Bags of IV saline may appear ubiquitous as props on TV medical dramas, but they're currently in short supply on the nation's hospital pharmacy shelves. In fact, more than 75 percent of U.S. hospitals and other health care settings were experiencing critical shortages of intravenous saline solutions, according to a February survey of pharmacy directors by the American Society of Health-Systems Pharmacists.
It's unsettling and hard to fathom that such an essential staple of medical and emergency health care could become so scarce. Many of us owe our lives to the ready availability of those precious bags of salt and water in ambulances, emergency rooms, intensive care units, chemotherapy suites, dialysis units, trauma and burn centers.
Infusions of saline into our veins have rescued us from shock, maintained our nourishment and hydration, allowed us to receive lifesaving antibiotics and other drugs directly into our bloodstreams.
On one hand, the IV saline shortage reflects old news about our long-standing national "crisis" with drug shortages in general. Indeed, in 2012 fully 456 medications had spent time on our official list of drug shortages, which has been heavily represented by generic injectable medications. Furthermore, the esteemed University of Utah Drug Information Service more recently classified 57 percent of the known shortages as "critical" because no equivalent alternative substitute drugs are available. For example, I and others have written in the past about critical shortages of certain chemotherapy drugs being causally linked to increased death rates from childhood cancers.
And yet, there is something new and uniquely troubling about this shortage. We have allowed something essential to all of medical practice to become scarce. Exactly what is required to sway our nation's health care industries to become more attentive and responsive to our health care needs?
In hospital and trauma settings, pharmacy shelves bare of IV saline are akin to pantry shelves bare of bread and butter. And yet, on Jan. 15, IV saline became just another official entry on our list of national drug shortages.
According to the FDA, all three major U.S. saline producers said they were unable to increase production to meet "unprecedented" demand for the product. Reportedly, cooperative talks between industry and the FDA have begun in hopes of finding solutions to address the problems behind the shortage.
Still, while salt may be set squarely on the table for that discussion, any real hope to address the saline shortage has to digest much more on the proverbial plate. And to sample that whole enchilada, we need look no further than last month's report on the bigger picture of national drug shortages by the nonpartisan U.S. Governmental Accountability Office. The blunt title of the GAO report serves a telling description: "DRUG SHORTAGES -- Threat to Public Health Persists, Despite Actions to Help Maintain Product Availability."
Beyond mere description of what's on our plate, the GAO report also offers the usual menu of oft-cited reasons to explain the shortages as well as some new recommendations to help the FDA address them.
For example, the GAO found that "the most frequently cited immediate cause of a drug shortage was when a manufacturer halted or slowed production" in response to discovering concerns with product quality. But the GAO also found that half the studies they reviewed "suggested that the immediate causes of drug shortages, such as quality problems, are driven by an underlying cause that stems from the economics of the generic sterile injectable drug market."
When studies addressed those economics, they often pointed to the low profit margins of the drugs in shortage, which "limited infrastructure investments or led some manufacturers to exit the market."
The GAO recommended that Congress give the FDA authority to more aggressively analyze and collect data to enhance understanding about drug shortage information in the hope it will help the FDA "to proactively identify drug shortage risk factors."
And that's a worthwhile goal. At least someone will be carefully monitoring the pharmacy shelves.
But it must also be noted that -- regardless what tonnage of data the FDA collects and analyzes -- still, the FDA cannot compel a pharmaceutical company to resume or increase production of a drug in shortage. And that is a critical point for anyone seriously looking for solutions to our very serious problem with drug shortages.
I am not advocating for government control of pharmaceutical production. But I'm also not advocating for the current arrangements, which repeatedly leave our nation's health and security in such an unhealthy and vulnerable state.
Developing and supporting a formal system of nonprofit pharmaceutical manufacturing dedicated to production of neglected or low-profit drugs might help. And a clearer view of the currently opaque drug-pricing system might help us see (and remedy) how drugs on the pharmacy shelves are priced in and out of our reach.
Meanwhile, unexpected shortages of critical drugs have become "business as usual" in the U.S. That forces an expensive scramble by pharmacies, hospitals and doctors to obtain the drugs as well as rationing of medication to needy patients in the world's "best health care system." It leaves vulnerable patients at the mercy of chance, often paying the cost with their lives and health.
Kate Scannell is a Bay Area physician and the author most recently of "Flood Stage."