Collaborative drug therapy management and comprehensive medication management-2015.

The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes.

Improving prescribing safety in patients with renal insufficiency in the ambulatory setting: the Drug Renal Alert Pharmacy (DRAP) program.

STUDY OBJECTIVE: To determine whether a computerized Drug Renal Alert Pharmacy (DRAP) program could decrease the rate of medication errors in drug selection or dosing for 15 target drugs in patients with renal insufficiency. DESIGN: Randomized, controlled, population-based effectiveness trial. SETTING: A large integrated health care delivery system. PATIENTS: A total of 32,917 health plan members who were at least 18 years old, had an estimated creatinine clearance of 50 ml/minute or lower, and were not receiving dialysis between December 1, 2003, and February 28, 2005, were randomly assigned to either the intervention group (16,577 patients) or usual care (control) group (16,340 patients). Of the 32,917 patients, 6125 patients (3025 in the intervention group and 3100 in the usual care group) were prescribed at least one target drug and were included in the analysis. INTERVENTION: A computerized tool--the DRAP program--was used to alert pharmacists at the time of dispensing to possible errors in target drug selection and dosing for patients with renal insufficiency. The 15 target drugs were previously identified based on frequency of use in our health care system and risk of serious adverse events. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the proportion of medication errors, defined as target drugs that should be avoided or were dosed inappropriately, in the intervention and usual care groups. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework was used to evaluate the intervention's potential for translation and generalizability. Among the 6125 patients who received a target drug, no significant differences were noted in age, sex, creatinine clearance, comorbid conditions, and number of target drugs between groups at baseline. Over the 15-month intervention period, the proportion of medication errors was significantly lower in the intervention group than the usual care group (33% vs 49%, p<0.001). After the study period, when the intervention was expanded to both groups, a 20% reduction in errors was sustained in the combined groups over the subsequent 7 months. CONCLUSION: The DRAP program was successful in reducing medication errors for patients with renal insufficiency in an ambulatory setting and was demonstrated to have sustainability after study completion.

Assessment of the impact of medication therapy management delivered to home-based Medicare beneficiaries.

BACKGROUND: Medication Therapy Management (MTM) is a voluntary patient participation program mandated for Medicare Part D sponsors by the Centers for Medicare and Medicaid Services for chronically ill beneficiaries with high medication costs/utilization. OBJECTIVE: To assess the impact of an MTM program on mortality, healthcare utilization, and prescription medication costs and to quantify drug-related problems (DRPs) identified during MTM. METHODS: This nonrandomized controlled study was conducted among beneficiaries who were targeted for MTM in 2006. The MTM intervention was designed to identify potential DRPs, educate the patient/caregiver about appropriate medication use, and ensure that the patient was appropriately integrated into clinical services. Data were collected from administrative databases and manual chart abstractions. Study outcomes included all-cause death (primary outcome), hospitalization, and emergency department (ED) visit rates and medication cost changes in the 180 days following MTM targeting and quantification of DRPs. Multivariate logistic regression was used to adjust the outcomes for baseline risk and other potential confounders. A mock MTM intervention was performed for beneficiaries who declined MTM and died, were hospitalized, and/or made an ED visit. RESULTS: A total of 459 opt-in and 336 opt-out beneficiaries who agreed and declined, respectively, to receive MTM were included in the analysis. Beneficiaries who opted in were less likely to die compared with beneficiaries who opted out (adjusted OR [AOR] 0.5; 95% CI 0.3 to 0.9) but were more likely to have had a hospitalization (AOR 1.4; 95% CI 1.1 to 2.0) and an increase in medication costs (AOR 1.4; 95% CI 1.1 to 1.9) during follow-up. There was no difference in ED visit rates. At least one DRP was identified in more than 83% of beneficiaries in both groups, with the most common DRP being drug-drug interaction. CONCLUSIONS: Our investigation supports the use of MTM, with its increased coordination of information between healthcare providers and patients, since it may impact mortality positively in a population of high-risk Medicare beneficiaries.

Clinical outcomes of a home-based medication reconciliation program after discharge from a skilled nursing facility.

STUDY OBJECTIVE: To assess the impact of a pilot pharmacist-managed medication reconciliation program on mortality and use of health care services in patients discharged to home from a skilled nursing facility (SNF). DESIGN: Quasi-experimental, controlled trial. SETTING: Health maintenance organization (HMO). PATIENTS: Five hundred twenty-one HMO members. INTERVENTION: Patients were assigned to the medication reconciliation program (113 patients) or to the usual care control group (408 patients) after discharge to home from an SNF. Assignment to the medication reconciliation group or to the control group was based on provider submission of a discharge summary within 0-48 hours of discharge or more than 48 hours after discharge, respectively. MEASUREMENTS AND MAIN RESULTS: Integrated electronic medical and pharmacy data and multivariate analyses were used to assess the medication reconciliation program with regard to its impact on postdischarge mortality, rehospitalization, and ambulatory clinic and emergency department visits. Compared with usual care during the 60 days after discharge from the SNF, patients who received the medication reconciliation intervention had an adjusted 78% reduction in the risk of death (adjusted hazard ratio 0.22, 95% confidence interval [CI] 0.06-0.88) and a trend toward an increased rate of ambulatory care visits (adjusted incidence risk ratio 1.17, 95% CI 0.99-1.37). No significant differences were noted in adjusted risks of an emergency department visit and rehospitalization (p>0.05) between the medication reconciliation and usual care groups. CONCLUSION: Our data support the hypothesis that a formal medication reconciliation process, with its increased coordination of information between health care providers and patients, can decrease mortality after discharge from an SNF. Our findings support the role of medication reconciliation as an integral step in the transitional care process and interests of health care accrediting agencies, such as the Joint Commission, that have included medication reconciliation as an important initiative.

Evaluation of an electronic critical drug interaction program coupled with active pharmacist intervention.

BACKGROUND: Failure to detect significant drug interactions may result in adverse outcomes. While proper screening and management of drug interactions can prevent the majority of adverse events, studies indicate that current practice is suboptimal. In the last quarter of 2001, physicians and pharmacists in Kaiser Permanente Colorado, a group model health maintenance organization, developed an electronic critical drug interaction alert program (CDIX). Electronic screening was coupled with active intervention to prevent dispensing of critically interacting drug combinations. OBJECTIVE: To assess the impact of CDIX on the co-dispensing of critically interacting drug combinations. METHODS: A physician and team of outpatient pharmacists and clinical pharmacy staff developed a condensed list of critical drug interactions (8 drug combinations) to be included in the evaluation of CDIX. Monthly electronic outpatient pharmacy data were collected 20 months before and 37 months after CDIX implementation, with no lag period following implementation. Univariate analyses were completed to compare baseline subject characteristics of the pre- and post-CDIX groups using chi2 and Wilcoxon Rank Sum tests. Interrupted time series analysis was used to estimate changes in the rates of critical drug interactions. RESULTS: Three hundred sixty-seven instances of co-dispensing were observed in 348 subjects during the pre-CDIX period and 256 instances of co-dispensing were observed in 248 subjects during the post-CDIX period. Following CDIX implementation, the overall rate of co-dispensing dropped abruptly from 21.3 to 14.7 per 10,000 prescriptions, representing a relative decrease in co-dispensing of 31% from the month before CDIX implementation (p = 0.0125). Significant reductions in co-dispensing were noted for 7 of the 8 drug class combinations. CONCLUSIONS: Employing an intervention system that limits electronic alerts regarding drug interactions to those deemed critical but that also requires pharmacist intervention and collaboration with the prescriber decreases the number of critical drug interactions dispensed.

Randomized trial to improve prescribing safety during pregnancy.

OBJECTIVE: This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed U.S. Food and Drug Administration pregnancy risk category D or X medications was effective in decreasing dispensings of these medications. DESIGN: Randomized trial. Pharmacy, diagnostic, and laboratory data were linked to identify pregnant patients prescribed targeted medications. Women (n = 11,100) were randomized to intervention or usual care. Physicians and pharmacists collaborated on the intervention. MEASUREMENTS: The primary outcome was the proportion of pregnant women dispensed a category D or X medication. The secondary outcome was the total number of first dispensings of targeted medications. RESULTS: A total of 2.9% of intervention (n = 177) and 5.5% of usual care (n = 276) patients were dispensed targeted medications (p < 0.001): 1.8% of intervention (n = 108) and 3.9% of usual care (n = 198) patients were dispensed only category D medication(s); 0.9% of intervention (n = 54) and 1.2% of usual care (n = 58) patients were dispensed only category X medication(s); 0.2% of intervention (n = 15) and 0.4% of usual care (n = 20) patients were dispensed both category D and X medications (p = 0.05). This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications (p = 0.03). The study was stopped primarily due to 2 false-positive alert types: Misidentification of medications as contraindicated in pregnancy by the pharmacy information system and misidentification of pregnancy related to delayed transfer of diagnosis information. CONCLUSION: Coupling data from information systems with knowledge and skills of physicians and pharmacists resulted in improved prescribing safety. Systems limitations contributed to project discontinuation. Linking ambulatory clinical, laboratory, and pharmacy information to provide safety alerts is not sufficient to ensure project success and sustainability.

A multidisciplinary approach to transition care: a patient safety innovation study.

INTRODUCTION: Patients with complex medical care needs often embark on multiple care transitions over an extended period of time. As these patients or their caregivers often become the chief source of communication for complex medical situations, each transition can create an opportunity for health care errors. Combining the efforts of the established departments of Chronic Care Coordination (CCC), Clinical Pharmacy Call Center (CPCC), and Continuing Care, Kaiser Permanente Colorado created programs to further safe care transitions. METHODS: Two key goals for safe care transitions were established: 1) reductions in medication errors and 2) increased follow-up with care plans. To achieve these goals, communication plans targeted at medication reconciliation, patient education, and coordination of outpatient recommendations were established. Expected outcomes included reductions in medication errors, decreased Emergency Department and hospital admissions, decreased readmissions, and increased outpatient follow-up and medication compliance. RESULTS: A review of medication-reconciliation records for intervention patients indicated that >90% of all discharge summaries contained at least one potential drug-related problem including duplicative drugs, omitted therapy, and medication contraindications. After skilled nursing facility discharge, patients who were transitioned by CPCC clinical pharmacists were: 1) 78% less likely to die; 2) 29% less likely to need an Emergency Department visit; and 3) 17% more likely to follow up with primary physicians and clinicians than were patients in the usual care group. Health care cost savings for patients seen by the CCC program demonstrated, conservatively, an annualized per patient savings of $5276. For 763 patients enrolled in 2003, this amounts to an estimated, annualized savings of $4,025,588. CONCLUSIONS: Patients are becoming more informed and involved in their care, but they require ongoing education and coaching to become effective advocates for themselves. Identification of unintended medication discrepancies and potential drug-related problems and increased follow-up during care transitions can improve patient safety and quality of care while saving health care resources.

Monitoring of drugs with a narrow therapeutic range in ambulatory care.

OBJECTIVES: To describe the proportion of patients receiving drugs with a narrow therapeutic range who lacked serum drug concentration monitoring during a 1-year period of therapy and to identify patient characteristics associated with lack of monitoring. STUDY DESIGN: Retrospective cohort. METHODS: Ambulatory patients (n = 17,748) at 10 health maintenance organizations who were receiving ongoing continuous drug therapy with digoxin, carbamazepine, divalproex sodium, lithium carbonate, lithium citrate, phenobarbital sodium, phenytoin, phenytoin sodium, primidone, quinidine gluconate, quinidine sulfate, procainamide hydrochloride, theophylline, theophylline sodium glycinate, tacrolimus, or cyclosporine for at least 12 months between January 1, 1999, and June 30, 2001, were identified. Serum drug concentration monitoring was assessed from administrative data and from medical record data. RESULTS: Fifty percent or more of patients receiving digoxin, theophylline, procainamide, quinidine, or primidone were not monitored, and 25% to 50% of patients receiving divalproex, carbamazepine, phenobarbital, phenytoin, or tacrolimus were not monitored. Younger age was associated with lack of monitoring for patients prescribed digoxin (adjusted odds ratio, 1.86; 95% confidence interval, 1.39-2.48) and theophylline (adjusted odds ratio, 1.58; 95% confidence interval, 1.23-2.04), while older age was associated with lack of monitoring for patients prescribed carbamazepine (adjusted odds ratio, 0.59; 95% confidence interval, 0.44-0.80) and divalproex (adjusted odds ratio, 0.50; 95% confidence interval, 0.38-0.66). Patients with fewer outpatient visits were also less likely to be monitored (P < .001). CONCLUSIONS: A substantial proportion of ambulatory patients receiving drugs with narrow intervals between doses resulting in beneficial and adverse effects did not have serum drug concentration monitoring during 1 year of use. Clinical implications of this finding need to be evaluated.

Randomized trial to improve laboratory safety monitoring of ongoing drug therapy in ambulatory patients.

STUDY OBJECTIVE: To determine whether an electronic tool effectively increases the percentage of patients receiving laboratory monitoring during ongoing drug therapy. DESIGN: Randomized trial. SETTING: Outpatient medical offices of a group model health maintenance organization. PATIENTS: A total of 9,139 patients prescribed ongoing therapy with any of 14 drugs, resulting in 4,871 patient-drug combinations in the intervention group and 4,780 in the usual-care (control) group. INTERVENTION: Physicians and pharmacists jointly developed monitoring guidelines based on published recommendations. Pharmacists were electronically alerted to missing laboratory results and then ordered tests, reminded patients to undergo tests, and reviewed and managed abnormal results. MEASUREMENTS AND MAIN RESULTS: In the intervention group, 64% of patientdrug combinations were monitored, whereas in the usual-care group 58% were monitored (p < 0.001). Differences in monitoring were observed in the intervention versus usual-care groups for amiodarone (71% vs 55%, p<0.01), theophylline (54% vs 28%, p<0.001), carbamazepine (49% vs 32%, p<0.001), lithium (42% vs 28%, p<0.01), phenytoin (44% vs 33%, p<0.001), and metformin (72% vs 67%, p<0.001). Of 1981 laboratory tests ordered, 1,472 (74%) were completed. The tests revealed 181 serum drug concentrations outside the therapeutic range and 126 abnormal serum creatinine, alanine aminotransferase, aspartate aminotransferase, and thyroid-stimulating hormone levels, and complete blood counts. CONCLUSION: A computerized tool plus collaboration of health care professionals effectively increased the number of patients who received laboratory safety monitoring of drug therapy.

Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial.

BACKGROUND: The importance of laboratory monitoring for drugs is reflected in product labeling and published guidelines, but monitoring recommendations are followed inconsistently. Opportunity exists to improve monitoring, with the potential to decrease therapy complications. METHODS: The objective of this randomized trial was to determine whether computerized alerts were effective at increasing the percentage of ambulatory patients with laboratory monitoring at initiation of drug therapy. Physicians and pharmacists teamed up to develop organization-specific guidelines for monitoring selected drugs. In collaboration with physicians, pharmacists were alerted to missing laboratory test results, ordered missing tests, reminded patients to obtain tests, assessed test completion, reviewed test results, and managed abnormal results. Eligible individuals included patients with therapy initiated for any of 15 drugs among 400,000 health plan members. RESULTS: In the intervention group, 79.1% (n = 4076; 95% confidence interval [CI], 78.0%-80.2%) of dispensings were monitored compared with 70.2% (n = 3522; 95% CI, 68.9%-71.5%) in the usual-care group (P < .001). For example, 78.6% of amiodarone (95% CI, 73.1%-83.5%) dispensing was monitored in the intervention group vs 51.4% (95% CI, 44.4%-58.4%) in the group receiving usual care (P < .001). CONCLUSIONS: This study demonstrates the effectiveness of a computerized tool plus collaboration among health care professionals at increasing the percentage of patients receiving laboratory monitoring at initiation of therapy. Coupling data available from information systems with the knowledge and skills of physicians and pharmacists can result in improved patient monitoring.

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

BACKGROUND AND OBJECTIVES: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation. DESIGN AND SUBJECTS: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes. RESULTS: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001). CONCLUSIONS: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice.