National Volume-Based Procurement (NVBP) exclusively for insulin: towards affordable access in China and beyond.

Universal access to insulin remains a global public health challenge mainly due to its high price. After unsuccessful healthcare reforms attempting to lower insulin prices over the past several decades, the novel pooled procurement-also known as the national volume-based procurement (NVBP)was initiated exclusively for insulin in China. The NVBP exclusively for insulin represents a unique approach to conquering the challenges in the pooled procurement many low-income and middle-income countries face. In this paper, we described how the pooled procurement mechanism was implemented for insulin in China. Forty-two insulin products from 11 companies were procured, with a median price reduction of 42.08%. The procurement price ranged from US$0.35 to US$1.63 (¥2.35-¥10.97) per defined daily dose (DDD). The median procurement price per DDD was US$$0.54 (¥3.63) for human insulins and US$0.92 (¥6.18) for analogue insulin (p<0.001), respectively. A total of 32 000 medical facilities participated in the procurement, and the pooled demand for insulin was 1.61 billion daily doses, with an estimated saving of US$2.85 billion (¥19 billion) for the first year of the procurement agreement. Insulin affordability and accessibility improved substantially. This study reveals that the NVBP exclusively for insulin could effectively reduce insulin prices and improve access to this essential medicine. Even though the pooled procurement option looks efficient, its long-term impacts on the healthcare system should be closely monitored.

Delivery of healthcare provider's lifestyle advice and lifestyle behavioural change in adults who were overweight or obese in pre-diabetes management in the USA: NHANES (2013-2018).

OBJECTIVE: The purpose of this study is to examine the association between delivery of healthcare provider's advice about lifestyle management and lifestyle behavioural change in pre-diabetes management in adults who were overweight or obese. DESIGN: This cross-sectional study included adults with body mass index (BMI) ≥25 kg/m2 and reporting pre-diabetes in USA. Outcomes included the prevalence of receiving provider's advice on lifestyle management and patterns of practicing lifestyle change. The association between delivery of provider's advice and lifestyle-related behavioural change in pre-diabetes management was examined. SETTING: US Continuous National Health and Nutrition Examination Survey (2013-2018). PARTICIPANTS: A total of 1039 adults with BMI ≥25 kg/m2 reported pre-diabetes. RESULTS: Of eligible adults with pre-diabetes, 76.8% received provider's advice about lifestyle change. The advice group showed higher proportions of ongoing lifestyle change than no advice group, including weight reduction/control (80.1% vs 70.9%, p=0.018), exercise (70.9% vs 60.9%, p=0.013) and diet modifications (83.8% vs 61.8%, p<0.001). After adjustment, those receiving provider's advice were more likely to increase exercise (OR 1.63, 95% CI 1.12 to 2.38) and modify diet (OR 3.0, 95% CI 1.82 to 4.96). CONCLUSION: Over 75% of US adults who were overweight or obese and reported pre-diabetes received healthcare provider's advice about reducing the risk of diabetes through lifestyle change. Provider's advice increased the likelihood of lifestyle-related behavioural change to exercise and diet.

Myocarditis and Pericarditis following COVID-19 Vaccination: Inequalities in Age and Vaccine Types.

An increasing number of myocarditis/pericarditis incidences has been reported after coronavirus disease-19 (COVID-19) vaccination in adolescents and young adults. This study was designed to investigate the incidence rate of-and risk for-myocarditis and pericarditis following COVID-19 vaccination in the United States according to age and vaccine type. This study used the Vaccine Adverse Events Reporting System (VAERS) from 11 December 2020 to 13 August 2021. A population-based data mining approach was performed based on the reporting odds ratio (ROR). Adverse events of myocarditis and pericarditis following COVID-19 vaccination were rare, with an incidence rate of 5.98 (95% CI = 5.73-6.24) cases per million doses administered. The incidence rate was higher in adolescents and after the administration of the second dose of messenger RNA (mRNA) vaccines. Overall, two mRNA vaccines were significantly associated with increased risks for myocarditis/pericarditis (mRNA-1273 (Moderna): ROR = 2.91, 95% CI = 2.21-3.83; BNT162b2 (Pfizer-BioNTech): ROR = 5.37, 95% CI = 4.10-7.04) compared to all other vaccines from VAERS. The viral vector vaccine of Ad26.COV2.S (Janssen) was not associated with signals of myocarditis/pericarditis (ROR = 1.39; 95% CI = 0.99-1.97). This study found increased risks for myocarditis/pericarditis following mRNA COVID-19 vaccines. For patients at high risk for myocarditis/pericarditis or with myocardial injuries, the viral vector vaccine may be an alternative for consideration.

Venue of receiving diabetes self-management education and training and its impact on oral diabetic medication adherence.

AIMS: To determine predictors associated with the diabetes self-management education and training (DSME) venue and its impact on oral antidiabetic (OAD) medication adherence. METHODS: The Medical Expenditure Panel Survey household component (MEPS-HC) data (2010-2012) identified adults with diabetes prescribed OAD medication(s) who completed a supplemental Diabetes Care Survey (DCS). Based on the DCS responses to questions about the number and type of DSME venue(s), two groups were created: (1) multiple venues (a physician or health professional plus internet and/or group classes) vs (2) single venue (physician or health professional only). The medication possession ratio (MPR) measured medication adherence, with 0.80 the cut-point defining adherent. Logistic regression examined factors associated with the DSME venue and its effect on OAD medication adherence. RESULTS: Of the 2119 respondents, 41.6% received DSME from multiple venues. Age (<65years), education-level (college or higher), high-income, and diet modification were significantly more likely associated with receiving DSME from multiple venues. In single vs multiple venues, medication adherence was suboptimal (mean MPR 0.66 vs 0.64, p=0.245), and venue showed no influence on adherence (OR: 0.92, 95% CI, 0.73-1.16). CONCLUSION: Sociodemographic characteristics influence where adults with diabetes receive DSME. Adding different DSME venues may not address suboptimal OAD medication adherence.

Clinical outcomes of levalbuterol versus racemic albuterol in pediatric patients with asthma: Propensity score matching approach in a medicaid population.

OBJECTIVE: Racemic albuterol and levalbuterol are used to treat acute episodes of asthma. The main objective of this study was to compare levalbuterol therapy to albuterol therapy on incidence rates of subsequent emergency department (ED) visits and hospitalizations. METHOD: We conducted a retrospective cohort study of asthmatic children who had pharmacy refills for levalbuterol/albuterol in the South Carolina Medicaid database in 2002-2011. Children receiving levalbuterol were matched to those receiving albuterol using propensity score matching technique. For ED visits and separately for hospitalizations, multivariable negative binomial regression was used to estimate the two group-specific incidence rates and the incidence rate ratio (IRR). RESULTS: A total of 8,172 asthmatic patients aged 2-18 years were identified in the South Carolina Medicaid database. During the 12-month follow-up period, the levalbuterol group had fewer asthma-related ED visits and hospitalizations: 939 (11.49%) children had asthma-related ED visits (levalbuterol: 8.76%; albuterol: 14.21%), and 89 (1.09%) children had asthma-related hospitalizations (levalbuterol: 1.07%; albuterol: 1.12%). Comparing the levalbuterol group to the albuterol group, the adjusted IRR estimate was 0.57 (95% confidence interval [CI], 0.49-0.65) for of asthma-related ED visits, and 0.93 (95%CI, 0.99-1.63) for hospitalizations. Children filling levalbuterol also had a lower IRR of all-cause ED visit (0.88; 95%CI, 0.82-0.95), but similar IRR of all-cause hospitalizations (1.08; 95%CI, 0.82-1.42). CONCLUSION: This observational study of children aged 2-18 demonstrated levalbuterol prescription fills were associated with reduced ED visits, but not hospitalizations. Additional research may be necessary to assess this association. Pediatr Pulmonol. 2017;52:516-523. © 2016 Wiley Periodicals, Inc.

Safety and Tolerability of Stribild in the Southeast United States.

PURPOSE: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]). METHODS: A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United States was conducted among adults receiving EVG/COBI/TDF/FTC. We evaluated incidence and treatment-related adverse events, including change in serum creatinine (SCr). RESULTS: Patients were primarily treatment experienced (n = 173, 60%), African American (n = 210, 73%), and males (n = 187, 65%). One hundred ninety-five (68%) patients had any increase in SCr, and 65 (23%) had an increase of ≥0.3 mg/dL. Mean SCr change from baseline to peak was 0.2 mg/dL. Being treatment experienced (odds ratio [OR] = 2.21, 95% confidence interval [CI]: 1.12-4.38) was associated with SCr ≥0.3 mg/dL, while body mass index ≥30 kg/m(2) (OR = 0.41, 95% CI: 0.18-0.93) was protective. Twenty (7%) patients discontinued therapy, 3 due to acute kidney injury. CONCLUSION: Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC.

Cardiac risks associated with antibiotics: azithromycin and levofloxacin.

INTRODUCTION: Azithromycin and levofloxacin have been shown to be efficacious in treating infections. The adverse drug events associated with azithromycin and levofloxacin were considered rare. However, the US FDA released warnings regarding the possible risk of QT prolongation with azithromycin and levofloxacin. AREAS COVERED: Case reports/case series, observational studies and clinical trials assessing cardiovascular risks associated with azithromycin and levofloxacin were critically reviewed, including 15 case reports/series, 5 observational studies and 5 clinical trials that investigated the cardiac risks associated azithromycin and levofloxacin. EXPERT OPINION: Results are discordant. Two retrospective studies utilizing large databases demonstrated an increased risk of cardiovascular death with azithromycin, when azithromycin was compared with amoxicillin. Two other retrospective studies found no difference in cardiovascular death associated with azithromycin and other antibiotics. For levofloxacin, the increased risk of cardiovascular death was only found in one retrospective study. Therefore, the risks and benefits of antibacterial therapies should be considered when making prescription decisions. This study should not preclude clinicians from avoiding azithromycin and levofloxacin. If a patient has an indication to receive an antibiotic and if azithromycin or levofloxacin is needed, it may be used, but the potential risks must be understood.