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Tuesday, March 27, 2012
Drug Shortages in the ED: Sorry, That’s on Back Order
By Graham Walker, MD
 
“Make it work” is Tim Gunn’s catchphrase on Project Runway, a television show where budding designers compete to make fashion from trash bags, newspaper, or grocery store produce. The physician equivalent is something we’ve sadly grown accustomed to on a daily basis: our national drug shortages.
 
Using only a fentanyl drip and pushes of benzos, this week the physicians will have to appropriately sedate their intubated, combative subarachnoid hemorrhage patients! Make it work!
 
The University of Utah’s Drug Information Resource Center and the American Society of Health System Pharmacists, which track medication stocks across the country, said shortages have tripled since 2006, with 267 shortages of medicines reported in 2011. Most of these shortages are generic IV formulations, and there’s no end in sight.
New drugs are developed (and we’re not talking “me-too” copycat drugs) because they are more efficacious or have fewer side effects or complications. Ondansetron (Zofran) is an effective antiemetic and lacks some of the complications of older antiemetics such as metoclopramide (Reglan) — sedation, akathisia, promotility. And it’s an IV push medicine, which nurses prefer to medicines that must be IV dripped. It also may work better for severe nausea, like that induced during chemotherapy, which is why it was initially a medicine used primarily in oncology.
 
Knowing this, we can easily predict the complications of these drug shortages: more side effects in patients and less efficacious care. We’ve all seen this in practice too many times to count.
 
There are related problems: delays and wasted time. I’m all for having a backup plan and knowing how to manage a condition with different, alternative, or second-line medicines, but when the nurse or pharmacy calls to tell me the hospital is out of the medicine I’ve ordered, that means a delay for the patient and an additional time investment to figure out an alternative agent and dosage. Usually these are little speed bumps in one’s day, but when they happen over and over again, they can really disrupt a shift. In the worst-case scenarios, scrambling to figure out what to give the alcohol withdrawal patient when there are no IV benzos can be a critical care issue.
 
I find these requests — “Can you change it to X? We’re out of Y” — run through an entirely different circuit in our brains (“Get it done”) than the usual one (“Get it done after checking for contraindications or allergies”), which puts them at much higher risk for medication errors. On a busy shift, hearing “We’re out of fentanyl” frequently makes my brain want to order something else immediately so I can check the task off my list.
 
These frequent drug shortages cause a number of documented problems and true medication errors. Some of the more horrifying:
  • Shortages of chemotherapy medications, so oncologists have to try regimens different from the ones that have been studied and proven efficacious.
  • Mix-ups of chemotherapy medications and administration of the wrong ones (cisplatin for carboplatin).
  • Morphine-for-hydromorphone dosage errors, with nurses giving the usual morphine dosage (4 mg) of hydromorphone instead.
  • Some pharmacies are stocking vials of morphine of varying concentrations to try to keep up with demand, so nurses are never sure if they’ll be getting 2 mg/mL vials or 10 mg/mL vials.
  • Phenytoin was given intraoperatively instead of fosphenytoin, causing hypotension and cardiac arrest.
  • Epinephrine was stocked in code carts at the wrong dosage or concentration, and in one instance, was placed in code carts with instructions to dilute the epi during a code.

And shortages only beget more shortages. A morphine shortage makes people give hydromorphone, which then creates a hydromorphone shortage. Hospitals, anticipating the shortages, place bigger orders for more medications, causing other hospitals to have worse shortages.
So why has all of this been happening? The practice of medicine has increasingly become the administration of medicines, and we’re certainly more reliant on medications. But most people point primarily to problems on the supply side.

Most shortages are of IV generic medicines, which have low profit margins and high FDA safety standards. These generics are not price-responsive, and because of their expiration dates, it’s expensive for factories to make excess that they’re not going to sell. The FDA also has to approve any changes to a factory’s production process, leading to months of delays. (And when it comes to route of administration, pills are easier to make.)

The “system” in place today does little to hold the FDA or private companies accountable for shortages or delays, and even worse, they rarely or never communicate with hospitals ahead of time to help them prepare for any delays coming down the pipeline. In fact, hospitals report they are rarely or never given advanced notice of a shortage more than 75 percent of the time.

What can be done about this? HR 2245/S 296, the Preserving Access to Life-Saving Medications Act of 2011, may help (and please contact your Congress member to support it), but it probably doesn’t go far enough. (See FastLinks.) A recent summit on this issue recommended:

  • Giving manufacturers a tax write-off for providing “vulnerable” drugs.
  • Penalizing manufacturers who do not warn the FDA when they are experiencing a production delay or have decided to stop producing a medicine; currently there is no such requirement. Occasionally, the FDA can act to help prevent a shortage if it receives notice of an impending problem, and was able to prevent 38 shortages when notified in the past.
  • Requiring the FDA to approve new production facilities faster. It currently takes months for a generic manufacturer to get approval.

The World Health Organization has a document called the WHO Model List of Essential Medicines, and it sets the bare minimum for a health care system and lists the most efficacious, safe, and cost-effective medicines for priority conditions. How do you think we’re faring?

Terribly. Absolutely terribly. I counted 24 drugs we’re missing by briefly skimming the list and comparing it with current shortages in the United States. And these aren’t the latest intrathecal snail enzyme for chronic pain patients. You’ve probably heard of some of these: atropine, calcium, ciprofloxacin, dopamine, dexamethasone, epinephrine, furosemide, haloperidol, heparin, lidocaine, lorazepam, vancomycin. No? None of them ringing a bell?

The drug shortages look like they are only getting worse. So when you’re on a shift and you know there’s a shortage, make sure you’re still doing right by your patient and confirm patients really need the medicine you’re about to prescribe (PO might work just as well). They say you’re not supposed to be the first or last to prescribe a new medicine. I just hope they’re referring to its approval date, not its supply.

Dr. Walker is a fellow in simulation medicine in the Stanford/Kaiser Emergency Medicine Residency Program. He has been blogging since medical school, first at Over My Med Body, and now as the developer and co-creator of MDCalc, a medical calculator for clinical scores, equations, and risk stratifications (www.mdcalc.com), and The NNT, a number-needed-to-treat tool to communicate benefit and harm (www.thennt.com).
 

FastLinks 
 

  • Read more about the Preserving Access to Life-Saving Medications Act of 2011 at http://bit.ly/HR2245.
  • Information about the University of Utah’s Drug Information Resource Center is available at http://bit.ly/UtahDIRC. Access the American Society of Health System Pharmacists website at http://www.ashp.org.
  • Use Dr. Walker’s medical calculator at www.mdcalc.com and his number-needed-to-treat tool at www.thennt.com.
  • Read all of Dr. Walker’s past columns in the EM-News.com archive.
  • Comments about this article? Write to EMN at emn@lww.com.
About the Author

Lisa Hoffman
Editor, Emergency Medicine News