31 May 2011


Drug shortages have always been a part of the medical world, however the problem is growing. Hospitals and care givers are concerned that the drugs they desperately need to save lives is hard to get. There are already record cases where vital treatment has been delayed while doctors wait for the drugs they need.
The number of drugs 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 girl, because of a months-long nationwide shortage of cytarabine, a drug considered key to curing a type of leukemia.
The parent commented that she is always fearful that if her child is going so long without chemo, that there may be a chance her cancer's going to come back. The mother says she'll be nervous until her daughter finishes her final treatments scheduled for this week. She can’t believe that in this day and age, we really shouldn't be having this kind of problem and putting children's lives at risk.
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.
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
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
Lawmakers are getting involved. Senator Herb Kohl of Wisconsin 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.
With all things considered, everyone and every company is out to provide the best drugs as needed so as to not put anyone’s life at risk. If a drug shortage is foretasted steps are being taken, and have successfully been taken, to prevent the worst from happening.

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