April 18, 2022 – Providers in the U.S. are reporting significant disruptions in the supply of pre-filled saline flush syringes, normal saline injection, and sterile water injection vials. The pharmaceutical space is also experiencing a fluid shortage in reconstitution, infusions, and dilutions of drugs.
In early December 2020, a notice regarding the shortage of normal saline prefilled syringes and vials was published by the Infusion Nurses Society.
Fluids are a fundamental aspect of patient care. A report by Premier says that “nursing standard of care is to flush IV lines using a prefilled syringe of saline, but when those run out, a safe alternative solution must be implemented.” One such alternative involves repackaging vials from saline solutions available as small-and-large volume fluids in pharmacy clean rooms.
This is not a viable long-term solution because of the amount of time and resources this would take. Healthcare workers are already experiencing strain in these areas, so this would only further burden a workforce that is stretched beyond capacity.
Premier is advocating for three things to mitigate potential or impending shortages:
- The FDA to make sourcing, quality, volume and capacity information publicly available for all medical products sold in the U.S. Different regulations for pharmaceuticals and medical devices are complicating fluid shortages, with the vials and syringes to administer saline classified as medical devices while the bags and solution are regulated as drugs. While manufacturers, hospitals and other stakeholders work to increase production capacity, a streamlined U.S. regulatory framework is needed that makes it easier to collect data, implement workarounds and guide conservation strategies for all products.
- Outsourcing compounders to continue producing drugs based on specific criteria, such as short-term or regional shortages or demand surges for certain dosage strengths and/or packaging sizes. This proved particularly helpful throughout the pandemic, as it allowed 503B facilities to address capacity gaps and alleviate spot shortages before they became severe enough to spread nationwide.
- The FDA to fully implement its new authorities granted under the Coronavirus Aid, Relief, and Economic Security (CARES) Act ─ soliciting a deeper level of reporting on manufacturer quality, contingency, redundancy and risk management plans to mitigate supply disruptions.