05-30-2011 by Linda S. Carbonell
According to the conservatives, America has the “greatest health care system in the world.” The fact that we’re only ranked 37th by all measures of health care delivery never breaks they unflinching faith in our medical system.
Maybe this will……
In 2005, we had critical shortages of 70 widely used drugs. By the end of last year, that number had grown to 211. Though some shortages have been resolved, another 89 drugs were added to the shortage list in the first three months of 2011. Dr. Eric Lavonas of the American College of Emergency Physicians said that “It’s just a matter of time now before we call for a drug that we need to save a patient’s life and we find out there isn’t any.” The drugs that are in short supply range from treatments for cancer to cystic fibrosis to cardiac arrest.
Most of the shortages are in injectable medications used in hospitals. The shortages can last from weeks to many months, placing patients in jeopardy. A shortage of cytarabine caused delays in treatments for luekemia. Shortages can be caused by recalls for contaminated vials, trouble importing ingredients, increases in demand or factories shut down for quality upgrades. Factories can also be shut down because they have been manufacturing improperly prepared drugs and the FDA has had to step in, which was the cause of a 2009 shortage of generic metaprolol, a medication that regulates heart rhythm.
Among the drugs in short supply are a sedative used on death row, Thiotepa which is used for bone marrow transplants, Norepiniephrine injections for septic shock, Acetylcysteine for cystic fibrosis, a range of electrolytes needed for premature infants and tube feedings for the critically ill, some leuprolide hormone injections used in fertility treatments, some drugs for ADHD and injections used for cardiac arrest in ERs.
There have been no records kept of patient impact, but the Institute for Safe Medication Practices reported two incidents of patient deaths from the wrong dose of a substitute for morphine.
The FDA has asked that foreign companies ship forms of the short drugs that are not usually used in America. That has helped ease the shortage of Thoitepa and Propofol, an anesthesia. Some American companies are increasing production, but other aspects of the shortage are not easily dealt with, like stockpiling by companies and shutdowns for misproduction.
Congress is getting involved as well. Sen. Herb Kohl, Democrat of Wisconsin, is asking the Federal Trade Commission to consider possible shortages when reviewing drug company mergers. Sen. Amy Klobuchar, Democrat of Minnesota, has introduced a bill that would require drug manufacturers to notify the FDA if there is a potential for a shortage. While the FDA cannot force a company to manufacture a drug, they can use other methods to prevent a shortage, such as notifying competing companies so that they can increase supplies or speeding up approval of changes in the manufacturing methods. Sen. Klobuchar said, “No patient’s life should have to be at risk when there is a drug somewhere,” that could fill the gap.
Pharmaceutical companies have been under attack for some time in America for creating new drugs by making small tweaks in old ones to hold on to their patents, creating combination drugs that are nothing more than two existing drugs that together cost less than the combo, advertising so effectively that doctors have complained about people demanding drugs they don’t need, and charging far more for medications than their costs in other countries. Allowing critical shortages in almost 300 vitally important drugs isn’t going to do anything for big Pharmas image.