Slow subcutaneous infusion of flumazenil for the treatment of long-term, high-dose benzodiazepine users: a review of 214 cases.

Despite the first reports concerning benzodiazepine dependence being published in the early 1960s literature, the risk of benzodiazepine addiction is still greatly debated. The severe discomfort and life threatening complications usually experienced by long-term benzodiazepine users who suddenly interrupt benzodiazepine intake have led to the development of several detoxification protocols. A successful strategy used by our Addiction Unit is abrupt benzodiazepine cessation by administering flumazenil slow subcutaneous infusion (FLU-SSI) with an elastomeric pump. Although some studies proved the efficacy of flumazenil infusion more than 20 years ago, only a few centres in the world offer this method to their patients. This paper reports the data related to 214 subjects addicted to high doses of benzodiazepine and treated with the FLU-SSI method between 2012 and 2014. This technique is less invasive and requires less nursing intervention than intravenous infusion. Our data support FLU-SSI as a possible efficient strategy for the treatment of patients with long-term, high-dose benzodiazepine addiction, and could become a routine therapy as long as the necessary further studies on dose, duration of infusion and safety issues are carried out.

α1-Adrenergic receptor antagonists and gynecomastia. A case series from the Italian spontaneous reporting system and VigiBase(™).

PURPOSE: The aim of this study was to analyze the cases of gynecomastia associated with α1A-adrenergic receptor antagonists (α1-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase(™)), focusing on tamsulosin use. METHODS: We analyzed the spontaneous reports of gynecomastia related to the use of α1-ARAs and collected from the RNF and from VigiBase(™) up to December 2012. Cases of gynecomastia have been defined as reports associated with gynecomastia according with Medical Dictionary for Regulatory Activities (MedDRA). Reporting odds ratio (ROR) and Information Component (IC) were calculated as measures of disproportionality in RNF and VigiBase(™), respectively. RESULTS: Up to December 2012, about 186,000 reports were recorded in the RNF. Among these, 902 reports of adverse drug reaction (ADR) have been associated with the use of at least one α1-ARAs. Of these, in 15 cases, gynecomastia was a listed ADR: in 10, the suspected drug was tamsulosin (in eight, it was the sole suspect); in two, doxazosin and alfuzosin, respectively; and in one, terazosin. ROR for tamsulosin was 5.3 (95% CI 1.8, 15.7). In VigiBase(™), 84 reports of gynecomastia indicated tamsulosin as suspected drug. Tamsulosin-associated gynecomastia showed the highest IC value within this class of drugs (IC 95% 2.43). CONCLUSION: In this study, we highlight a possible association between gynecomastia and tamsulosin use. To our knowledge, this association has not been described before and could represent a potential signal.

Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database.

PURPOSE: 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.

[Venus study: a research and education project on nurses and drug surveillance]. / Venus study: infermieri e farmacovigilanza sul campo. Progetto di formazione e ricerca.

INTRODUCTION: Adverse events (AE) are a relevant problem with major health consequences for both patients and health system in different countries. AIMS: To estimate and describe the AE and Adverse Drug Reactions (ADRs) detected by nurses in hospital during an observation time of six months. METHODS: The observational study involved 174 nurses and 36 head nurses. Nurses recorded for each patient: health condition, unexpected AE, administered drugs, and suspected ADR. Nurses were also requested to send ADR reports to the Italian Pharmacovigilance System. RESULTS: Data were collected from 4608 patients. Nurses identified AE in 2458 patients and observed 6647 different events, mostly psychiatric (800 cases). Female, elderly, and 0-1 years old patients, number of administered drugs, and poor health conditions were all risk factors for adverse events (p < 0.01). Nurses identified 160 patients with ADRs (3.5% of observed patients). CONCLUSIONS: Nurses have shown a good observational skill for AE, but low ability to detect ADRs probably due to lack of knowledge on drugs and ADR. For this reason a continuing education is essential.