Transcript Medication Shortage - the California Ambulatory Surgery Association

“Running On Empty”
Safe Medication Practices
California Ambulatory Surgery Association
Annual Conference
Thursday, September 12, 2013
1
Introduction
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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
3
Medication Shortage
• Causes:
– Unavailable ingredients
• Decreased raw materials
• Decreased production of ingredients
– Government interventions
• Changing regulations
• Closing production lines
– Excess demand
4
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
5
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 www.fda.com
– ASHP www.ashp.com
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Sources of Medications
• Drug Wholesalers
– Approved and monitored by government agencies
• Proprietary manufacturers
– Approved and monitored by government agencies
• Generic manufacturers
– Approved and monitored by government agencies
• Compounding companies
– Monitored primarily by State Boards of Pharmacy
7
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
8
Sources of Medications
• Proprietary Medications
– Researched and developed by manufacturer
– Studied in animals
• Studied to show efficacy and safety
– Studied in humans
• Studied to show efficacy and safety
– Usually in large studies
– Reviewed, approved, and monitored by the
FDA
9
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
10
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
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Potential Solutions
• GPOs
– Failure to supply clause
– Contract with multiple sources
• Manufacturers
– Increase inventory
– Early notification
– Institute direct buying
• Wholesaler/distributors
– Early notification
– Develop internal response process
– Responding to potential shortages
12
Potential Solutions
• Ideas on how to better manage shortages
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Link with other ASCs by geographical areas
Link with acute facilities
Manage and monitor medication inventory
Use compounding pharmacies?
13
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
14
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
15
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
16
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
17
Changing Regulations
• Update during the presentation
18
Questions?
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