Medication Safety

See also: Infusion Pumps

The Food and Drug Administration (FDA) is developing guidance on naming, labeling and packaging practices to reduce medication errors: (edocket.access.gpo.gov/2010/2010-8233.htm), and is holding a public workshop June 24–25, 2010, in Bethesda, MD, to discuss the guidance. Documents and minutes from the meeting can be reviewed at www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-N-0168.

The meeting will include four different panel discussions:

• Container label and carton labeling design as they relate to reducing the risk of medication errors.
• Study design, conduct and interpretation of human factors analysis, Failure Mode and Effects Analysis (FMEA), usability studies, and other studies specifically focused on evaluating the safety of container label and carton labeling designs to reduce the risk of medication errors.
• Manufacturers’ packaging used for medications as they relate to the safe use of the medicine from a medication errors perspective.
• Developing proprietary names as they relate to reducing medication errors.

By the end of fiscal year (FY) 2010, the FDA will publish draft guidance on best practices for naming, labeling and packaging drugs and biologics to reduce medication errors. Final guidance will be published by the end of FY 2011. In addition, by the end of FY 2012, the FDA will publish the draft guidance on proprietary name evaluation best practices, with final guidance to follow as soon as feasible.

Specific Error Reduction Initiatives

Intravenous Medication Concentrations Standardization

Standardization of intravenous (IV) infusion medication concentrations and dosage units with and across hospitals in San Diego County was identified as a significant opportunity to reduce morbidity and mortality due to preventable, high-risk IV-related adverse drug events. This toolkit provides the results of the work by the SDPSC IV Safety Task Force, along with tools and information to assist other acute care organizations in implementing this standard approach. (free full access).

ICU Sedation Guidelines of Care

Safe and effective management of an adult ICU patient’s pain and anxiety demands a delicate balance of analgesia and sedation protocols while managing delirium. The San Diego Patient Safety Council developed an evidence-based standard for safe and effective management of pain, sedation, and delirium in the adult ICU ventilated patient. (free full access).

Patient-Controlled Analgesia (PCA)

The use of PCA is a complex, high-risk treatment that is associated with harmful events and death. Extensive variability exists within and between hospital environments. Variability in patient response, clinical staffing, equipment, physician orders, medication dosages, and concentrations all contribute to risk for error. The San Diego Patient Safety Taskforce has provided San Diego County Acute Care settings with recommendations for the standardization of intravenous Patient Controlled Analgesia (PCA) medication administration in the care of the opioid naïve patient. These recommendations exclude the use of epidural PCA (PCEA), subcutaneous PCA use, the palliative care environment, and patients experiencing chronic pain. (free full access).

Preventing Microbial Contamination

Association for Professionals in Infection Control and Epidemiology (APIC) position paper: Safe injection, infusion, and medication vial practices in health care. (free full access).

Implementation Examples

Contra Costa Regional Medical Center

1. Improving Medication Reconciliation (posted on the American Hospital Association Hospitals in Pursuit of Excellence site). (free full access).

Kaiser Permanente Northern California

1. High Alert Medication Program. (free full access).
2. High Alert Medication List. (free full access).
3. High Alert Medication Policy. (free full access).

Health Services Advisory Group (HSAG) Resources

HASG, the QIO for California, has assembled a set of resources for medication safety efforts. Those can be found at www.hsag.com/caproviders/drugsafety.aspx.