Medication errors, defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. One source of medication errors occurs in the dosing of oral liquids. These doses are typically calculated for pediatric patients using the weight and/or size of the patient. This variation in dose means that there may be no commercially available oral dosage form that is suitable for the patient at hand and a product must be compounded by a pharmacist. There is no standardization of the concentrations of these oral liquids and pharmacists compound these liquids at various concentrations based on a variety of factors including the volume of the dose, the stability of the solution, product palatability, and convenience. One must understand the concentration and the volume of the dosage in order to determine the correct dose to administer to the patient. Changes in the concentration of the oral liquid may occur when patients change pharmacies, when they transition between the hospital and the outpatient environment, or when they return to the hospital after being on a medication in the home setting. Caregivers accustomed to dosing a particular volume of the medication may continue to give the same volume without realizing that the concentration has changed. Similarly, when the physician does a medication history and hears that a pediatric patient receives a certain volume of a liquid drug, they may not be aware that the drug may be compounded at different concentrations, and may order the wrong dose. To address these concerns, the University of Michigan and the Michigan Pharmacists Association are collaborating on a project to assess the potential threat caused by the lack of standardization of compounded oral liquids, and to convene a panel of experts to devise voluntary standards for the compounding of oral liquid prescription medications to reduce risk. The plan calls for an initial survey of pharmacies in Michigan, which will identify those drugs being formulated as oral liquids for pediatric use and determine which of them are being formulated at multiple concentrations. A panel of experts will consider these data, and devise a set of voluntary standards for compounding these products in the State of Michigan. The standards will be disseminated to hospitals, community pharmacies, and other sites of care throughout Michigan and shared with national pediatric, pharmacy and drug safety organizations. A follow-up assessment will be conducted to measure the adoption of standard concentrations by pharmacies across the state in order to estimate the degree of improvement from this effort.

Public Health Relevance

The University of Michigan and the Michigan Pharmacists Association have joined in a collaboration to improve the safety of compounded oral liquid medications prepared for pediatric patients in Michigan. The collaborators will gather information on the current practices relative to the preparation of oral liquid medications in pharmacies across the state, and then develop a set of voluntary standard concentrations that will be utilized by pharmacists in compounding these medications in order to reduce the potential risk of errors when patients change pharmacies or at transitions of care. Standardization will lower the risk of delivering the wrong dose because of confusion over the concentration of drug in the oral liquid medication.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZFD1-SRC (99))
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University of Michigan Ann Arbor
Schools of Pharmacy
Ann Arbor
United States
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