In September 2015, the American Society of Health-System Pharmacists (ASHP) announced a three year grant from the FDA to develop national standardized medication concentrations. ASHP has partnered with the Institute for Safe Medication Practices (ISMP), the Association for Advancement of Medical Instrumentation (AAMI), and The Pediatric Pharmacy Association (PPAG) to release plans for the “Standardize 4 Safety” initiative. This inter-professional, national project is the first attempt at developing and implementing standard medication concentrations in an effort to reduce medication related errors and improve patient safety.1
The initiative had its inception in 2008 when a group of physicians, pharmacists, nurses, and informaticists convened in Rockville, Maryland to discuss strategies for preventing intravenous (IV) medication related errors.2 At this summit, they described the national problem related to medication errors and identified one of the primary barriers to safe IV medication use as the lack of standardization and good process design. Therefore, they concluded that the solution would be to establish national standards for IV medications, as well as many oral preparations.
Today, almost 9 years later, ASHP is in the process of releasing standards for IV continuous infusions for adult and pediatric patients, intermittent IV concentrations, oral liquid concentrations and doses, and oral chemotherapy agents. The guiding principle for the project places the highest priority on patient needs but also suggests using commercially available products, limiting the number of concentrations available, and utilizing the most concentrated formulations possible. Along with these principles, operational concerns, such as cost and waste, have also been taken into consideration when developing these standards. More detailed information, including a proposed list of the adult standard continuous infusion concentrations, can be found on ASHP’s website: Proposed Standard Concentrations
There are obvious benefits to implementing the Standardize 4 Safety initiative. First, standardizing the concentrations may lead to a reduction in medications errors that occur during transitions of care across different institutions. Second, standardization establishes consistency among the various institutions. Not only will this lead to improved patient safety, but also more opportunities for optimized quality of care and innovation in practice. Practically, there should be faster dispensing times and less potential for error when more of these agents are available in standard concentrations and require less manipulation of dosage forms.
While the initiative is filled with potential for improving patient safety and outcomes, it does also come with some challenges. Particularly in pediatrics, the one size fits all model does not apply due to interpatient variability. The best example of this is the fact that the pediatric patient population can range from 500 grams to 100 kilograms. Additionally, since everyone is not currently obligated to abide by these standards, the full safety benefits will likely not be realized until this is a requirement. Finally, the transition period for a change of this scale could be difficult considering the amount of pharmacy practice process modifications that would be needed. However, with medication errors recently reported to have taken over as the third leading cause of death3, every effort should be made to reduce the risk of preventable events even if it may be labor intensive. The pediatric patient is more vulnerable to the potential consequences of medication errors; thus, they may be the patient population that would most benefit from a standardized approach to medication delivery.
Pediatric facilities ought to be at the forefront of this movement, promoting any and all strategies that enhance our ability to deliver safe and effective medications with minimal risk of harm. Phase 1 is well underway with guidance for adult IV continuous infusions and oral liquids already being released. Please look for ways your hospital and pharmacy department can get involved further with this project by contacting ASHP or PPAG and by spreading the word. To be successful in a project of this magnitude, we must come together as a team and share our experiences related to successful implementation of new processes related to standardized concentrations.
1. Available at: https://www.ashp.org/Pharmacy-Practice/Standardize-4-Safety-Initiative
2. Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008; 65:2367-79
3. Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016; 353:i2139