How Capitalism is Failing Health Care

This week the New York Times reported that Nitroglycerin is in short supply.

Nitro is what you take when you are having a heart attack. That's how serious this is getting. Other drugs impacted by drug shortages in the US include morphine, cancer medications just about everything we've used in the hospital -- including normal saline!

Baxter is the only supplier now. Despite the fact that this is a life saving medication used in critical care, it is not a big profit maker.

That's the basis for the drug shortages. Factories are getting old and drug companies - despite huge bankrolls and profits -- don't want to invest in factories that aren't producing high-profit drugs.

It's just another example at how the free market fails when it comes to healthcare. The medications we need most are not always the medications that turn the biggest profit. Moreover, drug shortages are getting worse, according to the most recent GAO report:

The number of drug shortages remains high. Although reports of new drug shortages declined in 2012, the total number of shortages active during a given year—including both new shortages reported and ongoing shortages that began in a prior year—has increased since 2007. Many shortages are of generic sterile injectable drugs. Provider association representatives reported that drug shortages may force providers to ration care or rely on less effective drugs.

As expected, those of us who working health care are flabbergasted. As the NYT noted:

Several doctors said they found the unpredictability of the shortages frustrating. “You want to feel that we’re living in a land where if you come into the hospital with a heart attack, that you can get the best of care,” said Dr. Ann Toran, chief of cardiac surgery at North Shore Medical Center, a hospital in Salem, Mass., whose pharmacy is down to a small supply of nitroglycerin. “To have that hanging over you as a doctor — a critical shortage of this essential medication — I just don’t know what to say.”

Now It's A Normal Saline Shortage

If you ever wonder about the US health care system's ability to scale up for a mass epidemic or disaster all you have to do is look at its ability to handle season fluctuations in demand.

Short answer: Not very well.

Over the past two years we have found our self short, or out of many basic drugs needed to treat our patients. (For the current drug shortage list, Click Here)

None of these medications is as profitable as Viagra, so there is not a lot of incentive to invest in infrastructure for making them. The latest shortage is also the most basic. Normal saline, the IV fluid used as a front-line prevention and treatment for shock, has been in short supply.

Here's the lastest from the Emergency Nurses Association that showed up in my mailbox just now:

The Emergency Nurses Association (ENA) is closely tracking reports from hospitals across the country of a shortage of IV saline solution. According to the Food and Drug Administration (FDA) and the drug manufacturers, the increased demand from a harsh flu season and temporary shutdowns at some manufacturing plants are the cause of the shortage. 

The FDA is aware of the problem and is working with the three U.S. manufacturers of IV saline solution - Baxter, Braun Medical and Hospira - to increase the supply of this product. It is also looking at alternative sources, including importation from overseas.
The American Society of Health-System Pharmacists has stated that suppliers are now
operating at full production capacity in an attempt to meet the increased demand.  

In a January 17 letter to customers, Baxter said they “anticipate gradual improvement in the weeks ahead and are confident that these steps will enable us to achieve expected service levels.” Baxter also stated they are manufacturing a greater amount of IV solutions than in previous years and are taking steps to further increase capacity in 2014.
ENA is monitoring the situation closely and communicating information we receive regarding the shortage of IV saline solution to the FDA.  

In addition, ENA is working closely with other national healthcare organizations to ensure that the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012, is fully implemented so it provides the FDA with the tools to minimize future shortages of drugs or biological products. 

The key provisions of FDASIA dealing with shortages include:
• Broadening the scope of the early notification requirements by requiring manufacturers to notify the FDA of potential drug discontinuances; and
• Clarifying that the notification requirement applies to drugs that are used in emergency medical care or during surgery.

For more information on drug shortages and the FDA’s efforts to alleviate the shortage of IV saline solution, please visit: http://www.fda.gov/Drugs/drugsafety/DrugShortages/default.htm. 

Baxter told to recall and destroy hospital IV pumps

The LA Times is reporting that medical manufacturing giant Baxter is being forced to "recall and destroy" Hospital IV pumps that we use at our hospital and at hospital across the nation. The pumps in question are known as Colleague Guardian pumps and the move is part of a larger effort by the FDA to crack down on IV pump safety issues.

The change comes after 710 deaths associated with malfunctioning infusion pumps used in homes and hospitals during the last five years, according to American Medical News. The agency has received 56,000 adverse-event reports regarding the devices during that time period and issued 87 recalls -- 14 of those in the FDA's highest-risk class I category. 

"There have been problems with every kind of infusion pump on the market, across the entire industry," said Jeffrey Shuren, MD, director of the agency's Center for Devices and Radiological Health. The initiative "represents a major shift in FDA's approach to medical device safety," Dr. Shuren said. "Instead of responding to problems one by one and manufacturer by manufacturer, we are taking comprehensive steps to prevent problems by fostering the development of safer, more effective infusion pumps industrywide."

The FDA said Baxter must "recall and destroy" all of its Colleague pumps, saying the action was based on "a long-standing failure" of the company to correct serious problems with them, the LA Times reported. Baxter issued a corrective action plan, however the FDA found it wanting, responding with the order for recall.


As the LA Times reported:

The agency called the plan "unacceptable" and said it would have allowed the company to keep a device with "known safety concerns" on the market until 2013. The FDA said it was not satisfied with Baxter's timetable for fixing Colleague, a pump the company stopped selling in 2005 because of various design flaws, battery failures and related software issues.

"The FDA has been working with Baxter since 1999 to correct numerous device flaws," the agency said in a statement. "Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors and other issues."

Based on a consent decree with FDA, Baxter hasn't sold the pumps directly since 2006, but they still remain on the market. 

Baxter is offering to exchange it's new Sigma smart pumps for the recalled pumps without charge. 

Personally I like Hospira's plum pumps, but I doubt we'd be able to get a hospital's worth for free ....