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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 Survey2011 1,373 Anesthesiologists - PowerPoint PPT Presentation

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The Drug Shortage

Drug ShortagesA Public Health Crisis

BackgroundU.S Healthcare System is experiencing an alarming increase in number of drug shortages causing a major public health threatIncreased > 200% between 2006 and 2010ASA DRUG Shortage Survey20111,373 Anesthesiologists90% reported a shortage of one or more anesthetics10% postponed or cancelled cases48% reported longer recovery times

Drug Shortage= total supply of all clinically interchangeable versions of a FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.

2IMPACTInterruptions in pts daily regimen can lead to dangerous effects/withdrawal symptoms (ex. Rebound HTN)Decreased pt satisfaction, prolonged awakening, delayed discharge, nauseaLonger procedure times and recovery times drive up healthcare costsWhen shortages occur, drugs can be obtained through a non-contracted supplier aka. gray market resulting in significantly increased prices and compromised safetyEthical issues backgroundAANA Drug Shortage Survey94.7% indicated they experienced a drug shortage affecting their practice in the last year.6.1% have had to cancel cases due to shortagesTop recommendation for stakeholders regarding shortages: Increase regulations of drug manufacturers/provide more incentives for or force companies to produce drugs in shortageHow do I know what drugs are on shortage?American Society of Health System Pharmacists (ashp.org)each manufacturer gives reason for shortageestimated resupply datesalternate agentsusually lists more drugsCDER Drug Shortage websitethru FDA siteencourage manufacturers to report shortages but not mandatoryReasons for shortagesDrug companies decrease the supply which increases the demand and costMany 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 BOnly 7 Pharm manufacturers produce a majority of sterile injectablesAny given sterile injectable is produced by 3 or less manufacturersDistributors tend to provide the best prices and most stable supply to high volume purchasersReasons for shortagesIn 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 wellSeveral manufacturers are expanding capacity but wont be ready for several yearsQUALITY PROBLEMS or Scarcity of an active pharmaceutical ingredient can lead to cascading and persistent shortages54% of shortage attributed to quality problemsleading to temporary closure or renovations of facilitiesAsymmetry of incentives: little cost of producing too little of a drug but a potentially high cost of producing too much of that drugAnesthesia related shortagesAlfentanil InjectionAcetylcysteine Inhalation SolutionAlcohol Dehydrated (Ethanol > 98 Percent)Atracurium BesylateAtropine Sulfate InjectionBupivacaine Hydrochloride InjectionBuprenorphine InjectionButorphanol InjectionCalcium Chloride InjectionCocaine Topical Solution Many of these are emergency drugs, blood pressure medsadditionally many antibiotics and chemotherapeutics are in critical shortage8Anesthesia related shortagesDesmopressin InjectionDexamethasone InjectionDiazepam InjectionDiltiazem InjectionDiphenhydramine Hydrochloride InjectionEtomidate InjectionFentanyl Citrate InjectionFosphenytoin Sodium InjectionFurosemide InjectionHydromorphone Hydrochloride Injection (New)Indigo Carmine InjectionKetorolac Injection

Anesthesia related shortagesOpana ER (oxymorphone hydrochloride)Pancuronium Bromide InjectionPhentolamine Mesylate for InjectionPotassium PhosphateProcainamide HCl InjectionProchlorperazine InjectionPromethazine InjectionSodium Acetate InjectionSodium Chloride 23.4 PercentSodium Phosphate InjectionSufentanil InjectionVasopressin InjectionVecuronium Injection Anesthesia related shortagesLabetalol Hydrochloride InjectionLidocaine Hydrochloride InjectionLorazepam InjectionMagnesium Sulfate InjectionMetoclopramide InjectionMidazolam InjectionMorphine Sulfate InjectionNalbuphineInjectionNaloxoneOndansetron Injection 2mg/mLOndansetron Injection 32 mg/50 mL premixed bags

The gray market: putting profits before patientsWhat is the Gray Market???A supply channel that is unofficial, unauthorized or unintended by the original manufacturerIn markets where the products are scarce or in short supply gray markets evolve to sell the item at any price the market will bearPrice gougingAverage of 650% markup of drugs needed to treat critically ill ptsHighest single markup was 4,533%Normally priced at $25.90 offered price was $1200!!!Not just a cost concern. Myriad of SAFETY issuesPose risks to your patients and the facilitydrugs can be counterfeit, stolen, mishandled, divertedNot regulated, no standards for storage and handling

Gray market: Price gougingOf 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 lymphoma3170% for drugs for cancer patients receiving bone marrow transplants3161% for sedatives/anestheticsA supply of Propofol that usually cost $1500 now being sold for $25,000!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!2979% for certain blood pressure medications2692% for meds to prevent damage during a heart attackWhere 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 relabeledComplex web of transactions making it impossible to determine the products origin, the supply source, or authenticityTemperature and climate conditions required for maintaining efficacy cannot be ensuredmay cause drugs to be inadequate or harmful

Stuck between a rock and a hard place!Record number of drug shortagesDrug scarcity forcing pharmacists to search for new sources of supplyPuts the pharmacist/buyer between a rock and a hard placeResults of a recent survey of purchasing agents and pharmacists at 549 hospitalsStockpiling and hoardingYou 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 faxContain language such as we only have 20% left and quantities are going fastMost frequent solicitations at university hospitalsI would like to know why hospitals cant get these products but the scalpers can. It is unreal to have to deal with scalpers in healthcare.They watch the wholesalers supply and if they sense an impending shortage they buy the entire supplyOur physicians DO NOT want to hear that a drug is unavailable.52% reported purchasing one or more drugs from gray market during past 2 yearsFeeling pressured by physicians and hospital administrators to purchase from gray market vendorsReasons to avoid the gray market

ETHICAL concerns

Concerns with authenticity

Cost

Concerns about storage conditionsWhat needs to be done to stop gray market vendors???Legislative action is needed to give the FDA the authority to better manage drug shortagesRequiring manufacturers to stop deliveries to wholesalers/distributors when the company knows their products are soon to be in short supplyThis way only direct accounts with hospitals, clinics, pharmacies, and other direct patient care to have access to the products at the contracted rateWith better control of drug shortages the gray market cant thrive!Stronger regulations needed for distribution of pharmaceutical productsNational pedigree lawlimits distribution to authorized dealers and appropriately licensed distributorsPricing of products should be standardized in a way that prohibits unfair price gougingWhat needs to be done to stop the gray market vendorsHealthcare provider organizations need to take steps to minimize the need for purchasing products from gray market vendorsLocal affiliations forming that identify shortages and determine appropriate limitations on use, and cooperatively borrow from each other to avoid using gray market vendorsPharmacy and committees seeking out alternatives for drugs in short supply and implemented safety strategies to avoid errors with these alternative drugsRegulatory and law enforcement action against counterfeiting and theftWhat is currently being done?ObamaOct. 2011 executive order for FDA to investigate price gougingGovernment 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 FDAIn 2009, the ASA worked with the FDA to allow importation of Propofol from European drug companiesSeveral leading manufacturers of generic sterile injectables are upgrading facilities or building new facilitieswill take timeProducing a new drug will often require manufacturers to reduce or stop production of another drugProfitability of generic drugs: an ethical issueMany 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 BMany 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 drugWe can write letters to drug companies pleading with them to continu

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