Fluid Shortages: Current Challenges in Accessing a Staple Supply

Key takeaways:

• Shortages of saline, other fluids as well as emergency syringes are extremely challenging and affecting large numbers of patients.
• Fluids in short supply are also shifting to the pharmaceutical space given their role in reconstitution, infusions and dilutions of drugs.
• Premier is committed to providing members with vital updates on product availability and sourcing options ─ and driving proven solutions to help alleviate shortages.

For more on this topic:

• Read Premier’s document outlining the flush shortage.
• Download your copy of the INSCRIPT thesis on drug shortages today.
• The National Home Infusion Association offered guidance for addressing shortages of sterile water for injection and sodium chloride 0.9% for injection for compounding sterile preparations.
• The Infusion Nurses Society outlined best practices and mitigation strategies during shortages of normal saline (0.9% sodium chloride) prefilled syringes and vials.
• Register for our upcoming HFMA webinar to learn about how one healthcare organization is leveraging technology and data to help stay ahead of disruptions.

While progress has been made in improving access to a number of at-risk products, shortages for low-cost injectable generic drugs and essential fluids vital to patient care remain a vulnerability.

A staple of medical care, U.S. providers are reporting significant disruptions in the supply of fluids ─ various presentations of pre-filled saline flush syringes, normal saline injection and sterile water injection vials. Fluids in short supply are also shifting to the pharmaceutical space given their role in reconstitution, infusions and dilutions of drugs.

Premier continuously analyzes our portfolio for necessary supply chain risk and resiliency measures – sharing education, data and taking proactive action to support our members in garnering vital products.

The FDA has posted the below product shortages as current, and Premier’s tracking of fill rates from manufacturers and distributors since December 2021 demonstrates that all are well below usual market performance.

Premier leverages fill rate trends as one mechanism to help determine the health of the supply chain. For drugs, Premier considers a healthy fill rate to be above 90%, and anything that falls below 80% is an early indication that demand is outpacing supply and that shortages may be imminent.

Monitoring fill rate and other data has allowed Premier to provide both early communication and recommendations to the FDA and other government stakeholders to mitigate potential or impending shortages. For instance, and related to the fluids issue, Premier is advocating for:

• 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.

Background: A Market Disrupted

Today’s core group of shortages are either utilized for COVID-19 treatment or affected by the global reprioritization of capacity utilization, labor challenges, logistics interruptions and rising prices. This fragile environment is exacerbated by ongoing natural disasters, raw materials shortages and demand spikes.

In early December 2020, the Infusion Nurses Society published notice regarding the shortage of normal saline (0.9% sodium chloride) prefilled syringes and vials.

Issues with sodium chloride access have been exacerbated by one supplier’s market recall for flush syringes in August 2021 as well as a focus on COVID-19 vaccine manufacturing. This sudden market disruption caused a cascade of additional shortages of 0.9% sodium chloride 10-mL, 20- mL, and 50-mL preservative-free vials. Major fluid manufacturers have also placed their small and large volume parenteral bags on allocation.

Adding to fluid supply issues, manufacturers saw significant COVID-related absenteeism and transportation challenges ─ causing a dip in production from 120% to as low as 80% for a period of 4-6 weeks from December to February 2022, according to supplier data. These production declines plus increased hospitalizations during the Omicron surge also impacted solutions safety stock, which manufacturers previously had on hand to make up for the shortages in flush needs as well as demand spikes.

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 ─ necessary materials needed to produce saline bags and syringes to administer fluids.

Front-line Impacts

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. Staff have needed to turn to saline vials, which have subsequently been impacted due to the added demand for saline as a dilutant for the COVID-19 vaccine. Given these constraints, institutions may have had to turn to repackaging vials from saline solutions available as small-and-large volume fluids in pharmacy clean rooms.

While this might sound like a small issue, the added time and resources it adds to already-strained staff can be significant ─ all while grappling with workforce challenges as well as other resource constraints and shortages. The reality of managing and chasing any shortages creates considerable burden on healthcare providers struggling to maintain adequate staffing levels and product availability to manage vital patient care.

Premier remains committed to providing members with vital updates on product availability and sourcing options ─ and driving proven solutions to help alleviate shortages.

• Premier Nursing and Pharmacy experts continuously collaborate to share intelligence, mitigation efforts and conservation strategies, and best practices with our members. We’re providing ongoing guidance for providers to reduce fluid shortage workarounds and support greater efficiency.
• Monitoring fill rate and other data has allowed Premier to provide early communication to our members and the FDA on potential or impending shortages. Experts from Premier’s Pharmacy, Nursing, Lab and Advocacy teams meet bi-weekly with the FDA ─ and following recent conversations, the FDA released Prefilled Saline Flush Syringe Conservation Strategies on March 21.
• With a comprehensive pharmacy portfolio of more than 18,000+ products, Premier remains committed to having every product possible on contract and available at competitive prices. The ProvideGx program offers sterile water for injection and emergency syringes to members. Leveraging our own distribution partner helps enable timely access to products and support dynamic allocation based on clinical need in addition to purchase history, which facilitates a nimble response during tight constraints.
• Recently, Premier offered a program for allocation for sterile water for injection (“Rapid Commit”). Rapid Commit assists Premier members with short-term drug market supply disruptions and features specific limited-time offers, enabling secured product availability while also driving cost savings.
• Premier is continuing conversations with outsourced 503B compounders for sterile water for injection, saline and other products. With a multifactorial approach critical to combating drug shortages, outsourced 503B compounding facilities can help to bridge gaps and mitigate the impact of continuing drug supply disruptions.
• Premier promotes contracting with suppliers who provide transparency on product and raw materials sourcing locations, safety stock, safety records and rapid replenishment capabilities. Together, we’re engaging supplier partners to enable open communication and sourcing avenues.
• Overall, Premier is driving greater transparency and risk mitigation through supply chain mapping and supplier risk assessments based on geographic diversity, recovery time, quality, Environmental, Social and Governance (ESG) and sustainability practices, and other key criteria. Premier continues to increase preparedness through investments in technology and manufacturing capacity and redundancy.

While disruptions are prevalent, Premier continues to share vital information and best practices – and pursue crucial strategies to help our members, and our nation, get the vital supplies needed to care for patients.

About Premier’s Data

Premier tracks hospitals’ purchasing data for pharmaceuticals and supplies through its group purchasing organization, which serves 4,400 U.S. hospitals and health systems and more than 225,000 non-acute providers. Our data provides a strong early indicator of how hospitals are prioritizing drugs, devices and supplies in their efforts to treat and mitigate COVID-19 and deliver patient care overall.