[Not Available].

OBJECTIVES: The increasing prevalence of latex allergy among healthcare workers is a large socio-economical problem for the society and affected individuals. The objective of this study was to describe and evaluate a nationwide, interdisciplinary campaign by the institution for the German workers' compensation scheme for non-public healthcare providers that targeted the reduction of exposure to powdered high-protein latex gloves. METHODS: The effectiveness of the prevention programme is described and evaluated with a before-and-after design comparing data on compensation claims for latex-related skin and airway diseases of the German statutory compensation scheme for work-related diseases in non-public health services. A survey on change in glove use was conducted after the programme. RESULTS: The main feature of the campaign among healthcare workers (budget 340,000 Euro ) was to increase awareness by means of educational components on the aetiology of latex hypersensitivity for healthcare workers and their providers, and professional trainers. The number of reported compensation claims for latex-induced skin diseases increased from a pre-measure of 664 in 1996 to 884 during the programme in 1998 and decreased after the programme (post-measure n = 567 in 1999 and n = 204 in 2002). Doctors' assistants in practices and nurses/nurse assistants/midwives filed most claims. Similar decreases were observed for confirmed claims and latex-related respiratory diseases, while two other prevalent occupational diseases in healthcare workers (low-back disorders, infections) increased during this time period. The survey demonstrated a considerable concurrent drop in the use of powdered latex gloves (hospitals 76% vs 37% for unsterile gloves and 86% vs 62% for sterile gloves). CONCLUSIONS: The campaign against latex allergy in connection with concurrent corresponding recommendations, activities of State authorities for worker protection, and regulations, is an example for the successful incorporation of research results into preventive measures that directly affect the frequency of a work-related disease. This effective programme can be regarded as a model for the reduction of other occupational diseases such as bakers' or isocyanate asthma.

Germany↗

PubMed2005

Efficacy and tolerability of almotriptan in postmarketing surveillance studies.

While randomized, double-blind, placebo-controlled trials are considered the gold standard of clinical evidence, they are limited by patient numbers, duration of patient exposure, and restricted patient populations. Data from controlled trials may not be generalizable to all individuals likely to take the drug under investigation. Postmarketing surveillance studies are designed to measure efficacy and safety in larger and more diverse populations, allowing them to detect less common and delayed adverse events. However, postmarketing surveillance studies are limited by their lack of randomization, open-label design that can result in patient and physician bias, incomplete follow-up, less than rigorous outcome measurement, and lack of a contemporaneous control group. With regard to acute treatment of migraine, clinical trials using per protocol primary endpoints do not reflect the more favorable experience with triptans in general practice. Postmarketing surveillance studies have been performed to determine whether the high levels of efficacy and tolerability of almotriptan reported in controlled clinical trials can been reproduced in routine practice. An observational study conducted in Spain with 2,074 migraine sufferers (4,183 attacks) reported a 2-hour pain-relief rate of 86.9%, a 2-hour pain-free rate of 51.5%, and a sustained pain-free rate of 46.0%; 1.1% of patients reported adverse reactions. A German postmarketing study in 899 patients (2,131 attacks) with acute migraine treated with almotriptan 12.5 mg reported 2-hour pain relief in 84.5% of attacks and 2-hour pain free in 41.4%; 1.1% of patients reported adverse reactions. The consistency of response (at least two out of three attacks successfully treated) with almotriptan 12.5 mg was 87.3%. Regarding satisfaction, 88.5% of patients were satisfied or very satisfied and 80.3% of patients stated that almotriptan was better compared to their prior therapy; 92% of physicians indicated that they would continue treating their patients' migraines with almotriptan. The results of these studies demonstrate that the high levels of efficacy and tolerability seen with almotriptan in controlled clinical trials are achieved in real-world clinical settings. In conclusion, a combination of controlled clinical trials, postmarketing surveillance studies, and physician's experience in the general population can give us a better understanding of the efficacy and tolerability of acute migraine agents.

Germany↗