Opinion
Video
Barriers to Bridging Clinical Trial Data to Routine Pharmacy Practice
Author(s):
A panelist discusses how implementing new clinical trial findings into practice involves multiple challenges including operationalizing treatment regimens in electronic medical records (EMR), procuring medications, obtaining formal approval through institutional committees, and, most significantly, securing insurance approval since insurers often update their formularies less frequently than FDA approvals occur, which can delay patient care.
Implementation Challenges for New Clinical Trial Findings in Practice
Key Operational Challenges
- EMR Integration:
- Building new treatment regimens into EMR systems
- Creating comprehensive supportive care protocols
- Establishing appropriate premedication orders
- Developing consistent documentation and communication tools for nurses and physicians across the health care system
- Medication Logistics:
- Procurement challenges with new medications
- Coordination with inventory managers to ensure adequate supply
- Establishing new stocking parameters and inventory controls
- Institutional Approval Process:
- Formal approval through Pharmacy and Therapeutics Committee
- While some institutions allow flexibility for outpatient treatments with insurance approval, procedural hurdles may still exist
Insurance Barriers
- Timing Discrepancies:
- Insurance formulary updates often lag behind FDA approvals
- Updates may occur only quarterly or semiannually
- This misalignment creates significant implementation delays
- Additional Administrative Burden:
- Need for insurance appeals
- Prior authorization requirements
- These processes create substantial delays in patient care
These multifaceted challenges highlight the gap between clinical trial evidence and practical implementation, with administrative and logistical barriers potentially delaying patient access to new therapeutic advances.
