The National Action Plan for Adverse Drug Event Prevention

An adverse drug event (ADE) is defined as harm that results from a medication intervention1. Approximately 1.3 million emergency department visits, 350,000 hospitalizations 2, and $2.5 billion in excess medical costs occur annually in the United States from ADEs2. ADEs are the 4th leading cause of death in the US.

In 2014, The United States Department of Health and Human Services (USDHHS) implemented The National Action Plan for Adverse Drug Event Prevention to prevent ADEs and promote medication safety4. The report focused on ADEs that were common, clinically significant, preventable, and measurable5. The only medication classes included in the USDHH plan were anticoagulants, diabetes agents, and opioids5.

Researchers and key industry opinion leaders have long been advocating the need to retool prevention efforts to include additional medication safety targets. The issue has most recently grabbed the attention of two US legislators, Representatives Tom Emmer (MN-06) and Eric Swalwell (CA-15), co-chairs of the Personalized Medicine Caucus. The two have recently introduced bipartisan legislation to better address adverse drug events with pharmacogenomics.

The bill, known as the Right Drug Dose Now Act7, would update the Department of Health and Human Services’ National Action Plan for Adverse Drug Event Prevention. The updates would include creating an educational campaign to prevent adverse drug events and improving electronic health record systems to alert healthcare providers to drug-gene interactions at the point of prescribing. Lastly, the bill would allocate additional funding to the Genomic Community Resources program at the National Institute of Health to integrate PGx testing into patient care.

Pharmacogenomic Testing

Pharmacogenomic (PGx) testing identifies variants in a person’s DNA that affect how the individual responds to specific medications. This test can help identify whether a medication will be effective and safe for the patient, before the medication is even prescribed. PGx testing has been proven to mitigate ADEs while also being cost-effective.

One study showed patients who had PGx testing had 6.3% fewer hospitalizations, 11% fewer emergency department (ED) visits and 35.2% fewer outpatient visits than matched patients who did not receive a PGx test. The rate of overall healthcare resource utilization was 72.2% in the tested group vs. 49.0% in the untested group8.

Another study looked at the effects of PGx testing for home health patients taking multiple medications. This study found that the PGx tested group had an 85% reduction in the risk of death compared to the untested group9.

Economic modeling has shown that a one-time pharmacogenetic testing for a 40-year-old patient can potentially save $43,165 per life-year and $53,680 per quality-adjusted life-year10.

The Right Drug Dose Now Act

With increased use of medications for mental health due to COVID and the rising costs of health care, now is the time to utilize PGx testing to reduce trial-and-error prescribing and help prevent ADEs. Please support this bill by reaching out to Sarah Shapiro (sarah.shapiro@mail.house.gov) in Representative Swalwell’s office or Christine Callaghan (christine.callaghan@mail.house.gov) in Representative Emmer’s office.

References:
  1. Nebeker JR, Barach P, Samore MH. Annals of Internal Medicine.  2004;  140:795-801.
  2. Centers for Disease Control and Prevention. (2017). Adverse Drug Events in Adults. Retrieved from https://www.cdc.gov/medicationsafety/adult_adversedrugevents.html
  3. Institute of Medicine. (2007). Committee on Identifying and Preventing Medication Errors. Retrieved from https://www.nap.edu/read/11623/chapter/1 
  4. S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.  (2014).  National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author.
  5. Health Research & Educational Trust (August 2018). Adverse Drug Events Change Package:  2018 Update.  Chicago, IL:  Health Research & Educational Trust. Accessed at http://www.hret-hiin.org/
  6. Agency for Healthcare Research and Quality, 2015 National Healthcare Quality and  Disparities Report and 5th Anniversary  Report on the National  Quality Strategy.  Retrieved at: http://www.ahrq.gov/research/findings/nhqrdr/ nhqdr15/priorities.html
  7. The Right Drug Dose Now Act. https://emmer.house.gov/2022/2/emmer-swalwell-introduce-legislation-to-prevent-adverse-drug-effects
  8. Brixner D, Biltaji E, Bress A, et al. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ. 2016;19(3):213-228. doi:10.3111/13696998.2015.1110160.
  9. Elliott LS, Henderson JC, Neradilek MB, Moyer NA, Ashcraft KC, Thirumaran RK. (2017). Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial. PLoS ONE 12(2): e0170905. doi:10.1371/journal.pone.0170905
  10. Alagoz, O., Durham, D. & Kasirajan, K. Cost-effectiveness of one-time genetic testing to minimize lifetime adverse drug reactions. Pharmacogenomics J16, 129–136 (2016). https://doi.org/10.1038/tpj.2015.39