A Series on Medication Safety in the United States: Defining the Problem

This 3-part series will describe the current status of medication safety in the United States, beginning with defining the problem, followed by discussing the published effective strategies to enhance safety and the underutilization of pharmacists.

What is an unmet clinical need? The criteria of an important unmet clinical need are threefold: 1) a highly prevalent and lethal condition with a major burden to health care systems; 2) an effective therapeutic strategy with published evidence of significant mortality reduction; and 3) underutilization of that therapy across the population.¹ Applying these 3 criteria to medication safety in the United States will define whether medication safety is an unmet clinical need.

The US health care system underperforms on many metrics. The United States spends more than $4.1 trillion per year on health care, 25% more per capita than the next highest-spending country.^2-4 In a comparison with 10 other developed countries, the United States ranks last on health outcomes.^5-6 Perhaps the most important area to optimize is medication management.⁶

There are approximately 20,000 prescription drug products and 300,000 over-the-counter (OTC) agents approved by US Food and Drug Administration (FDA) on the US marketplace.^8-9 When combined with the nutraceutical product categories of functional food (probiotic and omega free fatty acid fortified foods, ionized salts, wheat flour, and other functional food), functional beverages (fruit and vegetable juices and drinks, dairy and dairy alternative drinks, noncarbonated drinks [bottled water, tea, coffee], sports and energy drinks), dietary supplements (proteins and peptides, vitamins and minerals, herbals), and personal care items, the number of potential prescription drug-OTC-nutraceutical combinations that may cause harm is beyond the ability of any one person to comprehend.¹⁰ The number of potential combinations totals 6 billion.⁷ 

Approximately 70% of US citizens take at least 1 prescription drug, and more than 50% take 2.¹¹ The most common medications prescribed include antibiotics, antidepressants, and painkilling opioids. Perhaps most importantly, 20% of Americans take 5 or more prescription medications daily. These statistics make the potential for adverse drug events (ADEs) commonplace.

ADEs are described as nonoptimal medication therapy events which per se are defined as iatrogenic hazards or incidents associated with medications. ADEs continue to be a major health care crisis.^{6, 9-20} The estimated annual cost of ADEs based on drug-related morbidity and mortality is $528.4 billion (range: $495.3 to $672.7 billion) in the United States, which represents 16% of total US health care expenditures in 2016.¹³

The average cost of a patient’s ADE treatment failure, new medical problem, or both is $2481/event (range: $2233 to $2742).¹³ ADEs occur in the in-patient or outpatient setting and account for 1 in 3 hospital adverse events, affecting 2 million persons annually. ADEs prolong hospital stays by 1.7 to 4.6 days.¹² Outpatient ADEs lead to an excess of 3.5 million physician office visits,¹² 600,000 to 1 million emergency department visits,^13-15 and a projected 4.6 million hospital admissions between 2020-2030.^12-13 Therefore, the United States spends more money to correct problems related to medications than the amount we spend on the medications themselves.

Older adults (≥65 years of age) experience >10 million ADEs, 4.8 million outpatient visits, 280,000 hospitalizations, the highest hospitalization rate (43.6%), and 9000 deaths annually.^21-22 Studies to date have excluded several integrated health care systems, suggesting that current ADE evidence may be an underestimate of the true ADE incidence. Life expectancy in some patient groups may be reduced by ADEs.^{18, 20}

Therefore, medication safety in the United States is an important unmet clinical need.

The second part of this series, where Dr Munger shares strategies for providers and health systems to improve medication safety, can be found here.

The third part of this series, where Dr Munger discusses the underutilization of pharmacists, can be found here.

References:

1. Ahmad Y, Lansky AJ, Velazquez EJ. Current landscape and future directions of coronary revascularization in patients with heart failure. JAMA Cardiol. 2022;7(6):577-578. doi:10.1001/jamacardiol.2022.0659
2. Organization for Economic Co-operation and Development. Health Spending. 2020. Accessed June 29, 2022. https://data.oecd.org/healthres/health-spending.htm
3. Squires D, Anderson C. US health care from a global perspective. The Commonwealth Fund.  Published October 8, 2015. Accessed June 29, 2022. https://www.commonwealthfund.org/publications/issue-briefs/2015/oct/us-health-care-from-a-global-perspective
4. Centers for Medicare & Medicaid Services. National health expenditure data. CMS.gov. Updated December 15, 2021. Accessed June 29, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical
5. Schneider EC, Shah A, Doty MM, Tikkanen R, Fields K, Williams II RD. Mirror, mirror 2021: reflecting poorly. The Commonwealth Fund. Published August 4, 2021. Accessed June 29, 2022. https://www.commonwealthfund.org/publications/fund-reports/2021/aug/mirror-mirror-2021-reflecting-poorly
6. Kohn LT, Corrigan JM, Donaldson MS. Errors in health care: a leading cause of death and injury. In: Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. National Academies Press (US); 2000. Accessed June 29, 2022. https://www.ncbi.nlm.nih.gov/books/NBK225187/
7. Munger MA, Turgeon J, Pace WD. Why we need a modern act to prevent harm from medications. The Hill. April 6, 2022. Accessed June 29, 2022. https://thehill.com/opinion/healthcare/3260179-why-we-need-a-modern-act-to-prevent-harm-from-medications/ 
8. US Food and Drug Administration. Fact Sheet: FDA at a Glance. Updated November 18, 2020. Accessed June 29, 2022. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
9. FAQs about the regulation of OTC medications. Consumer Healthcare Products Association. Accessed June 29, 2022. https://www.chpa.org/faqs-about-regulation-otc-medicines
10. Vig H, Deshmukh R. Nutraceuticals market by type, (functional beverage, functional food, and dietary supplements), form (capsules and tablets, liquid, powder, others), and sales channel (hypermarkets/supermarkets, specialty stores, pharmacies, and online channels): global opportunity analysis and industry forecast, 2021–2030. Allied Market Research. Accessed June 29, 2022. https://www.alliedmarketresearch.com/nutraceuticals-market
11. Nearly 7 in 10 Americans take prescription drugs, Mayo Clinic, Olmsted Medical Center find. News release. Mayo Clinic; June 19, 2013. https://newsnetwork.mayoclinic.org/discussion/nearly-7-in-10-americans-take-prescription-drugs-mayo-clinic-olmsted-medical-center-find/
12. Besco K. Medication Misadventures I: Adverse Drug Reactions. In: Malone PM, Malone MJ, Park SK. eds. Drug Information: A Guide for Pharmacists, 6e. McGraw Hill; 2018. Accessed June 29, 2022. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2275&sectionid=177200213
13. Watanabe JH, McInnis T, Hirsch JD. Cost of prescription drug-related morbidity and mortality. Ann Pharmacother. 2018;52(9);829-837. doi:10.1177/1060028018765159
14. Assiri GA, Shebl NA, Mahmoud MA, et al. What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of international literature. BMJ Open. 2018;8:e019101. doi:10.1136/bmjopen-2017-019101
15. Lin CW, Wen YW, Chen LK, Hsiao FY. Potentially high-risk medication categories and unplanned hospitalizations: a case-time-control study. Sci Rep (Nature). 2017;7.41035 doi:10.1038/srep41035
16. US Department of Health and Human Services. National action plan for ADE prevention. Accessed June 29, 2022. https://health.gov/our-work/health-care-quality/adverse-drug-events 
17. Medication overload: America’s other drug problem. How the drive to prescribe is harming older adults. Lown Institute; 2019. Accessed June 29, 2022. https://lowninstitute.org/wp-content/uploads/2019/09/xs-medication-overload-lown-web.pdf
18. AHRQ National Scorecard on hospital-acquired conditions: updated baseline rates and preliminary results 2014-2017. Agency for Healthcare Research and Quality. 2019. Accessed June 29, 2022. https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/pfp/hacreport-2019.pdf
19. Budnitz DS, Pollock DA, Weidenbach KN, Menelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006; 296(15):1858-1866. doi:10.1001/jama.296.15.1858
20. Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US emergency department visits for outpatient adverse drug events, 2013-2014. JAMA. 2016;316(20):2115-2125. doi:10.1001/jama.2016.16201
21. Kessler C, Ward MJ, McNaughton CD. Reducing adverse drug events. JAMA. 2016;316(20):2092-2093. doi:10.1001/jama.2016.16392
22. Sarkar U, López A, Maselli JH, Gonzales R. Adverse drug events in US adult ambulatory medical care. Health Serv Res. 201146(5):1517-1533. doi:10.1111/j.1475-6773.2011.01269.x