US providers report substantial disruptions in vital supplies of saline injections, prefilled syringes.
Although access to several at-risk products has improved, supplies
of essential fluids and low-cost injectable generic drugs remain vulnerable. US providers are reporting significant disruptions in the supply of fluids, which are staples of medical care. These include various presentations of normal saline injections, prefilled saline flush syringes, and sterile water injection vials. The short supply is also shifting to the pharmaceutical space, given the fluids’ role in the dilution, infusion, and reconstitution of drugs.
The tracking of fill rates from manufacturers and distributors shows that various products are well below usual market performance. As of March 2022, Premier data showed that fill rates of injectable vial presentations for sterile water were at 31.3% and normal saline at 43.9%, whereas those for drugs, including dextrose 50% in water and potassium chloride, sit at 15.7% and 37.3%, respectively.1 Fill rates are one mechanism to help determine the health of the supply chain, and rates that fall below 80% provide an early indication that demand is outpacing supply and that shortages may be imminent.
These core groups are either being used for COVID-19 treatment or being affected by the global reprioritization of capacity utilization, labor challenges, logistical interruptions, and rising prices. This fragile situation is exacerbated by spikes in demand, natural disasters, and raw materials shortages. Looking ahead, sanctions on Russia and disruptions to oil and natural gas output in Eastern Europe or Russia could affect the global supply and pricing of plastics,2 necessary materials to produce syringes, and saline bags to administer fluids.
The standard of care is to flush intravenous lines using a prefilled syringe of saline. However, when syringes run out, a safe alternative solution must be implemented. Staff members have had
to turn to saline vials, which have subsequently been affected, because of the added demand for saline as a dilutant for the COVID-19 vaccines.3 Given these constraints, institutions may have had to repackage vials from saline solutions available as small and large volume fluids in pharmacy clean rooms.
The added resources and time that these workarounds add to already strained nursing and pharmacy departments can be significant, and staff are already grappling with workforce challenges and other resource constraints. Managing any shortages creates a considerable burden on providers struggling to maintain adequate staffing levels and product availability to manage vital patient care.
Alongside ongoing fluid and pharmaceutical disruptions, clinical staff members are considering changes in workflow, including centralizing inventory, adjusting electronic order entries, and implementing clinical alternatives. It is vital for nursing and pharmacy staff members to continuously share intelligence and collaborate to reduce shortage workarounds and for clinical staff members to work together with supply chain colleagues to pinpoint product use by fill or type. Amid this environment, conservation is another key priority, and best practices and mitigation strategies are available from the FDA,4 the Infusion Nurses Society, and the National Home Infusion Association, among others.
To smooth out demand volatility, providers are increasingly turning to commitment-driven sourcing programs. With committed purchasing volume and distribution, manufacturers gain the operating capital, predictable revenue, and stable ordering necessary to increase production and/or contingency supply. At the same time, providers gain reliable access to needed products at a fair price.
Legislative and regulatory activity is also required to address the challenges faced by suppliers, distributors, and providers due to drug and product shortages. Specifically, the FDA should:
• Allow the outsourcing of 503B compounders to continue producing drugs based on specific criteria, such as demand surges of certain dosage strengths and/or packaging sizes, as well as regional or short-term shortages. 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.
• Fully implement its new authority granted under the Coronavirus Aid, Relief, and Economic Security Act,5 soliciting a deeper level of reporting on manufacturer contingency, quality, redundancy, and risk management plans to mitigate supply disruptions.
• Make capacity, quality, sourcing, and volume information publicly available for all medical products sold in the United States. Different regulations for medical devices and pharmaceuticals are complicating fluid shortages, with syringes and vials to administer saline classified as medical devices, and bags and solution regulated as drugs. Although hospitals, manufacturers, and other stakeholders work to increase production capacity, a streamlined US regulatory framework is needed that makes it easier to collect data, guide conservation strategies, and implement workarounds for all products.
Disruptions remain prevalent, but meaningful policy solutions alongside essential strategies and tools can help mitigate impending or potential shortages, building resiliency now and for the future.
About The Author
Mike Wascovich, PharmD, MBA, RPh, is vice president for pharmacy field services at Premier Inc, in Charlotte, North Carolina.
1. Want different results? Take action on drug shortages. Premier.
April 1, 2022. Accessed April 19, 2022. https://premierinc.com/newsroom/ premier-in-the-news/want-different-results-take-action-on-drug-shortages
2. Report: supply chain impacts of Russia/Ukraine conflict. Premier.
March 1, 2022. Accessed April 11, 2022. https://premierinc.com/newsroom/ education/report-supply-chain-impacts-of-russia-ukraine-conflict
3. The unintended consequences of COVID-19 vaccine manufacturing: drug shortages. Premier. December 21, 2021. Accessed April 11, 2022. https://premierinc.com/newsroom/blog/the-unintended- consequences-of-covid-19-vaccine-manufacturing-drug-shortages
4. Prefilled saline flush syringe conservation strategies – letter to health care personnel. FDA. March 21, 2022. Accessed April 11, 2022. https://www.fda. gov/medical-devices/letters-health-care-providers/prefilled-saline-flush-syringe-conservation-strategies-letter-health-care-personnel
5. Coronavirus Aid, Relief, and Economic Security Act, HR 748,
116th Cong (2020). Accessed February 22, 2022. https://www.congress. gov/116/plaws/publ136/PLAW-116publ136.pdf