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SOPs/Patient-Safety/.gitkeep
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SOPs/Patient-Safety/.gitkeep
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SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md
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SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md
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# Standard Operating Procedure: High-Alert Medications in Pediatrics
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| Document ID | SOP-SAF-001 |
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| Title | High-Alert Medications in Pediatric Pharmacy |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Pediatric Pharmacy - Patient Safety |
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---
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## 1. Purpose
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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.
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## 2. Scope
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This procedure applies to all high-alert medications used in pediatric patients (birth through 18 years) across all care settings, including:
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- Inpatient units (including NICU, PICU)
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- Emergency department
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- Outpatient clinics
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- Ambulatory infusion centers
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- Discharge prescriptions
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## 3. Responsibilities
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### 3.1 Pharmacy Director
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- Maintains high-alert medication list
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- Reviews list annually and after sentinel events
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- Ensures adequate resources for safety measures
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- Reports metrics to leadership
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### 3.2 Pharmacists
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- Recognizes high-alert medications
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- Performs independent double-check verification
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- Implements additional safeguards
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- Documents verification appropriately
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- Educates patients/families on high-alert medications
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### 3.3 Pharmacy Technicians
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- Flags high-alert medications for pharmacist review
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- Applies auxiliary labels
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- Follows storage and handling protocols
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- Never performs final check on high-alert medications
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### 3.4 Quality/Safety Committee
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- Reviews errors involving high-alert medications
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- Updates protocols and safeguards
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- Monitors compliance with procedures
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| High-Alert Medication | Medication with increased risk of causing significant harm when used in error |
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| Independent Double-Check | Separate verification by second qualified individual without influence from first check |
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| Look-Alike/Sound-Alike (LASA) | Medications that appear similar or have similar names, increasing error risk |
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| Maximum Dose | Highest safe dose regardless of weight-based calculation |
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| Forcing Function | Design feature that prevents errors (e.g., requiring two signatures) |
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## 5. Pediatric High-Alert Medication List
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### 5.1 Injectable High-Alert Medications
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**Chemotherapy/Antineoplastics**
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- All chemotherapy agents (see SOP-CHEMO-XXX for additional protocols)
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- Methotrexate (all routes, all doses in pediatrics)
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**Cardiovascular**
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- Digoxin injection
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- Epinephrine (all concentrations)
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- Vasopressors (dopamine, norepinephrine, epinephrine, vasopressin)
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- Antiarrhythmics IV (amiodarone, lidocaine)
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**Anticoagulants**
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- Heparin (all formulations)
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- Enoxaparin
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- Alteplase (tPA)
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**Electrolytes (Concentrated)**
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- Potassium chloride injection (>0.3 mEq/mL or >20 mEq/dose)
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- Potassium phosphate injection
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- Sodium chloride injection (>0.9%)
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- Calcium chloride/gluconate injection
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- Magnesium sulfate injection (>50%)
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**Opioids and Sedatives (Neonates/Infants)**
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- Morphine injection
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- Fentanyl injection
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- Hydromorphone injection
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- Midazolam injection
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- Lorazepam injection
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- Propofol
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**Neuromuscular Blocking Agents**
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- Rocuronium
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- Vecuronium
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- Succinylcholine
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**Other Injectable**
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- Insulin (all formulations)
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- Oxytocin (when used for neonatal resuscitation)
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- Nitroprusside
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### 5.2 Oral/Enteral High-Alert Medications
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**Anticoagulants**
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- Warfarin (especially in infants)
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- Direct oral anticoagulants (apixaban, rivaroxaban) in pediatrics
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**Hypoglycemics**
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- Insulin (all formulations)
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- Oral hypoglycemic agents in pediatrics
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**Opioids (especially for infants)**
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- Liquid morphine
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- Oxycodone solution
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- Hydrocodone products
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- Methadone
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**Immunosuppressants**
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- Tacrolimus
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- Cyclosporine
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- Mycophenolate
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**Chemotherapy (Oral)**
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- Mercaptopurine
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- Methotrexate tablets
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- All oral chemotherapy agents
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**Other**
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- Concentrated liquid medications requiring dilution
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- Chloral hydrate (sedation)
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### 5.3 Moderate Sedation Agents
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- All agents used for moderate sedation in procedures
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## 6. Procedure
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### 6.1 Ordering Safeguards
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Prescriber orders must include:
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- Patient weight and age
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- Indication for use
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- Dose with units clearly specified (mg, not mL)
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- For weight-based dosing: dose per kg and total dose
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- Maximum dose consideration documented
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### 6.2 Independent Double-Check Process
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**Required for all high-alert medications in pediatrics**
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#### Step 1: First Pharmacist Verification
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1. Obtains current patient weight
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2. Calculates dose independently
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3. Verifies dose against reference
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4. Checks maximum dose
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5. Documents calculation and verification
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6. Does NOT communicate findings to second pharmacist yet
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#### Step 2: Second Pharmacist Independent Verification
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1. Performs completely independent check
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2. Obtains patient weight independently
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3. Calculates dose without seeing first calculation
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4. Verifies against references independently
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5. Checks maximum dose independently
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6. Documents independent verification
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#### Step 3: Comparison
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1. Both pharmacists compare results
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2. If calculations match and both agree dose is appropriate: PROCEED
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3. If discrepancy found:
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- STOP - do not dispense
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- Both review calculations together
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- Identify source of discrepancy
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- Re-calculate as needed
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- If question remains, contact prescriber
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- Document discrepancy and resolution
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#### Step 4: Documentation
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- Both pharmacists sign/initial verification
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- Use FRM-DOSE-001 or equivalent
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- Maintain in pharmacy records
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### 6.3 Preparation Safeguards
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1. **Workspace**
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- Minimize distractions during preparation
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- Clear workspace of other medications
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- Use separate designated area if available
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2. **Labeling**
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- Apply auxiliary label: "HIGH ALERT MEDICATION"
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- Include patient-specific calculated dose on label
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- For concentrated electrolytes: "MUST BE DILUTED"
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3. **Dilution (if required)**
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- Use pre-mixed solutions when available
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- If mixing required, independent double-check of dilution
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- Label final concentration clearly
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- Document dilution on preparation record
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4. **Verification Before Dispensing**
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- Right patient
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- Right medication
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- Right dose (verified calculation)
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- Right route
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- Right time/frequency
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### 6.4 Storage Safeguards
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1. **Concentrated Electrolytes**
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- Remove from general access areas
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- Store in designated, locked location
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- Require override for access
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- Maintain only minimal quantities
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2. **Neuromuscular Blocking Agents**
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- Separate from sedatives
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- Apply warning labels: "WARNING: PARALYZING AGENT"
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- Store in locked area with restricted access
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3. **Look-Alike/Sound-Alike (LASA) Medications**
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- Separate storage locations
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- Tall Man lettering on bins/shelves
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- Different bin colors if possible
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- Alert in computer system
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### 6.5 Dispensing Safeguards
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1. **Final Pharmacist Check**
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- Review independent double-check documentation
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- Verify auxiliary labels applied
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- Confirm appropriate concentration for patient age
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- For inpatients: verify order in patient profile
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2. **Patient/Family Counseling**
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- Explain this is a high-alert medication
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- Review extra precautions being taken
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- Emphasize importance of precise dosing
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- Demonstrate measurement technique
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- Provide written information
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- Encourage questions
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### 6.6 Special Considerations by Age
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**Neonates (0-28 days)**
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- All opioids and sedatives require double-check (not just high-alert list)
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- Extra caution with concentrated medications
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- Verify gestational age considered in dosing
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**Infants (29 days - 12 months)**
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- Weight changes rapidly - verify current weight
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- Many adult "routine" medications are high-alert in infants
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- Consider developmental immaturities affecting drug response
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**Children (1-12 years)**
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- Ensure dose appropriate for child vs. infant dosing
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- Verify maximum doses not exceeded
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- Consider if weight appropriate for age (obesity/malnutrition)
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**Adolescents (13-18 years)**
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- Verify if adult dosing appropriate or still pediatric
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- Consider if dose exceeds adult maximum
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- Address transition to adult care if applicable
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## 7. Error Prevention Strategies
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### 7.1 System-Based Safeguards
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- Clinical decision support in computer system
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- Hard stops for dangerous doses
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- Required fields (weight, indication)
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- Default maximum doses in system
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- Alert fatigue management (meaningful alerts only)
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### 7.2 Process-Based Safeguards
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- Standardized concentrations
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- Pre-mixed solutions when available
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- Elimination of concentrated stock when possible
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- Protocols and order sets
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- Independent double-check
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### 7.3 Human Factors
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- Minimize interruptions during critical tasks
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- Adequate staffing for verification process
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- Regular training and competency assessment
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- Culture of safety - encouraged to speak up
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- Non-punitive error reporting
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## 8. Monitoring and Reporting
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### 8.1 Metrics to Track
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- Number of high-alert medication doses verified
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- Discrepancies found in double-check process
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- Errors/near misses involving high-alert medications
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- Compliance with verification procedures
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- Time to verification (balancing safety with efficiency)
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### 8.2 Reporting
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- Monthly report to Pharmacy & Therapeutics Committee
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- Quarterly report to Quality/Safety Committee
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- Immediate reporting of serious errors or near-misses
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- Annual review of high-alert medication list
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### 8.3 Continuous Improvement
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- Review all errors involving high-alert medications
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- Implement additional safeguards as identified
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- Update protocols based on new evidence
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- Share learnings with staff
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## 9. Training Requirements
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All pharmacists must demonstrate competency in:
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- Recognizing high-alert medications
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- Performing independent double-check
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- Pediatric dose calculation and verification
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- Maximum dose application
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- Error prevention strategies
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Annual competency assessment required (see FRM-004).
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## 10. Records
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| Record | Location | Retention |
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|--------|----------|-----------|
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| Independent verification forms | Pharmacy records | Per patient record retention |
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| High-alert medication list | Pharmacy policy manual | Current + 3 years |
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| Error reports | Quality/Safety | 7 years |
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| Metrics reports | Pharmacy quality | 3 years |
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## 11. Related Documents
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- FRM-DOSE-001 Pediatric Dose Calculation Worksheet
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- SOP-DOSE-001 Weight-Based Dosing Verification
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- SOP-CHEMO-XXX Chemotherapy Verification
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- Institutional High-Alert Medication List
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- ISMP List of High-Alert Medications in Pediatrics
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## 12. References
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- ISMP List of High-Alert Medications in Acute Care Settings
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- ISMP List of High-Alert Medications in Community/Ambulatory Settings
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- Joint Commission National Patient Safety Goals
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- ASHP Guidelines on Preventing Medication Errors in Hospitals
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- State Board of Pharmacy regulations
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- Institutional medication safety policies
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---
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## Appendix A: Pediatric-Specific LASA Medications
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| Drug | Often Confused With | Differentiation Strategy |
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|------|---------------------|-------------------------|
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| vinBLAStine | vinCRIStine | Tall man lettering, separate storage |
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| DOPamine | DOBUTamine | Tall man lettering, different concentrations |
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| hydrOXYzine | hydrALAzine | Tall man lettering |
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| Morphine 20 mg/mL | Morphine 2 mg/mL | Different bin colors, concentration warnings |
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## Appendix B: Quick Reference - When is Independent Double-Check Required?
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☑ All chemotherapy/antineoplastic agents
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☑ Insulin (all formulations)
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☑ Anticoagulants (heparin, enoxaparin)
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☑ Concentrated electrolytes
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☑ Opioids in neonates/infants
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☑ Neuromuscular blocking agents
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☑ Vasoactive drips
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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