A nurse on a medical-surgical unit is reconciling a newly admitted clients medication

Abstract

Medication reconciliation arose as the solution to the well-documented patient safety problem of unintentionally introducing changes in patients' medication regimens due to incomplete or inaccurate medication information at transitions in care. Unfortunately, medication reconciliation has often been misperceived as a superficial administrative accounting task with a "pre-occupation with completing forms," resulting in the implementation of ineffective processes. In this article, the authors briefly review the evidence supporting medication reconciliation but focus more on key practical questions regarding the elements of an effective medication reconciliation process: what it should consist of, where and when it should occur, who should carry it out and how hospitals should implement it. The authors take the why of medication reconciliation to consist not just of the professional obligation to avoid causing harm, but also of a rational self-interest on the part of healthcare leaders. The authors argue that, rather than wasting time implementing a nominal reconciliation process, we should invest time and energy in a more robust and effective strategy, and they address specific practical questions that arise in such an effort.

At the monthly management meeting of a large urban hospital, the head of patient safety announces: "We had a critical incident last week. A patient was readmitted two days after discharge with severe hypoglycemia. The treating team discharged the patient on a new insulin regimen without realizing that the patient also had insulin 30/70 at home. The patient continued to take her previous regimen as well as the new one, and was found unresponsive by her husband. She's in the ICU and probably will have permanent neurological deficits." After various sighs and exclamations from the executives around the table, the chief medical officer asks, incredulously, "Why didn't this get picked up by medication reconciliation?" Before anyone can answer, the executive adds: "We had that other case six months ago in which a patient was discharged without restarting his Coumadin, and he ended up having a stroke. We implemented medication reconciliation last year: why is this still happening?"

The answer to this executive's question is that care transitions represent such an error-prone process that, even with robust medication reconciliation, catastrophic cases such as these can still occur. Moreover, the vast majority of hospitals do not have a robust medication reconciliation process in place, so these events can continue to occur with considerable frequency.

In this article, we use the existing literature, as well as results from our own research and experiences as clinicians, as pharmacist (O.F.) and a physician (K.S.) to address key practical questions regarding effective medication reconciliation: what it should consist of, where and when it should occur, who should carry it out and how hospitals should implement it. In terms of why, we do not formally review the evidence supporting medication reconciliation; however, we do briefly summarize key studies that indicate the likely impact on patient safety.

Transitions from one healthcare setting to another – whether from an intensive care unit to a general ward or from a rehabilitation facility to the patient's home – increase the risks of adverse drug events and can contribute to avoidable hospital visits (Dedhia et al. 2009; Fernandes 2009; Jack et al. 2009; Ong et al. 2006). For instance, incomplete or inaccurate medication information can introduce changes to patients' outpatient medication regimens that were not intended by hospital-based physicians. Two common unintended medication changes are omissions – pre-admission medications are omitted from hospital orders and therefore not continued after discharge – and commissions – previous medications that patients discontinued prior to admission are inadvertently re-initiated in the hospital and therefore continued upon discharge (Tam et al. 2005). In one study of 151 hospitalized medical patients (Cornish et al. 2005), 54% of patients had at least one unintended discrepancy between their hospital and outpatient medication regimens, and 39% of these discrepancies were judged to have the potential to cause moderate to severe discomfort or clinical deterioration. Because many unintended medication discrepancies are relatively minor, the better studies have assessed the likely clinical impact of the discrepancies identified by medication reconciliation (Gleason et al. 2004; Lalonde et al. 2008; Nickerson et al. 2005; Schnipper et al. 2009; Varkey et al. 2007; Vira et al. 2006). Despite varying definitions of clinical impact, these studies all identify a category that might be called "clinically important" discrepancies – unintended changes to patients' medications with a reasonable risk of some harm. Rates for these clinically important unintended discrepancies range from a low of 0.25 per patient to a high of 0.97. The best study to date – the only randomized controlled trial comparing medication reconciliation with usual care with an intervention that involved inter-professional process redesign from admission to discharge (Schnipper et al. 2009) – reported a relative reduction in potential adverse drug events of 28% (95% confidence interval 1.0–48%).

These studies of the impacts of medical reconciliation on clinically significant events all involve key roles for pharmacists. Accreditation standards do not stipulate involvement by pharmacists (Accreditation Canada 2011, Joint Commission 2011), and staffing constraints probably limit the degree to which pharmacists perform medication reconciliation outside academic medical centres. Thus, medication reconciliation as implemented in most hospitals does not correspond to the intervention for which the literature provides support.

What Is Medication Reconciliation?

Initial conceptions of medication reconciliation have evolved into a robust system for reducing potential adverse drug events and risks for unnecessary subsequent care (Figure 1 [High 5s 2009]; Fernandes 2009; World Health Organization 2006). Unfortunately, medication reconciliation has often been misperceived as a superficial administrative accounting task with a "pre-occupation with completing forms" (Boockvar et al. 2011). When conducted as intended, medication reconciliation is a conscientious, patient-centred, inter-professional process that supports optimal medication management (Greenwald et al. 2010).

The best possible medication history (BPMH) provides the cornerstone for medication reconciliation. It differs from a routine medication history in that it involves (1) a systematic process for interviewing the patient (or family) and (2) a review of at least at least one other reliable source of information (e.g., a provincial medication database, an inspection of medication vials or contact with the community pharmacy) to obtain and verify patient medications (prescribed and non-prescribed) (Safer Health Care Now! 2011). In practice, however, medication histories fall short of these recommendations, with clinicians skipping the time-consuming step of actually speaking with the patient to verify medications. Reconciling a suboptimal medication history with medication orders does nothing to improve care and may even "hard-wire" unintentional discrepancies. Finally, efforts to obtain a BPMH face the many challenges associated with patients who maybe unfamiliar with their medications.

The number and intensity of medication reconciliation activities may legitimately vary between hospitals and even clinical areas within a hospital. Table 1 outlines a proposed continuum of varying levels of medication reconciliation intensity, from bronze—just a BPMH and reconciliation, the current national accreditation indicator in Canada (Accreditation Canada. 2011)—through to silver, gold, platinum and diamond. The more advanced levels of medication reconciliation involve progressions in inter-professional collaboration, integration of medication reconciliation into discharge summaries and prescriptions, and the delivery of more comprehensive medication education to patients. In principle, individual patients might appropriately receive different levels of medication reconciliation, from bronze to platinum, given their different risks for adverse drug events. In practice, hospitals may choose a specific degree of medication reconciliation for all patients in a given clinical area.

Where Should Medication Reconciliation Occur?

Literature on medication reconciliation in ambulatory settings has begun to emerge (Bayoumi et al. 2009; Fernandes 2009; Varkey et al. 2007), but most studies remain focused on the hospital.

Within the in-patient arena, should hospitals target any specific clinical area first? The extent to which patients in some clinical areas benefit more from medication reconciliation than patients in others (e.g., general medicine versus surgery) remains unclear. (Realistically, the potential benefit probably depends on the number and type of medications taken by patients, not the clinical service.) Thus, rather than choosing to focus on clinically defined patient groups, many hospitals choose to target patients admitted through the emergency department and elective patients, typically in surgery. Focusing on elective patients offers the advantage of proactively conducting the BPMH in a controlled setting such as a pre-admission clinic (Kwan 2007). That said, the emergency department represents a much larger gateway for hospitalized patients, and the strategies used for medication reconciliation in a pre-admission clinic may not translate well to the busy, time-pressured setting of the emergency department.

When Should Medication Reconciliation Occur?

Should hospitals first target admission, discharge or internal transfers? Some studies have highlighted serious medication risks at internal transfer points, such as from intensive care to a ward (Santell 2006). Realistically, though, most hospitals initially choose to target medication reconciliation at admission or discharge. Both options involve implementation issues, and determining the optimal choice for a particular hospital is challenging. Ultimately, some form of discharge reconciliation needs to be present – after all, the main purpose of medication reconciliation is to avoid unintended medication errors created by hospitalization. The key challenge faced by discharge reconciliation is integrating it into the general discharge process, which already involves multiple activities on the part of physicians, nurses, pharmacists and other health professionals. It may be tempting to simply provide a medication reconciliation form or letter with a summary of medication changes. However, disconnecting medication reconciliation from related discharge processes, such as preparing discharge summaries and prescriptions, may minimize its full benefit and give rise to the false impression that medication reconciliation is not a clinically relevant process and just adds to clinicians' work.

Reconciliation at admission avoids the complexities of the discharge process, but the time pressure at admission, especially for acutely ill patients, presents challenges for obtaining a BPMH. In practice, hospitals deal with the time pressure issue by expanding "on admission" to mean within 24–48 hours of admission. This solves the time pressure problem but misses the opportunity to have the medication reconciliation support the process of creating medication orders at admission. As with the discharge process, not integrating medication reconciliation into a relevant clinical process (e.g., creating orders at admission) may foster the misperception of medication reconciliation as extra work that exists for purely administrative reasons.

On balance, starting the medication reconciliation process at or soon after admission may ultimately save time. Even if admission reconciliation does not directly generate admission orders, the discharge process will be more accurate and efficient if a BPMH already exists. Also, the Accreditation Canada indicator, a natural incentive, is currently focused on admission. Importantly, these ideas are not mutually exclusive. A "phased-in" approach that starts on admission, sustains gains throughout hospitalization and finishes at discharge may make the most sense.

The Who's Who of Medication Reconciliation

Should hospitals target all admitted patients or "high-risk" patients only? With limited human resources and hospitals struggling to fully implement medication reconciliation across the continuum, it may seem natural to target patients who will most benefit from medication reconciliation. However, evidence-informed criteria for high-risk patients' medication reconciliation remain unclear at this time. Some authors have suggested that medication reconciliation candidates can be focused by age (over 65 years old) or number of medications (more than four) (Coffey et al. 2009; Gleason et al. 2010). Others have proposed that "high risk criteria" include factors such as frequent hospitalizations, high-alert medications, chronic diseases prone to frequent medication changes and patients with a large number of in-hospital medication changes (Rumball-Smith and Hider 2009). Narrowing the scope of medication reconciliation promises a "quality job" for targeted patients versus a "superficial effort" for all.

Despite the plausibility of this approach, an important practical argument in support of medication reconciliation for all patients is that accurately identifying high-risk patients (e.g., based on the number or type of medications) often requires a proper BPMH process. Moreover, in some settings (e.g., medical wards), screening for a high-risk status may not practically eliminate many patients. Finally, patients who are considered low risk at admission may have changes made to their home medication regimens later in their hospitalization that would elevate their risk status. For all these reasons, Accreditation Canada's focus on applying medication reconciliation to all admitted patients seems reasonable. That said, a given hospital may recognize that certain wards generally treat patients with short medication lists and for whom few changes in pre-hospital medications occur. In such cases, a lower-level version of medication reconciliation (see Table 1) may be justified.

Who should optimally lead medication reconciliation activities? Some argue that, based on their educational training and expertise, hospital pharmacists are uniquely positioned to lead and support patients and inter-professional teams with medication reconciliation (Fernandes and MacKinnon 2008) and that this may result in better accuracy and clinical and economic outcomes (Bond and Raehl 2007; Carter et al. 2006; Coffey et al. 2009; Kaboli et al. 2006; Tam et al. 2005). Karnon et al. (2009) conducted a cost-effectiveness analysis suggesting that pharmacist-led reconciliation yields the highest expected net benefits and a probability of being cost-effective of more than 60% by a quality-adjusted life year value of £10,000.

However, there can be problems with pharmacists leading reconciliation. First, many wards do not have clinical pharmacists, and most hospitals do not have 24/7 pharmacy service or enough pharmacist resources to complete and sustain medication reconciliation at all interfaces. Limited pharmacist resources may thus result in a target of only complex patients. A feasible alternative adopted by some hospitals is the use of pharmacy technicians and students to support medication reconciliation (Lam et al. 2009; Mersfelder and Bicketl 2008; van den Bernt et al. 2009). Regardless of the profession, a key factor is having the clinician receive formal practical training on how to systematically and efficiently conduct a BPMH (Boockvar et al. 2011; Greenwald et al. 2010; Safer Health Care Now! 2011). Formal BPMH training also promotes professional "trust" in this critical shared information.

Second, if pharmacists lead, there is a danger that other health disciplines will divest themselves of the patient responsibility linked to this critical activity. Interviews with staff at hospitals across Canada as part of an ongoing study conducted by one of us (K.S.) confirmed this concern in some hospitals: the focus on the pharmacists/pharmacy technicians risks losing sight of medication reconciliation as a shared inter-professional accountability. A recent US panel of stakeholders, representing professional, clinical, healthcare quality, consumer and regulatory organizations, achieved consensus that hospital-based medication reconciliation should employ an inter-professional team approach as the ideal (Greenwald et al. 2010). Moreover, a coordinated, inter-professional process can improve efficiency by reducing redundancy in the traditional approach of physicians and nurses all conducting individual medication histories.

Regardless of which professionals carry out medication reconciliation, patients remain essential partners in the process. Even completely perfect reconciliation will serve little purpose if patients do not understand their new medication regimens. Thus, the higher levels of medication reconciliation shown in Table 1 include discharge medication counselling to patients. Other advanced features include the use of patient portals/kiosks to actively engage patients in the BPMH process and support a patient-accessible medication record (Bassi et al. 2010).

How to Implement Medication Reconciliation

One of us (K.S.) has led a study of the experiences of 25 adult and pediatric healthcare institutions across Canada with implementing medication reconciliation. The formal analysis of the interviews with 74 nurses, pharmacists, physicians, patient safety officers, project managers and senior executives has not yet been published, but some key themes are summarized here. First, what counts as medication reconciliation varies widely. Areas of variation included who conducted the medication history and how it was taken, the number of histories completed, the role of the medication order and which patients' medications were reconciled. Some of this variation reflects understandable decisions in response to local implementation challenges. However, some variation included clearly suboptimal processes, such as the absence of a systematic approach to history taking and obtaining medication information from more than one source.

The focus of this study, however, was on the practical challenges encountered in implementation. These barriers included the following:

• Substantial underestimation of the time and resources required to implement medication reconciliation
• Resistance from front-line staff due to impacts on workload and work flow (physicians sometimes resisted even independent of such impacts)
• A lack of implementation/change management experience
• Turnover on the core implementation team
• Limited resources for ongoing education and support to sustain the implementation
• Too rapid implementation, as a result of pressure due to accreditation, resulting in a poorly configured process

Not surprisingly, interviewees repeatedly identified that real support from senior management in appropriately resourcing teams and implementation efforts was key to success. Other facilitators included having physician "champions," inter-professional implementation teams and contact with other institutions to share and learn from implementation efforts (e.g., a formal collaborative, such as Safer Healthcare Now!)

Our interviews also revealed that, despite the accreditation requirement, many hospitals have not yet fully disseminated admission to discharge medication reconciliation beyond one or two pilot units, a finding confirmed anecdotally in discussion with colleagues across the country. Many of these implementation lessons thus remain relevant as hospitals struggle to spread and sustain quality medication reconciliation. Two specific practical decisions related to implementation also merit consideration, namely, whether to turn the medication reconciliation document into the admission orders (or the prescription at the time of discharge) and whether to strive for an electronic process. Table 2 presents some of the pros and cons related to these issues. Overall, hospitals should recognize that the successful implementation and maintenance of high-quality medication reconciliation practices, to the degree that they effectively prevent actual patient adverse events, require careful inter-professional and organizational planning along with effective change leadership. A number of hospitals in North America have published their successful medication reconciliation implementation journeys and valuable practical lessons learned (Coffey et al. 2009; Murphy et al. 2009; Schnipper et al. 2009).

Conclusion

Doing the bare minimum when it comes to medication reconciliation – just putting in place enough of a process to meet accreditation standards – will do little to prevent catastrophic cases, such as the ones described at the outset, from continuing to occur. Moreover, the occurrence of such cases will cause frustration (never mind risk management issues), given that implementing even a fairly superficial medication reconciliation process consumes substantial institutional time and resources. We argue that, rather than wasting time implementing a nominal medication reconciliation process, hospitals should invest additional time and energy in a more robust effective strategy, considering the issues we have outlined with respect to the what, where, when, who, why and how of implementing medication reconciliation.

Olavo Fernandes, BScPhm, PharmD, is a member of the Department of Pharmacy, University Health Network, and Leslie Dan Faculty of Pharmacy, University of Toronto; and the University of Toronto Centre for Patient Safety, in Toronto, Ontario. You can contact him at 416-340-4800, ext. 6436, or by e-mail to .

Kaveh G. Shojania, MD, is a member of the University of Toronto Centre for Patient Safety; and the Department of Medicine, Sunnybrook Health Sciences Centre, in Toronto, Ontario.

Acknowledgment

Our thanks go to Michelle Baker, BScPhm, of the University Health Network, for developing Table 1.

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