Drug Shortages

How one Start-up wants to do better.

Drug shortages. Everyone hates them, whether the patient that may suffer from lack of care, the prescriber that has to alter their plan, and the pharmacist that needs to rethink their inventory management. Drug shortages have been blamed for many issues, and even my early learning when in pharmacy school included a run-in with a lack of parentally administered loop diuretics back in 2010. I remember at the time institutions having to redo order sets and set up new protocols to substitute medications traditionally ordered on the floor. Lasix/Furosemide order? We don't have it, so you're getting XXXmg of Demedex/Torsemide, and when that runs out, we'll figure out the dose for Bumex/Bumetanide.

At the time, I remember looking into the different causes of drug shortages and found it quite surprising at the time of the multiple reasons for shortages. Naively, I honestly thought drugs were made, and patients got them. However, healthcare is a business and many of the common medications used in a hospital where cheap for all intents and purposes. Cheap to make, cheap to sell, and not really a great profitable area for manufacturers. So, only a few companies make those products, and if they have any issues with supply or manufacturing problems, or a lot of recall occurs, well, then you see shortages start to happen. Most of the time the manufacturer doesn't even list a reason. Now, this isn't the reason for all shortages, and if you are interested, I'd recommend looking into the American Society of Health-System Pharmacists (ASHP) website that helps monitor and detail shortages occurring across the US, and the FDA also has an app if interested (iOS | Android).

So, considering that, I was intrigued to learn about a new initiative called Civica Rx announced on September 6, 2018, aiming to "help patients by addressing shortages and high prices of lifesaving medications." Announced back in January, Civica Rx has already been contacted by a third of health organizations in the US. It's governing members are Catholic Health Initiatives, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health, who represent over 500 hospitals alone. The US VA system is also onboard it seems, and all this together really starts to make this a big deal. There is much buy-in at this time, and I am curious how it will roll out.

Now, Civica Rx has detailed it will concentrate on 14 medications at this time, but have not specified them for competitive reasons. I am intrigued by this, and can only guess what they may focus on for hospital products, but I looking at currently ongoing issues in the past five years I am sure competitors can make educated guesses.

Nonetheless, reading through Civica Rx Operations FAQs leads to several interesting items worth noting:

They aren't going to be making all of their drugs - They plan on making their own manufacturing site, but will also partner up with other manufacturers to create products. One thing that stands out is it seems to be a mission of theirs to have multiple sites to stop any issues affecting the drug supply chain (which I applaud). For drugs that they can't find a partner, they'll create, and it seems they will also file for ANDAs to have better control of what they make and sell (based on feedback from hospital partners).
Will be based in Utah/United States - As a start-up, they are looking to leverage the market in Utah, which seems to also be based on an upcoming shift to add and inland port (which will make supplies and distribution easier). There are already generic manufacturers in Utah such as Teva (which may be a partnership in the future). As to why the US, it seems Civica Rx is leaning on the VA collaboration which requires many of the drugs to be nationally sourced and produced.
R&D is a bit vague at this time - It's hard to tell, but they may also gear themselves to creating drugs as well, though in which therapeutic categories I am unsure. But the fact that they are really aiming to work closely with hospitals for developement purposes I think is telling.

Overall, Civica Rx has a fresh mission statement and thought process. We have recognized for years the drug supply chain is vulnerable to multiple issues, but with rising drug prices and oversea manufacturing issues, US hospitals have been clamoring for a better solution. So, instead of relying on Federal changes (which come slowly) I can understand the idea of creating a start-up to fix it themselves. Now, the hospital partnerships will be the intriguing part. Obvious issues will be regional needs (rural vs urban populations), but sticking with the core drugs will likely be the start of whatever they manufacture. Their partnerships will also be exciting, but based on their FAQs it seems to be alluding to a Teva partnership at some point. I can only hope that the people they bring on will have the same purpose to help our patients, and improve drug price transparency and target drugs that are needed in the end.

Civica Rx - Can a generic manufacturer partnership with hospitals decrease drug shortages?