Remdesivir, the pharmacy budget buster

I saw the discussion below in one of the pharmacy forums. Fact check true on this one.

Gilead would have everyone believe that remdesivir is a magic bullet for COVID-19 infection. Not true. Helpful? Useful tool? Maybe.

Remdesivir, while potentially beneficial, has limitations. For one, it should only be used on hospitalized patients that have falling oxygen saturation and chest infiltrates. Second, while it has been shown to potentially shorten the course of the disease, it has not been shown to reduce mortality.(1)

On the flipside, the drug is relatively expensive, has been overused, and contrary to data showing that it may shorten the course of the disease, may inadvertently lengthen hospital stays.

Based on the “Solidarity” trial, a WHO guideline committee went as far as to recommend against the use of remdesivir.(2)

“The Solidarity Trial published interim results on 15 October 2020. It found that all 4 treatments evaluated (remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients… So far, only corticosteroids have been proven effective against severe and critical COVID-19. [see RECOVERY trial (3)]… The researchers determined the evidence quality to be low for remdesivir in regard to improving time to clinical improvement, hospitalization duration and mechanical ventilation duration.”

However, you won’t find physicians touting this particular WHO recommendation. Why not? Simply put, it doesn’t fit the narrative put forward by Gilead and the media. Nor does the WHO recommendation give practitioners access to this new therapeutic toy. A combination of marketing and fear has led to remdesivir rapidly evolving into “best practice”. It is basically spreading through hospitals unchecked.

But Jerry, no hospital could have predicted the pandemic and therefor the cost of remdesivir. True. However, if remdesivir truly cut hospital stays by a couple of days and reduced time on mechanical ventilation, the cost of the drug would be a wash. I have not seen any large-scale data to support this notion. As of today, hospitals have spent millions upon millions of dollars on remdesivir. Not to mention that there are reports of providers prolonging patient stays to complete remdesivir treatment courses even when patients have met criteria for discharge. Such practice spits in the face of common sense.

But Jerry, even if it saves one life it will have been worth it. Ah yes, the battle cry of people who want something done, regardless of the consequences. Such sentiment seems reasonable on the surface, but quickly fades with analysis and thought. A philosophical debate for another time. Suffice it to say that real life doesn’t work that way.  

Overall, the unfettered use of remdesivir, combined with failure of healthcare to provide clear, concise, science-based use criteria, has created a budget pitfall that will take years to climb out of, if at all. It’s this type of fiscal irresponsibility that makes the U.S. healthcare system so special.

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  1. Healio.com. 2021. Remdesivir shortens time to improvement, but has no significant mortality effect. [online] Available at: <https://www.healio.com/news/primary-care/20210331/remdesivir-shortens-time-to-improvement-but-has-no-significant-mortality-effect> [Accessed 29 April 2021].
  2. Who.int. 2021. “Solidarity” clinical trial for COVID-19 treatments. [online] Available at: <https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments> [Accessed 30 April 2021].
  3. New England Journal of Medicine, 2021. Dexamethasone in Hospitalized Patients with Covid-19. 384(8), pp.693-704.

Pharmacy – Lessons from a pandemic

Quite some time ago I took to writing things down in a paper rather than digital notebook. This morning, as people will do when they are bored, I picked up one of those notebooks and began thumbing through the pages. Not too far in, I came across some notes dated Sunday, April 5, 2020 that form the foundation of this blog post.

As we enter year two of “two weeks to flatten the curve”, the notes I jotted down in April 2020 remain relevant. What I thought would be a short kneejerk overreaction, turned out to be quite long. Fortunately, at least in California, the predicted impact of COVID-19 never manifested. To date, our healthcare system has never been in danger of being overrun. In contrast, many facilities ran with patient loads less than average throughout most of 2020. The same remains true for the early months of 2021.

The “lessons” outlined below represent individual opinions, nothing more. They’re my thoughts from April 2020, with some updated experiences thrown in for good measure. Honestly, it is more about healthcare and people than it is “the virus”.

  • The pharmacy supply chain is broken. With hospital census numbers falling throughout most of 2020, the struggle to keep up with basic supplies became a real grind. Shortages are nothing new, but the problem was amplified during the pandemic. Personal Protective Equipment (PPE) became especially problematic, particularly for large facilities with cleanrooms. PPE was worth more than gold in the early months on the pandemic. Everyone scrambled to provide basic gear for IV room personnel. Reasons for the extreme shortage were many. A majority of PPE being made outside the country, fewer people available to work in production plants secondary to illness, and increased use were all factors. However, hoarding cannot be overlooked. Facilities were buying “as much as they could get” and stockpiling. It was a real problem.
  • Patient care became political. At no point in my career have I seen such a draconian dictation of what therapies could or could not be used. Historically, medication selection is based on physician’s professional judgement coupled with experience. That all changed in 2020. Legitimate, potentially beneficial treatments became political hotbeds. Physicians have always been the tip of the spear when caring for patients. They see things the rest of us don’t, which often gives them insight into treatment approaches. I’ve seen things throughout my career that I thought should never have been used but were. It often boiled down to “what they doctor wanted”. Not in 2020. Providers were denied therapies that were not “mainstream”. Normally, I’d get immense pleasure out of watching a physician turn into a 3-year-old that’s been told they can’t have a popsicle for dinner, but not this time.
  • 2020 exposed pretenders. I was shocked at the panic displayed by many healthcare providers. When things got tough, instead of rising up, they folded. The metal of which people are made becomes clear when the pressure is on. It’s often not pretty.
  • The approach for treating any disease evolves over time. Some things work, some don’t. Experience counts. COVID-19 has proven no different. Patients are doing better now because treatment has evolved. With that said, COVID-19 became the first disease in memory to have treatment dictated by reasons other than data. That’s a precedent no one should be celebrating.
  • Scientific literature died in 2020, and it will never be the same again. Instead of sharing information and ideas, it became political. In 2020, open discussion and thoughtful debate was traded for political correctness. Studies or opinions that dissented from mainstream political views were simply not tolerated. Articles were pulled. Commentary was written. Pop-up warnings were added to online journal articles that proposed alternate theories.
  • Healthcare systems were not prepared. The pandemic exposed many weaknesses in hospital practice. So much for “mass casualty preparedness” lauded by hospitals everywhere. See what I said above about the metal from which people are made. It became obvious in the early days of the pandemic that many in healthcare leadership have no metal at all. I saw much panic, flailing, paralysis, and poor decision making throughout 2020.
  • Healthcare forgot that other diseases existed. I simply stopped reading pharmacy forums and gave up on healthcare related websites. There was no reason to visit. Everything written was related to COVID-19. The same questions and commentary, day in and day out. It was monotonous and unnecessary. It’s a good thing all other illnesses and healthcare-related issues took a hiatus in 2020.
  • Media in general, but more specifically social media, replaced idea sharing, science, and data with politics. What a mess. I gave up on social media in 2020 – ironic that I’m sharing this online, right? There is no intellectual value left in social media, only hate-spewing, intolerant individuals.
  • Healthcare systems are technologically inept. No surprise here, I’ve been saying this for years. The arrival of COVID-19 exposed healthcare’s technology-last approach. Nowhere was this more evident than when “remote work” became a thing. Excluding telehealth, “remote work” for many healthcare systems was a joke. As someone that spent the better part of his career “working remotely”, I can tell you that it can be done, given the right equipment and infrastructure. Not in healthcare. “Here’s a laptop, you’ll be working remotely”. Good luck with that. Not everyone is cut out for remote work. Many lack the focus, attention, and discipline to make it work. 
  • Over regulation. Does anyone doubt that healthcare is a regulatory nightmare? I cannot speak about other states, but the California Board of Pharmacy and Department of Public Health (CDPH) proved themselves inept and tone-deaf during the pandemic. I could go into details, but it would probably cost me my job, so I’ll just leave it at that.
  • Waste. I will never again worry about “the environment”. Why bother? Given the millions of tons of unnecessarily wasted PPE that is surely piling up in landfills somewhere, I will never worry about what I toss in the trash. Day after day, I walked past trash receptacles full of used masks, booties, goggle, and gowns. Daily! The waste generated by any large facility in a week far exceeds my lifetime allotment of garbage. So please don’t pander to me about “saving the planet”.

Last year reminded me of all the reasons I left hospital pharmacy and spent a chuck of my career exploring other options. Healthcare is a mess and COVID-19 did nothing to improve it.

The impact of COVID-19 on Pharmacy Personal Protective Equipment (PPE)

COVID-19 has taught us many things, among them that our healthcare supply chain is poorly designed and flimsy. Just a few weeks into the pandemic and our supply chain for Personal Protective Equipment (PPE) has been completely disrupted. PPE is now in short supply, and I suspect that we will run out of PPE in just a few weeks if things continue on their current trajectory.

Are we using more PPE because of COVID-19? Of course! But we are unable to spin up production because a vast majority of the products we need are not made in the United States and the world is in lock down. An industry that is literally designed to provide care to others and save lives has no supply chain redundancy, no failover strategy for shortages, and no geographical diversity for equipment and supplies.

Any pharmacy that compounds sterile medications – intravenous antibiotics, for example – is required to wear a lot of PPE. Guidelines have lead to staff being required to wear a clean, low-lint gown, bouffant (head cover), mask, shoe covers, and sterile gloves when entering the buffer area of a pharmacy cleanroom; I also have to wear a beard cover, but most do not.

When leaving the area, a vast majority of the aforementioned PPE gets tossed, i.e. wasted. Up until about a week ago, much of the PPE worn by pharmacy personnel could not be reused. Now, because of the pandemic, regulatory agencies are lifting these restrictions. It’s an interesting shift in thinking.

In general – in theory? – the use of PPE during sterile compounding is designed to decrease risk of introducing bioburden into process. I suppose that makes sense. Unfortunately, the risk has never been quantified to any appreciable manner. There are no before and after statistics to determine whether or not strict adherence to PPE guidelines has done anything to improve sterile compounding safety, or lesson the risk of contamination. One thing is does, however, is generate a ton of waste and increase the cost of sterile compounding significantly .(1)

Current garbing practices are basically at the whim of groups like the United States Pharmacopeia (USP). The process by which USP creates these guidelines is not at all transparent. We have no idea what thought and/or research goes into their recommendations. Unfortunately, USP guidelines are frequently – almost universally – adopted in whole or part by other regulatory agencies like Boards of Pharmacy, Departments of Public Health, The Joint Commission (TJC), and so on. Few ever question the decisions because everyone is too busy trying to follow the rules and take care of patients to fight it.(2)

Over the past couple of weeks, organizations and regulatory agencies have been pulling back on the requirements for sterile compounding PPE, due in no small part to the disruption in the supply chain caused by COVID-19. It’s an evolving situation.

As we move through this crisis, I recommend the following:

  • Review your current PPE practices. Some folks are doing way more than is required. While noble on the surface, doing so is adding to the shortage and not necessarily benefiting anyone.  A prime example is pharmacies that use full PPE in anterooms.
  • Re-use PPE when allowed. See most recent USP recommendations here.
  • Do not place re-used PPE in plastic bags for safekeeping. I saw this recommendation somewhere and it makes no sense to me. People perspire in PPE, and zipping it up in a bag is akin to a makeshift incubator.
  • Sign up for USP, TJC, and local Board of Pharmacy email communications. Things are changing rapidly, at least they have been here in California. We’ve had to make several adjustments over the past 7-10 days, and I expect we’ll have to make even more in the coming weeks. It’s going to get weird.
  • Use common sense. Folks, pharmacists are highly trained, specialized professionals. Now is not the time to be averse to making judgement calls. It’s why we spent all those years in school and get paid the big bucks. Use your head. Be smart but be flexible.

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  1. It is not uncommon for large hospital pharmacies with busy cleanrooms to spend more than $10K per month on disposable PPE. Think about that the next time a hospital administrator complains about spending $3K on a “non-formulary” course of therapy
  2. Recently, a group successfully blocked the publication of new USP <797> guidelines. One of the reasons the group went after USP was due to lack of transparency in their process and failure to provide information when comments and requests were ignored.