Patient Centric Pharmaceutical Drug Product Design—The Impact on Medication Adherence

Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and paediatric populations as well as dermatological patients have special needs/preferences that should be considered when designing drug products. Patient Centric Drug Product Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and preferences of patients. Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process. These will be addressed in this review as well as their impact on medication adherence

Implementation of the gut microbiota prevents anastomotic leaks in laparoscopic colorectal surgery for cancer: the results of the MIRACLe study

The aim of this pilot study was to evaluate the effects of a novel perioperative treatment for the implementation of the gut microbiota, to prevent anastomotic fistula and leakage (AL) in patients undergoing laparoscopic colorectal resections for cancer. A series of 60 patients who underwent elective colorectal surgery at S. Eugenio Hospital (Rome—Italy) between December 1, 2020 and November 30, 2021 and received a novel perioperative preparation following the MIRACLe (Micro- biota Implementation to Reduce Anastomotic Colorectal Leaks) protocol (oral antibiotics, mechanical bowel preparation and perioperative probiotics), was compared to a group of 500 patients (control group) operated on between March 2015 and November 30, 2020, who received a standard ERAS protocol. In the MIRACLe Group only 1 anastomotic leak was registered. In this group the incidence of AL was just 1.7% vs. 6.4% in the control group (p = 0.238) and the incidence of surgical site infections (1.7% vs. 3.6%; p = 0.686), reoperations (1.7% vs. 4.2%; p = 0.547) and postoperative mortality (0% vs. 2.2%; p = 0.504) were lower. The postoperative outcomes were also better: the times to first flatus, to first stool and to oral feeding were shorter (1 vs. 2, 2 vs. 3 and 2 vs. 3 days, respectively; p < 0.001). Additionally, the postoperative recovery was faster, with a shorter time to discharge (4 vs. 6 days; p < 0.001). In this pilot study, the MIRACLe protocol appeared to be safe and considerably reduced anastomotic leaks in elective laparoscopic colorectal surgery for cancer, even if not statisti- cally significant, due to the small number of cases

Poorly differentiated thyroid carcinoma: single centre experience and review of the literature

There is controversy in the literature regarding a distinct subset of thyroid carcinoma whose histologically classification falls between well-differentiated and anaplastic carcinomas, previously identified as ‘poorly differentiated thyroid carcinoma’ (PDTC), or ‘insular carcinoma’, in view of the peculiar morphological characteristics of the cell groupings. The correct diagnosis and treatment of this entity have important prognostic and therapeutic significance. In this review, we describe the epidemiology, diagnosis, and management of PDTC and report our single centre experience to add to the limited evidence existing in the literature

Indicazioni ad interim sull’igiene degli alimenti durante l’epidemia da virus SARS-CoV-2. Versione del 19 aprile 2020

SARS-CoV-2 virus spreads by inter-human infection and there is currently no evidence of foodborne transmission or transmission from food business operators or from food packaging. Within the European legislation framework, food safety is ensured through a combined approach of prevention and control throughout the food chain, “for field to fork”. During the COVID-19 epidemic, however, the safeguard of food hygiene requires additional measures to reduce as much as possible the risk associated to the presence of potentially infected individuals in areas intended for food production or marketing. This report provides instructions and recommendations to ensure food and food packaging hygiene in the stages of food production, commercialization and consumption

Preoperative Ultrasonography in the Evaluation of Suspected Familial Non-Medullary Thyroid Cancer: Are We Able to Predict Multifocality and Extrathyroidal Extension?

Family history of thyroid cancer increases the risk of harboring thyroid malignancies that end up having extrathyroidal extension (ETE) and multifocality on histology; some authors suggest a more aggressive surgical approach. Their pre-operative identification could allow more conservative surgical procedures if none of these features are suspected. Our aim was to assess if neck ultrasonography could identify or exclude multifocality or ETE in these patients to tailor the extent of surgery. This retrospective study included patients with previous thyroid surgery, ≥1 first-grade relative with thyroid cancer, and who had undergone pre-surgical ultrasound. ETE was suspected in the case of thyroid border interruption or gross invasion of perithyroidal tissues. Multiple suspicious nodules were defined as suspicion of multifocal cancer. The cohort consisted of 45 patients (median age 49 years, 40 with thyroid cancer, 30 females). The positive predictive value of ultrasonography in predicting multifocality and ETE was 57.14% (25.25–84.03) and 41.67% (21.5–65.1%), respectively, while the negative predictive values were 63.2% (56.4–69.4%) and 72.7% (63.3–80.5%). Pre-operative ultrasound examination is unable to reliably identify or exclude multifocal disease or extrathyroidal extension. In patients scheduled for surgery and with a first-degree relative affected by DTC, a “negative” pre-operative US report does not exclude the potential finding of multifocality and ETE at final histopathology

Indicazioni ad interim sul contenimento del contagio da SARS-CoV-2 e sull’igiene degli alimenti nell’ambito della ristorazione e somministrazione degli alimenti. Versione del 27 maggio 2020

This report deepens the issues related to contagion containment and food hygiene in the food service industry in the "Phase 2" of the COVID-19 epidemic. The food service industry represents a noteworthy sector. Conditions such as crowding, limited air turnover, prolonged stay and - in relation to the consumption of meals - the impossibility of face mask use can occur within the premises intended for food administration. In addition, the consumption of food and drink inevitably determines the close exposure of hands, objects and products, potential vehicle of the virus, to the face. In the food service sector, physical distancing and other risk mitigation measures, a redefinition of the business organization and an increase of food hygiene standards are particularly relevant

Global Incidence and Risk Factors Associated With Postoperative Urinary Retention Following Elective Inguinal Hernia Repair

Importance Postoperative urinary retention (POUR) is a well-recognized complication of inguinal hernia repair (IHR). A variable incidence of POUR has previously been reported in this context, and contradictory evidence surrounds potential risk factors.Objective To ascertain the incidence of, explore risk factors for, and determine the health service outcomes of POUR following elective IHR.Design, Setting, and Participants The Retention of Urine After Inguinal Hernia Elective Repair (RETAINER I) study, an international, prospective cohort study, recruited participants between March 1 and October 31, 2021. This study was conducted across 209 centers in 32 countries in a consecutive sample of adult patients undergoing elective IHR.Exposure Open or minimally invasive IHR by any surgical technique, under local, neuraxial regional, or general anesthesia.Main Outcomes and Measures The primary outcome was the incidence of POUR following elective IHR. Secondary outcomes were perioperative risk factors, management, clinical consequences, and health service outcomes of POUR. A preoperative International Prostate Symptom Score was measured in male patients.Results In total, 4151 patients (3882 male and 269 female; median [IQR] age, 56 [43-68] years) were studied. Inguinal hernia repair was commenced via an open surgical approach in 82.2% of patients (n = 3414) and minimally invasive surgery in 17.8% (n = 737). The primary form of anesthesia was general in 40.9% of patients (n = 1696), neuraxial regional in 45.8% (n = 1902), and local in 10.7% (n = 446). Postoperative urinary retention occurred in 5.8% of male patients (n = 224), 2.97% of female patients (n = 8), and 9.5% (119 of 1252) of male patients aged 65 years or older. Risk factors for POUR after adjusted analyses included increasing age, anticholinergic medication, history of urinary retention, constipation, out-of-hours surgery, involvement of urinary bladder within the hernia, temporary intraoperative urethral catheterization, and increasing operative duration. Postoperative urinary retention was the primary reason for 27.8% of unplanned day-case surgery admissions (n = 74) and 51.8% of 30-day readmissions (n = 72).Conclusions The findings of this cohort study suggest that 1 in 17 male patients, 1 in 11 male patients aged 65 years or older, and 1 in 34 female patients may develop POUR following IHR. These findings could inform preoperative patient counseling. In addition, awareness of modifiable risk factors may help to identify patients at increased risk of POUR who may benefit from perioperative risk mitigation strategies