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Drug Shortages Have Hospitals Scrambling For Alternatives

Written by Christian Nordqvist
Article Date: 30 May 2011 - 9:00 PDT

Hospitals are finding themselves short of a wide range of medications more frequently and for longer. Delaying treatment is becoming less of a rarity at US hospitals today. Emergency doctors fear that soon lives will be lost when they cannot get their hands on some crucial drugs.

There are times when the supply and demand of certain drugs go in wrong directions and there is a shortage, and sometimes total unavailability. What concerns a growing number of health care professionals is that the problem is growing rapidly. 211 drugs were listed as in short supply in 2010, three times more than in 2006.

The University of Utah's Drug Information Service informs that during the first quarter of this year there have been 89 drug shortages. Just on the 25th and 26th of May, 2011, the American Society of Health-System Pharmacists reported new shortages of the following medications - Ciprofloxacin Immediate-Release tablets, Magnesium sulfate injection, Paclitaxel injection, Aminocrapoix acid injection, Prochlorperazine edisylate injection, Triamterene and Hydrochlorothiazide capsules and tablets, and Vasopressin injection.

Hospital pharmacists and medical personnel inform that some shortages can go on for several months. Many of these medications have no ideal substitute. Hospitals in several other countries are reporting similar problems.

In some cases it might be a chemotherapy medication for cancer treatment. Local media in Florida reported a case of a 14-year-old girl with leukemia whose chemotherapy sessions had to be postponed because of a long-lasting nationwide cytarabine shortage.

Pharmacists and drugmakers cite the following reasons for drug shortages:

* Product recalls

* Contaminated vials

* Difficulties in importing certain raw materials

* Demand fluctuations

* Production plants being upgraded (and closed while the upgrade is being carried out)

The more expensive the drug, the less likely there is a shortage of it, experts have noticed. Cheaper, older generic products have smaller profit margins and fewer pharmaceutical companies want to be involved in making them.

Shortages include drugs for a wide range of therapeutic areas, including premature babies, septic shock, intravenous feeding, fertility treatment, ADHD, emergency room cardiac arrest, cystic fibrosis, and cancer.

According to the Institute for Safe Medication Practices, two patients died last year because their substitute painkiller dosage was wrong - at the time there was a shortage of morphine. However, nobody is monitoring patient harm at a national level.

Approximately 40% of thyroid cancer patients will not have access to a drug - Thyrogen - until July or August this year. Thyrogen helps patients who have had their thyroid gland surgically removed avoid the considerable side effects of hormone withdrawal. For those who need this medication, there is no comparable available alternative drug. The European Journal of Endocrinology reports that patients on Thyrogen had 8.1 fewer absent days from work compared to those on withdrawal. Most endocrinologists prescribe Thyrogen before treatment.

Worldwide supplies of Thyrogen will be unreliable until about July, says the Genzyme Corporation, makers of the drug.

Recent shortages of ADHD (attention deficit hyperactive disorder) drugs have sent patients or their parents going from pharmacy-to-pharmacy desperately seeking medications such as Adderall and its generic equivalents. According to IMS Health, the shortage affected a combined 24.2 million prescriptions' worth of drugs in 2010.

Franciscan St. Elizabeth Health Clinical Manager, pharmacist Carol Miller said in a recent interview:

"As a pharmacist working for 20-some years, I've seen shortages, but nothing with the numbers of drugs out there that are short at this time."

Miller believes the recent global economic crisis has affected drug supplies. When the economy is tight pharmaceutical companies tend to drop production of the least money making drugs. If there are generic products available, some drug companies simply stop making their brand products.

With current federal regulations the way they are, it is difficult for generic makers to respond rapidly.

Copyright 2011 Medical News Today (emphasis added)

http://www.medicalnewstoday.com/articles/226896.php


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Hospitals Hunt Substitutes As Drug Shortages Rise

by The Associated Press
May 30, 2011, 07:41 am ET

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.

"In this day and age, we really shouldn't be having this kind of problem and putting our children's lives at risk," she adds.

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.

Some experts pointedly note that pricier brand-name drugs seldom are in short supply. The Food and Drug Administration agrees that the overarching problem is that fewer and fewer manufacturers produce these older, cheaper generic drugs, especially the harder-to-make injectable ones. So if one company has trouble — or decides to quit making a particular drug — there are few others able to ramp up their own production to fill the gap, says Valerie Jensen, who heads FDA's shortage office.

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.

—A whole list of electrolytes, injectable nutrients crucial for certain premature infants and tube-feeding of the critically ill.

—Norepinephrine injections for septic shock.

—A cystic fibrosis drug named acetylcysteine.

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

—Certain versions of pills for ADHD, attention deficit hyperactivity disorder.

—Some leuprolide hormone injections used in fertility treatment.

No one is tracking patient harm. But last fall, the nonprofit Institute for Safe Medication Practices said it had two reports of people who died from the wrong dose of a substitute painkiller during a morphine shortage.

"Every pharmacist in every hospital across the country is working to make sure those things don't happen, but shortages create the perfect storm for a medication error to happen," says University of Utah pharmacist Erin Fox, who oversees the shortage-tracking program.

What can be done?

The FDA has taken an unusual step, asking some foreign companies to temporarily ship to the U.S. their own versions of some scarce drugs that aren't normally sold here. That eased shortages of propofol, a key anesthesia drug, and the transplant drug thiotepa.

Affected companies say they're working hard to eliminate backlogs. For instance, Hospira Inc., the largest maker of those injectable drugs, says it is increasing production capacity and working with FDA "to address shortage situations as quickly as possible and to help prevent recurrence."

But the Generic Pharmaceutical Association says some shortages are beyond industry control, such as FDA inspections or stockpiling that can exacerbate a shortage.

"Drug shortages of any kind are a complex problem that require broad-based solutions from all stakeholders," adds the Pharmaceutical Research and Manufacturers of America, a fellow trade group.

Lawmakers are getting involved. Sen. Herb Kohl, D-Wis., is urging the Federal Trade Commission to consider if any pending drug-company mergers would create or exacerbate shortages.

Also, pending legislation would require manufacturers to give FDA advance notice of problems such as manufacturing delays that might trigger a shortage. The FDA cannot force a company to make a drug, but was able to prevent 38 close calls from turning into shortages last year by speeding approval of manufacturing changes or urging competing companies to get ready to meet a shortfall.

"No patient's life should have to be at risk when there is a drug somewhere" that could be used, says Sen. Amy Klobuchar, D-Minn., who introduced the bill.

EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Copyright 2011 The Associated Press (emphasis added)

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