C lin ical In teg ratio n Track

Clinical Integration Track:
Tracking From Raw Materials to Point of
Care
William Lee, Pharmacy System Director,
Carilion Clinic
Carilion Medical Center
Roanoke, Virginia
Carilion Response to the current
Drug Shortage Issue
William T. Lee D.Ph, MPA, FASCP
•  Presenter:
• 
•  Pharmacy System Director
Discussion
•  Notification of Drug Recall
•  Effect on Carilion Services: NECC
incident
•  Carilion’s Response
•  Carilion’s Solutions / Strategy
NECC ISSUES
! Facts : Fungal Meningitis :
Methylprednisolone acetate injection.
! No clear cut direction
•  Carilion Clinic
Community Care
•  Wound Care Center
•  Occupational
Medicine
•  Inpatient physical
rehabilitation
•  Pediatric dental
services
•  Outpatient services
Carilion Roanoke Memorial
Hospital (CRMH)
•  763 bed, tertiary
care, teaching
hospital
•  Level I trauma
center
•  Regional referral
center for SW
Virginia
•  Jefferson College of
Health Sciences
CMC Department of Pharmacy
•  72 Pharmacists, 63 Pharmacy Technicians
4,275 orders verified (1.56M/year)
14,000 doses dispensed
1,245 sterile products
1,829 Pyxis refills
1,200 clinical interventions
656 scheduled medication deliveries
•  Average Daily Workload
• 
• 
• 
• 
• 
• 
Carilion Clinical Services
! Pharmacokinetic monitoring
! Renal/hepatic dose monitoring
! Anticoagulation services (LMWH, heparin, oral
anticoagulants, DTI)
! Total parenteral nutrition
! Discharge planning/patient counseling
! Interdisciplinary team members
! Code Blue, Stroke, Heart Alert team member
Carilion’s Response to NECC
! EPIC advantage : EHR
! Patients identified through ER
! Review of Compounding pharmacies
! - Vetting process: ASHP; 797, GMP
!  Policy development
!  NABP initiative : implications on the
State Boards of Pharmacy and FDA
!  Congressional legislation
Current Status of Drug Shortages
! History
! Impact at Carilion
! NECC effect on drug shortages
! Strategy to address Drug Shortage
! Strategy to address Compounding
Pharmacy issue
Analysis of Current Issues
! No financial incentive in “generics” for
manufacturers eg: colchicine (COLCRYS),
parenteral electrolytes,
! Consolidation of generic manufacturers
! Commercial product restrictions on
Compounding
! Strict USP– 797 guidelines: shorter duration
! Wholesaler Issues
! Pedigree Issues: Gray Market
Strategy : Drug Shortage
! Biweekly review : all hospitals
! ASHP drug shortage center & list
serve
! FDA drug shortage listings
! Pharma advance notices
! Pharmacy networking
Carilion’s Process For Drug Shortage
! 1-manager, 1-tech-central point
! 30 day historical usage
! Critical meds : PAR levels – 2-4 weeks
! Communication-CommunicationCommunication! Secondary market – last resort
Conclusions
! Compounding Pharmacy not an
option ?
! Coordination of Back order
information
! Bi-weekly calls on shortages
! Future :
! back to “basics”
! Secondary wholesaler need