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

Introduction

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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

Changing Regulations Update during the presentation

Questions?