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 employ machine-readable systems (e.g., bar coding) in the management of the medication use process. Healthcare organizations should utilize industry standards to ensure machine-readable validity meets industry quality standards.
  2. Systematic approaches, including Healthcare Failure Mode and Effects Analysis (HFMEA) and root cause analysis, should be implemented within the healthcare organization to identify and evaluate actual and potential causes of errors related to labeling and packaging.
  3. Policies and procedures are developed for repackaging of medications that will clarify labeling to help prevent errors.
  4. Collaboration among healthcare organizations, healthcare professionals, patients, families/caregivers, the pharmaceutical industry, consumer organizations, standard-setters, and regulators should be encouraged to facilitate design of drug product packaging and labeling to help minimize errors.
  5. 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.

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.

March 30, 1998
October 22, 2014