From e332f86e2addba7683cca162a3245be491c402b6 Mon Sep 17 00:00:00 2001 From: AtomicQMS Service Date: Sat, 27 Dec 2025 11:24:16 -0500 Subject: [PATCH] Sync template from atomicqms-style deployment --- .gitea/workflows/atomicai.yml | 107 +++++ Forms/Compounding-Records/.gitkeep | 0 ...OMP-001-Oral-Suspension-Compounding-Log.md | 220 ++++++++++ Forms/Controlled-Substance/.gitkeep | 0 Forms/Dose-Calculation/.gitkeep | 0 ...01-Pediatric-Dose-Calculation-Worksheet.md | 193 +++++++++ Forms/Temperature-Logs/.gitkeep | 0 Forms/Training/.gitkeep | 0 ...ediatric-Pharmacy-Competency-Assessment.md | 339 ++++++++++++++++ Policies/POL-001-Quality-Policy.md | 107 +++++ README.md | 124 +++++- SOPs/Chemotherapy/.gitkeep | 0 SOPs/Compounding/.gitkeep | 0 ...SOP-COMP-001-Pediatric-Oral-Suspensions.md | 284 +++++++++++++ SOPs/Controlled-Substances/.gitkeep | 0 SOPs/Dosing-Verification/.gitkeep | 0 .../SOP-DOSE-001-Weight-Based-Dosing.md | 240 +++++++++++ SOPs/General/.gitkeep | 0 SOPs/Inventory/.gitkeep | 0 SOPs/Patient-Safety/.gitkeep | 0 .../SOP-SAF-001-High-Alert-Medications.md | 377 ++++++++++++++++++ SOPs/SOP-001-Document-Control.md | 164 ++++++++ SOPs/SOP-002-CAPA.md | 219 ++++++++++ SOPs/SOP-003-Training.md | 269 +++++++++++++ Templates/SOP-Template.md | 97 +++++ Work Instructions/WI-001-Template.md | 92 +++++ 26 files changed, 2830 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/Compounding-Records/.gitkeep create mode 100644 Forms/Compounding-Records/FRM-COMP-001-Oral-Suspension-Compounding-Log.md create mode 100644 Forms/Controlled-Substance/.gitkeep create mode 100644 Forms/Dose-Calculation/.gitkeep create mode 100644 Forms/Dose-Calculation/FRM-DOSE-001-Pediatric-Dose-Calculation-Worksheet.md create mode 100644 Forms/Temperature-Logs/.gitkeep create mode 100644 Forms/Training/.gitkeep create mode 100644 Forms/Training/FRM-004-Pediatric-Pharmacy-Competency-Assessment.md create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/Chemotherapy/.gitkeep create mode 100644 SOPs/Compounding/.gitkeep create mode 100644 SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md create mode 100644 SOPs/Controlled-Substances/.gitkeep create mode 100644 SOPs/Dosing-Verification/.gitkeep create mode 100644 SOPs/Dosing-Verification/SOP-DOSE-001-Weight-Based-Dosing.md create mode 100644 SOPs/General/.gitkeep create mode 100644 SOPs/Inventory/.gitkeep create mode 100644 SOPs/Patient-Safety/.gitkeep create mode 100644 SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md create mode 100644 SOPs/SOP-001-Document-Control.md create mode 100644 SOPs/SOP-002-CAPA.md create mode 100644 SOPs/SOP-003-Training.md create mode 100644 Templates/SOP-Template.md create mode 100644 Work Instructions/WI-001-Template.md diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..55c6d3c --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,107 @@ +name: AtomicAI Pediatric Pharmacy QMS Assistant + +on: + issue_comment: + types: [created] + issues: + types: [opened, assigned] + pull_request: + types: [opened, synchronize, assigned] + pull_request_review_comment: + types: [created] + +jobs: + claude-assistant: + runs-on: ubuntu-latest + if: | + github.actor != 'atomicqms-service' && + ( + (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || + (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || + (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') + + ) + permissions: + contents: write + issues: write + pull-requests: write + + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Run AtomicAI Pediatric Pharmacy QMS Assistant + uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main + with: + trigger_phrase: '@atomicai' + assignee_trigger: 'atomicai' + claude_git_name: 'AtomicAI' + claude_git_email: 'atomicai@atomicqms.local' + custom_instructions: | + You are AtomicAI, an AI assistant specialized in Pediatric Pharmacy Quality Management. + + ## Your Expertise + - Pediatric dosing calculations (weight-based, BSA-based) + - Neonatal intensive care medication safety + - Pediatric oncology chemotherapy preparation + - Pediatric compounding (suspensions, flavoring, low concentrations) + - Age-appropriate dosage forms + - Off-label medication use documentation (common in pediatrics) + - State Board of Pharmacy regulations for pediatric services + - DEA requirements for controlled substances in minors + - FDA regulations for pediatric drug handling + - USP <795> Non-Sterile Compounding (pediatric formulations) + - USP <797> Sterile Compounding (NICU, TPN, chemotherapy) + - USP <800> Hazardous Drug Handling (pediatric oncology) + - Joint Commission pediatric medication safety standards + - ISMP pediatric medication safety guidelines + - AAP (American Academy of Pediatrics) pharmacy standards + - PPAG (Pediatric Pharmacy Association) best practices + - ACIP vaccine storage and administration + - HIPAA requirements for minors + + ## Document Creation Guidelines + - Place Weight/BSA Dosing SOPs in SOPs/Dosing-Verification/ + - Place Pediatric Compounding SOPs in SOPs/Compounding/ + - Place Chemotherapy SOPs in SOPs/Chemotherapy/ + - Place Patient Safety SOPs in SOPs/Patient-Safety/ + - Place Controlled Substance SOPs in SOPs/Controlled-Substances/ + - Place Inventory SOPs in SOPs/Inventory/ + - Place General SOPs in SOPs/General/ + - Place Dose calculation worksheets in Forms/Dose-Calculation/ + - Place Compounding records in Forms/Compounding-Records/ + - Place Temperature logs in Forms/Temperature-Logs/ + - Place DEA forms in Forms/Controlled-Substance/ + - Place Training records in Forms/Training/ + + ## Numbering Convention + - POL-XXX for Policies + - SOP-DOSE-XXX for Dosing Verification SOPs + - SOP-COMP-XXX for Compounding SOPs + - SOP-CHEMO-XXX for Chemotherapy SOPs + - SOP-SAF-XXX for Patient Safety SOPs + - SOP-CS-XXX for Controlled Substance SOPs + - SOP-INV-XXX for Inventory SOPs + - SOP-GEN-XXX for General SOPs + - WI-XXX for Work Instructions + - FRM-XXX for Forms + - LOG-XXX for Logs + + ## Pediatric-Specific Considerations + - Always include weight-based and BSA-based dosing ranges + - Reference age-appropriate dose limits and maximum doses + - Address calculation verification (double-check systems) + - Include developmental considerations (neonate, infant, child, adolescent) + - Document off-label use appropriately + - Consider palatability and age-appropriate formulations + - Address parent/guardian counseling requirements + - Include high-alert medication protocols for pediatrics + - Reference transition of care considerations + + Always create branches and submit changes as Pull Requests for review. + Include regulatory references (USP, ISMP, AAP, PPAG, State Board) where applicable. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Compounding-Records/.gitkeep b/Forms/Compounding-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Compounding-Records/FRM-COMP-001-Oral-Suspension-Compounding-Log.md b/Forms/Compounding-Records/FRM-COMP-001-Oral-Suspension-Compounding-Log.md new file mode 100644 index 0000000..8e77b82 --- /dev/null +++ b/Forms/Compounding-Records/FRM-COMP-001-Oral-Suspension-Compounding-Log.md @@ -0,0 +1,220 @@ +# Pediatric Oral Suspension Compounding Log + +| Document ID | FRM-COMP-001 | +|-------------|--------------| +| Title | Oral Suspension Compounding Log | +| Revision | 1.0 | +| Effective Date | [DATE] | + +--- + +## Patient/Prescription Information + +| Field | Value | +|-------|-------| +| Patient Name | ________________________________ | +| Date of Birth | ________________________________ | +| Prescription Number | ________________________________ | +| Prescriber | ________________________________ | +| Date Compounded | ________________________________ | + +## Formulation Information + +| Field | Value | +|-------|-------| +| Medication | ________________________________ | +| Final Concentration | _________ mg/mL (or mcg/mL) | +| Total Volume | _________ mL | +| Flavor | _________ ☐ None | +| Beyond-Use Date (BUD) | ________________________________ | +| Storage Requirements | ☐ Refrigerate (2-8°C) ☐ Room temperature ☐ Protect from light | + +## Calculations + +### Dosage Form Used +☐ Tablets +☐ Capsules +☐ Bulk powder + +**Product Details:** +- Manufacturer: _______________________ +- Strength: _________ mg per tablet/capsule +- NDC: _______________________ +- Lot Number: _______________________ +- Expiration Date: _______________________ + +### Quantity Calculation + +**Quantity Needed:** +``` +Desired concentration: _______ mg/mL +Final volume needed: _______ mL +Total drug needed: _______ mL × _______ mg/mL = _______ mg total +``` + +**Dosage Forms Required:** +``` +_______ mg total ÷ _______ mg per unit = _______ units + +Round up to: _______ tablets/capsules +(includes overage: ______ %) +``` + +**Verified by:** _________________ (Second pharmacist initials) + +## Ingredients + +| Ingredient | Manufacturer/Brand | Lot Number | Expiration Date | Quantity Used | +|------------|-------------------|------------|-----------------|---------------| +| [Drug name] | _______________ | __________ | ______________ | ______ units | +| Suspending vehicle | _______________ | __________ | ______________ | ______ mL | +| Sweetening agent | _______________ | __________ | ______________ | ______ mL | +| Flavoring (if used) | _______________ | __________ | ______________ | ______ mL | +| Other: __________ | _______________ | __________ | ______________ | __________ | + +## Compounding Procedure + +### Preparation Checklist +☐ Hand hygiene performed +☐ Appropriate garbing (lab coat, gloves) +☐ Work area cleaned and disinfected +☐ Equipment cleaned and ready +☐ All ingredients verified and gathered + +### Compounding Steps Completed + +☐ **Step 1:** Counted and verified ______ tablets/capsules +☐ **Step 2:** Crushed tablets to fine powder / Emptied capsule contents +☐ **Step 3:** Triturated to uniform powder +☐ **Step 4:** Added small portion of vehicle, mixed to smooth paste +☐ **Step 5:** Used geometric dilution, added vehicle in portions +☐ **Step 6:** Transferred to graduated cylinder +☐ **Step 7:** Rinsed mortar with vehicle +☐ **Step 8:** Brought to final volume: _______ mL +☐ **Step 9:** Added flavor (if applicable): _______ mL +☐ **Step 10:** Transferred to final container +☐ **Step 11:** Shook thoroughly for 30 seconds + +## Quality Control + +### Visual Inspection +☐ Uniform suspension (no large particles) +☐ Appropriate color +☐ Smooth consistency +☐ No visible contamination +☐ Suspends well when shaken + +### Volume Verification +- Target volume: _______ mL +- Actual volume: _______ mL +- Within acceptable range (±5%): ☐ Yes ☐ No + +### Concentration Verification +``` +Total drug: _______ mg +Final volume: _______ mL +Concentration: _______ mg ÷ _______ mL = _______ mg/mL +``` +☐ Matches intended concentration + +**Independent calculation by:** _________________ (Pharmacist initials) + +## Beyond-Use Date Determination + +**Stability Reference:** +☐ Published study (citation): _________________________________ +☐ USP <795> general guidance: 14 days refrigerated / 30 days room temp +☐ Manufacturer information +☐ Trissel's Stability Reference +☐ Other: _________________________________ + +**BUD Assigned:** _________________________________ + +**Rationale:** ___________________________________________________ + +## Labeling + +☐ Patient name and date of birth +☐ Medication name and concentration +☐ "SHAKE WELL BEFORE EACH USE" +☐ Directions for use +☐ Beyond-use date +☐ Storage instructions +☐ "For Oral Use Only" +☐ Flavor (if added) +☐ Pharmacist initials +☐ Compounding date +☐ Auxiliary labels (if applicable) + +**Oral syringe provided:** ☐ Yes (size: _____ mL) ☐ No ☐ N/A + +## Final Verification + +### Pharmacist Final Check +☐ Correct medication and strength +☐ Accurate calculations verified +☐ Appropriate concentration for patient +☐ Correct labeling +☐ BUD appropriate and documented +☐ Storage instructions clear +☐ Quality checks passed + +**Verifying Pharmacist:** +- Name: _________________________ +- License #: _________________________ +- Signature: _________________________ +- Date/Time: _________________________ + +## Counseling Points Provided + +☐ Shake well before each use +☐ Use oral syringe for accurate dosing +☐ Storage requirements explained +☐ Beyond-use date explained +☐ Administration technique demonstrated +☐ Side effects discussed +☐ Importance of completing therapy + +**Counseled by:** __________________ Date/Time: __________ + +## Documentation + +### Compounded by +- Technician/Pharmacist Name: _________________________ +- Signature: _________________________ +- Date/Time: _________________________ + +### Checked by +- Pharmacist Name: _________________________ +- License #: _________________________ +- Signature: _________________________ +- Date/Time: _________________________ + +## Cleanup + +☐ All equipment washed and dried +☐ Work surface disinfected +☐ Waste disposed of appropriately +☐ Ingredients returned to storage + +**Cleaned by:** __________________ Date/Time: __________ + +## Notes/Deviations + +_____________________________________________________________________ +_____________________________________________________________________ +_____________________________________________________________________ + +--- + +## For Pharmacy Records + +**Record Retention:** Per state board requirements (minimum 3 years) + +**Filed in:** ☐ Compounding logs ☐ Patient profile ☐ Both + +**Log reviewed by:** ______________ Date: ________ + +--- + +*Form FRM-COMP-001 Rev 1.0 - Pediatric Pharmacy Compounding* diff --git a/Forms/Controlled-Substance/.gitkeep b/Forms/Controlled-Substance/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Dose-Calculation/.gitkeep b/Forms/Dose-Calculation/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Dose-Calculation/FRM-DOSE-001-Pediatric-Dose-Calculation-Worksheet.md b/Forms/Dose-Calculation/FRM-DOSE-001-Pediatric-Dose-Calculation-Worksheet.md new file mode 100644 index 0000000..a430a78 --- /dev/null +++ b/Forms/Dose-Calculation/FRM-DOSE-001-Pediatric-Dose-Calculation-Worksheet.md @@ -0,0 +1,193 @@ +# Pediatric Dose Calculation Worksheet + +| Document ID | FRM-DOSE-001 | +|-------------|--------------| +| Title | Pediatric Dose Calculation Worksheet | +| Revision | 1.0 | +| Effective Date | [DATE] | + +--- + +## Patient Information + +| Field | Value | +|-------|-------| +| Patient Name | _________________________ | +| Date of Birth | _________________________ | +| Age | _________________________ | +| Medical Record # | _________________________ | +| Date/Time of Calculation | _________________________ | + +## Patient Measurements + +| Measurement | Value | Date/Time Obtained | Source | +|-------------|-------|-------------------|---------| +| Weight (kg) | _________ kg | _____________ | ☐ Inpatient chart ☐ Outpatient ☐ Parent-reported | +| Height (cm) | _________ cm | _____________ | ☐ Inpatient chart ☐ Outpatient ☐ Parent-reported | +| BSA (m²) | _________ m² | _____________ | Calculation method: ☐ Mosteller ☐ DuBois ☐ Other: _____ | + +**Weight Status:** +☐ Current per policy (specify timeframe): _____________ +☐ Needs update - contacted: ☐ Nurse ☐ Clinic ☐ Parent + +## Medication Order + +| Field | Value | +|-------|-------| +| Medication | _________________________________________ | +| Indication | _________________________________________ | +| Ordered Dose | _________________________________________ | +| Dosing Frequency | _________________________________________ | +| Route | _________________________________________ | +| Prescriber | _________________________________________ | + +## Dose Calculation + +### Dosing Type +☐ Weight-based (mg/kg) +☐ BSA-based (mg/m²) +☐ Fixed dose (no calculation needed) +☐ Other: _______________ + +### Calculation Method + +**If Weight-Based:** +``` +Dose ordered: ________ mg/kg/dose OR ________ mg/kg/day + +Calculation: +_______ kg × _______ mg/kg/dose = _______ mg/dose + +OR (if total daily dose): +_______ kg × _______ mg/kg/day = _______ mg/day +_______ mg/day ÷ _______ doses/day = _______ mg/dose +``` + +**If BSA-Based:** +``` +Dose ordered: ________ mg/m²/dose OR ________ mg/m²/day + +Calculation: +_______ m² × _______ mg/m²/dose = _______ mg/dose + +OR (if total daily dose): +_______ m² × _______ mg/m²/day = _______ mg/day +_______ mg/day ÷ _______ doses/day = _______ mg/dose +``` + +### Final Dose +**Calculated Dose:** __________ mg/dose + +**Rounded/Dispensed Dose:** __________ mg/dose + +**Reason for rounding (if applicable):** +☐ Available dosage form +☐ Measurable quantity +☐ Patient-specific factors +☐ Other: _______________________ + +## Dose Verification + +### Reference Check +**Reference Source(s):** ☐ Lexicomp ☐ Micromedex ☐ Harriet Lane ☐ Neofax ☐ Other: __________ + +**Recommended Dosing Range for Indication:** +- Minimum: __________ mg/kg/dose (or mg/m²/dose) +- Maximum: __________ mg/kg/dose (or mg/m²/dose) +- Frequency: __________ + +**Calculated dose within range?** ☐ Yes ☐ No + +**If NO, action taken:** +☐ Clarified with prescriber (see notes) +☐ Clinical justification documented +☐ Order discontinued +☐ Other: _______________________ + +### Maximum Dose Check +**Maximum dose per dose:** __________ mg (if applicable) +**Maximum dose per day:** __________ mg (if applicable) + +**Does calculated dose exceed maximum?** ☐ Yes ☐ No ☐ N/A + +**If YES, dispensed dose:** __________ mg (maximum dose applied) + +### Age-Specific Considerations +☐ Dose appropriate for patient age +☐ Formulation appropriate for patient age/development +☐ No age-specific contraindications +☐ Age-specific warnings reviewed + +### Special Populations +☐ Renal adjustment needed - CrCl: _____ mL/min - Adjusted dose: _____ mg +☐ Hepatic adjustment needed - Severity: _____ - Adjusted dose: _____ mg +☐ Obese (>95th percentile) - Used: ☐ Actual weight ☐ Ideal weight ☐ Adjusted weight +☐ Premature infant - Gestational age: _____ weeks - PMA: _____ weeks + +## High-Alert Medication Independent Double-Check + +**Is this a high-alert medication?** ☐ Yes ☐ No + +**If YES, complete independent verification:** + +### First Pharmacist Calculation +- Pharmacist Name: _________________________ Date/Time: _________ +- Calculated Dose: __________ mg/dose +- Within Range: ☐ Yes ☐ No +- Signature: _________________________ + +### Second Pharmacist Independent Calculation +- Pharmacist Name: _________________________ Date/Time: _________ +- Calculated Dose: __________ mg/dose +- Within Range: ☐ Yes ☐ No +- Signature: _________________________ + +### Verification Result +☐ Calculations match - Proceed +☐ Discrepancy identified - see resolution below + +**Discrepancy Resolution:** +_________________________________________________________________ +_________________________________________________________________ + +## Final Verification and Approval + +**Final Dose to Dispense:** __________ mg per dose +**Quantity to Dispense:** __________ (doses/volume) +**Dosing Instructions:** _______________________________________________ + +**Off-Label Use?** ☐ Yes ☐ No +**If YES, clinical justification:** _____________________________________ + +**Pharmacist Final Verification:** +- Name: _________________________ +- License #: _________________________ +- Signature: _________________________ +- Date/Time: _________________________ + +## Notes/Comments + +_____________________________________________________________________ +_____________________________________________________________________ +_____________________________________________________________________ +_____________________________________________________________________ + +--- + +## Disposition +☐ Dose verified and approved - proceed with dispensing +☐ Contacted prescriber for clarification +☐ Order modified per prescriber +☐ Order discontinued + +--- + +**For Pharmacy Use Only** + +Calculation reviewed by: _____________ Date: ________ Time: ________ + +Filed in: ☐ Patient chart ☐ Pharmacy records ☐ Both + +--- + +*Form FRM-DOSE-001 Rev 1.0 - Pediatric Pharmacy* diff --git a/Forms/Temperature-Logs/.gitkeep b/Forms/Temperature-Logs/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/.gitkeep b/Forms/Training/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/FRM-004-Pediatric-Pharmacy-Competency-Assessment.md b/Forms/Training/FRM-004-Pediatric-Pharmacy-Competency-Assessment.md new file mode 100644 index 0000000..6ad45b8 --- /dev/null +++ b/Forms/Training/FRM-004-Pediatric-Pharmacy-Competency-Assessment.md @@ -0,0 +1,339 @@ +# Pediatric Pharmacy Competency Assessment + +| Document ID | FRM-004 | +|-------------|---------| +| Title | Pediatric Pharmacy Competency Assessment | +| Revision | 1.0 | +| Effective Date | [DATE] | + +--- + +## Employee Information + +| Field | Value | +|-------|-------| +| Employee Name | ________________________________ | +| Position | ☐ Pediatric Pharmacist ☐ Pharmacy Technician ☐ Pharmacy Resident ☐ Student | +| License/Registration # | ________________________________ | +| Hire Date | ________________________________ | +| Assessment Date | ________________________________ | +| Assessment Type | ☐ Initial ☐ Annual ☐ Triggered ☐ Return from leave | + +## Assessor Information + +| Field | Value | +|-------|-------| +| Assessor Name | ________________________________ | +| Title | ________________________________ | +| License # | ________________________________ | +| Date | ________________________________ | + +--- + +## Part 1: Pediatric Dosing Calculations + +**Instructions:** Complete all calculations. 100% accuracy required. Show all work. + +### Scenario 1: Weight-Based Dosing + +**Patient:** 3-year-old male, weight 14.2 kg + +**Order:** Amoxicillin 40 mg/kg/day divided every 8 hours + +**Questions:** +1. Calculate total daily dose: ____________ mg/day +2. Calculate individual dose: ____________ mg per dose +3. Is this dose within the recommended range for amoxicillin (20-90 mg/kg/day)? ☐ Yes ☐ No + +**Work shown:** +_____________________________________________________________________ +_____________________________________________________________________ + +### Scenario 2: Maximum Dose Application + +**Patient:** 12-year-old female, weight 52 kg + +**Order:** Ondansetron 0.15 mg/kg IV for nausea + +**Questions:** +1. Calculate dose based on weight: ____________ mg +2. Maximum dose for ondansetron is 16 mg. What dose would you dispense? ____________ mg +3. Why? _____________________________________________________________ + +**Work shown:** +_____________________________________________________________________ +_____________________________________________________________________ + +### Scenario 3: BSA-Based Dosing + +**Patient:** 7-year-old male, weight 25 kg, height 120 cm, BSA 0.92 m² + +**Order:** Vincristine 1.5 mg/m² IV (chemotherapy) + +**Questions:** +1. Calculate dose: ____________ mg +2. This dose will be independently verified by a second pharmacist because: + ☐ High-alert medication + ☐ Chemotherapy + ☐ Both + ☐ Neither + +**Work shown:** +_____________________________________________________________________ +_____________________________________________________________________ + +### Scenario 4: Neonatal Dosing + +**Patient:** Premature infant, gestational age 32 weeks, postnatal age 5 days, weight 1.8 kg + +**Order:** Gentamicin 4 mg/kg/dose IV every 24 hours + +**Questions:** +1. Calculate dose: ____________ mg +2. For a 10 mg/mL concentration, what volume is needed? ____________ mL +3. Does the extended interval (q24h) make sense for this patient? ☐ Yes ☐ No + Why? ____________________________________________________________ + +**Work shown:** +_____________________________________________________________________ +_____________________________________________________________________ + +### Scenario 5: Dilution Calculation + +**Patient:** 6-month-old infant, weight 7.5 kg + +**Order:** Digoxin 10 mcg/kg/day divided BID + +**Available:** Digoxin elixir 50 mcg/mL + +**Questions:** +1. Total daily dose: ____________ mcg/day +2. Individual dose: ____________ mcg per dose +3. Volume to administer per dose: ____________ mL + +**Work shown:** +_____________________________________________________________________ +_____________________________________________________________________ + +--- + +## Part 2: Knowledge Assessment + +**Instructions:** Answer all questions. + +### 1. Pediatric Age Categories +Match the age to the correct category: + +| Age | Category | +|-----|----------| +| 2 months | ☐ Neonate ☐ Infant ☐ Child ☐ Adolescent | +| 15 days | ☐ Neonate ☐ Infant ☐ Child ☐ Adolescent | +| 5 years | ☐ Neonate ☐ Infant ☐ Child ☐ Adolescent | +| 16 years | ☐ Neonate ☐ Infant ☐ Child ☐ Adolescent | + +### 2. High-Alert Medications +List 5 high-alert medications in pediatrics that require independent double-check: + +1. _________________________________ +2. _________________________________ +3. _________________________________ +4. _________________________________ +5. _________________________________ + +### 3. Weight Currency +What is the maximum age of weight for the following patient types? + +- NICU/critical care inpatients: ☐ 24 hours ☐ 72 hours ☐ 1 week +- General inpatients: ☐ 24 hours ☐ 72 hours ☐ 1 week +- Outpatient infants (<1 year): ☐ 1 month ☐ 3 months ☐ 6 months + +### 4. USP Standards +Which USP chapter covers non-sterile compounding? +☐ USP <795> +☐ USP <797> +☐ USP <800> + +Which USP chapter covers sterile compounding? +☐ USP <795> +☐ USP <797> +☐ USP <800> + +### 5. Off-Label Use +Approximately what percentage of medications used in pediatrics are off-label? +☐ <10% +☐ 25-30% +☐ 50-70% +☐ >90% + +--- + +## Part 3: Practical Skills Assessment + +**Instructions:** Assessor observes and evaluates performance. + +### Skill 1: Order Verification and Dosing + +**Task:** Process a pediatric medication order from start to finish + +| Step | Satisfactory | Needs Improvement | Not Observed | +|------|--------------|-------------------|--------------| +| Verifies patient identity (name, DOB, MRN) | ☐ | ☐ | ☐ | +| Obtains current patient weight | ☐ | ☐ | ☐ | +| Verifies weight is current per policy | ☐ | ☐ | ☐ | +| Calculates dose accurately | ☐ | ☐ | ☐ | +| Checks dose against reference range | ☐ | ☐ | ☐ | +| Verifies maximum dose not exceeded | ☐ | ☐ | ☐ | +| Documents calculation appropriately | ☐ | ☐ | ☐ | +| Obtains independent verification if required | ☐ | ☐ | ☐ | +| Selects age-appropriate formulation | ☐ | ☐ | ☐ | + +**Overall Performance:** ☐ Competent ☐ Needs additional training + +**Comments:** ___________________________________________________________ + +### Skill 2: Compounding Oral Suspension (if applicable) + +**Task:** Compound an oral suspension from tablets following SOP + +| Step | Satisfactory | Needs Improvement | Not Observed | +|------|--------------|-------------------|--------------| +| Performs calculations correctly | ☐ | ☐ | ☐ | +| Prepares workspace appropriately | ☐ | ☐ | ☐ | +| Uses proper hand hygiene and garbing | ☐ | ☐ | ☐ | +| Crushes tablets to fine powder | ☐ | ☐ | ☐ | +| Uses geometric dilution correctly | ☐ | ☐ | ☐ | +| Achieves smooth, uniform suspension | ☐ | ☐ | ☐ | +| Brings to accurate final volume | ☐ | ☐ | ☐ | +| Labels correctly with all required info | ☐ | ☐ | ☐ | +| Assigns appropriate BUD | ☐ | ☐ | ☐ | +| Documents in compounding log | ☐ | ☐ | ☐ | + +**Overall Performance:** ☐ Competent ☐ Needs additional training + +**Comments:** ___________________________________________________________ + +### Skill 3: Patient/Family Counseling + +**Task:** Counsel parent/guardian on pediatric medication + +| Step | Satisfactory | Needs Improvement | Not Observed | +|------|--------------|-------------------|--------------| +| Introduces self and confirms patient | ☐ | ☐ | ☐ | +| Uses age-appropriate language | ☐ | ☐ | ☐ | +| Explains indication for medication | ☐ | ☐ | ☐ | +| Demonstrates dose measurement | ☐ | ☐ | ☐ | +| Emphasizes importance of accurate dosing | ☐ | ☐ | ☐ | +| Explains administration technique | ☐ | ☐ | ☐ | +| Reviews storage requirements | ☐ | ☐ | ☐ | +| Discusses common side effects | ☐ | ☐ | ☐ | +| Emphasizes completing full course | ☐ | ☐ | ☐ | +| Provides opportunity for questions | ☐ | ☐ | ☐ | + +**Overall Performance:** ☐ Competent ☐ Needs additional training + +**Comments:** ___________________________________________________________ + +--- + +## Part 4: Scenario-Based Assessment + +### Scenario: Potential Error Identification + +**Situation:** A 2-month-old infant (4.5 kg) has an order for gentamicin 15 mg IV every 8 hours. + +**Usual neonatal dosing:** 4-5 mg/kg/dose every 24-48 hours (extended interval) + +**Questions:** + +1. Do you see any concerns with this order? ☐ Yes ☐ No + +2. If yes, what are they? + _________________________________________________________________ + _________________________________________________________________ + +3. What action would you take? + ☐ Dispense as ordered + ☐ Contact prescriber for clarification + ☐ Refuse to fill + ☐ Other: __________ + +4. Calculate what the dose should likely be: + _________________________________________________________________ + +**Assessor evaluation:** +☐ Correctly identified potential error +☐ Appropriate action plan +☐ Accurate alternative dose calculation + +--- + +## Assessment Results + +### Part 1: Dosing Calculations +- Scenarios correct: ______ / 5 +- **Required: 5/5 (100%)** +- Result: ☐ **PASS** ☐ **FAIL** + +### Part 2: Knowledge Assessment +- Questions correct: ______ / 9 +- **Required: 7/9 (78%)** +- Result: ☐ **PASS** ☐ **FAIL** + +### Part 3: Practical Skills +- Skills demonstrated competently: ______ / 3 +- **Required: 3/3** +- Result: ☐ **PASS** ☐ **FAIL** + +### Part 4: Scenario Assessment +- Result: ☐ **PASS** ☐ **FAIL** + +--- + +## Overall Assessment Result + +☐ **COMPETENT** - All sections passed, authorized for independent practice + +☐ **NEEDS REMEDIATION** - See below for areas needing improvement + +☐ **NOT COMPETENT** - Requires additional training before reassessment + +### Areas Needing Improvement: +_____________________________________________________________________ +_____________________________________________________________________ +_____________________________________________________________________ + +### Remediation Plan: +_____________________________________________________________________ +_____________________________________________________________________ +_____________________________________________________________________ + +**Reassessment Date:** ____________________ + +--- + +## Signatures + +### Employee +I have completed this competency assessment to the best of my ability. + +**Signature:** _________________________ **Date:** __________ + +### Assessor +I have assessed this employee's competency in pediatric pharmacy practice. + +**Signature:** _________________________ **Date:** __________ + +**Printed Name:** _________________________ **License #:** __________ + +### Pharmacy Manager (if remediation required) +**Signature:** _________________________ **Date:** __________ + +--- + +**Record Retention:** Maintained in employee file per regulatory requirements + +**Next Assessment Due:** ____________________ + +--- + +*Form FRM-004 Rev 1.0 - Pediatric Pharmacy* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..a2b9387 --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,107 @@ +# Pediatric Pharmacy Quality Policy + +| Document ID | POL-001 | +|-------------|---------| +| Title | Pediatric Pharmacy Quality Policy | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Policy Statement + +[ORGANIZATION NAME] Pediatric Pharmacy is committed to providing safe, effective, and developmentally appropriate pharmaceutical care for infants, children, and adolescents. We strive for excellence in pediatric medication therapy through evidence-based practices, continuous quality improvement, and unwavering commitment to medication safety for our youngest patients. + +## 2. Quality Objectives + +Our pediatric pharmacy commits to: + +1. **Pediatric Patient Safety**: Ensuring accurate dosing calculations and age-appropriate formulations for all pediatric patients +2. **Medication Error Prevention**: Implementing multiple verification systems to prevent calculation errors, wrong doses, and medication mix-ups +3. **Regulatory Compliance**: Maintaining compliance with all applicable pharmacy regulations, USP standards, and pediatric-specific guidelines +4. **Clinical Excellence**: Providing evidence-based pharmaceutical care appropriate to each developmental stage (neonate, infant, child, adolescent) +5. **Family-Centered Care**: Engaging parents, guardians, and age-appropriate patients in medication education and counseling +6. **Continuous Improvement**: Continually improving pediatric pharmacy processes through data analysis, error reporting, and quality initiatives +7. **Staff Competency**: Ensuring all pharmacy personnel are trained and competent in pediatric-specific calculations, compounding, and safety protocols +8. **Off-Label Use Management**: Documenting and monitoring off-label medication use with appropriate clinical justification + +## 3. Pediatric-Specific Commitments + +Top management and the pharmacy leadership demonstrate commitment to pediatric pharmaceutical care by: + +- Ensuring weight-based and BSA-based dosing verification for all pediatric orders +- Implementing independent double-check systems for high-alert medications in children +- Providing access to pediatric dosing references and calculation tools +- Maintaining competency in pediatric compounding, including flavoring and age-appropriate formulations +- Ensuring proper handling of neonatal medications, including dilutions and concentrations +- Supporting pediatric medication safety initiatives and error prevention programs +- Maintaining compliance with USP <795>, <797>, and <800> for pediatric preparations +- Documenting and reviewing all pediatric medication errors and near-misses +- Ensuring appropriate transition of care protocols from neonatal to pediatric to adult services + +## 4. Scope + +This policy applies to all personnel involved in: +- Pediatric medication order verification +- Dosing calculation and verification +- Pediatric compounding (sterile and non-sterile) +- Neonatal medication preparation +- Pediatric chemotherapy preparation +- TPN compounding for neonates and children +- Vaccine storage and administration +- Medication counseling for pediatric patients and families +- Controlled substance management for minors + +This policy covers patients from birth through 18 years of age (or up to 21 years as defined by institutional policy). + +## 5. High-Alert Medications in Pediatrics + +We recognize that certain medications pose heightened risk in pediatric populations and require additional safeguards: + +- Concentrated electrolytes (potassium, sodium chloride >0.9%, calcium) +- Insulin and hypoglycemic agents +- Opioids and sedatives in neonates and infants +- Chemotherapy agents +- Anticoagulants (heparin, enoxaparin) +- Neuromuscular blocking agents +- IV medications requiring dilution or dose calculation +- Medications with narrow therapeutic indices in children + +## 6. Dosing Safety + +All pediatric medication orders must include: +- Patient's current weight (in kg) +- Patient's age (or gestational age for neonates) +- Indication for use (especially for off-label medications) +- Dose expressed in appropriate units (mg/kg, mg/m², etc.) +- Maximum dose limits verified +- Calculation verification by independent pharmacist + +## 7. Communication + +This policy shall be: +- Communicated to all pharmacy personnel and relevant clinical staff +- Reviewed annually and updated as pediatric pharmacy practice standards evolve +- Available to parents and guardians upon request +- Integrated into new employee orientation and ongoing training + +## 8. Quality Monitoring + +Quality indicators for pediatric pharmacy include: +- Pediatric medication error rates (by category) +- Dosing calculation errors prevented +- Compounding accuracy and sterility testing results +- Time to preparation for stat neonatal/pediatric orders +- Off-label use documentation compliance +- Parent/guardian counseling completion rates +- Staff competency assessment results + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/README.md b/README.md index 54ecad8..c289a43 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,123 @@ -# pediatric-pharmacy +# Pediatric Pharmacy Quality Management System -A comprehensive QMS template designed for pediatric pharmacy operations including hospital pediatric services, neonatal intensive care, pediatric oncology, and specialized pediatric compounding. \ No newline at end of file +A comprehensive QMS template designed for pediatric pharmacy operations including hospital pediatric services, neonatal intensive care, pediatric oncology, and specialized pediatric compounding. + +## 👶 Designed For + +- **Pediatric Hospital Pharmacies** - Inpatient and outpatient pediatric services +- **Neonatal Intensive Care (NICU)** - Specialized neonatal medication preparation +- **Pediatric Oncology Pharmacies** - Chemotherapy preparation for children +- **Pediatric Compounding Pharmacies** - Age-appropriate formulations and flavoring +- **Children's Hospital Central Pharmacies** - Comprehensive pediatric medication services +- **Pediatric Specialty Clinics** - Outpatient pediatric medication management +- **Pediatric Home Infusion** - Home-based pediatric therapy + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **State Board of Pharmacy** regulations for pediatric services +- **DEA** (Drug Enforcement Administration) requirements for controlled substances in minors +- **FDA** regulations for pediatric drug handling and off-label use +- **USP <795>** - Non-Sterile Compounding (pediatric formulations) +- **USP <797>** - Sterile Compounding (NICU, TPN, chemotherapy) +- **USP <800>** - Hazardous Drug Handling (pediatric oncology) +- **Joint Commission** - Pediatric medication safety standards +- **ISMP** (Institute for Safe Medication Practices) - Pediatric medication safety guidelines +- **AAP** (American Academy of Pediatrics) - Pediatric pharmacy practice standards +- **PPAG** (Pediatric Pharmacy Association) - Best practices +- **HIPAA** - Patient privacy and data protection for minors +- **ACIP** - Vaccine storage and administration guidelines + +## Repository Structure + +``` +├── SOPs/ +│ ├── Dosing-Verification/ # Weight/BSA-based dosing verification +│ ├── Compounding/ # Pediatric formulations & flavoring +│ ├── Chemotherapy/ # Pediatric oncology preparations +│ ├── Patient-Safety/ # Pediatric-specific error prevention +│ ├── Controlled-Substances/ # DEA compliance for minors +│ ├── Inventory/ # Pediatric drug procurement +│ └── General/ # General pharmacy operations +├── Forms/ +│ ├── Dose-Calculation/ # Weight/BSA dosing worksheets +│ ├── Compounding-Records/ # Pediatric formulation logs +│ ├── Temperature-Logs/ # Vaccine & medication storage +│ ├── Controlled-Substance/ # DEA forms for pediatric patients +│ └── Training/ # Competency assessments +├── Policies/ # Pediatric pharmacy policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your pediatric pharmacy QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft pediatric pharmacy SOPs following best practices +- Create weight-based and BSA-based dosing protocols +- Generate pediatric compounding formulation records +- Develop neonatal medication safety procedures +- Create pediatric chemotherapy preparation protocols +- Review documents for pediatric medication safety compliance + +### Example Prompts + +- "@atomicai create an SOP for neonatal TPN compounding per USP 797" +- "@atomicai draft a weight-based dosing verification procedure" +- "@atomicai write a policy for pediatric high-alert medications" +- "@atomicai create a pediatric chemotherapy preparation checklist" +- "@atomicai develop an off-label medication documentation form" +- "@atomicai create a neonatal medication error prevention protocol" + +## Getting Started + +1. **Customize Policies** - Update policies in `/Policies` for your pediatric service +2. **Adapt SOPs** - Modify SOPs to match your pediatric workflow +3. **Set Up Dosing Tools** - Configure weight/BSA-based dosing verification forms +4. **Train Staff** - Use pediatric-specific competency forms +5. **Establish Safety Protocols** - Implement high-alert medication procedures for children + +## Key Documents to Create First + +1. **Weight-Based Dosing SOP** - Core pediatric dosing verification workflow +2. **Neonatal Medication Safety Policy** - Foundation for NICU safety +3. **Pediatric High-Alert Medications** - Critical safety protocols +4. **Compounding for Pediatrics SOP** - Age-appropriate formulations +5. **Off-Label Use Documentation** - Required for pediatric practice +6. **Chemotherapy Preparation SOP** - If providing pediatric oncology services +7. **TPN Compounding SOP** - If providing neonatal/pediatric nutrition support + +## Special Considerations for Pediatric Pharmacy + +### Dosing Calculations +- Weight-based dosing (mg/kg) +- Body surface area (BSA) calculations +- Age-appropriate dose ranges +- Maximum dose verification +- Renal/hepatic adjustments for children + +### Compounding +- Suspension preparation from tablets/capsules +- Flavoring for palatability +- Low-concentration preparations +- Unit-dose packaging for accuracy +- Stability considerations for pediatric formulations + +### Safety +- Double-check verification systems +- High-alert medications (concentrated electrolytes, insulin, etc.) +- Look-alike/sound-alike medications in pediatrics +- Calculation error prevention +- Transition of care (NICU to pediatric to adult) + +### Documentation +- Off-label use (>50% of pediatric medications) +- Age/weight at time of dispensing +- Parent/guardian counseling +- Developmental appropriateness + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Chemotherapy/.gitkeep b/SOPs/Chemotherapy/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Compounding/.gitkeep b/SOPs/Compounding/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md b/SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md new file mode 100644 index 0000000..d7dab33 --- /dev/null +++ b/SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md @@ -0,0 +1,284 @@ +# 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] | diff --git a/SOPs/Controlled-Substances/.gitkeep b/SOPs/Controlled-Substances/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Dosing-Verification/.gitkeep b/SOPs/Dosing-Verification/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Dosing-Verification/SOP-DOSE-001-Weight-Based-Dosing.md b/SOPs/Dosing-Verification/SOP-DOSE-001-Weight-Based-Dosing.md new file mode 100644 index 0000000..6723d5c --- /dev/null +++ b/SOPs/Dosing-Verification/SOP-DOSE-001-Weight-Based-Dosing.md @@ -0,0 +1,240 @@ +# 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] | diff --git a/SOPs/General/.gitkeep b/SOPs/General/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Inventory/.gitkeep b/SOPs/Inventory/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Patient-Safety/.gitkeep b/SOPs/Patient-Safety/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md b/SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md new file mode 100644 index 0000000..6affa1f --- /dev/null +++ b/SOPs/Patient-Safety/SOP-SAF-001-High-Alert-Medications.md @@ -0,0 +1,377 @@ +# 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] | diff --git a/SOPs/SOP-001-Document-Control.md b/SOPs/SOP-001-Document-Control.md new file mode 100644 index 0000000..c60b688 --- /dev/null +++ b/SOPs/SOP-001-Document-Control.md @@ -0,0 +1,164 @@ +# 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] | diff --git a/SOPs/SOP-002-CAPA.md b/SOPs/SOP-002-CAPA.md new file mode 100644 index 0000000..a7f2c24 --- /dev/null +++ b/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] | diff --git a/SOPs/SOP-003-Training.md b/SOPs/SOP-003-Training.md new file mode 100644 index 0000000..b8e1be5 --- /dev/null +++ b/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] | diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..5d86ee1 --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,97 @@ +# 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 + +## 7. Related Documents + +- [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] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..bc511e6 --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,92 @@ +# Work Instruction: [Title] + +| Document ID | WI-001 | +|-------------|--------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Pediatric Pharmacy | + +--- + +## 1. Purpose + +[Describe the purpose of this pediatric pharmacy work instruction] + +## 2. Scope + +[Define what activities this instruction covers and applicable patient populations] + +## 3. Safety Precautions + +- [List any safety requirements specific to pediatric preparations] +- [Personal protective equipment needed] +- [Hazards to be aware of] +- [Age-specific considerations] + +## 4. Equipment/Materials Required + +| Item | Specification | +|------|---------------| +| [Equipment] | [Spec - include pediatric-specific items like oral syringes, small volume supplies] | +| [Materials] | [Spec] | +| [References] | Pediatric dosing references, calculation tools | + +## 5. Procedure + +### Step 1: Patient Verification +- Verify patient name, age, weight +- Confirm appropriate for pediatric patient +- [Additional verification steps] + +### Step 2: Calculation/Preparation +[Detailed instructions including:] +- Formula or calculation method +- Units of measurement +- Independent verification requirement +- [Additional steps] + +### Step 3: [Title] +[Detailed instructions] + +### Step 4: Quality Check +- Visual inspection +- Volume verification +- Label verification (patient-specific) +- Expiration dating appropriate for pediatric use + +### Step 5: [Final Steps] +[Detailed instructions] + +## 6. Acceptance Criteria + +[Define what constitutes successful completion, including:] +- Accurate dose calculation within acceptable range +- Appropriate concentration for patient age +- Proper labeling with age-appropriate instructions +- Documentation complete + +## 7. Documentation Requirements + +| Record | Location | Retention | +|--------|----------|-----------| +| [Calculation worksheet] | Patient record | [Period] | +| [Compounding log] | Pharmacy records | [Period] | +| [Verification signature] | Batch record | [Period] | + +## 8. References + +- [Related SOPs] +- [Pediatric dosing guidelines] +- [Manufacturer specifications] +- [USP standards] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] |