Manufacturers Work To Overcome Cancer Drug Shortage

7:02 PM, Feb 15, 2012   |    comments
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  • Courtesy: WKYC
    

We're checking into how a cancer drug that is key in treating a common childhood cancer became in short supply.

The FDA said the shortage should ease in the next few weeks before any hospitals run out of it.  But how did it get to this point?

Methotrexate is used to treat acute lymphoblastic leukemia known as ALL.

According to the FDA, makers of the drug gave the federal agency different reasons for the shortage.

Ben Venue Laboratories in Bedford, Ohio reported multiple products were affected by the suspension of manufacturing in mid-November 2011. It has the drug on back order according to the FDA's website.

Other makers of the drug reported higher than anticipated demand while others also contributed it to manufacturing delays.

But many medical experts are blaming a shortage of several other relatively-inexpensive drugs on drug-makers choosing to put their focus on making more-profitable drugs. We talked to Dr. Michael Link, President of American Society of Clinical Oncology about the drug shortage problems.

"If there is a problem in manufacturing which would cost a lot of money to fix one could understand that a company would be reluctant to make a heavy investment in a drug that's not making any profit on or is losing money on," said Link.

Link added unfortunately the FDA has no power to make those companies produce more of the less-expensive drugs.

"I think most people would object to forcing a company to make a product that they're losing money on. So there's got to be a better solution that may involve the FDA keeping track of supplies," he explained. 

The FDA says in this case they are aggressively working with other manufacturers to boost production to fill the void.

The're calling it a top priority, using all of their resources and options to make sure patients and their families have access to this important medication.  Link added it only solves the shortage problem this time for this one drug,

"There are only a few companies that are making it which is a problem, and many of these drugs are made by one or two companies. So, when one of them has a problem or goes out of the market that creates an immediate shortage," explained Link. 

The FDA anticipates there will be enough Methotrexate available by the end of this month to meet the demand and avoid a shortage.

It says working with the other manufacturers is paying off in time in this case.

So how do you fix this mess for the future for good?

Members of Congress think the Drug Shortage Prevention Act is one solution.

It gives the FDA more power to watch over manufacturers that make drugs that are vulnerable to shortages.

We asked the FDA if it will help.

They told us the administration has not taken a position on the Drug Shortage Prevention Act, but they're interested in working with Congress in addressing drug shortages. 

Wake Forest Baptist Medical Center in Winston-Salem has been rationing drugs for years.

Methotrexate is just the latest drug to end up in short supply. Hospital staff members meet once a week to discuss what drugs are in stock and what drugs patients need. Many drugs need to get mixed by a pharmacist and that process can leave some leftover medication that would typically go to waste.

However, at Wake Forest Baptist Medical Center, staff members take steps to make sure every drop of medication goes to a patient.

Clinical Pharmacist LeAnne Kennedy said, "We never even thought we'd have to deal with this. It's been a learning curve. We've definitely learned throughout the years to learn how to maximize our drugs for our patients. "

So, what can you do right now if you need cancer drugs or treatment? What steps can you take to make sure those life-saving medications are available to you if you need them? Not much. However, you can contact your lawmaker and let them know you are concerned about this issue. Let them know it's a problem you'd like them to address.

Doctors say medication shortages have become a real problem.

Dr. Paul Savage, a Medical Oncologist, said, "We may have some patients who won't be cured who might have been cured... The reality is, for most patients, we've got alternative regiments that are just as effective, but the drugs may have more side effects

Many cancer drugs and other medications come with strict federal guidelines about how to store and use them. They also come with expiration dates that are often debated by people in the medical community. As a result, drugs all over the nation get thrown away because they have expired. However, so far, Wake Forest Baptist Medical Center says it has been able to avoid discarding any medications because of an expiration date. 

 

WFMY News 2