Recommendations for Healthcare Organizations to Reduce Medication Errors Associated with the Label, Labeling, and Packaging of Pharmaceutical (Drug) Products and Related Devices

These recommendations apply to healthcare systems, hospital systems, individual hospitals, long-term care facilities, and other organized health care settings. ¹

The Council recommends the following:

1. Healthcare organizations should develop processes to ensure that all medications are labeled prior to administration to a patient.
   1. Per USP General Chapter <7> Labeling, the term “labeling” includes all labels and other written, printed, or graphic matter on a medication’s immediate container or on, or in, any package or wrapper in which it is enclosed, except any outer shipping container.
   2. The term “label” is that part of the labeling on the immediate container.
   3. All clinician-prepared medications or solutions should be labeled, unless the medication or solution is prepared at the patient’s bedside and is immediately administered to the patient without any break in the process.
2. In accordance with State/Federal Laws and Regulations, healthcare organizations should employ machine-readable systems (e.g., bar coding) in the management of the medication use process. 
   1. Healthcare organizations should utilize industry standards to ensure machine-readable validity meets industry quality standards.
   2. Healthcare organizations should have procedures in place to address gaps and failure modes in the use of machine-readable systems.
   3. Healthcare organizations should have policies and procedures developed for repackaging of medications that will clarify labeling and include a bar code to help prevent errors.
3. Systematic approaches, including Healthcare Failure Mode and Effects Analysis (HFMEA) and root cause analysis (RCA), should be implemented within the healthcare organization to identify and evaluate actual and potential causes of errors related to labeling and packaging (e.g., failure to use bar code scanning, barcodes that don’t scan, and situations where patient armbands cannot be applied).
   1. These systematic approaches should be accompanied with guidance related to monitoring, auditing, and quality improvement initiatives (e.g., PDSA) to ensure changes improve the labeling of medications to reduce medication errors.
4. Healthcare organizations should develop and implement (or provide access to) education and training programs for healthcare professionals, technical support personnel, patients, and families/caregivers that address methods for reducing and preventing medication errors associated with the information provided on an organization’s medication labeling.
    

Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.

¹ For more information, see ISMP and USP guidelines and standards for labels and labeling.