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Original Research |

Effect of a Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge: A Randomized Trial

Sunil Kripalani, MD, MSc; Christianne L. Roumie, MD, MPH; Anuj K. Dalal, MD; Courtney Cawthon, MPH; Alexandra Businger, BA; Svetlana K. Eden, MSc; Ayumi Shintani, PhD, MPH; Kelly Cunningham Sponsler, MD; L. Jeff Harris, MD; Cecelia Theobald, MD; Robert L. Huang, MD, MPH; Danielle Scheurer, MD, MSc; Susan Hunt, MD; Terry A. Jacobson, MD; Kimberly J. Rask, MD, PhD; Viola Vaccarino, MD, PhD; Tejal K. Gandhi, MD, MPH; David W. Bates, MD, MSc; Mark V. Williams, MD; Jeffrey L. Schnipper, MD, MPH, for the PILL-CVD (Pharmacist Intervention for Low Literacy in Cardiovascular Disease) Study Group
[+] Article and Author Information

From the Vanderbilt Center for Health Services Research, Vanderbilt University, Veterans Affairs Tennessee Valley Geriatric Research Education Clinical Center, Health Services Research & Development Service Targeted Research Enhancement Program for Patient Healthcare Behavior, and Clinical Research Center of Excellence, Nashville, Tennessee; Brigham and Women's Hospital, Brigham and Women's Hospital Hospitalist Service, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts; Medical University of South Carolina, Charleston, South Carolina; University of Washington Hospitalist Service, Seattle, Washington; Emory University School of Medicine and Rollins School of Public Health, Emory University, Atlanta, Georgia; and Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Grant Support: By National Heart, Lung, and Blood Institute grant R01 HL089755 (Dr. Kripalani) and in part by National Heart, Lung, and Blood Institute grant K23 HL077597 (Dr. Kripalani); National Heart, Lung, and Blood Institute grant K08 HL072806 (Dr. Schnipper); Veterans Affairs Career Development Award 04-342-2 (Dr. Roumie); and National Center for Research Resources grant UL1 RR024975 (Dr. Bernard).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2442.

Reproducible Research Statement:Study protocol, data set, and statistical code: Available from Dr. Kripalani (e-mail, sunil.kripalani@vanderbilt.edu).

Requests for Single Reprints: Sunil Kripalani, MD, MSc, Department of Medicine, Vanderbilt University, 1215 21st Avenue South, Suite 6000 Medical Center East, Nashville, TN 37232; e-mail, sunil.kripalani@vanderbilt.edu.

Current Author Addresses: Dr. Kripalani, Ms. Cawthon, and Dr. Cunningham Sponsler: 1215 21st Avenue South, MCE 6000–HSR, Nashville, TN 37232-8300.

Dr. Roumie: Tennessee Valley Healthcare System, 1310 24th Avenue South GRECC, Nashville, TN 37212.

Dr. Dalal: Brigham and Women's Hospital, PBB-B4-428, 15 Francis Street, Boston, MA 02115.

Ms. Businger and Dr. Schnipper: Brigham and Women's Hospital, Division of General Medicine and Primary Care, 1620 Tremont Street, 3rd Floor, Boston, MA 02120-1613.

Ms. Eden and Dr. Shintani: Vanderbilt University School of Medicine, Department of Biostatistics, S-2323 Medical Center North, Nashville, TN 37232-2158.

Dr. Harris: 2336 MacGruder Cove, Memphis, TN 38119.

Dr. Theobald: 113 Bowling Avenue, Nashville, TN 37205.

Dr. Huang: 1223 Longholm Court, Chattanooga, TN 37405.

Dr. Scheurer: Medical University of South Carolina, 135 Rutledge Avenue, Room 1224, Charleston, SC 29425.

Dr. Hunt: University of Washington Medical Center, Department of Medicine, Box 356429, Seattle, WA 98195-6429.

Dr. Jacobson: Emory University, 49 Jesse Hill Jr Drive Southeast, Atlanta, GA 30303.

Dr. Rask: Emory University Rollins School of Public Health, 1518 Clifton Road, Room 636, Atlanta, GA 30322.

Dr. Vaccarino: Emory University School of Public Health, 1518 Clifton Road, Room 3011, Atlanta, GA 30322.

Dr. Gandhi: Partners Healthcare, 115 Fourth Avenue, Needham, MA 02492.

Dr. Bates: Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA 02120-1613.

Dr. Williams: Northwestern University Feinberg School of Medicine, 211 East Ontario Street, Suite 700, Chicago, IL 60611.

Author Contributions: Conception and design: S. Kripalani, T.A. Jacobson, K.J. Rask, T.K. Gandhi, D.W. Bates, J.L. Schnipper.

Analysis and interpretation of the data: S. Kripalani, C.L. Roumie, A. Dalal, A. Businger, S.K. Eden, A. Shintani, L.J. Harris, D. Scheurer, T.A. Jacobson, K.J. Rask, V. Vaccarino, T.K. Gandhi, M.V. Williams, J.L. Schnipper.

Drafting of the article: S. Kripalani, A. Dalal, C. Cawthon, S.K. Eden, T.A. Jacobson, K.J. Rask, M.V. Williams.

Critical revision of the article for important intellectual content: S. Kripalani, C.L. Roumie, C. Cawthon, A. Shintani, K. Cunningham Sponsler, T.A. Jacobson, K.J. Rask, V. Vaccarino, T.K. Gandhi, D.W. Bates, M.V. Williams, J.L. Schnipper.

Final approval of the article: S. Kripalani, C.L. Roumie, A. Dalal, A. Businger, K. Cunningham Sponsler, C. Theobald, D. Scheurer, T.A. Jacobson, K.J. Rask, V. Vaccarino, T.K. Gandhi, D.W. Bates, J.L. Schnipper.

Provision of study materials or patients: S. Kripalani, D.W. Bates.

Statistical expertise: S. Kripalani, S.K. Eden, A. Shintani, V. Vaccarino.

Obtaining of funding: S. Kripalani, J.L. Schnipper.

Administrative, technical, or logistical support: C.L. Roumie, V. Vaccarino.

Collection and assembly of data: S. Kripalani, A. Dalal, C. Cawthon, A. Businger, K. Cunningham Sponsler, C. Theobald, R.L. Huang, D. Scheurer, S. Hunt, T.K. Gandhi, J.L. Schnipper.


Ann Intern Med. 2012;157(1):1-10. doi:10.7326/0003-4819-157-1-201207030-00003
Text Size: A A A

Background: Clinically important medication errors are common after hospital discharge. They include preventable or ameliorable adverse drug events (ADEs), as well as medication discrepancies or nonadherence with high potential for future harm (potential ADEs).

Objective: To determine the effect of a tailored intervention on the occurrence of clinically important medication errors after hospital discharge.

Design: Randomized, controlled trial with concealed allocation and blinded outcome assessors. (ClinicalTrials.gov registration number: NCT00632021)

Setting: Two tertiary care academic hospitals.

Patients: Adults hospitalized with acute coronary syndromes or acute decompensated heart failure.

Intervention: Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge.

Measurements: The primary outcome was the number of clinically important medication errors per patient during the first 30 days after hospital discharge. Secondary outcomes included preventable or ameliorable ADEs, as well as potential ADEs.

Results: Among 851 participants, 432 (50.8%) had 1 or more clinically important medication errors; 22.9% of such errors were judged to be serious and 1.8% life-threatening. Adverse drug events occurred in 258 patients (30.3%) and potential ADEs in 253 patients (29.7%). The intervention did not significantly alter the per-patient number of clinically important medication errors (unadjusted incidence rate ratio, 0.92 [95% CI, 0.77 to 1.10]) or ADEs (unadjusted incidence rate ratio, 1.09 [CI, 0.86 to 1.39]). Patients in the intervention group tended to have fewer potential ADEs (unadjusted incidence rate ratio, 0.80 [CI, 0.61 to 1.04]).

Limitation: The characteristics of the study hospitals and participants may limit generalizability.

Conclusion: Clinically important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy–sensitive, pharmacist-delivered intervention.

Primary Funding Source: National Heart, Lung, and Blood Institute.

Figures

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Figure 1.

Study flow diagram.

ACS = acute coronary syndrome; ADHF = acute decompensated heart failure.

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Figure 2.

Adjusted treatment effect on clinically important medication errors, ADEs, and potential ADEs, by subgroups of interest.

Values less than 1.0 indicate that the mean count of outcomes in the treatment group is smaller than that in the usual care group. Clinically important medication errors are a composite of ADEs and potential ADEs. ADE = adverse drug event; IRR = incidence rate ratio.

* P values for the main treatment effect are based on negative binomial regression models, adjusted for covariates, using multiple imputation for missing predictor data.

P values for the interactions assess homogeneity among subgroup-specific treatment effects and are based on the likelihood ratio test that compared models with and without the interaction term.

Grahic Jump Location

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Effect of a Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge
Posted on July 9, 2012
Deirdre T Criddle
Sir Charles Gairdner Hospital
Conflict of Interest: None Declared
To the Editor;Kripalani and his colleagues1 provide important insights into improving the management of patients at transitions of care. Despite providing patients best practice care from pharmacists in medication education (including confirmation of understanding), adherence assistance tools and telephone follow-up post discharge, medication errors were not reduced. This unexpected result challenges our perception of the problem. Perhaps the answer lies in a re-examination of contextual factors which are not immediately obvious. In this respect it is important to understand the impact a sentinel event, such as a hospital admission for ACS or heart failure, has on patients and their capacity to comprehend and retain information provided about their medications during their hospital stay. More importantly the study underscores the importance of a collaborative approach that involves primary care, as ultimately the responsibility of the longitudinal care of patients will be in this arena. The authors suggest reduction of preventable or ameliorable ADEs may require interventions focused on closer discharge monitoring or home visits. To ensure cost effectiveness such interventions may need to be targeted to high risk groups likely to gain the greatest benefit such as those with cognitive deficits, poor health literacy or taking a high number of medications. In Australia, we are eagerly anticipating a hospital initiated home medication review in the early post discharge period, aimed at reducing these medication related problems. Hopefully pharmacists working in this area can take a lead role in bridging this gap, and ensure effective communication occurs between treating physicians, patients, carers and the primary care providers responsible for medication during this vulnerable transition. In light of the findings by Kripalani et al1, we should not abandon the concept of medication reviews by pharmacists but undertake further research to understand the complexity dynamics that lead to suboptimal care. Deirdre CriddleAccredited Pharmacist Dianella, Western AustraliaReference;1. Kripalani, S. Roumie, C.L. Dalal, A.K. Cawthon, C, Businger, A Eden,S.K et al Effect of a pharmacist intervention on clinically important medication erros after hospital discharge: A randomised trial. PIL-CVD Study Group Ann Intern Med. 2012;157:1-10.
Letter to the Editor
Posted on July 23, 2012
Jessica LaFosse, Pharm.D., BCPS; Jessica Dabady, Pharm.D.; Heather Stamper, Pharm.D
Per request of the Health System, please do not disclose place of employment, hospital or health system.
Conflict of Interest: None Declared

TO THE EDITOR: The potential bias throughout this study limits the credibility of the authors’ conclusions (1). A similar study was conducted at one of the same study institutions by Schnipper et al. in 2006, which demonstrated that pharmacists were beneficial in detecting preventable ADEs in a similar patient population (2). However, this present study altered methods enough to reverse the conclusion of the Schnipper et al study. In the current study, the usual care group allowed either physicians or nurses to provide one session of discharge counseling to patients, and medical residents preformed medication reconciliation with the option of consulting pharmacists. Therefore, pharmacists were included in both the usual care group and intervention group, making it difficult to form a conclusion on pharmacist intervention.The randomization process was performed by an unblinded research coordinator, whose position was never identified. It would have been beneficial to know how this individual randomized assignments of patients to the control and intervention groups. This unblinded coordinator performed all the follow-up patient interviews which could have had a direct impact on results. A pharmacists’ intervention may be measured reliably, but the reasons why a patient has an ADE or is non-compliant is not solely due to a pharmacist performing an intervention. Mueller et al. concluded that pharmacists do reduce medication discrepancies and potential ADEs in a review of 26 studies (3). In the outpatient setting, pharmacists can make a difference in patient adherence with patient education and adherence tools (4). A generalized statement is made concerning pharmacists’ role in patient care that could negatively impact the future of pharmacists. The reportedly “similar” numbers of clinically important medication errors in both groups show that neither the control or intervention group had a real benefit. Broad generalizations that come out of poorly developed studies can hinder healthcare, not advance it for the well-being of our patients.

References:

1. Kripalani S, Roumie CL, Dalal AK, et al. Effect of Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge: A randomized trial. Ann Intern Med. 3 July 2012; 157 (1):1-10.

2. Schnipper J, Kirwin J, Cotugno M, et al. Role of Pharmacist Counseling in Preventing Adverse Drug Events After Hospitalization. Arch Intern Med. 13 March 2006; 166: 565 – 571.

3. Mueller S, Sponsler K, Kripalani S, Schnipper J. Hospital-Based Medication Reconciliation Practices: A systematic review. Arch Intern Med. 25 June 2012; 246 (2): 1- 13.

4. Rife K, Ginty S, Hohner E, Stamper H, Sobota K, Bright D. Remember your MEDS: Medication Education Delivers Success. Innovations in Pharmacy. 2 Feb 2012; 3 (1): 1 -6.

Reply
Posted on November 16, 2012
Sunil Kripalani, Jeffrey L Schnipper
Vanderbilt University, Brigham and Women's Hospital
Conflict of Interest: Dr. Kripalani is a consultant to and holds equity in PictureRx, LLC, which makes patient education tools to improve medication management. Dr. Schnipper is a consultant to QuantiaMD, for whom he has helped create on-line educational materials for both providers and patients regarding patient safety, including medication safety. Dr. Schnipper 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. These entities had no role in the PILL-CVD study.

Dear Editors:We agree with the comments by Criddle that it is important to consider context when interpreting the results of the PILL-CVD study. Patients may indeed have difficulty retaining information provided prior to discharge. This should not lead us to abandon education, but rather to provide it longitudinally and in collaboration with primary care. We also agree that these types of interventions should be focused on those patients most likely to benefit and matched to the patients’ needs (e.g., where the barrier to safe medication use is a knowledge deficit, an educational intervention is appropriate). To this extent, the impact of our intervention was influenced by the high health literacy rates of our study population. LaFosse and colleagues indicate potential biases in the study. Pharmacists were indeed involved to some extent in the usual care group, which biased the findings toward the null. This occurred more often at Brigham and Women’s Hospital, where compared to Vanderbilt University Hospital, the study intervention had less effect. To randomize patients, we used a computer program, with permuted block randomization, stratification by site and diagnosis, and allocation concealment. The research coordinators who randomized patients were not involved in outcome assessment. We do not believe these aspects of the study introduced bias. The research coordinators, who did not have medical training, performed structured post-discharge phone calls and referred concerns to a study pharmacist. This aspect of the intervention may have been less effective than had pharmacists made the phone calls. Finally, we agree that many medication-related problems occurring after discharge are beyond the scope of what a hospital-based intervention could be expected to prevent.We agree with Criddle that “we should not abandon the concept of medication reviews by pharmacists.” Indeed, many other studies, including our own,(1,2) have shown the benefits of pharmacist involvement in medication reconciliation and in providing counseling and follow-up. We interpret the results of PILL-CVD to mean that, among hospitals with a similar level of care and patient health literacy as the study hospitals, additional attention to health literacy and provision of post-discharge phone calls, done initially by non-clinical staff, did not appear to further enhance post-discharge medication safety among cardiac patients. This type of intervention may yield different results in hospitals that have a different level of care, or among different patient populations. Broad generalizations about the role of pharmacists, based on this one study, should be avoided.

References

1. Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172(14):1057-1069.

2. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-571.

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