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 AfricaIn 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. 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 systemThe 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 capacitiesThe 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 shortagesApart 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. 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 viewThe 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.
Market Place
Share
