1. “Running On Empty” Safe Medication Practices
California Ambulatory Surgery Association
Annual Conference
Thursday, September 12, 2013

2. Introduction

3. Medication Shortages
150 medically necessary drugs are currently in short supply**
Cost to U.S. Healthcare providers is at least $200 million annually*
Inhibit correct medication therapy
Pose patient safety risks
Cause surgery cancellations
*BusinessWire.com
**klobuchar.senate.gov

4. Medication Shortage Causes: Unavailable ingredients
Decreased raw materials
Decreased production of ingredients
Government interventions
Changing regulations
Closing production lines
Excess demand

5. Medication Shortages Causes: Manufacturer retirements
Increased generic manufacturers
Profit margin shrinking
Developing more profitable products
Decreasing manufacturer inventory
Medication hoarding
Wholesalers, grey market vendors, black market vendors, healthcare facilities

6. Finding Sources of Medication
Obstacles:
Lack of timely information
Lack of understanding of reasons
Stress when shortages occur
Information on Shortages:
Lists from wholesalers
FDA
ASHP

7. Sources of Medications
Drug Wholesalers
Approved and monitored by government agencies
Proprietary manufacturers
Generic manufacturers
Compounding companies
Monitored primarily by State Boards of Pharmacy

8. Sources of Medications
Drug Wholesalers
Conduit from manufacturers to end-users
Have medications only if received from manufacturer
Purchase medications from manufacturer according to end-user demand
Taken out of loop during shortages by manufacturers
Approved and monitored by the FDA

9. Sources of Medications
Proprietary Medications
Researched and developed by manufacturer
Studied in animals
Studied to show efficacy and safety
Studied in humans
Usually in large studies
Reviewed, approved, and monitored by the FDA

10. Sources of Medications
Generic Medications
Contain exact active ingredient
May contain different non-active ingredients
Studied in humans
Compared to proprietary medication
Same pharmacokinetic profile
Small studies
Reviewed, approved, and monitored by the FDA

11. Sources of Medications
Compounded Medications
Must follow prescription compounding guidelines established for pharmacists
Compound for specific patients
No studies to prove quality
No required quality control evaluation
Production process not approved and monitored by the FDA
Must be approved as a pharmacy
Monitored by State Boards of Pharmacy

12. Potential Solutions GPOs Manufacturers Wholesaler/distributors
Failure to supply clause
Contract with multiple sources
Manufacturers
Increase inventory
Early notification
Institute direct buying
Wholesaler/distributors
Develop internal response process
Responding to potential shortages

13. Potential Solutions Ideas on how to better manage shortages
Link with other ASCs by geographical areas
Link with acute facilities
Manage and monitor medication inventory
Use compounding pharmacies?

14. Monitor Inventory Develop System
Understand the Importance of Inventory Management
Know Information Sources
Understand How Information is Derived
Determine Inventory Turnover Rate
Systematic Review of Product Movement
Knowledge of Anticipated Demand

15. Monitor Inventory Inventory Management Provides stock of products
Reduces number of out-of-stocks
Reduces out-of-date products
Eases removal of discontinued products
Eases removal of recalled products
Enables premium patient care
Provides base for potential changes in regulations

16. Monitor Inventory Obstacles to Inventory Management
Lack of personnel in ASCs
No systematic programs
Few tools to support inventory management
Not necessary in the past

17. Compounding Pharmacies
Choose wisely
Stay within your state
Pharmacy Compounding Accreditation Board (PCAB) certification
Third party sterility and particulate monitoring
Check on State Board of Pharmacy licensing
Request issue with recalled product within the last 3 years
Check with the State Board of Pharmacy regarding any issue with the vendor

18. Changing Regulations
Update during the presentation

19. Questions?