Objective Status

  • 2 Baseline only
  • 4 Developmental
  • 0 Research

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About the Workgroup

Approach and Rationale

Medicines are generally safe when used as prescribed or as directed on the label, but there are risks associated with taking any medicine. Medical products include drugs, biological products, and medical devices. Incorrect use and inadequate monitoring of many medical products can cause adverse effects. Therefore, a greater focus on the safe use of such products is critical. 

Each year in the United States, adverse drug events (ADEs) — or harm resulting from medication use — cause approximately 1.3 million emergency department visits and 350,000 hospitalizations1 and result in $3.5 billion in excess medical costs.2 ADEs are a serious public health problem, and many of them are preventable. ADEs include allergic reactions, side effects, overmedication, and medication errors. Increasing appropriate use and monitoring adverse effects of medical products will:

  • Decrease adverse events and harmful reactions by focusing safety efforts
  • Improve the overall effectiveness of treatment by reducing harm from medical products
  • Further personalize medical treatment

Ensuring the safe use of medical products aligns with the mission and ongoing initiatives of HHS. These include the National Action Plan for Adverse Drug Event Prevention3 and the 5-point strategy to combat the current opioid overdose crisis.4  These efforts will also improve patient safety and health care quality overall.

Understanding Medical Product Safety

Many factors influence the safety of medical products and their effects on patients. These include:

  • Appropriate prescribing and use
  • A patient’s physiological condition and genetic makeup
  • Drug ingredients, manufacturing, packaging, and labeling
  • Monitoring for adverse effects

The medications that cause the most emergency department visits for ADEs include blood thinners, antibiotics, diabetes drugs, and opioid analgesics:

  • Among children and adolescents, antibiotics are the leading drug class implicated in emergency department visits for ADEs
  • Among adults ages 20 to 64 years, antibiotics remain a leading cause of emergency department visits for ADEs
  • Among older adults, blood thinners and diabetes drugs are the leading causes of emergency department visits for ADEs

Patient safety and quality initiatives that focus on the medications and patient age groups most commonly involved in ADEs have the greatest potential to reduce the number of emergency department visits caused by ADEs. Also, interventions that can reduce the risk of medication overdoses in young children include implementing of flow restrictors,5 using unit-dose packaging,6 and standardizing dosing instructions in milliliters.7

Emerging Issues in Medical Product Safety

As health care continues to modernize, the number of ADEs may also grow because of:

  • The development of new medicines
  • The discovery of new uses for older medicines
  • An aging American population
  • The increased use of medicines for disease treatment and prevention
  • The expansion of insurance coverage for prescription medicines

In addition, focusing on the expanded use of health information technology is important for improving medical product safety. HHS is coordinating efforts to develop a national health information technology infrastructure that would include electronic medical records, digital prescribing programs, and electronic decision support systems.

Citations

1.

Centers for Disease Control and Prevention. (2017). Adverse Drug Events in Adults. Retrieved from https://www.cdc.gov/medicationsafety/adult_adversedrugevents.html

2.

Institute of Medicine. (2007). Committee on Identifying and Preventing Medication Errors. Retrieved from https://www.nap.edu/read/11623/chapter/1  

3.

Office of Disease Prevention and Health Promotion. (n.d.). National Action Plan for Adverse Drug Event Prevention. Retrieved from https://health.gov/our-work/health-care-quality/adverse-drug-events

4.

U.S. Department of Health and Human Services. (2018). 5-Point Strategy to Combat the Opioid Crisis. Retrieved from https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html

5.

Lovegrove, M.C., et al. (2013). Efficacy of Flow Restrictors in Limiting Access of Liquid Medications by Young Children. The Journal of Pediatrics, 163(4), 1134-1139. https://doi.org/10.1016/j.jpeds.2013.05.045

7.

Budnitz, D.S., Lovegrove, M.C., & Rose, K.O. (2014). Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications. Pediatrics, 133(2), e283-e290. https://doi.org/10.1542/peds.2013-2362