5 Vital Medicines Currently Suffering From Shortages

Earlier this year, the number of active drug shortages in the U.S. reached an all-time high of 323.¹ In September 2024, that number fell to 277, but 50% of these shortages have existed for two or more years and impact life-saving products.

Drug shortages occur when commercial supply cannot meet demand.² In general, these shortages fall into three main categories: product-specific issues, market-wide supply shortages, and reimbursement and market access restrictions. Contributing factors within these categories include natural disasters, market economies, product discontinuations, sourcing or manufacturing limitations, and changes in prescribing or patient demand patterns.

Although the overall number of shortages has decreased since their peak, many continue to persist. Here are 5 medications currently experiencing shortages in the United States:

1. ADHD medication

Various medications for the treatment of attention deficit hyperactivity disorder (ADHD) have been listed in the FDA Drug Shortage Database since 2022.³ These include amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate tablets; The shortage was first reported on October 12, 2022. This treatment contains central nervous system stimulants that contribute to hyperactivity and impulse control.⁴

It is available in all dosages through Elite Laboratories, Epic Pharma, Lannett Company, Sunrise Pharmaceutical and USPharma Windlas.³ In contrast, Alvogen, Aurobindo, Granules Pharmaceuticals and SpecGx reported shortages of all or some doses due to a shortage of an active ingredient. Additionally, Teva reported a shortage of select doses due to increased demand for the drug, and Sandoz had temporarily backordered most doses until October 2024.

Another ADHD medication currently in short supply is lisdexamfetamine deimsylate, which increases alertness and reduces agitation in adults and children who are overreactive, unable to concentrate for long periods of time, or who are easily distracted and impulsive.⁵ This treatment was added to the Drug Shortage Database on July 14, 2023.³

All or selected doses of this treatment are available through Takeda Pharmaceuticals and Rhodes Pharmaceuticals. Conversely, the availability of other manufacturers, including Alvogen, Apotex, Hikma, Lannett Company, Viatris, Solco Healthcare and Sun Pharma, is limited due to a shortage of active ingredients; Likewise, SpecGx has it on backorder due to this shortage.

2. Pain treatments

There is currently a lack of several treatment options for pain relief, including injectable opioids such as morphine sulfate and fentanyl citrate. Morphine sulfate injections were first added to the Drug Shortage Database 7 years ago, on October 31, 2017. It is currently available in select dosages through Amphastar, Fresenius Kabi, Hikma, Pfizer and Piramal Critical Care. In contrast, Fresenius Kabi, Hikma and Pfizer continue to face high demand, which is impacting their shares.

Additionally, Fentanyl Citrate Injection was first added to the Drug Shortage Database on January 1, 2012. It is available in most doses through Fresenius Kabi, Pfizer and Hikma. However, certain doses from Pfizer and Hikma are in limited supply or rely on planned production to meet demand.

3. Chemotherapeutic drugs

Although the shortage of cisplatin, a widely used chemotherapy drug, was resolved last summer, shortages of other chemotherapy drugs such as methotrexate sodium injection and carboplatin continue.⁶

Methotrexate sodium injection, a chemotherapy that kills cancer cells by stopping them from producing DNA, was first added to the Drug Shortage Database on March 13, 2023.³ It is currently available through Fresenius Kabi and Hikma Pharmaceuticals.

In contrast, methotrexate sodium injection is not available from Accord, Pfizer, and Teva. Accord noted that it will be unavailable for 30 to 45 days due to a shortage of an active ingredient, while Pfizer and Teva have limited availability due to increased demand for the drug.

Likewise, carboplatin injection was first added to the Drug Shortage Database on April 28, 2023. It is available from various manufacturers (Eugia, Fresenius Kabi, Gland Pharma Limited, Ingenus and Teyro Labs). However, Pfizer and Teva are facing carboplatin shortages due to increased demand, while Accord is facing production delays.

4. Insulin

Due to various shortages over the past year, many diabetics have had difficulty obtaining insulin.⁷ Eli Lilly reported shortages of 10 mL vials of Insulin Lipro (Humalog) as new regulations caused a brief delay in manufacturing. This was also due to increased demand as other manufacturers faced shortages, resulting in patients turning to Lilly's insulin. However, Lilly discontinued its 3 mL Humalog vials, used primarily in hospitals, to free up capacity for 10 mL vials.

Novo Nordisk reported similar shortages of insulin aspart (Fiasp or NovoLog). It has been announced that production delays will result in Fiasp vials being in short supply until October. At the beginning of the year, Novo Nordisk also reported shortages at NovoLog.

Another reason for the insulin shortage was the manufacturers stopping their products. For example, Novo Nordisk announced last November that it would withdraw insulin detemir injection (LevemirFlexPens and vials) from the US market by the end of 2024.⁸ Therefore, the offer is not enough for normal orders, as Novo Nordisk's inventory is expected to run out in early December 2024.

5. Diabetes/weight loss medications

On Thursday, after years of ongoing shortages due to rising demand, all doses of Ozempic and Wegovy (semaglutide; Novo Nordisk) were now listed as “available” on the drug shortage list.⁹ However, the FDA still considers it a shortage because there can be fluctuations in patients at a given pharmacy location regardless of whether a drug is in short supply.

Once the shortages of Ozempic and Wegovy are fully resolved, the FDA will list them as “resolved” and remove them from the deficiency list. This happened earlier this month for Mounjaro and Zepbound (Eli Lilly) as supply now exceeds demand.

Ozempic and Wegovy both contain semaglutide, while Mounjaro and Zepbound contain tirzepatide. Ozempic and Mounjaro are both approved by the FDA to treat patients with type 2 diabetes, and Wegovy and Zepbound are approved for weight loss.

Honorable mention: IV fluids

Earlier this month, the FDA added 70% intravenous (IV) dextrose solution, peritoneal dialysis solution, and IV lactate Ringer's solution to the Drug Shortage Database.¹⁰ This is due to the impact of Hurricane Helene on a Baxter manufacturing facility that produces over 60% of the high-volume IV fluids in the United States.¹¹ As a result, Baxter products are not available in sufficient quantities to meet current demand.

Given the shortage, the FDA has released guidance allowing temporary flexibility in compounding these medications without patient-specific prescriptions.¹⁰ It calls for careful monitoring of patients in the event of exacerbation of drug-related problems and encourages reporting of adverse events.

If supplies dwindle, more drugs could be added to the shortage list. The FDA also acknowledged concerns about expired infusion fluids and clarified that extending expiration dates requires stability data from the manufacturer; As of October 18, no such data was available to support an extension.

References

1. National Drug Shortages: January 2001 to September 2024. ASHP. Accessed October 31, 2024. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics
2. Pourmahram T. Collaborative solutions are needed to address and mitigate drug shortages in America. AJMC. June 17, 2024. Accessed October 31, 2024. https://www.ajmc.com/view/collaborative-solutions-are-needed-to-address-and-mitigate-america-s-drug-shortages
3. FDA drug shortages. FDA. Accessed October 31, 2024. https://dps.fda.gov/drugshortages
4. Durbin K. Adderall. Drugs.com. Updated August 23, 2023. Accessed October 31, 2024. https://www.drugs.com/adderall.html
5. Lisdexamfetamine dimesylate (oral route). Mayo Clinic. Updated February 1, 2024. Accessed October 31, 2024. https://www.mayoclinic.org/drugs-supplements/lisdexamfetamine-dimesylate-oral-route/description/drg-20070888
6. Keenan J. FDA Commissioner Announces End of US Shortage of Chemo Drug Cisplatin. Violent pharmaceuticals. July 1, 2024. Accessed October 31, 2024. https://www.fiercepharma.com/manufacturing/fda-heralds-end-us-shortfall-chemo-drug-cisplatin
7. Alltucker K. What diabetes patients can do if insulin deficiency persists. USA today. October 24, 2024. Accessed October 31, 2024. https://www.usatoday.com/story/news/health/2024/10/24/insulin-shortage-2024-ozempic-diabetes/75821654007/
8. Insulin detemir injection. ASHP. Updated September 22, 2024. Accessed October 31, 2024. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=1006
9. According to the FDA, Kindelan K. Ozempic and Wegovy are moving closer to the goal of no longer having a deficiency. ABC News. October 30, 2024. Accessed October 31, 2024. https://abcnews.go.com/GMA/Wellness/ozempic-wegovy-move-closer-longer-shortage-fda/story?id=115321505
10. Gallagher A. FDA adds intravenous fluids to list of drug shortages. Pharmacy hours. October 18, 2024. Accessed October 31, 2024. https://www.pharmacytimes.com/view/fda-adds-intravenous-fluids-to-list-of-drug-shortages
11. Addressing IV fluid shortages after Hurricane Helene: Insights from USP on compounding and preservation strategies. Pharmacy hours. October 24, 2024. Accessed October 31, 2024.