Combating the Drug
Shortage Crisis
Moderator
Ron Hartmann, PharmD, Senior Vice President, Pharmacy,
MedAssets
Panelists
Valerie Jensen, RPh, Cpatain, USPHS, Associate Director, Drug
Shortages Program, FDA
Erin Fox, PharmD, FASHP, Director, Drug Information Service,
University of Utah
Bona Benjamin, Director, Medication Use Quality
Improvement, American Society of Health System Pharmacists
Mark Hendrickson, Director of Sciences and Regulatory
Affairs, Generic Pharmaceutical Association (GPhA)
Combating the Drug
Shortage Crisis
Erin R. Fox, PharmD
Director, Drug Information Service
University of Utah Hospitals and
Clinicshttps://hscintranet.med.uta
h.edu/document_center/Documen
ts/DIS-Newsletter-InfluenzaVaccines-2013-2014-Season.pdf
Disclosure
This presentation represents my own opinions,
not those of the University of Utah.
Current Trends
National Drug Shortages
New Shortages by Year
January 2001 to September 30, 2013
300
267
250
211
200
149166
129
150 120
100
204
88
109
73
58
74 70
50
0
01 02 03 04 05 06 07 08 09 10 11 12 13
Note: Each column represents the # of new shortages identified
during that year
Shortage
National Drug Shortages –
Active Shortages by Quarter
Active Shortages
350
300
239
250
200
150
152 167
246 256
282
273 260
299 295 299 294
211
176 188
Shortages
100
50
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
Q1-12
Q4-11
Q3-11
Q2-11
Q1-11
Q4-10
Q3-10
Q2-10
Q1-10
0
Note: Each column represents the # of active shortages at the end of each
quarter.
University of Utah Drug Information Service
Active Shortages
Top 5 Drug Classes
Active Shortages 9/30/13
60
50
40
30
20
10
0
50
39
31
37
26
Active Shortages
University of Utah Drug Information Service
What do these numbers mean?
• Decreasing rate of new shortages
• Ongoing shortages are not resolving
• Continued daily impact for patients,
clinicians, health systems, health care
Why is this
happening?
Med Watch Trends – Reports
Related to Safety, Medication
Quality, and Compounding
Quality
90
80
70
1
10
7
21
60
19
32
50
40
30
22
Compounding
Quality
69
54
16
54
20
36
21
10
0
2009
2010
2011
2012
2013*
http://www.fda.gov/Safety/MedWatch/default.htm
*2013 are data through August
Safety
Fragile Supply Chain Generic Injectables
• Concentrated market
• Few products with > 3 suppliers
• Manufacturing capacity
– At capacity, no resiliency
– Multiple products made on single line
• Complex manufacturing process
– No simple fixes for quality problems
– Problems typically affect multiple products
– ISPE survey identifies “Quality systems of
manufacturing” as key cause of shortages
http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml
http://www.ispe.org/drug-shortages-initiative
Economic Drivers
Quality
No
Incentive
Clin Pharmacol Ther. 2013;93:170-176
Clin Pharmacol Ther. 2013; 93:145-147
Not
Transparent
Example – Fragile Supply Chain
Electrolyte / Nutrition Shortage
Key supplier
Warning letter 2011
Closed in 2012
Trace elements*
Zinc, Selenium*
Sodium phosphate
Potassium phosphate
Calcium gluconate
Calcium chloride
Sodium bicarbonate
Zinc shortage results in
dermatitis at Children’s
National
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a5.htm
Where does
FDA fit?
FDA’s Role
• FDA CAN require:
Notification
– FDASIA (Supply
disruptions,
discontinuations)
– Manufacturing
changes
– No penalties
• FDA CANNOT require
manufacturers to:
– Make a drug
– Make more
– Distribute in a
particular way
• FDA CANNOT fix a
manufacturing
problem
Patient care is top concern
FDA works to prevent and mitigate shortages
FDA’s Approach
• Prioritize based on medical necessity
• Review risks / benefits of medication
• Minimize risk to patients while maintaining
availability
• Work with manufacturers to address problems
• Toolkit
• Regulatory discretion
• Request increased production
• Expedite reviews
• Temporary importation
FDA Efforts
• Prevention doesn’t work for every
shortage
• Unforeseen breakdowns, API
shortage
• Longstanding quality problems
• Fixes can take a long time
Summary
• Drug shortages impact patients daily
and are not resolving.
• New suppliers are needed to
manufacture generic drugs with both
high quality and high reliability.
• Hospitals need unit of use products –
may be an opportunity for suppliers to
enter the generic injectables market.
Questions?
Contact:
Erin Fox
Erin.fox@hsc.utah.edu
Drug Shortages
Summit 2013
Seeking long-range solutions
for drug shortages
Presented to : Healthcare Supply Chain Expo
2013
By: Bona Benjamin, Director, Medication-Use
Quality Improvement
American Society of Health-System
Pharmacists
October 22, 2013
The “difficult problem” of shortages
Jul 12, 2002
Provisional Observations on Drug Product Shortages. Am J Health-Syst Pharm—Vol 59 Nov 15, 2002
Nov 5, 2010
Apr 19, 2013 Drug Shortages 2.0: Long range
solutions
Summit Agenda
• Update on FDASIA and FDA’s
strategic plan
• GPhA update on ARI
• Analysis of economic factors
• Group discussion of quality,
economic, and contributory factors
* Woodcock, J, Wosinska, M. Economic and Technological Drivers of Generic Sterile
Injectable Drug Shortages. Clinical Pharmacology and Therapeutics. 93-2: 170-176
http://www.nature.com/clpt/journal/v93/n2/pdf/clpt2012220a.pdf
Economic factors
• Inverse relationship between
tolerance for shortage risk and
price of drug
• Buyers in the dark
• Price remains fixed – market fails
to correct shortage
Discussion themes
• Ongoing shortages persistent
• Traceability issues
• Inequitable distribution
• Hoarding/stockpiling
• “Leaking” supply chain
• Paper pedigree
• Low bid trumps guarantee of
availability
Areas to explore
Legislative/Regulatory
1. Accelerate/streamline DEA quota
procedures
2. Continue to enhance FDA
communication to providers
3. Traceability
Areas to explore
Legislative/Regulatory
4. Consider the BARDA model
5. Give FDA sufficient resources to
manage shortages
6. Require data that extends
expiration dating, if needed.
Areas to explore
Economic incentives
7. Get payers involved
8. Offer multiple contract awards
9. Use FDA quality metrics in buying
decisions
10.Explore corporate tax credits for
firms that invest in quality
Areas to explore - Other
11.Better methods for demand
forecasting
12.Unit of use presentations
13.Essential Drug List
Some good news
• Increased collaboration between
industry and FDA DSP
• “Workable pathway”
• Increased interest from new firms
• End users: “Guaranteed availability
worth the price.”
Questions
http://www.ashp.org/menu/DrugShortages.aspx
Drug Shortages:
Industry Prospective
Mark Hendrickson
Director for Sciences and Regulatory Affairs
Generic Pharmaceutical Association
Introduction
• The drug shortage problem has hit crisis
proportions and is of extreme concern for
patients, clinicians, the pharmaceutical
industry and policymakers.
• Drug shortages represent a complex, multifaceted issue.
• The generic pharmaceutical industry is
devoted to working with all stakeholders to
minimize current shortages and mitigate
factors that could contribute to future
shortages.
Why Are Shortages Occurring?
Causal factors of drug shortages are numerous and do not
apply in every case. They include everything from:
• An insufficient supply of available raw materials to meet
demand.
• Inadequate and delayed communications about shortages.
• Unpredictable changes in product demand
• Problems associated with the manufacturing and release of
products.
• Quality compliance
• Limited number of production lines
• Complexity of manufacturing sterile injectables
• Most drugs are supplied by only one or two companies.*
• Seven manufactures supply most of the market
• Suppliers cite production-related issues and increased
demand as top reasons for shortages.*
• Hoarding of drugs in short supply can exacerbate
shortage
*Source: “Drug Shortages: A Closer Look At Products, Suppliers And Volume Volatility” IMS Institute
For Healthcare Informatics, Nov. 2011
Drug Shortage by The Numbers
The drug shortage problem is highly concentrated.
• 58% of the drugs on the shortage list are produced
by at least one facility undergoing remediation as a
result of FDA action.*
• Generic Injectables*
• Make up over 80% of drugs in shortage.
• Of the total generic injectable market, half are on
the shortage list.
• Oncology drugs make up the highest share of the
shortages list at 16 %.
*Source: “Drug Shortages: A Closer Look At Products, Suppliers And Volume Volatility” IMS Institute
For Healthcare Informatics, Nov. 2011
Primary Difficulties Reported by
Patients and Providers
• No advanced warning and suggested
alternatives
• No information about cause of shortage
• No information about duration of shortage
• Difficulty obtaining suitable alternatives
• Substantial resources necessary to educate
practitioners on the use of alternatives
• Possible loss of prior safety safeguards put in
place
Inspections & Drug
Shortages:
Is There a Correlation?
Inspections & Drug Shortages: Is
There a Correlation?
In recent years, four trends have increased:
•
•
•
•
Registered manufacturing sites
Foreign inspections
Warning letters
Drugs in shortage
Between 2000 and 2007, the number of warning letters
issued to the generic injectable companies, who represent a
significant portion of the generic injectable products currently
listed on the FDA Drug Shortage website, was one (1)*
Between 2008 and YTD 2013, the number of warning letters
issued to these same generic injectable companies, was
seven (7), a 7-fold increase*
As a result of FDA actions, generic injectable companies
have made the decision to take approximately 30% of the
total capacity off-line for remediation efforts.
*Source: FDA Website – FDA.gov/ICECI
Accelerating the
Recovery
Accelerated Recovery Initiative
• An unprecedented multi-stakeholder initiative
designed to provide FDA with additional scope of
vision into manufacturing production planning
schedules.
• Represents private-public sector partnership.
• Predicted on voluntary, confidential
communication between manufacturers, an
independent third party (IMS Health), and the
FDA.
• Information made available through ARI is designed
to increase visibility and improve decisions related
to manufacturing capabilities and production of
priority products.
Accelerated Recovery Initiative
The Premise:
• ARI is designed to expand FDA’s “scope of
vision”
ARI uses real-time supply, distribution, and demand
forecast information to determine current supply gaps
compared to historical market requirements.
This data could give the FDA a better understanding
of current conditions internal to manufacturing
company production planning and provide for realtime decisions. It could also provide the potential to
expand the supply of critical medications, or avert
future shortages.
Accelerated Recovery Initiative
The Process
•
GPhA will identify a subset of products on the Drug Shortage List
based on inclusion criteria, and provide this list of drugs to IMS
•
GPhA will contact all of the manufacturers of the products on the
list in an effort to sign them up to participate in ARI
•
Participating manufacturers are expected to:
• Provide IMS with their respective 90 day supply schedules/forecasts
covering those products
• Update monthly the supply schedules
• Provide IMS with immediate notice of unanticipated changes to the
existing supply schedule
•
•
IMS will prepare a “gap analysis” and send to the FDA
FDA could then utilize all available information to assist it’s
remediation efforts
Accelerated Recovery Initiative
The goal of the ARI is to:
• Put in place industry practices that provide a
more accurate, timely and comprehensive view
of the current drug shortage situation.
• Provide greater visibility to potential shortages
solutions.
• Establish processes that allow for potential,
voluntary production adjustments to lessen or
eliminate the impact of a current shortage.
Thank you!