澳大利亚登记药品注册申报的概况研究

对澳大利亚政府卫生部治疗用品管理部门（TGA）的登记药品注册申报制度和证据要求进行梳理，阐述了澳大利亚补充药品的监管模式，并对《支持登记补充药品适应症所需证据的指南》《经评估登记药品的证据指南》的关键信息进行分析。TGA登记药品、经评估登记药品属于简化注册的申报程序，基于“许可成分清单”“许可适应症清单”进行申报。TGA将适应症按风险程度的高低划分为3个级别，其中低风险和中级风险适应症分别对应登记药品和经评估登记药品。对于经评估登记药品的仿制药L（A）1申请途径，可考虑借鉴该方式为中级风险适应症中药非处方药（OTC）品种的仿制提供支持。对于经评估登记药品的新药L（A）3申请途径，可考虑借鉴该方式为中级风险适应症中药新药的简化申请提供支持，此类申请路径有可能为无特定适应症的证候类中药或民族药提供支持。     

The availability and age-appropriateness of medicines authorized for children in The Netherlands

AIM

To study the number of medicines and active chemical entities that are authorized and commercially available for children in the Netherlands and to evaluate the age-appropriateness of the available paediatric medicines.

METHODS

The availability of paediatric medicines and active chemical entities was studied with the help of a Dutch medicines database and the Summary of Product Characteristics. Medicines were categorized with respect to their route of administration, type of oral dosage form and therapeutic category. The age-appropriateness was assessed on three aspects: dose capability, suitability of the dosage form and inclusion of potentially harmful excipients.

RESULTS

Three thousand five hundred and forty-two paediatric medicines containing 703 different active chemical entities were identified. This equalled half of all the medicines and chemical entities available for human use. The percentage of paediatric medicines increased with age and varied for the route of administration from 22% (dermal) to 81% (inhalation) and for the therapeutic category from 11% (uro-genital, sex hormones) to 89% (anti-parasites). The appropriateness of the paediatric medicines with respect to their authorization status, dose capability and dosage form increased with age from 27–88%. Fifty-two percent of all oral paediatric liquid formulations contained a potentially harmful excipient.

CONCLUSION

This study confirms the limited availability of paediatric medicines for a broad range of therapeutic areas and shows that paediatric medicines may not be age-appropriate, even if authorized. While confirming the need for a legislative incentive, the results also provide baseline information for an estimation of the effect of the European Paediatric Regulation in the near future.     

越南传统药品管理及注册政策的分析

越南具有长期应用传统医学的历史,政府重视并且较早地开展了对传统医学的立法管理。结合越南现行的有关药品管理法规,对天然药物、古方药、天然药物原料的管理及注册要求进行分析,重点介绍药品注册的管理机构、申报程序、对申报材料的一般要求,为意欲进入越南市场的中医药科研单位及制药企业提供参考,从而可以更好地推进中成药在越南的登记注册。     

Influenza in The Netherlands

This paper reports on the occurrence of influenza and the associated burden of illness in The Netherlands. In addition, attention is paid to the effectiveness of vaccination vaccination status and the national strategy to raise the vaccination rate among risk groups. The incidence of influenza in the community appears to be 3 to 6 times higher than the incidence observed in general practice, since most cases do not present to the general practitioner (GP). Annually, 15,000 to 30,000 hospital admissions (1 to 2 per 1000 inhabitants) and 2000 to 2200 deaths (1.3 to 1.5 per 10,000), mostly among the elderly, are related to influenza. Vaccination has been shown to prevent about 50% of the influenza cases. Between 1991 and 1994 the vaccination rate among risk groups increased from 28 to 43%. In this period, a very active campaign was mounted. Much energy is being invested in further raising the vaccination rate among risk groups, with GPs holding a key position. In addition, the Dutch Health Council advises vaccination for persons > or = 65 years of age.     

The drug problem in The Netherlands

In the Netherlands, the drug problem among adolescents developed as a new phenomenon in the mid 1960s. Without remarkable success, methadone maintenance programs were introduced in 1968. Drug free treatment in therapeutic communities, developed since 1972, was successful after the first experimental years. This success provoked the illusion that drug related problems could be solved by treatment; low threshold programs, putting few demands on participants, were established to dispense methadone. The illusion was that addicts can be motivated into further treatment if they are brought into contact with professionals. As the addict population kept growing and their street crimes increased in number, Dutch drug policies changed in 1978, using methadone as a means to decrease criminal activities rather than to treat addicts. This also turned out to be an illusion. Currently, there is strong political pressure to distribute heroin to addicts to diminish the negative side effects of drug abuse. Dutch drug policies are characterized by the opinion that drug problems cannot be solved and have to be accepted.     

Imported Dengue in The Netherlands

Background :The clinical manifestations of imported dengue in adult Western travelers were analyzed.
Methods: The charts of all adult patients with dengue, who were seen in an academic hospital in The Netherlands from 1985 to 1994, were studied.
Results: Dengue was confirmed in 34 patients by a fourfold rise in complement fixation antibody titer or presence of IgM. Twelve probable cases with a single high titer in the complement fixation test were found. Annual numbers have increased since 1989. Most cases were imported from Asia. Malaise (98%), fever (96%), headache (64%), chills (58%), muscle pain (53%) and arthralgia (44%) were the main symptoms. A noncharacteristic skin eruption was seen in 84%. Leukocytopenia and thrombocytopenia were found in 87% and 75%, respectively during the first week, and elevated serum aminotransferase activities were noted in 75%. Only two patients developed dengue hemorrhagic fever.
Conclusions: Dengue in Western taravelers is usually a relatively mild disease. Leukocytopenia, thrombocytopenia, and elevation of serum aminotransferase activities are common laboratory features.     

The regulation of medicines post 1992

Summary The European Community (EC) is scheduled to become a fully integrated market by 1992. Currently the present national variations in pharmaceutical marketing authorization constitutes an unresolved barrier. The need is for agreed and clearly specified requirements to afford EC wide marketing authorization within agreed time frames. Great care will be required to avoid such problems as a European drug-lag and mounting cost, to the detriment of patients, government, and the research-based pharmaceutical industry     

The general pharmacy work explored in The Netherlands

OBJECTIVE: To determine the frequency and nature of general pharmacy work at three Dutch community pharmacies. METHODS: In a purposive and convenience sample of three Dutch community pharmacies the general work was investigated. Multi-dimensional work sampling (MDWS) was used. The study took six weeks: two weeks at each pharmacy. MAIN OUTCOME MEASURE: The number of care related items emerging in the general work. RESULTS: Care related work represented 34% of all pharmacy activities. CONCLUSION: Although care related work was present at all three studied pharmacies, this part of the work still needs serious attention of Dutch pharmacists in order to advance pharmaceutical care. It is suggested that an efficient pharmacy organization in combination with robotization, task specialization, and interior design can expand the care related work at the pharmacy.     

The medicines for children agenda in the UK

Children can expect the medicines prescribed for them to have at least as good an evidence base as in adult practice. Current licensing arrangements in the UK ensure a rigorous assessment of most drugs used for adults, whereas prescribing outside the licence is relatively common for children. Until the evidence base is increased, consensus guidelines or formularies, such as the new British National Formulary for Children, provide some protection for children and prescribers. For the future, there is optimism that the dearth of research on which to base children's prescribing will be addressed by new initiatives, such as the UK Medicines for Children Research Network and draft EU legislation providing incentives to industry.     

常用哮喘控制药物的安全性

哮喘是一种慢性气道炎症性疾病。哮喘控制药物通过抗炎作用控制哮喘的慢性气道炎症、从而预防哮喘发作,是哮喘药物治疗的重要组成。本文就常用的几类哮喘控制药物（包括糖皮质激素、长效β2-受体激动剂、白三烯受体拮抗剂和茶碱缓释制剂）的安全性作一概述,以期医生和药师能更合理、安全地使用这些药物。