DRUG SHORTAGES A PUBLIC HEALTH CRISIS. BACKGROUND U.S Healthcare System is experiencing an alarming...
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Transcript of DRUG SHORTAGES A PUBLIC HEALTH CRISIS. BACKGROUND U.S Healthcare System is experiencing an alarming...
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 Anesthesiologists90% reported a shortage of one or more
anesthetics 10% postponed or cancelled cases48% 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 SHORTAGESDesmopressin 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 SHORTAGESOpana 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 SHORTAGESLabetalol 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 non-Hodgkin'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 multi-
faceted 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/drug-shortages-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/11-aug/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/7-serious-effects-of-anesthesia-drug-shortages-on-surgery-centers.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
REFERENCESMalina, D. P. (2011, December, 23) [Commentary]. Retrieved from http://www.aana.com/resources2/professionalpractice/Documents/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+Brief&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-Propofol-by-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