Drug Shortages Problem Continues

Everything from manufacturing quality control problems to recalls is impacting the supply of hundreds of prescriptions, and that adds up to one big reduction.

Think about going into a local home improvement warehouse store and having a sales representative tell you they are out of lumber or hand tools. What if you went into a fast food restaurant only to find out they are out of French fries? That must be what it’s like for patients who take prescriptions to their local drugstore only to find out that the medication in question is now out of stock due to a back-order problem.

This drug shortages problem is affecting hospitals and community pharmacies alike and it is getting worse every year. Actually, it’s so bad now there are record numbers of prescription medication back-orders. The numbers are ugly but they represent exactly why pharmacists and patients are scratching their heads in disbelief. Frustration is mounting as we all must deal with this growing problem.

The US Food and Drug Administration (FDA) has a reporting system in place for medications that are in short supply or back-ordered for whatever reason. You can see the latest FDA drug shortages list here. Notice how far you have to scroll down to look at the entire list. Doesn’t that demonstrate just how big the problem has become? The data released putting numbers to this problem proves it has gotten much worse in recent memory.

According to this White House Fact Sheet, medication shortages reported to the FDA have risen from 61 in 2005 to a new record of 178 in 2010. I should say 2010’s numbers were a record. Why? Because the reported number of medication shortages to the FDA this year topped 180 by the month of July. We are well over 200 medication shortages going into the last months of 2011. And the problem seemingly has no end in sight for patients or providers.

But what is going on to cause all of these drug shortages? The answer might be summed up this way: what isn’t going on? You name it and it’s probably happening right now if you are talking about any negative factor affecting prescription drug supply in the United States. Everything from manufacturing quality control problems to recalls to base material shortages is negatively impacting the supply of hundreds of prescriptions. And that all adds up to one big reduction in the supply of many prescription medications.

And if that wasn’t bad enough, manufacturers are simply making the decision to stop producing some drugs altogether. That one factor alone can be a real problem for medications like injectable drugs that may only be produced by a limited number of manufacturers. Couple that with new waves of shortages being caused by patients being switched to prescriptions from other drugs that are already in short supply and you have a recipe for disaster. There are even reports of wholesaler price gouging in response to short stocked medications. It truly is a real mess right now.

Perhaps that is what prompted President Obama into action early last week. This Executive Order was issued by President Obama in response to the drug shortages problem in the United States. It specifically challenges the FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.” The order addresses staffing increases for the FDA’s Drug Shortages Program, specifies that the government will work with manufacturers to increase medication supplies, and also works to fight drug price gouging among other provisions.

I think President Obama’s action to issue this Executive Order is a good start for the administration and it at least demonstrates that the White House acknowledges the problem exists. It can be especially frustrating when the medications involved are potentially life-saving or other critical drugs like those used for cancer treatment. Patients may not have the time to wait for supply issues to be resolved. They often need medications immediately for the best possible outcomes.

And like many other retail pharmacists, I’ve also seen the fallout of this growing problem. Supplier orders go unfilled. Release dates are pushed back further and further. And patients are left with only a speech about asking their providers for alternatives instead of a filled prescription. It is frustrating for everyone involved.

For me personally, I can’t help but wonder about the manufacturing standards and policies that are in place at all of these plants producing prescription medications. With so many shortages coupled with so many drug recalls, one can’t help but wonder how high the standards are at these facilities. Do we really know what we are getting when these stock bottles or injectable drugs arrive at our pharmacies? Are the drugs we dispense to patients really as safe as we’d like to assume for our peace of mind?

I think overall the FDA does as good of a job regulating and overseeing the manufacturing process for prescription medications and quality control as they could, given their resources and the sheer size of the job in question. But with so many drug companies and generic drug manufacturers in existence today, is it a simple matter of volume of work versus staffing, or should we re-evaluate our whole safety standards and oversight in this country? I don’t have that answer for you, but all of these drug shortages do make me wonder what is going on and what needs to be done to correct the problem.

Modern medicine can do amazing things for patients. But that magic only happens if the right drugs get into the hands of the patients who need them. We’ve got to find a better way to ensure that drug shortages don’t happen as well as have an emergency response plan in place when the inevitable shortages do occur. But is there really anything we can do at this point to improve things? And if so, why aren’t we already doing it? What do you think?