Hospitals nationwide have struggled with their drug shortage strategy during the COVID-19 pandemic, from tests to personal protective equipment (PPE) to other supplies, such as ventilators. While hospitals are beginning to get these shortages under better control, they are confronting a growing challenge: The outbreak has placed a significant strain on the drug supply chain, leading to warranted fears about drug shortages and their effects on patients and providers.
There are many factors contributing to current shortages of drugs. These include reduced global production and distribution, increased use of medications to help treat COVID-19 patients, and people stocking up on drugs for various reasons. In late February, the U.S. Food & Drug Administration (FDA) announced the first shortage caused by COVID-19. In the weeks that followed, medical and industry experts have been increasingly sounding the alarm about drug shortages.
Drug Shortage Strategy: Key Steps to Take
Since these and other challenges are not likely to be resolved any time soon, health system pharmacists must strive to improve their ability to effectively manage their organizations’ drug shortages during this difficult period. Here are six steps to follow to help make this demanding task a little easier.
Step 1: Stay current with external and internal drug shortages
First and foremost, pharmacists must ensure they remain current with the latest drug shortages and discontinuations. There are several good websites that actively monitor the supply chain and provide updates on shortages. These include those from the FDA, American Society of Health-System Pharmacists (ASHP), GoodRx (which sources FDA and ASHP), and Drugs.com.
While staying current on external drug shortage data is critical, so is staying current with internal data. Pharmacists can leverage technology to enhance their management ability. For example, the OrbitalRX platform provides pharmacists with organized, easy-to-assess data about their health systems’ shortages and availability. This knowledge is critical to making educated decisions that can help systems mitigate the ongoing impacts of shortages.
Step 2: Monitor regulatory developments
As part of the effort to combat the chaos unleashed by the pandemic on the U.S. healthcare system, the federal government has undertaken regulatory initiatives. Some have been directed toward addressing the drug shortage.
For example, provisions included in the March “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) are directed at drug shortages, notes ASHP. These include the FDA prioritizing reviewing applications for generic drugs in shortage and enhanced reporting requirements for manufacturers with drug shortages.
As another example, as FiercePharma notes, the FDA announced in April that it would “… temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19.”
In the announcement, FDA stated, “… FDA generally tries to address potential and actual drug shortages by working through the global pharmaceutical supply chain, rather than relying on compounded drugs, and focuses on restoring supplies of FDA-approved drugs. However, in light of unprecedented disruptions to, and demands on, the global pharmaceutical supply chain as a result of the COVID-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to help ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19.”
Pharmacists should work to stay abreast of new regulatory developments and understand how these developments may affect their ability to secure drugs facing shortages.
Step 3: Follow production and accessibility developments
While regulatory developments such as those noted above can help improve the ability for pharmacists to acquire and compound the drugs they need, other significant contributors to drug shortages include disruptions to importing of critical medications and the ability for U.S. manufacturers and distributors/wholesalers to keep up with demand.
In late March, the Center for Infectious Disease Research and Policy (CIDRAP) announced preliminary findings from its Resilient Drug Supply Project — an effort to define and address vulnerabilities to the public health resulting from medical drug shortages. Among the findings: There are more than 150 critical drugs needed for acute care within a few hours to days or patient mortality rises and many of these drugs are made, formulated, packaged, or have an active pharmaceutical ingredient (API) made in China, India, Italy, or other countries severely affected by the pandemic. The pandemic has not only led to curtailed production and shipment of medications in these countries, but also led to countries restricting how much they export in the interest of maintaining enough drugs for their own population.
In April, the Drug Enforcement Administration (DEA) raised production quotas for many medications used to care for patients placed on ventilators. However, as the Advisory Board notes, “… it’s not clear whether companies will be able to adequately ramp up production of the medications to meet the increased demand.” DEA has also announced plans to increase importation of several of the drugs (e.g., ephedrine, pseudoephedrine, phenylpropanolamine).
The better that pharmacists and their departments can keep a finger on the pulse of the rapidly changing developments concerning production and accessibility, the better positioned they will be to execute an effective response plan.
Step 4: Step up communication and collaboration with wholesalers and distributors
Due to the rapid and significant developments impacting the drug supply chain, the availability of many vital medications seems to experience frequent, substantial changes. This is a time when communication with a pharmacy’s sources for medications is essential.
Pharmacists should keep open lines of communication with their primary wholesalers and secondary distributors and ensure these sources are well-informed about current inventory and the medications in highest demand in the hospital.
Furthermore, wholesalers and distributors should be encouraged to keep pharmacists informed about developments, such as those highlighted earlier, to ensure nothing of importance missed. Pharmacists should also explore how they can collaborate better with wholesalers and distributors within and outside of their health systems to help ensure medications are directed to the sites where vital drugs are needed most.
Step 5: Strengthen communication and collaboration with clinicians
Strong communication about shortages with affected clinicians — and other stakeholders, including administrators — is also crucial. The Institute for Safe Medication Practices (ISMP) produced a helpful document about managing a drug shortage crisis in 2010 that offers a great deal of information applicable to our current situation. It includes a section on how to establish ongoing communication with staff.
ISMP recommends regularly sharing information with clinicians about the following:
- Drug shortage, causes, and expected duration (if known)
- Assessment of current drug availability
- Temporary therapeutic guidelines, including use limitations for the shortage drug
- Alternative products and how they will be supplied to units
- Dosing, preparation, and administration guidelines for alternative products
- Error potential with alternative products and how to reduce risk
- Additional patient monitoring and safety steps that may be required when using an alternative drug.
ISMP advises pharmacists to prepare and update daily a report that includes this information on the most critical drug shortages and use this report to keep clinicians and other stakeholders informed. In addition, the organization recommends that pharmacy staff receive daily briefings concerning all aspects of drug shortages so they can serve as a resource to others in the organization.
Pharmacists should also communicate and work more closely with prescribers to coordinate the most effective use and conservation of drugs in short supply. Ways to do so include identifying clinically appropriate alternatives for shortage drugs and developing protocols to guide decisions concerning usage of such medications.
Step 6: Be diligent about diversion
Drug diversion remains a considerable challenge for pharmacists. Pharmacy Times recently reported on findings from Kit Check’s latest “Hospital Pharmacy Operations Report.” It showed that more than half of survey respondents reported having a diversion event within the last year. In addition, 37% were aware of at least one colleague who diverted controlled substances.
The COVID-19 pandemic opens up opportunities for diversion, including of drugs in short supply. Individuals looking to steal medications may try to take advantage of any disorder and reduced oversight in pharmacies and hospital departments. Drugs in high demand often command a high price on the black market, further enticing individuals thinking about diverting drugs to take risks. Some individuals may be interested in diverting shortage drugs for their own needs and the needs of family and friends.
In the rush to secure and distribute shortage drugs to departments and patients who need them, do not let your guard down as this can lead to the loss of vital medications and large penalties. If you’re concerned about diversion, considering implementing some of the recommendations from this HealthLeaders article.
Managing Drug Shortages: Stay Vigilant
Drug shortages were a fact of life before the COVID-19 pandemic. Now shortages are growing worse, putting increased strain on pharmacists and prescribers, particularly since some medications currently in high demand and short supply can be the difference between life and death for patients. Pharmacists must work with everyone involved in the drug supply and administration chain to best minimize interferences with patient care.
As emergency physician Dr. Jeremy Samuel Faust writes in his column titled “Medication Shortages Are the Next Crisis” and published in The Atlantic, “Doctors are only as good as our teams, our equipment, and our medicines. If we get the PPE we need, our teams will stay safe. If we receive much-needed equipment — tests, ventilators, IV pumps — in time, fewer of our patients will die needlessly. But if we can’t provide medications that make what we do effective, all our efforts will be for naught.”
About the Author:
Adam Orsborn PharmD, MS
Adam brings his experience as a successful health-system executive at a top academic medical center; a trusted design, development, and customer success advisor for pharmacy technology companies; and a pharmacy practice leader with extensive experience in specialty pharmacy, finance, operations, and organizational and leadership development to OrbitalRX. As the CEO, Adam is driving the vision and strategy of the company, while following market trends to ensure the product aligns with the needs of pharmacy teams.
COVID-19 is most evidently a potent respiratory virus at the heart of a global pandemic—neither of which are unheard of. What sets COVID-19 apart is that it is, at its heart, an unprecedented data crisis. By placing the emphasis on data as the source of truth, we obscure the political processes behind capturing, defining, and institutionalizing data, and downplay the power of the individual in judging and acting on data.
Is there truth in the COVID-19 data?
Data is at its core a contradiction, even when it creates valuable and significant knowledge. What we consider “data” is not an individual piece of knowledge, but the whole, an agglomeration of information presented as numerical insights. The contradiction here is that a single datum, or piece of data, is insignificant on its own, but gains more importance the more data there is. That one piece of information gains power by being understood in larger and larger contexts. So, data is both the annihilation of the individual, and its culmination in the group.
Despite the fact that data appears interchangeable with knowledge, “truth” in data is a moving target. Because the individual datum is inconsequential on its own, the “truth” of data resides in its interpretation and analysis. “Raw” data is indeed a valuable raw material that requires labor to form it into something meaningful. But because raw data is information (as opposed to some other raw material like cotton or ore), the work to form data into insights doesn’t “use up” the data, it can even endlessly multiply the data: for example interpreting a set of data against new variables, applying new formulas and algorithms, or defining the unit of data differently. There’s only so much cotton in a bushel…but data proliferates.
COVID-19 is a crisis in data because it brings the contradictions of truth in data to the forefront, and pushes the limits of data-driven decision making. Here I have two key examples: the tepid United States response to the pandemic and the admonition to “flatten the curve.” The first shows the inherent instability of “truth” in data, and the second shows the danger of believing the data is truth.
The United States response
Institutionally, COVID-19 shows how unstable a data-first analysis can be, because one’s point of view–measurements, chosen variables, applied formulas–define the data. As it spread across the world, we saw different countries’ health organizations struggle to analyze and communicate important information. And if key concepts differ between countries (for example, “confirmed cases”) we will get different pictures of the disease in each place. This also assumes that institutional standards and analyses are free of political influence, that everyone is simply “after the truth.” The fact remains that data analysis lends itself to politicization easily. How one researches, changes results. Those results might be overall similar for a layperson (thousands sick), but they will certainly affect public health priorities and policy decisions. This, combined with a capricious and insecure White House, led to a slow and often contradictory response from United States political leaders.
“Flatten the curve!”
Less formally, we hear “flatten the curve”: the slogan of every-day people to persuade others to act in light of the danger of COVID-19. The curve appears as the truth of the situation, be it calamitous or mild, but it requires the good faith (and good behavior) of the individual. Against the “curve” of millions, my individual actions bear statistical weight.To “flatten the curve” is a data-driven (based in fact, truth-bearing) moral argument about an individual’s social obligations to others. Such an argument conflates the factually-based with the inherently social, political, and moral realms of how to act toward others. This conflation contributes to a general moral panic and the social ostracization of those who are seen disobeying the new rules (not social distancing, visiting family, etc). It also serves to justify strong, centralized political institutions to enforce the moral law.
Thinking into the future of data
Ideally, data supports experienced and educated experts in making day-to-day judgment calls. In light of this, I consider OrbitalRX’s drug shortage management platform to be optimal: we find and organize important data around drug shortages and availability. But this data is not the answer: it serves to support hospital pharmacists in making their own practical decisions as the situation demands. We require this ethical fulcrum of human decision making in Healthcare, but it is the core of any meaningful data-decision.
For some, the lasting impact of COVID-19 will be tragedy. But for all, it will be a historical and political rupture, a sudden and unprecedented shift in governments and economies, that led to quick, extreme, and lasting social changes. I believe COVID-19 will come to define a crisis in our faith in data. The way beyond this crisis is not to search for greater truth in data, but to find the truth that data stands in for, and to attribute meaning to those who make it: the decision makers.
About the Author:
Juniper Alcorn PhD
Juniper received her PhD in Philosophy from The New School for Social Research in 2019, writing on new biotechnologies and their social impact. She works as a Software Developer at OrbitalRX.