Continue Efforts to Improve Medication Safety

With their article in the January 12, 2023, edition of the New England Journal of Medicine, David W. Bates, MD, and colleagues once again reminded us that adverse events during hospitalizations continue to be a major cause of patient harm. From a random sample of 2809 admissions in 11 Massachusetts hospitals during 2018, the investigators identified 978 adverse events (34.8 events per 100 admissions) of which almost one-quarter (22.7%) were judged preventable and almost one-third (32.3%) classified as being of serious or higher consequence. Adverse drug events (ADEs) were the most common events and represented 39% of the total (or 13.6 [3.8-23.4, 95% CI] events per 100 admissions), of which 26.7% were judged to be preventable. The rate of adverse events did vary by institution, with a trend toward higher rates in larger hospitals. For the 3 large hospitals included in the study (defined as > 700 beds), the rates ranged from 39.7 to 47.0 adverse events per 100 admissions.¹

So to put this into perspective, for clinicians practicing at a large health system hospital with roughly 50,000 admissions per year, an extrapolated estimate of the potential number of ADEs is 6800 per year (95% CI, 1900-11,700), with approximately 1815 of those events being preventable. To take it 1 step further, approximately 430 of the preventable ADEs would be expected to have serious or higher consequences for patients. Of course, all of these estimates have CIs associated with them, so the actual experience may vary, but this illustrates the importance of these data when applied to the real world. Additionally, it is important to note that this study did not include any ambulatory visits, diagnostics procedures, emergency department stays, or observation admissions (< 48 hours), so a hospital’s actual experience with ADEs is going to be greater. If we then consider the impact across the more than 6000 hospitals in the United States, and an estimated 33.3 million hospital admissions per year, we continue to have a significant medication safety issue among hospitalized patients.²

The publication of the results of the Harvard Medical Practice Study in 1991 first raised awareness of and better quantified the risk for adverse events in hospitalized patients, including preventable ADEs.^3,4 Since then, much has been done in health systems to improve overall patient safety as well as medication safety. Universally, we have introduced many steps to improve medication safety, including electronic order entry as a component of electronic medical records; electronic medication administration records; widespread institutional standardization of drug preparation; integrated or profiled automated dispensing technologies; universal unit of use packaging; barcode confirmation of both medication dispensing and administration activities; a growing presence of automated workflow technologies during preparation of intravenous (IV) drugs; and smart IV pump guardrails for infusion rates with expanding integration of those pumps with electronic medical records. There is also the emerging presence of the robotic preparation of IV drugs. These and other technologies have undoubtedly improved medication safety for hospitalized patients, and it is beyond the scope of this editorial to summarize all that data.

Most health system pharmacy departments have also greatly expanded the clinical role of their pharmacists over the same 3 decades of technology growth. Many preventable ADEs are due to issues such as incorrect drug selection, inadequacy of follow-up and monitoring, avoidable delays in treatment, subtle errors in dosing, and many other sophisticated clinical drug use issues that current technology solutions often miss. Therefore, proper defense against preventable ADEs involves a combination of effective implementation and maintenance of technology solutions, as well as targeted clinical practice programs to contribute to the optimization of drug use decisions for members of the interprofessional patient care team.

As health system pharmacists, are we doing enough? Do all our colleagues, including our pharmacy staff, buy into the medication safety efforts and investments? Should we be doubling down on medication safety efforts, or are we facing a scenario of diminishing returns? The answers to these questions undoubtedly vary by institution, but I believe we could do more to protect our patients.

Let’s consider the use of barcode medication administration (BCMA). Most institutions strive to reach a 95% rate of compliance with BCMA, which is advocated for by several organizations, including The Leapfrog Group.⁵ Again, if we use our large hospital with 50,000 admissions per year for illustrative purposes, you would anticipate approximately 500,000 doses administered per month. The 5% of doses not subjected to BCMA equates to approximately 25,000 doses per month (or 300,000 per year) not being subject to an accepted and available safety standard. Is that acceptable? If a patient suffers serious, preventable harm because of this lack of defined safety standards, how do you defend that? How do you explain that to the patient or family? I have heard all the possible explanations for why it is difficult to exceed a 95% compliance rate, but when you look at them objectively, most are excuses rather than valid explanations. We also need to better understand BCMA rates based on the risk categorization of the drug. Global compliance rates do not tell enough of the story to truly assess the safety risk associated with the 5%.

As another example, smart pump interoperability with the medical record offers significant safety advances, but also poses risks if not implemented well. Most institutions strive to break 80% compliance with “pump integration.” Are we really OK with 1 in 5 infusions not using our best safety standard? Even with pump integration, barcode scanning compliance with each new infusion bag during a continuous infusion is variable, so our celebrated 80% is probably an overstatement of true compliance. Most explanations offered for why greater than 80% use is difficult can be summarized as lack of buy-in across all involved disciplines. As with BCMA, understanding compliance as it relates to relative risk of the drug is important.

These are just a couple of examples of areas for improvement but they illustrate the challenges of truly broad and successful implementation of technologies in complex organizations. Nevertheless, industries outside health care sometimes seem to achieve safety standards more successfully.

In summary, ADEs are still common and many of them are preventable. Our work is not done and we need to continue to push for effective and sustained implementation of technologies and continue to advocate for the growth of clinical pharmacy presence if we want to further improve drug safety. Unfortunately, we also have a much bigger task ahead of us to improve medication safety outside of our 4 walls.

About the Author

Curtis E. Haas, PharmD, FCCP, is director of pharmacy for the University of Rochester Medical Center in New York.

References

1. Bates DW, Levine DM, Salmasian H, et al. The safety of inpatient health care. N Engl J Med 2023;388(2):142-153. doi:10.1056/NEJMsa2206117

2. Fast facts on US hospitals, 2022. American Hospital Association. Updated January 2022. Accessed January 15, 2023. https://www.aha.org/statistics/fast-facts-us-hospitals

3. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324(6):370-376. doi:10.1056/NEJM199102073240604

4. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324(6):377-384. doi:10.1056/NEJM199102073240605

5. Bar code medication administration. The Leapfrog Group. 2018. Accessed January 15, 2023. https://www.leapfroggroup.org/sites/files/Files/Leapfrog-Castlight_BCMA_Final.pdf.