Implications of Potential Heparin Shortage - Episode 2

Navigating Through Drug Shortages in the Pharmacy

December 6, 2019

Manesh R. Patel, MD: In the pharmacy, what are the things that would be a typical process to manage inventory levels to see a shortage coming—if you’re in a pharmacy and you saw a common therapeutic that might be at risk, I guess?

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: The pharmacy buyer is of utmost importance. There’s basically a team approach that’s used in the hospital pharmacies to manage the shortage. They are in communication with the wholesalers, so the wholesalers will let them know if their orders can’t be fulfilled. But oftentimes, you can put an order in, and you don’t find that out until the products were intended to be shipped but they don’t arrive. That kind of puts you behind the gun. I wouldn’t say it’s not necessarily hoarding, but they usually determine an inventory level. Most institutions can say, “I have a month of this on hand,” or “I have 3 months of this on hand.” They keep track of how many units are used over time. That way they can estimate how much is available to them from the wholesaler and how much they’re using.

Manesh R. Patel, MD: That was a little like the outpatient way of thinking about it. Does differ in the inpatient side in the hospital if there’s a shortage? Or do hospitals do some of the same things you’ve described?

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: The hospitals do some of the same things, and oftentimes there [are] weekly meetings [in which] you would review all the medications on shortage. The 1 that was most recent or urgent happened with the opioid medication shortage. For instance, there was a shortage of IV [intravenous] morphine and IV fentanyl, which is obviously a very acute need because you have patients undergoing surgery, as an example, who need anesthesia or pain management in an ICU [intensive care unit] setting. That happened a couple of years ago. That really led to this more team-based approach in hospitalized patients.

Manesh R. Patel, MD: This might have been going on in the past. I guess my perspective—and maybe it’s just my experience here, you know we’ve been taking care of patients for a while and having therapeutics—but it seems like these shortages are happening more frequently. Is that true, or is that just a perception that the physicians or maybe we have these days?

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: No. I think it is true. Some of the same medications we use commonly are now generic medications, as an example, where the shortage may happen. Also, I think the FDA is much more vigilant inspecting manufacturing outside the United States, where much of the manufacturing has gone overseas or in countries like China, as you mentioned before. With manufacturing occurring overseas and a heightened awareness of good manufacturing practices, there was counterfeit heparin in the past. That kind of raised the need [for] more vigilance outside the United States. There probably [are more shortages] related to that, both on the increased use of generic medication and [the practices] outside [the] US.

Manesh R. Patel, MD: As you said, it’s kind of like a world-is-flat problem, right? We’ve started doing manufacturing all over the world, but with that comes new regulations and concerns about how some of these places—where we’re getting manufacturing at a low cost—might put us at risk.

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: Exactly.

Transcript edited for clarity.