This is the third year of an unprecedented—and unplanned—shortage of emergency medications that’s resulted in a quickly expanding set of problems for hospitals and EMS systems. The cause of these shortages continues to be debated, but the root cause is due to disputes between American manufacturers of IV medications and the Food and Drug Administration (FDA) and Drug Enforcement Agency—the two federal agencies that oversee drug supply and manufacturing practices—over safe manufacturing and quality processes. These medication shortages present a risk area for emergency patients and their providers.
Over the last few months, the shortage problem has expanded to normal saline in the sizes that are most often needed by EMS services. As a result, all hospitals and agencies are now facing a critical shortage.
Brent Myers, MD, MPH, FACEP, director and medical director of Wake County (N.C.) EMS, says his agency normally uses about 1,200 bags of saline per month. His staff members were notified in April their supply chain would be severely disrupted—they now receive only about 85 bags per month. Although Wake County has an emergency reserve supply, managers have restricted use to patients in cardiac arrest, patients with blood glucose measurement above 500, and patients with symptomatic hypotension with systolic less than 90.
To address the shortage, the Department of Health and Human Services issued a memo on March 28 announcing Norwegian supplier Fresenius Kabi USA LLC would be allowed to distribute normal saline products in the U.S. The use of foreign sources for medications is extraordinarily rare.
In the memo, the FDA asks that “healthcare professionals contact Fresenius Kabi USA directly to obtain the product.” These initial shipments will help; however, they will not resolve the shortage. The FDA is working closely with manufacturers to meet the needs for normal saline across the U.S. in the coming weeks.
Beyond this expansion of supply, EMS leaders need to develop strategies to address the shortage of IV fluids, and, on an ongoing basis, the shortage of drugs that are unavailable or have become prohibitively expensive.
When agencies face drug shortages, strategies must be implemented to improve logistics and ensure timely and effective safety notifications to facilitate good EMS patient care. This includes active inventory management, medical protocol flexibility, provider education and a quality improvement initiative that focuses on compliance and delivering feedback to providers.
Some EMS agencies have developed incident management teams and action plans that allow for phased activation as shortages worsen. The phased approach creates flexibility to react based on a dynamic situation and ensures that EMS agencies and hospitals act cooperatively with local, regional and state response strategies.
With the shortage of normal saline, clinical leaders must find ways to reduce usual use of the bags of fluid and substitute items like IV locks in patients who have need by medical protocol for IV access but don’t immediately need fluid.
In patient encounters where saline is used for convenience, such as wound irrigation or eye flush, the substitution of clean or sterile water is adequate. For ongoing fluid therapy needs, the agency must consider the use of alternate IV fluids, like lactated Ringer’s. Where dextrose-containing fluids are available in the supply chain, those may be substituted for patients, including children, when acceptable.
Active Inventory Management
Leaders responsible for EMS logistics must address supply, utilization, packaging, rationing and storage of medications in short supply. The physical inventory must be managed by expanding supplies through interagency exchanges, when possible; by ensuring that medicines with short expiration windows are used first; and by providing regular (e.g., weekly) reports on use, supply and strategies for stretching the stocks. Medicines may be stored centrally and deployed “just in time” and based on anticipated patient need.
Services may want to consider a logistics change to highlight medicines or fluids in short supply by putting them in colored containers or marking them with a colored sticker that lists appropriate dosage and any warnings that are particular to that drug. A typical dose for adult and pediatric patients would be printed right on the container or sticker, to provide “just in time” guidance for the paramedic who’s going to administer it.
In fluid therapy and substituting for normal saline, the sticker may state when that substitute fluid is not appropriate for a certain patient (e.g., “this bag of lactated Ringer’s will be useful for fluid resuscitation in the field, but is not able to be mixed with blood if it’s going to be administered”).
Protocol Updates & Provider Education
Medical protocols must have the flexibility to address supply and shortage of fluids and medications. System medical directors must develop a list of therapeutic substitutions, medical protocols must be modified to expand options for therapeutic interventions, and the agency’s drug license must be expanded to include any new fluids and medications, in accordance with state law and rules.
Protocol changes can’t be done without appropriate training of all providers and implementing appropriate quality assurance measures. In-service continuing education must focus on the changes in protocols, modifications in labeling and safety elements.
Related to saline and IV fluid shortages, the training materials need to update the staff on the use of available supplies, indicate what IV medicines have compatibility issues, and detail the side effects and dangers of any of the new fluid products. Some EMS systems are putting up safety cards in their drug boxes and patient compartments for an immediate visual prompt.
Medication shortages have resulted in mistakes or near-mistakes in administering fluids and drugs. A quality improvement program should be considered that allows all EMS personnel to report problems, suggestions and “near misses” in non-punitive fashion to improve the medication administration process.
As the entire healthcare industry struggles to implement effective information technology strategies at all levels, new uses of EMS technology may assist in the efficient use, storage and planning for medication use, with greater flexibility, accountability and regulatory compliance.
For more information on the shortage of saline and other medications, visit www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.