STANDARDIZATION OF MEDICATION CONCENTRATIONS, DOSING UNITS, LABELED UNITS, AND PACKAGE SIZES

To support adoption of nationally standardized medication concentrations, dosing units, labeled units, and package sizes for medications administered to adult and pediatric patients, and to advocate that the number of standard concentrations, dosing units, labeled units, and package sizes be limited as much as possible; further, 

To encourage interprofessional collaboration on the adoption and implementation of these standards across the continuum of care; further,

To encourage manufacturers and registered outsourcing facilities to provide medications in those standardized concentrations, labeled units, and package sizes.

Rationale

Standardization and simplification are widely accepted methods for reducing variability in processes and risk for error. With increased adoption of intelligent infusion devices, use of standard concentrations has enhanced infusion safety by eliminating most dosing and rate calculations. Standardizing concentrations reduces the potential for errors, particularly during transitions of care; simplifies ordering by providing fewer choices, which decreases provider uncertainty; reduces operational variations, which enhances provider efficiency; and streamlines manufacturing, which accelerates production and allows for the formulation of premixed medications. In addition, broader use of standard concentrations might stimulate industry to offer a broader array of ready-to-administer infusions and facilitate the development of drug libraries.

To improve patient safety and availability of products, units of measure used for ordering, labeling, and administration of medications need to be standardized as well, as do package sizes for liquid formulations. All liquid formulations, including intravenous, oral, and topical formulations, need to be included in the standardization process, and standards specific to pediatric and adult populations are needed and should be limited in number to the extent possible. Development of these standards requires a holistic view of the medication-use process that considers all these aspects, as they all intersect and impact patient safety and the interoperability of automated systems.

In 2015, ASHP launched the Standardize 4 Safety (S4S) initiative. Funded by the U.S. Food and Drug Administration (FDA) and helmed by ASHP, S4S is the first national, interprofessional effort to standardize medication concentrations to reduce errors resulting from confusion over nonstandardized drug concentrations and errors that result from concentration differences when patients transition their care from one setting to another. To date, the expert committees have developed four lists—standardized concentrations for adult continuous infusions, pediatric continuous infusions, compounded oral liquids, and PCA/epidural infusion—and the S4S Initiative offers the pharmacy workforce other resources to help implement standardized concentrations.