Pharmacist Strategies for Mitigating Patient Harm, Inequities During Drug Shortages

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Researchers addressed pharmacists’ role in mitigating drug shortages.

As drug shortages reach a 10-year high, pharmacists can play a key role in managing shortages and mitigating the risks to patients, according to 2 articles published in the AMA Journal of Ethics.1,2

Since 2007, drug shortages have increased rapidly, most recently during the COVID-19 pandemic, when vaccines had to be rationed to reach populations at the highest risk.1

Key Takeaways

  • Addressing pharmacists' role in managing drug shortages in the US, researchers presented several strategies used to curb the growing issue of prescription drug scarcity.
  • Researchers highlight the issue of drug shortages and both the detriment it brings to patients and the challenges it brings to pharmacists.
  • The two main types of strategies—clinical and operational—look at multiple areas of the pharmacy practice and allow pharmacists to tackle the issue head on.

“[As of April 2024], the [FDA] listed 136 medications in shortage, ranging from inhaled albuterol solution to injectable vecuronium. Even before the pandemic, it was not uncommon to see over 100 drugs in shortage at any given time, but in recent years, the state of drug shortages has become even more severe,” wrote Erin R. Fox, PharmD, MHA, and Matthew K. Wynia, MD, MPH, in the first article.

With the ability to manage drug inventories, identify populations at the greatest risk, modify administration routes, and consider therapeutic alternatives, pharmacists serve as the first line of defense during a drug shortage.2

“When the pharmacy team learns about a drug shortage, it immediately plans how to manage the shortage. By using data on current inventory levels and utilization trends, the team calculates how long the supply on hand will last and begins exploring alternatives while also investigating the cause of the shortage to project its severity and duration,” noted Michael Ganio, PharmD, MS, in the second article.2

Fox and Wynia highlighted results from a 2018 survey, conducted ahead of even greater shortages that have followed, which showed that 92.4% of pharmacists had less than a month to prepare for a shortage and 81.3% reporting that “hoarding” was a main strategy to mitigating a shortage at its inception.1

In a more recent 2023 survey, 32% of respondents said that shortages have gotten so drastic that they now required “rationing, delaying, or canceling treatments or procedures,” according to the authors.1

Near-empty pill bottle | image credit: Jennifer / stock.adobe.com

Near-empty pill bottle | image credit: Jennifer / stock.adobe.com

But the increasing shortages have not stopped pharmacists in providing the proper alternatives to mitigate patient harm. To avoid medication delays or canceling treatment, pharmacists can look to alternative treatment methods as possible drug shortage solutions.

When it comes to managing these shortages, there are 2 strategic categories, operational and clinical, that address the ability to mitigate scarcities.

VIDEO: Majority of Pharmacists Say They Are Being Impacted by Drug Shortages

Operational Strategies to Address Drug Shortages

“Operational changes include procuring drugs from alternative suppliers or from compounding outsourcing facilities, sourcing different vial sizes or concentrations, employing different means of drug preparation in the pharmacy, repackaging larger vials as unit-of-use doses, and updating electronic health records (EHRs), smart infusion pumps, and other health care technologies,” wrote Ganio.2

These strategies also include alternative methods of distributing medications and the use of resources to alert patients of a shortage.

Operational changes focus more on what happens behind the scenes at a pharmacy, rather than changing the clinical aspects of a patient’s prescription or treatment regimen. The key aspect of these operational changes includes seeking alternative medication solutions from outside sources.2

“Alternatives can include the same product from a different manufacturer or sourcing from a secondary wholesaler,” Ganio continued.2

Despite increased risks and expert knowledge necessary to mitigate adverse effects, alternative sources can be sought within gray markets, where purchasers can experience increased mark-ups and counterfeit products, and the use of compounding methods.

“Compounding can involve starting with FDA-approved commercial products or starting from nonsterile bulk drug substances, which requires special expertise and compounding conditions,” wrote Ganio.2 “Compounding is not a comprehensive solution to drug shortages, but it is a common strategy to address specific shortages.”

READ MORE: Finding Solutions to the Ongoing US Generic Drug Shortage

Clinical Strategies to Address Drug Shortages

“Clinical strategies include conversion to other dosage forms (e.g., from injection to oral tablet or capsule), conversion to other routes of administration (e.g., from small-volume parenteral infusion to intravenous push injection), therapeutic interchange with an alternative drug, or rationing,” Ganio wrote.2

When clinical changes are necessary during drug shortages, ethical challenges can arise. Because these changes affect the way patients are administered their prescriptions, several harmful risks become an increasing possibility. The ethical challenges lie in pharmacists’ decision to choose which patients’ prescriptions can be delayed or canceled, while focusing on administering the drug in scarcity to the patients who need it most.

“Underlying any ethical rationing strategy is the notion of justice or fairness, although rationing strategies implicitly or explicitly also typically speak to a variety of related values, such as respect for persons, nonmaleficence, community engagement, and equity,” wrote the authors.1

Researchers further explain that the reallocation of medications during a shortage must be “transparent and relevant” to the specific situation, especially in communities with inequitable access to patient care.1

“The drug shortage crisis should be considered a threat to our nation’s health care security, and solutions must be implemented to prevent further compromising patient care,” concluded Ganio.2

Drug scarcity is a crisis that should be handled with transparency and fairness to the community. And, noted Fox and Wynia, “fair allocation within a community cannot be achieved without a coordinated response across the health care systems serving the community.”1

The best way this can be achieved is through collaboration between pharmacies, health care practices, and thorough community engagement to ensure the greatest effort is set forth for mitigation.

References
1. Fox ER, Wynia MK. How should critical medications be rationed during shortages? AMA J Ethics. 2024;26(4):334-340. doi:10.1001/amajethics.2024.334
2. Ganio M. How should we draw on pharmacists’ expertise to manage drug shortages in hospitals? AMA J Ethics. 2024;26(4):327-333. doi:10.1001/amajethics.2024.327
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