Does ARV Follow Open Vial Policy?
No, antiretroviral (ARV) medications do not follow an open vial policy—they should be dispensed as complete prescriptions for individual patient use only, not as multi-dose vials for multiple patients.
Standard ARV Dispensing Practice
The most recent CDC guidelines for HIV postexposure prophylaxis explicitly recommend providing a full 28-day prescription of antiretrovirals at initial assessment, rather than partial prescriptions or shared vial approaches 1. This represents the standard of care for ARV dispensing across all HIV treatment and prevention contexts.
Key Prescribing Principles
- Complete course dispensing: A full 28-day supply should be provided upfront for postexposure prophylaxis to maximize adherence and completion rates 1
- Individual patient use: ARV medications are formulated and approved for single-patient use, with dosing tailored to individual patient factors including weight, age, renal function, and drug interactions 1
- No vial sharing: Unlike some vaccines or medications that may permit multi-dose vial use under specific sterile conditions, ARVs are not designed or approved for this practice
Why ARVs Cannot Follow Open Vial Policy
Pharmaceutical Formulation Issues
ARV medications are available primarily as:
- Fixed-dose combination tablets (single-tablet regimens like bictegravir/emtricitabine/tenofovir alafenamide) 1
- Individual oral formulations requiring specific dosing schedules 1
- Pediatric formulations with weight-based dosing 1
These formulations are not designed as multi-dose injectable vials that could be shared between patients 1.
Patient-Specific Dosing Requirements
- Individualized regimens: ARV selection depends on patient-specific factors including concomitant medications, renal function, hepatic function, pregnancy status, and resistance patterns 1, 2
- Drug interaction considerations: Medications like dolutegravir require dose adjustments when combined with other drugs (e.g., metformin dosing limited to 1g daily when taking dolutegravir) 1
- Adherence monitoring: Each patient requires individual adherence counseling and monitoring to ensure treatment completion 1
Infection Control and Safety Concerns
While research on single-use vials shows that sterility can be maintained under controlled conditions 3, and healthcare facilities must comply with multi-dose vial policies for appropriate medications 4, ARVs are not formulated or approved as multi-dose vials for multiple patients.
Clinical Implications
For Treatment Initiation
- Provide complete 28-day courses for postexposure prophylaxis at the initial visit 1
- For ongoing HIV treatment, prescribe individualized regimens based on patient-specific factors 2
- Ensure patients receive enhanced adherence counseling at initiation 1
Cost and Access Considerations
The CDC acknowledges that ARV medications are expensive and cost barriers exist 1. However, the solution is not to share vials between patients, but rather to:
- Utilize patient assistance programs 1
- Prescribe generic formulations when available 1
- Connect patients to financial support resources 1
Common Pitfall to Avoid
Never attempt to use ARV medications as multi-dose vials for multiple patients, even if trying to reduce costs or waste. This practice would be: