Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19.

The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand sanitizer (ABHS) by evaluating the alcohol content and impurities present in ABHS products manufactured by establishments that registered with the FDA during March-April 2020. A stratified sampling design divided the population of manufacturers into independent groups based on each establishment's level of experience with FDA oversight and its geographic location. ABHS products were collected and analyzed by spatially offset Raman spectroscopy and gas chromatography with mass spectrometry (GC-MS). The GC-MS results for 310 products, from 196 newly registered domestic manufacturers, showed that 71.6% (± 5.7%) of these manufacturers had violative products. In 104 (33.5%) cases, the alcohol content did not meet label claim assay specifications but still fell within CDC efficacy ranges. Ethanol ABHS products failed more often overall (assay and impurities) (84.3%) and for impurities (84.3%), than isopropanol ABHS products (11.2% and 6.2%, respectively). Differences in test results across active ingredients were statistically significant. Ethanol ABHS products often (63.5% of cases) failed due to the presence of acetal or acetaldehyde, particularly in products with pH ≤ 6. Other impurities were also detected in several ABHS products, suggesting the use of low-grade alcohol in the manufacture of these products. Evidence was insufficient to conclude that having experience manufacturing FDA-regulated products, or lack thereof, influenced product-level violative results. This study highlights the importance of sourcing and testing active pharmaceutical ingredients to produce quality drug products.

Day case angioplasty in a secondary care setting - initial experience.

Background: Peripheral artery disease presents an increasing healthcare burden worldwide. Day-case angioplasty in a secondary care setting can be a safe and effective means of meeting the growing demand for lower limb revascularisation. We evaluated the safety and efficacy of a day-case-based angioplasty service in a UK district general hospital. Patients and methods: Consecutive patients undergoing endovascular revascularisation between August 2018-February 2020 were analysed retrospectively. All patients were discussed at a multi-disciplinary (diabetic foot) team meeting following a day case algorithm. Patient and procedural characteristics, technical success, peri-procedural complications, and 30-day outcome of day-case angioplasties were compared with those requiring overnight stay or were hospitalized. Results: Fifty-seven percent of 138 patients were diabetic, mean age 75 ± 12 years, 95% had critical limb ischaemia (Fontaine III 12%, IV 83%), and baseline ankle brachial pressure index [ABPI] 0.40 ± 0.30. Sixty-three patients (45%) were treated as planned day cases, 21 (15%) required overnight admission for social indications. Fifteen (11%) were planned admissions with the need for sequential debridement procedures, and 39 (28%) were already hospitalised at the time of referral to the vascular service. The overall technical success was 92% and not successful procedures mainly occurred in patients > 80 years. The ABPI increased at the initial follow-up to 0.84 ± 0.18. Fifty-three percent required treatment of > 1 level, 80% included recanalisations of chronic total occlusions, and average total lesion length was 133 ± 90 mm. Closure devices were employed in all cases. There were no major peri-procedural complications. A single minor access-site related bleeding episode (0.8%) occurred, requiring 24 h observation in hospital. While significantly more wounds had closed in out-patients, the mortality, major amputation and target lesion revascularization did not differ between groups. Conclusions: Safe and effective day-case-based angioplasty can be provided in a secondary care setting for patients with critical limb ischaemia needing complex multi-level procedures.