Fighting the Norms of Emergency Drug Shortages

Drug shortages aren’t a frequent hurdle in emergency departments; they’re an inevitability.

A survey from the American College of Emergency Physicians (ACEP) last year reported that 93% of 247 gauged emergency doctors did not believe their emergency departments (EDs) were fully prepared for capacity surge of patients in the event of a major disaster or casualty indecent.

Another 70% agreed with the statement that drug shortages had “increased a lot” in the past year, and about 90% reported they’ve been taken away from patient care to seek out alternative medications and care due to shortages.

The crux of ED drug shortage issue falls on critical but regulated therapies such as anesthesia, as well as generic therapy options. Though committees such as the US Food and Drug Administration’s (FDA) Agency Drug Shortages Task Force have been designed to deliver the administration’s standard of expedited review to drug classes at most risk for shortages, problems still exist.

New resolutions are necessary, and policy should be shaped by evidenced, collaborated discussion. In the first ever #DocTalk Tweet Chat, a trio of experts guided such discussion.

Topic 1: Where do drug shortages register on your list of concerns for your practice?

Jordan M. Warchol, MD, MPH, an emergency doctor and assistant professor at the University of Nebraska Medical Center College of Medicine, is set in a large healthcare center that hosts 7 transplant programs.

To her, drug shortages are often affecting the patients who present with more complex conditions—the varying interactions her patients could have when interacting with any of the alternative drugs drives concerns in an already high-stress setting.

Howard Mell, MD, a reservist emergency physician with Vituity, considered the burden of shortages on frontline EMS providers, a team with even fewer alternative drug options than the facility’s team of providers.

It’s also scary in EMS. Most EMS formularies are regulated by state or regional control systems that are slow to respond to shortages. It isn’t as easy for a paramedic to decide to give Nubian (a drug they don’t carry) instead of morphine (when short) as it is for a doc. #DocTalk

— Dr. Howie Mell (@DrHowieMell) July 17, 2019

This is where the benefit of an on-site pharmacy staff comes into play—though, even their best efforts to relieve ED care providers can’t guarantee time reserved for the patient if a shortage is occurring.

Topic 2: How well do you understand the drivers of increased drug shortages in the last decade?

Mell maintains the issue persists due to pharmacy benefit management (PBM) and group purchasing organizations (GPOs) benefitting from “safe harbor” regulations, which in turn helps monopolize drug manufacturing and limits the quantity and variety of therapies—most notably, less-profitable therapies such as intravenous (IV) drugs common in hospitals and emergency settings.

Warchol simplified the problem to a straightforward equation: a drug won’t get made unless a manufacturing believes they can profit from it. As such, she praised the efforts of non-profit generic manufacturers such as Civica Rx that enable better access to hospitals.

When prompted for opinion on the potential of smaller, or alternative-profit manufacturers in the US, Mell expressed hope. The bigger problem still must be addressed, though.

If we remove the safe harbor from regulatory action, probably. #DocTalk

— Dr. Howie Mell (@DrHowieMell) July 17, 2019

Topic 3: Have you ever had to work around a drug shortage? What drug was it? How did it affect the care of patients?

Angela Gardner, MD, former ACEP president, has a running list of constant drug shortages: epinephrine, lidocaine, diltiazem, and fluorescein. Some have alternatives; epinephrine does not—especially in the case of cardiac arrest in the ED.

Mell has found himself creating epinephrine concentration syringes in the ED, a prospect he couldn’t imagine being managed safely in the EMS setting. Warchol, meanwhile, cannot remember the last shift in which she was required to work around a shortage. As such, the algorithms of care which have been ingrained in her since medical school have been adjusted to compensate for constant shortages.

Scariest drug shortage story ever - Pt w/K of 7.6. No Calcium gluconate due to shortage. Asked pharmacist (by phone)to send alternative. Runner comes running to room with a bag of Tums. #Truestory #DocTalk

— Angela Gardner (@ACEPheadliner) July 17, 2019

As Gardner pointed out, everyone has a workaround story. Any improvisation can lead to medical errors.

Topic 4: How equipped is your field of care to work around any potential shortages? What concerns do you still have?

Experts shared praise for the role of emergency pharmacists in shortage response. Mell called their involvement in seeking alternative therapies a painless, quick process. Warchol echoed ED pharmacists serve as equal-parts life savers for both physicians and patients affected by shortages.

That said, Mell said their capability to navigate or manage a shortage depends on the affected drug. If a similar substitution is available, the problem is small. But substitutions degrees removed from standard practice grow in risk—while physicians’ capability to reduce such risks falls.

EM docs are known for being the MacGyvers of medicine... but that doesn't mean it's easy or that we can always do it. Any fix we have is temporary & has to be reevaluated for every patient. #DocTalk

— Jordan M. Warchol, MD, MPH (@ActuallyDrJ) July 17, 2019

Topic 5: What role do physicians play in pursuing improved legislation that would limit or reduce the rate of drug shortages in the US?

The options toward resolution are as vast as the issue itself. Gardner advocated for public awareness campaigns; she couldn’t help but imagine a national outcry coming from news that a necessary emergency drug was not readily available.

Mell maintains his stance the issue persists with PBM and GPOs being less regulated, but voiced agreement with Gardner’s suggestion that a detailed report from the FDA on the state of shortages is warranted. From there, perhaps a repeal of safe harbor policies could come to fruition.

Physicians play a MAJOR role in this & all other #healthpolicy issues. We are the impact experts for how changes will affect patients & physicians. #Physicianadvocacy is as essential to the practice of medicine as knowing about #chronicillness, & should be taught as such.

— Jordan M. Warchol, MD, MPH (@ActuallyDrJ) July 17, 2019

Warchol called on her colleagues to join their specialty societies, state societies, and the American Medical Association. It’s from those avenues by which physicians could potentially influence their legislation and bring legitimate change to their practices.