ASHP InterSections ASHP InterSections

November 12, 2020

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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September 23, 2011

In Their Own Words… Members Speak Out About Storm Experiences

Bryan Johnston, Facility Director/Chief Pharmacist, Choctaw Nation Health Clinic, Atoka, Okla.

Bryan Johnston’s home in Atoka, Okla., was severely damaged by a tornado on April 14, 2011. He has had a lot of previous experience with large storms as an officer in the U.S. Public Health Service. In September 2004, Johnston was deployed to Florida after hurricanes Frances and Ivan hit, and as Jeanne was on its way.

April 14 Tornado

As I watched the storm approach my house, I was in denial telling myself it was a normal wall cloud and we would just get some hail and rain. Then the wind started coming extremely strong from the east even though the storm was coming from the southwest. Tennis ball-sized hail started raining down. I ran into my daughter’s room, grabbed her mattress, pulled it over the heads of my wife, my daughter, myself and our puppy after we hunkered down in the laundry room and shut the door. We didn’t have a cellar or a safe room.

People asked me if the tornado sounded like a freight train, but to me it sounded like a jet engine. It seemed like five minutes, but truthfully it was probably two to three minutes at most. Afterward, there was glass and water everywhere. My workshop, a 45’x50’ insulated building out back, had bounced off the house and was thrown into the country road. It was just twisted metal and insulation.

The roof of the house had been torn bare on one side, and you could see where it had tried to pull the whole roof off by ripping the sheetrock along all of the seams. Rain had come into the house from the storm front right behind the tornado, and the ceilings started falling in. We lost all but a few pine trees on our property, which is 60 acres. My pick-up truck was thrown toward the house. It would have slammed into the house, but it hit one of the remaining pine trees. We came out unscathed.

My friend said that we were so lucky. I didn’t feel lucky, but that was before I’d left my place and driven through the places he saw. Once I saw them, I knew that we had been very fortunate.

September 2004 Hurricane Relief

When we first got to the shelter set up in an elementary school cafeteria, it was full of bedridden patients, most of whom had been transferred from long-term care facilities. There were close to 100 people who had been there for several days with one person babysitting them who had no health care experience. They didn’t have showers, so we converted a laundry room with a floor drain into a shower room. Many couldn’t stand on their own or were on oxygen or needed to be turned every few hours.

Within the first 24 hours, we got everyone clean clothes, clean bedding, and met their immediate medical needs. So, right off the bat, I turned from being a pharmacist to being a nurse’s aide. My wife finds it comical because she had been a nurse’s aide before she became a nurse.

After we got the patients clean, I went to work trying to get them their medications. The facilities had bagged up what they could. We just started doing reviews and setting up schedules and trying to acquire drugs. We were able to empty out the shelter and get everyone situated within one week.

Tim Holding, Pharm.D., Staff Pharmacist, St. John’s Mercy Hospital, Joplin, Mo.

Tim Holding was on duty when an EF5 tornado leveled a third of Joplin on May 22, 2011, killing more than 150 people and injuring thousands. The nine-story hospital will be demolished and rebuilt.

One of my technicians, Mica, and I were trying to find flashlights. In the wake of this event, I am now recommending that every staffer in a hospital know where they are and that they have batteries that work. There were so many wires hanging in hallways and water dripping all over that there was no way to safely walk out there without light. We smelled gas throughout the whole hospital.

I heard there were patients trapped on Six West. We went up there to pull them out. How we ended up getting patients down the stairways was the fun part: mattresses, wheelchairs… if the patients could walk, we helped them walk down. Many were able to walk out or be carried out into the parking lot and get onto ambulances, trucks, anything that could move them to other hospitals.

I didn’t know how bad it was around town even when I got home that night. I turned on the TV and they were covering it, but I wasn’t really watching, I was talking to my wife. I didn’t know how bad it was until the next day when my dad drove me to the temporary hospital at Memorial Hall and I could see the hardest-hit areas.

When you’re going through this kind of storm, it’s surreal. You don’t really think about what’s going on and what has happened. You really never think about a tornado actually hitting. Then, seeing the destruction afterward, you think to yourself, “this isn’t where this is supposed to be, and why is this like this?” At this point, though, I guess you could say that I’ve gotten to point of acceptance.

Tim Martin, Pharm.D., Director of Pharmacy, DCH Regional Medical Center, Tuscaloosa, Al.

On April 27, 2011, Tim Martin was at the DCH Regional Medical Center when a funnel cloud 1.5 miles wide came within a few blocks. The storm killed more than 65 people and injured more than a 1,000 during its 80-mile path.

I positioned myself in the emergency department (ED) and brought two pharmacists with me who could respond to immediate medication needs that couldn’t be met through the normal channels. Some patients were severely and critically injured; some came in and went straight to the OR. There were some lives lost immediately after the storm, and several individuals were admitted. We saw about 800 people in six hours in our ED. Every wall had a patient on it either on a stretcher or in a wheelchair.

The emotional response comes in several waves. The initial wave is just “all hands on deck,” and you have to put yourself in a position where you can do whatever is needed. At one point, I was changing a tire on an ambulance. Ten minutes later, I was doing eye irrigations on an 89-year-old lady. Twenty minutes after that, I was helping a man who was about to leave the hospital. He was frustrated, upset, and still in shock. I was trying to convince him to stay and let us take a look at his head, which had a pretty bad bang. I held the guy’s hand for 20 minutes until he calmed down.

Over the next few days, I was kind of numb. Some of your patient interactions can be very intense. You keep wondering when things will get back to normal and if you’re out of the woods yet.

About a week after the tornado, I started feeling like I didn’t want to go into the worst-hit zones anymore. I had been out in the field, working in some of the more heavily damaged areas out in the community removing debris, cutting trees out of houses, things like that. But after about a week of that, I started having to pull back emotionally. Even today, more than two months out, when I have to drive through that area of town, I can feel myself needing to prepare emotionally.

Sarah Boyd, Pharm.D., BCPS, Pharmacy Clinical  Coordinator, St. John’s Mercy Hospital, Joplin, MO.

As soon as Sarah Boyd learned that St. John’s Mercy Hospital had been hit, she headed in from her home in nearby Carthage. The first night, she was assigned to the triage center in the temporary hospital set up in Memorial Hall, about a mile from the hospital.

The hospital evacuated 183 patients in 90 minutes. I was the first pharmacist to get to the triage center. There were no beds. There was really nothing there. Supplies started trickling in, and we organized what we had. Most of the patients coming in were walking wounded. We had patients who had taken insulin but hadn’t eaten, so we were trying to handle blood sugar issues as well. I think I left about 3 a.m., went home and slept for a while.

At first, I felt more disbelief than anything. You have disaster preparedness, you go through the drills, but you never think it will happen or happen to the magnitude it did. First, you experience shock and disbelief. Then comes the impact of what we have to do and how we will do it. When I went back and saw the damage to the hospital itself, I thought it was amazing that more people weren’t hurt in the storm.

Steven Stoner, Pharm.D., BCPS, Clinical Professor and Chair, Division of Pharmacy Practice and Administration, University of Missouri-Kansas City School of Pharmacy

Steven Stoner helped with relief efforts for the Joplin, Mo., tornado, which included locating, collecting and transporting drugs and other crucial medical supplies to the disaster zone, treating patients, and cleaning up debris. More than 30 students and faculty from the pharmacy school traveled to Joplin on school-organized trips.

I’ve seen a lot of disheartening things in my career, things that pull at my heartstrings, but the magnitude of the devastation was probably the most humbling experience I’ve ever had. You would clean up one lot that’s on a little bit of a slope. Then, you’d go to the top of the slope and look at what is behind it, and you see total destruction. Your thoughts then go out to the families who lost everything, and you begin to appreciate the simple things you take for granted.

One thing that I can’t emphasize enough to people who want to help in these situations is to go with an organized group that has a plan. When people just showed up and wanted to help, it was difficult and more chaotic. At the Missouri state clinics that were set up, the dispensary had an organized check-in system. Someone was in charge and assigned you to your area. If you were a pharmacist, you had to provide certification and identification that you were a licensed professional. Showing up willy nilly makes it very difficult for those on the ground. Lot of people want to help, but being organized is critical.

Lois F. Parker, R.Ph., Pediatric Pharmacy Team Lead, Massachusetts General Hospital Pharmacy Department, Boston

In Holliston, Mass., we are rarely affected by hurricanes due to our inland location 25 miles west of Boston. However, Hurricane Irene was different than most, as it travelled north and veered west, affecting a wide swath of interior New England in late August of this year.

By the time the storm arrived in Holliston Sunday morning, it had been downgraded to a tropical storm. The news media was warning people to not become complacent, since even a tropical storm carries winds greater than 45 mph.

My daughter had already learned that classes had been canceled for her first day of college at the University of Vermont, and students were asked to stay in their dorms on Sunday due to heavy wind warnings. Clearly, this was another layer of worry we had not anticipated when we sent her off to college. As it turned out, much of Vermont was ravaged by this storm.

We lost power briefly at 8 a.m. and were relieved when it came back quickly. Throughout the morning, the rain and wind were heavy, and the skies were dark. Several times, I heard branches fall, and then at 10 a.m., after a gust of wind that sounded like a train coming through, we lost power, and it stayed off.

By 4 p.m., the worst of the storm had passed. We discovered the reason for our power failure: A telephone pole and tree had come down, blocking our entire road and pulling the wires down with them. It was astounding to see the extent of the damage. A tree had come down on the roof of a neighbor’s house, the roof of a convertible was heavily damaged by a branch, and a large old tree was completely uprooted from a nearby yard.

Fortunately, a recent renovation to our house included a wiring upgrade. So, once the generator was up and running, we had power to the refrigerator, freezer, some lights and electrical outlets, and hot water. We were without a microwave, oven, kitchen outlets, a dishwasher, and cable. However, we knew how fortunate we were to have what we did.

I went to Haiti twice after the earthquake as a volunteer pharmacist with Project Medishare. Among the many positives that came from these trips was the perspective that I gained. It definitely helped me endure the inconvenience of four days without power. The whole experience left us feeling fortunate that our home sustained no damage and that our inconvenience was short-lived. Emergency preparedness is not just a cliché.


June 1, 2010

Uncle Sam Wants YOU for Disaster Relief

AS NEWS SPREADS OF THE DEVASTATION wrought by the earthquakes in Haiti and Chile this winter, many pharmacists wondered what they could do to help. One option was joining the National Disaster Medical System, which is part of the U.S. Federal Response Plan. Responding to a disaster or other emergency is grueling work, but pharmacists who are healthy and can pass a background check can qualify to be on a Disaster Medical Assistance Team (DMAT) or an International Medical Surgical Response Team (IMSuRT).

DMAT personnel provide care ranging from triage to preparing patients for evacuation. Although DMATs are designed primarily to provide help in their own regions, they also assist in other parts of the country as needed and may deploy to disaster sites around the world, usually in conjunction with an IMSuRT.

Can You Rough It?

Erasmo (Ray) Mitrano, M.S.

Serving on a DMAT or an IMSuRT is fulfilling, but it is no easy task, according to Shannon Manzi, Pharm.D., team leader for emergency services and combined programs at Children’s Hospital Boston. Manzi is a member of DMAT MA-1 and has deployed on seven missions, most recently to Haiti.

“You have to be very flexible,” she said, noting that you may not have a bed to sleep in or a shower for several weeks, you eat military MREs (meals ready to eat), and often work 12- to 16-hour shifts.

“You dig toilets, carry boxes, and set up tents,” Manzi said. “Whether you’re a brain surgeon, a medical technician, or a pharmacist, it’s all the same job, all in a very austere environment.” There are three IMSuRTs, each of which has a rapid-assembly hospital that includes mobile equipment and supplies. IMSuRT personnel stabilize patients, perform surgery, provide critical care, and prepare patients for evacuation.

To an untrained eye, field pharmacies may look like organized chaos, but they serve DMATs and IMSuRTs pharmacists well.

Members of DMATs and IMSuRTs are activated for two weeks at a time. During their deployments, members are considered federal employees, and their regular jobs are protected by federal law.

Creativity Part of Job Description
During deployments, pharmacists must use all of their pharmacy knowledge and problem-solving skills, according to Manzi. “Items may be in limited supply, and there may be no sterile area. You may end up rationing or using things in novel ways,” she said. For example, in Haiti, Manzi created rehydration solution with the salt and sugar packets that came with the MREs.

Shannon Manzi, Pharm.D., far left, assists a medical team during her recent deployment in Haiti.

The work is not without its risks, said Erasmo (Ray) Mitrano, M.S., associate chief of pharmacy, inpatient operations, at Massachusetts General Hospital in Boston, who deployed with IMSuRT East to Haiti.

“It’s easy to forget about yourself in that kind of situation, but if you don’t eat, drink, and get rest, then you aren’t going to be able to help others,” he said, recalling how several team members in Haiti had to be treated for dehydration.

If you are interested in joining a team, Mitrano suggests that you talk to someone who is already a member. “Get an overall understanding of what the commitment really is,” he said. “It’s an honor to serve, but getting onto a team is a long, involved process.”

Indeed, it is not something that pharmacists can just sign up for and start doing. A candidate must either be sponsored by an existing team member or have two professional letters of recommendation. This is followed by several interviews and background checks.

Shannon Manzi, Pharm.D.

Candidates accepted and assigned to a team then undergo extensive training that includes incident command courses, online courses, and hands-on instruction in assembling equipment and setting up field hospitals. All told, the entire process can take nine months.

“We do need a bigger pool of pharmacists,” Mitrano said. “If you are interested, now would be a great time to look into it—before disaster strikes.” 

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