2024 United States drug shortages

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In 2024, the United States suffered from an "all-time high" scarcity of over three hundred different kinds of drugs and medications in healthcare and pharmacy settings, surpassing the number of drug shortages present in 2014. Drugs and medications impacted by the shortage included asthma medications, anesthesia and analgesic medications, psychiatric medications for conditions such as ADHD, depression, and bipolar disorder; diabetic medications, injectable sterile drugs, emergency medications stored in rapid response carts, and chemotherapy drugs for cancer patients. Most of the named drug shortages present in the initial April 2024 report were still occurring as of July 2024. [1] [2] [3]

Contents

Background

The United States Senate Homeland Security Committee released a report stating that the COVID-19 pandemic had significantly increased scarcity of multiple categories of drugs. Lockdown orders and the necessity of remote working lowered the production and distribution of pharmaceuticals, while decreased trade with China and India for active ingredients further worsened scarcity. [2]

In May 2023, the American Cancer Society released a statement alerting healthcare systems to significant shortages in chemotherapy drugs according to several healthcare professionals and patients. It warned that many of the limited drugs were first-line therapies that did not have any alternatives, which at the minimum could cause treatment delays, leading to worse symptoms, prognosis, and health outcomes for patients depending on the medications. [4]

Impact

The American Society of Health-System Pharmacists (ASHP) reported that 323 "active medication shortages" were reported in January–March 2024. As a result of drug scarcity, many healthcare systems were forced to either ration out essential drugs, triage patients based on the severity of their condition and their need for the drug, or both. Most of the medications impacted by the shortage were generic, low-cost drugs with sterile injectable medications such as chemotherapy agents being the most impacted. [3]

Tornado damage to a pharmaceutical manufacturing plant responsible for a large amount of national injectable drug production exacerbated shortages. [1]

List of significant impacted medications

The abbreviated list is based on the FDA's Drug Shortages list, updated as of 27 July 2024: [5]

MedicationTherapeutic categoriesShortage reason(s) [a]
Albuterol SulfatePulmonary/Allergy; Pediatric
AlprostadilUrologyShipping delay
AmifostineOncologyDiscontinuation [b]
Aminosyn Amino Acid injectionGastroenterologyShortage of an active ingredient
AmoxapinePsychiatricOther, estimated recovery September 2024
AmoxicillinAnti-Infective; PediatricIncreased demand
Amphetamine/DextroamphetaminePsychiatricShortage of an active ingredient, increased demand
Atropine SulfateAnesthesia; Neurology; Pediatric"Requirements related to complying with good manufacturing practices"
AzacitidineOncologyOther
BumetanideCardiovascular
Bupivacaine HydrochlorideAnesthesiaIncreased demand
CarboplatinOncology"Requirements related to complying with good manufacturing practices", increased demand
Cefotaxime SodiumAnti-Infective; PediatricIncreased demand
Cefotetan DisodiumAnti-InfectiveShipping delay, discontinuation from one company
Chloroprocaine HClAnesthesiaIncreased demand
Clindamycin PhosphateAnti-InfectiveShipping delay, increased demand
ClonazepamNeurology; Pediatric; Psychiatry"Requirements related to complying with good manufacturing practices", increased demand, estimated recovery Oct-Dec. 2024
Conivaptan HClCardiovascularShipping delay
Cromolyn SodiumRespiratoryIncreased demand
CytarabineOncology, Pediatric
DacarbazineOncologyIncreased demand
Desmopressin AcetateHematologyIncreased demand
DexamethasoneEndocrinology, Rheumatology, Pulmonary/AllergyIncreased demand, shipping delay
Dexmedetomidine HClAnesthesiaDiscontinuation, increased demand, "Requirements related to complying with good manufacturing practices"
Dextrose Monohydrate InjectionEndocrinology/Metabolism; Gastroenterology; PediatricShipping delay, increased demand
Diltiazem HClCardiovascular
Dobutamine HClCardiovascular; Pediatric; RenalShipping delay
Dopamine HClCardiovascularShipping delay, increased demand
DulaglutideEndocrinology/MetabolismIncreased demand
Echothiophate IodideOphthalmologyShipping delay
EpinephrineCardiovascular, Pulmonary/AllergyIncreased demand
Fentanyl CitrateAnalgesia/AddictionIncreased demand
Flurazepam HClNeurologyRegulatory delay
FurosemideCardiovascular"Requirements related to complying with good manufacturing practices", increased demand
Heparin SodiumHematologyIncreased demand
Hydrocortisone Sodium SuccinatePulmonary/Allergy, Endocrinology/MetabolismIncreased demand
Hydromorphone HydrochlorideAnalgesia/AddictionShipping delay, increased demand
HydroxocobalaminEndocrinology/Metabolism
IsoniazidAnti-InfectiveOther, Estimated recovery Nov. 2024
Ketamine HClAnesthesiaIncreased demand, active ingredient shortage
Ketorolac TromethamineAnalgesia/AddictionIncreased demand
Leucovorin CalciumOncology; PediatricShipping delay, increased demand
Lidocaine HClAnesthesia; PediatricShipping delay, increased demand
LiraglutideEndocrinology/MetabolismShipping delay, increased demand
Lisdexamfetamine DimesylatePsychiatryActive ingredient shortage
LorazepamNeurologyIncreased demand
Mefloquine HClAnti-Infective
Methamphetamine HClPsychiatryActive ingredient shortage
Methotrexate SodiumOncology"Requirements related to complying with good manufacturing practices", shipping delay, increased demand
Methylphenidate HClPsychiatryDiscontinuation, active ingredient shortage, increased demand
Methylprednisolone AcetateRheumatologyIncreased demand
MetronidazoleAnti-InfectiveIncreased demand
Midazolam HClAnesthesia; NeurologyShipping delay, increased demand
Morphine SulfateAnalgesia/AddictionShipping delay, active ingredient shortage
Naltrexone HClAnalgesia/AddictionActive ingredient shortage, increased demand
NitroglycerinCardiovascularIncreased demand
Parathyroid HormoneEndocrinology/MetabolismDiscontinuation
Penicillin G BenzathineAnti-InfectiveIncreased demand
Potassium AcetateEndocrinology/Metabolism; GastroenterologyShipping delay, increased demand
Promethazine HClAnalgesia/Addiction; Gastroenterology; Pediatric; Pulmonary/AllergyIncreased demand
Propranolol HClCardiovascularActive ingredient shortage, increased demand
Quinapril HClCardiovascular"Requirements related to complying with good manufacturing practices", shipping delay, discontinuation, active ingredient shortage
Remifentanil HClAnalgesia/AddictionShipping delay, increased demand
RifampinAnti-InfectiveShipping delay
RiluzoleNeurology"Requirements related to complying with good manufacturing practices"
Rocuronium BromideAnesthesiaIncreased demand
Ropivacaine HClAnesthesiaShipping delay, increased demand
SemaglutideEndocrinology/MetabolismIncreased demand
Sodium AcetateEndocrinology/Metabolism; GastroenterologyIncreased demand
Sodium BicarbonateEndocrinology/Metabolism; Gastroenterology; PediatricShipping delay, increased demand
Sodium ChlorideEndocrinology/Metabolism; GastroenterologyShipping delay, increased demand, discontinuation
Sodium PhosphateEndocrinology/Metabolism; GastroenterologyIncreased demand
SomatropinEndocrinology/MetabolismShipping delay, increased demand, discontinuation
Sterile Water InjectionOther"Requirements related to complying with good manufacturing practices"
StreptozocinOncologyOther
SucralfateGastroenterologyIncreased demand
Sufentanil CitrateAnalgesia/Addiction; PediatricShipping delay, increased demand
Technetium TC-99M PyrophosphateMedical imagingActive ingredient shortage
TriamcinoloneRheumatologyShipping delay
Valproate SodiumNeurology
Vecuronium BromideAnesthesiaIncreased demand
Vinblastine SulfateOncologyIncreased demand

ADHD medication

CEO of the ASHP Dr. Paul Abramowitz reported that shortages in Adderall medication developed to a point where they were "demand-driven". [6]

Shortages beginning in October 2022 were caused or exacerbated by limited prescriptions amounts controlled by the Drug Enforcement Administration, [7] coupled with over-diagnosis of ADHD and overprescription of Adderall. [8] [9] Scarcity continued in 2024 as a result of continually increased demand and supply chain problems, despite increases in production and distribution of Adderall. Patients and healthcare providers have expressed concerns about the impact on treatment plans for ADHD and narcolepsy, as many individuals rely on this medication for managing their symptoms. [6]

Causes

The American Cancer Society noted that several factors contributed to escalating nationwide drug shortages, which included decreased or restricted drug manufacturing capacity, increased drug demands coupled with corresponding shortages in supplies, and lower profit margins for several generic drugs decreasing corporate desires towards creating surpluses. The organization also noted that the Food and Drug Administration's means to prevent drug shortages were fundamentally centered around contact with the drug manufacturers involved, giving early warnings that requested them to increase production instead of directly pushing for specific drug quotas. [4]

The ASHP reported that one of the main causes of continuous severe shortages was due to "extreme price competition" between generic dug manufacturers. Challenges to quick-enough production of high-quality medications coupled with possible supply chain disruptions pushed many of these companies to shift their manufacturing to producing drugs with higher profit margins, with some completely stopping production of less lucrative drugs. The organization also pointed out the role that difficult and multi-year federal regulatory approval processes for new manufacturers played in lowering the number of new drug manufacturers and resulting supply decreases. Generic drug user fees noted in section 506C(g) of the Federal Food Drug and Cosmetics Act further made it difficult for companies to keep their businesses profitable. [1]

U.S. Representatives Gary Peters (D-MI) and Iowa Republican Senator Joni Ernst emphasized the role of supply chain breakdowns and weak points in medication shortages. They also argued that U.S. "over-reliance" on foreign nations for key ingredients would lead to future shortages out of American control, especially for dependence on "foreign adversaries" and "bad actors", with China named as an example. [2] Dr. Stephen Schondelmeyer further stated that while the number of pharmaceutical production facilities in the United States was cut in half since 2014, the numbers of pharmaceutical plants were steadily growing in several countries such as Taiwan, India, Israel, and China. He reported that China and India's conditions for pharmaceutical production were greatly enhanced by having less environmental regulations and cheaper labor. [10]

Mitigation efforts

The ASHP recommended expedited reviews for new generic drug manufacturing companies, and recommended regular and publicly released inspection reports to provide purchasers with information on present difficulties or issues in manufacturing, and to inform buyers of companies with production or compliance issues. It also recommended amendments to Section 510(j) of the Federal Food, Drug, and Cosmetics Act to introduce non-negligible penalties on drug manufacturers that lack plans for managing production or supply chain difficulties and who do not keep track of or release data related to production and supply chain metrics. [1]

The United States Department of Health and Human Services adopted these recommendations in a white paper outlining policy proposals for future laws and amendments. The paper also recommended penalties for hospitals that did not follow "HHS-required inventory and purchasing practices", which the ASHP stating that such penalties could negatively impact lesser-financed hospitals more susceptible to drug shortages by preventing them from investing in means to mitigate shortages. [11]

Notes

  1. Per the Food and Drug Administration Safety and Innovation Act
  2. Discontinuation of production drug in one or more forms from one or more companies.

References

  1. 1 2 3 4 "Policy Solutions to Address the Drug Shortage Crisis" (PDF). ASHP. Retrieved 26 July 2024.
  2. 1 2 3 Pecorin, Allison (15 June 2023). "Senators propose 'first step' to address US drug shortages by examining supply chains". ABC News. Retrieved 2024-07-26.
  3. 1 2 Kekatos, Mary (12 April 2024). "Drug shortages hit record high, pharmacists warn". ABC News. Retrieved 2024-07-27.
  4. 1 2 "Nationwide Drug Shortage Could Cause Disruptions for Cancer Patients in Active Treatment". American Cancer Society Cancer Action Network. 2023-05-12. Retrieved 2024-07-26.
  5. "FDA Drug Shortages". FDA. Archived from the original on 2024-07-27. Retrieved 2024-07-27.
  6. 1 2 Smith, Jane (2024-05-15). "Ongoing Adderall Shortage Affects Millions". Health News. Retrieved 2024-07-12.
  7. Hart B (27 March 2023). "Where's the Urgency on the Adderall Shortage?". Intelligencer. Retrieved 27 March 2023.
  8. "'Exciting Time': FDA Commissioner Talks AI and Misinformation". WebMD. 31 May 2023.
  9. "FDA Commissioner Blames Adderall Shortage on Stimulant Overuse, Telehealth, Generics". Anni Layne Rodgers via Additidemag. 2 June 2023.
  10. Abovyan, Kristina (7 February 2024). "Drug shortage can put patients' lives at risk, experts warn". ABC News. Retrieved 2024-07-27.
  11. "HHS Adopts ASHP Recommendations on Drug Shortages, But Proposes Concerning Penalties". ASHP. 3 April 2024. Retrieved 2024-07-26.