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Whose back is it?

This is a question that every nurse should consider as it could be a major factor in their nursing career. Indeed if training needs and education at all levels of the National Health Service are not reviewed and brought up to date, nursing could be heading for serious difficulties in the near future. Fortunately for nursing, the European Community has decided to bring manual lifting and handling to the forefront by issuing directives which they hope will 'harmonise health and safety standards throughout the European Community such that competitive advantage cannot be gained by lowering costs as a direct result of lowering standards'. The most important of these as far as nursing is concerned is Directive 90/269, especially articles three to four which state employers have 'an existing duty to prepare and revise as necessary and bring to the attention of their employees, a written Health and Safety Policy'. It also expects employers to provide equipment which will allow workers to avoid manual handling and to ensure that a full assessment of all manual lifting tasks is carried out prior to their commencement, whether there is a risk of injury or not to the employee.

Back Pain↗

[Vocational integration of handicapped patients into rehabilitation programs and recommendations of international organizations].

The number of disabled persons worldwide being estimated to amount to more than 500 million, with over 30 million living in the European Community, the author deals with vocational integration of disabled persons in the programmes and recommendations of the United Nations, Rehabilitation International, the International Labour Organization, the Council of Europe, the European Community, as well as the International Social Security Association.

Disability Evaluation↗

[Influence of pharmacologically active substances on food safety].

In the European Community and in Germany drug residues are scarcely found in food of animal origin. Therefore, a high degree of safety is ensured for consumers. Problems may result from imported foods, because limitations of drug use in livestock of the European Community do not exist everywhere. Because antibacterial drugs are administered frequently, the problem of transferred multiple-drug resistance of bacteria has to be especially considered.

Consumer Product Safety↗

Free trade and occupational health policy: an argument for health and safety across the North American workplace.

This article considers the argument that the North American Free Trade Agreement (NAFTA) would encourage US and Canadian industry to relocate their hazardous manufacturing operations to Mexico. Proponents of this view believe that this industrial flight south would worsen working conditions in Mexico as well as lower occupational health and safety standards in the US and Canada. In evaluating this argument, the article examines working conditions in US-owned factories in the Mexican maquiladora zone, reviews the current occupational health and safety regulatory structure in Mexico, and considers those institutions established by the European Community to protect workers against the flight of hazardous industries. The article concludes that the harmonization of labor norms throughout North American and the establishment of a functional North American regulatory structure following the precedents set by the European Community are necessary steps to ensure that NAFTA does not produce the feared flight of hazardous industries to Mexico nor degrade the health of workers in Mexico, Canada, or the US.

Adolescent↗

Progress in the fight against cancer in EC countries: changes in mortality rates, 1970-90.

The question of how much effective progress against cancer is being made has been raised repeatedly during the last decade; one approach to evaluating such progress is represented by the analysis of mortality, which has been used by several researchers. Here we report mortality trends for 1970-90 for four age-groups, calculated for each 3-year period, and presented as the percentage change of the rate of the first period examined. Detailed graphs for each country and for the European Community as a whole are presented for 'all cancers', and for cancer of the colon-rectum, lung, breast and ovary. For other cancers (stomach, melanoma, uterus, testis and Hodgkin's disease), the graphs are presented only for the whole of the European Community. Variations in mortality are discussed, in terms of changes in incidence, efficacy and diffusion of prevention, as well as improvement in diagnosis and treatment.

Adolescent↗

Characterization of acute promyelocytic leukemia cases lacking the classic t(15;17): results of the European Working Party. Groupe Français de Cytogénétique Hématologique, Groupe de Français d'Hematologie Cellulaire, UK Cancer Cytogenetics Group and BIOMED 1 European Community-Concerted Action "Molecular Cytogenetic Diagnosis in Haematological Malignancies".

Acute promyelocytic leukemia (APL) is typified by the t(15;17), generating the PML-RAR alpha fusion and predicting a beneficial response to retinoids. However, a sizeable minority of APL cases lack the classic t(15;17), prompting the establishment of the European Working Party to further characterize this group. Such cases were referred to a workshop held in Monza, Italy and subjected to morphologic, cytogenetic, and molecular review, yielding 60 evaluable patients. In the majority (42 of 60), molecular analyses revealed underlying PML/RAR alpha rearrangements due to insertions (28 of 42) or more complex mechanisms, including 3-way and simple variant translocations (14 of 42). Metaphase fluorescence in situ hybridization (FISH) demonstrated that insertions most commonly led to formation of the PML-RAR alpha fusion gene on 15q. In 11 of 60 workshop patients, PLZF/RAR alpha rearrangements were identified, including 2 patients lacking the t(11;17)(q23;q21). In one case with a normal karyotype, FISH analysis revealed insertion of RAR alpha into 11q23, and PLZF-RAR alpha was the sole fusion gene formed. Two patients were found to have t(5;17), one with a diffuse nuclear NPM staining pattern and with NPM-RAR alpha and RAR alpha-NPM transcripts detected. In the other with an unbalanced der(5)t(5;17)(q13;q21) and a nucleolar NPM localization pattern, an NPM/RAR alpha rearrangement was excluded, and FISH revealed deletion of one RAR alpha allele. In the remaining 5 workshop patients, no evidence was found for a rearrangement of RAR alpha, indicating that in rare instances, alternative mechanisms could mediate the differentiation block that typifies this disease. This study highlights the importance of combining morphologic, cytogenetic, and molecular analyses for optimal management of APL patients and better understanding of the pathogenesis of the disease. (Blood. 2000;96:1297-1308)

Adult↗

Immunoaffinity extraction in veterinary residue analysis--a regulatory viewpoint.

The utility of immunoaffinity chromatography (IAC) for the purification of veterinary drug residues from extracts of foods of animal origin is widely acknowledged. However owing to the unique nature of the specific antibody reagent used when synthesising an immunosorbent, certain reassurances are needed before an IAC process can be considered an acceptable stage in a routine analytical method. European Community legislation requires applicants for Maximum Residue Limits or national Marketing Authorization for veterinary medicinal products, used in food producing animals, to provide a routine analytical method in accordance with Volume VI of the Rules Governing Medicinal Products in the European Community. In order to ensure the continued supply of immunosorbent material, applicants wishing to use IAC sample clean-up procedures should consider generating the following data: a standard operating procedure (SOP) for antibody production (or cell-line maintenance in the case of monoclonal antibodies), a specifications document of antibody characterisation, an SOP for immunosorbent synthesis, validation of immunosorbent operating conditions and an assessment of its performance criteria. This paper aims to introduce analysts to the technique of IAC and to suggest how those areas of concern highlighted above may be addressed.

Animals↗

Comparative study of certified reference materials and quality control materials for the quality assurance of blood-lead determination.

In order to ensure a high standard in the analytical methods used to determine lead in blood, reference materials, quality control materials and several quality assessment schemes exist. However, since 1988 the blood lead level in the European Community has decreased owing to a decline in environmental and occupational exposure; consequently there is a need for certified reference materials (CRMs) at low level. A study of the biological CRMs for blood lead, CRMs 194-196 from the European Community Bureau of Reference (BCR) and the quality control materials STE 901-906 from Nyegaard A/S, and AMI B601-B604 and AMI B701-B705 from the Danish National Institute of Occupational Health (AMI), was made in order to evaluate the control materials AMI B701-B705 against the CRMs 194-196, and to verify the homogeneity and influence of the biological matrix of commercially available blood-lead quality control materials. Internal quality control data were collected and an interlaboratory study was carried out on lyophilized human blood versus lyophilized bovine blood certified for lead. The calculated standard deviations for the BCR CRMs were comparable to the standard deviations for AMI control materials, although the biological matrix was different. No significant difference was demonstrated between the blood-lead levels certified by BCR in 1985 and the levels measured by AMI in 1991, indicating the homogeneity and stability of the lyophilized materials. All analytical results were obtained from selected international laboratories by using atomic absorption spectrometry and anodic stripping voltammetry. The study emphasizes the need for CRMs, control materials and quality assessment schemes for trace elements in biological fluids.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Quality and accreditation systems in clinical biochemistry in the European Union.

The European Community Confederation of Clinical Chemistry (EC4) formed in Nice in April 1993 has established a working group on laboratory accreditation. The aim of the group is to explore the possibilities for harmonisation of accreditation and quality systems in clinical laboratories in the European Community (EC). It is felt essential that professions should play a key role in the process, and that the principle of subsidiarity should be observed in relation to implementation and organisation in individual member states. The first task has been to collect information concerning such systems. In September 1993 a questionnaire was distributed to the twelve IFCC related societies for clinical chemistry in the EC. By December 1994 eleven societies had responded. The questionnaire related to the existence or planned introduction of quality and accreditation systems, the basis of the standards used and requirements for analytical aspects and qualifications of staff as well as professional aspects. Questions also addressed the way in which inspection were organised, the selection and training of inspectors, the organisation of systems and what interest there was in harmonisation. The results of this study are presented in this paper.

Accreditation↗

[The International Chemical Safety Cards].

Information is given on a new form of safety data sheets for chemical substances: the "International Chemical Safety Cards", that were developed by the "International Programme on Chemical Safety" of the WHO, in cooperation with the Commission of the European Communities. The Cards are prepared by various scientific institutions and then peer-reviewed by a committee of internationally-recognized experts. At the moment, 349 Cards are available in English. The Commission has also translated 78 Cards into the other eight official languages of the European Community. Among the aims of this undertaking, the most significant are: (a) the possibility of comparing risks associated with different substances, through the use of "standard phrases", whose meaning is given in a specific Guide; (b) circulation of information on chemical risks on a global level, particularly in those countries that are not able to make their own evaluations.

European Union↗

Harmonization of guidelines for toxicity testing of pharmaceuticals by 1992.

In the past there has been considerable disagreement between various regulatory authorities regarding the type and design of animal tests that should be required before a new medicine can be used ethically and safely in the clinic. However, regulatory variations have largely been removed within politically and geographically similar regions (e.g., the U.S.A., the European Community, the Nordic countries) and there now appears to be a consensus regarding the value of harmonizing international requirements. In order to assist the process of harmonization, a detailed table of preclinical toxicity requirements in the U.S.A., Canada, Japan, and the European Community for each test (acute, subacute, chronic, carcinogenicity, mutagenicity, reproduction) has been compiled. This has been circulated to the relevant regulatory authorities to ensure that it accurately reflects current requirements. The major differences between authorities were found to be the duration of chronic, repeated-dose tests and the design of reproduction studies. International pharmaceutical companies were asked to complete a questionnaire, indicating how they design their preclinical testing program to comply with varying regulatory requirements. Most of the respondent companies indicated that chronic tests of longer than 6 months were conducted solely to comply with some regulatory requirements. Many companies repeat reproduction studies in order to comply with Japanese requirements. This emphasizes the need to harmonize these guidelines and discussions are currently underway to attempt to develop protocols acceptable to the FDA, the EC, and the Japanese Ministry of Health and Welfare.

Animals↗

EEC hearing impairment programme: collaboration in Europe, 1974-1988.

The Commission of the European Communities funds a 'concerted action' programme in the area of hearing impairment. The programme does not fund research directly, but is intended to provide funds for coordination of research in different countries. Previous projects funded by the programme include a comprehensive study of the prevalence of childhood deafness in the European Community, and meetings on cochlear implants, human temporal bone histopathology, diagnostic techniques and hearing impairment in children. The programme is currently concerned with new technologies for communication in the hearing impaired and activities in 1988 will include workshops on signal processing hearing aids and early diagnosis in children.

Child↗