Reviewing Medication Safety

Reviewing Medication Safety

Identifies high-alert medication risks with ISMP guidelines and safety barriers to prevent medication errors across the prescribing, dispensing, and administration continuum.

Why This Skill Exists

Medication errors affect approximately 1.5 million people annually in the United States and cause over 7,000 deaths per year. The Institute for Safe Medication Practices (ISMP) maintains a list of high-alert medications that bear a heightened risk of causing significant patient harm when used in error. These include anticoagulants, insulins, opioids, neuromuscular blocking agents, concentrated electrolytes, and chemotherapy agents.

The Joint Commission National Patient Safety Goals require healthcare organizations to implement specific safeguards for high-alert medications. CMS Conditions of Participation mandate prospective drug utilization review (DUR) for every prescription. Pharmacists serve as the principal medication safety officers in healthcare systems, responsible for error prevention, detection, reporting, and system redesign. A structured medication safety review process—incorporating ISMP high-alert lists, tall-man lettering conventions, independent double-check protocols, and root cause analysis—is essential for meeting accreditation standards and reducing preventable harm.

Checkpoint A: Pre-Draft Intake (Mandatory)

1. What is the scope of this review—single medication order, patient profile, or system-wide process? (Default: single patient medication profile)
2. Which high-alert medication categories are involved? (Default: screen all ISMP categories)
3. What is the care setting—acute care, ambulatory, long-term care, or home infusion? (Default: acute care inpatient)
4. Has a medication error or near-miss prompted this review? (Default: proactive review)
5. What technology safeguards are in place (CPOE, barcode scanning, smart pumps)? (Default: assess current state)
6. What is the patient's allergy and ADR history? (Default: review chart documentation)
7. Are look-alike/sound-alike (LASA) medications involved? (Default: cross-check ISMP LASA list)
8. What institutional medication safety policies exist? (Default: request P&T approved policies)

Documents to Request

• Current ISMP High-Alert Medication List (acute care and community/ambulatory settings)
• ISMP Targeted Medication Safety Best Practices
• Institutional medication error reporting data (past 12 months)
• Current medication administration record (MAR) for patient-level review
• CPOE order set configurations for high-alert medications
• Smart pump drug library with programmed concentration and dose limits
• Allergy and adverse drug reaction documentation
• ISMP List of Confused Drug Names (LASA pairs)

Step 1: Identify High-Alert Medications in Scope

Screen against the ISMP High-Alert Medication List for acute care settings:

ISMP High-Alert Categories:

• Adrenergic agonists IV (epinephrine, norepinephrine, phenylephrine)
• Adrenergic antagonists IV (propranolol, metoprolol, labetalol)
• Anesthetic agents (propofol, ketamine)
• Anticoagulants (heparin, warfarin, DOACs, enoxaparin)
• Antiarrhythmics IV (amiodarone, lidocaine)
• Antithrombotic agents (alteplase, tenecteplase)
• Cardioplegic solutions
• Chemotherapy/hazardous drugs
• Dextrose ≥20% concentration
• Dialysis solutions
• Epidural/intrathecal medications
• Hypoglycemics oral and insulin
• Inotropic agents IV (milrinone, dobutamine)
• Liposomal formulations (liposomal amphotericin B vs. conventional)
• Moderate sedation agents (midazolam, dexmedetomidine)
• Neuromuscular blocking agents (succinylcholine, rocuronium, cisatracurium)
• Opioids (all routes and formulations)
• Parenteral nutrition
• Sodium chloride >0.9% concentration
• Sterile water for injection/inhalation in containers ≥100 mL

Step 2: Assess Error-Prone Conditions

For each high-alert medication identified, evaluate common error-prone conditions:

Prescribing errors:

• Wrong dose (10x errors from decimal point misplacement)
• Wrong patient (LASA name confusion)
• Wrong drug (confusion between liposomal and conventional formulations)
• Wrong indication (e.g., methotrexate daily instead of weekly for rheumatologic indication)
• Incomplete orders (missing rate for infusions, missing route)

Dispensing errors:

• LASA name pairs (e.g., hydrOXYzine vs. hydrALAZINE, predniSONE vs. prednisoLONE)
• Concentration confusion (insulin U-100 vs. U-500, heparin 1,000 vs. 10,000 units/mL)
• Look-alike packaging (vial size, label color similarity)

Administration errors:

• Wrong route (oral medication given IV, vincristine intrathecal—universally fatal)
• Wrong rate (rapid IV push of potassium, phenytoin infusion >50 mg/min)
• Wrong time (insulin without concurrent meal, time-critical medications)
• Pump programming errors (dose, concentration, rate mismatch)

Step 3: Evaluate Safety Barriers and Controls

Assess whether the following ISMP-recommended safeguards are in place:

Step 4: Conduct Root Cause Analysis (If Error Occurred)

If reviewing a medication error or near-miss:

1. Timeline reconstruction: Exact sequence of events from prescribing to administration
2. Contributing factors: System issues (staffing, distraction, technology failure), knowledge deficit, communication breakdown
3. NCC MERP severity classification:
   • Category A: Circumstances that could cause error (no error)
   • Category B-D: Error occurred, no harm to minimal harm
   • Category E-F: Error with temporary harm requiring intervention
   • Category G-H: Error with permanent harm or life-threatening
   • Category I: Error contributing to death
4. System redesign recommendations: Apply hierarchy of effectiveness—forcing functions > automation > standardization > education

Step 5: Generate Medication Safety Report

Structure the deliverable:

1. Medications reviewed with high-alert classification
2. Error-prone conditions identified with risk rating (high/medium/low)
3. Safety barrier assessment with gap analysis
4. Specific recommendations prioritized by impact and feasibility
5. Metrics for monitoring effectiveness (error rates, near-miss reports, BCMA scan rates)
6. Timeline for implementation and reassessment

Checkpoint B: Post-Draft Alignment (Mandatory)

1. Were all ISMP high-alert categories screened for the care setting?
2. Are LASA pairs identified and tall-man lettering recommendations applied?
3. Do recommendations follow the hierarchy of effectiveness (forcing functions over education)?
4. Are smart pump library limits and CPOE alerts aligned with current dosing references?
5. Has the report been reviewed by a second pharmacist for completeness?

Quality Audit

• All high-alert medications in scope are identified against current ISMP list
• LASA pairs are flagged with ISMP-approved tall-man lettering
• Error-prone conditions are assessed across prescribing, dispensing, and administration
• Independent double-check requirements are verified for applicable medications
• Smart pump drug library matches approved standardized concentrations
• CPOE dose range alerts are configured with appropriate hard/soft stops
• BCMA scan compliance rate is documented for high-alert medications
• Neuromuscular blocking agents are stored separately with auxiliary warnings
• Concentrated electrolytes are removed from floor stock or have safeguards
• Vincristine is dispensed in minibag (not syringe) per ISMP/ASCO/ONS recommendation
• Insulin pen safety protocol prevents multi-patient use
• Methotrexate non-oncologic orders have weekly dosing verification
• Root cause analysis follows NCC MERP classification if applicable
• Recommendations prioritize system-level fixes over individual behavioral changes

Guidelines

• Always reference the most current ISMP High-Alert Medication List; it is updated periodically
• Prioritize system-based safeguards (forcing functions, automation) over education-only interventions
• Never rely on a single safety barrier—defense in depth requires multiple independent checks
• Vincristine must NEVER be administered intrathecally; it must be dispensed in a minibag, not a syringe
• Concentrated potassium chloride must not be available as floor stock without automated dispensing safeguards
• Insulin and heparin are the two most common causes of high-alert medication harm—prioritize their safety systems
• Report all medication errors and near-misses through institutional and national reporting systems (ISMP MERP, FDA MedWatch)
• Conduct medication safety rounds and proactive risk assessments quarterly, not only after errors occur