Transcript Drug Shortages Trollway

Drug Shortages:
Where we are and
where we will be!
Timothy Finn CRNA, MSN, PhDc, MBAc
Drug Shortages
Objectives
Understand the history
Recognize the many causes
Know the stakeholders involved
Understand the impact
Address new plans to avoid future shortages
History of drug shortages
 Drug Shortages are nothing new
 1957

Vaccine shortage during Influenza Pandemic
 1990s increasing shortages

3 medications in short supply 1996
 1999 FDA - Drug Shortage Program

Address shortages both actual and potential
 1997-2000, 20 drugs
 After 2000, 199 drugs
 December 2010, > 170 medications

CRISIS LEVELS!!!!
History of Drug Shortages
 Sterile injectable medications
 Anesthesia and Oncology drugs are the largest in this
category
  Sterile injectable drug shortages have increased
(Oliveira et al, 2010)
 2005 23%
 2010 60%
Timeline of Shortages
Oliviera et al:Shortage of Perioperative Drugs: Implications for
Anesthesia Practice and Patient Safety Anesth Analg 2011;113:1429 –35
New and Prevented
Shoratges
Oliviera et al: Shortage of Perioperative Drugs: Implications for
Anesthesia Practice and Patient Safety Anesth Analg 2011;113:1429 –35
Trends
 2010 shortage due to:
 54% due to quality of production (particulate,





contamination)
21% delay
11% discontinuation
5% raw material access
4%  demand due to another shortage
3% loss of manufacturing
FDA Regulations
 FDA Drug Shortage Program: 1999
 Regulations were loose
 No strict enforcement
 Led to contamination/manufacturing problems
 Improve quality issues





Sterility problems
Foreign matter
Crystallization
Precipitation
Impurities and degradents
FDA Regulations
 After 2008, FDA  regulations
 Margaret Hamburg FDA Commissioner (2009)
 Strict production regulations
 Plant shut downs
 Ex. FDA stopped production of Propofol from Hospira
 Contamination of Propofol vials/particulate matter
 Led to back order
 International produced drugs to offset shortages
 Allowed medical necessary drugs to enter the United States
Multifactorial Causes of
Shortages
Multifactorial Causes of
Shortages
 Many different causes:
 FDA regulations
 “overzealously enforced manufacturing regulations that have
choked supplies”
 Shutdown >30% production line of sterile injectable drugs






Drug companies
Medicare legislation
Consolidation of companies
Raw materials
Supply/Demand Issues
New drug production/Business Decisions
4 Major IV Pharmaceutical
Companies
 Anesthesia/sterile injectable drugs
 TEVA
 Shut down production lines after Hepatitis C outbreak
lawsuits
 Bedford
 Microbial contaminants
 Bottle of unknown fluid (contained urine)
 APP Pharmaceuticals
 Metal particles and precipitate found in vials
 Hospira
 Contaminants/particles
Medicare Legislation on Drug
Shortages
 Changed reimbursement for medications
 Originally 95% while cost was 60-80%
 Now price plus 6% handling fee “price control”
 FDA regulations + Medicare price controls = drug
shortages
 No attractive incentive
 Minimal profit once off-patent
Consolidation of Companies
 Consolidation leads to
  profitability
  costs of competition for drugs
 Consolidation of companies  fewer suppliers
 FDA regulations forced companies to merge
 Caraco Pharmaceutical Laboratories were shut down by
FDA.
 Acquired by Sun Pharmaceuticals to form Sun Pharma
Global
Raw Materials
 Disruptions in supply of raw materials
 Estimated 80% of raw materials come from outside the
United States
 Natural disasters and over production lead to shortages
 Ephedrine shortage from over harvesting of Ephedra plant
(Ephedraceae) grown in Asia
 Japan earthquake caused several potential shortages
 Iceland volcano caused transportation delays for several days
 Hurricane Katrina led to transportation disruption
 Animal disease contamination
 Heparin shortage 2007 due to Swine flu
Fox, et al. ASHP Guidelineson Managing Drug Product Shortages in
Hospitals & Health Systems Am J Health- Pharm
Supply/Demand
 Supply and demand is unresponsive to changes in price
 Regulations have halted the production of many drugs
 Demand  as the shortages continue
 Hospitals and Institutions are stock piling on limited drugs
 Buying in bulk
 Gray Market
 Not a trigger but a consequence
 Answer to drugs on short supply
Supply/Demand
 “Just in Time” – facilities obtaining drugs at last moment
to stay afloat
 Accepting medically necessary drugs
 European Drugs
 European Medicines Agency (EMA)
 Lethal injection issue
New Drugs on the Horizon
 Development of new drugs can lead to the
discontinuation of older drugs
 As companies lose their patent and drugs become
generic
 Profitability vs. Bankruptcy
 Can be for financial cost or popularity
 Hospira  Propofol, which is used for sedation and
induction
 Hospira  Dexmedetomidine, newer drug used for
sedation

Stakeholders
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
Pharmaceutical Companies
 Producers of the drugs
 Goal is to produce a product for a profit
 Private business entrepreneur
 FDA regulations forcing production overseas
 Cost cutting measures
 Ethics behind decision making
 Hospira produces Propofol and Precedex
 Decrease production of Propofol and increase production of
Precedex
 Sedation drug is needed for ICU patients and OR cases?
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
Hospital Facilities/Staff
 Pressure to meet demands
 Problematic solutions
 Cancel surgeries due to shortages
 Inhalational inductions
 Obtain drugs in alternative ways
 Gray Market
 International production lines
 Clinical frustrations
 Cannot provide adequate care
 Forced to use alternative drugs
 Adverse/sentinel events
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
Gray Market
Gray Market
“The Middle Man”
 Similar to the so called ‘black market’
 Unknown distributors supplying drugs to facilities
 Unknown potency of these drugs
 Unknown production lines
 Significantly marked up prices for desired drugs
 Exploit the drug shortage problem
 Mark up can be 20-650 x the original cost (Armen Keteyian CBS Nightly
News Oct 13, 2011)
 Solution for some facilities to keep active
 Cancel surgeries or stay open and pay more for drugs
 Could we be heading to a “hotel like situation”
 Pay more and get better drugs I.E. Pay more for Propofol or pay basic and
receive Versed or Thiopental
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
Stockholders
 Like hospitals, stockholders are frustrated
 Stock shares have fluctuated
 Companies merging or going out of business
 Stockholders profiting from push of new drugs
 i.e. Dexmedetomidine to replace Propofol
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
FDA
 Enforced sanctions for better drug production
 Did not envision the problem escalating to current
situation
 Control restrictions
 Allowing foreign production of drugs that are “medically
necessary”
 Commitment to quality products
 Driver in prevention of future trends
 Set up guidelines and protocols
FDA
Gray Market
Hospital
facilities/ Staff
Drug
Companies
Stockholders
Drug
Shortages
Government
officials
Government Officials
 Along with FDA, government officials are investigating
avenues for prevention
 Oct. 2011, President Obama issues an executive order to
ease drug shortages
 Addresses efforts to help prevent life saving medicines
 Protect consumers and avoid price gouging
 Congress constituents are the ones affected
 Preserving Access to Life-Saving Medications Act
 Brings attention to an escalating problem
Drug Shortage Solution
 The Executive Order is one in a series of steps that will
help address the shortage of drugs and ensure patients
have access to the lifesaving medications they need.
 Send a letter to manufacturers reminding them of their
responsibility to report potential shortages and
Drug Shortages
Drug Shortage Solution
Drug Shortage Solution
 FDA’s solution
 Flexibility
 Allow the release of medically necessary products
 Build in exemptions for medically necessary products
 Outreach to stakeholders
 Continue to improve oversight of production lines
 Continue working together with firms
 Encourage voluntary reporting of drug supplies and
track shortages
Drug Shortage Solution
 Industry’s Role
 Plan ahead, avoid raw material supplies
 Push to increase production lines
 Commitment to quality products
 Prevention of future drug shortages, especially life
saving drugs
 Encourage voluntary reporting
The Future


Plug the hole
Its going to get worse before it gets better
Thank You!
References
 www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
 www.haponline.org/about/fop/disaster/.../NN7h7N1JfTchgd5Da5N
0
 Meyer, T. (2012). The Antomy of the Drug Shortages. Anesthesia
Patient
Safety Foundation. Spring ed.
 Olivera, G.S., Theilken, L.S. & McCarthy, R.J. (2011). Shortage of
Perioperative Drugs: Implications for Anesthesia Practice and
Patient
Safety. Anesthesia-Anlagesia. 113 (6).
 Dutton, R.P. & Cohen, J. A. (2011). Medication Shortages: Are we
the Iron Chefs or Our Own Worst Enemies? Anesthesia-Analgesia.
113 (6).