pediatric-pharmacy/SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md

# Standard Operating Procedure: High-Alert Medications in Pediatrics

| Document ID | SOP-SAF-001 |
|-------------|---------|
| Title | High-Alert Medications in Pediatric Pharmacy |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Pediatric Pharmacy - Patient Safety |

---

## 1. Purpose

To establish additional safety measures for medications that have heightened risk of causing significant patient harm when used in error in pediatric populations, ensuring multiple layers of verification and safeguards.

## 2. Scope

This procedure applies to all high-alert medications used in pediatric patients (birth through 18 years) across all care settings, including:
- Inpatient units (including NICU, PICU)
- Emergency department
- Outpatient clinics
- Ambulatory infusion centers
- Discharge prescriptions

## 3. Responsibilities

### 3.1 Pharmacy Director
- Maintains high-alert medication list
- Reviews list annually and after sentinel events
- Ensures adequate resources for safety measures
- Reports metrics to leadership

### 3.2 Pharmacists
- Recognizes high-alert medications
- Performs independent double-check verification
- Implements additional safeguards
- Documents verification appropriately
- Educates patients/families on high-alert medications

### 3.3 Pharmacy Technicians
- Flags high-alert medications for pharmacist review
- Applies auxiliary labels
- Follows storage and handling protocols
- Never performs final check on high-alert medications

### 3.4 Quality/Safety Committee
- Reviews errors involving high-alert medications
- Updates protocols and safeguards
- Monitors compliance with procedures

## 4. Definitions

| Term | Definition |
|------|------------|
| High-Alert Medication | Medication with increased risk of causing significant harm when used in error |
| Independent Double-Check | Separate verification by second qualified individual without influence from first check |
| Look-Alike/Sound-Alike (LASA) | Medications that appear similar or have similar names, increasing error risk |
| Maximum Dose | Highest safe dose regardless of weight-based calculation |
| Forcing Function | Design feature that prevents errors (e.g., requiring two signatures) |

## 5. Pediatric High-Alert Medication List

### 5.1 Injectable High-Alert Medications

**Chemotherapy/Antineoplastics**
- All chemotherapy agents (see SOP-CHEMO-XXX for additional protocols)
- Methotrexate (all routes, all doses in pediatrics)

**Cardiovascular**
- Digoxin injection
- Epinephrine (all concentrations)
- Vasopressors (dopamine, norepinephrine, epinephrine, vasopressin)
- Antiarrhythmics IV (amiodarone, lidocaine)

**Anticoagulants**
- Heparin (all formulations)
- Enoxaparin
- Alteplase (tPA)

**Electrolytes (Concentrated)**
- Potassium chloride injection (>0.3 mEq/mL or >20 mEq/dose)
- Potassium phosphate injection
- Sodium chloride injection (>0.9%)
- Calcium chloride/gluconate injection
- Magnesium sulfate injection (>50%)

**Opioids and Sedatives (Neonates/Infants)**
- Morphine injection
- Fentanyl injection
- Hydromorphone injection
- Midazolam injection
- Lorazepam injection
- Propofol

**Neuromuscular Blocking Agents**
- Rocuronium
- Vecuronium
- Succinylcholine

**Other Injectable**
- Insulin (all formulations)
- Oxytocin (when used for neonatal resuscitation)
- Nitroprusside

### 5.2 Oral/Enteral High-Alert Medications

**Anticoagulants**
- Warfarin (especially in infants)
- Direct oral anticoagulants (apixaban, rivaroxaban) in pediatrics

**Hypoglycemics**
- Insulin (all formulations)
- Oral hypoglycemic agents in pediatrics

**Opioids (especially for infants)**
- Liquid morphine
- Oxycodone solution
- Hydrocodone products
- Methadone

**Immunosuppressants**
- Tacrolimus
- Cyclosporine
- Mycophenolate

**Chemotherapy (Oral)**
- Mercaptopurine
- Methotrexate tablets
- All oral chemotherapy agents

**Other**
- Concentrated liquid medications requiring dilution
- Chloral hydrate (sedation)

### 5.3 Moderate Sedation Agents
- All agents used for moderate sedation in procedures

## 6. Procedure

### 6.1 Ordering Safeguards

Prescriber orders must include:
- Patient weight and age
- Indication for use
- Dose with units clearly specified (mg, not mL)
- For weight-based dosing: dose per kg and total dose
- Maximum dose consideration documented

### 6.2 Independent Double-Check Process

**Required for all high-alert medications in pediatrics**

#### Step 1: First Pharmacist Verification
1. Obtains current patient weight
2. Calculates dose independently
3. Verifies dose against reference
4. Checks maximum dose
5. Documents calculation and verification
6. Does NOT communicate findings to second pharmacist yet

#### Step 2: Second Pharmacist Independent Verification
1. Performs completely independent check
2. Obtains patient weight independently
3. Calculates dose without seeing first calculation
4. Verifies against references independently
5. Checks maximum dose independently
6. Documents independent verification

#### Step 3: Comparison
1. Both pharmacists compare results
2. If calculations match and both agree dose is appropriate: PROCEED
3. If discrepancy found:
   - STOP - do not dispense
   - Both review calculations together
   - Identify source of discrepancy
   - Re-calculate as needed
   - If question remains, contact prescriber
   - Document discrepancy and resolution

#### Step 4: Documentation
- Both pharmacists sign/initial verification
- Use FRM-DOSE-001 or equivalent
- Maintain in pharmacy records

### 6.3 Preparation Safeguards

1. **Workspace**
   - Minimize distractions during preparation
   - Clear workspace of other medications
   - Use separate designated area if available

2. **Labeling**
   - Apply auxiliary label: "HIGH ALERT MEDICATION"
   - Include patient-specific calculated dose on label
   - For concentrated electrolytes: "MUST BE DILUTED"

3. **Dilution (if required)**
   - Use pre-mixed solutions when available
   - If mixing required, independent double-check of dilution
   - Label final concentration clearly
   - Document dilution on preparation record

4. **Verification Before Dispensing**
   - Right patient
   - Right medication
   - Right dose (verified calculation)
   - Right route
   - Right time/frequency

### 6.4 Storage Safeguards

1. **Concentrated Electrolytes**
   - Remove from general access areas
   - Store in designated, locked location
   - Require override for access
   - Maintain only minimal quantities

2. **Neuromuscular Blocking Agents**
   - Separate from sedatives
   - Apply warning labels: "WARNING: PARALYZING AGENT"
   - Store in locked area with restricted access

3. **Look-Alike/Sound-Alike (LASA) Medications**
   - Separate storage locations
   - Tall Man lettering on bins/shelves
   - Different bin colors if possible
   - Alert in computer system

### 6.5 Dispensing Safeguards

1. **Final Pharmacist Check**
   - Review independent double-check documentation
   - Verify auxiliary labels applied
   - Confirm appropriate concentration for patient age
   - For inpatients: verify order in patient profile

2. **Patient/Family Counseling**
   - Explain this is a high-alert medication
   - Review extra precautions being taken
   - Emphasize importance of precise dosing
   - Demonstrate measurement technique
   - Provide written information
   - Encourage questions

### 6.6 Special Considerations by Age

**Neonates (0-28 days)**
- All opioids and sedatives require double-check (not just high-alert list)
- Extra caution with concentrated medications
- Verify gestational age considered in dosing

**Infants (29 days - 12 months)**
- Weight changes rapidly - verify current weight
- Many adult "routine" medications are high-alert in infants
- Consider developmental immaturities affecting drug response

**Children (1-12 years)**
- Ensure dose appropriate for child vs. infant dosing
- Verify maximum doses not exceeded
- Consider if weight appropriate for age (obesity/malnutrition)

**Adolescents (13-18 years)**
- Verify if adult dosing appropriate or still pediatric
- Consider if dose exceeds adult maximum
- Address transition to adult care if applicable

## 7. Error Prevention Strategies

### 7.1 System-Based Safeguards
- Clinical decision support in computer system
- Hard stops for dangerous doses
- Required fields (weight, indication)
- Default maximum doses in system
- Alert fatigue management (meaningful alerts only)

### 7.2 Process-Based Safeguards
- Standardized concentrations
- Pre-mixed solutions when available
- Elimination of concentrated stock when possible
- Protocols and order sets
- Independent double-check

### 7.3 Human Factors
- Minimize interruptions during critical tasks
- Adequate staffing for verification process
- Regular training and competency assessment
- Culture of safety - encouraged to speak up
- Non-punitive error reporting

## 8. Monitoring and Reporting

### 8.1 Metrics to Track
- Number of high-alert medication doses verified
- Discrepancies found in double-check process
- Errors/near misses involving high-alert medications
- Compliance with verification procedures
- Time to verification (balancing safety with efficiency)

### 8.2 Reporting
- Monthly report to Pharmacy & Therapeutics Committee
- Quarterly report to Quality/Safety Committee
- Immediate reporting of serious errors or near-misses
- Annual review of high-alert medication list

### 8.3 Continuous Improvement
- Review all errors involving high-alert medications
- Implement additional safeguards as identified
- Update protocols based on new evidence
- Share learnings with staff

## 9. Training Requirements

All pharmacists must demonstrate competency in:
- Recognizing high-alert medications
- Performing independent double-check
- Pediatric dose calculation and verification
- Maximum dose application
- Error prevention strategies

Annual competency assessment required (see FRM-004).

## 10. Records

| Record | Location | Retention |
|--------|----------|-----------|
| Independent verification forms | Pharmacy records | Per patient record retention |
| High-alert medication list | Pharmacy policy manual | Current + 3 years |
| Error reports | Quality/Safety | 7 years |
| Metrics reports | Pharmacy quality | 3 years |

## 11. Related Documents

- FRM-DOSE-001 Pediatric Dose Calculation Worksheet
- SOP-DOSE-001 Weight-Based Dosing Verification
- SOP-CHEMO-XXX Chemotherapy Verification
- Institutional High-Alert Medication List
- ISMP List of High-Alert Medications in Pediatrics

## 12. References

- ISMP List of High-Alert Medications in Acute Care Settings
- ISMP List of High-Alert Medications in Community/Ambulatory Settings
- Joint Commission National Patient Safety Goals
- ASHP Guidelines on Preventing Medication Errors in Hospitals
- State Board of Pharmacy regulations
- Institutional medication safety policies

---

## Appendix A: Pediatric-Specific LASA Medications

| Drug | Often Confused With | Differentiation Strategy |
|------|---------------------|-------------------------|
| vinBLAStine | vinCRIStine | Tall man lettering, separate storage |
| DOPamine | DOBUTamine | Tall man lettering, different concentrations |
| hydrOXYzine | hydrALAzine | Tall man lettering |
| Morphine 20 mg/mL | Morphine 2 mg/mL | Different bin colors, concentration warnings |

## Appendix B: Quick Reference - When is Independent Double-Check Required?

☑ All chemotherapy/antineoplastic agents
☑ Insulin (all formulations)
☑ Anticoagulants (heparin, enoxaparin)
☑ Concentrated electrolytes
☑ Opioids in neonates/infants
☑ Neuromuscular blocking agents
☑ Vasoactive drips

---

## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |