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Drug Shortage Statistics in the U.S and the FDA Response

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. Since 1999, the U.S Food and Drug Administration (FDA) has been working with drug manufacturers to address possible drug shortages and to ensure a patient's access to critical and lifesaving medications. Today, FDA also works closely with healthcare professionals and patients to prevent and mitigate drug shortages of medically necessary drugs.

Which Drugs Are Involved in U.S. Drug Shortages?

FDA officials work closely with industry, health care providers, and patients to prevent and mitigate shortages of “medically necessary” medicines. For the FDA, identified drug shortages would involve medically necessary products that can have a significant effect on public health. 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. The agency consider all possible drug shortages to determine if they are medically necessary.

Main Reasons for Drug Shortages

  • Quality Issues: Manufacturing issues or delays/capacity: 64%
  • Raw materials may be in short supply: 27%
  • Loss of drug manufacturing site or production line: 2%
  • Increased demand: 5%
  • Drug discontinuation or lack of financial incentive: 2%
As might be expected, the top reason for drug shortages revolves around quality concerns. According to a recent infographic 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 financial incentive to continue manufacturer production can all affect drug availability.

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.
  • Patients may decide to buy unapproved drugs online or from foreign countries.

A survey conducted with pharmacists by The Institute for Safe Medication Practices (ISMP) in 2012 revealed medications most commonly involved in side effects due to drug shortages:

  • Chemotherapy (27%), particularly doxorubicin
  • Opioid analgesics (17%), mostly fentanyl and morphine
  • Electrolytes (7%)
  • Antibiotics (5%)
  • Phentolamine (4%)
  • Phytonadione (4%)

FDA’s Response to Mitigate Drug Shortages

FDA has made a significant impact by taking action on drug shortages and working to improve access. FDA addresses shortages by:

  • Working with firms 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 firms 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

Has the FDA Response to Drug Shortages Made an Impact?

According to the Title X of the Food and Drug Administration Safety and Innovation Act of 2012, all pharmaceutical manufacturers must give advanced notice to the FDA about upcoming critical drug 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, when required.

Shortages Reported


2011 2012 2013 2014

All Forms

251

117

44

44

Injectables

183

84

35

30

Shortages Averted


2011 2012 2013 2014

All Forms

191

282

170

101

Injectables

165

213

145

62

While progress is evident, there is still a high percentage of drug shortages which include sterile injectables like chemotherapy, anesthesia medications, intravenous (IV) fluid replacements, IV nitroglycerin, and antibiotics. 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?

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