Margaret D. Scheffler, MD, FAAP; Steven Willis, PharmD
Adverse drug events (ADEs) are responsible for 1.3 million physician visits, 350,000 hospitalizations, and an estimated cost of $3.5 billion per year, according to the Centers for Disease Control and Prevention.1 An estimated 40% of these costs are due to medication errors that are potentially preventable. Children are especially vulnerable to these preventable errors for several reasons, including the need for weight-based dosing and unique formulations (such as liquids) for enteral medications. In addition, many enteral medications must be compounded into liquid form for children since commercially manufactured liquids are not available. The variety of concentrations produced by community pharmacies, hospitals, and even different units within the same hospital system leaves significant gaps in the safeguards established to protect patients.
In 2012, the State of Michigan, led by the University of Michigan, embarked on a project to standardize the concentrations of many prescription medicines for pediatric patients in an effort to strengthen the medication safety net for children across the state.2 With support from the U.S. Food and Drug Administration’s Safe Use Initiative, the project resulted in the statewide adoption of a list of standard concentrations for dozens of medicines and a belief that standardization had improved patient safety.3 Building on the success of the Michigan experience, in 2016 the American Society of Health-System Pharmacists (ASHP), in collaboration with the Institute for Safe Medication Practices and the Pediatric Pharmacy Advocacy Group, developed a “national, interprofessional effort to standardize medication concentrations in order to reduce errors and improve transitions of care.”4 This three-year, threephase effort expands on the initial pilot program to include both enteral compounded medicines and IV infusions for children and adults, and to standardize dosing units as well.
The goal is to reduce medication use errors and ADEs, especially during transitions of care when patients are most vulnerable. Draft proposals of adult continuous infusions and oral compounded liquids are currently available for comment and discussion by stakeholders. While the standard concentrations proposed by the ASHP are not yet fully approved, hospitals can begin by performing a gap analysis using the proposed standards to ignite the conversation. An initial gap analysis performed by Hasbro Children’s Hospital, assessed the current oral liquid medicines on formulary that have standard proposed concentrations on the ASHP list and compared its preparations to the standards proposed. At Hasbro, topiramate is prepared at a concentration of 6 mg/mL, compared to a proposed standard of 20 mg/ mL; this could result in a threefold overdose if a patient is educated to take one volume while in the hospital and a different concentration on discharge.
Patients in the intensive care unit (ICU) are prescribed twice as many medicines as patients outside the ICU.5 At the same time, critically ill patients are at particular risk of medication errors and ADEs for many reasons: They are often at age extremes, require weight-based dosing, are sedated or otherwise altered and unable to verbalize or participate in their care, and are in a complex environment with high turnover of both patients and staff.6 Standardizing medication concentrations for pediatric continuous infusions has already been shown to be effective at reducing medication errors.7 Likewise, diligent medication reconciliation during patient transition has also been proven effective.8 Simplifying the catalog of available products will reduce confusion for patients, clinicians, and pharmacies, while reducing risk and providing consistency. Determining universally accepted concentrations will hopefully improve the availability of commercially prepared products, as companies may be induced to manufacture these medicines. Standardizing medication concentrations across the continuum of care, from ICU to general ward to outpatient pharmacies, will add a valuable layer of safety.
- Centers for Disease Control and Prevention. Medication Safety Basics. Last updated June 29, 2018. Atlanta, GA: Centers for Disease Control and Prevention. www.cdc.gov/medicationsafety/basics.html. Accessed November 20, 2018.
- Rood, JM, Engels MJ, Ciarkowski SL, Wagenknecht LD, Dickinson CJ, Stevenson JG. Variability in compounding of oral liquids for pediatric patients: a patient safety concern. J Am Pharm Assoc (2003). 2014 Jul-Aug;54(4):383-389.
- Engels, MJ, Ciarkowski SL, Rood J, et al. Standardization of compounded oral liquids for pediatric patients in Michigan. Am J Health Syst Pharm. 2016 Jul 1;73(13):981-990.
- American Society of Health-System Pharmacists. Standardize 4 Safety Initiative. Initiative Overview. Bethesda, MD: American Society of Health-System Pharmacists. https://www.ashp.org/Pharmacy-Practice/Standardize-4-Safety-Initiative/Initiative-Overview. Accessed January 4, 2019.
- Cullen, DJ, Sweitzer BJ, Bates DW, Burdick E, Edmondson A, Leape LL. Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units. Crit Care Med. 1997 Aug;25(8):1289-1297.
- Moyen E, Camiré E, Stelfox HT. Clinical review: 0edication errors in critical care. Crit Care. 2008;12(2):208.
- Larson GY, Parker HB, Cash J, O’Connell M, Grant MC. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. Pediatrics 2005 Jul;116(1): e21-e25.
- Provonost P, Weast B, Schwarz M, et al. Medication reconciliation: a practical tool to reduce the risk of medication errors. J Crit Care. 2003 Dec 18(4):201-205.