Transcript Power point template with registered trademark symbol

NAVIGATING THE DRUG
SHORTAGE CRISIS IN
AMERICAN HEALTHCARE
Coleen A. Cherici, RPh, MBA
Director of Pharmacy Consulting
[email protected]
© 2010 Premier, Inc. 7/21/2015
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7/21/2015
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Objectives
• Describe the major environmental and economic root
causes of drug shortages
• Describe the major clinical and operations impact of drug
shortages
• Describe the key strategies for avoiding a crisis mode
when dealing with drug shortages
• Describe best practice in avoiding drug misadventures that
might be caused by drug shortages
7/21/2015
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The Problem
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Multifaceted industry wide problem with many root causes
Member operations are impacted clinically and financially
In 2010 77% of drug shortages - injectable drugs
Premier Survey (January to February 2010)
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Institute of Safe Medication Practices (ISMP) Survey (July
to Sept 2010)
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311 acute care respondents
90%: affected patient care
82%: delayed or caused cancellation in patient care intervention
100%: resulted in a higher cost of drug cost and staffing
Large survey looking at risk to patient care and safety
American Hospital Association (AHA) July 2011
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Demonstrates that the Premier data collected 6 months accurately
quantified the impact to acute care
Major impact continues to worsen
Quantify Impact on Pharmacy Expense
Quantify Financial Impact of Drug Shortages
• Most respondents have not measured financial Impact
• Only 19 hospitals in the survey were able to quantify dollars
spent as result of drug shortages
• Those that could did not have a common methodology
• A review of the Premier data allowed for an extrapolation of
cost for generic drugs that had a replacement substitute in
the distribution channels
– Cost to ALL Hospitals in the US is ~ $200 Million in 2010
– This cost does not consider the expense associated with clinical
and operations labor needed to control the work associated with a
load increase needed to safely control the shortage
The Causes
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Raw material quality issues
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Manufacturer economic issues
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42% of sterile injectable drug shortages in 2010
9% raw material Active Pharmaceutical Ingredient (API) concern
5% manufacturing plant shutdown due to quality issues
Financial decisions to discontinue products and limit volume of
manufacturing volume in particular low margin products
18% of shortages in 2010 were due to product line discontinuation
FDA enforcement of GMP and Plant inspections
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The Nation expects high quality pharmaceuticals
Cost of maintaining requirements cuts into product margins
Unapproved Drug Initiative (2006) mandates submission of a New
Drug Application containing clinical trial data to prove the safety
and efficacy of products that were brought to market prior to more
stringent approval processes
The Causes
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Just-In-Time Inventory Processes
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Results in leaner inventory levels
All Supply Chain points for reserve are affected
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Drugs in short supply emerge in the gray market
Costs are tracked at 100 to 1000 times the normal price
Supply availability when approved distributors have no stock
Change in Drug Use Patterns
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API License ownership
Gray Market Supply Intrusions
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Manufactured product runs
Distributor/wholesaler inventory on hand
End User inventory on hand
Shortage for one drug may cause another’s demand to increase
Shift in demand is not picked up by other manufacturers
4% of 2010 shortages were as a result of this concern
Hoarding by end users
How Can Premier Help Members Navigate
Through the Drug Shortage Crisis?
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What is Premier doing about this growing problem?
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Review data on backorders by supplier and drug
Published backorder status reports in Pharmacy Weekly Update
PharmacyConnect® Website on Drug Shortages
Resource contracts when possible to manufacturers that can
supply
Premier and Members meeting with and other Professional
Organizations
Premier Research Survey and Navigating the Drug Shortage Crisis
Published in Economic Outlook Spring 2011
Study the Unauthorized Gray Market that is proliferating as result of
the deficiencies in the supply chain
Develop tools to measure expense and Impact on Pharmacy
Expense
Development of an Advocacy Platform on Drug Shortages
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Support of S 296
Support GAO investigation
Help to Share Knowledge and Just-inTime Solutions