Advances in Patient Safety and Medical Liability

Abstract

Purpose: To identify barriers to and solutions for improving medication safety and reducing medical liability during patients’ transition from hospital to home.

Methods: A qualitative descriptive study, guided by the Sensemaking Conceptual Framework, was completed with 10 focus groups of stakeholders that were segregated according to whether they represented patients and family members or a professional group. During each focus group, two case studies about patients experiencing medication discrepancies following a hospital to home transition were presented. Participants were asked to identify factors contributing to medication discrepancies, health system solutions to prevent medication discrepancies, and how assignment of responsibility should be accomplished if patients were permanently harmed because of a medication discrepancy.

Results: Stakeholder groups identified common barriers and solutions to hospital-home transitional care medication safety. Barriers to medication safety included themes related to patient- and family-level factors (competency, retaining old prescriptions, and access to medication), as well as health system-level factors (communication and care coordination, complex discharge processes, and staffing and time constraints). Solution themes were improving information management, increasing access to medicines, and enhancing human resources. Participants across focus groups also reported that attributing responsibility for medication discrepancies was contextual and complex, but they agreed that full disclosure was desired when an error that caused harm occurred.

Conclusions: A wide range of stakeholders identified similar themes regarding barriers contributing to medication discrepancies during care transitions and solutions for reducing or overcoming barriers. Approaches to address many of the identified barriers are available. Full disclosure when harm occurs from a medication error is a best practice. Study findings support more widespread adoption of evidence-based strategies and legislative provisions to improve transitional care medication safety and to reduce medical liability.

Introduction

Health systems expend considerable resources to reduce medication errors in hospital settings. Increasingly, inpatient medication risk management efforts focus on preventing errors by improving systems and creating safety cultures rather than assigning blame for unsafe practice.^1-3 Unfortunately, the potential for patient harm and increased medical liability due to medication discrepancies and errors does not end at hospital discharge. The transition from hospital to community settings is an exceptionally risky time for patients.^4-8 Data suggest that up to 90 percent of patients experience at least one medication discrepancy in the transition from hospital to home, and discrepancies occur for all classes of medicines.^9-11 Medication discrepancies that occur during the transition from hospital to home are defined as differences in the medicines that patients are actually taking compared to medicines listed on the hospital discharge list.¹² Patients with hospital-to-home medication discrepancies are almost twice as likely to be readmitted to the hospital within 30 days as patients with no transitional care medication discrepancies.¹³

The transitional care period begins the day the patient is discharged from the hospital and continues for the next 29 days.¹⁴ During this period, the hospital provider transfers care to the outpatient primary care provider (PCP), but there is usually minimal follow-up to this hand over. The transitional care period is a time of concern because it is when patients are particularly vulnerable to experiencing adverse events. An adverse event is defined as an injury resulting from health care management, rather than the underlying disease, within 3 weeks of discharge.¹⁵ Poor care coordination that occurs during the transitional period may lead to adverse events that could result in hospital readmissions and/or greatly increase the patient’s chances of morbidity and mortality. A recent study suggests that up to 23 percent of patients experienced an adverse event within 5 weeks of discharge, 72 percent were drug related, and up to one-third were preventable.¹⁶

Patients at high risk to experience medication discrepancies and errors include older adults, those with polypharmacy (both prescribed and non-prescribed medicines), drug interactions, multiple comorbidities, altered drug pharmacokinetic profiles and/or pharmacodynamic responses as a result of aging, and altered medication adherence caused by depression or cognitive impairment.^17,18 Preventable medication errors are estimated to impact more than 7 million patients, contribute to 7,000 deaths, and cost $21 billion in direct health care costs annually in the United States.¹⁹ Adverse drug events (ADEs) are multifactorial and are attributed to both human and system errors. Some of these factors include a breakdown in health professionals’ communication, medication discrepancies, poor patient follow-up, and inadequate patient education. To emphasize the importance of eliminating the occurrence of adverse events and ADEs, several health care agencies have acknowledged them as a patient safety priority. For example, the National Priorities Partnership declared patient safety from potentially preventable adverse events, including medication discrepancies, a national priority.²⁰ The hospital-to-home transitional care period provides an important opportunity to reduce medication discrepancies and ADEs and improve patient safety. Furthermore, Joint Commission National Patient Safety Goals state, “when a patient leaves an organization’s care directly to his or her home, the complete and reconciled list of medications is provided to the patient’s known primary care provider, or the original referring provider, or a known next provider of service.”²¹ The Joint Commission’s safety goals confirm the importance of medication reconciliation as a way to prevent ADEs, yet despite the medication reconciliation mandate, transitional care medication discrepancies remain high, and safety concerns persist.^10,11,16

The focus of this paper is on identifying stakeholders’ perceptions of barriers to and solutions for improving medication safety and reducing medical liability during patients’ transition from hospital to home. The medication management components of transitional care that are perceived by stakeholders as most important for improving patient outcomes, reducing health care costs, and minimizing medical liability have not been systematically explored. As part of a larger study to understand how to maximize medication safety while improving patient outcomes and minimizing medical liability during transitional care, our team gathered data from diverse stakeholders during segregated focus groups (N=10).

The study aims were to identify barriers to and solutions for accurate and complete medication information transfer during patients’ transition from hospital to home. Thus, the primary purpose of this study was to make sense of the phenomenon of medication discrepancies during the hospital-to-home transition and, using sensemaking processes, identify stakeholders’ strategies for reducing medication discrepancies to improve patient safety, which may offer potential solutions for medication information transfers. A secondary aim was to explore medical liability issues associated with medication discrepancies that result in permanent patient harm.

Methods

The study was guided by the “Sensemaking Conceptual Framework” described by Weick.²² Sensemaking involves conversations about ambiguous issues with the goal of, literally, trying to make sense of them.²³ Conversations allow for a shared representation of a phenomenon.²³ Following Institutional Review Board (IRB) approval, the study was implemented using a descriptive qualitative design.²⁴ Divergent groups of stakeholders were recruited to participate in one of ten focus groups. Participants were identified based on their membership in a stakeholder population. A total of 69 participants made up the 10 stakeholder focus groups, which were segregated according to stakeholder status (e.g., comprising either solely patients and family members or solely professionals from a specific discipline). The 10 stakeholder focus groups included: patients and family members from urban hospitals (n=11); patients and family members from rural hospitals (n=6); primary care ambulatory physicians and hospitalist physicians (n=7); home care nurses (n=4); urban hospital nurses (n=5); rural hospital nurses (n=7); retail and acute care pharmacists (n=8); acute care, home care, and long-term care social workers (n=12); health plan contract administrators (n=3); and health care lawyers (n=6).

In all cases, potential participants were invited to participate via written letter and asked to contact the research assistant (Balogh) for more information about the study. Focus groups lasted 1½ - 2 hours and were held at public locations convenient to the participants, such as conference rooms at area hospitals and universities. Notes were taken during the focus group conversations by the principal investigator and by a research assistant who also recorded the focus group discussions using a smart pen.

At each focus group, researchers presented two case studies about medication discrepancies experienced during a hospital-to-home transition. The case studies were based on actual medication discrepancies that occurred during a hospital-to-home care transition. They were selected to capture critical safety and medical liability risk characteristics based on the following criteria: (1) adult patient with multiple chronic conditions; (2) patient prescribed five or more medicines when discharged from the hospital; and/or (3) medication discrepancy identified that involved a medicine on the Institute for Safe Medication Practices’ list of high-alert medications in community/ambulatory health care.²⁵ Pseudonyms were used for the patient names, and some of the details were changed in each case study to ensure patient anonymity. After presentation of the case studies, we sought the stakeholders’ perspectives and interpretation of barriers to and solutions for transition-related medication discrepancies.

Case Study One: Mrs. Brown

Mrs. Brown was a 61-year-old woman who had been admitted to the hospital with sepsis. Her past medical history included diabetes mellitus, cellulitis, and pyelonephritis. She reported taking 16 medicines at home. During the hospital-to-home transition period, several discrepancies were noted when her discharge medication list was compared to the medicines she reported taking at home. Focus group participants were asked to specifically consider two medication discrepancies that involved Lantus^® and NovoLog^® insulin. The Lantus^® dose noted on the discharge instructions was half the dose Mrs. Brown reported as her usual home medication dose. Mrs. Brown had also been using NovoLog^® prior to her hospitalization, and there was not a discharge prescription for NovoLog^®; thus she was unsure if she should continue using Novolog^TM and if so, what the correct dose would be.

Case Study Two: Mr. Adams

Mr. Adams was a 69-year-old man admitted for difficulty walking. His past medical history included obesity, arthritis, hypertension, and hypercholesterolemia. The patient reported taking nine home medicines, including warfarin. The warfarin was not written on the discharge medication orders, and other discrepancies were also found when comparing his home medicines to his discharge list.

At each focus group, Mrs. Brown’s case study was presented to the focus group members, followed by Mr. Adams’s case study. Four questions/issues were addressed separately through group discussion:

1. Based on your professional expertise and/or personal experience, what factors may have contributed to the medication discrepancies described in the case studies?
2. Now, let’s consider the reason each of those contributing factors have occurred.
3. Considering these potential contributing factors or causes, what systems could be implemented to prevent this from occurring in the future?
4. If you or, for example, Mrs. Brown or Mr. Adams, had been permanently harmed because of a medication discrepancy, at what point should someone be responsible for that harm?

Data Analysis

Notes and recordings from all focus groups were independently analyzed by two members of the research team (Corbett and Smith) with the goal of transforming (making sense of) the data by identifying concepts and themes.²⁶ Concepts identified as important were written in the margins of the transcripts. The two investigators then compared and discussed their findings to establish shared meaning of terms and phrases. There was overall accordance between the two investigators’ findings; on the rare occasions when interpretations differed, discussion ensued until consensus was reached. Discussion primarily centered on refining and labeling the concepts and then identifying themes that reflected the best transformation of the data. For example, one investigator identified a barrier related to “financing medications,” whereas the other investigator labeled this barrier as “access to medications.” The investigators then jointly reviewed the data and observed that multiple barriers to medication access (e.g., transportation to obtain medications, pharmacy closures on evenings and weekends) were discussed in several focus groups. Therefore, the concept “access to medications” was chosen as a better reflection of the data. Concepts to support the main themes were identified in each focus group.

Using the same sensemaking approach and qualitative descriptive techniques,²⁶ other members of the research team independently analyzed a subset of randomly selected focus groups. Their notes and identified concepts, written in the margins of the transcripts, were reviewed and found to be congruent with those identified by Corbett and Smith, which provided additional reliability to the study findings. Transforming or making sense of the data allowed the researchers to identify strategies that best addressed the transitional care medication safety themes generated by the diverse groups of stakeholders.

Results

Throughout the 10 focus groups, although there were some unique perspectives, participants’ answers from the disparate stakeholders shared many commonalities. Based on participants’ responses to the case study questions, we identified three major themes related to barriers to medication safety, potential solutions to medication discrepancies, and liability for medication discrepancies.

Theme 1: Barriers to medication safety during transition from hospital to home. We asked participants to identify factors that may have contributed to the medication discrepancies identified in the case studies. Two sub-themes emerged: patient specific barriers and health system barriers (Table 1).

Sub-themes related to patient level barriers. Three patient-level factors were reported as obstacles to medication safety and included: (a) competency; (b) retaining old prescriptions; and (c) access to medications. Competency refers to a patient’s limited understanding of the medications or how to successfully manage medications. This concern was raised in all of the focus groups. A social worker commented, “Patients are overwhelmed and may not have prior education on medications.” Health literacy, was also identified as a component of patient competency that many patients face.

Table 1.  Theme 1: Barriers to Medication Safety

Sub-theme 1: Patient Level Barriers	Sub-theme 2: Health System Level Barriers
Competency	Poor communication and coordination of care between physicians
Retaining old prescriptions	Lengthy and confusing discharge process/paperwork
Access to medications	Staffing and time constraints

 

Nearly all groups of stakeholders mentioned the issue of patients’ abilities to provide accurate and complete medication histories at hospital admission. When patients are unable to provide accurate medication histories, it reflects less than optimal competence in medication management. An inaccurate medication history often initiates a trail of medication discrepancies that sets up an erroneous medication reconciliation process, culminating in an inaccurate discharge medication list. A lawyer stated, “The intake case history (self-reported) is incomplete,” and a nurse from a rural hospital commented, “It’s not uncommon to have an inaccurate list from the patient or family at intake.” Finally, in regard to competency, focus groups with patients and family members confirmed that the information communicated to them was often too complex, and that they sometimes were unable to understand the discharge instructions, either due to their educational level or their comprehension of terminology when reading through the medication instructions. The situation may be further compounded by patients’ reluctance to ask questions. One patient commented that he did not ask questions because he “doesn’t want to look uneducated.”

Another common patient-specific barrier was patients’ use of medicines already in the home. A lawyer stated, “Patients stockpile medicines at home—sometimes for cost reasons or because ‘they might need it later.’” A home care nurse reported that “Patients want to take the same (medicines) because they are at home and have already purchased the meds.” Pharmacists noted that patients often retain old medicines and do not fill new prescriptions if they happen to be for the same medicine, but the new post-discharge prescription order may contain changes in the dosage or frequency of administration. A home care nurse confirmed this as an issue, stating that when patients continue to use the same medicines after discharge “they take what it says on the bottle label, not what it says on the discharge list.”

Finally, a frequently mentioned patient barrier was that medication discrepancies sometimes stem from patients’ challenges in accessing medicines. Medication access had multiple contributing factors including financial constraints experienced by patients, an inability to pick up prescriptions related to mobility confinement, and limited pharmacy access due to living in a rural location.

Sub-themes related to health system issues. The three specific health system-level barriers identified were: (a) poor communication and coordination of care between physicians; (b) lengthy and confusing discharge process/paperwork; and (c) staffing/time constraints. Poor communication and coordination of care between providers stemmed from either specialists not communicating adequately with hospitalists or hospitalists not communicating adequately with PCPs. One social worker commented, “(Specialists) all come in at different times and add discharge orders. One might add COUMADIN® when the patient is already on aspirin.” A health plan administrator stated “Hospitalists aren’t getting information back to the PCPs,” and a physician concurred with that perception, indicating that “Only 1 in 20 of the discharge summaries are being sent to the PCP in a timely manner.”

Lengthy and confusing discharge forms further complicate communication issues and contribute to the likelihood of discrepancies. One patient stated, “It was a blizzard barrage of paperwork.” A rural-dwelling patient stated “Too much red tape…..most people don’t read all that!” While the discharge paperwork in general is confusing, several stakeholder groups identified that in regard to medication discrepancies, electronic health record (EHR) systems that print prescriptions on regular paper make it difficult for patients and family members to distinguish between prescriptions and other discharge forms. A nurse from an urban setting asked “Why do the home discharge sheets look like the prescription sheets?” A pharmacist further noted that “Prescription paper is another layer of confusion for the patient. The patient brings in a reconciliation sheet, and it looks just like the discharge (prescription) sheet.”

Finally, time limitations were discussed as another system barrier. Hospital staff often have limited time to thoroughly discuss discharge paperwork with patients, and consequently, important patient education may not happen. The lack of information transfer and education may lead to further patient and family confusion. An urban patient stated, “Moving too fast without enough time spent with explanations.” An urban nurse shared, “The family is there and ready to go, but there are many other patients that need help and then you may also have an admit or two thrown in.” A rural patient commented on staffing patterns saying “There are too many duties, too few nurses, short-staffed--unrealistic staffing patterns because administration is disassociated with what’s happening on the floor.”

Theme 2: Potential solutions to hospital to home medication discrepancies. We asked stakeholders to identify systems to prevent future medication discrepancies. Three sub-themes emerged from the data: (a) improving information management; (b) increasing access to medicines; and (c) enhancing human resources. Solutions to these sub-themes include those that may be fairly easily addressed by health systems within a short timeframe and solutions that require longer-term planning and/or significant resource allocation.

Sub-theme related to improving information management. Several common solutions for system improvements centered on information management, such as having unified EHRs, using e-scripts, and simplifying discharge forms. While focus group participants reported understanding the barriers (e.g., the Health Insurance Portability and Accountability Act [HIPAA]) to establishing unified or universal EHRs, many mentioned how this strategy could reduce medication discrepancies. A nurse from a rural hospital commented that a solution would be “One registry that all pharmacies use,” while a lawyer advocated for “a central database,” and a physician suggested a “universal med list that is stored in the clouds.” A centralized health record has significant privacy implications and will require policy changes and a significant investment in resources and, thus is a potential solution with a long-term timeline.

Additional common solutions proposed in most focus groups could have a shorter timeframe for change, including having prescriptions sent electronically to pharmacies and simplifying discharge forms. A pharmacist stated, “The discharge form given to the patient needs to be very simple,” and a physician commented, “The community should have the same forms, but they must be better than what’s out there now!” A patient from a rural hospital recommended “Organize the paperwork with separate categories to clearly define ‘wound care,’ ‘medicines,’ etc.”

Sub-theme related to increasing access to medicines. Each of the potential solutions suggested by stakeholders could be implemented by health systems within a fairly short timeframe by integrating the activities into the health care team’s workflow. Several stakeholder groups noted that receiving prescriptions at the hospital would be a primary solution to increasing access. However, both physician and pharmacist stakeholder focus groups cautioned that if this were done, the patient’s usual pharmacy would have to be alerted to the new prescriptions so as to prevent future confusion that could lead to medication discrepancies. Other suggestions were pre-planning and coordinating with community pharmacies to ensure they had the required medicines and to ensure that the pharmacy would be open at the time the patient was discharged, particularly if a weekend discharge was expected. Another issue with regard to medication access was cost. One patient remarked “Options for costs need to be given so we can plan ahead.” Others concurred that being apprised of the cost of the prescriptions they would receive at discharge and knowledge as to whether their insurance would cover that medicine would be helpful. If they were aware of potential financial barriers prior to discharge, they felt they could discuss options with the hospital staff.

Sub-theme related to enhancing human resources. More hospital staff to allow for better communication and care coordination during hospitalization was cited by nearly all stakeholder groups as a solution to reduce medication discrepancies during the hospital-to-home transitional period. For example, providing special interventions, such as post-discharge follow-up, for patients receiving prescriptions for medicines considered “high risk,” was thought to be particularly important. A physician stated, “Anticoagulants, insulins, steroids, oral hypoglycemic and BP meds need extra attention at intake and discharge.” A nurse from a home health agency asserted that the “main (high risk) meds such as warfarin and other anticoagulants and insulin need to be in line before the patient goes home.” Care management services were suggested as a potential solution to both preventing and resolving medication discrepancies because the care manager would move through the care settings with the patient and could facilitate communication about a variety of issues, including an accurate medication list. In our study, stakeholder consensus was that hospital personnel had the knowledge and skills to improve communication and care coordination, but they were overburdened with responsibilities and often did not have time to thoroughly communicate nor coordinate care with one another or with patients and families. Thus, it was felt that care quality could be improved by reducing the workload of current staff or hiring additional staff to specifically focus on communication and care coordination with patients and families, including a focus on medication management. Such solutions could be done in a short timeframe if health systems had the financial resources for more personnel or could alter workflow to improve communication and care coordination activities without additional human resources.

Theme 3: Liability for medication discrepancies is contextual and complex. In each focus group, we also explored medical liability issues associated with medication discrepancies that resulted in permanent patient harm. Each group consistently responded that more information about the context and the details of the case would be required to assign responsibility about the medication discrepancy. However, a sub-theme emerged that when someone is harmed as a result of a discrepancy that leads to harm from a medication error, there are generally multiple layers of responsibility. Several groups mentioned that patients also have some degree of accountability, particularly for medication discrepancies during hospital-to-home transitions, and that solutions for improvement included enhanced patient education that could be done prior to hospital discharge and/or with a follow-up phone call or home visit after discharge. A patient from an urban hospital stated “Follow-up phone calls after discharge would be helpful because now we are ‘tuned in.’”

When harm resulted from a medication error, the second sub-theme of full disclosure emerged.^27,28 There was consensus from each group of stakeholders that when errors are discovered, they should be reported, an apology given, and when appropriate due to patient harm or inconvenience, compensation should be offered. Further, stakeholder groups were in uniform agreement that health systems had a responsibility to implement system improvements to prevent similar errors in the future.

Discussion

Relying on the Sensemaking Conceptual Framework to evaluate information from the voices of crucial stakeholders, we identified both patient-level and health system-level barriers that stakeholders noted as important contributors to medication discrepancies. Acutely ill patients are often discharged with instructions to follow complex inpatient-initiated therapeutic regimens at home. Stakeholders noted that patients and family members frequently lack the knowledge, education, or competency to understand these complex regimens. The competency level of patients is compounded by the fact that they are extremely vulnerable during this transition due to illness severity and/or functional impairment.²⁹ During this fragile transition, patients and their family members require simplified, yet thorough, medication instructions. Kripalani and colleagues³⁰ provide specific guidance for communicating medication instructions for patients at discharge: (1) patients should receive a complete list of medicines to be taken at home, with indications and instructions for administration written in everyday language; (2) overarching orders such as “continue home medications” and “resume all medications” need to be avoided to prevent confusion between the current medication regimen and the pre-hospitalization medication regimen; and (3) specific instructions should be provided regarding changes in medicines that the patient had been taking at home prior to hospital admission. In addition, stakeholders from our study noted the importance of assuring patient access to new prescriptions, both in terms of affordability and ability to obtain them from the pharmacy.

In regard to health system-level barriers, stakeholders reported that poor communication, limited staff, time, and complex discharge processes were also problematic. In line with these findings, Bayley and colleagues³¹ described similar failures associated with medication information communication during transfers: wrong or incomplete admitting order input by staff, inadequate or incomplete discharge orders, insufficient explanation of discharge medications, and poor communication with the PCP regarding discharge medications. To improve information transfer from hospitalist to PCP, attention must be paid to the content, format, and timely delivery of discharge information. According to Kripalani and colleagues,³⁰ the following information should be included in discharge summaries: diagnoses, abnormal physical findings, important test results, discharge medications, follow-up arrangements made and appointments that still need to be made, counseling provided to the patient and family, and tests still pending at discharge.

Gleason and colleagues³² also noted that medication discrepancies often begin with the initial input of the medicines and continue throughout the hospital stay, due to communication deficits between staff and patients. The researchers suggested incorporating improved medication history taking and reconciliation skill attainment in health professions’ curricula and pointed out that because physicians, nurses, and pharmacists all play key roles in medication management throughout hospitalization and into the transitional care period, a multidisciplinary team approach is required for optimal outcomes.³² The importance of implementing an up-to-date medication reconciliation program is also noted in a study completed by McMillan and colleagues.³³ Overall, when taken together, both patient- and family-level barriers, along with health system-level barriers, often lead to chaotic, inefficient, and ineffective hospital-to-home transitions and give rise to the potential for medication discrepancies and errors. Feasible solutions to these barriers are critically needed to improve medication safety.

Importantly, stakeholders also offered insight as to practical system solutions that could be implemented to improve medication safety during the transitional period. Preventing or promptly resolving medication discrepancies during the hospital to home transition are crucial for improving patient safety. The stakeholder focus groups were conducted during 2010, shortly after the Patient Protection and Affordable Care Act (ACA) was passed into law. In the ensuing years, we are heartened to report that there are available, evidence-based strategies that coincide with our stakeholder-suggested solutions to improve medication safety during transitional care and/or legislative provisions that provide resources to improve medication safety during care transitions. Evidence-based strategies that can be used to improve medication safety throughout hospitalization and during the transitional care period include the Medications At Transitions and Clinical Handoffs (MATCH) program³⁴ and Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS).³⁵ The Health Information Technology for Economic and Clinical Health Act, which created incentives for health systems and ambulatory care providers to initiate EHRs, commonly known as meaningful use, has several benefits that contribute to better utilizing information management.³⁶ In addition, the ACA, research, quality improvement efforts, and other trends in health care delivery have prompted many health systems, including our partner health system, to implement strategies to improve the quality of care transitions, including the safety of medication use. For example, since the completion of this study, our health system partner now:

1. Employs hospital-based transitional care registered nurse coordinators who work closely with hospitalists and with patients and their families to plan and execute safe transitions.
2. Uses aggregated data to predict which patients are at high risk for readmission and assures that resources, such as care coordinators and social services, are provided to facilitate safe transitions.
3. Provides ambulatory care RN coordinators who assist with navigation across the care continuum and utilizes ACA care coordination and transition codes as payment mechanisms.
4. Provides comprehensive medication consultation to patients and families following hospital discharge at an outpatient pharmacotherapy clinic.

Strategies that enhance care coordination across the continuum are critical for reducing medical liability, since it is anticipated that the advent of health care reform may lead to the creation of coordinated care systems, such as Accountable Care Organizations (ACOs), that could increase the likelihood of medical liability if medication errors are experienced during the transitional period. Despite the 2009 Transitions of Care Consensus Policy Statement asserting that the sending provider, institution, or team maintains responsibility for patient care until the receiving clinician or institution confirms the transfer and assumption of responsibility,¹⁵ assigning liability for errors that occur during transitions in a fragmented system remains confusing and complex. Stakeholders in our focus groups recognized that medication errors resulting in harm are generally multi-focal in origin, and they resisted assigning responsibility. However, ACOs are designed to provide more comprehensive care across the continuum and share financial risk associated with that care. Thus, as less fragmented systems, ACOs may create entities that are seen as accountable for errors across the continuum, and liability may be pursued more frequently than is currently realized.

The unanimous sub-theme of our focus group findings regarding patient harm and liability was that full disclosure should occur when an error that causes harm is identified. This conclusion is consistent with other research. Further, such a policy has been endorsed as a best practice by The Joint Commission and the National Quality Forum.³⁷ Earlier research suggests a relationship between full disclosure and decreased liability claims and overall costs.³⁸ Despite widespread support for full disclosure, it is not uniformly implemented, and there is little attention to the topic in health professional education programs.³⁹ Stroud and colleagues ⁴⁰ found the training in the skill of full disclosure had not been well studied among medical professionals, and attention to the skill is rare for other health professionals. The Sorry Works! Coalition is attempting to change the culture of full disclosure and offers resources for health care professionals and health systems.⁴¹ In summary, our findings in support of full disclosure for medication errors that result in harm are consistent with other research, but there are opportunities to improve educational strategies so that health care professionals have the skills to implement full disclosure and to establish full disclosure as a standard practice across disciplines.

Limitations and Strengths

Our stakeholder focus group members were all recruited from a limited demographic area of the Northwest, which means our findings may not be generalizable to other regions or groups. Participants also volunteered for the study, possibly introducing self-selection bias. Additionally, as with any focus group study, a limitation of the study included the possibility of a social desirability bias or participants feeling pressured to give similar answers as other members to the facilitator’s questions.

The use of focus groups was a unique strength of this study because it allowed participants to generate new ideas from each other. Furthermore, a qualitative approach using the Sensemaking methodology allowed us to obtain detailed information directly from a diverse group of stakeholders. To our knowledge, this is the most detailed and inclusive analysis of transitional care medication discrepancies carried out to date, in that it reflects the voices of patients, family members, and multiple groups of professionals from both rural and urban settings.

Conclusion

Preventing medication discrepancies and ADEs remains a national priority. Our findings indicate that stakeholders are aware of both barriers and solutions to medication safety, and they are motivated to implement change to improve outcomes. Recent policy shifts have promoted changes that were suggested by stakeholders to improve medication safety during care transitions. Improved hospital systems (staffing and EHRs), patient education, and provider communication and preparation can minimize the occurrence of medication discrepancies and ADEs, thereby improving patient satisfaction and safety. When errors that result in harm occur, full disclosure is the best practice. Public policy may reinforce progress; however, more widespread implementation and adoption of these provisions and strategies is now needed at the health care system-level to improve transitional care medication safety.

Acknowledgments

This project was funded by grant from the Agency of Healthcare Research and Quality (HS19552). In memoriam, we acknowledge the leadership and vast contributions to this work from Dr. Stephen M. Setter. Finally, we appreciate revision suggestions and assistance from the AHRQ staff and from Amy Barrett Thomas.

Author Affiliations

Cynthia F. Corbett, PhD, RN, FAAN (Professor and SmartState Endowed Chair), University of South Carolina, College of Nursing; Alice E. Dupler, JD, APRN (Clinical Associate Professor, retired); Suzanna L. Smith, MN, FNP (Clinical Instructor); and E’Lise M. Balogh, BS (formerly Research Assistant); College of Nursing, Washington State University. Cory R. Bolkan, PhD (Associate Professor), Department of Human Development, Washington State University.

Address correspondence to: Cynthia F. Corbett, PhD, RN, FAAN, Professor and SmartState Endowed Chair, University of South Carolina, College of Nursing, 1601 Greene Street, Columbia, SC 29208; email corbett@sc.edu.

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