Patient Care in an Era of Drug Shortages
Published on: June 17, 2024
One of the latest issues affecting our daily care of patients in the Neuro ICU is an ever-growing list of critical medications and intravenous solutions on shortage. Tragically, patients are being subjected to ongoing critical shortages of almost every class of medications used in our daily practice. This may lead to a major decline in how we are able to handle both routine and emergency care of our patients both in the outpatient and hospital settings. Drug shortages not only affect individual patients but also impact the entire health system, both in costs and flow of care.
Many classes of medications have been affected—from drugs used to treat seizures, hypertension, cardiac arrythmias, sedatives and cancer medications—and virtually no drug class has been spared. The latest shortages of drugs used to treat heart arrhythmias (adenosine, amiodarone) and bradycardia (atropine) are of major concern to emergency departments and ICUs, as are the shortages of important common sedatives such as lorazepam, which are especially critical for patients with seizures, withdrawal, agitation, and intractable nausea.
Of further relevance for neurocritical care, the FDA shortage database and the University of Utah drug information website (1, 2) reported a national shortage of many antiseizure medications often used in the management of status epilepticus, including rectal diazepam, oral clonazepam, and intravenous preparations of lorazepam, midazolam, and valproic acid. Between 2019 and 2020, there were 97 reported shortages among sponsor-reported antiseizure medications, of which 93% were common generic brands (3). This affects the entire neurocritical care team, as antiseizure medications are a mainstay of our daily practice. Our skilled pharmacists are now working overtime to find supplies, replace medications, and educate us about contingency plans and next steps. It now feels like a daily event for pharmacists to inform us of shortages and whether there are alternatives available for that day or week. The landscape of what is in short supply on any given day is ever-changing (4).
There are a multitude of factors contributing to the ongoing medication shortages, the most important of which is the loss of our nation’s ability to manufacture medications domestically. By moving production facilities abroad, we have been witness to increasing issues with existing supply chains. Offshore manufacturing has also led to other important issues such as quality, sterility, and potency of these medications. There have even been disturbing reports of counterfeit medications entering both the hospital and retail markets in both the lay press and in peer-reviewed papers, including a report in our journal (5).
As frontline neurocritical care providers, how do we address these issues of drug shortages and inconsistent quality? To begin with, we must join forces with our patients and the general public along with political leadership to pressure the pharmaceutical industry to address this crisis. One of the simplest ways to address this issue would be a simple commonsense solution: bring drug manufacturing and supply chains back to North America. This would ensure that our supply chain is simplified and truncated, enhancing our ability to safeguard medications and security via our robust regulatory framework. In this way, medications would be under the watchful eye of federal and state agencies in order to guarantee purity and safety. National databases would also allow increased adaptability in addressing local and regional shortages with real time data that can facilitate more rapid responses in the manufacturing sector. Our modern health system cannot reach its full potential without the drugs we need to care for our patients, and we all need to advocate that this crisis be addressed.
References
1. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages access May 21, 2023
2. https://pharmacyservices.utah.edu/rx-web-links/drug-information access May 23,2024
3. Javarayee P, Maylor J, Shahrukh s, Pollack S, et al. US Generic Antiseizure Medication Supply Chain: Observations from Analysis of Government Databases. European Journal of Epilepsy. 2024;117: 83-89.
4. Asadi-Pooya AA, Patel AA, Trinka E, et al. Recommendations for Treatment Strategies in People with Epilepsy During Times of Shortage of Antiseizure Medication. Epilepic Disord. 2022; 24(5): 761-764.
5. Yakhkind A, Lang AE, Brophy G, et al. Substandard and Falsified Medications: A Barrier to Global Health Equity Exemplified in Ecuador. 2023; 38(1): 1-6