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pediatric-pharmacy/Templates/SOP-Template.md

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Standard Operating Procedure: [Title]

Document ID SOP-XXX
Title [Title]
Revision 1.0
Effective Date [DATE]
Author [AUTHOR]
Approved By [APPROVER]
Department Pediatric Pharmacy

1. Purpose

[State the purpose of this pediatric pharmacy procedure]

2. Scope

[Define the scope and applicability - specify age ranges (neonate, infant, child, adolescent) if relevant]

3. Responsibilities

3.1 Pediatric Pharmacist

  • [Responsibility specific to pediatric pharmaceutical care]
  • [Responsibility]

3.2 Pharmacy Technician (Pediatric-Trained)

  • [Responsibility]
  • [Responsibility]

3.3 [Other Role]

  • [Responsibility]
  • [Responsibility]

4. Definitions

Term Definition
Neonate Infant from birth to 28 days of age
Infant Child from 29 days to 12 months of age
Child Person from 1 year to 12 years of age
Adolescent Person from 13 years to 18 years of age
Weight-based dosing Medication dose calculated based on patient weight (mg/kg)
BSA-based dosing Medication dose calculated based on body surface area (mg/m²)
Off-label use Use of medication outside FDA-approved age, indication, or dosing
[Add other terms] [Definition]

5. Procedure

5.1 [Section Title]

[Procedure steps specific to pediatric pharmacy]

5.2 Dosing Verification (if applicable)

  1. Verify patient weight and age
  2. Calculate dose using appropriate formula
  3. Verify dose is within age-appropriate range
  4. Verify maximum dose not exceeded
  5. Independent verification by second pharmacist

5.3 [Additional Section]

[Procedure steps]

6. Safety Considerations

[Pediatric-specific safety considerations, such as:]

  • High-alert medication protocols
  • Calculation verification requirements
  • Age-appropriate formulation selection
  • Dilution requirements for neonatal use
  • [List related procedures, forms, dosing references, etc.]
  • POL-001 Pediatric Pharmacy Quality Policy
  • [Pediatric dosing guidelines]

8. References

  • USP <795> Pharmaceutical Compounding - Nonsterile Preparations
  • USP <797> Pharmaceutical Compounding - Sterile Preparations
  • USP <800> Hazardous Drugs - Handling in Healthcare Settings
  • ISMP Guidelines for Pediatric Medication Safety
  • AAP/PPAG Pediatric Pharmacy Practice Guidelines
  • [Facility-specific references]
  • [State Board of Pharmacy regulations]

Revision History

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