How to help patients during medication shortages

In this article:

• What is a medication shortage?
• What causes a medication shortage?
• How to help patients during a drug shortage
• Bottom line

In this article

• What is a medication shortage?
• What causes a medication shortage?
• How to help patients during a drug shortage
• Bottom line

Drug shortages in the United States are extremely common, with the number of ongoing and active shortages at their highest since the American Society of Health-System Pharmacists (ASHP) began tracking in 2001. Shortages negatively impact the health system, as they can compromise medical care, increase the risk of medication errors, raise the amount of labor and resources required, and increase patient morbidity and mortality. In addition, they can be extremely stressful for patients since they can limit their treatment options, delay care, increase costs, and expose them to potential side effects of unfamiliar drugs.

As frontline providers, pharmacists play a key role in mitigating the impact of drug shortages on patients. Luckily, there are many ways a pharmacist can help patients during a medication shortage, such as procuring the drug through alternate suppliers or recommending therapeutic alternatives.

What is a medication shortage?

A medication shortage occurs when the demand for a drug is greater than the supply, according to the Food and Drug Administration (FDA). This means the total supply of all versions of the drug cannot meet the demand for that drug. The FDA tracks drug shortages at the national level by obtaining information from drug manufacturers about their ability to produce medications.

Common drug classes that have been in short supply include:

• Antibiotics
• Electrolytes
• Hormone agents
• Chemotherapy
• Central nervous system drugs
• GLP-1 agonists

What causes a medication shortage?

Many factors cause medication shortages. According to the FDA, manufacturing issues are the main reason for drug shortages. Supply and demand issues are also among the most common known causes of shortages.

Other causes of medication shortages include drug recalls and business decisions such as a manufacturer discontinuing a product.

Manufacturing issues

Many factors can cause drug manufacturing issues. These may include outdated equipment, shortages in raw materials, and loss of production staff.

The FDA also only approves a specific manufacturing line for each specific drug at a specific facility. If there is a drug shortage, manufacturers cannot simply produce that drug in a different facility or with different equipment.

Supply and demand issues

Another cause of drug shortages is supply and demand issues. In some cases, the demand for a drug can increase suddenly, such as when an existing drug gets a new indication or therapeutic guidelines are updated. When this occurs, the supply of the drug can fall behind quickly, leading to a drug shortage.

Drug recall

A drug recall is a voluntary action taken by a manufacturer to remove a defective drug from the market due to a potential risk. Drug recalls typically have a swift and significant effect on drug supply. While recalls are usually temporary, they have the potential to cause a drug shortage, depending on how long they last.

Business decisions

Shortages may also occur due to a manufacturer’s business decisions. For example, a manufacturer may discontinue a drug due to insufficient profits, introduction of generic products, or mergers. Drug discontinuations can quickly lead to drug shortages as the FDA can’t require a manufacturer to keep making a drug it wants to discontinue.

How to help patients during a drug shortage

In many cases, the pharmacy may be the first place patients learn of a drug shortage. Pharmacists may find themselves in a position to explain what a drug shortage is, what the reason for the shortage is, and offer solutions. Unfortunately, this means pharmacists may also encounter frustration from patients who cannot get their medication right away.

When dealing with a medication shortage, pharmacists may address the shortage from an operational or clinical approach. Patients don’t typically recognize operational strategies, as they involve processes that happen behind the scenes. However, clinical strategies focus on alterations to a patient’s treatment regimen.

Operational approaches

Pharmacists have a thorough understanding of medication workflow. With this knowledge, they can implement operational changes that mitigate the harm of drug shortages to patients. According to the AMA Journal of Ethics, these operational changes may include:

• Ordering the drug from an alternate supplier
• Purchasing the drug from a compounding facility
• Implementing different drug preparation processes
• Repackaging medications

Depending on the specific shortage, inventory level, and familiarity with utilization trends, pharmacists can decide which of these methods would benefit their patients the most. For example, securing the same product from a different manufacturer or ordering it from a secondary wholesaler is a relatively seamless way to increase a pharmacy’s supply of a drug. However, if this isn’t an option, pharmacists may need to consider outsourcing to a compounding pharmacy.

Clinical approaches

As medication experts, pharmacists are well-equipped to recommend clinical changes that can minimize the impact of a medication shortage. Clinical changes may include:

• Switching to an alternate dosage form or route
• Recommending therapeutic alternatives
• Rationing
• Canceling or delaying treatment

However, clinical strategies are typically riskier than operational ones since they alter a patient’s treatment plan in some way. Some strategies present ethical challenges as changing a patient’s treatment regimen increases their risk of adverse effects and medication errors and can lead to suboptimal treatment of their condition. This is especially true for rationing and delaying or canceling treatment since both involve reserving the drug for a specific patient population that meets rationing criteria. Nevertheless, rationing is typically more common in hospitals than in community pharmacies.

Another impactful way pharmacists can mitigate the impact of shortages on their patients is by educating them about the risks of purchasing drugs from unverified online pharmacies. Many unsafe online pharmacies sell medications that are fake, expired, or harmful. Pharmacists can help their patients by explaining the signs of an unsafe online pharmacy and discouraging them from purchasing from these sources.

Bottom line

There are many ways pharmacists can support patients during a medication shortage. Whether implementing an operational strategy or clinical change to mitigate patient harm during a shortage, pharmacists play a crucial role in ensuring continuity of patient care.