Drug Shortages Force Hospitals To Scramble

[+EdwardGlen]

A shortage of life saving drugs is unacceptable.

 

They (pharma) do mot need to inform the FDA when they are stopping production of any medications but the FDA is asking for a six month heads up now. Even with a six month heads up as slow as the FDA is to approve any new drugs they could ask for a six year warning and probably still not have drugs in the pipe-line to help ease the problem.

 

This is a situation where the feds do need to step in and tell pharma what they are going to do not the other-way around.

 

People who die because a pharma manufacture stopped production on a not so profitable drug their families should have the right to sue for wrongful death.

 

http://www.mailtribune.com/apps/pbcs.dll/article?AID=/20110531/BIZ/105310303/-1/rss05

 

May 31, 2011

By LAURAN NEERGAARD

The Associated Press

 

WASHINGTON — A growing shortage of medications for a host of illnesses — from cancer to cystic fibrosis to cardiac arrest — has hospitals scrambling for substitutes to avoid patient harm, and sometimes even delaying treatment.

 

"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," says Dr. Eric Lavonas of the American College of Emergency Physicians.

 

The problem of scarce supplies or even completely unavailable medications isn't a new one, but it's getting markedly worse. The number listed in short supply has tripled over the past five years, to a record 211 medications last year. While some of those have been resolved, another 89 drug shortages have occurred in the first three months of this year, according to the University of Utah's Drug Information Service. It tracks shortages for the American Society of Health-System Pharmacists.

 

The vast majority involve injectable medications used mostly by medical centers — in emergency rooms, ICUs and cancer wards. Particular shortages can last for weeks or for many months, and there aren't always good alternatives. Nor is it just a U.S. problem, as other countries report some of the same supply disruptions.

 

It's frightening for families.

 

At Miami Children's Hospital, doctors had to postpone for a month the last round of chemotherapy for 14-year-old Caroline Pallidine because of a months-long nationwide shortage of cytarabine, a drug considered key to curing a type of leukemia.

 

"There's always a fear, if she's going so long without chemo, is there a chance this cancer's going to come back?" says her mother, Marta Pallidine, who says she'll be nervous until Caroline finishes her final treatments scheduled for this week.

 

There are lots of causes, from recalls of contaminated vials, to trouble importing raw ingredients, to spikes in demand, to factories that temporarily shut down for quality upgrades.

 

The shortage that's made the most headlines is a sedative used on death row. But on the health-care front, shortages are wide-ranging, including:

 

Thiotepa, used with bone marrow transplants.

Norepinephrine injections for septic shock.

A cystic fibrosis drug named acetylcysteine.

Injections used in the ER for certain types of cardiac arrest.

[greenbuddha]

Money and politics?

[solabeirtan]

That sums it up pretty concisely. The story I see emerging is for instance regarding the Death row 'Drugs', this is like ALL pharmacuetical cos a multinational conglomerate who feeds the world . Most of them gained their commercial success in the USA. However like all technology, schools, even government were ideas that had been concieved elsewhere [europe] and brought to fruition / hatched in the USA, then distributed globally. IE Nuclear Energy, Nuclear Science, Pharmacueticals....

 

The story is we the People without any form of Health Insurance are denied our ancillary benefits of this technology.

 

It is used more as a means to keep us subjugated. It even had finally been the primary negotiating items with union/employer negotiations, untill the recent attempts to strip their actual Collective Bargaining Rights. What their chipping away at now is our Democratic Rights !

 

The crux of my discussion is that as seen in the Death Row deal the Pharmacuetical Companies are wiseley dictating terms to our government. Seems the tail can wag the dog these days. The Carraige preceeds the horse, etc ...... Our government is pretty resourcefull at killing people, probably their most skilled trade, now they just OD you and shove you in the box ..... ........ .......

 

ps Did somebody say something about Change ... not Spare Change, not Chump Change, we want Real Change.

[+EdwardGlen]

Drug shortages at all-time high

 

Curious to know why this wouldn't be considered a national security issue?

 

http://money.cnn.com/2011/06/10/news/economy/drug_shortages_fda/index.htm

 

By Parija Kavilanz @CNNMoney June 10, 2011: 3:41 PM ET

 

NEW YORK (CNNMoney) -- The number of drug shortages is at a record high, and the Food and Drug Administration is warning that they are getting even worse.

 

Fueling the problem are shortages of raw materials. Also, drugmakers are discontinuing older, and off-patent drugs in favor of newer and more profitable ones, and issuing large recalls of drugs due to quality problems, the agency said.

 

In 2010, 178 drug shortages were reported to the FDA. These include cancer drugs, anesthetics used in surgery, a large number of "sterile injectables" -- medicines that are given intravenously -- and "crash cart" drugs used in emergency treatments.

 

Valerie Jensen, FDA's expert on drug shortages, said regulators are seeing a large number of new drug shortages in 2011 as well.

 

FDA: Another tainted drug crisis seems inevitable

 

Jensen said the agency is especially concerned about the danger to consumers from shortages of injectable drugs, which represented more than half of the shortages reported last year to the FDA.

 

"Companies have told us that these injectable drugs are older drugs and not as profitable," she said. "They've told us it's a business decision to discontinue production."

 

Over the last six years, the number of prescription drug shortages in the country has nearly tripled, the agency said.

 

Recently, several over-the-counter drugs such as Tylenol and Motrin made by Johnson & Johnson (JNJ, Fortune 500), have also been recalled in large quantities, reportedly leading to shortages of these drugs as well.

 

But Jensen said the FDA did not have an assessment of shortages of those and other non-prescription medicines.

 

The FDA defines a drug shortage as a situation in which the total supply of all a drug, and all of its approved alternatives, is inadequate to meet demand.

 

Many prescription drugs that consumers take by mouth each day, such as medicines to treat Attention Deficit Hyperactivity Disorder, are also in short supply, the agency said.

 

Drug shortages are hitting patients in hospitals particularly hard, the agency said.

 

Since drugmakers aren't mandated to report drug shortages to the FDA, the agency said it is urging companies to voluntarily alert regulators of impending scarcities "in the interest of public health."

 

"FDA is doing everything within its regulatory authority to address these shortages when they occur," Jensen said.

 

The FDA is especially focusing that effort on shortages of the most critical drugs, those that are used to treat or prevent a serious disease or medical condition.

 

Many of these critical drugs don't have alternative medicines available in sufficient supply, the agency said.

 

The agency said when it gets advance warning from a manufacturer that a shortage could occur, it will approach other firms that also make the drug to see if they can ramp up production to avoid any supply gap.

 

The FDA may also approve limited imports of foreign versions of a drug that is in scarce supply.

 

Even though last year's level marks a new high for drug shortages, the FDA also noted that the 2010 tally didn't include shortages of other medicinal products such as vaccines and products made from blood, tissue and other biological sources.

 

Jensen said last year's tally would be even higher if shortages for those products were also added in.

 

First Published: June 10, 2011: 2:10 PM ET