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SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md

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+# Standard Operating Procedure: Compounding Pediatric Oral Suspensions
+
+| Document ID | SOP-COMP-001 |
+|-------------|---------|
+| Title | Compounding Pediatric Oral Suspensions from Solid Dosage Forms |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy - Compounding |
+
+---
+
+## 1. Purpose
+
+To establish a standardized process for compounding oral suspensions from tablets or capsules to provide age-appropriate, accurately dosed medications for pediatric patients when commercial liquid formulations are unavailable.
+
+## 2. Scope
+
+This procedure applies to non-sterile compounding of oral suspensions from solid dosage forms for pediatric patients. It covers:
+- Crushing tablets or opening capsules
+- Preparing suspensions in appropriate vehicles
+- Flavoring for palatability
+- Labeling and beyond-use dating
+- Quality verification
+
+This procedure does not apply to:
+- Hazardous drugs (see USP <800> procedures)
+- Sterile preparations
+- Commercial liquid formulations
+
+## 3. Responsibilities
+
+### 3.1 Pharmacist
+- Verifies formulation and calculations
+- Selects appropriate vehicle and flavoring
+- Determines beyond-use date
+- Performs final verification
+- Provides counseling on administration and storage
+
+### 3.2 Pharmacy Technician
+- Prepares workspace
+- Compounds suspension following procedure
+- Labels container appropriately
+- Cleans and documents
+
+### 3.3 Quality Reviewer
+- Verifies calculations independently
+- Checks final product
+- Approves for dispensing
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Oral Suspension | Liquid dosage form containing solid particles dispersed in liquid vehicle |
+| Vehicle | Liquid base used to suspend active ingredient |
+| Beyond-Use Date (BUD) | Date after which compounded preparation should not be used |
+| Geometric Dilution | Technique for mixing small quantity with larger quantity by doubling proportions |
+| Ora-Plus/Ora-Sweet | Common suspending vehicle and sweetening agent for pediatric suspensions |
+
+## 5. Equipment and Materials
+
+### 5.1 Equipment
+- Mortar and pestle (appropriately sized)
+- Graduated cylinder (appropriate volume)
+- Amber or light-resistant bottle
+- Spatula
+- Weighing scale (class III or better)
+- Calibrated oral syringes for measuring
+
+### 5.2 Materials
+- Solid dosage form (tablets or capsules)
+- Suspending vehicle (Ora-Plus, SyrSpend SF, methylcellulose, etc.)
+- Sweetening agent (Ora-Sweet, Ora-Sweet SF, syrup, etc.)
+- Flavoring (if needed)
+- Appropriate label
+- Compounding log
+
+## 6. Procedure
+
+### 6.1 Preparation and Planning
+
+1. **Review Prescription**
+   - Verify medication, strength, and quantity
+   - Calculate total amount needed plus overage (typically 10-20%)
+   - Determine final concentration
+   - Check for drug-vehicle compatibility
+
+2. **Select Vehicle and Flavoring**
+   - Choose appropriate vehicle for medication stability
+   - Consider patient age and preferences
+   - Select sugar-free vehicles if appropriate (diabetic patients)
+   - Choose flavoring (see Appendix A for flavor recommendations)
+
+3. **Calculate Beyond-Use Date**
+   - Reference stability data (published studies, manufacturers)
+   - Apply USP <795> guidelines if no data available:
+     - Aqueous formulations: Maximum 14 days refrigerated
+     - Non-aqueous formulations: Maximum 30 days
+   - Use most conservative date if multiple sources
+
+4. **Gather Materials**
+   - Obtain correct tablets/capsules (verify NDC)
+   - Obtain vehicle and flavoring
+   - Select appropriate bottle size
+   - Prepare workspace
+
+### 6.2 Compounding Process
+
+1. **Hand Hygiene and Garbing**
+   - Wash hands thoroughly
+   - Don lab coat and gloves
+   - No jewelry on hands/wrists
+
+2. **Clean Workspace**
+   - Disinfect compounding area
+   - Ensure equipment is clean and dry
+   - Remove unnecessary items
+
+3. **Preparation of Solid Dosage Form**
+
+   **For Tablets:**
+   - Count correct number of tablets
+   - Place in mortar
+   - Crush to fine, uniform powder
+   - Triturate until no large particles remain
+
+   **For Capsules:**
+   - Count correct number of capsules
+   - Empty capsule contents into mortar
+   - Discard empty capsule shells appropriately
+   - Mix powder thoroughly
+
+4. **Geometric Dilution with Vehicle**
+
+   - Measure small amount of vehicle (approximately equal volume to powder)
+   - Add to powder in mortar
+   - Triturate to form smooth paste (no lumps)
+   - Add another equal portion of vehicle
+   - Mix thoroughly
+   - Continue doubling portions until all powder incorporated
+   - Transfer to graduated cylinder
+
+5. **Add Remaining Vehicle**
+
+   - Rinse mortar with vehicle to capture all medication
+   - Transfer to graduated cylinder
+   - Add vehicle to desired final volume
+   - Add flavoring if using separate flavoring agent
+
+6. **Mix Thoroughly**
+
+   - Cap bottle securely
+   - Shake vigorously for 30 seconds
+   - Visually inspect for uniform suspension
+   - No clumps or settling immediately after shaking
+
+### 6.3 Quality Checks
+
+1. **Visual Inspection**
+   - Color appropriate for ingredients
+   - Smooth consistency (no large particles)
+   - Uniform suspension when shaken
+   - No visible contamination
+
+2. **Volume Verification**
+   - Final volume matches calculated volume (±5%)
+   - Adequate overage to allow for bottle hold-up
+
+3. **Concentration Verification**
+   - Independent pharmacist verifies calculation
+   - Example: 30 tablets × 100 mg = 3000 mg in 150 mL = 20 mg/mL
+
+### 6.4 Labeling
+
+Apply pharmacy label with following information:
+- Patient name and date of birth
+- Medication name and strength per volume (e.g., "20 mg/mL")
+- Directions for use
+- "SHAKE WELL BEFORE EACH USE"
+- Beyond-use date
+- Storage instructions (e.g., "Refrigerate" or "Store at room temperature")
+- "For Oral Use Only"
+- Flavor (if added)
+- Auxiliary labels as appropriate
+- Pharmacist initials
+- Compounding date
+
+### 6.5 Final Verification
+
+Pharmacist verifies:
+- Correct medication and strength
+- Accurate calculation
+- Appropriate concentration for patient age and weight
+- Correct labeling
+- BUD appropriate
+- Storage instructions clear
+- Oral syringe provided for accurate dosing
+
+### 6.6 Counseling Points
+
+Provide to patient/caregiver:
+- Shake well before each use
+- Use provided oral syringe for measuring (never household spoon)
+- Storage requirements (refrigerate if required)
+- Beyond-use date
+- What to do if dose missed
+- Possible side effects
+- Complete full course even if feeling better
+
+### 6.7 Documentation
+
+Complete compounding log with:
+- Date and time
+- Patient name
+- Medication and strength
+- Lot numbers of all ingredients
+- Expiration dates of ingredients
+- Calculations
+- Final concentration and volume
+- BUD assigned
+- Compounding pharmacist/technician
+- Verifying pharmacist
+
+### 6.8 Cleanup
+
+- Wash all equipment with hot soapy water
+- Rinse thoroughly and dry
+- Disinfect work surface
+- Dispose of waste appropriately
+- Return ingredients to storage
+
+## 7. Common Pediatric Suspensions
+
+| Medication | Typical Concentration | Vehicle | Stability (refrigerated) |
+|------------|----------------------|---------|--------------------------|
+| Atenolol | 2 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 60 days |
+| Captopril | 1 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 56 days |
+| Clonidine | 0.1 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 91 days |
+| Enalapril | 1 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 60 days |
+| Propranolol | 1 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 42 days |
+| Spironolactone | 5 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 60 days |
+
+*Always verify stability data from current references before compounding*
+
+## 8. Appendix A: Pediatric Flavoring Guide
+
+| Age Group | Preferred Flavors |
+|-----------|-------------------|
+| Infants (< 1 year) | Minimize flavoring; consider mother's diet if breastfeeding |
+| Toddlers (1-3 years) | Cherry, grape, bubblegum, strawberry |
+| Children (4-12 years) | Watermelon, grape, cherry, bubblegum, chocolate |
+| Adolescents (13-18 years) | Fruit flavors, vanilla, chocolate |
+
+| Medication Type | Flavoring Recommendation |
+|-----------------|--------------------------|
+| Bitter medications | Chocolate, vanilla, or cream flavors |
+| Salty medications | Citrus or fruit flavors |
+| Acidic medications | Fruit punch or grape |
+
+## 9. Related Documents
+
+- FRM-COMP-001 Compounding Record
+- Master Formulation Records (if established)
+- USP <795> Pharmaceutical Compounding - Nonsterile Preparations
+- Pediatric dosing references
+
+## 10. References
+
+- USP <795> Pharmaceutical Compounding - Nonsterile Preparations
+- ASHP Guidelines on Compounding Sterile Preparations
+- Trissel's Stability of Compounded Formulations
+- Paddock Laboratories Flavoring Guide
+- State Board of Pharmacy compounding regulations
+- Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients (ASHP)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Dosing-Verification/SOP-DOSE-001-Weight-Based-Dosing.md

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+# Standard Operating Procedure: Weight-Based Dosing Verification
+
+| Document ID | SOP-DOSE-001 |
+|-------------|---------|
+| Title | Weight-Based Dosing Verification for Pediatric Patients |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy |
+
+---
+
+## 1. Purpose
+
+To establish a standardized process for verifying weight-based medication dosing calculations for pediatric patients to ensure safe and accurate dosing and prevent calculation errors.
+
+## 2. Scope
+
+This procedure applies to all weight-based (mg/kg or mcg/kg) medication orders for pediatric patients from birth through 18 years of age (or institutional age limit). This includes orders for:
+- Inpatient medications
+- Outpatient prescriptions
+- Emergency department medications
+- Chemotherapy (see also SOP-CHEMO-XXX)
+- Investigational medications
+
+## 3. Responsibilities
+
+### 3.1 Prescriber
+- Orders medication with appropriate indication
+- Specifies patient weight or references weight in system
+- Includes dosing frequency and duration
+
+### 3.2 Pharmacist
+- Verifies patient weight is current
+- Calculates dose based on weight
+- Verifies dose is within therapeutic range
+- Verifies maximum dose not exceeded
+- Performs independent double-check for high-alert medications
+- Documents verification
+
+### 3.3 Pharmacy Technician (if applicable per state law)
+- May perform initial calculation
+- Documents calculation method
+- Flags order for pharmacist verification
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Weight-based dosing | Medication dose calculated based on patient body weight (mg/kg or mcg/kg) |
+| Current weight | Weight obtained within timeframe per institutional policy (typically 24-72 hours for inpatients) |
+| Maximum dose | Upper limit of dose regardless of calculated weight-based dose |
+| Therapeutic range | Accepted dosing range for specific indication and patient age |
+| Independent double-check | Separate calculation by second pharmacist without viewing first calculation |
+
+## 5. Equipment/Resources Required
+
+- Pediatric dosing references (Lexicomp, Micromedex, Harriet Lane, etc.)
+- Calculator or verified dosing calculator software
+- Access to current patient weight in medical record
+- Age-appropriate dosing guidelines
+
+## 6. Procedure
+
+### 6.1 Patient Information Verification
+
+1. **Confirm Patient Identity**
+   - Verify patient name and date of birth
+   - Confirm medical record number
+
+2. **Obtain Current Weight**
+   - Check date/time of most recent weight
+   - Ensure weight is current per institutional policy:
+     - NICU/critical care: Within 24 hours
+     - Inpatient: Within 72 hours
+     - Outpatient: Within 3-6 months (per age)
+   - If weight not current, request updated weight before proceeding
+   - Document weight used (value and date obtained)
+
+3. **Verify Weight Units**
+   - Confirm weight in kilograms (kg)
+   - If weight in pounds, convert: kg = pounds ÷ 2.2
+   - Round to appropriate decimal places (typically 0.1 kg)
+
+### 6.2 Dose Calculation
+
+1. **Identify Prescribed Dose**
+   - Note ordered dose (mg/kg/dose or mg/kg/day)
+   - Identify dosing frequency
+   - Determine if dose is per dose or per day (total daily dose)
+
+2. **Calculate Individual Dose**
+   ```
+   If ordered as mg/kg/dose:
+   Dose = Weight (kg) × mg/kg/dose
+
+   If ordered as mg/kg/day:
+   Total daily dose = Weight (kg) × mg/kg/day
+   Individual dose = Total daily dose ÷ number of doses per day
+   ```
+
+3. **Round Appropriately**
+   - Follow institutional rounding guidelines
+   - Consider available dosage forms
+   - Round to measurable quantity
+   - Be cautious with high-potency drugs (may require more precision)
+
+### 6.3 Dose Verification
+
+1. **Reference Check**
+   - Consult pediatric dosing reference
+   - Verify dose is appropriate for:
+     - Patient age
+     - Indication
+     - Renal/hepatic function (if applicable)
+   - Check for age-specific restrictions
+
+2. **Range Verification**
+   - Confirm calculated dose is within therapeutic range
+   - Check if dose falls within:
+     - Minimum effective dose
+     - Maximum recommended dose
+   - For unusual doses, document clinical rationale
+
+3. **Maximum Dose Check**
+   - Identify if medication has maximum dose
+   - Verify calculated dose does not exceed adult or absolute maximum
+   - Document if maximum dose applied instead of calculated dose
+
+4. **Special Populations**
+   - **Neonates**: Check if gestational age affects dosing
+   - **Obese patients**: Determine if ideal body weight should be used
+   - **Renal/hepatic impairment**: Apply dose adjustments if needed
+
+### 6.4 Independent Double-Check (High-Alert Medications)
+
+For high-alert medications, independent verification required:
+
+1. **First Pharmacist**
+   - Performs calculation as outlined above
+   - Documents result
+   - Does not communicate result to second pharmacist
+
+2. **Second Pharmacist**
+   - Independently obtains patient weight
+   - Independently calculates dose
+   - Independently verifies range and maximum
+   - Compares result with first pharmacist
+
+3. **Discrepancy Resolution**
+   - If calculations match, proceed
+   - If discrepancy identified:
+     - Both pharmacists review calculation together
+     - Identify source of error
+     - Re-calculate if needed
+     - Document discrepancy and resolution
+
+### 6.5 High-Alert Medications Requiring Independent Double-Check
+
+- Chemotherapy agents
+- Insulin
+- Opioids (for neonates/infants)
+- Concentrated electrolytes
+- Anticoagulants (heparin, enoxaparin)
+- Neuromuscular blocking agents
+- Moderate sedation agents
+- [Add institution-specific medications]
+
+### 6.6 Documentation
+
+Document in pharmacy system or dosing worksheet:
+- Patient weight and date
+- Dose ordered (mg/kg)
+- Calculated dose
+- Dose rounded/dispensed
+- Maximum dose verification (if applicable)
+- Reference source
+- Pharmacist initials/signature
+- Second pharmacist verification (if applicable)
+
+### 6.7 Unusual Doses
+
+For doses outside normal range but clinically justified:
+1. Contact prescriber for clarification
+2. Document prescriber confirmation
+3. Document clinical rationale in pharmacy record
+4. Consider additional verification by clinical pharmacist or pharmacy manager
+5. Monitor patient response
+
+## 7. Examples
+
+### Example 1: Amoxicillin for Otitis Media
+- Patient: 2-year-old, weight 12.5 kg
+- Order: Amoxicillin 45 mg/kg/day divided BID
+- Calculation:
+  - Total daily dose = 12.5 kg × 45 mg/kg/day = 562.5 mg/day
+  - Individual dose = 562.5 mg ÷ 2 = 281.25 mg per dose
+  - Rounded dose = 280 mg per dose (or 300 mg if using suspension)
+- Reference check: Within range for acute otitis media (40-80 mg/kg/day)
+- Maximum: Does not apply for amoxicillin
+
+### Example 2: Vancomycin for MRSA (with maximum dose)
+- Patient: 14-year-old, weight 75 kg
+- Order: Vancomycin 15 mg/kg IV q12h
+- Calculation:
+  - Individual dose = 75 kg × 15 mg/kg = 1,125 mg
+- Maximum dose check: 1,000 mg per dose (typical maximum)
+- **Dispense: 1,000 mg** (maximum dose applied)
+- Document that maximum dose used instead of calculated dose
+
+## 8. Quality Checks
+
+- Monthly review of dosing errors/near misses
+- Audit of weight documentation compliance
+- Review of maximum dose overrides
+- Trending of calculation discrepancies in double-check process
+
+## 9. Related Documents
+
+- FRM-DOSE-001 Pediatric Dose Calculation Worksheet
+- SOP-CHEMO-XXX Chemotherapy Dosing Verification
+- High-Alert Medication List
+- Pediatric Dosing Reference Guide
+
+## 10. References
+
+- ISMP Guidelines for Standard Order Sets
+- ASHP Guidelines on Preventing Medication Errors in Hospitals
+- Pediatric dosing references (Lexicomp, Micromedex)
+- Institutional dosing guidelines
+- State Board of Pharmacy practice standards
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

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

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+# 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] |

SOPs/SOP-001-Document-Control.md

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+# Standard Operating Procedure: Document Control
+
+| Document ID | SOP-001 |
+|-------------|---------|
+| Title | Document Control |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy - Quality |
+
+---
+
+## 1. Purpose
+
+To establish a standardized process for the creation, review, approval, distribution, and revision of all pediatric pharmacy Quality Management System (QMS) documents.
+
+## 2. Scope
+
+This procedure applies to all controlled documents within the pediatric pharmacy QMS, including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions (WIs)
+- Forms and Templates
+- Dosing protocols and guidelines
+- Compounding formulations
+- Training materials
+
+## 3. Responsibilities
+
+### 3.1 Quality Manager
+- Oversees the document control system
+- Ensures documents are reviewed and approved appropriately
+- Maintains the master document list
+- Coordinates periodic reviews
+
+### 3.2 Document Owners
+- Initiates creation or revision of documents
+- Ensures technical accuracy and clinical appropriateness
+- Coordinates reviews with subject matter experts
+- Maintains pediatric-specific content accuracy
+
+### 3.3 Approvers
+- Reviews documents for compliance and quality
+- Provides final approval for implementation
+- Ensures pediatric safety considerations are addressed
+
+### 3.4 All Pharmacy Staff
+- Uses only current, approved versions of documents
+- Reports discrepancies or improvement opportunities
+- Follows documented procedures
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Controlled Document | Any document that is part of the QMS and subject to version control |
+| Master Document List | Comprehensive list of all controlled documents |
+| Revision | Any change to a controlled document requiring re-approval |
+| Obsolete Document | Document that is no longer current and has been superseded |
+| Effective Date | Date when a new or revised document becomes active |
+
+## 5. Procedure
+
+### 5.1 Document Creation
+
+1. Document owner identifies need for new document
+2. Selects appropriate template from `/Templates`
+3. Drafts document following standard format
+4. Ensures pediatric-specific considerations are included
+5. Assigns unique document ID according to numbering convention
+6. Routes for technical review
+
+### 5.2 Document Review
+
+1. Subject matter experts review for technical accuracy
+2. Quality Manager reviews for compliance with standards
+3. Clinical pharmacist reviews for pediatric appropriateness
+4. Reviewers provide feedback within 5 business days
+5. Document owner incorporates feedback
+
+### 5.3 Document Approval
+
+1. Document owner submits final version for approval
+2. Approver reviews complete document
+3. Approver signs/dates document or provides approval comment
+4. Quality Manager assigns effective date (minimum 7 days from approval)
+5. Document added to Master Document List
+
+### 5.4 Document Distribution
+
+1. Quality Manager publishes approved document to repository
+2. Notification sent to all affected personnel
+3. Training conducted if required
+4. Old version moved to archive (if revision)
+
+### 5.5 Document Revision
+
+1. Anyone may initiate revision request via change request form
+2. Document owner evaluates need for revision
+3. If approved, follows creation process with new revision number
+4. Revision history table updated with change description
+5. All copies of previous version removed from use
+
+### 5.6 Periodic Review
+
+1. All documents reviewed at least annually
+2. Review verifies:
+   - Content remains accurate and current
+   - Regulatory references are up to date
+   - Pediatric practice standards are current
+   - Process remains effective
+3. Review documented even if no changes made
+4. Documents may be re-approved or revised as needed
+
+### 5.7 Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-DOSE-XXX**: Dosing Verification SOPs
+- **SOP-COMP-XXX**: Compounding SOPs
+- **SOP-CHEMO-XXX**: Chemotherapy SOPs
+- **SOP-SAF-XXX**: Patient Safety SOPs
+- **SOP-CS-XXX**: Controlled Substance SOPs
+- **SOP-INV-XXX**: Inventory SOPs
+- **SOP-GEN-XXX**: General SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms
+- **LOG-XXX**: Logs
+
+## 6. Version Control
+
+- Major revisions: Change whole number (1.0 → 2.0)
+- Minor revisions: Change decimal (1.0 → 1.1)
+- All revisions require re-approval
+- Revision history maintained in document footer
+
+## 7. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| Master Document List | Quality folder | Permanent |
+| Obsolete documents | Archive folder | 3 years after obsolescence |
+| Change requests | Quality records | 3 years |
+| Review records | Quality records | 3 years |
+
+## 8. Related Documents
+
+- FRM-001 Document Change Request
+- Master Document List
+- Document templates in `/Templates`
+
+## 9. References
+
+- ISO 9001:2015 Section 7.5 (Documented Information)
+- FDA 21 CFR Part 211.186 (Master Production and Control Records)
+- State Board of Pharmacy record-keeping requirements
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-002-CAPA.md

@@ -0,0 +1,219 @@
+# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
+
+| Document ID | SOP-002 |
+|-------------|---------|
+| Title | Corrective and Preventive Action (CAPA) |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy - Quality |
+
+---
+
+## 1. Purpose
+
+To establish a systematic approach for identifying, investigating, and resolving quality issues in pediatric pharmacy operations, and for implementing preventive measures to minimize recurrence of pediatric medication errors and safety events.
+
+## 2. Scope
+
+This procedure applies to all quality events in pediatric pharmacy, including:
+- Pediatric medication errors (actual and potential)
+- Dosing calculation errors
+- Compounding deviations
+- Equipment failures affecting pediatric preparations
+- Process non-conformances
+- Patient/family complaints
+- Near-miss events specific to pediatric medications
+- Regulatory observations or deficiencies
+
+## 3. Responsibilities
+
+### 3.1 All Pharmacy Personnel
+- Report quality events immediately
+- Participate in investigations
+- Implement corrective actions as assigned
+
+### 3.2 Quality Manager
+- Oversees CAPA process
+- Assigns investigations
+- Tracks CAPA completion
+- Reviews effectiveness of actions
+
+### 3.3 Pediatric Pharmacy Manager
+- Approves corrective and preventive actions
+- Allocates resources for implementation
+- Reviews trends in pediatric medication events
+
+### 3.4 Investigation Team
+- Conducts root cause analysis
+- Develops action plans
+- Implements and verifies effectiveness
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| CAPA | Corrective and Preventive Action |
+| Corrective Action | Action to eliminate the cause of a detected nonconformity |
+| Preventive Action | Action to eliminate the cause of a potential nonconformity |
+| Root Cause | Fundamental reason for an event's occurrence |
+| Medication Error | Any preventable event that may cause or lead to inappropriate medication use or patient harm |
+| Near Miss | Event that could have resulted in harm but did not reach the patient |
+| Sentinel Event | Unexpected occurrence involving death or serious physical/psychological injury |
+
+## 5. Procedure
+
+### 5.1 Event Identification and Reporting
+
+1. **Immediate Response**
+   - If patient safety is at risk, take immediate action to prevent harm
+   - For pediatric medication errors reaching patient, notify prescriber and document
+   - Notify supervisor and pharmacy manager immediately for serious events
+
+2. **Event Documentation**
+   - Complete medication error report within 24 hours
+   - Include patient age, weight, and calculated dose
+   - Document all relevant facts without speculation
+   - Classify severity using institutional scale
+   - Report to external systems as required (state board, ISMP)
+
+3. **Initial Assessment**
+   - Quality Manager reviews within 24 hours
+   - Determine if CAPA is required
+   - Assign severity and priority
+   - Initiate CAPA form
+
+### 5.2 Investigation
+
+1. **Team Assignment**
+   - Quality Manager assigns investigation team
+   - Include pediatric pharmacist if dosing-related
+   - Include compounding specialist if preparation-related
+   - Team leader designated
+
+2. **Data Collection**
+   - Gather all relevant information
+   - Interview involved personnel
+   - Review related documentation
+   - Examine physical evidence (if applicable)
+   - Calculate what dose was intended vs. what was prepared/dispensed
+
+3. **Root Cause Analysis**
+   - Use appropriate tools (5 Whys, Fishbone diagram, etc.)
+   - Identify all contributing factors:
+     - Human factors (calculation error, distraction, fatigue)
+     - Process factors (unclear protocols, verification gaps)
+     - System factors (inadequate tools, staffing issues)
+     - Environmental factors (interruptions, workspace design)
+   - Document analysis in CAPA form
+   - Avoid blame; focus on system improvements
+
+### 5.3 Action Planning
+
+1. **Develop Corrective Actions**
+   - Address immediate issue
+   - Prevent recurrence
+   - Consider hierarchy of controls:
+     - Elimination (remove the hazard)
+     - Substitution (replace with safer alternative)
+     - Engineering controls (equipment, software verification)
+     - Administrative controls (policies, training)
+     - PPE/other safeguards (alerts, forcing functions)
+
+2. **Develop Preventive Actions**
+   - Identify similar risks in other processes
+   - Implement preventive measures
+   - Update procedures or protocols
+
+3. **Action Plan Documentation**
+   - Assign responsibility for each action
+   - Set target completion dates
+   - Define success criteria
+   - Identify required resources
+
+### 5.4 Implementation
+
+1. Execute action plan according to timeline
+2. Update SOPs, work instructions, or forms as needed
+3. Communicate changes to all affected staff
+4. Provide training if procedures changed
+5. Document completion of each action
+
+### 5.5 Effectiveness Check
+
+1. **Verification** (within 30 days of implementation)
+   - Verify actions were implemented as planned
+   - Confirm staff are following new procedures
+   - Check for unintended consequences
+
+2. **Validation** (30-90 days after implementation)
+   - Analyze data to confirm problem resolved
+   - Monitor for recurrence
+   - Review related metrics
+   - For pediatric medication errors, review if similar errors have occurred
+
+3. **Documentation**
+   - Document effectiveness check results
+   - If ineffective, re-open CAPA and revise action plan
+   - If effective, close CAPA with Quality Manager approval
+
+### 5.6 CAPA Closure
+
+1. Quality Manager reviews completed CAPA
+2. Verifies all actions completed
+3. Confirms effectiveness demonstrated
+4. Approves closure
+5. Files CAPA record
+
+### 5.7 Trending and Analysis
+
+1. Quality Manager reviews all CAPAs quarterly
+2. Identify trends:
+   - Types of pediatric medication errors
+   - Medications frequently involved
+   - Time of day patterns
+   - Staff training needs
+3. Report to management and pharmacy staff
+4. Initiate preventive actions for trends identified
+
+## 6. Pediatric-Specific Considerations
+
+- **Dosing Errors**: Analyze calculation methods, reference sources, verification processes
+- **Age-Appropriate Issues**: Review if formulation, concentration, or route was suitable for patient age
+- **Communication**: Consider if parent/guardian counseling could have prevented issue
+- **Off-Label Use**: Review documentation and clinical justification
+- **High-Alert Medications**: Ensure additional safeguards in place for pediatric use
+
+## 7. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| CAPA Forms | Quality records | 5 years |
+| Medication error reports | Pharmacy records | 5 years |
+| Root cause analysis | CAPA file | 5 years |
+| Effectiveness checks | CAPA file | 5 years |
+| Trend reports | Quality records | 3 years |
+
+## 8. Related Documents
+
+- FRM-003 CAPA Form
+- Medication Error Reporting Policy
+- POL-001 Pediatric Pharmacy Quality Policy
+- SOP-SAF-XXX Medication Error Prevention
+
+## 9. References
+
+- ISMP Guidelines for Pediatric Medication Safety
+- FDA Guidance for Industry: CGMP for Drugs
+- Joint Commission Sentinel Event Policy
+- State Board of Pharmacy reporting requirements
+- ISO 9001:2015 Section 10.2 (Nonconformity and Corrective Action)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-003-Training.md

@@ -0,0 +1,269 @@
+# Standard Operating Procedure: Training and Competency
+
+| Document ID | SOP-003 |
+|-------------|---------|
+| Title | Training and Competency |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy |
+
+---
+
+## 1. Purpose
+
+To ensure all pediatric pharmacy personnel are properly trained, competent, and maintain current knowledge in pediatric pharmaceutical care, medication safety, and specialized pediatric pharmacy practices.
+
+## 2. Scope
+
+This procedure applies to all personnel involved in pediatric pharmacy operations, including:
+- Pediatric pharmacists
+- Pharmacy technicians working with pediatric medications
+- Pharmacy students and residents in pediatric rotations
+- Compounding personnel preparing pediatric formulations
+- Quality and administrative staff
+
+## 3. Responsibilities
+
+### 3.1 Pharmacy Director
+- Ensures adequate training resources
+- Approves training program
+- Reviews competency trends
+- Ensures regulatory compliance
+
+### 3.2 Training Coordinator
+- Maintains training records
+- Schedules training sessions
+- Tracks competency assessments
+- Coordinates continuing education
+
+### 3.3 Department Managers/Preceptors
+- Identifies training needs
+- Provides on-the-job training
+- Conducts competency assessments
+- Documents training completion
+
+### 3.4 All Personnel
+- Complete required training
+- Demonstrate competency
+- Maintain continuing education
+- Report training needs
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Competency | Demonstrated ability to perform job functions safely and accurately |
+| Initial Training | Training provided before independent practice |
+| Ongoing Training | Periodic training to maintain and update skills |
+| Competency Assessment | Evaluation of ability to perform specific tasks |
+| Preceptor | Licensed pharmacist qualified to train and assess others |
+
+## 5. Procedure
+
+### 5.1 Training Needs Assessment
+
+1. **New Hire Assessment**
+   - Review job description and required competencies
+   - Assess prior experience with pediatric pharmacy
+   - Identify knowledge gaps
+   - Develop individualized training plan
+
+2. **Ongoing Needs**
+   - Annual competency reviews
+   - New procedures or equipment
+   - Quality events or errors
+   - Regulatory changes
+   - Expansion of services
+
+### 5.2 Initial Training Program
+
+#### 5.2.1 General Orientation (All Staff)
+- Facility tour and emergency procedures
+- Introduction to pediatric patient population
+- Quality Management System overview
+- Documentation requirements
+- HIPAA and patient privacy for minors
+- Medication error reporting
+
+#### 5.2.2 Pediatric Pharmacy Fundamentals (All Clinical Staff)
+- Pediatric developmental stages (neonate, infant, child, adolescent)
+- Weight-based and BSA-based dosing principles
+- Pediatric dosing references and resources
+- Common pediatric medications and indications
+- Off-label medication use in pediatrics
+- Pediatric high-alert medications
+- Age-appropriate counseling techniques
+- Parent/guardian communication
+
+#### 5.2.3 Dosing and Calculations (Pharmacists and Technicians)
+- Dosing calculation methods (mg/kg, mg/m²)
+- Maximum dose verification
+- Dilution calculations for neonates
+- BSA calculation methods (Mosteller, DuBois)
+- Use of dosing calculators and verification tools
+- Independent double-check procedures
+- Common calculation errors and prevention
+
+#### 5.2.4 Pediatric Compounding (Compounding Staff)
+- USP <795> pediatric applications
+- USP <797> for neonatal/pediatric sterile preparations
+- Suspension preparation from solids
+- Flavoring systems and palatability
+- Low-concentration formulations
+- Unit-dose preparation
+- Stability and beyond-use dating for pediatric formulations
+- Aseptic technique for small volumes
+
+#### 5.2.5 Specialized Areas (As Applicable)
+
+**Neonatal Pharmacy**
+- Prematurity and gestational age considerations
+- Neonatal dosing adjustments
+- TPN compounding for neonates
+- Medication administration in NICU
+- Drug concentrations for neonatal use
+
+**Pediatric Oncology**
+- Chemotherapy dosing (BSA-based)
+- USP <800> compliance
+- Pediatric chemotherapy protocols
+- Supportive care medications
+- Safe handling and disposal
+
+**Controlled Substances**
+- DEA requirements for minors
+- Opioid dosing in children
+- Controlled substance documentation
+- Prescription monitoring programs
+
+### 5.3 Competency Assessment
+
+#### 5.3.1 Initial Competency
+Must demonstrate competency before independent practice:
+
+**Written Assessment**
+- Pediatric pharmacy knowledge test (minimum 80%)
+- Dosing calculation test (100% accuracy required)
+- Medication safety scenarios
+
+**Practical Assessment**
+- Dosing calculation with verification
+- Prescription order processing
+- Compounding technique (if applicable)
+- Patient counseling simulation
+- Computer system use
+
+**Direct Observation**
+- Preceptor observes minimum 20 orders/preparations
+- Uses standardized competency checklist
+- Documents satisfactory performance
+
+#### 5.3.2 Ongoing Competency
+Assessed annually for all staff:
+
+**Annual Competencies**
+- Dosing calculations (5-10 scenarios, 100% required)
+- High-alert medication protocols
+- Medication error prevention
+- One specialty area relevant to role
+
+**Triggered Competencies**
+- After medication error (within 30 days)
+- New equipment or technology
+- New procedures or protocols
+- Return from extended leave (>6 months)
+
+### 5.4 Continuing Education
+
+#### 5.4.1 Requirements
+- Pharmacists: State board requirements + 5 hours pediatric-specific annually
+- Technicians: State board requirements + 3 hours pediatric-specific annually
+
+#### 5.4.2 Approved Activities
+- Pediatric pharmacy conferences (PPAG, ASHP)
+- Online CE with pediatric focus
+- Journal clubs on pediatric topics
+- In-service training programs
+- Specialty certification preparation (BCPPS)
+
+### 5.5 Documentation
+
+1. **Training Records**
+   - Training date and topic
+   - Trainer name
+   - Training method (classroom, online, OJT)
+   - Completion status
+
+2. **Competency Records**
+   - Date of assessment
+   - Assessor name
+   - Competency demonstrated
+   - Score/result
+   - Remediation if needed
+
+3. **File Maintenance**
+   - Individual training files for each employee
+   - Accessible for inspections
+   - Updated within 30 days of training
+   - Retained per regulatory requirements
+
+### 5.6 Remediation
+
+If competency not demonstrated:
+1. Identify specific deficiency
+2. Provide additional training/practice
+3. Re-assess within 30 days
+4. Document remediation and outcome
+5. Escalate to Pharmacy Director if unsuccessful after second attempt
+
+### 5.7 Preceptor Qualification
+
+To serve as preceptor/trainer:
+- Licensed pharmacist with minimum 2 years pediatric pharmacy experience
+- Demonstrated competency in area of training
+- Completed preceptor training program
+- Annual review of preceptor performance
+
+## 6. Pediatric-Specific Competencies
+
+All pediatric pharmacy staff must demonstrate:
+- Accurate weight-based dosing calculations
+- Recognition of age-inappropriate doses
+- Identification of pediatric high-alert medications
+- Appropriate use of pediatric dosing references
+- Understanding of developmental considerations
+- Effective parent/guardian communication
+
+## 7. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| Individual training files | HR/Pharmacy | Duration of employment + 3 years |
+| Competency assessments | Training files | 3 years |
+| Training attendance logs | Training coordinator | 3 years |
+| CE certificates | Individual files | Per state board requirements |
+
+## 8. Related Documents
+
+- FRM-004 Training Record
+- FRM-XXX Competency Assessment Checklists
+- Job Descriptions
+- Annual Competency Calendar
+
+## 9. References
+
+- State Board of Pharmacy CE requirements
+- USP <795>, <797>, <800> training requirements
+- ASHP Guidelines on Pharmacy Technician Training
+- PPAG Pediatric Pharmacy Practice Standards
+- Joint Commission HR standards
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |