Tuesday, May 17, 2011

Not what the doctor ordered

After decades of gleeful consumption, we seem to be finally coming up against the reality of limits. We may not know the details [1], which in any case are impossible to pin down with certainty, but the gist is familiar: the pie is shrinking, there are more of us trying to get a piece of it, and the two trajectories are on a collision course. Oil and water supplies, rainforests, and animal species have been decimated by our wasteful, anthropocentric ways, and the most we seem to be able to manage in global response is a collective shrug.

To top it all off, we are now facing a serious shortage of . . . prescription drugs.

I had my own brush with a drug shortage two years ago, when I could no longer procure the thyroid medication that works best for me, but I had no idea of the scope of the problem. Leave aside for a moment the first question that pops into any reasonable person’s mind, namely, how on earth we have become so sick that the mighty pharmaceutical industry can’t keep up. What's actually happening?

In the late 90's . . .
Drug shortages apparently started attracting attention in medical publications in the late 90’s. The British Medical Journal reported in their January 20, 2000 issue that afew years ago a hospital might run short of one or two critical drugs a year, whereas in the past year the number has run to as many as two dozen drugs.” The report gave three examples, one of which was the following:
      . . . Brigham and Women's Hospital in Boston found itself unable to buy sufficient supplies of oxytocin, which is used in almost every one of its 10,000 annual deliveries. Doctors therefore had to cut back on their use of the drug. Fortunately no patient suffered, said Dr David Acker, the hospital's chief of obstetrics.
The BMJ article offered three explanations for the shortages: manufacturing difficulties, “just in time” inventories (keeping minimal supplies on hand to save outlays and storage space), and “price inflation in the ‘grey’ market for drugs, under which small drug wholesale distributors obtain drugs and resell them at large markups to hospitals unable to obtain them from regular suppliers.” According to the BMJ, the grey market accounted for about 1% of total sales of prescriptions drugs in 1999 (~ $1 Billion). Although only the manufacturing difficulties would account for an actual reduction in supply, distribution practices presented a significant problem. In 1999, the American Society of Health System Pharmacists protested to then-secretary of Health and Human Services, Donna Shalala, that hospitals weren't receiving their orders for flu vaccine yet the vaccine was shipping regularly to supermarkets and other retail outlets. In response, the US Food and Drug Administration set up a website to serve as a central repository of information on scarce drugs: www.fda.gov/cder/drug/shortages/.

. . . and now.
As of May 2011 there are over 240 drugs in such scarce supply that no one knows when they’ll become available; another 400+ are on backorder (you can see the list of drugs here). Most of these drugs are used in the hospital setting for sedation, emergency care and chemotherapy, but antibiotics and other meds are also affected. 

Over the past few months, dozens of journalists have been riffing on a survey performed last year by a “performance improvement alliance” of 2,500 U.S. hospitals, the Premier Healthcare Alliance (PHA), which asked 311 “pharmacy experts” at hospitals, surgery centers, and long-term care facilities about their experience with shortages during a six-month period in 2010.[2]  Among the survey respondents:
53% said treatment-plan-changing shortages had occurred more than six times during the six-month period 
80% experienced shortages that caused delay or cancellation of patient care (surgeries and oncology treatments in particular); 34% reported such a shortage occurred more than 6 times in the six-month period
89% experienced shortages that “may have caused” a medication safety issue or error in patient care. Eight out of 10 times a shortage occurred, the patient’s care was delayed or the medication intervention was canceled.
98% experienced shortages that led to increased costs. Drug shortages are estimated to cost U.S. hospitals “$200 million a year, in part because providers pay an average of 11% more for shortage products.” 
What is the fallout from a drug shortage?
The unavailability of a favored drug can disrupt healthcare—providing or receiving it—at multiple levels. Most obviously, there are the logistical imperatives of scarcity: because pharmacists and physicians often don’t find out until the day the drug is needed that it is not going to be available, scrambling about for a substitute requires time and tactical adjustments that can only add tension to a system already stretched thin.

In some cases, there isn’t a good substitute. A related drug might be less effective for a particular use, in a particular patient, or less well tolerated. It might also be much more costly. A brand-name cancer drug called Fusilev (levofolinate) contains similar active ingredients as the now-scarce $7.41/dose leucovorin, but at $177 per dose it costs nearly 24 times as much. (It’s noteworthy that most of the supply problems affect inexpensive generics and off-patent drugs.) The two drugs also have different treatment profiles, and no one knows how Fusilev interacts with other compounds in the chemotherapy cocktails that used to contain leucovorin. Even if an effective substitute is available, greater demand for that substitute is likely to create a secondary shortage. Sudden interruptions in supply also create headaches for clinical trials.

Most problematically, scarcity sets the stage for dangerous mistakes. Drugs in the same family can differ greatly in dosing requirements: two patients died after receiving hydromorphone at the same dose as its chemical kin, morphine. A September survey by the nonprofit Institute for Safe Medication Practices documented more than a thousand errors, near-misses, and adverse patient outcomes directly attributable to drug shortages.

Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) recently sponsored a bill that would require pharmaceutical companies to notify the FDA when they expect a shortage of a particular drug or plan to discontinue it. Even though the proposal is merely an early-warning system, and a toothless one at that, the pharmaceutical industry has not yet decided whether it supports the legislation, which just might be able to grow teeth in the future. (Currently, drug companies are not required by law to alert the FDA when they expect a shortage, even though in about a dozen cases when the FDA received early word of a supply problem they were able to avert a crisis.) 

In the meanwhile, physicians, nurses and pharmacists are devising heroic workarounds, sharing resources, forming networks with other providers, strategizing for the near future. Perhaps their effectiveness, all the more remarkable considering the other pressures they labor under, is why more of the public is not aware of the problem.

In the next post, I'll analyze the way the shortages are being understood by the industry itself.


1.  Some of these statistics are estimates, but they're unlikely to be too pessimistic:
Non-Opec nations passed peak oil production in 2010
Potable water has already caused bloodier conflicts than petroleum, including the Rwandan genocide
Rainforests once covered 14% of the earth’s surface, now cover less than 6%, and the rest could be consumed in the next forty years
About 137 species disappear every day because of deforestation
Half of all ocean species have vanished in the past fifty years
2. The AHP mission and vision statements deserve an analysis on their own (and will receive one in due course).

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