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Resident & Student Association rESidENt PrESidENt'S MESSagE
2012 Brings New Projects for aaEM/rSa
Teresa M. Ross, MDAAEM/RSA President JM is a 35yo female with a history of recurrent calcium chloride, etomidate, fentanyl, furosemide, ketorolac, migraines. labetalol, ondansetron, phenytoin, prochlorperazine and rabies immunoglobulin.6 The majority of the medications are for iv use, As instructed by her neurologist, she takes and the suspicion is that the cost to produce these generic drugs ibuprofen for minor headaches and reaches for outweighs the negotiated reimbursement by most hospital or her Imitrex (sumatriptan) when she feels the insurance systems – in particular, medicare.
building aura and temporal throbbing that signals a true migraine. Every 6 months or so, even two what is the impact of these shortages? few of these medications doses of sumatriptan fails to control her severe have adequate alternatives by function or cost. change is also prone headache, at which time her husband drives her to the emergency to error. This crisis means worse outcomes for our patients, increased department, her head buried in her knees, for rescue medication. By risk of medical error, increased costs for caregivers and taxpayers, the time she arrives, she is sometimes vomiting from the intensity and a general undermining of confidence in our country's health care of her pain. system. according to research by Premier, drug shortages could cost u.s. hospitals at least $415 million annually.4 The NEJM cited expert Typically, an IV is placed, and she receives IV ketorolac and IV opinion that federal government pricing and rebate programs are a prochlorperazine. She then rests in a dark room, and within 20 significant contributing factor to the current drug shortage crisis.5 minutes, the pain and nausea subside. Within 2 hours, she is home, many u.s. pharmaceutical companies earn more by selling their feeling better. This is not an unexpected outcome: IV administration generic drugs abroad.
of prochlorperazine is first line treatment for migraine in the emergency department according to the American Academy of what's been done? President obama's executive order on "reducing Neurology 2000 migraine guidelines.1 Prescription drug shortages" heightened reporting requirements for potential manufacturing shortages, in particular for "critical drugs" The other week, JM was unable to get her usual medications, due - those that are life supporting or life sustaining, or that prevent to a nationwide shortage of IV prochlorperazine. Could she take the debilitating disease. The order also instructed the fda to accelerate medication by mouth? It was still available PO, the nurse offered. reviews of new applicants seeking to enter the generic market and Looking at JM gagging into her plastic emesis bag, we determined to inform the Justice department about possible collusion or price the answer was definitely no. Now what? gouging related to the shortages.
and so the nationwide issue of drug shortages, pharmaceutical company disclosures, and fda (federal food and drug adminis- house bill h.r. 2445 and senate bill s. 296 are now on the table to tration) oversight comes to life for another patient. further strengthen the executive order. They propose a formal six month notice for manufacturing shortages of "critical drugs" and The issue of drug shortages is finally receiving attention in congress, heighten enforcement by empowering the fda to expand its drug with two active house and senate bills (h.r. 2445/s. 296) striving shortage Program (dsP). currently, only three staffers within the to add enforcement to an october executive order that pushed to fda dsP handle drug shortages for the entire country, and there is condemn drug stockpiling and improve drug shortage reporting.2, 3 a no mandatory reporting. bipartisan senate working group is investigating root causes of the drug shortages, and a utah senator is drafting another bill to add in the works is a bill by senator orrin hatch (r-utah) proposing financial incentives to proposed enforcements.
financial incentives for manufacturers to avoid letting drug shortages 4 The New England develop or create contingency plans for when they do. in his december Journal of Medicine (NEJM) published a strong call to action for legislators and pharmaceutical companies to rise to public obligation 7 address to congress, the senator said he is "working on a solution and meet demand of critical generic drugs.
that will continue to improve coordination between manufacturers and the government, but that also addresses some of the federal as physicians, we should care. as emergency physicians, we price control and rebate structures that prevent the true costs of must care. aaem/rsa's advocacy committee is working to show bringing these important medicines to patients."4 options include why this issue needs to be on our radar: drug shortages don't just making drugs on the fda's drug shortage Program temporarily affect patients – they now affect our patients and our treatment exempt from the heavily discounted drug Pricing Program.
choices. in order to advocate for patients like Jm, we must familiarize ourselves with a growing list of unavailable medications and the in the same vein, a recent New York Times piece by oncologist and surrounding issues. former white house adviser emanuel ezekiel proposed that such relaxation of fda price controls could promise a long-term solution between 2009 and 2010, the list of drugs on shortage grew from by empowering supply and demand. he writes (regarding cancer 157 to 178 and currently exceeds 275 fda approved therapies.4 drugs), "[o]nce a drug becomes generic, medicare should stop originally comprised of mostly anesthetic and oncologic drugs, paying, and it should be covered by a private pharmacy plan. That the list is creeping into our domain: black widow spider venom, continued on page 14 Resident & Student Association Resident President's Message - continued from page 13 way prices can better reflect the market, and market incentives can work to prevent shortages."7 1. silberstein, stephen d. "Practice parameter: evidence-based guidelines while that may be a viable long-term solution, measures like h.r. for migraine headache (an evidence-based review): report of the Qual- 2445 and s. 296 may help patients like Jm now. along with supporting ity standards subcommittee of the american academy of neurology." such legislation, we should aim to help to shape it. of particular Neurology 2000:55; 754.
vities significance are the yet-undefined "critical drugs" to be included in 2. house bill h.r. 2445 and senate bill s. 296, "Preserving access to life-
senator hatch's bill – and aaem/rsa is on board to help craft the saving medications act." definition to include emergency-relevant drugs. 3. executive order 13588: "reducing Prescription drug shortages," oct how do we help? The definition of "critical drugs" is currently determined by the "regulatory and legislative recommendations from the drug shortages summit steering group." historically, this 4. address to the united states senate hearing: "drug shortages in group includes the following associations (because their medications america," senator orrin hatch, (r-utah), dec 7 2011. <http://www.
were often listed): american society of health-system Pharmacists, the american hospital association, the american society of 5. chabner, bruce a. "drug shortages — a critical challenge for the anesthesiologists, the american society of clinical oncology, and generic-drug market." N Engl J Med dec 8 2011; 365:2147-2149. the institute for safe medication Practices. aaem/rsa is looking to add our support, because the national shortages are increasingly 6. american society of health-system Pharmacists. "current drug short- affecting er docs, and we believe that our patients' interests need be age bulletins." accessed dec 28 2011: <http://www.ashp.org/drugshort- included in determining what drugs are counted as "critical drugs." we are on capitol hill to introduce our thoughts on critical drugs: 7. emanuel, ezekiel J. "shortchanging cancer patients." New York Times, what we rely on for sick and dying patients, what we reach for to treat opinion; aug 6 2011. <http://www.nytimes.com/2011/08/07/opinion/sun- pain safely, and what we need to meet joint commission measures and medical standards of care. only by communicating with our legislators can we ensure that our interests and the interests of our patients are clearly represented.
for questions or further resources, remember that rsa is "With you all the way!"Dr. Ross welcomes your email correspondence at teresa.ross@ Paid AAEM/RSA members now have FREE access to
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