Figure. Selection process for study inclusion.
Mueller SK, Sponsler KC, Kripalani S, Schnipper J. Hospital-based medication reconciliation practices: a systematic review. Arch Intern Med. Published online June 25, 2012. doi: 10.1001/archinternmed.2012.2246.
eAppendix. Descriptive (Noncontrolled) Studies
This supplementary material has been provided by the authors to give readers additional information about their work.
Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-Based Medication Reconciliation PracticesA Systematic Review. Arch Intern Med. 2012;172(14):1057-1069. doi:10.1001/archinternmed.2012.2246
Author Affiliations: Brigham and Women's Hospital Hospitalist Service and Division of General Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Harvard Medical School, Boston (Drs Mueller and Schnipper); Section of Hospital Medicine, Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University, Nashville, Tennessee (Drs Sponsler and Kripalani); Department of Veterans Affairs, Tennessee Valley Healthcare System, Nashville (Dr Sponsler); and Vanderbilt Center for Health Services Research, Nashville (Dr Kripalani).
Background Medication discrepancies at care transitions are common and lead to patient harm. Medication reconciliation is a strategy to reduce this risk.
Objectives To summarize available evidence on medication reconciliation interventions in the hospital setting and to identify the most effective practices.
Data Sources MEDLINE (1966 through February 2012) and a manual search of article bibliographies.
Study Selection Twenty-six controlled studies.
Data Extraction Data were extracted on study design, setting, participants, inclusion/exclusion criteria, intervention components, timing, comparison group, outcome measures, and results.
Data Synthesis Studies were grouped by type of medication reconciliation intervention—pharmacist related, information technology (IT), or other—and were assigned quality ratings using US Preventive Services Task Force criteria.
Results Fifteen of 26 studies reported pharmacist-related interventions, 6 evaluated IT interventions, and 5 studied other interventions. Six studies were classified as good quality. The comparison group for all the studies was usual care; no studies compared different types of interventions. Studies consistently demonstrated a reduction in medication discrepancies (17 of 17 studies), potential adverse drug events (5 of 6 studies), and adverse drug events (2 of 2 studies) but showed an inconsistent reduction in postdischarge health care utilization (improvement in 2 of 8 studies). Key aspects of successful interventions included intensive pharmacy staff involvement and targeting the intervention to a high-risk patient population.
Conclusions Rigorously designed studies comparing different inpatient medication reconciliation practices and their effects on clinical outcomes are scarce. Available evidence supports medication reconciliation interventions that heavily use pharmacy staff and focus on patients at high risk for adverse events. Higher-quality studies are needed to determine the most effective approaches to inpatient medication reconciliation.
Adverse drug events (ADEs), defined as patient injuries related to using a drug,1 are an epidemic patient safety issue, occurring in 5% to 40% of hospitalized patients and in 12% to 17% of patients after hospital discharge.2,3 Transitions of care, such as hospital admission and discharge, contribute to ADEs in part through medication discrepancies, that is, unexplained differences in documented medication regimens across different sites of care.4,5 Medication discrepancies are common, occurring in up to 70% of patients at hospital admission or discharge,6- 10 with almost one-third of these having the potential to cause patient harm (ie, potential ADEs [PADEs]).10 ADEs associated with medication discrepancies can prolong hospital stays and, in the postdischarge period, may lead to emergency department visits, hospital readmissions, and use of other health care resources.11,12
Medication reconciliation is a strategy for reducing the occurrence of medication discrepancies that may lead to ADEs. Medication reconciliation is the “process of identifying the most accurate list of all medications a patient is taking . . . and using this list to provide correct medications for patients anywhere within the health care system.” 13(p1) Recognizing the potential impact of properly reconciling medications during care transitions, in 2005 The Joint Commission added medication reconciliation to its list of National Patient Safety Goals.14
During the last decade, various medication reconciliation interventions have been described, but the specific elements important to successful efforts have not been fully appreciated. We performed a systematic review of the literature to summarize the available evidence on medication reconciliation in the hospital setting and to identify the most effective practices.
We initially performed a systematic search of English-language articles published between January 1, 1966, and October 31, 2010, on medication reconciliation during patient hospitalization. Using MEDLINE, we first searched a combination of Medical Subject Headings and keywords, including medication reconciliation; medication errors/prevention and control; medication systems, hospital; medical records systems, computerized; medication list; medication record; and patient discharge. Second, we searched medication reconciliation interventions combined with patient admission, and we mannually searched the reference lists for relevant articles. We later updated the literature search through February 29, 2012.
Controlled intervention studies that met the following criteria were eligible for inclusion: English language, medication reconciliation was the primary focus of the intervention, the comparison group was defined, the intervention was clearly described, the intervention occurred in the hospital during hospitalization or transition in or out of the hospital, and quantitative results were provided. One reviewer (S.K.M. or K.C.S.) performed initial independent assessments of titles for relevance and subsequent examination of abstracts and articles for inclusion, which was then verified by a second reviewer (S.K.M. or K.C.S.). Discrepancies were resolved by a third reviewer (J.L.S. or S.K.).
One reviewer (S.K.M.) extracted relevant data from included articles, which was then verified by 2 others (K.C.S. and J.L.S.). Information was obtained regarding study design, setting, number of participants, inclusion/exclusion criteria, components of the intervention, timing of the intervention related to hospital course, comparison group, outcome measures, and results (for the data extraction tool see the eAppendix).
Studies were first grouped into the following 3 categories, based on the primary component of the intervention: (1) pharmacist related, (2) information technology (IT), or (3) other type. Two authors (S.K.M. and J.LS.) then collectively determined 4 common types of reported outcomes, including (1) medication discrepancies, defined as unexplained differences in documented medication regimens across different sites of care; (2) PADEs, defined as medication discrepancies with potential to cause patient harm; (3) ADEs, defined as patient injuries related to using a drug; and (4) health care utilization, defined as postdischarge emergency department visits, hospital readmissions, and use of other health care resources. Meta-analysis was infeasible owing to heterogeneity in methods, interventions, and reported outcomes. Two authors (S.K.M. and S.K.) categorized study quality as “good,” “fair,” or “poor” on the basis of US Preventive Services Task Force criteria15; adaptations were made for pre-post studies.
Intervention studies that lacked a control group but otherwise met the inclusion criteria were abstracted and summarized in a similar manner, although they are not the subject of this review (eAppendix).
Of the 1632 articles initially identified via electronic search, 173 abstracts were reviewed. A second electronic search and hand search of references yielded an additional 57 abstracts. Of the 230 abstracts reviewed, 80 publications warranted full review, and 17 of these met the inclusion criteria. An updated search identified 9 additional articles, for an inclusive total of 26 studies (Figure). Among the included articles were 10 randomized controlled trials, 3 nonrandomized trials with a concurrent control group, and 13 pre-post studies. Fourteen of the studies were conducted in countries other than the United States, including Canada,16,17 Australia,18,19 New Zealand,20 Northern Ireland,21 United Kingdom,22 Belgium,23 Denmark,24 the Netherlands,25 and Sweden.26- 29
Fifteen studies reported on pharmacist-related interventions,16- 19,21,22,24- 26,28- 33 6 reported on IT-focused interventions,34- 39 and 5 reported on other types of interventions, including educating staff about medication reconciliation20,40 and use of a standardized medication reconciliation tool.23,27,41 Most studies (15 of 26) were classified as poor quality,18- 23,27,29,30,34,35,37,38,40,41 5 were classified as fair quality,16,17,26,32,33 and the remaining 6 were classified as good quality.24,25,28,31,36,39 A summary of the timing and components of the interventions and study quality is given in Table 1, and the results are summarized in Table 2A and Table 2B. The comparison group in each study was “usual care,” as defined in Table 1.
The 15 studies involving pharmacist-related interventions included diverse roles of the pharmacy staff in the medication reconciliation process and varied timing of pharmacy staff involvement during the patient's hospitalization. Four of 15 studies were rated as good quality (Table 1).24,25,28,31 Most of these studies involved licensed pharmacists, although pharmacy residents32 and pharmacy technicians30 were also used. Most of these interventions reduced medication discrepancies (10 of 10 studies)16- 19,21,22,25,26,30,33 and PADEs (2 of 3 studies)16,18,25 but less often reduced preventable ADEs (1 study)31 and health care utilization (2 of 7 studies)21,24,28,29,31- 33 (Table 2A and Table 2B). In the larger of these last 2 studies, Gillespie et al28 used a pharmacist to perform medication histories and reconciliation on hospital admission and discharge, patient and provider medication counseling during hospitalization, communication with the primary care physician on discharge, and follow-up communication with the patient 2 months after discharge. This intervention reduced the odds of all hospital visits by 16% (odds ratio, 0.84; 95% CI, 0.72-0.99), including a 47% reduction in emergency department visits and an 80% reduction in drug-related readmissions in the 12 months after hospital discharge; no difference was seen in all-cause hospital readmission or mortality.28 Koehler et al32 reported on a similar intensive intervention but used pharmacy residents instead of licensed pharmacists. This intervention decreased 30-day emergency department visits/readmissions (10% in the intervention group vs 38.1% in the control group, P = .04). Common themes of these 2 successful studies included (1) limiting the intervention to elderly patients (age ≥80 and ≥70 years, respectively); (2) intensive pharmacy staff involvement, including medication history taking on admission and medication reconciliation on admission, during hospitalization, and at discharge; (3) communication with the primary care physician via direct communication or use of a template; and (4) telephone follow-up after hospital discharge. The 5 studies that demonstrated no effect on health care use had more limited roles for the intervention pharmacist21,29,31 or used them for a more limited time during hospitalization (eg, admission or discharge only).24,31,33
The 6 studies that reported IT-focused medication reconciliation interventions all improved access to electronically available sources of preadmission medication information, such as ambulatory electronic medical records.34- 39 These interventions leveraged data to create a preadmission medication list and facilitated comparison of this list with admission or discharge orders to help with the medication reconciliation process. Two of 6 studies were rated as good quality.36,39 The IT-related interventions reduced medication discrepancies (3 of 3 studies),34,35,37 PADEs (1 of 1 study),36 and ADEs (1 of 1 study)38 but demonstrated no improvement/slightly increased health care use (1 of 1 study).39 Through implementation of an electronic medication reconciliation tool and process redesign, Schnipper et al36 decreased the average number of PADEs (1.05 per patient in the intervention arm vs 1.44 per patient in the control arm; relative risk, 0.72; 95% CI, 0.52-0.99). However, Showalter et al39 demonstrated that implementation of an automated medication reconciliation tool on hospital discharge that also included autopopulation of other discharge instructions resulted in no difference in composite 30-day health care use (emergency department visits or readmissions) and was associated with a slight increase in 30-day hospital readmission (11.0% after the intervention vs 10.2% before the intervention, P = .02). The authors hypothesized that improving the discharge instructions to inform patients of worrisome symptoms may have led to higher rates of subsequent (appropriate) readmissions.39
Of the 5 studies that described other types of interventions, 2 provided education/feedback to staff about medication reconciliation20,40 and 3 used a standardized medication reconciliation tool.23,27,41 The standardized tools included a discharge report that provided a brief hospital summary detailing all medication changes that occurred during hospitalization,27 a 6-step standardized nursing approach to medication history taking and reconciliation on admission,41 and a standard questionnaire used by emergency department physicians on admission.23 None of these studies were rated as good quality. These studies demonstrated improvement in medication discrepancies (4 of 4 studies)20,23,40,41 and in PADEs (2 of 2 studies).20,27 For example, Midlöv et al27 described use of a physician-generated medication report for postdischarge providers that included a brief summary of the hospitalization, medications on discharge, and detailed medication changes made during hospitalization and reasons for those changes, which decreased PADEs from 8.9% before the intervention to 4.4% after the intervention (P = .049). The intervention was limited to elderly patients admitted from and returning to a nursing home.
Of all 26 studies, 13 focused the intervention on a high-risk subgroup of patients. This high-risk category was most commonly defined as older patients, with an age threshold from 55 to 80 years.18,20,21,24,26- 29,32,37 Other definitions of high risk included polypharmacy, with thresholds ranging from greater than 4 to 13 medications,18,20,21,25,32,33,36 and having greater than 3 comorbid conditions.18,32 Several studies included a combination of these criteria to define the intervention cohort.18,20,21,32 Noncontrolled intervention studies described similar approaches, with pharmacist-led interventions being most common (eAppendix).
This systematic review of hospital-based medication reconciliation practices found that various interventions, including those involving pharmacy staff, IT, and other types, successfully decreased medication discrepancies and PADEs but demonstrated inconsistent benefit on ADEs and health care utilization compared with usual care.
The medication reconciliation literature is most robust for pharmacist-related interventions, which were evaluated in 15 of 26 included studies and in 4 of 6 good-quality studies.24,25,28,31 Several of these articles evaluated clinical outcomes, such as preventable ADEs31 and health care utilization,21,24,28,29,31- 33 rather than solely examining process measures such as medication discrepancies. In the 2 studies28,32 that demonstrated improvement in health care utilization, the pharmacy staff was heavily involved, performing a comprehensive medication history at hospital admission, medication reconciliation at hospital admission and discharge, patient counseling, discharge communication with outpatient providers, and postdischarge communication with the patient.
Notably, most reported pharmacist-related interventions also included the taking of an accurate medication history at the time of admission, as noted in Table 1. Errors in obtaining an accurate preadmission medication history have great potential for harm as they can propagate throughout a patient's hospitalization and after discharge. They are also the most common reason for PADEs caused by medication discrepancies.8 Although it is difficult to distinguish the impact of an accurate medication history from the impact of successful medication reconciliation when both are included in the intervention, in reality, these 2 process steps are necessary components of the overall medication reconciliation process. It is, therefore, unrealistic to consider a successful medication reconciliation program that does not also include an initial accurate medication history from which to begin the reconciliation process.
Other common elements of the successful pharmacist-related medication reconciliation efforts included communication with postdischarge providers regarding the discharge medication regimen, including how and why the regimen differed from before admission17,21,28,32,33 and patient education and follow-up.17,21,26,28,31- 33 The pharmacist-related interventions comprised studies that used licensed pharmacists and studies that used less resource-intensive pharmacy staff, such as pharmacy residents32 and pharmacist technicians,30 demonstrating the viability of using other personnel in this role. In review of all the pharmacist- and nonpharmacist-related interventions, common elements of successful interventions were the targeting of a high-risk subgroup,18,26- 28,32,36,37 evidence of institutional support,28,36 and performing the intervention in a defined population, for example, patients to/from a nursing home27 or in the setting of an elective surgical admission.19
This review highlights the scarcity of rigorously designed studies on inpatient medication reconciliation. Only 26 studies met the inclusion criteria for this review, and of these, only 10 were randomized controlled trials,16,17,19,21,24,25,28,31,32,36 only 1 of which was conducted at more than 1 site.36 On quality review, only 6 of 26 studies met the criteria to be classified as good quality.24,25,28,31,36,39 Furthermore, comparison groups in all the studies were usual care rather than alternative interventions. This is understandable given the state of medication reconciliation efforts before 2005, but it limits our ability to draw conclusions on the most effective practices of medication reconciliation. For example, because pharmacist interventions were compared only with usual care, the evidence does not definitively support pharmacist-led medication reconciliation as superior to other reported interventions. Also, usual care relating to medication reconciliation efforts has likely improved since it was first mandated by The Joint Commission, making it difficult to compare the efficacy of certain interventions in older vs newer studies. In addition, most studies investigated process measures alone, such as the presence of medication discrepancies with potential for harm, rather than clinical outcomes, which were reported in only 9 of the 26 studies.21,24,28,29,31- 33,38,39 Although process measures are easily studied, are pertinent to the issue of medication safety, and are responsive to change, it is important to distinguish between these and actual patient outcomes.
There are many reasons why it has been difficult to rigorously examine medication reconciliation efforts despite its recognized importance to patient safety. As noted in the Society of Hospital Medicine 2010 Consensus Statement,42 medication reconciliation efforts are often resource intensive and need to overcome several challenges, including the disjointed nature of American health care, the need to maintain up-to-date and accurate medication lists across different patient care venues, and difficulty with identifying and maintaining roles and responsibility in the process. Furthermore, electronic medication reconciliation solutions are often part of larger electronic medical record systems, making it difficult to study them in isolation. Therefore, studies comparing 2 different interventions are logistically difficult, and it may be more feasible to expect comparisons of 1 intervention currently in use with that intervention plus the addition of another one.
There are several limitations of this review. Along with the lack of rigorous study design in most included studies, as discussed previously herein, it is possible (and, in fact, likely) that other medication reconciliation interventions have been implemented and studied, found to be unsuccessful, and never published. Second, many of the included studies were from outside the United States, which potentially limits generalizability in US health care settings. Differences in patient safety culture or better access to medication information (eg, through nationalized health records) may make implementation efforts more successful in other countries than in the United States. Third, this review is intentionally limited to medication reconciliation practices within, or in transition to/from, the hospital setting and, therefore, does not include the broader scope of all medical settings, including primary care and other clinic venues.
In summary, there are limited data on the most effective practices of inpatient medication reconciliation and a lack of rigorously designed controlled studies comparing different medication reconciliation approaches with each other. In the context of these limitations, existing evidence most supports pharmacist-related interventions compared with usual care in producing the best patient outcomes, with a high degree of pharmacist or pharmacy staff involvement in all medication reconciliation–related processes being most effective. Targeting interventions to a subset of patients considered at greatest risk for an ADE, such as elderly patients, patients taking many medications, and patients with many comorbid conditions, may be of highest yield. This evidence also suggests that taking an accurate medication history and communicating with postdischarge providers are important steps, especially for reducing postdischarge health care utilization.
Future research should include randomized controlled trials when possible (and interrupted time series or “stepped wedge” designs when not possible), using rigorous outcome assessment that includes clinical and process outcomes. Studies should also compare interventions with each other or evaluate the incremental benefits of adding a second intervention to one already in use, ensuring standardized and consistent measurement methods and detailed descriptions of usual care. In addition, the Society of Hospital Medicine consensus statement on medication reconciliation recommends a set of key action items for addressing identified barriers to implementation and reporting42; these items should also be used in future research and quality improvement efforts. Despite the aforementioned difficulties in performing these types of rigorous studies, it should be emphasized that it is because of the resources required for successful medication reconciliation efforts that precise estimates of impact, based on rigorously conducted studies, are required. This review should help inform the development of future interventions, both for research and for institutions that want to improve medication safety during transitions in care.
Correspondence: Jeffrey L. Schnipper, MD, MPH, Division of General Internal Medicine, Brigham and Women's Hospital, 1620 Tremont St, Roxbury, MA 02120 (firstname.lastname@example.org).
Accepted for Publication: April 11, 2012.
Published Online: June 25, 2012. doi:10.1001/archinternmed.2012.2246
Author Contributions: Dr Schnipper had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Mueller, Sponsler, Kripalani, and Schnipper. Acquisition of data: Mueller and Sponsler. Analysis and interpretation of data: Mueller, Sponsler, Kripalani, and Schnipper. Drafting of the manuscript: Mueller and Sponsler. Critical revision of the manuscript for important intellectual content: Sponsler, Kripalani, and Schnipper. Obtained funding: Schnipper. Study supervision: Kripalani and Schnipper.
Financial Disclosure: Dr Kripalani is a consultant to and holds equity in PictureRx LLC. The terms of this agreement were reviewed and approved by Vanderbilt University in accordance with its conflict of interest policies. PictureRx did not provide materials or support for this review. Dr Schnipper is a consultant to the Society of Hospital Medicine in its Glycemic Control Mentored Implementation project; is a consultant to QuantiaMD, for whom he has created online educational materials for providers and patients regarding patient safety, including medication safety; and has received grant funding from Sanofi Aventis for an investigator-initiated study to design and evaluate an intensive discharge and follow-up intervention in patients with diabetes. The terms of these agreements were reviewed and approved by Brigham and Women's Hospital and Harvard Medical School in accordance with their conflict of interest policies.
Funding/Support: This study was supported in part by grant R01 HL089755 from the National Heart, Lung, and Blood Institute (Drs Kripalani and Schnipper), grant 1 R18 HS019598-01 from the Agency for Healthcare Research and Quality (Dr Schnipper), Institutional National Research Service Award T32-HP10251 (Dr Mueller), and the Division of General Medicine at Brigham and Women's Hospital (Dr Mueller).
Role of the Sponsor: No funders had a role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health.