Premier Data Shows Key Factors that Contribute to Drug Shortages

While progress has been made to protect supply of at-risk products, drug shortages remain a concern for healthcare providers and patients alike. A complex pharmaceutical industry and supply chain, coupled with ongoing disruptions and unpredictable demand, make shortages of vital medications a persistent issue.

Premier continuously analyzes our portfolio for supply chain risk and resiliency measures – sharing education, data insights and taking proactive action to mitigate drug shortages.

Via a new analysis, Premier’s tracking of data from manufacturers and distributors from January 2022 through April 2023 demonstrates vital products well below usual market availability.

This Premier data highlights three key factors that contributed to recent drug shortages.

1. Tripledemic-Driven Demand Spikes

The “tripledemic” of COVID-19, influenza and respiratory syncytial virus (RSV) during the fall and winter of 2022 created a perfect storm of outbreaks. As a result, higher than anticipated demand led to supply risks for drugs used to treat patients with these highly contagious respiratory infections, including acetaminophen and ibuprofen for pain relief, and amoxicillin to treat secondary infections.

In the case of acetaminophen, Premier data shows units ordered spiked higher than usual in November through January, and only recently (February) has product availability started to recover as demand has subsided.

ACETAMINOPHEN – ORAL SUSPENSION, SOLUTION, LIQUID - VARIOUS STRENGTHS AND PACKAGE SIZES

Source: Premier purchasing and fill rate data

The story is similar for both amoxicillin and ibuprofen, with unanticipated demand spikes in September and November of 2022, respectively. A particularly bad season of strep throat, short for Streptococcus, has created recent challenges for amoxicillin in March and April 2023, which is regularly used to treat strep infections.

For these products, suppliers had forecasted production at a similar rate to previous years, however tripledemic-driven demand was far greater than anticipated. Overall, manufacturers rank unpredictable volumes among their top challenges to consistently supply drugs, according to a 2022 Premier survey.

AMOXICILLIN – SUSPENSION RECON - VARIOUS STRENGTHS AND PACKAGE SIZES

Source: Premier purchasing and fill rate data

IBUPROFEN – ORAL SUSPENSION (LIQUID) - VARIOUS STRENGTHS AND PACKAGE SIZES

Source: Premier purchasing and fill rate data

2. Overconcentration of Markets

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3. Manufacturing Issues

Shortages for many drugs also have an outsized impact as a result of overconcentration, i.e., two or fewer primary manufacturers producing these products. In this environment, a single manufacturer going offline can make it difficult or impossible for the others to keep up.

With markets that lack adequate competition, drug shortages are regularly exacerbated by production issues, including quality concerns, manufacturing delays or other disruptions.

Premier data demonstrates that albuterol supply has been suboptimal over the last year, particularly alongside moments of heightened demand seen during the tripledemic. However, when the market leading producer of albuterol (one of three supplying the market) stopped shipments following a U.S. Food and Drug Administration (FDA) inspection, product availability plummeted, leaving the other two suppliers playing catch up to satisfy the entire market.

Notably, the 20mL presentation of albuterol is not included within Premier’s data as there is no longer an FDA ANDA-approved generic product available in the market after the sole FDA-approved supplier declared bankruptcy. ANDA filings are planned by other suppliers for later in 2023.

ALBUTEROL SULFATE – VIAL NEBULIZER - VARIOUS STRENGTHS AND PACKAGE SIZES

Source: Premier purchasing and fill rate data

Current Access Challenges with Oncology Drugs

Shortages of vital oncology therapies, including carboplatin and others, are at the forefront of pharmaceutical supply chain challenges for U.S. healthcare providers. As examples, cisplatin and carboplatin disruption began in February 2023 after the primary supplier voluntarily stopped shipment of product from one manufacturing plant following an FDA inspection.

Cisplatin and carboplatin are produced on the same lines, and product availability declined mainly due to the need to compete for line capacity.

For these critical oncology therapies, Premier continues to share management, conservation and clinical alternative strategies, and provided crosswalks for our members to manage manufacturer production delays. Premier has also contracted with alternate suppliers for product, giving members alternative supply sources so they can better weather the shortages while the overall market stabilizes.

Additionally, in mid-May Premier shared data with the FDA related to ongoing shortages of oncology drugs alongside recommendations to support more stable supply for healthcare providers, including interim supplier allowances to resume production under stringent supervisory conditions and the facilitation of alternate manufacturers ramp capabilities.

For all of these products, suppliers who remain in the market are ramping up production, but continue to struggle to meet demand and make up the supply gap.

The More We Know

Data can provide actionable insights on the factors that contribute to drug shortages – arming stakeholders with greater visibility and a stronger ability to develop meaningful solutions that tackle the root causes.

Monitoring robust data using CognitiveRx^® – a comprehensive drug shortage risk management and communication platform containing hundreds of millions of proprietary and open-source data points spanning more than 30 years – Premier provides early communication to our members, the FDA and other government stakeholders on potential or impending shortages of any healthcare product.

Robust data informs Premier’s product watch list, which is shared weekly with White House leadership to provide insights on backorders and potential shortages, and advocate for prioritization of critical products. Premier also continues to work closely with federal and state agencies and industry organizations on strategies to gather data, forecast demand, identify needed regulatory changes, increase available supplies and allocate based on need.

• Following the Premier team’s engagement in early spring to share data and report the contrast media shortage, contrast media was added to the FDA’s shortage list – paving the way for waived prior authorizations and improved patient access.
• Premier voluntarily supported the FDA through the COVID-19 pandemic by supplying robust data on 250 drugs critical for the treatment of COVID-19 – and to help monitor for any potential supply chain challenges.
• Several 503B suppliers have seen recent supply disruptions or product discontinuations, the latter of which are being discontinued as there are available FDA-approved products on the market and not in active shortage status. Premier expects additional suppliers will follow suit on discontinuations as a final FDA guidance document provides information on how the FDA intends to determine whether a compounded drug product is essentially a copy of an approved drug under section 503B. Premier has created a 503B Advisory Group for insights on outsourcing needs and supplier challenges, in addition to support for managing supply disruptions, including insource compounding guidance and available alternatives on the market. Premier also continues engagement with the FDA on the impact of 503B regulatory decisions and problematic preparation shortages. For more information, members can refer to 503B resources in the PINC AI™ community.
• Premier’s Pharmacy team continuously monitors proprietary technology and actionable data to identify early markers of supply disruption. Early identification of alternative sources and suppliers enables members to reduce shortage workarounds, maintain efficiencies and savings, and gain access to new and expanded inventory.
• Premier and our members continue to advocate that the FDA make sourcing, quality, volume and capacity information publicly available for all medical products sold in the U.S. to improve transparency and support risk mitigation. A streamlined U.S. regulatory framework is needed to make it easier to collect data, implement workarounds and guide conservation strategies for all products.

Drug shortages are complex issues that require a broad array of measures to remediate – actionable data can help us get there.

For More:

• For the latest intelligence on the state of the pharma markets, consult the Monthly Drug Shortages Update, accessible for members in the PINC AI™ community.
• Learn more about Premier’s leadership and action to prevent and resolve drug shortages for the long term.
• See how ProvideGx is helping to tackle drug shortages and enable greater access to at-risk products.