Highly automated bioburden-free continuous manufacturing biologics GMP operations: How to get there?

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Opioid Use Disorder Curriculum: Medicine Clerkship Standardized Patient Case, Small-Group Activity, and Patient Panel

INTRODUCTION: The overdose crisis remains a critical public health problem, creating an urgent need to train physicians in the treatment and management of opioid use disorder (OUD). Our medicine clerkship module aimed to close this gap by training and assessing students’ motivational interviewing skills, harm reduction knowledge, and use of nonstigmatizing language in the treatment of patients with OUD. METHODS: We evaluated the impact of a small-group, case-based activity and patient panel on the clinical documentation skills of students in a medicine clerkship. Clinical documentation was based on an observed structured clinical examination of a standardized patient with OUD and was evaluated using a grading rubric that followed the module learning objectives. Students also submitted reflections on the curriculum. RESULTS: Qualitative responses (n = 40) from students evaluating the small-group activity and patient panel exercise revealed overall student satisfaction with the patient panel and exposure to patients living with OUD. Three themes emerged from student reflections: (1) humanity, (2) different paths to recovery, and (3) using nonstigmatizing language. For the quantitative test, students’ (n = 39) mean clinical documentation scores before and after the small-group activity and patient panel increased from 10.1 to 11.3 out of 13.5 possible points. There was a significant difference between mean pretest and posttest scores (p < .001). DISCUSSION: The medicine clerkship provided an acceptable and feasible opportunity for implementing a multifaceted educational experience for students with significant immediate impact on their evaluation of patients with OUD

Availability of medications for opioid use disorder in outpatient and inpatient pharmacies in South Florida: a secret shopper survey

BACKGROUND: Despite the proven efficacy of medications for opioid use disorder (MOUD) and recent reduction in barriers to prescribers, numerous obstacles exist for patients seeking MOUD. Prior studies have used telephone surveys to investigate pharmacy-related barriers to MOUD. We applied this methodology to evaluate inpatient and outpatient pharmacy barriers to MOUD in South Florida. METHODS: Randomly selected pharmacies in South Florida (Miami-Dade, Broward, and Palm Beach Counties) were called using a standardized script with a “secret shopper” approach until 200 successful surveys had been completed. The primary outcome was the availability of any buprenorphine products. Second, a list of all 48 acute care hospitals within the aforementioned counties was compiled, and hospitals were contacted by telephone using a second structured script. RESULTS: A total of 1374 outpatient pharmacies and 48 inpatient pharmacies were identified. 378 randomly selected outpatient pharmacies were contacted to accrue 200 successful calls (53% success rate). All 48 inpatient pharmacies were contacted to successfully complete 25 inpatient surveys (52%). Of the 200 outpatient pharmacies contacted, 38% had any buprenorphine available. There was a significant difference in buprenorphine availability by county, with Miami-Dade having the least availability and Palm Beach having the most availability (27% vs. 47%, respectively; p = 0.04). Of the 38% with buprenorphine available, 82% had a sufficient supply for a two-week prescription of buprenorphine 8 mg twice daily. Of the pharmacies that did not have buprenorphine, 55% would be willing to order with a median estimated time to receive an order of 2 days (IQR 1.25–3 days). Of the 25 surveyed inpatient pharmacies, 88% reported having buprenorphine on inpatient formulary, and 55% of hospitals had at least one restriction on ordering of buprenorphine beyond federal regulations. CONCLUSIONS: The results of this study highlight significant pharmacy-related barriers to comprehensive OUD treatment across the healthcare system including both acute care hospital pharmacies and outpatient community pharmacies. Despite efforts to increase the number of MOUD providers, there still remain downstream obstacles to MOUD access

«All We Are Saying Is Give Pizza Chance»: L’effetto YBA e l’irruzione di una nuova generazione alle Biennali degli anni Novanta del Novecento

The chapter addresses the rise of the Young British Artists (YBA) in their home country and their subsequent international spread during the 1990s as seen in connection with the Venice Biennale occurring between 1993 and 2003. Particularly, the author argues that the Aperto ’93 section devoted to young artists at the Arsenale for the 45th Biennale was an unexpected starting point for the YBAs on the global stage and their first Venetian appraisal convinced home institutions such as the British Council to finance a large program of international exhibitions for this new artistic generation. Throughout the 1990s the Biennale thus became a major stage for the rising YBAs, which in turn deeply influenced the artistic language and installation practices shown at the Venetian exhibition. In conclusion, the chapter intends to present the 1990s at the Biennale as a decade of progressive struggle between different artistic generations – of both artists and curators – that climaxed with the 50th Biennale in 2003 and eventually shaped the new face of the Venetian exhibitions for the new millennium

A Survey of Empirical Results on Program Slicing

International audienceBACKGROUND:Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS:This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS:Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION:Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding