Staying Informed: Pharmacists, Drug Shortages, and What’s on the Horizon

Drug shortages present a significant challenge for pharmacists, limiting the availability of medications crucial for patient care. These local shortages can quickly escalate into nationwide shortages. In April 2024, the American Society of Health-System Pharmacists (ASHP) reported 323 active drug shortages, marking the highest number in nearly ten years. By comparison, the period from 2016 to 2017 saw 176 active shortages. Over the last year and a half, the shortage count has remained above 300. Such shortages can arise from various factors and impact a wide range of conditions, from saline vials to chemotherapy drugs. Pharmacists must remain vigilant and keep up to date with current availability, ongoing discussions about the causes and solutions, and the expected duration of each shortage.

As of June 2024, the ASHP reported 300 drugs in shortage, a slight decrease from recent highs. Despite this downtrend, pharmacists must stay cautious of any potential shifts in supply. The FDA offers an up-to-date database on its website that tracks verified reports of new, updated, or resolved shortages, as well as discontinued medications. If a new shortage is detected, it should be reported to the FDA using the appropriate channels, with distinct contact details for the public and industry professionals. The database is updated daily, relying on accurate reports to confirm legitimate shortages.

Commonly reported shortages include medications in the following categories: antimicrobials, chemotherapy agents, central nervous system drugs, electrolytes, fluids, and hormones. Shortages can arise if a manufacturer fails to meet demand or if production practices fall short, potentially compromising drug stability or sterility. Even if production is ramped up, it may not always align with manufacturing standards. Generic, injectable, low-cost, and older drugs are typically more prone to shortages, especially generic injectables. These shortages often result from high demand, limited supply, and delays in manufacturing.

“Drug shortages not only leave patients without essential medications but also heighten the risk of errors and adverse effects due to the substitution of treatments and inadequate care.”

Wholesalers and group purchasing organizations often buy drugs in bulk, which prevents manufacturers from raising prices. Generic drugs are reimbursed at a fixed rate, regardless of the version, prompting buyers to opt for the least expensive options to reduce costs. This reduces the incentive for manufacturers to produce low-cost medications in large quantities, potentially disrupting the supply chain when production levels fall.

Several strategies have been proposed to address these issues, with similar ideas emerging from researchers and lawmakers. Discussions around solutions to drug shortages increasingly focus on providing financial incentives to maintain medication stockpiles. Hernandez et al. suggested a value-based reimbursement model to encourage manufacturers and purchasers to stabilize supply chains. This model would increase the profit margin for producing generic drugs, making it more financially viable for manufacturers to maintain consistent production. A similar approach was proposed by members of Congress. In June 2024, a draft of the Drug Shortage Prevention and Mitigation Act was introduced in Congress, which would involve Medicare offering financial incentives to hospitals to keep a steady supply of essential medications, encouraging manufacturers to enhance production while adhering to good manufacturing practices. If enacted, this legislation would prompt manufacturers to decide which drugs to stockpile, where to store them, and in what quantities. Hospitals would need to assess their most commonly prescribed and hard-to-find medications, purchasing based on prescribing patterns. The legislation would initially apply to generic injectables that are not self-administered, with broader applications potentially beginning in 2027 for drugs at high risk of shortage.

In addition to monitoring shortage trends, pharmacists should familiarize themselves with extended beyond-use dating for drugs affected by shortages. The FDA, after conducting stability testing, may recommend using certain drugs beyond their expiration date. The ASHP also provides useful guidelines for institutions to manage shortages effectively.

Drug shortages pose risks not only due to the unavailability of proper medications but also by increasing the likelihood of errors and adverse effects from treatment substitutions and lapses in care. These disruptions can lead to worse patient outcomes and complicate treatment plans. Pharmacists play a critical role in navigating these challenges to ensure the best possible patient care.

At Mediserv Pharmacy, we understand how crucial it is to have consistent access to the medications you need. As a locally-owned pharmacy in the Bronx, New York, we are committed to providing personalized care and staying informed about the latest trends in drug shortages and pharmaceutical advancements. Our team is dedicated to supporting the community, ensuring that patients can rely on us for timely information, medication availability, and expert advice. Whether you’re dealing with a medication shortage or need assistance with prescription management, Mediserv Pharmacy is here for you. We take pride in helping our customers navigate through challenges and ensuring they receive the care they deserve.