Medication shortage means life or death for some

CHARLESTON, SC (WCSC) - The next time you need medication you might not be able to get it.

According to the Food and Drug Administration, the number of drug shortages in the United States has reached a critical level. Last year, the country hit a record high and some experts say there will be even more shortages in 2011.

What makes this problematic is that some patients affected by these shortages have different types of cancer and time is not on their side.

Karen Collins doesn't want people to think of her as a victim of cancer, but instead as a victim of circumstance when it comes to drug shortages.

"You have the disease itself to worry about," Collins said. "The side effects from what you're doing, and then now you have to deal with the fact that one of the drugs that's supposed to be helping you is not available."

Nine months ago, Collins' battle with stage four colon cancer became even more serious due to a nationwide backorder. The cancer fighting drug she needs, Leucovorin, became unavailable.

"It is extremely frustrating," she said.

Collins is being treated at the Charleston Cancer Center. They have two pages full of various cancer drugs they can't get their hands on and for cases like Collins, when the drug runs out, that's it.

"It's very difficult as Karen's physician to walk into the room and explain to her that you know we've been giving you this treatment for several years, you've been doing well on it, but unfortunately the drug is now unavailable," said Collins' oncologist Dr. Douglas Michaelsen. "We don't have a reasonable alternative to the drug so we just have to alter your treatment to try to keep things going as best we can without that particular drug."

In an online cancer forum, comments posted call the drug shortages a disgrace, unacceptable and even criminal.

Some doctors and administrators say pharmaceutical companies rarely explain the delays for drugs that may prolong someone's life, if not save it.

"Just like if you order something online and they send you back an e-mail back that says manufacturer backorder, may be available at such-and-such a time, but you don't get an explanation as to why," Michaelsen said.

On top of that, cancer clinics often receive little notice of drug shortages.

"Our staff has to scramble sometimes to try to find drug," Michaelsen said. "You know there's trading amongst institutions to try to get drugs if we're short and somebody has a little bit of extra and vice versa."

Lawmakers want drug companies to give the FDA advanced notice if there is an issue with supply. Right now companies don't have to do that, leaving it up to the FDA to fill the gap.

"Early notification is something that really helps us," says Valerie Jensen with the FDA. "If a company does let us know early on that they have an issue that just helps us to work with them that much sooner and hopefully avoid a shortage."

Short notice is just one of many factors causing widespread drug shortages. The FDA says many times a patient's health and wellness comes down to the drug company's bottom line.

"When something is discontinued we do normally ask them why," Jensen said. "We also would ask them to reconsider making a product such as if it's a medically necessary drug and we know that they have significant market share. What we normally hear from them for these older drugs is that these were not profitable for them."

According to a national organization representing pharmaceutical companies, other reasons for shortages include a lack of ingredients and manufacturing problems.

There are so many reasons, but for patients like Collins, there is so little time to focus on them. After going months without Leucovorin, at the end of May she will have a scan to find out if her cancer has spread.

"Am I a little more nervous not having the drug for nine months?" Collins asked. "Yeah, but any scan that I get is always nerve racking. Is this one probably the hardest one? Probably."

Last week the FDA approved an alternate drug for Collins' treatment. The Charleston Cancer Center is now checking its availability and trying to find out if Collins' insurance will cover the newly approved drug.

For a complete list of drug shortages, visit this website.

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