Standardize 4 Safety: How Did It Start and Where Is It Going?

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Standardize 4 Safety

When and How Did This Effort Begin?

The first formal initiative to standardize medication concentrations arose from the San Diego, California region in 2006. The San Diego Patient Safety Consortium, and the Cardinal Health Center for Safety and Clinical Excellence announced the formation of a first-of-its-kind regional task force to im­prove patient safety by eliminating variation in intravenous (IV) medica­tion practices among county hospitals¹.  The Patient Consortium efforts^2,3,4 laid the groundwork for a landmark summit in 2008 involving ASHP and the ASHP Research and Education Founda­tion along with the Institute for Safe Medication Practices (ISMP), United States Pharmacopeial Convention (USP), Infusion Nurses Society, Joint Commission, and National Patient Safety Foundation.  The “IV Safety Summit” was the first national concerted effort aimed at preventing pa­tient harm and death from IV medication errors. ASHP House of Delegates also passed a policy in 2008 supporting the standardization of IV medication concentrations⁵.

Other standardization efforts started around the country led by state (Indiana, Maine, North Carolina, Michigan) or regional (Aurora, CO) medication safety collaboratives and teams.  Most efforts were focused on IV medications given the risks associated with administering medications through a vein and if an error occurred the patient could be in immediate danger.  The Pediatric Pharmacy Advocacy Group (PPAG) also published recommended pediatric concentrations for IV medications along with ISMP.  These lists were later used by ASHP to create a consolidated list that is supported by all three organizations.

However, another risk had been percolating for years and was finally recognized by the University of Michigan Health System (UMHS).  Inpatient and outpatient pharmacies from around the state were compounding varying concentrations of numerous oral liquids.   Pharmacy investigators from UMHS were awarded an FDA Safe Use Initiative Grant that enabled them to conduct a large pharmacist survey through the assistance of the Michigan Pharmacists Association (MPA).  The survey asked about 146 specific medications and within those 146 medications there was significant variability of concentrations revealing a range of between 1 and 9 concentrations per medication⁶.  Their pharmacy team, with assistance of the MPA, reviewed the data and developed standard concentrations that were posted to a website that could be accessed by any pharmacist within or outside of Michigan. Their work brought national attention to the variability in concentrations of compounded liquid medications. Compounded liquid medications carry an inherent safety risk for vulnerable patient populations such as pediatric and geriatric patients that routinely receive liquid medications due to swallowing difficulties.

ASHP Creates the Standardize 4 Safety Initiative

The S4S project was started in 2015 after ASHP was awarded a Safe Use Initiative Grant from the FDA.  It is an inter-professional effort spanning several years involving pharmacists, nurses, and physicians across the continuum of care.  The clinical experts developed standards for intravenous and oral liquid medications using guiding principles and existing industry standards.

Standardize 4 Safety (S4S) is the first national, inter-professional effort to standardize medication concentrations to reduce errors, especially during transitions of care. It establishes standardized concentrations for intravenous and oral liquid medications for patients of all ages in settings ranging from hospital to home.

Methodology

The Expert Panels

At the start of the S4S initiative ASHP gathered clinicians (pharmacists, nurses, and physicians) from around the nation that had expertise and practiced in patient care specialties such as anesthesia, critical care, pediatrics, neonatology, emergency room, medication safety, and even Survival Flight.

The panelists were tasked with bringing their own local (hospital/health system) specific concentration lists and they all participated in 1-2 all day meetings along with regularly scheduled phone conferences.  They reviewed the previous work done by regions, states, patient safety organizations, other pharmacy associations, in addition to individual lists and any publications on the topic.

Determining the Concentrations

The panelists used guiding principles applicable to the various practice areas along with considerations of the infusion pumps used in practice.  The guiding principles are too numerous to list here but the ASHP S4S website explains in greater detail.  Some examples include:

• An overarching premise for the IV and oral liquid medications was to only recommend one concentration whenever possible.
• If more than one concentration was needed, do not recommend 10-fold concentrations based upon medication safety principles.
• Recommend higher, more concentrated infusions (vs. dilute) when possible, so the overall flow rates did not interfere with the patients’ fluid requirements needed for nutritional support (whether IV or enteral).
• Recommend concentrations that resulted in flow rates conducive to the pump operational parameters. For example, in neonates it is a common practice to use the most concentrated infusion possible and the flow rate recommended could not be less than approximately 0.1 mL/hour.

Once a panel had thoroughly vetted their recommendations, a draft list was shared externally with the partner medical associations and posted to the ASHP Connect community for comments.  The posts were visible and open for comment for approximately 6-8 weeks after a new list was released.  The draft lists were shared with the FDA at regular scheduled meetings for discussion and to talk through any concerns.

Finalizing the Lists

Once all comments were taken into consideration the panel reviewed the associated comments and made any changes necessary.  The lists went through a rigorous quality control process internally and were reviewed by ISMP before publication to ensure medication safety rules such as spacing, TALLman lettering, etc. were followed.  ASHP published the finalized lists as they were ready on the ASHP S4S national list website in addition to sending the lists to the partner medical associations.

Where is S4S going?

The next horizon for standardizing concentrations for IV and oral liquid medications is to test if the recommended concentrations are being used in practice.  Surveys (such as the ASHP annual national survey) over the next several years will help us understand the adoption of the standards. In addition, more quantitative analyses of the IV concentrations need to be completed to determine if the concentrations recommended are indeed the right concentrations for patient care.  If they are, then it has always been the hope of the FDA, safety organizations, hospitals, pharmacies, and practitioners across the nation that the life science companies will consider commercially manufacturing both the IV and oral liquid medications so more stringent Good Manufacturing Practices (GMPs) can be used to mass produce these medications and decrease the risk for compounding errors to occur.

It takes a village to embark upon any medication safety initiative and this project is an excellent example of that concept.  I am humbled by the desire and drive of many ASHP members to work countless hours on this project for the benefit of creating a safer health ecosystem for patients.  I would like to also personally thank key personnel from ASHP, ISMP/ECRI, PPAG, USP, and the FDA.   Their input and dedication to this project has been immense.

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