86,573 research outputs found
Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination
No full textAccording to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [. Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1,162 (87.37%) AE reports were classified 'non serious', 91 (6.84%) 'serious', 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries
Metformin-associated lactic acidosis requiring hospitalization. A national 10 year survey and a systematic literature review
No full textMetformin is known to be rarely associated with lactic acidosis, a serious condition with a poor prognosis. To review the National Pharmacovigilance Network of the Italian Medicines Agency reporting cases of metformin-associated lactic acidosis. The National Pharmacovigilance Network of the Italian Medicines Agency, was searched for cases of lactic acidosis that occurred in a 10 years period (from November 2001 to October 2011). Data were analyzed, to identify associated clinical features. A systematic literature research was performed to identify other large case series on metformin associated lactic acidosis. Metformin was the antidiabetic drug most frequently associated with lactic acidosis in the assessed period. Metformin-associated lactic acidosis was the most frequent serious adverse reaction related to metformin reported to the national authority (18.2% of all 650 adverse drug reactions reported). There were 59 cases of metformin-associated lactic acidosis (mortality rate of 25.4%). In most patients (89.8%) there was at least one risk factor for the occurrence of lactic acidosis. The predictors of death were low arterial blood pH and absence of acute renal failure. The systematic research of the literature identified only six case-series with more than 30 patients. This is the second largest case series ever reported on metformin-associated lactic acidosis. We confirmed that this rare complication of metformin is frequently fatal. Death can be predicted when the patient arrive in the hospital with low pH and, not intuitively, if the patient has no acute kidney injury. Risk minimisation measures taken at national level to prevent this serious complication are described
Metformin-associated lactic acidosis requiring hospitalization. A national 10 year survey and a systematic literature review
No full textBACKGROUND: Metformin is known to be rarely associated with lactic acidosis, a serious condition with a poor prognosis. AIM: To review the National Pharmacovigilance Network of the Italian Medicines Agency reporting cases of metformin-associated lactic acidosis. MATERIALS AND METHODS: The National Pharmacovigilance Network of the Italian Medicines Agency, was searched for cases of lactic acidosis that occurred in a 10 years period (from November 2001 to October 2011). Data were analyzed, to identify associated clinical features. A systematic literature research was performed to identify other large case series on metformin associated lactic acidosis. RESULTS: Metformin was the antidiabetic drug most frequently associated with lactic acidosis in the assessed period. Metformin-associated lactic acidosis was the most frequent serious adverse reaction related to metformin reported to the national authority (18.2% of all 650 adverse drug reactions reported). There were 59 cases of metformin-associated lactic acidosis (mortality rate of 25.4%). In most patients (89.8%) there was at least one risk factor for the occurrence of lactic acidosis. The predictors of death were low arterial blood pH and absence of acute renal failure. The systematic research of the literature identified only six case-series with more than 30 patients. CONCLUSIONS: This is the second largest case series ever reported on metformin-associated lactic acidosis. We confirmed that this rare complication of metformin is frequently fatal. Death can be predicted when the patient arrive in the hospital with low pH and, not intuitively, if the patient has no acute kidney injury. Risk minimisation measures taken at national level to prevent this serious complication are described
Therapeutic and other interventions to reduce the risk of mother-to-child transmission of HIV-1 in Europe. The European Collaborative Study
No full textC. Thorne, M.-L. Newell, A. Bailey, C.S. Peckham, C. Giaquinto, E. Ruga, A. De Rossi, D. Truscia, I. Grosch-Worner, A. Schafer, J. Mok, F. Johnstone, F. Omenaca, J. Jiminez, C.De Alba, M.C. Garcia-Rodriguez, I. Bates, I. De Jose, F. Hawkins, R. Martinez Zapico, F. Asensi-Botet, M.C. Otero, D. Perez-Tamarit, A. Gonzalez Molina, H. Canosa, H. Scherpbier, K. Boer, A.B. Bohlin, S. Lindgren, E. Belfrage, J. Levy, A. Alimenti, P. Barlow, A. Ferrazin, A. Dre Maria, C. Gotta, V. Maritati, A. Mur, M.T. Rovira, A. Paya, O. Coll,
C. Fortuny, J. Boguna, M. Casellas Caro, Y. Canet, G. Pardi, A.E. Semprini, M. Ravizza, C. Castagna,
S. Fiore, B. Guerra, S. Bianchi, L. Bovicelli, E. Prati, S. Zanelli, M. Duse, A. Soresina, G. Scaravelli,
M. Stegagno, M. De Santis, M.-L. Muggiasca, P. Marchisio, A. Iasci, A. Spinillo, A. Bucceri, E. Grossi,
L. Rancilio, R. Smith, A.-M. Lewi
PROCEDURA SELETTIVA PUBBLICA PER TITOLI ED ESAME-COLLOQUIO, PER LAUREATI IN SCIENZE BIOLOGICHE PER L'ATTRIBUZIONE DI N. 5 POSTI DI DIRIGENTE DELLE PROFESSIONALITA' SANITARIE NEL RUOLO DEI DIRIGENTI DELL'AIFA.
No full textNon steroidal anti-inflammatory drugs-associated acute generalized exanthematous pustulosis (AGEP): reports from the Italian pharmacovigilance database
No full textVariations on the Author
No full text“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Thromboembolic Events or Stroke related to Intravitreal Injections of ranibizumab: a signal from Italian Pharmacovigilance System
No full textAdverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database
No full textPurpose The aim of this study was to describe the pattern of adverse drug reaction (ADR) reports sent by Italian nurses after the enactment of the law involving them in the pharmacovigilance system. We also compared the quantity and quality of reports by nurses with those of reports by hospital physicians sent in the same period.
Methods We analysed the reports sent to the Italian pharmacovigilance database by nurses from January 2004 to December 2010. Only reports with ADRs causality assessment defined as definite, probable or possible were included in the analysis. The nurses’ reports were compared with those sent by hospital physicians in the same period. We excluded from this analysis reports associated with vaccines.
Results A total number of 1403 reports by nurses have been evaluated. The percentage of nurses’ reports of ADRs, which were serious, were 22.9% lower than the 44.9% of reports by physicians, whereas the proportion of probable ADR reports were higher among nurses than hospital physicians (76% vs 67%). Nurses put more emphasis than physicians on application site disorders (log OR= 0.91, 95%CI = 0.55–1.27), skin reactions (log OR= 0.81, 95%CI = 0.70–0.92) and nervous system reactions (log OR= 0.28, 95%CI = 0.11–0.44), whereas
physicians more frequently report blood, platelet and liver disorders. Six drugs are present in both the top 10 drugs reported by nurses and hospital doctors.
Conclusion This study gives evidence for the potential capacity of nurses to improve the detection of ADRs
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