About the Initiative

Many children receive prescriptions for oral liquids because of their inability to swallow tablets and capsules. Commercially manufactured oral liquids are not available to fill many of these prescriptions, thus requiring the oral liquid to be compounded by a pharmacy. Before this initiative there was no standardization of the concentrations of these oral liquids, allowing for significant variation in concentrations compounded, volumes of products to be administered, and leading to potentially serious medication errors.

This initiative, funded by the US Food and Drug Administration (FDA) was conducted in several phases. The first phase involved surveying pharmacists across Michigan to gain a better understanding of the variability in compounding practices for oral liquids throughout the state. Click here to view the publication. The second phase involved collaboration with healthcare providers to determine standard concentrations for a range of medications. This was accomplished by assessing the concentrations that pharmacies were compounding and determining whether the concentration would meet the needs of the majority of patients. We also required that there was published literature to support the formulation. Formulations were assessed for shelf stability and feasibility (ease of obtaining ingredients and compounding). Proposed standard concentrations were endorsed by task forces involving prescribers and pharmacists. The third phase was to create a website and other communication tools to disseminate information on the standard concentrations.

This website should be consulted as a source document for standardized concentrations and to obtain a formulation sheet for each of the medications that requires compounding. In a few cases, there may be an alternate concentration in addition to the standard concentration. Alternate concentrations were accepted if the task force felt that the standard concentration may not meet the needs of all our patients. Please only use the alternate concentration if the patient meets the outlined criteria for use. Instructions on converting patients and use of the alternate concentrations are included in the “Toolbox Kit” in the left menu bar. We strongly recommend using commercially manufactured oral liquid products when available. After dissemination of the information on standard concentrations, we will be evaluating the utilization of these standards and utilization of the website by practitioners across the state. 

This research project received financial support from the FDA Safe Use Initiative through the "Novel Interventions and Collaborations to Improve the Safe Use of Medications" grant program. The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use. If you would like more information about the Safe Use Initiative, please visit the website at http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative. The project has also been judged to be exempt by the University of Michigan Institutional Review Board (IRBMED).