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ASHP’s Standardize 4 Safety Initiative Helps Pharmacists Reduce Medication Errors

Nathaniel Sims, M.D.

ASHP released its recommended list of concentrations and dosing units for intravenous continuous medications for pediatric patients in November 2020, representing the culmination of a multi-year, multidisciplinary effort to improve medication safety for children and adults nationwide.

The Standardize 4 Safety (S4S) initiative, funded by the U.S. Food and Drug Administration (FDA) and helmed by ASHP, is the first national, interprofessional effort to standardize medication concentrations to reduce errors resulting from confusion over non-standardized drug concentrations and errors that result from concentration differences when patients transition their care from one setting to another. Expert committees with the program previously released two lists—standardized concentrations for adult continuous infusions and compounded oral liquids.

ASHP standardization leadership

Many health care systems have developed their own local standardized concentrations, or formularies, for how drugs are mixed or compounded for administration, and have shared these widely, said Nathaniel Sims, M.D., a cardiac anesthesiologist and medical device developer at Massachusetts General Hospital (MGH) in Boston. Dr. Sims served on the expert committee to develop the MGH intravenous continuous medications for pediatric patients. However, the S4S initiative is “special in that it arose as a project of the FDA,” he said. Because the FDA does not have authority to mandate such lists, it partnered with ASHP and other entities with high credibility. “The S4S initiative is exceptionally well-positioned to influence clinical practice,” Dr. Sims said.

For over a decade ASHP has supported the creation of nationally standardized drug concentrations for adult and pediatric medications, but the work began in earnest in 2015, when the FDA awarded ASHP a three-year contract to develop and implement lists of such concentrations for intravenous and oral liquid medications. That contract, which was later renewed, was part of the FDA’s Safe Use Initiative—an effort to reduce preventable harm from medications by fostering and facilitating public and private collaborations within the healthcare community.

Through these efforts, ASHP gathered a variety of pharmacist, physician, and nurse experts from across the care continuum and partnered with national patient safety organizations such as the Pediatric Pharmacy Association, the Institute for Safe Medication Practices (ISMP), and the Association for the Advancement of Medical Instrumentation, as well as regional and local health care organizations.

Although additional lists are planned, finalization of the first three lists is timely. Concurrent with many hospitals launching ambitious initiatives to integrate drug infusion pumps with their clinical information systems for automatic programming. Dr. Sims noted that since smart IV pumps will not accept auto programming instructions unless there is a perfect match between the concentration in the pump’s drug library and the pharmacy order, hospitals including MGH are working hard to create compatible systems using the ASHP standard lists as a benchmark.

Benefits of standardization

Standardization is helpful in many ways, said Rachel Meyers, Pharm.D., B.C.P.S., B.C.P.P.S., F.P.P.A., a pediatric pharmacy specialist at Saint Barnabas Medical Center in Livingston, N.J., who served on the committee for the pediatric continuous infusion list. It can simplify medication ordering for providers; enhance efficiency for pharmacies, who can then purchase less stock; and streamline production and allow for the formulation of premixes.

Rachel Meyers, Pharm.D., B.C.P.S., B.C.P.P.S., F.P.P.A.

“It might sound meaningless, caring what concentrations other hospitals use,” said Dr. Meyers, also a clinical associate professor of pharmacy practice administration at Rutgers University’s Ernest Mario School of Pharmacy. “But it’s actually really important, because we often transfer our patients between hospitals. It helps a lot if we’re all using the same concentrations.”

Having a standardized library for syringe pumps also is beneficial, she noted. “When you think about smaller hospitals who might not have a pediatric pharmacist on staff, then when they get a pediatric patient admitted to the Emergency Department, they’ll have a syringe pump ready to go already programmed with the appropriate concentrations,” Dr. Meyers said. “It just makes this whole process that much safer for the patient, so we can fully utilize tools at our disposal to their maximum effect.”

In the pediatric population, wide variations of weight range, dosing units, and fluid tolerance need special consideration, Dr. Sims cautioned. These factors may require multiple concentrations. Out of about 43 unique drugs in the ASHP pediatric concentration list, approximately 10 have three recommended standard concentrations and 30 have two recommended standard concentrations.

The key benefits of ASHP’s lists are several-fold, Dr. Sims said. The ASHP standard concentrations were created by many health care system experts using a disciplined consensus process informed by best practices for all patient groups, from “micro-preemies” in the neonatal intensive care units to adults. They also include stability data and other information essential to validate the safety of these standard concentrations. ASHP can use its broad network to publicize the lists, as well as additional educational materials, including an online course directed by Dr. Sims. Launched in November, it covers a comprehensive overview of syringe pumps and considerations for use at low flow rates. The online course offers free continuing education credits for pharmacists, nurses, and physicians, emphasizing the importance of ASHP’s standard concentrations for the safe use of infusion pumps.

Pharmacists at the helm

Pharmacists, as the “original safety champions for drug safety,” are primed to help lead efforts to adopt these lists at their home institutions, said Jared Cash, Pharm.D., M.B.A., B.C.P.S., F.P.P.A., director of pharmacy at Intermountain Primary Children’s Medical Center, in Salt Lake City. “Pharmacists are both the production crew as well as the clinical crew involved with communication of medication information and assuring the correct dose.”

Jared Cash, Pharm.D., M.B.A., B.C.P.S., F.P.P.A.

Pharmacists can employ various strategies to help push for adoption of these lists at their hospitals and health systems, Dr. Sims said. For example, they can leverage a “sentinel safety event” to convene a discussion about adoption of S4S.

A second approach is to combine a discussion about the ASHP standards with a local initiative, such as a planned revision of infusion pump drug libraries. Additionally, pharmacists can create a multidisciplinary initiative within a hospital or health system to validate and benchmark the ASHP standard concentrations against what they already are doing. They could use the ASHP lists as a prompt to “spring clean” the infusion pump drug libraries, Dr. Sims suggested, or run queries in electronic medical record systems to capture utilization of each of the medications, and learn the range of real-world dose rates clinicians program into infusion pumps to see whether resulting flow rates match patient needs.

“Be aware of the lists as you’re reviewing your formularies and EMR product selections,” Dr. Cash added. “Many places are already compounding these items and to change their compounding to the specific concentration is strongly encouraged.”

Process improvements

Some hospitals have already adopted a list of standard concentrations for neonatal drug infusions that was published several years ago by the Vermont Oxford Network, a nonprofit voluntary group of healthcare professionals, and the ISMP, Dr. Meyers said, so there is a precedent. ASHP’s working group was conscientious to include considerations of that previous list in their own work, Dr. Cash noted.

“The ASHP list is bigger, and I think it’s important for pharmacists to stress the safety of standardizing those concentrations,” Dr. Meyers said. “It not only makes transfer between hospitals easier, but if you’re part of a health system, it can help make all processes of care safer, from your EMR to your syringe pumps.”

Experts working on the S4S standards hope that the work may motivate drug manufacturers to produce some of the recommended standard concentrations, Dr. Meyers added.

“One thing we really struggle with in pediatrics is we have to compound so many of these medications,” she said. “By making this list and selecting standards, we’re hoping some drug manufacturers will pick up on this and say it may be worth it to make these items, because we know that commercially available products are safer.”

While pediatrics may have the most to gain from standardized lists, Dr. Cash said, there is still a lot of medication safety the lists can improve for adults, too. “The amount of compounding within the adult population is more significant than people recognize, and having standardized concentrations for any of that compounding reduces risk,” he said.

By Karen Blum

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