To the Editor: We wish to update the pediatric gastroenterology community on a critical issue for children with intestinal failure (IF) that threatens to increase emergency department visits and hospitalizations during the pandemic related to SARS-CoV-2. Intestinal rehabilitation (IR) programs seeking to protect their vulnerable patients from COVID-19 are taking unprecedented steps to minimize healthcare exposure, efforts undermined by the recent price increase, and shortage of sterile ethanol.
Children with IF are dependent on central venous catheters for parenteral fluids and nutrition (PN), risking central line-associated blood stream infection (CLABSI), sepsis, liver injury, and death. Locking the central venous catheter with ethanol, a frequently studied and beneficial intervention in IR, reduces the CLABSI rate by 63% (6 infections per 1000 catheter days) (1).
Belcher Pharmaceuticals received FDA approval with orphan drug designation for Ablysinol (dehydrated alcohol) for adult heart disease (2). Such designation precludes medical marketing by others until 2025 and recently resulted in shortage and almost 8-fold price increase (3).
On March 29, 2020, we notified the FDA of a national survey of IR programs on the impact of this decision to IF patients in North American. Twenty centers from 14 US states caring for approximately 950 patients receiving home PN responded. All programs prescribed ethanol with the majority (18, 90%) prescribing 70% concentration. Frequency of use was evenly split between daily (10, 50%) and thrice weekly (10, 50%). Recent shortage was experienced by 17 (85%) centers and 15 (75%) had been requested or mandated to change prescribing practices by homecare agencies due to cost or shortage. This is particularly concerning as a reduction in ethanol lock frequency during a previous shortage resulted in “complete failure” in prophylaxis (4).
There is a need to rapidly regain access to ethanol or other agents used internationally, such as 4% tetrasodium ethylenediaminetetraacetic acid or taurolidine citrate. Both are efficacious antimicrobials and may offer other desirable benefits such as anticoagulation (5,6). Always important, the prevention of CLABSI and ensuing hospitalization and resource utilization is ever more relevant while a highly transmissible infectious disease ravages our health care system.
On behalf of the NASPGHAN Intestinal Rehabilitation Special Interest Group.
1. Rahhal R, Abu-El-Haija MA, Fei L, et al. Systematic review and meta-analysis of the utilization of ethanol locks in pediatric patients with intestinal failure. JPEN J Parenter Enteral Nutr
3. Williams D. 2020. Douglas Williams On Linkedin: Statement On Belcher Pharmaceuticals | 10 Comments
. Linkedin.com. https://www.linkedin.com/feed/update/urn:li:activity:6635900853532311553/
. Accessed April 6, 2020.
4. Ralls MW, Blackwood RA, Arnold MA, et al. Drug shortage-associated increase in catheter-related blood stream infection in children. Pediatrics
5. Lambe C, Poisson C, Talbotec C, et al. Strategies to reduce catheter-related bloodstream infections in pediatric patients receiving home parenteral nutrition: the efficacy of taurolidine-citrate prophylactic-locking. JPEN J Parenter Enteral Nutr
6. Liu F, Hansra S, Crockford G, et al. Tetrasodium EDTA is effective at eradicating biofilms formed by clinically relevant microorganisms from patients’ central venous catheters. mSphere