Transcript The Drug Shortage

DRUG
SHORTAGES
A PUBLIC HEALTH CRISIS
BACKGROUND
 U.S Healthcare System is experiencing an
alarming increase in number of drug shortages
causing a major public health threat
 Increased > 200% between 2006 and 2010
 ASA DRUG Shortage Survey—2011
 1,373 Anesthesiologists
 90% reported a shortage of one or more
anesthetics
 10% postponed or cancelled cases
 48% reported longer recovery times
IMPACT
 Interruptions in pt’s daily regimen can lead to dangerous
effects/withdrawal symptoms (ex. Rebound HTN)
 Decreased pt satisfaction, prolonged awakening, delayed
discharge, nausea
 Longer procedure times and recovery times drive up
healthcare costs
 When shortages occur, drugs can be obtained through a
non-contracted supplier aka. “gray market” resulting in
significantly increased prices and compromised safety
 Ethical issues
BACKGROUND
 AANA Drug Shortage Survey
 94.7% indicated they experienced a drug shortage
affecting their practice in the last year.
 6.1% have had to cancel cases due to shortages
 Top recommendation for stakeholders regarding
shortages: Increase regulations of drug
manufacturers/provide more incentives for or “force”
companies to produce drugs in shortage
HOW DO I KNOW WHAT
DRUGS ARE ON
SHORTAGE?
 American Society of Health System Pharmacists
(ashp.org)
 each manufacturer gives reason for shortage
 estimated resupply dates
 alternate agents
 usually lists more drugs
 CDER Drug Shortage website—thru FDA site
 encourage manufacturers to report shortages but not
mandatory
REASONS FOR
SHORTAGES
 Drug companies decrease the supply which increases the
demand and cost
 Many drug companies will stop producing a drug if the
profitability is less than 6% above cost.
 Medicare reimburses sterile injectables at 6% above
average sales price under Part B
 Only 7 Pharm manufacturers produce a majority of sterile
injectables
 Any given sterile injectable is produced by 3 or less
manufacturers
 Distributors tend to provide the best prices and most
stable supply to high volume purchasers
REASONS FOR
SHORTAGES
 In 2009, 2 out of 3 U.S. Manufacturers of Propofol stopped
production which led to increases in use of other
induction drugs which led to a shortage of those as well
 Several manufacturers are expanding capacity but won’t
be ready for several years
 QUALITY PROBLEMS or Scarcity of an active
pharmaceutical ingredient can lead to cascading and
persistent shortages
 54% of shortage attributed to quality problems—leading to
temporary closure or renovations of facilities
 Asymmetry of incentives: little cost of producing too little
of a drug but a potentially high cost of producing too
much of that drug
ANESTHESIA
RELATED SHORTAGES
Alfentanil Injection
Acetylcysteine Inhalation Solution
Alcohol Dehydrated (Ethanol > 98 Percent)
Atracurium Besylate
Atropine Sulfate Injection
Bupivacaine Hydrochloride Injection
Buprenorphine Injection
Butorphanol Injection
Calcium Chloride Injection
Cocaine Topical Solution
ANESTHESIA
RELATED SHORTAGES
Desmopressin Injection
Dexamethasone Injection
Diazepam Injection
Diltiazem Injection
Diphenhydramine Hydrochloride Injection
Etomidate Injection
Fentanyl Citrate Injection
Fosphenytoin Sodium Injection
Furosemide Injection
Hydromorphone Hydrochloride Injection (New)
Indigo Carmine Injection
Ketorolac Injection
ANESTHESIA
RELATED SHORTAGES
Opana ER (oxymorphone hydrochloride)
Pancuronium Bromide Injection
Phentolamine Mesylate for Injection
Potassium Phosphate
Procainamide HCl Injection
Prochlorperazine Injection
Promethazine Injection
Sodium Acetate Injection
Sodium Chloride 23.4 Percent
Sodium Phosphate Injection
Sufentanil Injection
Vasopressin Injection
Vecuronium Injection
ANESTHESIA
RELATED SHORTAGES
Labetalol Hydrochloride Injection
Lidocaine Hydrochloride Injection
Lorazepam Injection
Magnesium Sulfate Injection
Metoclopramide Injection
Midazolam Injection
Morphine Sulfate Injection
Nalbuphine Injection
Naloxone
Ondansetron Injection 2mg/mL
Ondansetron Injection 32 mg/50 mL premixed bags
THE GRAY MARKET:
PUTTING PROFITS
BEFORE PATIENTS
 What is the Gray Market???
 A supply channel that is unofficial, unauthorized or
unintended by the original manufacturer
 In markets where the products are scarce or in short supply
gray markets evolve to sell the item at any price the market
will bear
 Price gouging
 Average of 650% markup of drugs needed to treat critically ill
pts
 Highest single markup was 4,533%
 Normally priced at $25.90 offered price was $1200!!!
 Not just a cost concern. Myriad of SAFETY issues
 Pose risks to your patients and the facility—drugs can be
counterfeit, stolen, mishandled, diverted
 Not regulated, no standards for storage and handling
GRAY MARKET: PRICE
GOUGING
Of the markups…
 96% were at least double normal price (100%)
 45% were at least 10 X normal price (1000%)
 27% were at least 20 x normal price (2000%)
WHAT DRUGS ARE BEING
AFFECTED BY THE GRAY
MARKET???
The highest markups…
 3980% for chemotherapy drugs to treat leukemia and nonHodgkin's lymphoma
 3170% for drugs for cancer patients receiving bone
marrow transplants
 3161% for sedatives/anesthetics
 A supply of Propofol that usually cost $1500 now being
sold for $25,000!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
 2979% for certain blood pressure medications
 2692% for meds to prevent damage during a heart attack
WHERE DOES MY
HOSPITAL GET THE
DRUGS I USE???
 Drugs moving thru the gray market can be bought and
sold across state lines multiple times, moved in whole or
partial lots, repackaged or relabeled
 Complex web of transactions making it impossible to
determine the product’s origin, the supply source, or
authenticity
 Temperature and climate conditions required for
maintaining efficacy cannot be ensured—may cause drugs
to be inadequate or harmful
STUCK BETWEEN A
ROCK AND A HARD
PLACE!
 Record number of drug shortages
 Drug scarcity forcing pharmacists to search for new sources
of supply
 Puts the pharmacist/buyer between a rock and a hard place
 Results of a recent survey of purchasing agents and
pharmacists at 549 hospitals…
 Stockpiling and hoarding
 “You are hesitant to tell gray market vendors what you need
because they will buy it all up if they find it, and then harass
you to buy it for months afterwards.”
 More than half of all respondents were solicited daily from up
to 10 different gray market vendors by phone, email, or fax
 Contain language such as “we only have 20% left” and
“quantities are going fast”
 Most frequent solicitations at university hospitals
 “I would like to know why hospitals can’t get these
products but the scalpers can. It is unreal to have to deal
with scalpers in healthcare.”
 They watch the wholesaler’s supply and if they sense an
impending shortage they buy the entire supply
 “Our physicians DO NOT want to hear that a drug is
unavailable.”
 52% reported purchasing one or more drugs from gray
market during past 2 years
 Feeling pressured by physicians and hospital
administrators to purchase from gray market vendors
REASONS TO AVOID THE
GRAY MARKET
 ETHICAL concerns
 Concerns with authenticity
 Cost
 Concerns about storage conditions
WHAT NEEDS TO BE
DONE TO STOP GRAY
MARKET VENDORS???
 Legislative action is needed to give the FDA the authority to better
manage drug shortages
 Requiring manufacturers to stop deliveries to
wholesalers/distributors when the company knows their products
are soon to be in short supply
 This way only direct accounts with hospitals, clinics, pharmacies, and
other direct patient care to have access to the products at the
contracted rate
 With better control of drug shortages the gray market can’t thrive!
 Stronger regulations needed for distribution of pharmaceutical
products
 National pedigree law—limits distribution to authorized dealers and
appropriately licensed distributors
 Pricing of products should be standardized in a way that prohibits
unfair price gouging
WHAT NEEDS TO BE
DONE TO STOP THE
GRAY MARKET VENDORS
 Healthcare provider organizations need to take steps to
minimize the need for purchasing products from gray
market vendors
 Local affiliations forming that identify shortages and
determine appropriate limitations on use, and
cooperatively borrow from each other to avoid using gray
market vendors
 Pharmacy and committees seeking out alternatives for
drugs in short supply and implemented safety strategies to
avoid errors with these alternative drugs
 Regulatory and law enforcement action against
counterfeiting and theft
WHAT IS CURRENTLY
BEING DONE?
 Obama—Oct. 2011 executive order for FDA to investigate
price gouging
 Government is now requiring drug manufacturers to
report production interruptions in drugs that have no
generic equivalent or those that are critical to maintaining
life to the FDA
 In 2009, the ASA worked with the FDA to allow importation
of Propofol from European drug companies
 Several leading manufacturers of generic sterile
injectables are upgrading facilities or building new
facilities—will take time
 Producing a new drug will often require manufacturers to
reduce or stop production of another drug
PROFITABILITY OF
GENERIC DRUGS: AN
ETHICAL ISSUE
 Many drug companies will stop producing a drug if it
brings in less than 6% profit above cost.
 Medicare reimburses sterile injectables at 6% above
average sales price under Part B
 Many of the current drug shortages are sterile injectable
GENERIC drugs.
 This is an ethical issue:
 Should drug companies continue to make drugs that they
profit little from out of an ethical obligation?
 Should we create an incentive to keep them making these
drugs to prevent shortages?
WHAT CAN WE DO?
 The FDA does not have the authority to “force” drug
companies to continue making a drug or to increase
production of a drug
 We can write letters to drug companies pleading with them
to continue to make drugs that may not profit them and
include specific pt stories.
 Drug companies are businesses whose goal is to be
profitable
 Updating Medicare’s generic drug reimbursement
methods frequently, especially for shortage drugs
 Providing tax incentives to encourage makers of generic
drugs to upgrade their facilities and continue or begin
producing shortage drugs
TAX INCENTIVES:
THE BOTTOM LINE
 It is unfortunate that drug companies are for-profit
businesses who will probably show a weak response to
our pleads for them to make drugs out of an ethical
obligation
 Tax incentives for drug companies to continue making
lower profit drugs has been suggested by many
respondents to a recent questionnaire sent to members of
the AANA
 Unfortunately, “money talks” and tax incentives may be a
logical way to stimulate them
CONCLUSION
 The solution to the drug shortage problem must be multifaceted due to the vast number of causative issues
 Many of the solutions thus far have focused on reporting
shortages which may encourage rationing and slow the
shortage, but this does not “fix” the problem
 This advocacy project focuses on two main solutions:
 Regulate the gray market
 Find ways to get drug companies to manufacture the less
profitable generic sterile injectable drugs that are on
shortage
REFERENCES
American Association of Nurse Anesthetists website. (2012).
http://www.aana.com/resources2/professionalpractice/Pages/
Drug-Shortages.aspx
Drug shortages in the U.S.-An industry prospective
[Newsgroup comment]. (2011, October, 11). Retrieved from
http://bournepartners.wordpress.com/2011/10/11/drugshortages-in-the-u-s-%E2%80%93-an-industry-perspective/
Drug shortages leading to price gouging, possible safety
issues, according to research [Newsgroup comment]. (2011,
August 16). Retrieved from
https://www.premierinc.com/about/news/11aug/drugshortages081611.jsp
REFERENCES
Fields, R. (2012, February 9). 7 serious effects of anesthesia
drug shortages on surgery centers [ Newsgroup comment].
Retrieved from http://www.beckersasc.com/anesthesia/7serious-effects-of-anesthesia-drug-shortages-on-surgerycenters.html
Haninger, K., Jessup, A., & Koehler, K. (2011, October).
Economic analysis of the causes of drug shortages (Issue
Brief ASPE). Washington, DC: Department of Health and
Human Resources.
Harris, G. (2011, August 19). U. S. scrambling to ease
shortage of vital medicine. New York Times. Retrieved from
http://www.nytimes.com/2011/08/20/health/policy/20drug.html
?_r=1&pagewanted=all
REFERENCES
Malina, D. P. (2011, December, 23) [Commentary]. Retrieved from
http://www.aana.com/resources2/professionalpractice/Documen
ts/20111223%20FDA%20Drug%20Shortage%20Comments.pdf
Senate bill addresses drug shortages. (2011, May).
Anesthesiology News. Retrieved from
http://www.anesthesiologynews.com/ViewArticle.aspx?d=In+Bri
ef&d_id=220&i=May+2011&i_id=729&a_id=17102
Stone, K. F. (2012, January, 14). Where has all the Propofol
gone? [Newsgroup comment]. Retrieved from
http://www.opednews.com/articles/Where-Has-All-the-Propofolby-Kurt-Stone-120114-156.html?show=votes
U. S. Food and Drug Administration. (2011, October, 31). A
review of FDA’s approach to medical product shortages
(Executive Summary). Retrieved from FDA Website:
http://www.fda.gov/DrugShortageReport