221 lines
6.2 KiB
Markdown
221 lines
6.2 KiB
Markdown
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# Pediatric Oral Suspension Compounding Log
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| Document ID | FRM-COMP-001 |
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| Title | Oral Suspension Compounding Log |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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---
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## Patient/Prescription Information
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| Field | Value |
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|-------|-------|
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| Patient Name | ________________________________ |
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| Date of Birth | ________________________________ |
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| Prescription Number | ________________________________ |
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| Prescriber | ________________________________ |
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| Date Compounded | ________________________________ |
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## Formulation Information
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| Field | Value |
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|-------|-------|
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| Medication | ________________________________ |
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| Final Concentration | _________ mg/mL (or mcg/mL) |
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| Total Volume | _________ mL |
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| Flavor | _________ ☐ None |
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| Beyond-Use Date (BUD) | ________________________________ |
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| Storage Requirements | ☐ Refrigerate (2-8°C) ☐ Room temperature ☐ Protect from light |
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## Calculations
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### Dosage Form Used
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☐ Tablets
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☐ Capsules
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☐ Bulk powder
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**Product Details:**
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- Manufacturer: _______________________
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- Strength: _________ mg per tablet/capsule
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- NDC: _______________________
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- Lot Number: _______________________
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- Expiration Date: _______________________
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### Quantity Calculation
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**Quantity Needed:**
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```
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Desired concentration: _______ mg/mL
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Final volume needed: _______ mL
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Total drug needed: _______ mL × _______ mg/mL = _______ mg total
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```
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**Dosage Forms Required:**
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```
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_______ mg total ÷ _______ mg per unit = _______ units
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Round up to: _______ tablets/capsules
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(includes overage: ______ %)
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```
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**Verified by:** _________________ (Second pharmacist initials)
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## Ingredients
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| Ingredient | Manufacturer/Brand | Lot Number | Expiration Date | Quantity Used |
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|------------|-------------------|------------|-----------------|---------------|
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| [Drug name] | _______________ | __________ | ______________ | ______ units |
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| Suspending vehicle | _______________ | __________ | ______________ | ______ mL |
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| Sweetening agent | _______________ | __________ | ______________ | ______ mL |
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| Flavoring (if used) | _______________ | __________ | ______________ | ______ mL |
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| Other: __________ | _______________ | __________ | ______________ | __________ |
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## Compounding Procedure
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### Preparation Checklist
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☐ Hand hygiene performed
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☐ Appropriate garbing (lab coat, gloves)
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☐ Work area cleaned and disinfected
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☐ Equipment cleaned and ready
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☐ All ingredients verified and gathered
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### Compounding Steps Completed
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☐ **Step 1:** Counted and verified ______ tablets/capsules
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☐ **Step 2:** Crushed tablets to fine powder / Emptied capsule contents
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☐ **Step 3:** Triturated to uniform powder
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☐ **Step 4:** Added small portion of vehicle, mixed to smooth paste
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☐ **Step 5:** Used geometric dilution, added vehicle in portions
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☐ **Step 6:** Transferred to graduated cylinder
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☐ **Step 7:** Rinsed mortar with vehicle
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☐ **Step 8:** Brought to final volume: _______ mL
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☐ **Step 9:** Added flavor (if applicable): _______ mL
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☐ **Step 10:** Transferred to final container
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☐ **Step 11:** Shook thoroughly for 30 seconds
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## Quality Control
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### Visual Inspection
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☐ Uniform suspension (no large particles)
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☐ Appropriate color
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☐ Smooth consistency
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☐ No visible contamination
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☐ Suspends well when shaken
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### Volume Verification
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- Target volume: _______ mL
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- Actual volume: _______ mL
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- Within acceptable range (±5%): ☐ Yes ☐ No
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### Concentration Verification
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```
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Total drug: _______ mg
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Final volume: _______ mL
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Concentration: _______ mg ÷ _______ mL = _______ mg/mL
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```
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☐ Matches intended concentration
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**Independent calculation by:** _________________ (Pharmacist initials)
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## Beyond-Use Date Determination
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**Stability Reference:**
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☐ Published study (citation): _________________________________
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☐ USP <795> general guidance: 14 days refrigerated / 30 days room temp
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☐ Manufacturer information
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☐ Trissel's Stability Reference
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☐ Other: _________________________________
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**BUD Assigned:** _________________________________
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**Rationale:** ___________________________________________________
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## Labeling
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☐ Patient name and date of birth
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☐ Medication name and concentration
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☐ "SHAKE WELL BEFORE EACH USE"
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☐ Directions for use
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☐ Beyond-use date
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☐ Storage instructions
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☐ "For Oral Use Only"
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☐ Flavor (if added)
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☐ Pharmacist initials
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☐ Compounding date
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☐ Auxiliary labels (if applicable)
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**Oral syringe provided:** ☐ Yes (size: _____ mL) ☐ No ☐ N/A
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## Final Verification
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### Pharmacist Final Check
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☐ Correct medication and strength
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☐ Accurate calculations verified
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☐ Appropriate concentration for patient
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☐ Correct labeling
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☐ BUD appropriate and documented
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☐ Storage instructions clear
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☐ Quality checks passed
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**Verifying Pharmacist:**
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- Name: _________________________
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- License #: _________________________
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- Signature: _________________________
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- Date/Time: _________________________
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## Counseling Points Provided
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☐ Shake well before each use
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☐ Use oral syringe for accurate dosing
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☐ Storage requirements explained
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☐ Beyond-use date explained
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☐ Administration technique demonstrated
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☐ Side effects discussed
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☐ Importance of completing therapy
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**Counseled by:** __________________ Date/Time: __________
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## Documentation
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### Compounded by
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- Technician/Pharmacist Name: _________________________
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- Signature: _________________________
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- Date/Time: _________________________
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### Checked by
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- Pharmacist Name: _________________________
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- License #: _________________________
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- Signature: _________________________
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- Date/Time: _________________________
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## Cleanup
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☐ All equipment washed and dried
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☐ Work surface disinfected
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☐ Waste disposed of appropriately
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☐ Ingredients returned to storage
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**Cleaned by:** __________________ Date/Time: __________
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## Notes/Deviations
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_____________________________________________________________________
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_____________________________________________________________________
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_____________________________________________________________________
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## For Pharmacy Records
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**Record Retention:** Per state board requirements (minimum 3 years)
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**Filed in:** ☐ Compounding logs ☐ Patient profile ☐ Both
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**Log reviewed by:** ______________ Date: ________
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*Form FRM-COMP-001 Rev 1.0 - Pediatric Pharmacy Compounding*
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