Transcript Drug Shortages: We’re in This Together

Drug Shortages: We’re in This Together
NPPA Conference, Las Vegas, NV
August, 2011
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©2011 Novation Confidential.
On Pace for Unprecedented Number of Drug Shortages in 2011
National Drug Shortages (January 2001 to July 31, 2011)
250
211
200
149
150
100
166
180
129
120
Shortages
88
73
58
74
70
50
0
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Note: Each column represents the # of new shortages identified
during that year by University of Utah Drug Information Service
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Contracting Strategy to Minimize Drug
Shortage Impact
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Stronger contract template language in 2011 requires prompt
notification of supply problems to Novation
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Select most reliable suppliers possible for contract awards. Past
performance on supply is one factor considered in evaluating
contract awards
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For products with history of supply problems make multi-awards
where possible
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Insulate customers from having to pay more for a non-contract
product by securing strong “failure to supply” reimbursement
terms in contract. Over $10 million returned to members in 2010
through the Failure to Supply Reimbursement Service.
– FTS reimbursement is not intended as a substitute for
obtaining contract coverage on available products
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Contracting Response if Shortage Occurs
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Investigate market for alternatives and
review current agreement for options
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If generically equivalent product available,
seek to add it to contract on a temporary
basis. Prevents member from paying WAC
price.
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If multiple suppliers are in the market,
conduct a competitive procurement to
obtain best price on available supply.
Efficient process allows quick decisions.
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Helping with Information
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Financial support for ASHP’s drug shortage
information postings on www.ashp.org
Weekly electonic member newsletter and
other communication vehicles
Marketplace web site contains many
resources
– Drug Shortage Information Alerts
– Key supplier inventory updates provided
on regular basis
– Archived web conferences for playback
Sponsor/participate in venues for
stakeholders to exchange information
– Regional and national meetings
– Ongoing participation in work groups
formed at 2010 Drug Shortage Summit
– Represent members in ongoing
discussions with FDA and participation in
upcoming CDER Drug Shortage
Workshop
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Drug Shortage Summit
November 5, 2010
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Co-convened by
– ASHP
– American Society of
Anesthesiologists
– American Society of Clinical
Oncology
– Institute for Safe Medication
Practices
Participants
– FDA
– CDC
– Pharmaceutical suppliers
– Pharmaceutical distributors
– Novation and other GPOs
– Other healthcare organizations
Drug Shortage Summit
Goals
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Discuss the scope and causes of drug
shortages
Shed light on the harm to patients due to
drug shortages
Discuss need for changes in public
policy and stakeholder practices to
prevent shortages
Develop plan to stop harm and patient
care disruptions caused by drug
shortages
Participants continue to work on above
goals through conference calls
Our Continued Focus on Drug Shortage Issues
• Web conference series related to drug shortages during
Q3
– Will offer pharmacy and nursing continuing education
– Incorporating noted external subject matter experts in
addition to Novation staff
• Contract templates changed to require better
manufacturer communication on shortages
• Revised non-financial weighting for future bids
• Reviewing opportunities to improve/streamline
communications on shortages with new
Marketplace/Procure Web platform
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Government Gets Involved
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Government’s Efforts to Ease Drug Shortages
Proposed Senate Legislation
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“Preserving Access to Life-Saving Medications Act” (S.296) introduced late 2010
Sponsors
– Klobuchar (D-Minnesota)
– Casey (D-Pennsylvania)
Key components
– Manufacturer reporting of discontinuance (at least 6 months notice),
interruption or action that may result in a shortage
– Public notification by FDA through its web site
– Identification of drugs vulnerable to shortage
• Continuity of operations planning for vulnerable and medically
necessary products
• Requiures FDA to revise definition of medically necessary to include the
prevalence of use of the drug
– http://thomas.loc.gov/cgi-bin/bdquery/z?d112:s.296:
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Government’s Efforts to Ease Drug Shortages
Proposed House Legislation
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“Preserving Access to Life-Saving Medications Act of 2011” (H.R. 2245)
– Introduced June 21, 2011
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Sponsors
– Rep. Diana L. DeGette (D-Colo.)
– Rep. Thomas J. Rooney (R-Fla.)
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Key components
– Requires drug manufacturers to provide advance notice to FDA regarding
manufacturing problems or when a drug product will be discontinued
– Institutes civil monetary penalties for manufacturers who fail to report
– Requires FDA to:
• Maintain an online list of drugs in shortage situations
• Implement evidence-based criteria for identifying drugs vulnerable to a shortage
• Provide annual report to Congress followed by a report every five years on the
actions taken to address and prevent drug shortages
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Text of Bill
– http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.2245:
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Other Government Efforts: Drug Shortages
GAO Investigation Requested
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Senator Richard Blumenthal (D-Conn.), early March 2011
GAO office requested to open an investigation to examine
– Hospital shortages of pharmaceutical products and prevalence in recent
years
– Impact of shortages on patient care
– Possible explanations
– Potential legislative or administrative approaches to address the problem
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Investigation is currently underway
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What Can You Do?
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Drug Shortages: Actions You Can Take
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Report them to ASHP
http://www.ashp.org/shortages, FDA or your GPO
Have a plan in place for handling shortages
– ASHP Guidelines on Managing Drug Product
Shortages in Hospitals and Health Systems
Keep informed
Keep all communication channels open
Explore all purchasing avenues
– Cultivate good relationships with company
and distributor representatives
– Jump through all the hoops
– Backorders, direct orders (timing)
Consider supporting legislation –ASHP’s
Grassroots Action Center on www.ashp.org
Report concerns about trade practices to FTC:
http://www.ftc.gov/. Use customer complaint link.
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•Questions??
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