Drug Shortages

In the past week, we encountered another drug shortage for one of Dear Son's medications. Dear Son wears a Transderm Scopolamine drug patch to dry up secretions in his throat. Dear Son's muscles have deteriorated and he has excess saliva that causes him to cough, choke and is at risk for aspiration. Recently, I was notified by Walgreen's that due to a manufacturing issue, they could not get any Scopolamine since it's been on back order for months. This is the second time this year, that we have been plagued by drug shortages, first with Klonopin and now with Scopolamine.

I was unable to find another pharmacy that had some Scopolamine so we had to switch to an alternative, Robinul. We had tried it several years ago and it didn't work for Dear Son. He has been on it for four days now and it still doesn't work. He chokes more every night and he's awake a lot from choking and I am awake worrying he'll choke to death and getting up to help him stay on his side and to suction him.

Several years ago, we tried botox injections to decrease the saliva however the effect was short lived. It lasted about two weeks and then it no longer worked.

Drug shortages are becoming more frequent and becoming a problem. When you have patients like Dear Son, whose life depends on these drugs, it's scary. Often, I can't find information on the FDAs website but I did locate the reason for the Scopolamine shortage on this website by the American Society of Health System Pharmacists. They list the reason for the shortage as, "increased demand". No release dates are given as to when it might be back in stock.

Drug shortages are serious problems. In September, there was a public workshop addressing drug shortages. Douglas Throckmorton, Deputy Director of the FDA's Center for Drug Evaluation and Research (CDER) states,

"Despite the efforts of all the partners in the room, and particularly the FDA, our drug shortages are getting worse and not better."

At this meeting, they urged all of the stakeholders to work together towards a solution. This problem has become so large that:

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  The FDA acknowledged that drug shortages for 2011 have already surpassed the 178 new shortages of medically necessary drugs in 2010 per Edward Cox, who is part of the four person team that constitutes CDER's Drug Shortage Program.



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  The FDA also reports that many of these recent shortages involve emergecy medicine drugs, cancer drugs, anesthetics and electrolyes, to name a few.

One proposed solution was suggested by DeWayne Pursley, neonatologist-in-chief at Beth Israel Deaconess Medical Center in Boston,who asked FDA, " to develop a list of critical medications and establish a federal stockpile of them and a fair and equitable method for distributing them. "

It's a bit shocking to even read a statement like that. I mean, I would have thought that a system would have been in place regarding critical medicines. Worse, it's hard to believe that more of these drug shortages are occurring. Dear Son has been on seizure medications since he's been two months old (he'll turn 20 in 10 days) and during that time, there was only one drug shortage. I remember one time there was an issue with Dilantin due to a fire in the warehouse that caused a drug shortage. Other than that, I can't remember any others and yet, in 2011, two of his medications have encountered shortages.

According to this public workshop, drug shortages are occurring for several reasons: Problems with product quality due to manufacturing issues, delay or capacity issues, and contractural obligations of manufacturers to reuse manufacturing lines to make other medications under contract. This problem can result in one manufacturer stopping production on multiple drugs to make drugs under contract.

At a minimum, ASHP's Director of Medication-Use Quality Improvement, Bona Benjamin, urged all involved stakeholders to support the "federal Preserving Access to Life-Saving Medications Act." The purpose of this bill is to require manufacturers to promptly notify the FDA of any manufacturing issues that may result in a shortage and also require them to notify the FDA six months prior to discontinuing any drug. Ironically, while the drugs they may discontinue may be critical or medically necessary, the FDA can't force any manufacturer to continue making a particular drug.

As a result of these shortages, I am shocked to learn that there really aren't any safeguards in place at the present time. Not only are there patients like Dear Son who depend on these drugs, but what about those drugs that would be medically necessary in case of a global disaster?

And finally, if nothing else, you would think that with the focus on saving healthcare costs, that medical safeguards would be put in place to prevent these shortages. After all, when we lack critical or medically necessary drugs, we increase the risk to patients for worse case scenarios which escalate costs. For example, the lack of Scopolamine could cause Dear Son to choke or aspirate, leading to an aspiration pneumonia which would result in a hospitalization. That hospitalization would most likely last a week or so and have billed charges associated of $40-$50k.

If nothing else, the one thing that typically gets people to take action is when the costs outweigh the current process, which is to do nothing. So in this case, what about the dollars that are spent on hospitalizations that occur as a result of a drug shortage? If a person on Medicaid or Medicare sustained a hospitalization that resulted in $40k or more in billed charges, you have to wonder at what point the federal government will step in and say enough is enough and enact a bill to force manufacturers to maintain supplies of critical drugs. Of course, first, they'll have to get a commission together, then do a huge study that will cost millions of dollars only to learn that yes, indeed, drug shortages cost money due to adverse events suffered from the lack of availability of critical medications. In the meantime, I can only hope that this shortage gets resolved so Dear Son and I can get some sleep.