Nipple margin assessment at the time of nipple-sparing mastectomy.

BACKGROUND: Documenting negative margins at the nipple-areolar complex (NAC) during nipple-sparing mastectomy (NSM) remains the standard, but how to achieve this and how to manage a positive margin is debated. We sought to review nipple margin assessments at our institution and to analyze the risk factors of a positive margin and rate of local recurrence. METHODS: Patients who underwent NSM between 2012 and 2018 were reviewed and divided into 3 groups based on indication - cancer, contralateral prophylactic mastectomy (CPM) and bilateral prophylactic mastectomy (BPM). RESULTS: Nipple-sparing mastectomies were performed on 337 patients; 72% for cancer, 20% for CPMs and 8% for BPMs. Nipple margin assessments were performed in 87.8% of patients; 10 patients (3.4%) had a positive margin, 7 of whom underwent NAC excision and 3 were managed with observation. CONCLUSION: As indications for NSM increase, assessment of nipple margin provides valuable information to manage the NAC in patients with cancer. The routine use of nipple margin biopsies in patients undergoing CPM and BPM may no longer be required, as rates of occult malignant disease are low with no positive biopsies. Further studies with larger sample sizes are needed.

The availability, price and affordability of antidiabetic drugs in Hubei province, China.

Based on the high prevalence and undiagnosed rate of diabetes mellitus in China in recent years, the aim of this work was to evaluate the availability, price and affordability of pharmacotherapy for diabetes in public hospitals in Hubei province, China. In 2016, a cross-sectional survey was conducted using World Health Organization/Health Action International (WHO/HAI) methodology. Information on the availability and prices of 20 antidiabetic drugs was collected from 34 public hospitals representing three levels of care. Of the 20 antidiabetic drugs, 70.6% were below 50% availability. Total availability of the 20 drugs was higher in secondary and tertiary hospitals than in primary hospitals. All three hospital levels had higher availability of essential than non-essential antidiabetic medicines. The median markup ratios of originator brands (OBs) and lowest-price generics (LPGs) were 15.6% and 2.1%, respectively. The median potential saving ratio of using generics was 31.3%. Overall, the median affordability of 31 antidiabetic drugs ranged from 1.2 to 8.5 days of disposable income for residents with three income levels. After insurance reimbursement, the increase in the proportion of affordable drugs in urban and rural areas averaged 35.5% and 12.9%, respectively. The proportion of drugs with low availability and low affordability dropped from 54.8% to 38.7%. However, 41.7% of urban diabetic patients and 74.0% of rural diabetic patients remained unable to afford the drugs surveyed. Higher income and generic substitution are factors facilitating affordability. In Hubei province, the overall availability of 20 antidiabetic drugs was low, especially in primary hospitals. The affordability of most drugs surveyed was also low. Current health insurance can greatly improve affordability for urban residents with middle or high income. Policy changes should focus on the supply, pricing and clinical use of antidiabetic drugs and special health insurance plan for low income population with diabetes.

Impact of universal medical insurance system on the accessibility of medical service supply and affordability of patients in China.

BACKGROUND: China's universal medical insurance system (UMIS) is designed to promote social fairness through improving access to medical services and reducing out-of-pocket (OOP) costs for all Chinese. However, it is still not known whether UMIS has a significant impact on the accessibility of medical service supply and the affordability, as well as the seeking-care choice, of patients in China. METHODS: Segmented time-series regression analysis, as a powerful statistical method of interrupted time series design, was used to estimate the changes in the quantity and quality of medical service supply before and after the implementation of UMIS. The rates of catastrophic payments and seeking-care choices for UMIS beneficiaries were selected to measure the affordability and medical service flow of patients after the implementation of UMIS. RESULTS: China's UMIS was established in 2008. After that, the trending increase of the expenditure of the UMIS was higher than that of increase in revenue compared to previous years. Up to 2014, the UMIS had covered 97.5% of the entire population in China. After introduction of the UMIS, there were significant increases in licensed physicians, nurses, and hospital beds per 1000 individuals. In addition, hospital outpatient visits and inpatient visits per year increased compared to the pre-UMIS period. The average fatality rate of inpatients in the overall hospital and general hospital and the average fatality rate due to acute myocardial infarction (AMI) in general hospitals was significantly decreased. In contrast, no significant and prospective changes were observed in rural physicians per 1000 individuals, inpatient visits and inpatient fatality rate in the community centers and township hospitals compared to the pre-UMIS period. After 2008, the rates of catastrophic payments for UMIS inpatients at different income levels were declining at three levels of hospitals. Whichever income level, the rate of catastrophic payments for inpatients of Urban Employee's Basic Medical Insurance was the lowest. For the low-income patients, a single hospitalization at a tertiary hospital can lead to catastrophic payments. It is needless to say what the economic burden could be if patients required multiple hospitalizations within a year. UMIS beneficiaries showed the intention of growth to seek hospitalization services in tertiary hospitals. CONCLUSIONS: Introduction of the UMIS contributed to an increase in available medical services and the use thereof, and a decrease in fatality rate. The affordability of UMIS beneficiaries for medical expenses was successfully ameliorated. The differences in patients' affordability are mainly manifested in different medical insurance schemes and different seeking-care choices. The ability of the poor patients covered by UMIS to resist catastrophic medical payments is still relatively weak. Therefore, the current UMIS should reform the insurance payment model to promote the integration of medical services and the formation of a tiered treatment system. UMIS also should establish supplementary medical insurance packages for the poor.

Potential of mean force between oppositely charged nanoparticles: A comprehensive comparison between Poisson-Boltzmann theory and Monte Carlo simulations.

Ion-mediated interactions between like-charged polyelectrolytes have been paid much attention, and the Poisson-Boltzmann (PB) theory has been shown to fail in qualitatively predicting multivalent ion-mediated like-charge attraction. However, inadequate attention has been paid to the ion-mediated interactions between oppositely charged polyelectrolytes. In this work, the potentials of mean force (PMF) between oppositely charged nanoparticles in 1:1 and 2:2 salt solutions were investigated by Monte Carlo simulations and the PB theory. Our calculations show that the PMFs between oppositely charged nanoparticles are generally attractive in 1:1 and 2:2 salt solutions and that such attractive PMFs become weaker at higher 1:1 or 2:2 salt concentrations. The comprehensive comparisons show that the PB theory can quantitatively predict the PMFs between oppositely charged nanoparticles in 1:1 salt solutions, except for the slight deviation at very high 1:1 salt concentration. However, for 2:2 salt solutions, the PB theory generally overestimates the attractive PMF between oppositely charged nanoparticles, and this overestimation becomes more pronounced for nanoparticles with higher charge density and for higher 2:2 salt concentration. Our microscopic analyses suggest that the overestimation of the PB theory on the attractive PMFs for 2:2 salt solutions is attributed to the underestimation of divalent ions bound to nanoparticles.

The availability and affordability of orphan drugs for rare diseases in China.

BACKGROUND: Orphan drugs are intended to treat, prevent or diagnose rare diseases. In recent years, China healthcare policy makers and patients have become increasingly concerned about orphan drug issues. However, very few studies have assessed the availability and affordability of orphan drugs for rare diseases in China. The aim of this study was to provide an overview of the availability and affordability of orphan drugs in China and to make suggestions to improve patient access to orphan drugs. METHODS: Two components of the availability of orphan drugs were examined. Market availability was assessed by the extent to which orphan drugs were marketed in China with a comparison to orphan drugs in international markets, such as the U.S., EU and Japan. We conducted surveys and collected data from 24 tertiary public hospitals in China to measure hospital-level availability of orphan drugs. The affordability of orphan drugs was calculated using hospital dispensary prices and was expressed as days of average daily income required for the cost of a course of treatment. Affordability was also analyzed under the Chinese basic medical insurance system. RESULTS: Orphan drugs approved in the U.S., EU and Japan had 37.8%, 24.6% and 52.4% market availability in China, respectively. Median availability of 31 orphan drugs surveyed at the 24 tertiary public hospitals was 20.8% (very low). Within a periodic treatment course, the average treatment cost of 23 orphan drugs is approximately 4, 843. 5 USD, which equates to 505.6 days of per capita net income for an urban resident with a middle income (187.4 days for a high-income urban resident) or 1,582.8 days's income for a rural resident with a middle income (657.2 days for a high-income rural resident). Except for homoharringtonine, 22 orphan drugs for 14 rare diseases were unaffordable for the most of residents in China. With 5% out-of-pocket expenses, only three generics could be afforded by middle-income residents, whereas seven drugs for high-income urban residents. CONCLUSIONS: The Chinese government can take more responsibility for improving the availability and affordability of orphan drugs through setting up incentive policies and public platforms for sharing of orphan drug information. Control of the high price of orphan drugs, combined with a joint funding model from both government and private enterprise can efficiently reduce the economic burden of affected patients in China.