When you have access to copious amounts of data in an area people naturally ask you questions about it. I recently was introduced to an Emergency Room doctor who, upon finding out what kind of work I do, asked, “Can you see what happened to Droperidol? It was my favorite go to medication for many situations; a few years ago, it just disappeared.” I had my laptop with me and access to VisionaryRX through the portal so I just logged in and looked. It took a few seconds and I saw this…
It surely displayed that in 2014 the two manufacturers of Dropoeridol dropped it. The American Society of Hospital Pharmacists monitors drug shortages and reports on their site.
There have been “manufacturing delays” and “raw material shortage” on this critical ER and Post Operation drug for half a decade now. We at Blue Diesel thought we’d dig in a little deeper and see what we could find.
When writing about the overall problem of drug shortages, Thomas Nickels, Executive VP of Government Relations and Public Policy at the American Hospital Association warns, “AHA is concerned that patients could face harm if these shortages are not resolved quickly.”
Why do drug shortages happen? Well, one obvious cause is natural disasters. The hurricanes that battered our coast and Puerto Rico in 2017 depleted our drug reserves. However, that is not our case with Droperidol. Another reason for shortages is that drug companies simply quit making the product. Pharmaceutical manufactures, especially generic manufacturers, hone in on more profitable generic drugs and discontinue others that don’t make much money. Droperidol has been a panacea in hospital emergency departments and operating rooms for over 40 years, but for some reason it is on the list of drug shortages and has been for a long time.
It doesn’t stop there. Let’s continue the investigation using VisionaryRX and see what could be replacing Droperidol and perhaps a little more information about how this happened.
In 2001 the FDA issued a black box warning on Droperidol, citing a risk of cardiac arrhythmias. This slowed down the use of Droperidol in hospitals nationwide however, not long after, the FDA’s report came under significant scrutiny. Despite the black box warning, Droperidol still was an important medication in ER and OP. This was mainly because of the backlash by anesthesiologists and emergency physicians believing the black box warning unwarranted.
What are the other medications that have taken Droperidol’s place? My research and my ER doctor friend said that overwhelmingly Haloperidol and Olanzapine have replaced Droperidol. We wanted to look at this from another perspective. In VisionaryRX we have the capability to sort drugs by a pharmacologic class. Droperidol is a dopamine antagonist; a drug that prevents actions stimulated by dopamine. This class of drug has a wide array of uses and among them:
There is also a class of drugs called serotonin antagonists that some studies have stated has very similar effects to dopamine antagonists. So we know from this that the pharmacologic classes of antipsychotics and serotonin antagonists will be of interest to us.
With this information I can now call up our two Droperidol manufactures from above and see what they could possibly have replaced (or intended to replace) Droperidol with.
We first sorted by the firm Hospira and selected these pharmacologic classes.
The results are below. You can see the noticeable uptick in Medicaid reimbursements for Metoclopramide and Ondansetron in 2013. That barely-noticeable green line at the bottom? That’s Droperidol. The year after Droperidol drops off the scale, Medicaid reports reimbursements to Hospira for drugs of a similar pharmacologic class of >42M.
We did the same thing for the firm American Regent using these pharmacologic classes.
The results are below. They are surprising; it seems Droperidol was more profitable than Olanzapine for American Regent.
Why then drop Droperidol just to make less on Olanzapine? Or perhaps there is no correlation at all here. This puzzled me so I looked at Olanzapine itself and I noticed something I’d seen many times before.
This is a very distinctive chart for Medicaid Reimbursements of Olanzapine. We’ve seen this layout many times and it indicates that a drug has come off patent and/or exclusivity. Eli Lilly was making billions annually off Olanzapine (Zyprexa). All those little ribbons in the chart to the right are generic manufacturers coming in by the masses to get a share of that huge market. When there are that many at the gate, they drive the price down rapidly. Olanzapine was an attractive market, but when 16 generics come in all at once it waters down the market substantially. Oddly enough, this is one of the main functions of VisionaryRX. It provides a view into this potential event and helps companies avoid making this precise mistake.
We also wanted to look at Haloperidol, which is an antipsychotic that is widely used as a replacement to Droperidol.
We can see quickly that there are 8 manufacturers and that Medicaid reimbursements show a distinct uptick in 2014. When we look at just the numbers, it appears that Droperidol did not have significant Medicaid reimbursements and its potential replacements did. However, Droperidol has been around for a long time and surely these newer more expensive medications are safer and more effective. We cannot attest to a medications efficacy. If you are a doctor with experience using Droperidol please comment on this for us. However, there are ways to see if a drug is safer than another.
Remember that black box warning by the FDA in 2001? Let’s make sure that there isn’t a hidden dark side to Droperidol. Perhaps it is a dangerous drug, which would be seen in the Federal Adverse Event Reporting System.
We took a selection date range from 2001 to 2017 for the drug Droperidol from the FDA’s dashboard.
This chart illustrates the reported reaction groups. Despite the FDA issuing a black box warning for cardiac arrhythmia, it is the third (not the first) most common reported adverse event.
Summary of the number of events by year.
To be as open as possible, perhaps it was pre-2001 when there were a lot of adverse events for Droperidol. We took at the same 17-year period from 1983 to 2000. The results were more favorable.
Here are the same results but for Haloperidol.
Here are the results for Olanzapine.
Total percent change in Federally Reported Adverse Events between Droperidol and Haloperidol and Droperidol and Olanzapine not accounting for the number of prescriptions in Medicaid.
|Substance||Total Cases||% Change||Serious Cases||% Change||Deaths||% Change|
To be fairer here, we would have to know the number of prescriptions reported by Medicaid for the period from 2001 to 2017, which unfortunately we do not have. We can however, extrapolate for a given year…let’s just take 2012.
|Percentage Increase for 2012||% Increase Total||% Increase Serious||% Increase Death|
The replacements for Droperidol appear both more expensive and less safe. The data speaks to this. However, perhaps there is more to the story? If you are a doctor with experience using Droperidol we’d love for you to comment. We’d love to know if this affection is universal for Droperidol. Clearly the ER doctors I’ve spoken with overwhelmingly want it back. However, my sample size is 3; hardly statistically significant. If you have noticed any glaring problems with our work here please leave a comment.