Drug Shortages: Endangering Human Lives and Pets, Too


That’s how many critically needed antibiotics, cancer drugs, diuretics, sedatives, stimulants and vaccines — among other drug categories — currently are in short supply in the United States. If you print out the list, which is maintained by the American Society of Health System Pharmacists, it runs to seven pages.

Back in February, I wrote in the Annals of Emergency Medicine, and also here at this blog, about ongoing shortages of critical drugs, and how physicians were beginning to worry about them. At the time, the list of drugs in short supply was up to about 140.

I assumed the problem was slowly getting better. Then this week, I got an email from a reader. He said (quoting with his permission):

I was diagnosed with multiple myeloma in 2009. A stem cell transplantation put the cancer into remission but
it returned this year. The next logical step was to treat me with a combination of Velcade and Dioxil. The … combination of Velcade and Dioxil was studied at length and shown to be effective at putting myeloma into remission.

Unfortunately, after I had started treatments at [redacted by Maryn] they ran out of Dioxil. The manufacturer told my doctor that the drug would be available in mid-August. So far it isn’t. My doctor, and the clinic, had warned the drug company a year ago that supplies were running low… So here I am, using an older version of Dioxil. The old drug was NOT studied for use in people suffering from relapsed myeloma. It’s a shot in the dark. And the old Dioxil causes neuropathy, so now I’m experience increased pain and numbness in my feet and fingers. This is seriously impairing my life, making it difficult to walk properly, to play music (I’m a musician), and forcing me on to pain killers I shouldn’t have to deal with.

And within a day, I found this in my RSS, from Ed Silverman’s excellent blog Pharmalot:

Humans aren’t the only ones suffering from drug shortages this year. A widely used medication used to treat heartworm in dogs is currently unavailable and some shelters, mostly in the Southern US, say they may have to consider euthanizing dogs that become extremely ill. And Merial, the Sanofi animal health unit that makes Immiticide, may not be able to resume supplies for months… This is not the first time that Merial has run into production problems with Immiticide. A shortage arose early last year due to unspecified manufacturing issues. Nonetheless, the prospect of an indefinite shortage does not bode well for dogs. As (Marsha Williams, director of the Guilford County Animal Shelter in Greensboro, NC) notes, “who knows how many may have to be put down.”

People who are concerned about the spread of antibiotic resistance have been worried for a long time about the dearth of new antibiotics. In the spring, physicians-researchers speaking for the Infectious Diseases Society of America said in Clinical Infectious Diseases:

The antibiotic pipeline problem may change the practice of medicine as we know it. Advanced interventions currently taken for granted—for example, surgery, cancer treatment, transplantation, and care of premature babies—could become impossible as antibiotic options become fewer.

But far less attention is being paid to ongoing shortages of other categories of drugs — and it should be, because they are widespread. Last spring, one emergency physician told me: “I am sure that, in the next few weeks, somebody is going to come into my emergency department in congestive heart failure, and I’m not going to have Lasix to give him.” Another said that because only certain concentrations of epinephrine — the critical stimulant for both cardiac arrest and anaphylactic shock — were available, hospital pharmacies were making up home-brew kits hat contained the drug, the right-size needles, and bottles of saline that it would let it be diluted on the go.

“Doctors, nurses, paramedics are being forced to use drugs they are not familiar with,” that physician told me. “Sooner or later, someone is going to make an error and hurt a patient.”

The American Hospital Association said in July that 99.5 percent of 820 hospitals they surveyed had run short of some drug in the previous 6 months, and 44 percent had run short of 20 or more drugs in that time. The drugs were needed across the range of specialties — surgery, emergency care, cardiology, gastroenterology, pain management, cancer care – and the shortages were so serious that four out of five hospitals said they were rationing drug use and having to delay treatment. (Here are the AHA’s detailed slides.)

That’s 2011 — but this trend isn’t new, it’s just getting worse. In 2010, a nonprofit organization called the Institute for Safe Medication Practices surveyed 1,800 clinicians and health-system pharmacists about shortages:

  • 80 percent said they faced difficulty obtaining comparable drugs;
  • 78 percent said there were significant costs to obtaining comparable drugs;
  • 70 percent said they had been unable to find comparable alternatives;
  • 64 percent believed the shortages posed a risk of adverse patient outcomes
  • and more than 1,000 of the 1800 described hair-raising overdoses, under-doses, and life-threatening mix-ups as a result.

Yet no one can figure out what to do. Many of the drugs are made by a single manufacturer, leaving their supply particularly vulnerable to disruption if a raw material runs out or a plant experiences infrastructure failures. Others are made by offshore manufacturers. The Food and Drug Administration, which approves drugs for sale, has no power to force a manufacturer to keep selling a drug if the company finds it unprofitable. The best that legislators have come up with is a proposed bill to force manufacturers to at least give advance notice when a drug is about to disappear.

That’s small comfort to patients such as my reader who are enduring treatment with substandard drugs, or forgoing treatment altogether. Later in the week, he wrote me again. He’d just experienced insult added to injury: When he went for his chemo treatment, he discovered his clinic had run out of nausea medication too.

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