Impact of a clinical pharmacist in a multidisciplinary consultation on the switch to a biosimilar for inflammatory rheumatic diseases.

OBJECTIVE: Despite several studies proving the efficacy and safety of biosimilars compared with original drugs, switching to a biosimilar remains challenging when the decision is at the discretion of physicians with mandatory consent from patients. Educating patients about biosimilars seems important to increase the prescription rate of biosimilars. This study aimed to evaluate the impact of a clinical pharmacist consultation on the switch to and retention rate of a biosimilar for patients with inflammatory rheumatic diseases. METHODS: This retrospective study compared 2 groups of adult patients receiving (intervention) or not (control) a consultation with a pharmacist right before the rheumatologist consultation. The primary outcome was the frequency of patients who switched to a biosimilar at the end of the rheumatologist visit. RESULTS: We analysed 141 patients (50% women, 50±15years old, on original adalimumab (62%) or etanercept (38%)) who had never used biosimilars: 85 in the intervention group and 56 in the control group. The switch rate to a biosimilar significantly differed between the groups: 69.4% versus 41.1% in the intervention group versus the control group respectively (P<0.01). After a 1-year follow-up period, 72.5% versus 81.3% of patients who switched were still on biosimilar in the intervention versus control group respectively. CONCLUSIONS: This study highlights the positive impact of a pharmacist consultation before the physician's one on switching to a biosimilar, but more studies are needed to assess the impact of this pharmacist consultation on preventing the nocebo effect and therefore on improving the retention rate of biosimilars.

Stability of Pentobarbital Hydrogel for Rectal Administration in Pediatric Procedural Sedation.

Purpose: Pentobarbital is a sedative agent to limit children motion during computed tomography or magnetic resonance imaging (MRI) and ensures the successful completion of the imaging procedure. However, data on rectal drug formulation and its stability in practice are not available. The aim of this study was to formulate and evaluate the stability of a ready-to-use rectal pentobarbital gel. Methods: The formulation consisted of a hydrated gel containing 25 mg/mL of pentobarbital sodium, packaged in 10-mL amber glass bottles and stored at either 22°C to 25°C or 2°C to 8°C. At each predetermined time point, samples were taken for visual inspection, pH measurement, and analysis by a validated stability-indicating high-performance liquid chromatography (HPLC) method. The viscosity parameters of the hydrogel formulation were assessed. Results: The freshly prepared rectal formulations appeared clear, colorless, and particular-free with pH readings of 9.75 to 9.83. Over the 90 days of the study period, there was no significant change in appearance or pH values for all stability samples. The HPLC results confirmed the chemical stability when stored at 2°C to 8°C or at 22°C to 25°C. Conclusion: Pentobarbital hydrogel 25 mg/mL are stable chemically at least 90 days and can be administered to children for an effective and fast sedation.

Simultaneous determination of four antiepileptic drugs in human plasma samples using an ultra-high-performance liquid chromatography tandem mass spectrometry method and its application in therapeutic drug monitoring.

Therapeutic drug monitoring of antiepileptic drugs is widely practiced to achieve optimal efficacy and avoid adverse side effects. We describe an ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC/MS/MS) method developed for the monitoring of four frequently prescribed antiepileptic drugs - lamotrigine, levetiracetam, oxcarbazepine and topiramate. The main pharmacologically active metabolite of oxcarbazepine (mono-hydroxy-derivative metabolite, MHD) was also quantified. After addition of internal standards and a simple stage of protein precipitation, plasmatic samples were analyzed on a C18 column. All antiepileptic drugs were separated and quantified in 6 min, without interference. A good linearity was observed all over the calibration range (r2 > 0.99), up to 20 µg/mL (40 µg/mL for MHD). The limit of quantification was 0.20 µg/mL (0.40 µg/mL for MHD) with precision and accuracy ranging from 1.0 to 2.1% and from 96.7 to 110.8%, respectively. Intra- and inter-day precision and accuracy values were within 15%. No significant matrix effect was observed for all analytes. Clinical application was successfully evaluated in 259 samples from patients treated for epilepsy or bipolar disorders. In conclusion, a rapid, specific and sensitive UHPLC/MS/MS method was developed and validated for simultaneous quantification of antiepileptic drugs, suitable for therapeutic drug monitoring in neurology and psychiatry.