Section 1 presents detail on the data used for the parameter values, and Section 2 presents the sensitivity and scenario analysis results. Section 3 includes proofs of the lemmas and theorem presented in the text. Parameters Distribution of time to recoverWe have three recovery time distributions: time to supplier recovery, time to plant recovery, time to line recovery. The specific data on recovery times were unavailable. As a proxy, we used the distributions of shortage durations and adjusted them to account for reporting delays (UUDIS, 2016).For the supplier recovery distribution, we fit the distribution of shortage durations for all resolved shortages 2001-2016 in which the reported cause was due to raw material issues. For the plant recovery distribution, we fit the distribution of sole-source injectable shortage durations for which the cause was a manufacturing-related issue. We did not have data for the time to line recovery and assumed it was equal to 0.1 of the time to plant recovery. We evaluated this in sensitivity analysis. For each of these distributions, we also factored in the time the product is partially available (ASHP, 2018) and evaluated several types of distributions and determined that an exponential distribution fit best (Delignette-Muller and Dutang, 2015; R Core Team, 2018). Because we consider discrete time periods, we discretized the distributions to apply a geometric distribution. Disruption of time to disruptionTo estimate the distribution of the time to disruption for suppliers, plants, and lines, we fit distributions for the time of FDA approval for the generic drug application to the date the shortage began (FDA, 2018a; UUDIS, 2016).For suppliers, we considered drugs that were short due to raw material issues, and for plants, we considered shortages where the direct cause was a manufacturing issue. We assumed the time to line disruption was 0.3 times the time to a disruption of a plant. Similarly to the time to recover, we evaluated different types of distributions and fit geometric distributions for each. DemandWe estimated the annual demand in the United States for vinblastine and vincristine based on Medicare Part B data for individuals at least 65 years old and the demographic information of the population that the drugs are used to treat.The amounts of vinblastine and vincristine charged to Medicare Part B were approximately 45,000 mg in 2015and 2016 (CMS, 2018. These drugs are commonly used to treat certain cancers (vinblastine -Hodgkin's disease, testicular cancer, and AIDS-related Kaposi's sarcoma; vincristine -Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Hodgkin's Disease, and Non-Hodgkin lymphoma; ("Drugs.com," 2018). The average proportion of new cases that are in individuals at least 65 years old are 13% for vinblastine-treated cancers and 51% for vincristine-treated cancers (National Cancer Institute, 2018). Then we produced a rough estimate of the total national demand and converted to liquid volume (ml) based on the strengths provided in the Red Book (IBM M...
Background The effect of a kidney transplant on a recipient extends beyond the restoration of kidney function. However, there is limited qualitative analysis of recipient perspectives on life following transplantation, particularly in the United States. To understand the full patient experience, it is necessary to understand recipient views on life adjustments after kidney transplantation, medical management, and quality of life. This could lead to improvements in recipient care and sense of well-being. Methods We conducted a paper-based survey from March 23 to October 1, 2015 of 476 kidney transplant recipients at the University of Michigan Health System in Ann Arbor, Michigan. We analyzed their open-ended responses using qualitative research methods. This is a companion analysis to a previous quantitative report on the closed-ended responses to that survey. Results Common themes relating to changes following transplantation included: improvements in quality of life, a return to normalcy, better health and more energy. Concerns included: duration of graft survival, fears about one day returning to dialysis or needing to undergo another kidney transplant, comorbidities, future quality of life, and the cost and quality of their healthcare. Many recipients were grateful for their transplant, but some were anxious about the burdens transplantation placed on their loved ones. Conclusions While most recipients reported meaningful improvements in health and lifestyle after kidney transplantation, a minority of participants experienced declines in energy or health status. Worries about how long the transplant will function, future health, and cost and quality of healthcare are prevalent. Future research could study the effects of providing additional information, programs, and interventions following transplantation that target these concerns. This may better prepare and support kidney recipients and lead to improvements in the patient experience. Electronic supplementary material The online version of this article (10.1186/s12882-019-1368-0) contains supplementary material, which is available to authorized users.
Drug shortages continue at crisis levels in the United States, with no end in sight. Extensive research in disparate areas has been conducted to explore the impact that shortages have on patients and the healthcare system. We conducted a scoping review to categorize existing work in order to identify opportunities for further research. We considered peer‐reviewed and non‐peer‐reviewed articles involving non‐vaccine, human drug shortages in the United States published in English between January 2001 and May 2019. In total, 430 papers were charted according to the following categories: causes, impacts on care, health outcomes, costs, management, prevention, and federal government response. Of these, 112 papers considered causes; 199 discussed effects, 158 considered management strategies, and 140 discussed prevention. We provide a resource to navigate the vast literature on drug shortages in the United States, identifying areas in need of further research. This review highlights the widespread negative effects that drug shortages have on patients, providers, and health system costs in the United States. Evidence of their ramifications should be sufficient to justify policy change. Future work should move from characterizing the problem to working toward solutions to reduce the impact, occurrence, and effects of shortages.
Achieving national HIV care goals will require different levels of effort by race/ethnicity but likely will result in substantial declines in cumulative HIV incidence. HIV-related disparities in incidence and prevalence may be difficult to resolve.
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