US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production
US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production

By PharmaCompass

2024-08-29

Impressions: 3066

Drug shortages are threatening healthcare systems the world over. Be it the US, Canada, Europe or Africa, drug scarcities are straining healthcare systems and costing lives.

In the US, the first quarter (Q1) of 2024 saw a staggering 323 drug shortages, the highest number recorded since the American Society of Health-System Pharmacists (ASHP) began tracking such data in 2001. However, Q2 2024 saw active drug shortages reduce to 300 drugs.

While the shortages span a wide range of medications, five categories have been severely impacted in the US — central nervous system drugs, antimicrobials, hormone agents, injectable fluids and electrolytes, and chemotherapy drugs. Other critical medications in short supply include drugs to treat attention deficit hyperactivity disorder (ADHD).

View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)

Chemo scarcities spark concerns; vaccine shortage hampers mpox response in Africa

In the US, shortage of at least 21 chemotherapy drugs has impacted cancer treatments. A survey undertaken by the National Comprehensive Cancer Network found 89 percent of participating centers reporting shortages of at least one critical systemic anticancer therapy. These included drugs like vinblastine, etoposide and topotecan.

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

Since early 2023, supply issues have led to what’s now known as the “carboplatin shortage”, a key platinum-based chemo drug that is impacting cancer treatment. Carboplatin is crucial for treating various cancers, including ovarian, lung, and breast cancer.

The good news is that there has been a reduction in shortages of platinum-based chemo drugs such as carboplatin and cisplatin. In fact, the FDA website now mentions the shortage of cisplatin as resolved. However, the shortage of carboplatin persists.

Meanwhile, Africa is facing an acute shortage of diagnostic kits, treatments and vaccines to fight the outbreak of monkeypox (mpox). The Africa Centers for Disease Control and Prevention estimates it would need 10 million vaccines to stop the outbreak. Bavarian Nordic’s Jynneos is currently the only widely approved mpox vaccine, and countries like the US, Spain, France and Germany have pledged doses of Jynneos to help Africa fight the outbreak.

View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)

Drug shortages impacts ADHD patients in US; Canada implements tiered system

The US Food and Drug Administration (FDA) first reported a shortage of Adderall, a common ADHD treatment, in October 2022. Since then, the shortage has spread to other crucial medications like Ritalin, Vyvanse, and Focalin. This is a significant issue for the roughly 10 million adults and six million children in the US who rely on such drugs to manage their ADHD symptoms.

An already concerning shortage of ADHD medications in the US has the potential to worsen due to some recent events. The Centers for Disease Control and Prevention (CDC) issued a health advisory in June, warning that the arrest of two telehealth executives from Done Global, a digital health company, could exacerbate the ADHD medication shortage. Done Global was accused of illegally distributing Adderall online. The arrests could disrupt care not only for Done Global patients but also for those who use other telehealth services.

Meanwhile, Canada has implemented a tiered system for addressing drug shortages, with tier 3 shortages being those with the greatest potential impact on the country’s drug supply and healthcare system. Currently, there are 20 drugs listed under tier 3.

View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)

GLP-1 drug shortages create US$ 1 bn shadow industry; Lilly, Novo expand capacities

The shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, such as Ozempic, Saxenda, Trulicity, Victoza, Mounjaro, and Zepbound, has been grabbing headlines. These drugs are used in the treatment of diabetes and in weight management.

The shortage of these drugs has led to a surge in demand for compounded versions of these medications, creating both opportunities and significant risks. While the FDA’s Food, Drug, and Cosmetic Act allows it to turn a blind eye to pharmacists producing and selling non-approved compounded versions under certain circumstances, this practice has led to a billion-dollar shadow industry of compounded GLP-1 drugs.

Eli Lilly has discovered compounded drugs advertised as tirzepatide (Mounjaro and Zepbound) with significant safety, sterility, and efficacy issues. In response to the safety risks, Lilly has taken legal action against several wellness centers, medical spas, and other sellers in the US.

To address the supply issues, Lilly has announced its largest manufacturing investment yet, investing an additional US$ 5.3 billion at its Indiana site. Similarly, Novo Nordisk’s parent company is acquiring Catalent for US$ 16.5 billion to increase Wegovy production. Novo is also investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US).

The FDA website continues to list Novo and Lilly’s GLP-1 drugs as “Currently in Shortage”, even though the drugmakers say otherwise. The EMA website says the shortage of Novo’s Wegovy has been resolved but Lilly’s Trulicity and Novo’s Saxenda continue to be in shortage.

View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)

FDA works closely with cancer drugmakers; France introduces roadmap to address drug shortages

Apart from pharma companies, health authorities and governments are also taking steps to reduce drug shortages. FDA is working closely with five cancer drug manufacturers to increase production capacities. It has also facilitated the re-entry of a previously discontinued cisplatin product into the market.

On the legislative front, the US Senate Finance Committee has proposed a draft of a policy that would incentivize generic drug manufacturers to prioritize production of essential medications. These incentives include minimum three-year contracts with stable pricing, contingency contracts with alternate manufacturers, transparency in quality control issues, and modifications to the Medicaid Drug Rebate Program.

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

France, like most European nations, is also facing shortages of medicines like insulin and anti-cancer drugs. But most problematic are its shortages of antibiotics, paracetamol and corticoids. The French government has introduced a new three-year "roadmap" (from 2024 to 2027) to address these shortages. A significant step in this direction is the planned opening of the first European paracetamol factory in Toulouse in 2025, which will help reduce Europe’s dependence on China, India, and the US for this widely used medication.

View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)

Our view

The global drug shortages underscore the fragility of pharmaceutical supply chains and the urgent need for reform. Longstanding drug shortages, particularly those affecting cancer treatments, antibiotics, and essential medications often stem from the low profitability of generic drugs.

While investments in manufacturing capacity and regulatory measures are steps in the right direction, a more comprehensive, concerted global approach is needed to resolve the deep-seated systemic issues in the pharmaceutical industry.

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