rubrica

Farmacoepidemiologia

  • Giuseppe Traversa1

  1. Istituto superiore di sanità, Roma

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Ricerca bibliografica periodo 16 gennaio 2011 – 1 aprile 2011

Per leggere le caratteristiche di questa ROUTINE di ricerca clicca qui

Database: Pubmed/MEDline
Stringa: ((Pharmacoepidemiolog*[All] OR "Pharmacoepidemiology"[Mesh]) OR ((“epidemiology”[Mesh] OR "epidemiology"[subheading]) AND ("Pharmaceutical Preparations"[Mesh]))) AND ("italy"[MeSH Terms] OR "italy"[All Fields] OR ital*[Title/Abstract] OR ita*[Language] OR ital*[ad]) AND ("2011/01/16"[PDat] : "2011/04/01"[PDat])

Di ogni articolo è disponibile l'abstract. Per visualizzarlo basta cliccare sul titolo.

1. Parretta E, Ianniello B, Ferrazin F, Rossi F, Capuano A.. Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination. Vaccine. 2011 Mar 12. [Epub ahead of print]
Regional Center for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Faculty of Medicine and Surgery, Second University of Naples, Via De Crecchio, 7, 80138 Naples, Italy.
Abstract
According 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.

Breve commento a cura di Giuseppe Traversa
Una delle maggiori preoccupazioni nel corso della pandemia influenzale della stagione 2009-2010 riguardava le incertezze sull’efficacia e sicurezza del vaccino pandemico. Il vaccino infatti, pur sviluppato in coerenza con procedure approvate in precedenza dalle agenzie regolatorie, disponeva inevitabilmente di evidenze più limitate. Nell’articolo, Parretta e collaboratori documentano il profilo di rischio osservato in Italia: emerge nel complesso un quadro rassicurante, in coerenza con quanto riportato anche negli altri paesi. Il lavoro si basa sull’attività di sorveglianza post marketing e testimonia il ruolo che possono svolgere i centri regionali di farmacovigilanza, insieme al settore della farmacovigilanza dell’AIFA, nel validare i dati delle segnalazioni spontanee fino a creare un prodotto sul quale costruire un’attività scientifica.

Corsonello A, Pedone C, Lattanzio F, Semeraro R, D'Andria F, Gigante M, Coppola A, Cadeddu G, Laino I, Antonelli Incalzi R. Agreement between equations estimating glomerular filtration rate in elderly nursing home residents and in hospitalised patients: implications for drug dosing. Age Ageing. 2011 Mar 10. [Epub ahead of print]
Unit of Geriatric Pharmacoepidemiology, Italian National Research Centres on Aging (INRCA), C.da Muoio Piccolo, Cosenza I-87100, Italy.
Abstract
BACKGROUND: detecting chronic kidney disease (CKD) may have important implications for the management of older and frail people. We aimed at investigating whether clinical setting (nursing home: NH versus hospital: H) affects the agreement between glomerular filtration rate (GFR) values estimated by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI), Cockcroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) equations. DESIGN: observational study.
SETTING: comparison between NH residents and H patients.
SUBJECTS: we used data from 177 NH residents, and 439 H patients. METHODS: the agreement between estimating equations and the odds of a discrepancy >25% between formulas in relation to setting (NH versus H) were investigated.
RESULTS: the agreement between MDRD and CKD-EPI formulas was good either in NH (k = 0.82) or H (k = 0.87) patients, while corresponding figures for CG indicate only a fair agreement with CKD-EPI (k = 0.50 for both populations). Setting (NH versus H) was associated with discordance between MDRD and CKD-EPI (OR = 3.97; 95% CI = 1.75-9.01), but not between CG and EPI (OR = 1.25; 95% CI = 0.87-1.81).
CONCLUSIONS: in NH residents, MDRD and CKD-EPI formulas yield highly concordant GFR values, but CG behaves differently in up to one-third of patients. Such findings have important implications in dosing drugs cleared by the kidney. Setting should be taken into consideration in studies for validation of GFR equations.
Rossi A, Maggio R, Riccardi I, Allegrini F, Stratta P. A quantitative analysis of antidepressant and antipsychotic prescriptions following an earthquake in Italy. J Trauma Stress. 2011 Feb;24(1):129-32. doi: 10.1002/jts.20607. Epub 2011 Jan 19.
Dipartimento di Medicina Sperimentale, Sezione di Psichiatria, Università de L'Aquila. alessandro.rossi@cc.univaq.it
Abstract
Because natural disasters provoke an increase in mental and medical disorders in survivors, an increase in psychotropic prescriptions has been observed following disasters. This study assesses the pharmacoepidemiology of antidepressant and antipsychotic drug prescriptions after an earthquake in Italy by using an administrative database. Statins and diabetic medications served as control medications. Comparison of the rates in the 6 months after the earthquake to the same period one year before revealed a 37% increase of new prescriptions for antidepressants and a 129% increase for antipsychotic prescriptions. Older age and female gender was associated with the increased number of prescriptions.

Breve commento a cura di Giuseppe Traversa
Che lo stress aumenti la probabilità di ricevere prescrizioni di psicofarmaci può essere considerato atteso. Tuttavia, documentare l’eventuale entità dell’incremento è un’attività utile anche per attrezzarsi a gestire il problema in gruppi di individui. L’articolo di Rossi e collaboratori mette a confronto le prescrizioni di farmaci antidepressivi e antipsicotici nella popolazione dell’Aquila, nei 6 mesi successivi al terremoto del 2009 rispetto all’anno precedente. L’aumento di prescrizioni di antidepressivi (+37%) è sovrapponibile a quello osservato per statine (+37%) e inferiore a quello degli antidiabetici (+51%), due categorie per le quali non ci si attendeva variazioni di rilievo. Un maggiore incremento si è osservato per i farmaci antipsicotici (+130%). Tuttavia, un elemento di cautela da considerare nei confronti riguarda possibili differenze nel ricorso alla distribuzione diretta da parte delle strutture sanitarie pubbliche nei due periodi.

Passariello A, Terrin G, De Marco G, Cecere G, Ruotolo S, Marino A, Cosenza L, Tardi M, Nocerino R, Berni Canani R. Efficacy of a new hypotonic oral rehydration solution containing zinc and prebiotics in the treatment of childhood acute diarrhea: a randomized controlled trial. J Pediatr. 2011 Feb;158(2):288-92.e1. Epub 2010 Sep 9.
Department of Pediatrics, University of Naples Federico II, Naples, Italy.
Abstract
OBJECTIVE: To evaluate the efficacy of a hypotonic oral rehydration solution (ORS) containing zinc and prebiotics for treatment of acute diarrhea in children.
STUDY DESIGN: We conducted a single-blind, prospective, controlled trial including children (age range, 3-36 months) with acute diarrhea randomly assigned to standard hypotonic ORS (group 1) or to new hypotonic ORS containing zinc and prebiotics (group 2). The main outcome was the rate of resolution of diarrhea at 72 hours.
RESULTS: A total of 60 children in group 1 (34 male; mean age, 18.58 months; 95% CI, 15.5-21.6) and 59 in group 2 (36 male; mean age, 19.26 months; 95% CI, 15.9-22.6) completed the study protocol. The rate of diarrhea resolution at 72 hours was higher in group 2 (50% versus 72.9%, P = .010). Total ORS intake in the first 24 hours was higher in group 2 (50 mL/kg; 95% CI, 41-59 versus 22 mL/kg; 95% CI, 17-29; P < .001). The mean number of missed working days by the parents of children in group 2 was lower (0.39; 95% CI, 0.08-0.70 versus 1.45; 95% CI 1.02-1.88; P < .001). Fewer patients in group 2 needed adjunctive drugs for the treatment of diarrhea 6/59 versus 19/60, P = .004. No adverse events were observed in either of the two groups.
CONCLUSION: The addition of zinc and prebiotics to ORS limits diarrhea duration in children.