U.S. Drug Shortages: Root Causes and Statistics
The top goal for every healthcare provider and institution in the United States is the highest standard of patient care. But this care often involves prescription medicines. Drug shortages can compromise a patient’s medical care plan and result in dangerous outcomes. A patient's ability to have access to safe and lifesaving medications should always be a priority for the FDA.
In addition, the COVID-19 global pandemic has added to the strain on the supply chain. Newly authorized antivirals such as Paxlovid and monoclonal antibodies like sotrovimab (specifically need for the Omicron variant) are in short supply over backlogs due to shipping issues, raw material supply, manufacturing delays and employee absences.
Which drugs are currently in shortage in 2022?
Hundreds of drug shortages are reported each year. However, the total number of new shortages in 2021, at 114 new products, was the lowest in 10 years. Over 60% of these products were injectables and 24% of medicines were sole source products. Unfortunately, for many drugs, shortages are not resolved from prior years and roll into the next.
In 2021, common classes of drugs in short supply in the US included:
- Central nervous system (CNS) agents
- Cardiovascular drugs
- Hormone therapies
- Gastrointestinal agents
- Chemotherapy medicines
See more: 2022 List of All Current U.S. Drug Shortages
What is the FDA doing to address drug shortages?
The FDA maintains a list of extended use dates for specific lot numbers of drugs that are in short supply in the US. This list is based on stability data provided by the manufacturers and reviewed by FDA. These extended dates typically give an extra year of expanded use past the original expiration date.
View list: Extended Use Dates to Assist with Drug Shortages
The FDA has worked with a Task Force committee members, scientists, healthcare providers, economists and the public in recent years to explore the reasons and determine the root causes of why drug shortages remain an ongoing problem.
What is the most common reason for drug shortages?
The FDA Task Force has worked to understand the drugs most commonly involved in drug shortages, as well as gain insight from patients, the public, industry, and the health care community. Based on this information, the FDA issued a report entitled "Drug Shortages: Root Causes and Potential Solutions" that attempts to identify the causes and offers recommendations for government and industry.
The Task Force analyzed 163 drugs that went into a shortage between 2013 to 2017 and compared these products to similar drugs without shortages. Results revealed:
- Many shortages began due to discontinuation of products for commercial reasons like low drug price and business reasons.
- Products are more likely to be sterile injectables
- Drug prices for the product rarely rose after the shortage began
- During the shortage, production of the medication did not increase enough to reach pre-shortage levels.
FDA officials work closely with industry, health care providers, and patients to prevent and lessen the clinical impact of shortages of “medically necessary” medicines. Medically necessary drugs are given the highest priority. A medically necessary drug is used to treat or prevent a serious disease or medical condition and for which no acceptable drug alternative is available in adequate supply.
A survey from The Institute for Safe Medication Practices (ISMP) revealed the treatment categories most commonly involved in drug shortages. A majority of sites were affected by at least one drug shortage each day, especially specialty pharmacies (80%), community pharmacies (77%), and teaching hospitals (73%).
Table 1. Treatment Categories Commonly Involved in Drug Shortages
|Treatment categories||Frequency of shortages|
|Infectious disease treatment||71%|
|Obstetrics / gynecology||33%|
|Hematology / oncology||33%|
|Allergy / asthma care||15%|
|Intravenous (IV) fluids||5%|
What percent of drug shortages are caused by quality issues?
One main reason for drug shortages, over 60% of the time, involves problems with quality and manufacturing issues.
- Quality, manufacturing issues, delays or capacity: 64%
- Raw material shortage: 27%
- Increased demand: 5%
- Loss of drug manufacturing site or production line: 2%
- Drug discontinuation or lack of financial incentive: 2%
- Natural disasters
As might be expected, one top reason for drug shortages revolves around quality concerns. According to recent data supplied by FDA, quality issues affect 64% of all drug shortages. A lack of raw material, boost in drug demand (as has occurred with COVID therapeutics) and lack of manufacturer financial incentive can all affect drug availability. The root causes of drug shortages often involve economic factors that occur due to both public- and private-sector decision-making.
Data from ASHP notes that in 2021 most shortages (as reported by manufacturers) were for "unknown" reasons (42%). Supply and demand (27%), manufacturing (22%) and business decisions (4%) made up the next three top reasons.
Drug shortages can occur especially during natural disasters affecting manufacturing plants. Hurricane Maria that impacted Puerto Rico in September 2017 led to a widespread shortage of intravenous (IV) bags needed for saline solutions and other products.
Why are drug shortages dangerous?
Drugs shortages can lead to inadequate medical care, medical mistakes and increased possibility of fraudulent drug sales. These include:
- Medical procedure delays
- Shortages may involve sole source products with no alternatives
- Interruption to disease treatment
- Possible medication errors
- Ethical concerns
- Lack of experience with dosing or preparation of required therapeutic alternatives
- Added cost of obtaining drug alternatives; higher priced drugs in short supply
- Patients decision to buy unapproved drugs online or from foreign countries
How can drug shortages be reduced?
FDA has made a significant impact by taking action on drug shortages and working to improve access. FDA addresses shortages by the following actions:
- Working with industry to resolve manufacturing issues to allow medications to return to the market.
- Speeding up FDA’s review process so that new manufacturers can supply needed products as soon as possible.
- Helping manufacturers to get new sources of raw material.
- Expediting review of pharmaceutical manufacturing lines.
- Extending expiration dates if pharmaceutical data can confirm safety and effectiveness.
- Procuring critical drugs from foreign manufacturing plants that meet FDA quality standards.
- Development of a long-term strategic action that drug makers can take to help prevent future shortages.
FDA is a government regulatory authority that can institute rules to address drugs in short supply, but it cannot force a manufacturer to supply a medication it decides to stop making. A manufacturer may simply stop making a drug due to low consumer demand, increased costs associated with production, or a business decision to move into new therapeutic areas. Patent loss and the advent of lower-cost generics can also greatly impact a manufacturer’s decision to continue making a brand-name medication.
FDA cannot require a pharmaceutical company to:
- make any drug, even if it is a medically necessary drug
- increase production of a drug
- change how much and to whom the drug is distributed.
However, manufacturers are required to report information about shortages to the FDA, including the reasons and expected duration for shortages.
Where Can I Obtain Information on U.S. Drug Shortages?
- Drug Shortage Statistics. ASHP. Accessed Feb. 8, 2022 at https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics
- Drug Shortages: Root Causes and Potential Solutions A Report by the Drug Shortages Task Force 2019. U.S. Food and Drug Administration. Accessed Feb. 8, 2022 at https://www.fda.gov/media/131130/download
- Drug Shortages Continue to Compromise Patient Care. ISMP. Accessed Feb. 8, 2022 at https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care
- Drug Shortages Infographic. U.S. Food and Drug Administration. Accessed Feb. 8, 2022 at https://www.fda.gov/drugs/drug-shortages/drug-shortages-infographic
- Report. Drug Shortages: Root Causes and Potential Solutions. U.S. Food and Drug Administration. Accessed Feb. 8, 2022 at https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions
- Frequently Asked Questions about Drug Shortages. U.S. Food and Drug Administration. Accessed Feb. 8, 2022 at https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages
- Drug Shortages: Contributing Factors, Mitigating the Impact. Pharmacy Times. March 21, 2019. Accessed Feb. 8, 2022 at https://www.pharmacytimes.com/news/drug-shortages-continue-to-be-a-challenge
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.