1,721,110 research outputs found
Direct to consumer information in Europe: the blurred margin between promotion and information
No full textarticle withour abstrac
Cosmetovigilance: the 'beautiful' risk
No full textA cosmetic is classically defined as any preparation that is applied to the skin, eyes, mouth, hair or nails for the purpose of cleansing, enhancing appearance, giving a pleasant smell or giving protection. Unlike drugs, which are used to treat or prevent a disease in the body, cosmetics are not thought to change or affect the body's structure or functions. However, the distinction between drugs and cosmetics is sometimes not clear. Regulations for cosmetic products primarily address the safety of products that may be used by large populations of healthy consumers. However, the efficacy and safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the public. The identification and analysis of adverse effects related to cosmetic products is a process that is currently still, to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed, and then to collect reports of adverse reactions. However, although the manufacturers do their best to monitor the safety profile of their products, we should consider that there is always a potential inherent conflict of interest
Analisi del segnale e ruolo dei Centri Regionali di Farmacovigilanza
No full textNel capitolo vegnono illustrati i metodi e le procedure per l'identificazione di segnali di allarme nell'ambito della segnalazione delle reazioni avverse da farmaci, viene inoltre descritto il ruolo e le funzioni dei Centri Regionali di Farmacovigilanza nel contesto della realtà italian
Paediatric Adverse Drug Reactions: Data from an Italian Interregional Database of Spontaneous Reporting
No full textIMPATTO DI UN CORSO DI FORMAZIONE A DISTANZA SULLA SEGNALAZIONE SPONTANEA DI REAZIONI AVVERSE DA FARMACI
No full textObiettivo del lavoro: verificare l'eventuale impatto di un corso di formazione a distanza accreditato sul sistema della segnalazione spontanea di reazioni avverse da farmac
Anti-inflammatory properties of superoxide dismutase derivatives (SOD-PEG-3 and 18) in carrageenan pleurisy
No full textConsultancy and surveillance of post-immunization adverse events in the Veneto region of Italy for 1992-2008
No full textPrevention and control of adverse events following immunization (AEFI) are fundamental activities of successful immunisation programs. AEFI reporting, investigation and analysis, integrated by consultancy for subjects needing a specialized evaluation, represent an ideal model for vaccine safety surveillance. In the Veneto Region of Italy the Green Channel Centre has been created by the local Public Health authority, to offer a consultancy activity for vaccinations at risk of adverse events and to ensure an efficient AEFI surveillance system with regular feedback data for vaccine personnel. This report updates the overall activity provided by the Green Channel between 1992 and 2008, concerning consultations for previous AEFI and contraindications to vaccinations and analysis of AEFI reports. After 1280 consultancy cases, 998 (78%) subjects were found eligible for vaccination, with personalized precautions suggested in 42% of cases. Of a total of 724 patients actually vaccinated as per the Green Channel instructions, only 55 subjects (7.6%) reported mild symptoms and one (0.3%) a moderate allergic reaction. Since 1993, a total of 5,006 AEFI reports have been collected and evaluated by the Green Channel against more than 20 millions of vaccine doses administered with an estimate mean AEFI rate of 2.3 x 10.000 doses per year. The majority of them (94%) were found in causal relationship with vaccines; of these, 267 reports (5,6% - 0.1/10,000 doses) were serious and 9 of these subjects, affected by a neurological event, were not recovered or were still on therapy at follow up. This regional activity has proven efficacious in evaluating and managing individual cases at potential risk of AEFI and integrating the national passive surveillance system
Adverse drug reactions related the use of NSAIDs with a focus on nimesulide. Results of spontaneous reporting from a northern Italian area.
No full textObjective: To analyse and compare the adverse drug reactions (ADRs) associated with the use of oral nimesulide, diclofenac, ketoprofen, and piroxicam which were spontaneously reported in a northern Italian area (Veneto and Trentino).
Methods: Data were obtained from the spontaneous reporting system database of Veneto-Trentino, the principal contributor to the Italian spontaneous surveillance system. All reports of ADRs that occurred in association with the non-steroidal anti-inflammatory drugs (NSAIDs) under investigation during the period from January 1988 to December 2000 were analysed in detail. An estimate of drug consumption during June 1996-May 1999 was made by calculating the number of defined daily doses for each drug.
Results: During the study period, 10,608 reports describing 16,571 reactions were entered into the system. We found 207 reports for nimesulide, 187 for diclofenac, 174 for ketoprofen, and 137 for piroxicam. Some differences were found regarding the age- and sex-related reporting rate among these NSAIDs. Ketoprofen showed the highest number of serious ADR reports/consumption, while the lowest number was found for nimesulide. Significantly different toxicity profiles among these drugs emerged. In particular, nimesulide was associated with fewer and less severe gastrointestinal (GI) ADRs compared with the other NSAIDs. The percentage of GI reactions to nimesulide (10.4%) was about one-half of those reported for the other three NSAIDs (21.2 for diclofenac, 21.7%n for ketoprofen, 18.6 for piroxicam).
Conclusions: Nimesulide appears a well tolerated drug, with a lower reports/consumption ratio compared with diclofenac, piroxicam and ketoprofen. Age-related reporting analysis suggests a higher toxicity of diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. In line with its COX-2 selectivity profile, nimesulide showed the best GI tolerability, with few reports of severe GI reactions. The analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their safety profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics
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