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Ethanol locks are now going to be ridiculously expensive (possibly $30,000 per month -for 1 oz) due to an FDA initiative which aims to improve drug safety. Paradoxically, this could endanger the health of many vulnerable children.
Modern Healthcare: Unapproved Drug Initiative adds up to $30 billion in healthcare costs Thanks to Jennifer Sterner-Allison for this reference.
An excerpt:
A regulatory pathway that aims to ensure drug safety is inflating healthcare spending by billions of dollars, according to a new report.
Four widely used drugs funneled through the Unapproved Drug Initiative will increase spending by more than $20.25 billion over a five-year span as manufacturers hiked prices between 525% to 1,644%…
“Hospitals are absorbing additional cost for drugs that are not innovative, not curing new diseases, do not have overwhelming R&D investment, and are often the preferred drug of choice.”…
The 2006 Unapproved Drug Initiative requires manufacturers to pull these drugs and prove to the FDA that they are safe. Typically, fewer manufacturers remain in the market after the FDA intervenes, which allows price manipulation.
Drugs that go through the UDI pathway can earn the manufacturer up to seven years of patent protection, which can prevent competition. At minimum, other suppliers of the drug targeted by the UDI also have to leave the market and receive approval, which can reduce competition.
The situation with ethanol is particularly egregious, said Erin Fox, a drug shortage expert and senior director of drug information and support services at University of Utah Health.
Belcher Pharmaceuticals is charging $1,000 per milliliter, which equates to $30,000 for one shot of ethanol, since it received an orphan drug designation through the UDI, granting Belcher’s drug exclusivity through 2025, she said. Belcher won the orphan drug classification, a status for drugs that treat rare diseases, for its treatment of hypertrophic obstructive cardiomyopathy.
“It is the perfect example of how this FDA approval process is broken,” Fox said. “Pediatric hospitals are going to be particularly impacted because ethanol is sometimes used to ‘lock’ IV ports to prevent infections in high-risk patients.”..
“FDA’s Unapproved Drug Initiative continues to have serious unintended consequences and in my opinion should be halted,” she said
My take: I have contacted the American Academy of Pediatrics and asked them to try to work on this problem. The high cost of ethanol may prevent its routine use and result in central line infections, hospitalizations and even death in vulnerable children.
Related blog posts (on utility of Ethanol Locks):
Blogs related to Pharmaceutical Practices:
Ethanol locks can minimize infections among patients who receive intravenous nutrition (“TPN”) which was popularized by Dr. Dudrick. Due to the exorbitant costs of ethanol, this may lead to increased infections, hospitalizations and even death.
This article is from 2018 and still relevant:
Full Text Link: NEJM 2018; 379: 1193-6: How to Stop Mass Shootings
Figure shows Age-Adjusted Rates of Death (per 100,000) from Firearms in 2016 (All Intents). Data are from the Centers for Disease Control and Prevention.
A recent study (EB Tapper et al. Hepatology 2020; 71: 225-34, editorial 11-13) shows that advanced practice providers (APPs) provide care that translates into better outcomes for adults with cirrhosis. APPs include physician assistants and nurse practitioners.
In a retrospective analysis (2001-15) of the Optum Clinformatics database (private insurance) with 389,257 adult patients, the authors show that patients who had an APP involved in their care had better outcomes.
Key findings among patients with APP care (with and without specialist involvement):
My take: Based on my experience, this study likely could be replicated in most medical fields. APPS improve patient outcomes.
Island Ford National Recreational Area, Sandy Springs
A recent study (D Ohnemus et al. Liver Transplantation 2020; 26: 45-56, editorial 9-11) examined health-related quality of life (HRQOL) and cognitive functioning approximately 15 years after liver transplantation (LT).
Study details:
Median age 16 years. Original group was a SPLIT research cohort recruited from 20 centers and then tested at multiple time points; for this study, 8 sites of the original 20 were included. It is noted that patients with serious neurologic injury were excluded. Among an initial group of 108, there were 79 available for potential enrollment. In this group, 65 parent surveys were completed and 61 child surveys.
Key findings:
The editorial notes that the PedsQL Cognitive Functioning Scale scores used by the investigators were considered subjective. “The more objective PedsPCF scores fell within the normal range.”
My take: This report indicates that a majority of children are likely to have some cognitive deficits and many are likely to have reduced HRQOL following liver transplantation; in addition, if these problems are detected at a younger age, they are likely to persist.
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Mural on Atlanta’s Beltway
A recent retrospective study (SH Baek et al. JPGN 2020; 70: 171-77) provide useful information on cholangitis following a Kasai portoenterostomy in patients (n=160) with biliary atresia (BA).
Key points:
It is worth noting that Up-to-Date has several recommended regimens for acute cholangitis (in adults). For lower-risk infections, the authors recommend either a single agent like piperacillin-tazobactam or dual therapy with specific cephalosporins (eg. cefotaxime, ceftriaxone) and metronidazole. For higher-risk infections, the Up-to-Date recommendations include meropenem or piperacillin-tazobactam as single agents or one of two cephalosporins (cefepime or ceftazidime) along with metronidazole.
My take: Cholangitis is common after biliary atresia. Familiarity with changing susceptibility, particularly local patterns, will help optimize outcomes.
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Piedmont Park
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A recent study has shown how pervasive surprise billing has become. This is another area in medicine in which deceptive billing practices undermine the relationship between families and health care providers.
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The “weekend effect” is a term used to indicate that outcomes for many medical conditions are worse when patients are admitted to the hospital on the weekend.
A recent study (MD Egberg et al. Inflamm Bowel Dis 2020; 26: 254-60; editorial by C Ballengee Menchini 261-2) documents the degree of this effect on the risk of complications for pediatric patients with inflammatory bowel disease (IBD).
This study used a cross-sectional analysis with the Kids’ Inpatient Database (KID), a nationally representative database. The study included 3255 urgent surgical hospitalizations and included patients 18 years old and younger.
Key findings:
Possible Reasons for Weekend Effect:
Limitations include reliance on administrative data and potential for misclassification and unidentified confounding variables.
Related blog post:
From Weekend Hike on Mount Yonah:
Climate change:
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Sugary beverage Law:
Related blog posts –Sugary Beverages/Diet:
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Cost of IBD Care is Increasing. From Healio Gastro: Chronic inflammatory disease expenditures nearly double over last 2 decades Reference: Click B, et al. Poster 22. Presented at: Crohn’s and Colitis Congress; Jan. 23-25, 2020; Austin, Texas
An excerpt from Healio Gastro summary: [Using] the Medical Expenditure Panel Survey (MEPS), a nationally representative database of health care use and expenditure data collected since 1998…The researchers assessed total annual, outpatient, inpatient, emergency and pharmacy expenditures in both patients with IBD (n = 641) and RA (n = 641). They used three separate time periods – 1998-2001, 2006-2009 and 2012-2015 –to compare expenditures over time…
Median per-patient annual health care expenditure in patients with IBD was $6,570 compared with $4,010 in patients with RA across all years of the study. Total annual spending increased approximately 2.2 times (95% CI, 1.6-3; P < .01) over the study period and was 36% higher in IBD than RA (P = 0.01).
Pharmaceutical spending increased more than fourfold (95% CI, 3.2-6.1; P < .01) and became the largest cost category (44% total). However, inpatient expenses in IBD decreased 40% over the study period.
My take: While the cost has increased, these new treatments are improving outcomes. With the emergence of biosimilars, there may be improvement in pharmaceutical spending.
More on Proactive Therapeutic Drug Monitoring (pTDM) Being Helpful: SR Fernandes et al. Inflamm Bowel Dis 2020; 26: 263-70, editorial 271-2. In this study, a prospective group of patients (n=56) undergoing pTDM were compared with a historical control group (n=149). pTDM had less frequent surgery (9% vs. 21%) and higher rates of mucosal healing (73% vs. 39%). Treatment escalation was 3 times more common with pTDM than in the control group.
Increased risk of VTE in IBD patients: JD McCurdy et al. Inflamm Bowel Dis 2020; https://doi.org/10.1093/ibd/izaa002
Abstract Link: Risk of Venous Thromboembolism After Hospital Discharge in Patients With Inflammatory Bowel Disease: A Population-based Study
In a population-based study from Ontario, the authors analyzed a total of 81,900 IBD discharges (62,848 nonsurgical and 19,052 surgical) which were matched to non-IBD controls… The cumulative incidence of VTE at 12 months after discharge was 2.3% for nonsurgical IBD patients and 1.6% for surgical IBD patients…Nonsurgical IBD patients and surgical patients with ulcerative colitis are 1.7-fold more likely to develop postdischarge VTE than non-IBD patients.
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