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    Drug shortages in the US: The time to act is now!

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    Many in the world are envious of our seemingly inexhaustible national healthcare resources. We have no long waits for surgery, and our hospitals rival their best hotels. To many foreigners US healthcare appears to be a "land of plenty." But for American obstetricians the first blemish in this idyllic façade appeared in the late 1990s when a serious shortage of betamethasone forced many of us to think critically about the use of other agents to accelerate fetal lung maturity and consider rationing our short supply.

    By 2002, the US Food and Drug Administration (FDA) had acknowledged the betamethasone shortage as well as a looming shortage of other generic agents.1 Back then FDA officials blamed shortages on manufacturers, citing technical problems, limited production capacity, mergers, etc. A decade ago the agency noted, "FDA has no authority over the business decisions made by drug manufacturers." It then promised to do what it could to expedite reviews and approvals.

    However, in the ensuing 10 years access to betamethasone has remained intermittently constrained. Worse, availability of the only practical alternative, dexamethasone, also has been compromised. Thus, the only two drugs recommended to unequivocally reduce complications of prematurity remain in limited supply.Moreover, the overall problem of generic drug availability has grown far worse over the last decade. There are now growing shortages of antibiotics, antihypertensives, and even electrolyte solutions used daily by ob/gyns. Drug shortages also now include many chemotherapeutic agents used for gynecologic malignancies, such as methotrexate, leucovorin, 5-fluorouracil, vincristine, etoposide, paclitaxel, and cisplatin.2

    Indeed, a total of 22 chemotherapy drugs were in short supply by August 2011.3 Chemotherapy shortages have included drugs that are integral to first-line treatment and maintenance regimens. Patient therapies are increasingly being changed to alternative and potentially less-effective and/or riskier therapies. I have been contacted by a patient's advocate desperate to obtain daunorubicin, which had been the only agent found effective against his rare sarcoma.

    How can the shortage affect your practice today?

    What does all this mean for ob/gyns? Do you have a patient with preeclampsia who requires induction of labor? Well, oxytocin was added to the shortage list in December 2011. If you are able to get the patient into labor, of course you would want to minimize the risk of seizures by using magnesium sulfate, right? Good luck with that one because magnesium is also on the list, and is in particularly short supply because its use is not limited to obstetrics. If you are fortunate enough to get your hands on magnesium sulfate and the patient shows signs of toxicity, calcium gluconate may not be at your fingertips for treatment because it, too, is on the list. If this makes you anxious, you are on your own because injectable diazepam also is on the list! By the way, if your patient becomes severely hypertensive, don't expect to always find labetalol: That's on the list, too.3

    Causes of generic drug shortages

    There are several major contributors to the current crisis, including the 2003 Medicare Modernization Act (MMA), which mandated greater standardization of drug pricing and altered Medicare reimbursement for intravenous drugs. Reimbursements now are based on the drug's average sale price plus 6%, creating little incentive to increase production of low-margin drugs.2 However, although much attention has been directed at the lack of profitability of the generic market, the US General Accountability Office (GAO) has determined that the leading driver of recent shortages, as was the case in 2002, is manufacturing issues. "Most drug shortages we reviewed in detail were reportedly caused by manufacturing problems, including those that resulted in manufacturing shutdowns," GAO investigators told a Senate hearing. Moreover, the GAO investigators reiterated the argument made by FDA officials a decade before, that the "FDA is constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages." 4

    To address the growing crisis, President Obama signed an executive order "directing the FDA to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews that can help prevent or respond to shortages... . Under the president's order, FDA will also work with the Department of Justice, which will examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications."

    The Obama administration also sent a letter to drug manufacturers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA and increased staffing resources for the FDA's Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.5

    However, I have doubts that such executive branch "jawboning" will have any material impact. Ultimately, unless the government plans to manufacture these agents itself, it is market forces that account for supply and demand. Thus, paradoxically, less, not more government regulation may be needed. Although I agree with the GAO that recent generic drug manufacturing problems are largely to blame for current shortages, in my opinion, these "problems" reflect the very lean profit margins available to such manufacturers. This, in turn, has led to chronic underinvestment in plant maintenance and construction of up-to-date facilities.

    Financial incentives for increased production of generic drugs, especially sterile injectables, would help, as would maintaining sufficient reimbursement for these drugs from Medicare. Sen Orrin Hatch (R-Utah) is currently working on legislation that could enhance reimbursement for drugs that are scarce and Sen Amy Klobuchar (D-Minnesota) has introduced a bill that would mandate that drug manufacturers notify FDA about discontinuances or interruptions in manufacturing.6

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    Charles J. Lockwood, MD, MHCM
    Dr. Lockwood, Editor-in-Chief, is Dean of the Morsani College of Medicine and Senior Vice President of USF Health, University of South ...

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