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U.S. Department of Health and Human Services


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Safe Use Initiative Fact Sheet

Today, tens of millions of people in the United States depend on prescription and over-the-counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, and some die as a result of preventable medication errors.

The goal of U.S. Food and Drug Administration’s Safe Use Initiative is to create and facilitate collaborations among groups vested in the safe use of medications with the intention of identifying specific, preventable medication risks; and developing, implementing, and evaluating cross-sector interventions to reduce the preventable harm from these risks.

FACT: Improper medication use increases the risk of harm from medication, often resulting in hundreds of thousands of injuries or deaths each year. Many of these injuries and adverse events could have been prevented with currently available knowledge.


  • The Institute of Medicine (IOM) estimates that at least 1.5 million preventable adverse drug events occur within the healthcare system each year.1 The costs of these preventable adverse drug events has been estimated to exceed $4 billion annually.
  • Unintended exposure to medications causes a significant number of injuries and deaths, primarily in children. One study found that more than 9,000 children were accidentally exposed to prescription opioid drugs between 2003 and 2006.2  It is estimated that 60,000 emergency department visits occur each year as a result of unsupervised ingestion of medications by children under 12 years of age.3
  • In 2007, 5.2 million Americans 12 years and older reported using a prescription pain reliever for a non-medical use one month prior to being surveyed.4
  • Substance abuse treatment admissions in the United States for non-heroin opiates/synthetics has increased from 15,000 in 1997 to more than 85,000 in 2007.5  And in 2006, there were more than 165,000 Emergency Department (ED) visits related to non-medical use of hydrocodone, oxycodone, and methadone-containing products.6
  • In 2006, it was estimated that more that 180,000 drug-related Emergency Department visits were because of suicide attempts and nearly two-thirds of these involved multiple drugs.6 Ninety-two percent of these suicide attempts involved pharmaceuticals. Fifty-eight percent involved psychoactive compounds such as benzodiazepines or antidepressants. Forty-five percent involved CNS agents, mostly prescription and over-the-counter (OTC) analgesics (19% of suicide attempts used NSAIDs; 7% of suicide attempts used aspirin).


FACT: All medications have inherent risks and when a person decides to use medication, he or she is agreeing to take certain risks. Some of the risks are unavoidable, while others can be avoided and managed. The Safe Use Initiative targets medication risks that can be managed, reducing the incidence of preventable harm.

  • Unavoidable medication risks result from gaps in current knowledge; i.e., risks that are not known to the medical scientific community. There are also unavoidable risks from known side effects of medication. These risks are present even when all parts of the medication use process are optimally executed.
  • Manageable medication risks come from four broad sources. One source comes from medication errors. These mistakes occur anywhere in the medication use process because of informational errors in prescribing, informational errors by patients and consumers, and/or through procedural and process errors with medication. Informational errors are a result of failing to use available information in the medication decision making process. Other sources of manageable medication risks are unintended or accidental exposure, intentional misuse, abuse and self-harm, and manageable, but small, risks from drug quality defects.


FACT: Reducing harm from manageable medication risks requires a collaborative process from all parties involved in the medication manufacturing, distribution, and use system, as the potential for preventable errors can be increased along any point of this complex system. FDA is in a unique position to facilitate the collaborative process, given this Agency’s intersection with industry, the healthcare system, and other government agencies directly involved with public health. These stakeholders include:

  • Federal agencies, such as the Drug Enforcement Agency (DEA), the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and others.
  • Pharmacies, hospitals, and other healthcare entities (including those operated by the Federal government and the states).
  • Healthcare professionals, including physicians and physician assistants, dentists, pharmacists, nurses, and their professional societies.
  • State regulatory bodies, including professional licensure and oversight boards.
  • Healthcare insurers.
  • Patients, caregivers, consumers, and organizations representing their interests.

FACT: FDA has already launched several medication risk reduction projects that could benefit from collaboration with relevant stakeholders. These efforts are described on the Safe Use Initiative: Opportunities for Collaboration page.


You can find additional information in the Safe Use Initiative Report.




  1.  Institute of Medicine of the National Academies, Preventing Medication Errors, National Academies Press, 2007, p 124.

  2.  Bailey JE, Campagna E, Dart RC. The Underrecognized Toll of Prescription Opioid Abuse on Young Children, Ann Emerg Med 2009;53:4129-24.

  3.  Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network, 2006: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2008. (DAWN Series D-30, DHHS Publication No. (SMA) 08-4339.

  4.  Johnston, L. D., O’Malley, P. M., Bachman, J. G., & Schulenberg, J. E. (2009). Monitoring the Future national survey results on drug use, 1975–2008: Volume I, Secondary school students (NIH Publication No. 09-7402). Bethesda, MD: National Institute on Drug Abuse.

  5.  Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Treatment Episode Data Set (TEDS): 1997-2007. National Admissions to Substance Abuse Treatment Services, DASIS Series: S-47, DHHS Publication No. (SMA) 09-4379, Rockville, MD, 2009.

  6.  Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network, 2006: National Estimates of Drug-Related Emergency Department Visits. DAWN Series D-30, DHHS Publication No. (SMA) 08-4339, Rockville, MD, 2008.



Contact FDA

Safe Use Initiative Team

Professional Affairs and Stakeholder Engagement (PASE)

Office of the Center Director

WO 51-2341

10903 New Hampshire Avenue

Silver Spring, MD 20993