Patient Safety

1. Ways Medication Errors Can Occur

Medication errors can happen at any stage of the medication-use process:

• Prescribing: Wrong drug, dose, or patient.

• Order Communication: Misinterpretation of orders (e.g., poor handwriting, ambiguous abbreviations).

• Product Labeling/Packaging: Look-alike/sound-alike drugs, confusing packaging.

• Compounding/Dispensing: Incorrect preparation or labeling.

• Distribution/Administration: Wrong route, dose, or patient.

• Monitoring/Education: Inadequate patient counseling or failure to monitor for side effects.

System-based causes are the most common, not individual mistakes. Poor system design allows errors to reach patients.

Examples:

• Drug binds to the IV bag (incompatibility).

• Amoxicillin powder dispensed without reconstitution.

• Anticoagulant IV not started or clamped.

2. Medication Error vs. Adverse Drug Reaction (ADR)

• Medication Error: Preventable event leading to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional,patient or consumer.
  Example: Wrong drug dispensed, but caught before patient takes it (close call).

• Adverse Drug Reaction (ADR): Harm caused by a drug at normal doses, during normal use; not preventable.
  Example: Vancomycin-induced acute kidney injury, despite correct dosing.

3. Key Definitions

• Medication Error: Any preventable event that may cause or lead to inappropriate medication use or patient harm.

• Adverse Drug Reaction (ADR): Harm caused by a drug at normal doses, not due to error.

• Close Call/Near Miss: Error corrected before reaching the patient (e.g., patient notices wrong tablet).

• Error of Omission: Failing to do something necessary for safety (e.g., not starting an infusion).

• Error of Commission: Doing something incorrectly (e.g., dispensing wrong drug).

• Sentinel Event: Unexpected event causing death or severe harm (e.g., wrong-site surgery, undiluted KCl injection).

4. Patient Safety Organizations and Efforts

• Institute for Safe Medication Practices (ISMP): Non-profit, shares safety alerts, runs MERP (Medication Errors Reporting Program).

• The Joint Commission (TJC): Accredits healthcare organizations and programs, sets National Patient Safety Goals (NPSG) for medication safety.

• Centers for Medicare & Medicaid Services (CMS): Sets safety standards for reimbursement on behalf of US HHS

• National Association of Boards of Pharmacy (NABP): Regulates pharmacy practice.

• Utilization Review Accreditation Commission (URAC): Accredits healthcare organizations.

Efforts include: Reporting programs, safety alerts, setting standards, and regular accreditation surveys.

5. Implementing Error Reduction in Healthcare Systems

• Tall Man Lettering: Highlights differences in look-alike drug names by using uppercase letters (e.g., hydrOXYzine vs. hydrOMORPHone).

• Standardized Protocols: For high-alert medications (e.g., heparin dosing order sets).

• Limiting Concentrations: Only certain strengths available to reduce dosing errors.

• Barcoding: Ensures right drug, dose, route, and patient.

• E-prescribing: Reduces prescription errors and increases efficiency.

• Education: Staff and patient training, in-services.

• Patient Profiles: Check allergies, interactions, polypharmacy.

• "Five Rights": Correct patient, drug, dose, route, time.

6. High-Alert Medications (ISMP List)

• Anticoagulants (heparin, warfarin)

• Insulin

• Oral hypoglycemics

• Opioids

• Antiarrhythmics

• Anesthetics

• Chemotherapeutics

• Injectable Potassium Chloride

• Hypertonic Saline

Strategies: Avoid storing in automated cabinets, use premixed products, monitor labs closely.

7. “Do Not Abbreviate” List (ISMP & TJC)

Common unsafe abbreviations:

• U (unit) – write “unit”

• IU (international unit) – write “international unit”

• QD/QOD (daily/every other day) – write “daily” or “every other day”

• Trailing zero (1.0 mg) – write “1 mg”

• Lack of leading zero (.5 mg) – write “0.5 mg”

• MS/MSO4/MgSO4 – write “morphine sulfate” or “magnesium sulfate”

  

Example corrections:

• “Nitroglycerin .4 mg PO Q5 min PRN” → “Nitroglycerin 0.4 mg PO every 5 minutes as needed”

8. REMS: Risk Evaluation and Mitigation Strategies

• Definition: FDA-required programs for certain drugs to manage serious risks so that benefit outweighs risks.

• Components: Prescriber/pharmacy certification, patient education, restricted distribution.

• Examples:

  • iPLEDGE (isotretinoin)

  • ESA APPRISE (erythropoiesis-stimulating agents)

9. Evaluation and Quality Improvement Methods

• Failure Mode and Effects Analysis (FMEA): Proactive, prospective assessment to identify and fix potential failures before they occur in design and medication delivery systems.

• Root Cause Analysis (RCA): Retrospective, investigates errors after they happen to find and fix root causes that lead to error

• Continuous Quality Improvement (CQI): Ongoing process to improve efficiency, quality, satisfaction, and reduce costs.

  • Lean: Minimize waste.

  • Six Sigma: Reduce defects using DMAIC (Define, Measure, Analyze, Improve, Control).

Summary Table: Learning Objectives & PDF Content