Infrastructure, funding and follow-up in a programme of noninvasive ventilation.
(65/804)
Originating from centres charged with the care of patients with chronic respiratory insufficiency, noninvasive ventilation (NIV) has been used increasingly in chronic and acute respiratory failure during the last decade. Despite a considerable number of series and randomised studies advocating access to NIV for units that treat acute or chronic ventilatory failure, the number of units and the proportion of total ventilatory support remains poor. This is due to lack of education, as many units treat only a few patients per year. Indication, technique, education, monitoring and home care require special experience and a special environment and there is a wide range throughout Europe. With respect to home care in particular, there are many organisations, which range from totally private to hospital based or run for profit. A concerted action, funded by the European Union, will soon provide valuable information about the practice of home ventilation in Europe based on a European survey. (+info)
Restrictions on import of drugs for personal use within the European single market.
(66/804)
BACKGROUND: The European Union (EU) has harmonized legislation on pharmaceutical products to implement the single market in this field. European consumers are offered with high quality and safe products that have been brought onto the market through harmonized procedures. The aim of the study was to find out if there still were legislative restrictions to purchasing prescription only medicines (POMs) for personal use from another EU member state. METHODS: The medicines authorities in the EU were inquired about the possibilities of a citizen to obtain POMs for personal use from another EU country. The method used was a questionnaire covering both the delivery of foreign prescriptions and import of prescription-only medicines. The questionnaire was mailed, e-mailed or faxed to the national medicines authorities. RESULTS: An answer was obtained from 11 of the 15 member states. The results showed that the delivery of foreign prescriptions was regulated only in the Nordic countries. All the countries reported prohibitions on delivering prescriptions for drugs that act on the central nervous system and prescriptions that were suspicious. The personal import of drugs was restricted as to the amounts and reimbursement policy. CONCLUSIONS: The import of drugs for personal use is not yet comparable to other consumables in the EU. The prevailing restrictions contravene the community legislation and this problem has not yet been solved. It is probable that problems will arise in the near future when information technology is likely to be used increasingly in the delivery of drugs. (+info)
Information from primary care: its importance and value. A comparison of information from Slovenia and England and Wales, viewed from the 'Health 21' perspective.
(67/804)
BACKGROUND: The WHO have set health standards in the form of 21 targets--Health 21--and the EU are developing a set of health indicators whereby national health status can be measured. Data from Slovenia and from England and Wales assessing information systems in primary care and their capacity to deliver the requirements of these initiatives have been examined. In both countries, primary care is provided through a state-led service. METHODS: Consultation data from the annual report of the Department of Health Slovenia (1999) are compared in respect of relevant targets with data from the Fourth National Morbidity Survey (1992) in England and Wales. Consultation rates were standardized to the European Union 15 country population (1998). RESULTS: Consultation rates in females were similar in the two countries whereas in males rates were higher in Slovenia. The proportionate distributions of consultations by chapter of the International Classification of Diseases (ICD) were similar in both countries, respiratory (17%) and musculoskeletal (9%) disorders ranked first and second. For eye diseases, injury and poisoning, factors influencing health status (e.g. medical examination). proportions were higher in Slovenia: for mental disorders higher in England and Wales. The relativity of male to female consultation rates was broadly similar with higher rates in females in most ICD chapters. These differences are considered in detail against the background of WHO targets. CONCLUSIONS: Data gathered systematically from the surveillance of consultations in primary care are important to the measurement of WHO 'Health 21' targets. (+info)
Information disclosure and smoking risk perceptions. Potential short-term impact on Spanish students of the new European Union directive on tobacco products.
(68/804)
BACKGROUND: The Directive 1999/0244 (COD), recently approved by the European Parliament, proposed that the content and presentation of health warnings on cigarette packets be modified. The aim of the present study was to analyse the potential effect of the planned measures on the perceptions by Spanish youth of the risks associated with smoking. METHOD: A sample of 435 students attending the University of La Rioja were surveyed on their perceptions of the principal health risks attributable to the consumption of tobacco i.e. lung cancer, respiratory diseases and cardiovascular disease. A questionnaire was administered before and after they were presented with a demonstration of the health warnings on cigarette packets based on the new European Union directive. RESULTS: Perceptions changed significantly following exposure to the content and type of information of the new packaging. In general, the university students attributed a higher health risk to smoking following the presentation. CONCLUSIONS: The measures developed by the public sector to present a higher profile of anti-tobacco health warnings do influence the target population in the desired direction, at least in the short term. Hence, given that the perception of risk influences the election to smoke, it is predictable that when these types of policy decisions are applied, there will be a tendency towards a reduction in the incidence and prevalence of tobacco consumption. (+info)
International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice.
(69/804)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products" (66 FR 56332, November 7, 2001). It is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R). (+info)
Dental education in Europe: the challenges of variety.
(70/804)
Dental education varies considerably across Europe, with differing traditions of stomatology (dentistry as a specialty of medicine) and odontology (single autonomous discipline). Dental curricula within the European Union (EU) are governed by European law expressed in directives that are binding on all EU member states. The Dental Directives (78/686/EC) base the curriculum on the odontological model, but compliance by individual schools is often poor. The differences within the EU will likely intensify with the accession of Eastern/Central European countries where the stomatological tradition is strong. Moreover, current proposals within the EU will reduce even the limited existing effectiveness of the Dental Directives. The DentEd Thematic Network Project, which aims to promote convergence of European curricula through voluntary self-assessment and outside peer review, has involved about 25 percent of European schools. Its effectiveness in inducing changes in individual schools is unknown. It is not an accreditation system, and there is no intention to establish a European-wide common curriculum. Dentists' vocational training, here defined as "the organised education of the newly qualified dentist in supervised practice," is present in various models in many European countries, but is compulsory in only a few. Continuing dental education (CDE) is encouraged in most countries, but CDE-dependent licensure is required in only two. (+info)
eEurope 2002: Quality Criteria for Health Related Websites.
(71/804)
BACKGROUND: A number of organisations have begun to provide specific tools for searching, rating, and grading this information, while others have set up codes of conduct by which site providers can attest to their high quality services. The aim of such tools is to assist individuals to sift through the mountains of information available so as to be better able to discern valid and reliable messages from those which are misleading or inaccurate. OBJECTIVE: Recognising that European citizens are avid consumers of health related information on the internet and recognising that they are already using the types of rating system described above, the European Council at Feira on June 19-20 2000 supported an initiative within eEurope 2002 to develop a core set of Quality Criteria for Health Related Websites. The specific aim was to draw up a commonly agreed set of simple quality criteria on which Member States, as well as public and private bodies, may draw in the development of quality initiatives for health related websites. These criteria should be applied in addition to relevant Community law. METHODS: A meeting was held during 2001 which drew together key players from Government departments, International Organisations, non-governmental organisations and industry, to explore current practices and experiments in this field. Some sixty invited participants from all the Member States, Norway, Switzerland, and the United States of America took part in the meeting of June 7-8, 2001: they included delegates from industrial, medical, and patient interest groups, delegates from Member States' governments, and key invited speakers from the field of health information ethics. These individuals, and many others, also took part in the web-based consultation which was open from august to November 2001. RESULTS: The broad headings for quality criteria identified include Transparency and Honesty, Authority, Privacy and data protection, Updating of information, Accountability, Responsible partnering, Editorial policy, Accessibility, the latter includes attention to guidelines on physical accessibility as well as general findability, searchability, readability, usability, etc. A metadata labelling system may be used to make health data more findable. Such a system may also be used in conjunction with quality criteria to give higher ranking by search engines to those sites or pages labelled as complying with defined quality criteria. CONCLUSIONS: The set of quality criteria is based upon a broad consensus among specialists in this field, health authorities, and prospective users. It is now to be expected that national and regional health authorities, relevant professional associations, and private medical website owners will 1) implement the Quality Criteria for Health Related Websites in a manner appropriate to their website and consumers; 2) develop information campaigns to educate site developers and citizens about minimum quality standards for health related websites; 3) draw on the wide range of health information offered across the European Union and localise such information for the benefit of citizens (translation and cultural adaptation); 4) exchange information and experience at European level about how quality standards are being implemented. (+info)
International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.
(72/804)
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State. (+info)