Medication errors, defined as any preventable event that may cause or lead to inappropriatemedication use or patient harm while the medication is in the control of the health careprofessional, patient, or consumer. One source of medication errors occurs in the dosing oforal liquids. These doses are typically calculated for pediatric patients using the weight and/orsize of the patient. This variation in dose means that there may be no commercially availableoral dosage form that is suitable for the patient at hand and a product must be compounded bya pharmacist. There is no standardization of the concentrations of these oral liquids andpharmacists compound these liquids at various concentrations based on a variety of factorsincluding the volume of the dose, the stability of the solution, product palatability, andconvenience. One must understand the concentration and the volume of the dosage in orderto determine the correct dose to administer to the patient. Changes in the concentration of theoral liquid may occur when patients change pharmacies, when they transition between thehospital and the outpatient environment, or when they return to the hospital after being on amedication in the home setting. Caregivers accustomed to dosing a particular volume of themedication may continue to give the same volume without realizing that the concentration haschanged. Similarly, when the physician does a medication history and hears that a pediatricpatient receives a certain volume of a liquid drug, they may not be aware that the drug may becompounded at different concentrations, and may order the wrong dose. To address theseconcerns, the University of Michigan and the Michigan Pharmacists Association arecollaborating on a project to assess the potential threat caused by the lack of standardizationof compounded oral liquids, and to convene a panel of experts to devise voluntary standardsfor the compounding of oral liquid prescription medications to reduce risk. The plan calls for aninitial survey of pharmacies in Michigan, which will identify those drugs being formulated asoral liquids for pediatric use and determine which of them are being formulated at multipleconcentrations. A panel of experts will consider these data, and devise a set of voluntarystandards for compounding these products in the State of Michigan. The standards will bedisseminated to hospitals, community pharmacies, and other sites of care throughout Michiganand shared with national pediatric, pharmacy and drug safety organizations. A follow-upassessment will be conducted to measure the adoption of standard concentrations bypharmacies 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.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD004259-01
Application #
8302723
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2011-09-15
Project End
2014-09-14
Budget Start
2011-09-15
Budget End
2012-09-14
Support Year
1
Fiscal Year
2011
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109