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Drug Shortages: What Rheumatologists and Dermatologists Need to Know

Drug Shortages: What Rheumatologists and Dermatologists Need to Know

Fri, 05/22/2020 - 16:25

Matthew Grissinger, RPh, FISMP, FASCP, discusses concerns related to drug shortages associated with the COVID-19 pandemic that dermatologists and rheumatologists should be aware of and steps they can take to prepare themselves and their patients for possible interruptions.

Mr Grissinger is the director of Error Reporting Programs at the Institute for Safe Medication Practices ISMP.

Resources:

ISMP COVID-19
ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps
American Society of Health-System Pharmacists COVID-19
ASHP Shortages of Hydroxychloroquine ​​​​
ASHP Drug Shortage Bulletin 

Transcript

Melissa: Hello, I’m Melissa, editor of the Autoimmune Learning Network, or ALN. For our first‑ever podcast on ALN, we’ll be speaking with Matt Grissinger, director of the Error Reporting Program at the Institute for Safe Medication Practices about concerns related to drug shortages associated with the COVID‑19 pandemic. Thank you for joining us today.

At this time, which drugs appear to be at risk for interruptions in the supply chain?

Mr Matthew Grissinger: Right now, really, as everyone hears on the news, the big problem is going to be with hydroxychloroquine and its availability. Unfortunately, a lot of people came out with some studies that showed some effectiveness, but very limited people and it wasn’t really a big, extensive study of how well that works for COVID.

Unfortunately, because of the fact this got into the media, then everybody started ordering hydroxychloroquine for the COVID situation. The problem is, not only is it partially, it may work it, may not, but all the patients like rheumatologists, dermatologists, who need hydroxychloroquine for rheumatoid arthritis or other conditions, now are getting impacted by these change of events.

I’ll add on top of that, there’s already a lot of drug shortages out there in the world, especially for generic formulations of drugs. If you go to a website like the American Society of Health-System Pharmacists, ASHP, has a drug shortage website. They’re probably the leaders in finding out what drugs could be in shortage.

I went on there today before this call and saw there are nine manufacturers of hydroxychloroquine who are saying they’re short on that drug. I don’t know who has it available now in great quantities.

Melissa: Going off of that is there a risk as more data is released for this drug to become unavailable or hard to access for patients who really need it?

Mr Grissinger: What we’re trying to do, at least working with the hospital or acute care world, is we have to really make sure people limit that use of hydroxychloroquine. Again, it’s funny, any new drug that comes on the market takes years of studies to prove the drug works. Now all of a sudden for hydroxychloroquine, we’re happy with five to eight studies.

That being said, we’ve been, at least for acute care organizations, to really restrict or stop using hydroxychloroquine, thinking, because you have to think about it, the rheumatologists need that drug for their patients and now it’s being hoarded for other people.

I even added had…obviously you’ve heard on the news, there are doctors out there who have written prescriptions for their family members for hydroxychloroquine, for a questionable drug that may treat COVID. In the meantime, the people who legitimately need it are missing out because of this demand.

Melissa: Obviously at this time there’s still some in the market, but what should physicians be doing to prepare for a shortage?

Mr Grissinger: Really, sit with their patients, see what they have on supply. Hopefully, some of these patients may be getting a three‑month supply at a time from mail‑order pharmacy so they may be OK getting through this time period.

I’m worried about new people getting new prescriptions for that, and people who are only maybe getting a month’s supply, so maybe they were able to get some of it in March, but did they get some in April?

I would suggest for the rheumatologists and dermatologists to ask the patients up front about what they have on hand, their supply on hand, make sure you’re aware that they may have stopped taking the drug because they can’t get it. I would take the lead and bring the subject up with your patients and ask them, “hey, how are you doing on this? Were you able to get this drug?”

That’s one thing I think we see, generally speaking, with a lot of physicians and patients, is patients aren’t good at telling you when they stop taking meds. Doctors often don’t ask the question, so ask the question, make sure they’re getting that drug up front. Hopefully, you have some relationships with local pharmacies. Assess their level of inventory, how they’re able to get any if possible, and that might be a tricky thing.

I don’t know which pharmacies may or may not have it, because I’m not really familiar with the whole drug distribution staging of where we are with the manufacturer producing it and getting shipped out to the pharmacies. Definitely, always look with your local pharmacist to see now only how we’re doing on inventory, but also listen, if we run out of this, do you guys have any other suggestions?

Although, I would probably lean on rheumatologists and dermatologists with their experience, I would say: Listen, right now what’s your back‑up plan? You write a prescription today for hydroxychloroquine, it’s not available, so what’s the back‑up plan?

Unfortunately, this seems like a short moment in time we have to worry about this shortage of hydroxychloroquine, but I can tell you in other areas of healthcare, the number of a drugs in shortages, is unbelievable, that ASHP site I referred to earlier, there were over 200 drugs on that list that were in shortage. Hydroxychloroquine is one of them.

That just gives you an idea how big it is. That applies to really any drug therapy you guys may be prescribing, be prepared for a back‑up plan just in case.

Melissa: For our patients who have a supply or have a short supply about are concerned about accessibility or cost, is there a way dermatologists/rheumatologists can partner with the pharmacy to figure out a way to help patients get access to medications?

Mr Grissinger: Yeah, as soon as possible start making phone calls. It depends, obviously, where you work, if you’re in New York City versus a rural area, start contacting local pharmacies in the area to assess inventory. Listen, it’s going to depend not just on your patients, but all the other practices too looking for drug inventory.

Not only work with your local pharmacies, pharmacy chains, and independent pharmacies, but also consider approaching the acute care facilities as well in your area, see what they have. I would even suggest for some of the physicians listening in, maybe you can call some of these generic companies directly to get a direct link. That may help as well.

Again, it may seem like you’re butting in front of the line to get the drug, but unfortunately in today’s day and age, you have to be either aggressive in trying to find a drug, or wait for things to happen and hope it comes to you. I just can’t suggest that route.

Melissa: For biosimilars, is there any possible concern regarding these medications in terms of accessibility issues or possibly shortages down the line?

Mr Grissinger: I think overall, the biosimilars, I’m not as concerned about shortages as other drugs, primarily because often many of them are branded drugs, and of course they’re not going to run out of making branded drugs. Really, the bigger issue has been generic drugs, generic injectables and generic oral formulations.

Those are the ones that are cheaper, and therefore the profit margin is not as good, and there’s a little bit of other issues for drug shortages for those products, but I’m far more concerned about generic hydroxychloroquine than I would be about biosimilars, just because unfortunately listen, you guys know the money is there.

They charge a lot of money for that, it ends up being sole‑source manufacturers at times too, so they have not been having issues compared to these cheaper things that sometimes people are reluctant to make.

Now, there’s shortages of things from diphenhydramine injection to treat allergic reactions, epinephrine, a lot of other critical meds that are in shortage injectable‑wise, that I’m a lot more concerned with than I am with the biosimilars.

Melissa: What other drug shortages are you concerned about?

Mr Grissinger: The big issue with shortages because of the COVID crisis, are all the medications you need for two things, putting someone on a ventilator. If someone’s on a ventilator, they have to be unconscious, they can’t be awake.

They need neuromuscular blockers, anxiolytics, and so on, and also drugs to revive people like epinephrine, but also anesthesia meds, propofol, any sedating med, anything to put someone asleep for a ventilator, all that demand went through the roof for those drugs.

People are also running out of IV opioids, to the point where they’re out of IV morphine and hydromorphone, and they’re struggling to get something to have pain meds for these people, too.

That’s been a big increase for the COVID is, also if you hear in the news, all the needs for the ventilators, and people are having to get intubated to be on ventilators, and all the drugs associated with that, and I think to reverse patients who are having a cardiac arrest.

That’s been one of the symptoms is cardiac arrest from this COVID pandemic, so all those drugs I think I’m really concerned. They were already in shortage coming into the pandemic, so you can imagine how bad it is now for hospitals trying to find these drugs.

Melissa: Are there any particular concerns for medications administered as an infusion?

Mr Grissinger: I would say I’d be concerned about more issues of contamination. I think when these offices like dermatologists and rheumatologists are preparing infusions, they should treat every single one like there’s COVID in the office. Believe it or not, I think this probably, hopefully wakes people up to realize that now’s not the time to start making IVs safer, or cleaner, or worry about contamination.

Contamination’s a problem 100% of the time, we just know about COVID now, but anything on your hands…I think anytime, hope this really gets people to, especially outpatient practices who may be making infusions, are you guys doing it safe now, before COVID? How do you know that?

ISMP has guidelines on making sterile preparations on our website, I would suggest looking at that to make sure you assess the processes associated with making infusions. I think the concern I’d have now if anything, is the protection that you would wear in making infusions. You should be having a face mask on now and gloved up. How is the availability of supplies impacting preparation?

But otherwise, it should be, right now it should be the same it should have been a year ago when making infusions. If anything, I hope this wakes people up to realize that we need to be better and safer preparing sterile infusions in an office setting.

Melissa: Dermatologists, in particular, work a lot with compounding pharmacies, would you mind touching on that a little bit and how compounding pharmacies might be a helpful alternative?

Mr Grissinger: I think the use of a compounding pharmacy, depending on the product being used, obviously, because some drugs in a rheumatologist’s office have to be made on the spot for infusion. For other medications, from a safety perspective, it’s always safer to have people who specialize in certain areas of medicine to let them do that specialty.

Compounding pharmacies, there job is to make sterile, compounded products for all physician offices and ambulatory surgery facilities. I would always suggest going that route, but just because the pharmacy says they’re a compounding pharmacy doesn’t make them good or safe at it either.

Make sure that if you’re going to use a compounding pharmacy, especially for infusions, have them prove to you that they’re safe. Don’t just accept the fact that the name on the wall says compounding pharmacy. What testing they do of their products to prove sterility and stability that have to be done as a part of practice? Ask for those. Don’t assume that their compounding is safe.

I would just say definitely use them, but also like anything, do your due diligence to make sure that they’re also making a safe product.

Melissa: Do you have any other advice for dermatologists, rheumatologists to build that relationship with their pharmacists?

Mr Grissinger: I would suggest go visit the pharmacy. Actually, be nice, probably a change of pace for the day [laughs], get out of the office for the day, but hey, ask for a tour of the pharmacy. See how they make things, see the process flow how they make things. Are they making things one infusion at a time?

Really, get a personal relationship, see the person, see what they look like, see the pharmacy. I think as part of any relationship in a business dealing, it’s great to see the people and have that personal touch. At the same time, investigate and see what it looks like so you appreciate they’re doing it safely as they should be.

Melissa: Thank you so much Mr Grissinger. And, thank you for listening. If you have any additional questions or concerns about drug shortages that was not addressed in this podcast, please leave your comments in the feedback box below. We really appreciate anything you send us.

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