviewed to determine the incidence of idiosyncratic reactions to tartrazine. From 4% to 14% of individuals with asthma or allergies or both and from 7% to 20% of persons who are sensitive to acetylsalicylic acid may react to this dye. The mechanism of such reactions is unknown. Pharmaceutical manufacturers and distributors were surveyed and a list was prepared of approximately 450 Canadian pharmaceuticals that contain tartrazine. The 53 pharmaceutical and manufacturers and distributors whose drug products do not contain this dye were also listed. It is recommended that information concerning the tartrazine content of drugs be included on package labels.     

口腔速溶膜剂的研究进展

口腔速溶膜剂（oral fast dissolving films,OFDF）是口腔黏膜给药系统中一个新剂型,表现出的许多优点引起广泛的关注,许多制药公司都将快速溶解技术作为一个研究重点。OFDF制剂的生产制备方法主要有溶剂浇铸法和热熔挤压法。目前该制剂产品涉及食品、药品领域,既有治疗口腔疾病的局部药膜,也有发挥全身作用的药膜,由于其独特的剂型优势,许多大公司对此产生浓厚的兴趣,将某些药物进行剂型转换来延长专利期是目前研究的热点。     

Gluten in pills: a hazard for patients with celiac disease.

It has recently been recognized that many pharmaceutical products contain gluten. Patients with celiac disease are at risk of acute illness if they are treated with such products. This paper lists the products available in Canada, according to the "Compendium of Pharmaceuticals and Specialties, 1985", that contain gluten and the Canadian manufacturers who stated that they do not use gluten as an excipient.     

银翘散血清药物化学研究

目的对银翘散的血清药物化学进行研究。方法建立银翘散及灌胃银翘散的大鼠血清的HPLC指纹色谱分析方法;分析银翘散给药后及未给药所得血清样品与其体外银翘散和单味生药的成分比较,鉴定灌胃银翘散后大鼠血中移行成分、来源生药及其代谢产物。结果从灌胃银翘散的大鼠血中发现了15个入血成分,其中3个为新产生的代谢产物;12个成分为银翘散所含成分的原型,其中有一成分是来自金银花中的绿原酸。结论运用保留时间相对偏差为谱峰来源,对银翘散可作定性分析。     

Guidelines for antiretroviral therapy for HIV infection

OBJECTIVE: To develop guidelines for health care providers and their HIV-positive patients on the clinical use of antiretroviral agents for HIV infection. OPTIONS: Recommendations published in 1996 by an international panel. OUTCOMES: Improvement in clinical outcomes or in surrogate markers of disease activity. EVIDENCE AND VALUES: The Canadian HIV Trials Network held a workshop on Oct. 19-20, 1996, to develop Canadian guidelines that incorporate information from recent basic and clinical research. RECOMMENDATIONS: Recommendations for the use of antiretroviral drugs in HIV infection are provided for initial therapy, continuing therapy, primary infection, vertical transmission, pediatric therapy and postexposure prophylaxis. VALIDATION: The guidelines are based on consensus of the participants attending the workshop: Canadian investigators, clinicians and invited representatives from the community, government and the pharmaceutical industry. They are subject to review and updating as new information on clinical benefits is published. SPONSORS: The workshop was organized by the National Centre of the Canadian HIV Trials Network. Unrestricted educational grants were provided by 8 pharmaceutical companies. Additional support was provided from the National AIDS Strategy of Health Canada.