Saline Compounding a Poor Option for Hospitals
Despite a continuing shortage of saline solution among hospitals, safety concerns make it prohibitive for hospitals to compound their own solutions, says a quality executive with the American Society of Health-System Pharmacists.
Hospitals are learning how to stretch their limited supplies of IV fluids and are unlikely to resort to compounding saline for routine use, pharmacists say.
Three times in the past year, the Food and Drug Administration responded to the ongoing shortage by allowing three top US suppliers—BBraun, Fresenius Kabi USA and Baxter—to distribute supplies from European plants. While there is some hope that the shortage may clear up in 2015, the once plentiful and much-in-demand product remains in short supply.
Bona E. Benjamin, director of medication use quality improvement with the American Society of Health-System Pharmacists (ASHP), says she is unaware of any hospitals that are routinely compounding their own solutions. Logistics and safety concerns would make it prohibitive, says Benjamin, who spent roughly 30 years working in hospital compounding services.
Because hospitals use saline for both rehydration and drug delivery, any in-house compounding effort would "approach the scope of manufacturing," she says. And the volume of saline solution needed by a hospital would overwhelm a hospital- based compounding service.
"As an IV person , I would not want to be tasked with doing that," she said. "You would need a lot of space, a lot of people, and a lot of equipment, and you would have to run it 24/7"
A survey by the AHSP earlier this year found that 6% of the responding hospitals reported a shortage of IV saline. "While conservation strategies are working for 53% of respondents experiencing this shortage, 29% of respondents reporting a shortage have a supply inadequate to meet all patient needs," the group reported.
Compounding of saline would fall under the same regulatory rules as other compounding activities. While the FDA regulates commercial compounding companies, state pharmacy boards oversee hospital pharmacy operations. In-house compounding efforts must comply with the rules set by the United States Pharmacopeia (USP), a federally recognized standards-setting organization. Compliance is also reviewed as part of Joint Commission accreditation process.
David Jaspan, director of pharmacy and materials management at Union Hospital of Cecil County in Elkton, MD says he's beginning to see "some loosening up " of the supply, but noted that it's still a problem. Hospitals are getting limited allocations based on their past routine use.
"If we routinely use 100 bags a week, and I'm given 60, after a period of time it is gong to be a problem," he says.
He sees compounding as a last report that his staff members use on occasion to produce half-normal saline, which Jaspan says is also currently unavailable. Both Jaspan and Benjamin cited another downside of using concentrated sodium chloride for compounding – it too is in short supply too and there is no substitute.
Hospital Compounding Discouraged
The non-profit Association for Safe Medication Practices also defines compounding as a last resort. A January "safety alert" issued by the group's website notes that: "We can't stress enough the importance of exhausting all other alternatives before compounding IV sodium chloride solutions."
One major safety concern is labeling, Benjamin says. Bags of saline come from the manufacturers with labels. If the hospitals were to reuse bags, they would have to be re-labled, which raises the risk of medication errors.
So, hospitals are finding ways to conserve. But, the shortage can have an impact on patient services and budgets. With scarcity, comes price increases.
At Union Hospital, that means a greater awareness of a product that many once took for granted.
"For every patient who comes into the emergency department, they used to hang a liter of normal [saline] and now maybe they hang a 500cc bag because if they don't use it all, they throw it away after the patient is evaluated," Jaspan said.
Benjamin says that efforts like these have kept the shortage from having a visible impact on care. She encourages hospital administrators to be sure they are monitoring the shortages and giving staff the resources they need to cope.
"It's only by of a lot of dancing behind the scenes and just-in-time management that patients are not feeling this worse than they already are," she says.