Finding Solutions for Drug Shortages: Short and Long-Term Management

Magnitude of Current Shortages

According to Michael Ganio, PharmD, Senior Director of Pharmacy Practice and Quality for the American Society of Health-System Pharmacists (ASHP), by the end of 2022, there were nearly 300 drug shortages, the highest rate of scarcity in the past decade.

These drug shortages are pervasive and have impacted nearly every sector of healthcare. Most recently, the limited availability of over-the-counter cold and flu medications has alarmed parents attempting to manage the tripledemic, a rise in COVID, RSV, and influenza cases among pediatric populations.

In 2022, other medication shortages included Adderall, amoxicillin, and Tamiflu. The ASHP also notes that there have been significant shortages in cancer or chemotherapy medications, including fluorouracil and cisplatin. This crisis has also affected lidocaine, a local anesthetic often used during medical procedures.

Causes of Drug Shortages

To effectively manage drug shortages or shortages of any kind, it is critical to understand the root cause. Drug shortages can be attributed to multiple factors in the pharmaceutical space, including manufacturing errors and other supply chain issues.

Ganio notes that a recent shortage trend has also been associated with increased medication demand. “It's a little unusual to have shortages due to increased demand. Some of these are more transparent regarding the cause,” Ganio told PharmaNewsIntelligence. “We had this surge in RSV, flu, and COVID over the winter, and that led to an increase in demand for antibiotics like amoxicillin and the fever reducer medications that are over the counter, like acetaminophen and ibuprofen.”

Beyond the apparent increases in demand, fueled by the tripledemic, there are some less obvious increases for medications such as Adderall and others.

“It's probably worth noting that last spring into summer, there was a shortage of those medications due to manufacturing issues at one of the plants,” notes Ganio. “It was more of a workforce than a quality issue.”

According to an article in the New York Times, Teva Pharmaceuticals, a major manufacturer of Adderall, experienced manufacturing delays due to a labor shortage. While the medication was being produced, the company needed more workers to meet the demand.

“The majority of shortages are due to some sort of quality issue with manufacturing,” revealed Ganio. “Something happens with a production line, a batch fails and can't be released, or a recent FDA inspection with some significant findings. That's typically what we see. These current shortages that are due to increasing demand are unusual.”

Impact of a Shortage

Shortages affect conditions beyond ADHD and the common cold, including life-threatening illnesses like cancer. Many chemotherapy drugs are currently experiencing shortages related to quality issues. The limited availability of medications has strained patients, providers, and the healthcare industry.

Acute Illness Medications

As previously mentioned, the tripledemic led to multiple shortages in acute illness medications, including acetaminophen, ibuprofen, Tamiflu, and amoxicillin. The depleted resources have disadvantaged parents as they attempt to manage illness in their children.

In December 2022, many pharmacies even limited the number of over-the-counter cold and flu medications their customers could purchase. For many viral infections, including RSV, fever reducers and other medicines to manage symptoms are the only treatment options available. Without them, pediatric patients are at an increased risk of febrile seizures and other complications.

ADHD

In addition to the impacts of medications for acute illness, many people have been disadvantaged by the Adderall shortage. Adderall is a medication commonly used to treat ADHD. An article in the New York Times notes that many patients reported waiting over three weeks for their prescription.

Commentary from hospital officials notes that the inability to access medication can impair daily functioning for many patients who are reliant on the drug.

Beyond impaired functioning, the Adderall shortage has caused withdrawal symptoms in many patients. These symptoms can include mood swings, irritability, appetite changes, suicidal ideations, headaches, fatigue, and gastrointestinal issues.

Oncology

Shortages in oncology medications may have severe life-threatening impacts. Unlike some other conditions, substituting drugs may not provide a good outcome.

“When discussing oncology, the best predictor of good outcomes is the patient’s ability to stick to the regimen,” explained Ganio. He explains that patients who must reduce their dose due to side effects or reschedule chemotherapy appointments tend to have worse outcomes. “Those are predictors of poorer response to the regimen,” he said.

Medication shortages can compromise patient outcomes. Providers cannot wait for a shortage to be over to begin treatment. “The bottom line is, if this is in a preferred regimen for a patient, they either have to drop this medication from that regimen and continue to treat them with that same regimen, or they have to go to the next regimen in line,” he said.

The caveat is that the next treatment in line may be more expensive, less effective, or have more side effects.

Healthcare Spending

In addition to patient impacts, Ganio explained that shortages dramatically increase healthcare spending. From a labor standpoint alone, pharmacy technicians may do more work for drug preparation, and nurses may have to spend more time at a patient’s bedside.

Beyond that, he notes, “Electronic health records are everywhere, so converting medications, especially for some of these oncology regimens, if the medication in the protocol has to be swapped for something else, is a lot of work on the electronic health record side. The labor expenses alone are significant.”

Short-Term Management Strategies

Managing drug shortages is critical to ensuring patient safety and access to healthcare. It can be challenging to manage needs depending on the medication involved and the condition it treats. Navigating a drug shortage requires an immediate short-term strategy and long-term strategic plans.

PharmaNewsIntelligence asked Ganio to explain what happens when a patient cannot get a prescription that was written due to a drug shortage.

“If it's a drug like amoxicillin, management can usually be a phone call between the pharmacy and the prescriber's office,” began Ganio.

For common conditions such as ear infections and strep throat, the pharmacist may be able to offer the provider some alternatives they have in stock. However, if the diagnosis is unknown, providers must offer another option.

Other conditions, like ADHD, usually treated by Schedule II controlled substances such as Adderall, are more complicated to manage during a shortage.

“Phone prescriptions are not allowed. It has to be either an electronic or a physical prescription handed to the pharmacist,” remarked Ganio. “Unfortunately, pharmacists may not be comfortable disclosing whether they have inventory over the phone because of the potential for abuse and pharmacy shopping patients. It adds a layer here where just calling around may not be enough to find the medication.”

He revealed that some pharmacies, specifically smaller pharmacies, with repeat customers that need the same medication periodically might reserve some of their supplies to ensure they can refill the medicines for their regular patients.

“It's more likely to happen at a smaller store or an independent pharmacy where patients may have a relationship with that pharmacist in your community, but it really could just depend on the pharmacist there, the size, and the volume they're filling, and their relationship,” said Ganio.

Long-Term Solutions

Beyond developing short-term solutions to manage current shortages, Ganio discussed potential long-term solutions to strengthen the pharmaceutical supply chain and responses to future deficits.

Supply Chain Transparency

To start, he suggests transparency in the drug manufacturing process. While there are ways to see issues in the supply chain, it requires a lot of digging. 

“If there was a little more transparency into the quality, where drugs were made, and where they were coming from, the purchasing patterns could follow where better quality and more reliability lie,” noted Ganio.

He explained that consumers already have a relatively easy model that provides price transparency. For most products, there is a platform for consumers to provide reviews, allowing other consumers to get an idea of the product’s quality before purchasing.

“We don't have that anywhere in our pharmacy supply chain. Building that level of transparency, understanding of quality, and the ability to reward quality reduces shortages,” asserted Ganio.

Technology

Another recommendation by Ganio is to implement new manufacturing technologies that are more reliable, improving the quality process.

“The technologies are expensive to adopt. They are only used by a few brand-name manufacturers,” he commented. “There's a government-supported manufacturer in Virginia called Phlow that is using these technologies to start building a stockpile of raw materials on behalf of the government. But the barrier to entry is too high for many of these generics.”

Supporting these technologies may help minimize shortages associated with manufacturing errors and quality issues. 

National Stockpile

Finally, Ganio suggests developing and re-imagining the strategic national stockpile of medications. He explained that the FDA and WHO both have an essential medicines list that they find critical to have in stock. Having a 3–6 month stockpile of these medications may help effectively manage drug shortages.

“I would call it more of a buffer,” commented Ganio. “Unlike a stockpile that sits in a warehouse and collects dust, this would be a 3–6 month buffer of these essential medications, probably maintained by the private sector, likely our wholesalers.”

Ganio added, “If there was a government program to support maintaining that kind of inventory, and it was something we rotated through so that it didn't collect dust and expire, it would give us the ability to respond to a surge in demand and gives manufacturers time to scale up. Also, if there is a manufacturing quality issue at a facility that makes one of these drugs, we have inventory on hand to start to burn through while that manufacturer addresses whatever the quality issue is.”