2024 United States drug shortages
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]
Background
[edit]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
[edit]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
[edit]The abbreviated list is based on the FDA's Drug Shortages list, updated as of 27 July 2024:[5]
| Medication | Therapeutic categories | Shortage reason(s)[a] |
|---|---|---|
| Albuterol Sulfate | Pulmonary/Allergy; Pediatric | |
| Alprostadil | Urology | Shipping delay |
| Amifostine | Oncology | Discontinuation[b] |
| Aminosyn Amino Acid injection | Gastroenterology | Shortage of an active ingredient |
| Amoxapine | Psychiatric | Other, estimated recovery September 2024 |
| Amoxicillin | Anti-Infective; Pediatric | Increased demand |
| Amphetamine/Dextroamphetamine | Psychiatric | Shortage of an active ingredient, increased demand |
| Atropine Sulfate | Anesthesia; Neurology; Pediatric | "Requirements related to complying with good manufacturing practices" |
| Azacitidine | Oncology | Other |
| Bumetanide | Cardiovascular | |
| Bupivacaine Hydrochloride | Anesthesia | Demand increase |
| Carboplatin | Oncology | "Requirements related to complying with good manufacturing practices", demand increase |
| Cefotaxime Sodium | Anti-Infective; Pediatric | Demand increase |
| Cefotetan Disodium | Anti-Infective | Shipping delay, discontinuation from one company |
| Chloroprocaine HCl | Anesthesia | Demand increase |
| Clindamycin Phosphate | Anti-Infective | Shipping delay, demand increase |
| Clonazepam | Neurology; Pediatric; Psychiatry | "Requirements related to complying with good manufacturing practices", demand increase, estimated recovery Oct-Dec. 2024 |
| Conivaptan HCl | Cardiovascular | Shipping delay |
| Cromolyn Sodium | Respiratory | Demand increase |
| Cytarabine | Oncology, Pediatric | |
| Dacarbazine | Oncology | Increase demand |
| Desmopressin Acetate | Hematology | Demand increase |
| Dexamethasone | Endocrinology, Rheumatology, Pulmonary/Allergy | Demand increase, shipping delay |
| Dexmedetomidine HCl | Anesthesia | Discontinuation, Demand increase, "Requirements related to complying with good manufacturing practices" |
| Dextrose Monohydrate Injection | Endocrinology/Metabolism; Gastroenterology; Pediatric | Shipping delay, demand increase |
| Diltiazem HCl | Cardiovascular | |
| Dobutamine HCl | Cardiovascular; Pediatric; Renal | Shipping delay |
| Dopamine HCl | Cardiovascular | Shipping delay, demand increase |
| Dulaglutide | Endocrinology/Metabolism | Demand increase |
| Echothiophate Iodide | Ophthalmology | Shipping delay |
| Epinephrine | Cardiovascular, Pulmonary/Allergy | Demand increase |
| Fentanyl Citrate | Analgesia/Addiction | Demand increase |
| Flurazepam HCl | Neurology | Regulatory delay |
| Furosemide | Cardiovascular | "Requirements related to complying with good manufacturing practices", demand increase |
| Heparin Sodium | Hematology | Demand increase |
| Hydrocortisone Sodium Succinate | Pulmonary/Allergy, Endocrinology/Metabolism | Demand increase |
| Hydromorphone Hydrochloride | Analgesia/Addiction | Shipping delay, demand increase |
| Hydroxocobalamin | Endocrinology/Metabolism | |
| Isoniazid | Anti-Infective | Other, Estimated recovery Nov. 2024 |
| Ketamine HCl | Anesthesia | Demand increase, active ingredient shortage |
| Ketorolac Tromethamine | Analgesia/Addiction | Demand increase |
| Leucovorin Calcium | Oncology; Pediatric | Shipping delay, demand increase |
| Lidocaine HCl | Anesthesia; Pediatric | Shipping delay, demand increase |
| Liraglutide | Endocrinology/Metabolism | Shipping delay, demand increase |
| Lisdexamfetamine Dimesylate | Psychiatry | Active ingredient shortage |
| Lorazepam | Neurology | Demand increase |
| Mefloquine HCl | Anti-Infective | |
| Methamphetamine HCl | Psychiatry | Active ingredient shortage |
| Methotrexate Sodium | Oncology | "Requirements related to complying with good manufacturing practices", shipping delay, demand increase |
| Methylphenidate HCl | Psychiatry | Discontinuation, active ingredient shortage, demand increase |
| Methylprednisolone Acetate | Rheumatology | Demand increase |
| Metronidazole | Anti-Infective | Demand increase |
| Midazolam HCl | Anesthesia; Neurology | Shipping delay, demand increase |
| Morphine Sulfate | Analgesia/Addiction | Shipping delay, active ingredient shortage |
| Naltrexone HCl | Analgesia/Addiction | Active ingredient shortage, demand increase |
| Nitroglycerin | Cardiovascular | Demand increase |
| Parathyroid Hormone | Endocrinology/Metabolism | Discontinuation |
| Penicillin G Benzathine | Anti-Infective | Demand increase |
| Potassium Acetate | Endocrinology/Metabolism; Gastroenterology | Shipping delay, demand increase |
| Promethazine HCl | Analgesia/Addiction; Gastroenterology; Pediatric; Pulmonary/Allergy | Demand increase |
| Propranolol HCl | Cardiovascular | Active ingredient shortage, demand increase |
| Quinapril HCl | Cardiovascular | "Requirements related to complying with good manufacturing practices", shipping delay, discontinuation, active ingredient shortage |
| Remifentanil HCl | Analgesia/Addiction | Shipping delay, demand increase |
| Rifampin | Anti-Infective | Shipping delay |
| Riluzole | Neurology | "Requirements related to complying with good manufacturing practices" |
| Rocuronium Bromide | Anesthesia | Demand increase |
| Ropivacaine HCl | Anesthesia | Shipping delay, demand increase |
| Semaglutide | Endocrinology/Metabolism | Demand increase |
| Sodium Acetate | Endocrinology/Metabolism; Gastroenterology | Demand increase |
| Sodium Bicarbonate | Endocrinology/Metabolism; Gastroenterology; Pediatric | Shipping delay, demand increase |
| Sodium Chloride | Endocrinology/Metabolism; Gastroenterology | Shipping delay, demand increase, discontinuation |
| Sodium Phosphate | Endocrinology/Metabolism; Gastroenterology | Demand increase |
| Somatropin | Endocrinology/Metabolism | Shipping delay, demand increase, discontinuation |
| Sterile Water Injection | Other | "Requirements related to complying with good manufacturing practices" |
| Streptozocin | Oncology | Other |
| Sucralfate | Gastroenterology | Demand increase |
| Sufentanil Citrate | Analgesia/Addiction; Pediatric | Shipping delay, demand increase |
| Technetium TC-99M Pyrophosphate | Medical imaging | Active ingredient shortage |
| Triamcinolone | Rheumatology | Shipping delay |
| Valproate Sodium | Neurology | |
| Vecuronium Bromide | Anesthesia | Demand increase |
| Vinblastine Sulfate | Oncology | Demand increase |
ADHD medication
[edit]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
[edit]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
[edit]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
[edit]References
[edit]- ^ a b c d "Policy Solutions to Address the Drug Shortage Crisis" (PDF). ASHP. Retrieved 26 July 2024.
- ^ a b c Pecorin, Allison (15 June 2023). "Senators propose 'first step' to address US drug shortages by examining supply chains". ABC News. Retrieved 2024-07-26.
- ^ a b Kekatos, Mary (12 April 2024). "Drug shortages hit record high, pharmacists warn". ABC News. Retrieved 2024-07-27.
- ^ a b "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.
- ^ "FDA Drug Shortages". FDA. Archived from the original on 2024-07-27. Retrieved 2024-07-27.
- ^ a b Smith, Jane (2024-05-15). "Ongoing Adderall Shortage Affects Millions". Health News. Retrieved 2024-07-12.
- ^ Hart B (27 March 2023). "Where's the Urgency on the Adderall Shortage?". Intelligencer. Retrieved 27 March 2023.
- ^ "'Exciting Time': FDA Commissioner Talks AI and Misinformation". WebMD. 31 May 2023.
- ^ "FDA Commissioner Blames Adderall Shortage on Stimulant Overuse, Telehealth, Generics". Anni Layne Rodgers via Additidemag. 2 June 2023.
- ^ Abovyan, Kristina (7 February 2024). "Drug shortage can put patients' lives at risk, experts warn". ABC News. Retrieved 2024-07-27.
- ^ "HHS Adopts ASHP Recommendations on Drug Shortages, But Proposes Concerning Penalties". ASHP. 3 April 2024. Retrieved 2024-07-26.