Stability study of a clonidine oral solution in a novel vehicle designed for pediatric patients.

Clonidine hydrochloride is administered to opioid-addicted mothers' neonates to reduce neonatal abstinence syndrome. It is prescribed off-label to neonates at 0.5-1 µg/kg/6 h, alone or in combination. The commercially injectable form of clonidine-Catapressan® 0.15 mg/mL-is being orally given after an appropriate dilution in water. However, this practice is not suitable for a perfectly safe and accurate administration. The objectives were to design a 10 µg/mL oral solution of clonidine hydrochloride in Inorpha® and to study the stability of this solution by a validated stability-indicating liquid chromatography (LC) method. The chemical, physicochemical and microbiological stability of the compounded formulation stored at 5 ± 3 °C and 25 ± 2 °C was tested over 60 days. The LC method used is specific, linear, accurate and precise. Upon storage between 2 and 8 °C according to classical and 'in use' schedules, the concentrations of clonidine and potassium sorbate (preservative) were found to be between 90.0 and 110.0% of the initial concentration, the pH between 4.4 and 4.7 and no microbial growth was noted. The stability of clonidine hydrochloride oral solution in Inorpha® sets the basis for individualized, easy and safe administration of clonidine in pediatric populations.

[A Woman Experienced Severe Thrombocytopenia When Treated With Fluvastatin]. / Thrombopénie sévère chez une patiente traitée par fluvastatine.

A 62-year-old woman treated with fluvastatin experienced three separate thrombocytopenic illnesses, severe on two occasions associated with nadir platelet count of 57 000/µL and 75 000/µL. The hospital pharmacist replaced fluvastatin by pravastatin during three stays. Platelet count has increased some days after this substitution. These results suggest that fluvastatin could be involved in these thrombocytopenic episodes.

Enhancing pharmaceutical decision support system: evaluating antithrombotic-focused algorithms for addressing drug-related problems.

OBJECTIVES: To evaluate the efficacy of integrating antithrombotic-focused pharmaceutical algorithms (PAs) into a pharmaceutical decision support system (PDSS) for detecting drug-related problems (DRPs) and facilitating pharmaceutical interventions. METHODS: A set of 26 PAs (12.4%) out of a total of 210 were created to model patient situations involving antithrombotics, and their contributions were compared with the entire PDSS system.The observational prospective study was conducted between November 2019 and June 2023 in two health facilities with 1700 beds. Pharmacists, who followed a DRP resolution strategy to support human supervision, analysed alerts generated by these encoded PAs. They registered their interventions and the acceptance by physicians. RESULTS: From 3290 alerts analysed targeting antithrombotics, the pharmacists issued 1170 interventions of which 676 (57.8%) were accepted by physicians. With the 184 other PAs, from 9484 alerts the pharmacists issued 3341 interventions of which 1785 were accepted (53.4%).Results indicate that the detection of DRPs related to antithrombotics usage represents a high proportion of those detected by the PDSS, highlighting the importance of incorporating tailored PA elements at the modelling stage. CONCLUSIONS: The system evolves alongside the physiological changes associated to the patient situations, adapts the alerts and complements the current care. Therefore, we recommend that all PDSS should integrate specific algorithms targeting DRPs associated with antithrombotics to enhance pharmaceutical interventions and improve patient safety.

Clinical risk assessment of modelled situations in a pharmaceutical decision support system: a modified e-Delphi exploratory study.

BACKGROUND: Pharmaceutical decision support systems (PDSSs) use reasoning software to match patient data to modelled situations likely to cause drug-related problems (DRPs) or adverse drug events. To aid decision-making, modelled situations must be linked to well-defined systemic clinical risks. AIM: To obtain expert consensus on the level of clinical risk for patients associated with each modelled situation that could be addressed using a PDSS. METHOD: A two-round e-Delphi survey was conducted from February to April 2022, involving 20 experts from four French-speaking countries. Participants had to rate modelled situations on two five-point Likert scales, assessing the likelihood of clinical consequences and their severity. The degree of consensus was determined as the proportion of participants providing risk scores in line with the median. The combined median scores for likelihood and severity provided the level of risk according to the Clinical Risk Situation for Patients (CRiSP) scale, formalized via validated tools. RESULTS: The expert panel achieved consensus (≥ 75% agreement) on 48 out of 52 modelled clinical situations. Among these, 45 were categorized as high or extreme risk. The most common DRP identified was overdosing, accounting for 22% of cases. Furthermore, DRPs involving cardiovascular, psychiatric, and endocrinological drug classes were prevalent, constituting 45, 13, and 9% of cases, respectively. CONCLUSION: Through consensus, our study identified 45 modelled clinical situations associated with high or extreme risks. This study highlights the interest of using PDSSs to prevent harm in patients and, on a large scale, document the impact of the pharmacist in preventing, intercepting and managing iatrogenic drug risk.

Feasibility of the Glissonian approach during right hepatectomy.

OBJECTIVE: The Glissonian approach during hepatectomy is a selective vascular clamping procedure associated with low rates of technical failure and complications. The aim of the present study was to assess the feasibility of a right Glissonian approach in relation to portal vein anatomy. METHODS: This was a prospective study conducted over a 12-month period, which included 32 patients for whom preoperative three-dimensional reconstruction using contrast-enhanced computed tomography in the portal venous phase and portography for right portal vein embolization were available, and in whom a right Glissonian approach was applied during right hepatectomy. Preoperative imaging data were correlated with intraoperative Doppler ultrasound findings (considered as the reference dataset). Causes of failures and complications specifically related to the Glissonian approach were identified. RESULTS: Right hepatectomy was performed for colorectal liver metastases (n = 25), hepatocellular carcinoma on cirrhosis (n = 6) and intrahepatic cholangiocarcinoma (n = 1). The Glissonian approach was effective in 24 (75%) patients. In the remaining eight (25%) patients, failure was caused by incomplete clamping (n = 2) or clamping of the left portal pedicle (n = 6). The portal anatomy was aberrant in six patients with failure, showing portal trifurcation (n = 1), right portal trifurcation (n = 1) and a common trunk between the right anterior and left portal branch (n = 4). An angle of less than 50° between the portal vein and left portal branch was reported in association with extended clamping to the left portal branch (selectivity = 72%, specificity = 71%). Intraoperative bleeding and biliary fistula occurred in two patients with non-normal portal anatomy. CONCLUSIONS: The right Glissonian approach was effective in 75% of patients. Failure of the procedure (including the extension of clamping to the left pedicle) mostly occurred in patients with portal vein variations, which can be accurately assessed using a combination of preoperative imaging and intraoperative Doppler ultrasound.

Comparison of the validity, perceived usefulness, and usability of I-MeDeSA and TEMAS, two tools to evaluate alert system usability.

OBJECTIVE: Two tools are currently available in the literature to evaluate the usability of medication alert systems, the instrument for evaluating human factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aimed to compare their convergent validity, perceived usability, usefulness, strengths, and weaknesses, as well as users' preferences. METHOD: To evaluate convergent validity, two experts mapped TEMAS' items against I-MeDeSA's items with respect to the usability dimensions they target. To assess perceived usability, usefulness, strengths, and weaknesses of both tools, staff with expertise in their medication alerting system were asked to use French versions of the TEMAS and I-MeDeSA. After the use of each tool, participants were asked to complete the System Usability Scale (SUS) and answer questions about the understandability and usefulness of each tool. Finally, participants were asked to name their preferred tool. Numeric scores were statistically compared. Free-text responses were analyzed using an inductive approach. RESULTS: Forty-five participants from 10 hospitals took part in the study. In terms of convergent validity, I-MeDeSA focuses more on the usability of the graphical user interface while TEMAS considers a wider range of usability principles. Both tools have a fair level of perceived usability (I-MeDeSA' SUS score = 61.85 and TEMAS' SUS score = 62.87), but results highlight that revisions are necessary to both tools to improve their usability. Participants found TEMAS more useful than I-MeDeSA (t = -3.63, p =.005) and had a clear preference for TEMAS to identify problems in formative evaluation (39 of 45; 0.867, p <.001) and to compare the usability of alert systems during the procurement process (36 of 45; 0.8, p <.001). CONCLUSIONS: The TEMAS is perceived as more useful and is preferred by participants. The I-MeDeSA seems more relevant for quick evaluations that focus on the graphical user interface. The TEMAS seems to be more suitable for in-depth usability evaluations of alert systems. Even if both tools are perceived to be equally usable, they suffer from wording, instructional, and organizational problems that hinder their use. The results of this study will be used to improve the design of I-MeDeSA and TEMAS.

Anatomy and surgical landmarks for the ansa pectoralis: application to pectoralis major nerve selective neurotomy.

BACKGROUND: Ansa pectoralis neurotomy is a surgical approach in the treatment of the pectoralis major muscle spasticity causing an attitude in adduction and internal rotation of the shoulder. OBJECTIVE: To establish the anatomical landmarks allowing an easier localisation of the ansa pectoralis during neurotomy. MATERIAL AND METHODS: Fifteen adult human cadavers (10 embalmed and 5 fresh) were dissected in order to determine anatomical landmarks allowing an easier localization of the ansa pectoralis during neurotomy. RESULTS: In all the cadavers, the lateral pectoral nerve arose from the lateral cord of the brachial plexus, 0.2 cm above to 1.5 cm below the inferior border of the clavicle with a mean distance of 0.76 cm for left and right side, whereas the medial pectoral nerve arose from the medial cord of the brachial plexus, 0.7-2.3 cm below the inferior border of the clavicle with a mean distance of 0.61 cm for the left side and 0.68 cm for the right side. We systematically found both the origin of pectoral nerves and the ansa pectoralis at the level of the middle third of the distance between the sternoclavicular and the acromioclavicular joints. Moreover, ansa pectoralis was constantly localized lateral to the thoracoacromial artery. In four cases, the division of the lateral pectoral nerve was not found. In one case, medial pectoral nerve did not exist. CONCLUSION: Ansa pectoralis can be found by a curved incision made at the mid-third of the distance between the sternoclavicular and the acromioclavicular joints, the medial point being located just below the lower edge of the clavicle and the lateral point 2 cm below the inferior edge of the clavicle.

Pharmaceutical algorithms set in a real time clinical decision support targeting high-alert medications applied to pharmaceutical analysis.

BACKGROUND: Pharmaceutical analysis of the prescription has to prop up the quality of patients' medication management in a context of medication's risk acculturation. But this activity remains highly variable. Medication-related clinical decision support may succeed in reducing adverse drug events and healthcare costs. PURPOSE: This study aims to present AVICENNE as a real time medication-related clinical decision support (rt-CDS) applied to pharmaceutical analysis and its ability to detect Drug related problems (DRP) consecutively resolved by pharmacists. Basic procedures A Medication-related rt-CDS is created by integrating the software PharmaClass® (Keenturtle), 5 health data streams on the patient and Pharmaceutical algorithms (PA). PA are created by modeling the pharmaceutical experiment about DRP and the thread of their criticality. They are partially encoded as computerized rules in Pharmaclass® allowing alerts' issue. An observational prospective study is conducted during 9-months among 1000 beds in 2 health facilities. The first step is to identify alerts as DRP; their resolution follows with clear guidelines worked out for the pharmaceutical analysis. A basis on predictive positive values (PPV) of the PA is being built today helping to know the performance of DRP detection and resolution. Main findings 71 PA are encoded as rules into Pharmaclass®: 40 targeted serious adverse drug events. 1508 alerts are analyzed by pharmacists. Among them 921 DRPs were characterized and 540 pharmaceutical interventions transmitted of which 219 were accepted by prescribers. Three PPV are defined depending on software, pharmacist and patient. Principal conclusion Clinical pharmacy societies should host, share and update a national corpus of PA and exploit its educational interest.

Are there any surgical and radiological correlations to the level of ligation of the inferior mesenteric artery after sigmoidectomy for cancer?

INTRODUCTION: The Société Française de Chirurgie Digestive and the American Society of Colon and Rectal Surgeons recommend a ligation at the origin of the primary feeding vessel for sigmoid cancer to ensure optimal lymphadenectomy. We evaluated the correlation between the level of ligation defined by the surgeon and the real level of ligation visualized on postoperative CT scan. PATIENTS AND METHODS: From December 2004 to August 2010, in a series of 146 patients undergoing colectomy for sigmoid cancer, 51 (19 women) CT measurements (visualization of the left colonic artery (LCA), length of the arterial stump) were performed by a radiologist blinded to operative data. RESULTS: This series comprised 63% of men with a mean age of 69 years. A correlation was demonstrated between the level of ligation assessed by the surgeon and the real level of ligation demonstrated on postoperative CT scan in 41% of cases. No risk factors for absence of correlation were identified (laparoscopy, gender, BMI, emergency, and ASA score). In the "no correlation" group, the site of ligation was overestimated in 70% of cases. No significant difference was observed between the "correlation" and "no correlation" groups for lymphadenectomy (21.6 and 18 lymph nodes, p=0.5593) or 5-year overall survival (71.4 and 93.1 months, p=0.57). CONCLUSION: In conclusion, the surgical and radiological correlations are low as the intraoperative estimation of the level of IMA ligation was correlated with CT findings in less than 50% of cases. No risk factors for non-correlation were identified, and there was no impact on lymphadenectomy. Overestimation of the level of ligation was the most frequent situation but did not appear to have any impact on tumor staging or on patient management in this group of patients.