543485

research-article2014

AOPXXX10.1177/1060028014543485Annals of PharmacotherapyLehnbom et al

Review Article

The Impact of Medication Reconciliation and Review on Clinical Outcomes

Annals of Pharmacotherapy 1­–15 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1060028014543485 aop.sagepub.com

Elin C. Lehnbom, PhD1, Michael J. Stewart, MIPH1, Elizabeth Manias, PhD2,3,4, and Johanna I. Westbrook, PhD1

Abstract Objective: To examine the evidence regarding the effectiveness of medication reconciliation and review and to improve clinical outcomes in hospitals, the community, and aged care facilities. Data Source: This systematic review was undertaken in concordance with the PRISMA statement. Electronic databases, including MEDLINE, PsycINFO, EMBASE, and CINAHL were searched for relevant articles published between January 2000 and March 2014. Study Selection and Data Extraction: Randomized and nonrandomized studies rating the severity of medication discrepancies and medication-related problems identified during medication reconciliation and/or review were considered for inclusion. Data were extracted independently by 2 authors using a data collection form. Data Synthesis: Of the 5292 articles identified, 83 articles met the inclusion criteria. Medication reconciliation identified unintentional medication discrepancies in 3.4% to 98.2% of patients. There is limited evidence of the potential of these discrepancies to cause harm. Medication reviews identified medication-related problems or possible adverse drug reactions in 17.2% to 94.0% of patients. The studies reported conflicting findings regarding the impact of medication review on length of stays, readmissions, and mortality. Conclusions: The evidence demonstrates that medication reconciliation has the potential to identify many medication discrepancies and reduce potential harm, but the impact on clinical outcomes is less clear. Similarly, medication review can detect medication-related problems in many patients, but evidence of clinical impact is scant. Overall, there is limited evidence that medication reconciliation and medication review processes, as currently performed, significantly improve clinical outcomes, such as reductions in hospital readmissions. Keywords medication reconciliation, medication review, clinical outcomes, systematic review

Introduction Guaranteeing the safe use of medications is of paramount importance because medication therapy is one of the most pervasive interventions in the health system. However, medication errors occur frequently1-3 and are considered to be the single most preventable cause of patient harm in hospitals, the community, and residential aged care facilities (RACFs).4-8 Medication errors have the potential to cause serious harm and may even result in death.9 Injuries from the use of medications are known as adverse drug events (ADEs), and it is estimated that 25% of all ADEs are a result of medication errors.10 Transitions of care, when a patient transfers between different locations or different levels of care within the same location,11 are risk points for medication management.12 Adequate and timely communication, including information about medications that have been started, stopped, or changed, is important at care transitions to prevent medication errors that might lead to new or worse symptoms, rehospitalization, or death. Medication reconciliation and medication review are two interventions that have been designed to guard against

medication errors at transition points. They are separate processes, often performed in concert, which require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies 1

Centre for Health Systems and Safety Research, Australian Institute of Health Innovation,The University of New South Wales, Sydney, NSW, Australia 2 School of Nursing and Midwifery, Deakin University, Burwood, VIC, Australia 3 Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Melbourne, VIC, Australia 4 Melbourne School of Health Sciences, The University of Melbourne, Melbourne, VIC, Australia Corresponding Author: Elin C. Lehnbom, Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, UNSW Medicine, Level 1, AGSM Building (G27), The University of New South Wales, UNSW Sydney, NSW 2052 Australia. Email: [email protected]

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before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. It is an essential part of pharmaceutical care, which was defined by Hepler and Strand13,(p539) as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life.” Medication reconciliation and medication review can facilitate safer medication use. Studies have shown that when these processes are performed, patients experience fewer medication errors when compared with patients receiving standard care—that is, the routine care received by patients.14-17 What is not known, however, is whether undertaking these processes has an impact on clinical outcomes. Previously published literature reviews have focused on either medication reconciliation18 or medication review19 conducted in only one setting, such as only hospitals or only RACFs. The aim of this review was to evaluate how effective medication reconciliation and medication review are in identifying and rectifying harmful discrepancies and medication-related problems across a broad range of settings (hospitals, RACFs, and the community) and to assess their impact on clinical outcomes, such as length of stay, readmissions, and mortality.

Methods Identification of Studies The PRISMA statement on how to conduct and report systematic reviews was used as a guide in undertaking this review.20 Health care is often provided and evaluated in silos, but we decided to take a more holistic approach and included medication reconciliation and review articles describing research conducted in hospitals, community settings, and RACFs. Literature searches focussing on medication reconciliation and review in hospitals; medication reconciliation and review in community settings; and medication reconciliation and review in aged care were performed. Researchers decided on a standard set of terms prior to beginning the search (Appendix A). This search strategy was used in the following key bibliographic databases: Ovid MEDLINE, PsycINFO, CINAHL, EMBASE, and The Cochrane Library. The bibliographies of relevant articles were then hand searched. The research team held regular meetings to discuss terms and resolve any issues that arose. If there were any doubts about an article meeting the inclusion criteria, then other members of the research team were asked their opinions, and decisions were made based on majority opinion. Searches were limited to English language articles published between January 2000 and March

2014. The following publication types were excluded: implementation guidelines, user-satisfaction surveys, studies reporting qualitative data only, conference presentations, review articles, opinion pieces, and letters.

Study Selection and Data Extraction Articles eligible for inclusion were peer-reviewed journal articles evaluating medication reconciliation or medication review that also reported the impact of identifying and rectifying discrepancies and medication-related problems in terms of either potential harm or actual clinical outcomes. A medication-related problem is a potential or actual interference with optimal outcomes of medication use and can stem from selecting the wrong medication or using the correct medication but at dosages too high or too low, overlooking untreated indications or using medications for which there is no valid indication, using medication that results in an interaction or adverse drug reaction (ADR), and failing to receive a medication.13 Articles that only reported the number of identified discrepancies or medication-related problems but failed to identify the potential or actual impact of these discrepancies on patient outcomes were excluded. Articles were also excluded if the sample size was fewer than 50 patients because the impact on clinical outcomes could not be reliably evaluated with such a small sample size. Data were extracted and compiled using a data collection form. The form was designed and pilot tested on 2 studies from each setting (hospital, community setting, and RACFs) for both processes (medication reconciliation and medication review) by 2 researchers (ECL, MJS). Information from studies was extracted on transition point (admission to or discharge from hospitals or RACFs); setting (where in the community setting the intervention was conducted— that is, in the patient’s home or a primary care clinic); study design, number of participants, and method (type of intervention and who it was delivered by); the number and types of identified medication discrepancies and medicationrelated problems; the proportion of patients with discrepancies or medication-related problems; medications frequently associated with discrepancies or medication-related problems; and the clinical impact of discrepancies and medication-related problems. Included articles were analyzed and summarized based on their process (medication reconciliation or medication review) and setting (hospital, community setting or RACFs). The primary outcome measure was the impact of medication discrepancies or medicationrelated problems, detected during medication reconciliation or medication review, on potential harm or actual clinical outcomes.

Results The database searches yielded 5292 potentially relevant published studies. The removal of duplicates and the

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Medline 1,046

PsycINFO 98

EMBASE 2,820

CINAHL 1,203

Other 125

5,292 studies idenfied Idenficaon of duplicates 2,196 removed Title and abstract review 2,761 excluded 335 studies idenfied

Full text analysis Irrelevant – 57 Review paper – 12 Non quantave studies – 55 Conference presentaon/poster – 6 Clinical outcomes not discussed – 107 Fewer than 50 parcipants – 15

83 studies included

Figure 1.  Flow chart showing identification of individual studies for inclusion.

application of inclusion and exclusion criteria to the title and abstract eliminated 4957 studies, and a further 252 studies were eliminated after full-text analysis. Thus, 83 published studies met all the inclusion criteria (Figure 1) and were further analyzed.

Medication Reconciliation Hospitals A total of 33 studies were identified that investigated the effectiveness of medication reconciliation in identifying medication discrepancies and their impact on clinical outcomes; 23 of those studies compared the medication histories taken by doctors on hospital admission with medication histories taken by another health care provider.1,3,15,21-40 The health care provider was usually a pharmacist using a medication reconciliation form to prompt questions about use of commonly forgotten medications such as pro re nata (as required) medications. Some studies reported on discrepancies without explaining if these were intentional (clinically

justifiable) or unin-tentional (done in error) discrepancies. Hence discre-pancies include both types, unless otherwise stated. Three studies explicitly excluded over-the-counter (OTC) medications, vitamins, herbal agents, and food supplements.3,26,39 The percentage of patients with at least 1 medication discrepancy varied considerably between studies: between 3.4% and 97.0% at admission1,3,22-26,28-32,34-36,38-40 and between 25% and 80% at discharge.2,3,14,16,21,23,26,29,30,41,42 Four studies reported the percentage of patients with at least 1 unintentional medication discrepancy at both admission and discharge.3,23,26,30 Three of these studies showed that a higher proportion of patients had one or more unintentional medication discrepancies at discharge than at admission (38.0% vs 41.0%, 33.7% vs 71.3%, and 19% vs 40%, respectively).3,26,30 Only 1 study reported the proportion of patients with one or more unintentional medication discrepancies during internal hospital transfer43 and found that 62% (n = 80) of patients had at least one unintentional discrepancy during internal transfer. A total of 7 studies

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reported the proportion of medication orders with a discrepancy, ranging from 24.2% to 31.0% at admission31,37,44 and from 8.4% to 16.3% at discharge2,41,42,45 from hospital. Also, 20 studies reported the most frequently identified type of unintentional medication discrepancy during medication reconciliation,1-3,23-27,29,30,32,35-38,40-43,46 whereas other studies also included intentional discrepancies (clinically justified changes).14,15,21,28,31,45,47 Despite being conducted at different stages during hospitalization, all but three studies reported that medication omission was the most frequent type of medication discrepancy identified. The three exceptions reported medication omissions as the second42,47 or third46 most common type of discrepancy. Whereas most studies reported medication omissions as a proportion of all unintentional medication discrepancies, Walker et al16 reported the proportion of patients with a medication omission, and Grimes et al45 reported the proportion of inpatient episodes with a medication omission. At admission, medication omissions accounted for 40.0% to 100.0% of all identified unintentional medication discrepancies.1,3,23,25,26,30,32,35-38,40 Omissions accounted for 55.6% of all unintentional medication discrepancies identified during internal hospital transfers43 and for 22.9% to 46.0% of unintentional medication discrepancies at discharge.2,3,23,24,26,30,41,42 Studies that also included intentional discrepancies reported medication omission rates of 47.8% to 64.8% at admission and 33.0% to 80.0% at discharge.14,21,28,31,45,47 Also, 4 studies looked at unintentional medication discrepancies at admission and discharge.3,23,26,30 All 4 studies reported a higher proportion of medication omission at admission than at discharge (72.0% vs 45.0%, 74.0% vs 62.0%, 63% vs 40.4%, 40% vs 25%, respectively).3,23,26,30 Villanyi et al,32 who analyzed unintentional medication discrepancies for OTC medications among 67 patients found that 100% (n = 43 OTC medications) of OTC medications had been omitted.32 We found 18 studies that explored which medications were most frequently associated with medication discrepancies, and 13 studies identified cardiovascular medications as those most frequently associated with medication discrepancies,1,2,25-27,29,31,35,36,39,40,42,45 ranging from 20.0% to 47.0% for unintentional discrepancies.1,2,25-27,29,35,36,39,42 There were three studies that had all found that the largest volume of discrepancies involved cardiovascular agents; they also analyzed the proportion of medication discrepancies (number of identified medication discrepancies divided by the number of prescribed drug orders). Gleason et al25 found that ophthalmic medications had the highest proportion of discrepancies. Pippins et al29 identified gout medications and Grimes et al45 identified obstetrics, gynecology, and urinary tract drugs as the drug classes with the highest proportion of medication discrepancies. Five studies16,21,33,34,47 measured the impact of discrepancies on actual clinical outcomes rather than the potential impact. None of the studies found a significant difference

between patients receiving medication reconciliation and those receiving usual care in rates of hospital readmission. Tompson et al34 found no difference in readmission rates within 5 days of initial discharge; Pal et al47 found no difference in overall 30-day readmission rates; Walker et al16 found no difference in rates of emergency department (ED) visits within 72 hours, 14 days, or 30 days of hospital discharge; and Bolas et al21 found no difference in the length of stay during readmission for patients whose medications had been reconciled at prior discharge compared with usual care. Medication reconciliation by a clinical pharmacist at admission and medication review by a clinical pharmacist during the hospitalization offered no improvements in terms of number of ED visits, hospital readmissions, or mortality rates, compared with standard care (which included medication reconciliation by a physician at discharge).33 Apart from these five studies, which assessed actual impact on clinical outcomes, all other studies assessed the discrepancies identified during reconciliation in terms of their potential impact on clinical outcomes. The scales used to rate the potential clinical significance of discrepancies identified during medication reconciliation varied between studies, making direct comparisons difficult. A commonly used rating scale was the 3-point scale used by Cornish et al1: “unlikely to cause discomfort or clinical deterioration,” “potential to cause moderate discomfort or clinical deterioration,” and “potential to result in severe discomfort or clinical deterioration.” Of all the medication discrepancies that were assessed for their reported potential impact on clinical outcomes, between 18.4%37 and 80.5%36 had the potential to cause no or minor harm, 17.9%36 to 78.1%37 had the potential to cause moderate harm, and 0%41 to 24.3%32 had the potential to cause severe or life-threatening harm. The studies have been summarized in Table S1 available online at aop.sagepub.com/ supplemental.

Community Settings Four studies were identified that reported the effectiveness of medication reconciliation in identifying potentially harmful medication discrepancies in community settings.48-51 The medication reconciliation process was conducted in patients’ homes,48,50 in a primary health care clinic prior to doctor appointments,49 or over the phone.51 The studies have been summarized in Table S2 available online at aop.sagepub.com/supplemental. The proportion of patients with at least 1 medication discrepancy ranged from 14.1%48 to 98.2%.49 Setter et al50 did not report how many patients were affected by discrepancies but instead reported that control (n = 110) and intervention patients (n = 110) experienced 226 and 222 discrepancies, respectively. In contrast to medication reconciliation performed in hospitals, most studies identified in

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Lehnbom et al community settings explicitly stated the inclusion of OTC medications in medication reconciliation.48,49,51 In 2 studies,48,50 the type of medication discrepancies were categorized according to patient-associated factors, such as nonadherence, or system-associated factors, such as conflicting information from different information sources. Setter et al50 reported that 45.7% and 54.3% of all discrepancies were patient associated and system associated, respectively. Coleman et al48 reported that 50.8% of all discrepancies were patient associated, with nonintentional nonadherence being the most common patient-associated factor (33.9%). The most frequent type of discrepancy identified by Varkey et al49 was omissions, whereas Kilcup et al51 reported that inclusion of discontinued medications was the most frequently identified discrepancy. The study by Coleman et al was the only one that reported which medications were most frequently associated with medication discrepancies; they reported that 50% of all discrepancies were associated with anticoagulants, diuretics, angiotensin-converting enzyme inhibitors, lipid-lowering agents, and proton pump inhibitors. Varkey et al49 reported that the majority of identified medication discrepancies had minimal potential clinical impact. They showed that 24.0% of discrepancies in phase I (usual care) and 17.0% in phase II (intervention) were classed as significant, with only one discrepancy (0.3% in phase I) classed as serious. Coleman et al48 found that 14.3% of patients who experienced a discrepancy, compared with 6.1% of patients who did not experience a discrepancy, were rehospitalized within 30 days—a significant difference (P = 0.04). Setter et al50 found that control patients (where no medication reconciliation was performed) had a lower rate of discrepancy resolution and reported a nonsignificant trend toward more planned and unplanned physician visits compared with intervention patients. Intervention patients in the study by Kilcup et al51 had significantly decreased readmission rates at 7 (P = 0.01) and 14 days (P = 0.04) but not at 30 days (P = 0.29) after discharge.

Residential Aged Care Facilities Three studies were identified that reported on the effectiveness of medication reconciliation in recognizing potentially harmful medication discrepancies in RACF settings.52-54 In all three studies, a pharmacist conducted medication reconciliation,53 a review of discharge summaries,52 or coordinated care transitions.54 The studies have been summarized in Table S3 available online at aop.sagepub.com/ supplemental. When the discharge summary from the hospital was compared with the medication list in the nursing home, 26.9% of patients who had had their discharge summary

reviewed by a hospital pharmacist were found to have at least 1 medication discrepancy.52 For control patients, who had not had their discharge summary reviewed by a pharmacist, the proportion of patients with at least 1 medication discrepancy was 36.6%. A higher proportion of patients who had received the services of a pharmacist transition coordinator (57.1%) compared with control patients, who did not receive this service (48.1%), were found to have discrepancies.54 A clinical pharmacist who conducted medication reconciliation of medication orders from the hospital with what the resident received before hospitalization identified a total of 696 discrepancies, with a mean number of 6.4 discrepancies per patient.53 The most common type of discrepancies in RACFs was reported in only 1 study. Boockvar et al53 did not distinguish between intentional and unintentional discrepancies and reported that omissions, additions, and dosage changes, were the most common discrepancies and that cardiovascular, neuropsychiatric, and analgesic/anti-inflammatory agents were the most common drug classes involved in discrepancies. Clinical outcomes were reported in 2 studies, and intervention patients had significantly shorter hospital stays (P = 0.026),53 less pain (P = 0.023), and fewer ED visits or readmissions (P = 0.035) when compared to control patients.54

Medication Review Hospitals A total of 14 studies were identified. In 10 studies, a pharmacist or pharmacy student performed medication review during the patient’s stay in the hospital.55-64 Two studies used nurses to identify medication-related problems and ADRs,65,66 and another study used a multidisciplinary team consisting of a geriatrician, a social worker, and a nurse to identify medication-related problems.67 The studies have been summarized in Table S4 available online at aop.sagepub.com/supplemental. The proportion of patients requiring intervention varied greatly between studies, from 17.2%66 to 88.0%.62 Medication-related problems were identified in 17.2%66 to 81.0%55 of patients. In an intention-to-treat analysis—that is, analyzing data for all 210 patients who were enrolled in the study regardless of whether they completed the study or not—Hellström et al63 found that 18.4% and 21.9% of medications used by intervention and control patients, respectively, were rated as inappropriate. The proportion of medications rated as inappropriate were 15.1% and 20.2%, respectively, in a per-protocol analysis—that is, analyzing only the results for the 176 patients who completed the study.63 Using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions/Screening Tool to Alert Right Treatment (STOPP/START) criteria, Gallagher et al17

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reported that approximately 20.0% of 400 patients had unnecessary polypharmacy at admission. Also, six studies reported the number of recommendations for changes to patients’ medications that resulted from medication reviews. Gallagher et al17 made 183 recommendations that affected 111 patients (58.0%); Slee et al61 made 464 recommendations for 301 patients (38%), and Scullin et al64 made 1628 recommendations for 294 intervention patients (79.2%). O’Dell and Kucukarslan,59 Kucukarslan et al,57 and Lisby et al62 reported that a total of 124, 150, and 187 recommendations, respectively, were made during ward rounds but did not report how many patients were affected. Between 39.0%62 and 98%57 of all changes suggested by pharmacists were accepted by physicians. In total, 13 studies reported the type of medicationrelated problems most often identified during medication review.17,33,55-62,65-67 The studies measured different clinical outcomes, making it difficult to compare study results. One study reported significantly lower readmission rates at 12 months post-discharge for intervention patients compared with control patients (50.7% and 59.2%, P = 0.027),64 and another study56 reported lower drug-related readmissions for intervention patients compared with control patients (95% CI = 0.10-0.40). However, 7 other studies reported no difference in the proportion of intervention and control group patients who re-presented to the ED or were readmitted to hospital.17,58-60,62,65,66 In terms of possible, probable, and certain medication related revisits, Hellström et al63 found a significant difference between intervention and control patients (P = 0.0469). Patients with an ADE were reported to have a longer average length of stay compared with patients who did not experience an ADE.57 Three studies17,60,65 used mortality rates as an outcome measure. Two60,65 of the 3 studies had enough power to detect an absolute difference of 20.0% in death rates between the two groups (ie, one with medication review and one without) but found that death rates in the intervention groups did not differ significantly from those in the control group (19.3% and 14.7%, P = 0.2865; 22.5% and 30.1%, P = 0.3060).

Community Settings In all, 20 studies were identified. In 17 studies, a pharmacist performed medication review either in patients’ homes or in a clinic.68-84 One study used a general practitioner assistant to review medications, but potential ADRs were checked by a pharmacist,85 and 2 studies used administrative claims data to evaluate the impact of home medicines review on the time to next hospitalization.86,87 The studies have been summarized in Table S5 available online at aop.sagepub. com/supplemental. The proportion of patients with potential medicationrelated problems as identified via medication review was reported in nine studies and ranged from 18.0% to

94.0%.69-72,74,75,78,79,85 The 12 studies that used hospital admissions or readmissions as an outcome measure reported mixed results. In six studies, no statistically significant differences were found between intervention and control patients.68,72,73,75,76,82 Intervention patients compared with control group patients in five other studies were found to have lower rates of hospital admission or readmissions.74,78,83,86,87 However, Holland et al70 found that medication review by a pharmacist was associated with an increase in hospital readmissions by 30% compared with patients who did not have a medication review by a pharmacist. They offered three potential explanations for this counterintuitive finding: (1) pharmacists helped patients understand their conditions better, therefore recognizing warning signs earlier and prompting them to seek help; (2) patients were prescribed a large number of medications, and the medication review resulted in better adherence, which caused iatrogenic illness; (3) a home visit by a pharmacist may have added complexity to patients’ care, caused confusion, or increased dependence on health care services.70

Residential Aged Care Facilities In this category, nine studies were identified. Medication review was performed by pharmacists88-90,92-96 or consultants.91 Following medication review, when compared with control group patients, intervention patients had significantly fewer medications per patient per day,91 more medication changes,92 and improved appropriateness of prescribed medications.88,90,93 The studies have been summarized in Table S6 available online at aop.sagepub.com/ supplemental. Following medication review, 93% of patients had recommendations made to improve medication management.88,91 Other studies reported the mean number of recommendations per patient,96 the mean number of medication changes,89,92 or the difference in medication appropriateness index score between intervention and control groups.93 The use of different metrics made it difficult to abstract a single value for the proportion of patients with inappropriate prescribing. Three studies investigated which classes of medication were altered as a result of medication review.89,93,94 All three studies mentioned more appropriate prescribing of psychiatric medications, including benzodiazepines and neuroleptics. Four studies demonstrated positive clinical outcomes in terms of improved cumulative survival,94 reduced mortality rate,89 fewer falls,92 and improved mood, alertness, and social interaction.95 Three studies reported differences that did not reach statistical significance.88,91,93 Furniss et al89 reported negative clinical outcomes, with patients in the intervention group experiencing greater clinical deterioration in cognitive function and behavioral disturbance than the control group. Patterson et al90 found no differences in

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Lehnbom et al the rate of falls between intervention and control groups. Lapane et al96 compared medication review by consultant pharmacists with and without the Geriatric Risk Assessment MedGuide (GRAM). GRAM generated reports of problems identified in complex medication regimens. When the consultant pharmacist used the GRAM, positive clinical outcomes, including lower rates of potential delirium and reduced mortality, were observed compared with when the consultant pharmacist manually conducted the medication review.

Discussion This review showed that medication reconciliation conducted at admission and discharge, to and from hospitals, in RACFs and in the community, identified unintentional medication discrepancies in 3.4% to 98.2% of patients. Most discrepancies had little potential or actual impact on clinical outcomes. Studies of medication reviews in hospitals, RACFs, and in the community reported that 17.2% to 94% of patients had medication-related problems. There is some evidence that medication review can reduce the incidence of preventable ADEs.57,74 However, there is little evidence that medication review reduces length of stay, hospital readmissions, or mortality. Some of the few medication review studies undertaken in RACFs reported significant improvements in the appropriateness of prescribed medications88,90,93 and significant between-group differences in clinical outcomes, such as fewer falls92 and better survival rates.89,94 Our analysis identified several reasons why medication reconciliation and review studies have not consistently demonstrated significant improvements in outcomes. These relate to both study design issues and the nature of the interventions.

Limited Evidence Base on Impact of Interventions on Health Outcomes Over the past decade, a large number of studies on the topic of medication reconciliation and medication review have been published, but only 83 studies were identified that sought to measure the impact of these interventions on health outcomes. These were the studies that met the inclusion criteria for this review. Thus, the evidence base regarding the effectiveness of medication reconciliation and medication review to improve health outcomes is small. The majority of studies were conducted in hospitals, with very few medication reconciliation studies conducted in community settings and RACFs. All but five medication reconciliation studies conducted in hospitals rated the potential impact of identified discrepancies. Future studies should focus on utilizing more effective measures to

determine the impact of medication reconciliation on health outcomes by considering hospital readmissions, number of visits to primary care physicians or general practitioners, and morbidity. Few studies reported significant improvements in clinical outcomes following medication review. Although most studies did not find a difference at all, two studies reported worse outcomes for intervention patients compared with control patients. Future studies should be well powered, with clearly defined comparison groups, to allow the detection of relatively small improvements.

Study Design Issues Many studies included in this review were observational studies without control groups. This general absence of robust study designs limited the ability of these studies to draw clear conclusions. Many studies used insufficient sample sizes to detect changes in the relatively “rare” outcome indicators selected, and often, statistical analyses to test for significant differences between comparison groups were not performed. Therefore, this review could only infrequently report the results of tests of statistical significance. The large cohort studies conducted by Roughead et al86,87 are excellent examples of the advantages of largescale cohort studies designed to detect statistical differences between control and intervention groups in clinical outcomes such as hospitalizations. One design feature of many studies that may have limited the ability to demonstrate a significant improvement in health outcomes was the choice of comparison groups. Many studies compared usual care with ideal processes. Although it was not always clear what constituted usual care, sometimes usual care involved the intervention that was being evaluated. This suggests that the distinction between usual and ideal processes is not great. For example, as part of usual care, physicians could request that a pharmacist or nurse documented and reconciled a patient’s medication use history. The ideal process was to conduct medication reconciliation for all patients. The choice of control group resulted in measuring the difference between always and sometimes performing medication reconciliation. Studies never evaluate no reconciliation or review versus ideal processes (nor, for ethical reasons, should they contemplate such comparisons). However, more information about usual care is needed in future studies to allow readers to clarify the extent to which usual care relates to ideal practices. A limitation of this review is that we did not perform a quality assessment of each individual article, meaning that each article is treated as being equal in study design robustness, even though the studies were clearly of varying degrees of quality.

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Role of Consumers Patients’ medication histories are dynamic, and thus, reconciliation and review at multiple points in time are required to have an effect, but few studies accounted for this dynamic nature. Cohort and longitudinal study designs may be beneficial in understanding the longer-term benefits of improved medication management. To date, most studies have relied exclusively on patients and/or their carers to provide a medication history, and few studies have evaluated the effect of actively engaging patients and their carers in the medication reconciliation process. Many discrepancies were identified during medication chart review that were later clarified during patient interviews, highlighting the importance of using multiple sources of information and including patients and/or their carers in these processes.

Conclusions The evidence presented in this review demonstrates that medication reconciliation in hospitals, community settings and RACFs has the potential to identify a high proportion of medication discrepancies and reduce potential harm, but the actual impact on health outcomes resulting from this process is less clear. Similarly, medication review in hospitals, community settings, and RACFs can detect medicationrelated problems in a high proportion of patients, but evidence of clinical impact is scant. Overall, there is limited evidence indicating that medication reconciliation and medication review processes, as currently performed, significantly improve patient management or outcomes. Only a few studies measured and demonstrated that medication reconciliation and medication review resulted in significant reductions in ADEs, lengths of stay, hospitalizations, readmissions to hospital, or mortality. These findings are consistent with other reviews that have included medication reconciliation and review activities.5,18,97 The literature is very disparate, with no study comparing medication reconciliation and medication review in terms of their impact on clinical outcomes; few studies used the same methods and outcomes measure to evaluate the impact of medication reconciliation or medication review at multiple transition points; and no study used the same methods and outcome measure to evaluate in which setting medication reconciliation and medication review is of more value. Research focused on evaluating medication management in community settings and RACFs should be a priority because evidence from these settings is particularly scant. There would be considerable value in a future, sufficiently powered study that applies both a broader range of outcome indicators and considers a variety of different study settings to assess the

impact of medication reconciliation and medication review on clinical outcomes.

Appendix A Search Strategy Medication Reconciliation EMBASE (2000-2014) 1. medication reconciliation.mp. or exp medication therapy management/ 2. medication discrepancy.mp. 3. adverse drug event$.mp. 4. 1 or 2 or 3 5. exp hospital/ 6. exp patient admission/ 7. exp patient discharge/ 8. exp patient transfer/ 9. exp emergency medicine/ 10. exp emergency health service/ 11. 5 or 6 or 7 or 8 or 9 or 10 12. 4 and 11 13. limit 12 to (english language and embase and yr=“2000 - 2014”) 14. exp general practice/ 15. exp general practitioner/ 16. exp primary health care/ 17. 14 or 15 or 16 18. 4 and 17 19. limit 18 to (english language and embase and yr=“2000 - 2014”) 20. exp home for the aged/ 21. exp nursing home/ 22. exp elderly care/ 23. residential aged care facilities.mp. 24. 20 or 21 or 22 or 23 25. 4 and 24 26. limit 25 to (english language and embase and yr=“2000 - 2014”) 27. 13 or 19 or 26 Ovid MEDLINE (2000-2014) 1. medication reconciliation.mp. or exp medication therapy management/ 2. medication discrepancy.mp. 3. adverse drug event$.mp. 4. 1 or 2 or 3 5. exp hospital/ 6. exp hospital admission/ 7. exp hospital discharge/

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Lehnbom et al 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26.

patient transfer.mp. exp emergency medicine/ exp emergency health service/ 5 or 6 or 7 or 8 or 9 or 10 4 and 11 exp general practice/ exp general practitioner/ exp primary health care/ 13 or 14 or 15 4 and 16 exp homes for the aged/ exp nursing homes/ exp health services for the aged/ exp elderly care/ residential aged care facilities.mp. 18 or 19 or 20 or 21 or 22 4 and 23 4 or 12 or 24 limit 21 to (english language and yr=“2000-2014”)

PsycINFO (2000-2014) 1. medication reconciliation.mp 2. medication discrepancy.mp. 3. adverse drug event$.mp. 4. 1 or 2 or 3 5. exp hospitals/ 6. exp hospital admission/ 7. exp hospital discharge/ 8. exp client transfer/ 9. emergency medicine.mp. 10. exp emergency services/services/ 11. emergency medical services.mp. 12. 5 or 6 or 7 or 8 or 9 or 10 or 11 13. 4 and 12 14. exp family physicians/ 15. 15 exp primary health care/ or exp family medicine/ 16. exp general practitioners/ or exp general practice. mp 17. 14 or 15 or 16 18. 4 and 17 19. exp nursing homes/ or exp residential care institutions/ or exp elder care/ 20. health services for the aged.mp. 21. residential aged care facilities.mp. 22. 19 or 20 or 21 23. 4 and 22 24. 13 or 18 or 23 25. limit 24 to (english language and yr=“2000-2014”) CINAHL (January 2000 to January 2014) 1. (MM “Medication Reconciliation”) 2. “medication discrepancy”

3. (MH “Adverse Drug Event+”) 4. S1 OR S2 OR S3 5. (MH “Hospitals, Urban”) OR (MH “Hospitals, Community”) OR (MH “Hospitals, Public+”) OR (MH “Hospitals, Rural”) 6. “hospital admission” 7. “hospital discharge” 8. “patient transfer” 9. (MM “Emergency Medicine”) 10. (MH “Emergency Service”) 11. (MH “Emergency Medical Services+”) 12. S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR S11 13. S4 AND S12 14. (MH “Family Practice”) OR (MH “Physicians, Family”) 15. (MH “Primary Health Care”) 16. (MH “Medical Practice”) 17. S14 OR S15 OR S16 18. S4 AND S17 19. “home for the aged” 20. (MH “Nursing Homes”) 21. (MH “Health Services for the Aged”) 22. “elderly care” 23. “residential aged care facilities” 24. S19 OR S20 OR S21 OR S22 OR S23 25. S4 AND S24 26. S13 OR S18 OR S25 Limiters – Date published from: 20000101-20140331; English Language Medication Review EMBASE (2000-2014) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.

drug utilization review.mp. medication review.mp. medication therapy management.mp. medication history review.mp. medical history review.mp. exp hospital/ exp hospital admission/ exp hospital discharge/ patient transfer.mp. exp emergency medicine/ exp emergency health service/ 6 or 7 or 8 or 9 or 10 or 11 exp general practice/ exp general practitioner/ exp primary health care/ 13 or 14 or 15 exp home for the aged/ exp nursing home/ exp elderly care/ residential aged care facilities.mp. 17 or 18 or 19 or 20 1 or 2 or 3 or 4 or 5

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23. 12 and 22 24. 16 and 22 25. 21 and 22 26. 23 or 24 or 25 27. limit 26 to (english language and embase and yr=“2000 - 2014”) Ovid MEDLINE (2000-2014) 1. exp hospital/ 2. exp emergency medicine/ 3. exp emergency health service/ 4. exp general practice/ 5. exp general practitioner/ 6. exp primary health care/ 7. residential aged care facilities.mp. 8. exp patient admission/ or exp patient discharge/ or exp patient transfer/ 9. exp Homes for the Aged/ or exp Nursing Homes/ or exp Health Services for the Aged/ 10. elderly care.mp. 11. 1 or 2 or 3 or 8 12. 4 or 5 or 6 13. 7 or 9 or 10 14. exp “Drug Utilization Review”/ 15. medication review.mp. or exp Medication Therapy Management/ 16. medication history review.mp. 17. medical history review.mp. 18. 15 or 16 or 17 19. 11 and 18 20. 12 and 18 21. 13 and 18 22. 19 or 20 or 21 23. limit 22 to (english language and yr=“2000 - 2014”) PsycINFO (2000-2014) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

exp Hospitals/ exp Hospital Admission/ exp Hospital Discharge/ exp Client Transfer/ emergency medicine.mp. exp Emergency Services/ emergency medical services.mp. 1 or 2 or 3 or 4 or 5 or 6 or 7 exp Family Physicians/ exp Primary Health Care/ or exp Family Medicine/ exp General Practitioners/ or general practice.mp. 9 or 10 or 11

13. exp Nursing Homes/ or exp Residential Care Institutions/ or exp Elder Care/ 14. health services for the aged.mp. 15. residential aged care facilities.mp. 16. drug utilization review.mp. 17. medication review.mp. 18. medication therapy management.mp. 19. medication history review.mp. 20. medical history review.mp. 21. 16 or 17 or 18 or 19 or 20 22. 8 and 21 23. 12 and 21 24. 13 or 14 or 15 25. 21 and 24 26. 22 or 23 or 25 27. limit 26 to (english language and yr=“2000 - 2014”) CINAHL (January 2000 to January 2014) 1. (MH “Hospitals, Urban”) OR (MH “Hospitals, Community”) OR (MH “Hospitals, Public+”) OR (MH “Hospitals, Rural”) 2. “hospital admission” 3. “hospital discharge” 4. “patient transfer” 5. (MM “Emergency Medicine”) 6. (MH “Emergency Service”) 7. (MH “Emergency Medical Services+”) 8. S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR S11 9. (MH “Family Practice”) OR (MH “Physicians, Family”) 10. (MH “Primary Health Care”) 11. (MH “Medical Practice”) 12. S9 OR S10 OR S11 13. “Home for the aged” 14. (MH “Nursing Homes”) 15. (MH “Health Services for the Aged”) 16. “Elderly care” 17. “Residential aged care facilities” 18. S13 OR S14 OR S15 OR S16 OR S17 19. (MH “Utilization review”) 20. “Medication management therapy 21. “Medical history review” 22. “medication history review” 23. S19 OR S20 OR S22 24. S8 AND S23 25. S8 AND S24 26. S18 AND S24 27. S24 OR S25 OR S26 Limiters – Date published from: 20000101-20140331; English Language

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Appendix B PRISMA checklist.a Section/Topic

Number

Checklist Item

Reported on Page Number

Title Title Abstract Structured summary

1

Identify the report as a systematic review, meta-analysis, or both

2

Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number

1

Introduction Rationale Objectives

3 4

Describe the rationale for the review in the context of what is already known. Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).

2 2

Methods Protocol and registration

5

Eligibility criteria

6

Information sources

7

Search

8

Study selection

9

Indicate if a review protocol exists, if and where it can be accessed (eg, Web address), and, if available, provide registration information including registration number. Specify study characteristics (eg, PICOS, length of follow-up) and report characteristics (eg, years considered, language, publication status) used as criteria for eligibility, giving rationale. Describe all information sources (eg, databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched. Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated. State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis). Describe method of data extraction from reports (eg, piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators. List and define all variables for which data were sought (eg, PICOS, funding sources) and any assumptions and simplifications made. Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis. State the principal summary measures (eg, risk ratio, difference in means). Describe the methods of handling data and combining results of studies, if done, including measures of consistency (eg, I2) for each meta-analysis. Specify any assessment of risk of bias that may affect the cumulative evidence (eg, publication bias, selective reporting within studies). Describe methods of additional analyses (eg, sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.

Data collection process

10

Data items

11

Risk of bias in individual studies

12

Summary measures Synthesis of results

13 14

Risk of bias across studies

15

Additional analyses

16

Results Study selection

17

Study characteristics

18

Risk of bias within studies

19

Results of individual studies

20

Synthesis of results

21

Risk of bias across studies Additional analysis

22 23

Discussion Summary of evidence

24

Limitations

25

Conclusions

26

Funding Funding

27

Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram. For each study, present characteristics for which data were extracted (eg, study size, PICOS, follow-up period) and provide the citations. Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot. Present results of each meta-analysis done, including confidence intervals and measures of consistency. Present results of any assessment of risk of bias across studies (see Item 15). Give results of additional analyses, if done (eg, sensitivity or subgroup analyses, meta-regression [see Item 16]).

Title page

N/A 3 3 Appendix 1 2-3 3 3-4 12

3 11-12 12 N/A

Figure 1 Appendix 2 12 Appendix 2

N/A 12 N/A

Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (eg, healthcare providers, users, and policy makers). Discuss limitations at study and outcome level (eg, risk of bias), and at review-level (eg, incomplete retrieval of identified research, reporting bias). Provide a general interpretation of the results in the context of other evidence, and implications for future research.

10-12

Describe sources of funding for the systematic review and other support (eg, supply of data); role of funders for the systematic review.

Title page

12 13

a Moher D, Liberati A, Tetzlaff J, Altman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097. doi:10.1371/journal.pmed1000097.

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Acknowledgments The authors would like to acknowledge Dr Janice Wiley for contributing to the initial search and Dr Magda Raban, Dr Melissa Baysari, and Mr Elia Vecellio for contributing to the editing of the manuscript.

Authors’ Note This work has not been presented as an abstract or poster.

Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The National E-Health Transition Authority Limited (NETHA) was established by the Australian, State and Territory governments to develop better ways of electronically collecting and securely exchanging health information. NETHA funded this literature review but had no role in study design, data collection and analysis, decision to publish, or preparation of the article.

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