Skip to Content

U.S. Drug Shortages: Root Causes and Recent Statistics

Medically reviewed by Leigh Ann Anderson, PharmD Last updated on Dec 6, 2019.

Introduction

The highest standard of patient care is a top goal for every healthcare provider and institution in the United States. However, 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 is a priority for the U.S. Food and Drug Administration (FDA). What is the FDA doing to address drug shortages? 

In 2018, the FDA developed a new Drug Shortages Task Force to explore the reasons and determine the root causes of why drug shortages remain an ongoing problem. The FDA worked with scientists and economists to review recent drug shortages. They interacted with the public, gathered comments, and worked with stakeholders such as patients, healthcare providers and pharmaceutical industry to better understand the causes of drug shortages and determine a solution.

Which drugs are involved in U.S. 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 in October 2019 entitled "Drug Shortages: Root Causes and Potential Solutions" that attempts to identify the causes and offers recommendations for government and industry.

Drugs.com: Status of All Current U.S. Drug Shortages

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:

  • Low price and financially unattractive to industry; many shortages began due to discontinuation of products for commercial reasons.
  • 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.
  • Identified drug shortages would involve medically necessary products that can have a significant effect on public health.
  • The agency considers all possible drug shortages and determines if they are a medically necessary medication.

A 2017 survey from The Institute for Safe Medication Practices (ISMP) revealed the treatment categories most commonly involved in drug shortages. The survey was collected from varied practice sites, such as critical access hospitals, teaching hospitals, and community hospitals. A majority of sites were affected by at least one drug shortage each day, especially specialty (80%), community (77%), and teaching hospitals (73%).

Table 1. Treatment Categories Commonly Involved in Drug Shortages

Treatment categories Frequency of shortages
Emergency care 87%
Anesthesia care 85%
Pain management 81%
Infectious disease treatment 71%
Cardiovascular care 68%
Parenteral nutrition 55%
Obstetrics / gynecology 33%
Hematology / oncology 33%
Neurology 18%
Allergy / asthma care 15%
Psychiatry 10%
Endocrinology 10%
Ophthalmology 5%
Intravenous (IV) fluids 5%

Why do drug shortages occur?

  • Quality, manufacturing issues: 37%
  • Quality, delays or capacity: 27%
  • 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, the 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 in the past with flu vaccines and antiviral treatments) and lack of manufacturer financial incentive can all affect drug availability.

However, as noted by the 2019 report from the FDA Drug Shortages Task Force, the root causes of drug shortages often involve economic factors that occur due to both public- and private-sector decision-making.

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.

What are the impacts due to drug shortages?

  • Medical procedure delays
  • 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 may decide to buy unapproved drugs online or from foreign countries

FDA’s response to lessen drug shortages

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.

2018-2019: FDA Drug Shortages Task Force

According to the Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA), pharmaceutical manufacturers must give advance notice to the FDA about upcoming critical drug and biologic shortages, including discontinuations (at least 6 months in advance) or production interruptions. However, FDA encourages suppliers to notify FDA of any impending shortage at any point in the manufacturing process. With this advance notice, FDA is able to implement action to minimize the patient care impact of the drug shortage.

As outlined in the FDASIA, the agency also convened the Drug Shortages Task Force. The Task Force made the following three recommendations to address shortages:

  1. To research and better understand the impacts of drug shortages and contracting practices that may lead to these shortages. Improve efforts to characterize shortages, quantify their effects, and observe how these drugs are contracted in business.
  2. Develop a system to measure and rate manufacturing facility quality and ability to deliver consistent, high quality products. Improve transparency for the public about quality of manufacturers and their facilities.
  3. Consider new contracting approaches to ensure a more reliable supply of drugs. Options here involve: financial incentives for industry (especially of older generics), paying higher prices for drugs rated high in quality, requiring quality measures as a condition of contracting, or buying a set volume of drug from industry that has met a quality standard.

The Task Force also made budget proposals, is releasing new industry guidance, and encourages greater flexibility around the international market, their manufacturing processes, and ability of FDA to implement post-approval changes to drugs produced outside the U.S.

Table 2. Drug Shortages: All Dosage Forms

  2011 2012 2013 2014 2015 2016 2017 2018

Drug Shortages Reported

251

117

44

44

 

26

23

35

50

Drug Shortages Prevented by FDA 

191

282

170

101

145

115

132

146

Table 3. Drug Shortages: Injectables Only

  2011 2012 2013 2014 2015 2016 2017 2018

Drug Shortages Reported

183

84

35

30

15

17

 

26

24

Drug Shortages Prevented by FDA

165

213

145

62

92

87

51

109

*Source: https://www.fda.gov/drugs/drug-shortages/drug-shortages-infographic

While progress is evident, there is still a high percentage of drug shortages which include sterile injectables like cancer drugs (chemotherapy), anesthesia medications used in surgery, electrolytes for IV feeding and drugs used in emergency medicine. FDA will continue to work with pharmaceutical industry and other stakeholders to ensure that needed medicines are available to the American public.

Where Can I Obtain Additional Information on U.S. Drug Shortages?

Sources

  1. Drug Shortages: Root Causes and Potential Solutions A Report by the Drug Shortages Task Force 2019. U.S. Food and Drug Administration. Accessed Dec. 6, 2019 at https://www.fda.gov/media/132059/download
  2. Drug Shortages Continue to Compromise Patient Care. ISMP. Jan 11, 2019. Accessed Dec. 7, 2019 at https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care
  3. Drug Shortages Infographic. U.S. Food and Drug Administration. Updated October 22, 2019. Accessed November 26, 2019 at https://www.fda.gov/drugs/drug-shortages/drug-shortages-infographic
  4. Report. Drug Shortages: Root Causes and Potential Solutions. U.S. Food and Drug Administration. Updated October 29, 2019. Accessed December 6, 2019 at https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions
  5. Frequently Asked Questions about Drug Shortages. U.S. Food and Drug Administration. Updated July 5, 2018 at Accessed Dec. 7, 2019 at https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages
  6. FDA Establishes New Task Force on Drug Shortages. Drugs.com. Accessed Dec. 7, 2019 at https://www.drugs.com/news/fda-establishes-new-task-force-shortages-75712.html
  7. Drug Shortages: Contributing Factors, Mitigating the Impact. Pharmacy Times. March 21, 2019. Accessed Dec. 7, 2019 at https://www.pharmacytimes.com/news/drug-shortages-continue-to-be-a-challenge

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide