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]
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]
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]
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 |
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]
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]
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]
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Adderall and Mydayis are trade names for a combination drug containing four salts of amphetamine. The mixture is composed of equal parts racemic amphetamine and dextroamphetamine, which produces a (3:1) ratio between dextroamphetamine and levoamphetamine, the two enantiomers of amphetamine. Both enantiomers are stimulants, but differ enough to give Adderall an effects profile distinct from those of racemic amphetamine or dextroamphetamine, which are marketed as Evekeo and Dexedrine/Zenzedi, respectively. Adderall is used in the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. It is also used illicitly as an athletic performance enhancer, cognitive enhancer, appetite suppressant, and recreationally as a euphoriant. It is a central nervous system (CNS) stimulant of the phenethylamine class.
Ranitidine, previously sold under the brand name Zantac among others, is a medication used to decrease stomach acid production. It was commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It can be given by mouth, injection into a muscle, or injection into a vein.
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion.
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas. The company produces over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.
Valsartan, sold under the brand name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It belongs to a class of medications referred to as angiotensin II receptor blockers (ARBs). It is a reasonable initial treatment for high blood pressure. It is taken by mouth.
Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. It had approximately 19,000 employees. Before its acquisition by Pfizer, Hospira was the world's largest producer of generic injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. It was formerly the hospital products division of Abbott Laboratories. On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical.
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$2.5 billion. By 2023, Apotex employed close to 8,000 people as Canada's largest drug manufacturer, with over 300 products selling in over 115 countries. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacturing of generic drugs. The company ranked 100th in the Fortune India 500 list in 2020.
In the field of pharmacy, compounding is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest, or to avoid a non-active ingredient a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.
Obetrol was the brand name of a drug combining several amphetamine salts indicated for the treatment of exogenous obesity. It was originally sold by the American company Obetrol Pharmaceuticals. Obetrol was a popular diet pill in America in the 1950s and 1960s.
Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brazil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, around five years later nearly 30, by 2008 200, and by 2015 300.
The Association for Accessible Medicines (AAM), Washington, D.C., is a trade association representing the manufacturers and distributors of generic prescription drugs, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the U.S. generic drug industry. As the primary lobby for makers of generic drugs, AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.
Civica Rx is a nonprofit generic drug company founded in 2018 by leading U.S. health systems and philanthropies for the purpose of preventing and mitigating drug shortages in the United States, and the price hikes that can accompany them.
Done Global Inc., is a San Francisco-based telehealth provider specializing in the diagnosis and treatment of attention deficit hyperactivity disorder (ADHD) and other chronic psychiatric conditions. Through virtual consultations the company connects patients with clinicians who may prescribe medications such as Adderall, Ritalin (methylphenidate), and Vyvanse (lisdexamfetamine). The company also offers digital therapies and support systems to provide mental health care to its patients.