Vyvanse 50 mg Refill Protocol
Vyvanse (lisdexamfetamine) 50 mg is a Schedule II controlled substance that requires a new written prescription for each refill with no refills permitted under federal law.
Regulatory Requirements
As a Schedule II controlled substance, Vyvanse 50 mg cannot be refilled in the traditional sense 1. Each dispensing requires:
- New prescription for every 30-day supply (or whatever quantity prescribed)
- No refills allowed on the prescription
- Written or electronic prescription (if state law permits e-prescribing for Schedule II)
- DEA regulations strictly prohibit refills on Schedule II medications
Standard Dispensing Quantity
The FDA labeling indicates standard packaging of 100 capsules per bottle for the 50 mg strength (NDC 59417-105-10) 1. However, typical prescribing practice involves:
- 30-day supply (30 capsules) for monthly dispensing
- Once-daily dosing is standard
- Patient must obtain a new prescription each month
Monitoring Requirements During Maintenance Phase
Once the patient is stabilized on 50 mg, follow-up should include 2:
- Monthly appointments until symptoms are fully stabilized
- Quarterly blood pressure and pulse checks for adults
- Weight monitoring at each visit (particularly important as appetite suppression is common)
- Systematic assessment of side effects including insomnia, anorexia, headaches, social withdrawal, and tics
Critical Prescribing Considerations
The 50 mg dose falls within the therapeutic range established in clinical trials 3, 4, 5:
- Therapeutic range: 30-70 mg/day for ADHD in adults
- 50 mg represents a mid-range maintenance dose
- This dose showed significant efficacy in reducing ADHD symptoms compared to placebo
Common Pitfalls to Avoid
- Never write "refills" on a Schedule II prescription - it will be rejected by the pharmacy and is a DEA violation
- Do not provide post-dated prescriptions - this is also prohibited for Schedule II substances
- Ensure proper storage counseling - patients should store in a locked cabinet at room temperature (68-77°F) 1
- Disposal instructions - unused medication should go to a DEA-authorized take-back program, not simply discarded 1
Practical Workflow
For ongoing treatment, establish a system where:
- Patient schedules monthly follow-up (can be brief once stabilized)
- New prescription is generated at each visit or sent electronically
- Prescription specifies exact quantity (typically 30 capsules for 30 days)
- No refill notation on prescription