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Refused Medication Error
A man with end-stage renal disease was admitted with acute renal failure and mental status changes. The patient refused to take his lactulose owing to loose stools. Although nursing staff noted the refusal in the medical record, they did not inform his primary team. When the patient became more confused, a nurse alerted the team but did not describe the missed doses of lactulose. The patient continued to decline and was transferred to the ICU. In the accompanying commentary, Mary Foley, PhD, RN, of the UCSF School of Nursing, explores how medication nonadherence, communication failures, and deficiencies in electronic health records can hinder patient safety and recommends tactics to address these challenges.

Cases & Commentaries
Published February 2017

Refused Medication Error

Commentary by Mary Foley, PhD, RN

The Case

A 59-year-old man was admitted to the hospital with acute renal failure and mental status changes. He was alert to self and place only. The patient had end-stage liver disease and was not following his home treatment regimen. Specifically, he was noted to have doubled his daily dose of furosemide for more than 5 days in an attempt to remove edema. He was also noted to be poorly adherent with his lactulose.

Initial therapy was to carefully correct his acute renal injury while using lactulose to improve his hepatic encephalopathy. With treatment, both his mental status and his creatinine improved. Throughout his admission, he was assessed as a very high fall risk on a standard risk scale. As his platelet level was less than 40,000 µl, the staff's level of concern was heightened, in that a fall could be associated with dangerous bleeding.

As his hospitalization progressed, the patient refused to take his lactulose because of frustration with frequent, loose stools. The nursing staff noted the patient refusal in his medication record, but did not inform his primary care team. On the fourth day after his initial refusal, the patient became more confused, now only oriented to self, and began acting impulsively, including getting out of bed without assistance. The nurse alerted the primary care team of the patient's declining mental status and their concern about increased fall risk, but did not describe the missed doses of lactulose. The patient was placed on close observation for safety purposes but continued to decline and was transferred to the intensive care unit (ICU).

After being transferred to the ICU, the patient's mental status further deteriorated, and he became comatose and required intubation. The following morning, his next-of-kin and health care surrogate provided documentation of the patient's wish to forego mechanical ventilation. Less than 24 hours after admission to the ICU, the patient was extubated and died shortly thereafter.

The Commentary

by Mary Foley, PhD, RN

While this case is problematic on many levels, this commentary focuses on the three likely causes of the unfortunate outcome: medication nonadherence, poor transitions in care related to ineffective communication, and deficiencies of the electronic health record (EHR).

Medication nonadherence is a major cause of ineffective medical treatment.(1) It is estimated that 20% to 30% of medication prescriptions are never filled, and 50% of medications for chronic disease are not taken as prescribed. Nonadherence has been estimated to cost the United States health care system between $100 billion and $289 billion annually.(2) Barriers to medication adherence and safe medication use include knowledge deficits, practical barriers, and attitudinal factors.(3) For patients like this one with chronic diseases that compromise quality of life, unwanted adverse effects and a complex medication regimen (polypharmacy) are likely contributors to nonadherence.(4)

Current evidence indicates that the first-line agent to prevent acute or persistent hepatic encephalopathy is a nonabsorbable disaccharide, such as lactulose. For patients who develop gastrointestinal bloating or debilitating diarrhea, a second-line agent, such as the antibiotic rifaximine, should be considered.(5) In this case, the patient's refusal of the prescribed lactulose (due to the unwanted adverse effect of frequent loose stools) suggests that a second-line agent was indicated.

Poor transitions in care and ineffective communication during handoffs between and among nurses and physicians are another feature of this case. Throughout the admission and transfer process, the patient's refusal of the prescribed lactulose and continued decline in mental status were recorded, but apparently not communicated verbally to the primary medical team. The medical team members could have, or should have, been aware of the patient's decline through their own review of the medication record, nursing progress notes, and laboratory findings, and by physical examination of the patient.

Communication failures, particularly during transfers and handoffs, are the leading causes of inadvertent patient harm.(6,7) It is estimated that US hospitals waste more than $12 billion annually from communication inefficiencies. The average 500-bed hospital is estimated to lose more than $4 million per year, with increased length of stay accounting for 53% of that cost.(8) Communications training, protocols, and aids such as checklists can assist clinicians in preventing communication failures and in more rapid detection to mitigate patient harm.(6)

This case does not provide information regarding whether there was direct communication with the patient and family or significant others who may have been engaged in his care. Such communication can help prevent communication errors. In this case, it might even have resulted in a family member helping to improve the patient's adherence through closer monitoring or better understanding of risks and benefits. Nursing and medical documentation should have included an assessment of the patient's understanding (or lack thereof) of the prescribed medications, the level of distress caused by the medication adverse effects, and any context such as support or disagreement with the treatment plan by family members or significant others.(7)

The third likely contributing factor in this case was the EHR, which failed to support critical information sharing. Throughout the care in the hospital, the patient's refusal to take lactulose had been entered into the EHR. Additionally, the patient's laboratory results and mental status updates were documented. There is no indication in this case that the EHR alerted the medical team to the abnormal findings and the medication nonadherence.

Medical errors that occur in an EHR environment can usually be categorized as either those that occur in the process of entering and retrieving information, or as those that occur in the communication and coordination processes the EHR is intended to support.(9) In 2014, an information breakdown occurred at a Texas hospital that allowed a patient with Ebola to leave the hospital undetected. Analysis of the communication breakdowns in that case included a critique of the EHR.(10) As stated in the critique, the hope has been that EHRs would help solve communication problems by making information clearer and more readily accessible to all team members. In thinking about this case, one can imagine an improved EHR that alerted team members of both the fact that the patient had not taken his lactulose and that his confusion was unimproved, perhaps even making a connection between these two findings.

Why did this EHR fail to provide essential support? The information may have been entered in separate sections of the record not viewed by all providers, or the EHR system may have added to the workload and interfered with smooth working relations and communication routines.(9) The introduction of health information technology can be very disruptive to existing workflows. By understanding nursing and physician workflow, barriers and facilitators for information transfer can be discussed and improved upon.(11)

Several best practices might have led to a different outcome had they been implemented in this case. First, patient and family engagement is an important component in all health care safety programs.(12) This cultural shift requires resources to support patients and providers in a patient-centered, collaborative partnership.(3) The Agency for Healthcare Research and Quality provides many educational resources and tools for health care facilities to improve safety and quality through better patient engagement.(13)

Second, a successful handoff is defined as a transfer and acceptance of responsibility for patient care achieved through effective communication.(9) It is a real-time process of passing patient-specific information from one caregiver to another (or from one care team to another) to ensure the continuity and safety of that patient's care.(6) Additional best practices for communication include deliberate team training activities, such as crew resource management, teaching staff about the differences among professional communications, and educating them about how to overcome those barriers to effectively communicate.(7) Such practices might have led to a better outcome in this case.

Third, for EHR information to be shared effectively, it must be integrated into the workflow of all care providers. Standardizing provider-to-provider communications (such as from a triage nurse to the treating ED physician) can dramatically reduce medical errors, especially where computerized tools are in use. EHRs can incorporate tools for effective communication across all points of care.(10) Most important to effective implementation is the active involvement of clinicians and learning from evaluation of the system's impact on the work organization.(6)

Take-Home Points

A holistic approach to medication adherence with engagement of the entire team, patient, and family to more deeply understand the contributing factors will enable safer solutions to a patient's medication nonadherence.
Good team communication is a critical element of patient safety and should be an ongoing priority for all patient care teams.
Patient care teams need to have a thorough and realistic understanding of how their particular EHR system might facilitate or create barriers for good communication and safety. Patient care teams should be actively engaged in the design (or redesign) of EHR features that present barriers to safe patient care.

Mary Foley, PhD, RN
Clinical Professor
Director, Center for Nursing Research and Innovation
UCSF School of Nursing
San Francisco, CA

References

1. Priority Areas for National Action: Transforming Health Care Quality. Rockville, MD: Agency for Healthcare Research and Quality; 2003. [Available at]

2. Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012;157:785-795. [go to PubMed]

3. Aspden P, Wolcott JA, Bootman JL, Cronenwett LR, eds. Committee on Identifying and Preventing Medication Errors, Institute of Medicine. Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academies Press; 2006. ISBN: 9780309101479. [Available at]

4. Dunbar-Jacob J, Erlen JA, Schlenk EA, Ryan CM, Sereika SM, Doswell WM. Adherence in chronic disease. Annu Rev Nurs Res. 2000;18:48-90. [go to PubMed]

5. NeSmith M, Ahn J, Flamm SL. Contemporary understanding and management of overt and covert hepatic encephalopathy. Gastroenterol Hepatol (N Y). 2016;12:91-100. [go to PubMed]

6. Facts about the Hand-off Communications Project. Oakbrook Terrace, IL: Joint Commission Center for Transforming Health Care; 2016. [Available at]

7. Chapman KB. Improving communication among nurses, patients, and physicians. Am J Nurs. 2009;109:21-25. [go to PubMed]

8. Agarwal R, Sands DZ, Schneider JD. Quantifying the economic impact of communication inefficiencies in U.S. hospitals. J Healthc Manag. 2010;55:265-282. [go to PubMed]

9. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc. 2004;11:104-112. [go to PubMed]

10. Cartwright-Smith L, Thorpe JH, Rosenbaum S. Ebola and EHRs: an unfortunate and critical reminder. Health Affairs Blog. October 28, 2014. [Available at]

11. Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality; 2008. AHRQ Publication No. 08-0043. [Available at]

12. Agency for Healthcare Research and Quality. The role of consumers, families and the community in patient safety: learning from experience. Presented at: AHRQ 2008 Annual Conference; September 7-10, 2008; Rockville, MD. [Available at]

13. Guide to Patient and Family Engagement. Rockville, MD: Agency for Healthcare Research and Quality; October 2014. [Available at]

14. Ventura ML, Battan A, Zorloni C, et al. The electronic medical record: pros and cons. J Matern Fetal Neonatal Med. 2011;24(suppl 1):163-166. [go to PubMed]