Implementation of infliximab standardized doses after pharmacokinetic modelization in a cohort of patients with Crohn's disease.

BACKGROUND: According to infliximab (IFX) license in Crohn's disease (CD), infusion doses are based on patient's body-weight. Dose banding providing standardized doses (SD) has been implemented in parenteral chemotherapy in order to optimize aseptic unit capacity and reduce drug expenditure, duration of hospital stay and costs without decreasing efficacy. MATERIAL AND METHOD: The first part was a single-center retrospective analysis of consecutive CD patients receiving IFX maintenance therapy to determine standardized doses covering more than 50% of infusions. The second part was a prospective cohort study assessing the impact of SD compared to body-weight doses (BWD) on admission duration and costs. RESULTS: Six IFX SD covering more than 90% of infusion doses were implemented for dose banding. According to the Monte-Carlo simulation, there was no significant difference between IFX SD and BWD maintenance regimens. When assessed prospectively in 116 patients (75 patients treated with SD and 41 with BWD) corresponding to 128 infusions, hospitalization duration was shortened by 70 min per patient (p < 0.001). CONCLUSION: According to a pharmacokinetic model, IFX SD has a pharmacokinetic profile close to BWD and is associated with reduced length of hospitalization in a cohort of patients with CD. IFX SD implementation could optimize infusion units functioning and, save time and costs without decreasing efficacy.

Tamper-resistant prescription forms for narcotics in France: Should we generalize them?

In France, prescription of narcotics must be written on a tamper-resistant prescription form with specific technical particularities. Dosage and daily dose of medicines shall be written out entirely in letters. These prescription forms are also mandatory for buprenorphine, clorazepate, clonazepam, tianeptine, buccal midazolam and zolpidem owing to traffic, abuse or diversion. In 2012, to assess the use of standard and tamper-resistant prescription forms and the acceptability of the generalization of the latter to all medicines, a national opinion survey was performed, with a postal questionnaire, within three randomized samples of 1500 prescribers (physicians, dentists and midwives). Of the 403 participating prescribers (participation rate of 26.8%), 373 were physicians, 14 dentists and 16 midwives. Tamper-resistant prescription forms were used by 76.2% of prescribers, but only by 5.1% in a computerized version, whereas for standard prescription forms, 61% used computer assisted prescription software. The main reason was the inability of the prescription software to print these forms or to respect the mandatory prescription rules for narcotics. Theft and falsification of prescriptions had ever occurred (working life). Most prescribers (62.5%) were against the generalization of tamper-resistant prescription forms. Those in favour were for a generalization to all medicines (65%) and not only to psychotropic agents. Generalization of tamper-resistant prescription forms is not a consensual solution to prevent medicines' diversion. Some prescribers alluded to the possibility of dematerialization and electronic transmission of prescription forms, which could avoid theft, forgery or falsification.