221 lines
6.2 KiB
Markdown
221 lines
6.2 KiB
Markdown
# 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*
|