pediatric-pharmacy/SOPs/SOP-003-Training.md

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

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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

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Revision History

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