Easy Medication Reconciliation at Hospital Admission: The EzMedRec Decision Support System.

Medication reconciliation (MR) aims at preventing medication errors at care transitions. It is a complex, time-consuming, cognitively demanding pharmacological task. We have developed a decision support system, EzMedRec, to assist retroactive MR at hospital admission. EzMedRec compares the best possible medication history (BPMH), i.e., all medications taken by the patient before hospitalization, to the list of admission medication orders (AMO). The process includes (i) the decomposition of BPMH and AMO drugs into their active ingredients (AIs), (ii) the detection of medication discontinuations and additions, and (iii) the identification of modified medication orders. The ATC classification is used to semantically enrich MR by comparing discontinued AIs and added AIs and suggesting a potential intentional drug substitution serving the same therapeutic objective. EzMedRec has been evaluated on a sample of 52 actual MRs involving 822 medication order lines, 406 in BPMHs, and 416 in AMOs with a global accuracy of 98,3%.

Development and Assessment of RecosDoc-MTeV to Improve the Quality of Direct Oral Anticoagulant Prescription for Venous Thromboembolic Disease.

Potentially inappropriate prescribing of direct oral anticoagulants is frequent with the most common errors being dosage, administration, and duration of therapy. We developed RecosDoc-MTeV, a documentary-based clinical decision support system (CDSS) for the management of direct oral anticoagulant prescription to prevent and treat venous thromboembolism. Simultaneously, the network of Parisian public hospitals (AP-HP, France) developed narrative clinical practice guidelines (CPGs) and a companion smartphone application to enhance medication and patient safety related to direct oral anticoagulant prescription. To assess the effectiveness of these CDS tools, we performed a retrospective review of 274 random patients hospitalized in 2017, which were either at risk of venous thromboembolism or actually treated for the disease. Consistency between the two CDS tools was measured at 96.7%. Administered treatments were compliant in 67.2% and 72.3% of the cases, with AP-HP CPGs and RecosDoc-MTeV, respectively. These results support that implementing CDSSs for the prescription of direct oral anticoagulants may ensure safe prescribing of high-risk medications.

Trabectedin for sarcomas in daily clinical practice: analysis of 45 patients treated in a French institution.

INTRODUCTION: The active clinical research programme of trabectedin continues to improve knowledge on the therapeutic activity and toxicity of the drug in the treatment of soft tissue sarcomas (STS). In contrast, limited number of data is available on its use outside of clinical trials. PATIENTS AND METHODS: We retrospectively analysed efficacy and safety of trabectedin when given in daily practice to patients with advanced/recurrent STS. Outcomes were compared with previously published works including clinical and retrospective studies. RESULTS: Forty-five patients received trabectedin between January 2005 and May 2014. Sarcomas were histologically heterogeneous in our cohort (37.9% of other types of sarcomas than L-sarcomas). Our patients had poor baseline health status (ECOG ≥ 2 [17.8%]) and had received multiple previous lines of chemotherapy. Patients received a median of five cycles of treatment (1-22). The objective response rate was statistically superior in our study (37.8%) compared to the other works. However, median PFS was similar. Trabectedin-related serious adverse events (AEs) induced hospitalizations and treatment discontinuation in 22 and 15% of patients. CONCLUSION: This analysis confirms the efficacy of trabectedin in clinical practice (with a third of patients experiencing prolonged disease control) and highlighted the importance of its administration as early line therapy to allow the best management of serious AEs.

Levofloxacin for the treatment of pyelonephritis.

INTRODUCTION: Levofloxacin , the l-isomer of ofloxacin has become one of the cornerstones of antibiotic therapy of pyelonephritis since its introduction in the 1990s, thanks to its exceptional pharmacokinetic (PK) and pharmacodynamic (PD) profile, broad-spectrum antibacterial action and satisfactory tolerance. However, the emergence of widespread fluoroquinolone resistance over the past decade, has prompted to re-examine its place in the treatment of urinary tract infection. AREAS COVERED: This review covers the medical literature in any language through December 2012, on 'levofloxacin'. To identify relevant articles, the search terms 'pyelonephritis', 'urinary tract infections', 'levofloxacin', 'levaquin' and 'ofloxacin' were obtained through PubMed, MEDLINE and Clinicaltrials.gov queries. The authors focus on clinical trials, articles related to the PK and PD properties of levofloxacin as well as recent development in the mechanisms and prevalence of levofloxacin resistance. Major points stemming from international guidelines are also reviewed. EXPERT OPINION: Levofloxacin has achieved satisfactory bacterial eradication rates and clinical success across all available trials, similar to the antibiotic comparator. High-dose (750 mg) orally administrated levofloxacin over a short 5-day course is a reasonable option for patients eligible for outpatient management. Levofloxacin is no longer a suitable option for first-line empirical treatment of pyelonephritis in areas where resistance rates are high (> 10%) when pyelonephritis is hospital-acquired. Efforts to promote fluoroquinolone-sparing agents should be encouraged and its prescription should be performed in compliance with antimicrobial guidelines.

Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial.

BACKGROUND: Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). OBJECTIVE: To establish the superiority of duloxetine over placebo in SUI after RP. DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. MEASUREMENTS: The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. RESULTS AND LIMITATIONS: Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. CONCLUSIONS: Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.

[Anticancer chemotherapy in the elderly: a review of the literature]. / Chimiothérapies anticancéreuses et personnes âgées: revue de la littérature.

Few elderly cancer patients are included in clinical trials, resulting insuffisant data of the effectiveness and tolerance of anticancer drugs in this patient population. The aim of this study was to analyse the studies concerning the effectiveness and tolerance of chemotherapy prescribed for elderly patients treated for colorectal, breast and lung cancer. The data of this population showed that the older patients are less likely to receive chemotherapy than the younger. The age is considered as significant important factor for the decision of chemotherapy of this population. However elderly patients seem to have the same benefit as compared with younger patients. Rather than the criteria of age, comorbidities should be considered. It is necessary to develop specific geriatric assessment and development of clinical trials specifically including elderly patients remains a necessity.

Phase III study comparing a semimonthly with a monthly regimen of fluorouracil and leucovorin as adjuvant treatment for stage II and III colon cancer patients: final results of GERCOR C96.1.

PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly regimen (fluorouracil [FU] and leucovorin [LV] semi-monthly is LV5FU2) with a monthly regimen of FU and LV (mFU/LV) as well as 24 weeks versus 36 weeks of each regimen as adjuvant treatment of stage II and III colon cancer. PATIENTS AND METHODS: LV5FU2 was administered semimonthly for 2 days as racemate (dl) or levogyre (l-; 200 or 100 mg/m(2)) as a 2-hour infusion, followed by 400 mg/m(2) FU bolus and a 600-mg/m(2) FU 22-hour continuous infusion. FU and LV were administered monthly (mFU/LV) for 5 days as dl- or l-LV 15-minute infusion, followed by a 400 mg/m(2) FU 15-minute infusion. The primary end point was disease-free survival (DFS). RESULTS: Between September 1996 and November 1999, 905 patients with stage II (43%) and III (57%) colon cancer were enrolled. The median follow-up was 6 years. There was no statistically significant difference between mFU/LV and LV5FU2 in terms of DFS (150 v 148 events; hazard ratio [HR],1.01; 95% CI, 0.806 to 1.269; P = .94) and overall survival (OS; 104 v 103 events; HR,1.02; 95% CI, 0.77 to 1.34; P = .91). No statistical difference was observed between 24 or 36 weeks of chemotherapy. Median survival from metastatic relapse was 24 months. The survival of patients with metastatic relapse (n = 243) was significantly longer for patients with a longer time from random assignment to relapse (< 1, 1 to 2, >or= 2 years; log-rank test for trend P, .0497). CONCLUSION: DFS and OS were not statistically different between treatment groups and treatment durations. These data confirm the value of LV5FU2 as control arm in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer and Pan-European Trials in Adjuvant Colon Cancer studies.

[Multidisciplinary consultation for the prescription of danaparoid in suspected heparin-induced thrombocytopenia]. / Impact d'une organisation pluridisciplinaire pour la "juste prescription" du danaparoïde sodique en cas de suspicion de thrombopénie immuno-allergique à l'héparine.

INTRODUCTION: Heparin-induced thrombocytopenia (HIT) is a serious immune complication of heparin therapy and presents a risk of severe thromboembolic events. Withdrawal of heparin together with administration of an alternative antithrombotic agent is always necessary in patients with suspected HIT. Diagnosis of this complication, however, is often difficult, particularly in hospitalized patients. The aim of this study was to evaluate the impact of multidisciplinary consultation on the appropriate prescription of danaparoid, widely used as an alternative antithrombotic treatment in HIT. MATERIAL AND METHODS: Multidisciplinary consultation between clinician, hematologist, and pharmacist called for reassessment of the HIT diagnosis at day 3 and between day 3 and 10 after the beginning of danaparoid treatment. Continuation or stopping treatment depended on their joint conclusion. All danaparoid prescriptions were evaluated according to this procedure for one year. RESULTS: HIT was suspected in 26 in-patients. The multidisciplinary approach made it possible to reassess the HIT diagnosis on day 3 and stop the alternative treatment in 42.3% of cases. Danaparoid use decreased by 52% compared with the previous year. CONCLUSION: Multidisciplinary consultations between clinician, hematologist, and pharmacist appear useful for minimizing inappropriate prescription of this alternative treatment in cases of suspected HIT.

[Anticancer drugs off label used of: what do the experts think about?]. / Prescriptions hors AMM en cancérologie: qu'en pensent les experts?

Anticancer drugs off label used in Tenon hospital were analysed by a panel of 12 experts not working at Tenon hospital. They distinguished 3 groups of off-label prescribing according to scientific evidence, labelling anticancer drugs alternative in presence and patient's characteristics: justified off label used (62%), unjustified off label used (26%) and prescriptions for which no consensus had been reached between the experts (12%). Nineteen per cent of unjustified off label used had labelling alternative and 7% did not have anticancer drugs labelling alternative. Questions who experts had to answer to analyse drugs prescribing could be systematically asked when a chemotherapy is prescribed. It could allowed to take into account scientific, economic and ethical requirements. This method proposed by the local drug committee could be used to regulate economic resources and to justify financing of some expensive anticancer drugs.

[Anticancer drugs use evaluation: limits of the approved labeling]. / Evaluation du bon usage des anticancéreux: les limites des indications AMM.

A practice survey was performed in Tenon hospital on 396 consecutive patients treated for solid tumors during 4 weeks in november 2002. 33% of anticancer drugs were off label used. The wording heterogeneity of the different anticancer drugs approved labeling and the lack of anticancer drugs in a number of cancers can explain those results. On one hand, randomised comparative clinical trial, considered as the best level of evidence to obtain a label used, is not always possible in cancerology, especially for rare tumors. One the other hand, pharmaceutical firm are not obliged to asked a label used for an anticancer drugs in spite of high level of evidence. So, label used can not be the own references for anticancer drugs prescribing, therapeutic advanced can be realised and disseminated before their taking into account in the label used.