Health care providers' roles and responsibilities in management of polypharmacy: Results of a modified Delphi.

BACKGROUND: Little is known about the roles that allow interprofessional teams to effectively manage older patients experiencing polypharmacy. OBJECTIVES: To identify and examine the consensus on salient interprofessional roles, responsibilities and competencies required in managing polypharmacy. METHODS: Four focus groups with 35 team members practising in geriatrics were generated to inform survey development. The sessions generated 63 competencies, roles or responsibilities, which were categorized into 4 domains defined by the Canadian Interprofessional Health Collaborative. The resulting survey was administered nationally to geriatric health care professionals who were asked to rate the importance of each item in managing polypharmacy; we sought agreement within and across professions using a confirmatory 2-round Delphi method. RESULTS: Round 1 was completed by 98 survey respondents and round 2 by 72. There was high intra-professional and interprofessional consensus regarding the importance of competencies among physicians, nurses and pharmacists; though pharmacists rated fewer competencies as important. Less consensus was observed among other health care professionals or they indicated the nonimportance of competencies despite focus group discussion to the contrary. DISCUSSION: Although there is a strong consensus of polypharmacy management competencies across team members who have been more traditionally involved in medication management, there continue to be health care providers with differing understandings of competencies that may contribute to reduced reliance on medication. Lower importance ratings suggest pharmacists may not acknowledge or recognize their own potential roles in interprofessional polypharmacy management. CONCLUSION: Further exploration to understand the underutilization of professional expertise in managing polypharmacy will contribute to refining role clarity and translating competencies in practical settings, as well as guiding educators regarding curricular content.

The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study.

BACKGROUND: Primary nonadherence is probably an important contributor to suboptimal disease management, but methodological challenges have limited investigation of it. OBJECTIVE: To estimate the incidence of primary nonadherence in primary care and the drug, patient, and physician characteristics that are associated with nonadherence. DESIGN: A prospective cohort of patients and all their incident prescriptions from primary care electronic health records between 2006 and 2009 linked to provincial drug insurer data on all drugs dispensed from community-based pharmacies were assembled. SETTING: Quebec, Canada. PATIENTS: 15 961 patients in a primary care network of 131 physicians. MEASUREMENTS: Primary nonadherence was defined as not filling an incident prescription within 9 months. Multivariate alternating logistic regression was used to estimate predictors of nonadherence and account for patient and physician clustering. RESULTS: Overall, 31.3% of the 37 506 incident prescriptions written for the 15 961 patients were not filled. Drugs in the upper quartile of cost were least likely to be filled (odds ratio [OR], 1.11 [95% CI, 1.07 to 1.17]), as were skin agents, gastrointestinal drugs, and autonomic drugs, compared with anti-infectives. Reduced odds of nonadherence were associated with increasing patient age (OR per 10 years, 0.89 [CI, 0.85 to 0.92]), elimination of prescription copayments for low-income groups (OR, 0.37 [CI, 0.32 to 0.41]), and a greater proportion of all physician visits with the prescribing physician (OR per 0.5 increase, 0.77 [CI, 0.70 to 0.85]). LIMITATION: Patients' rationale for choosing not to fill their prescriptions could not be measured. CONCLUSION: Primary nonadherence is common and may be reduced by lower drug costs and copayments, as well as increased follow-up care with prescribing physicians for patients with chronic conditions. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research.

Adherence to anti-estrogen therapy in seniors with breast cancer: how well are we doing?

A third of breast cancers (BC) occur in women ≥65 years (seniors). Anti-estrogen therapy (AET) significantly reduces BC recurrence and death. This study characterizes determinants of adherence to AET in seniors with BC. Provincial cancer registry and administrative claims data were accessed for all non-metastatic BC diagnosed in Quebec (1998-2005) to identify seniors treated for 5 years with AET. Multivariate linear regression was used to assess the association with patient, disease, and physician characteristics and the 5-year medication possession ratio (MPR) for each patient. 4,715 women were included (mean age: 72.9). Mean MPR was 83.5%, 79% of patients reached a 5-year MPR of ≥80%, and 34% discontinued AET at some point during treatment. The cumulative probability of discontinuation was 33.8% (mean time to discontinuation 2.3 years). The MPR decreased with increasing age and non-BC related hospitalizations, p < 0.05. Each new medication added during the 5-years decreased the MPR by 0.3% (p < 0.05). Women with in situ disease, on antidepressants at baseline, or treated with Tamoxifen had a lower MPR by 6.5% (p = 0.0002), 4.7% (p = 0.003) and 6% (p = 0.001), respectively. Switching AET type was associated with a lower MPR by 5.3% (p = 0.002) if the switch occurred during the first year. Optimal 5-year adherence to AET in seniors with BC remained a challenge and medication discontinuation rates were high. Advanced age, increasing number of hospitalizations, in situ disease, baseline use of antidepressants, Tamoxifen (versus aromatase inhibitors), early switches of AET type, and newly added medications significantly reduced the MPR.

Pharmacist provision of primary health care: a modified Delphi validation of pharmacists' competencies.

BACKGROUND: Pharmacists have expanded their roles and responsibilities as a result of primary health care reform. There is currently no consensus on the core competencies for pharmacists working in these evolving practices. The aim of this study was to develop and validate competencies for pharmacists' effective performance in these roles, and in so doing, document the perceived contribution of pharmacists providing collaborative primary health care services. METHODS: Using a modified Delphi process including assessing perception of the frequency and criticality of performing tasks, we validated competencies important to primary health care pharmacists practising across Canada. RESULTS: Ten key informants contributed to competency drafting; thirty-three expert pharmacists replied to a second round survey. The final primary health care pharmacist competencies consisted of 34 elements and 153 sub-elements organized in seven CanMeds-based domains. Highest importance rankings were allocated to the domains of care provider and professional, followed by communicator and collaborator, with the lower importance rankings relatively equally distributed across the manager, advocate and scholar domains. CONCLUSIONS: Expert pharmacists working in primary health care estimated their most important responsibilities to be related to direct patient care. Competencies that underlie and are required for successful fulfillment of these patient care responsibilities, such as those related to communication, collaboration and professionalism were also highly ranked. These ranked competencies can be used to help pharmacists understand their potential roles in these evolving practices, to help other health care professionals learn about pharmacists' contributions to primary health care, to establish standards and performance indicators, and to prioritize supports and education to maximize effectiveness in this role.

Monitoring community pharmacist's quality of care: a feasibility study of using pharmacy claims data to assess performance.

BACKGROUND: Public pressure has increasingly emphasized the need to ensure the continuing quality of care provided by health professionals over their careers. Health profession's regulatory authorities, mandated to be publicly accountable for safe and effective care, are revising their quality assurance programs to focus on regular evaluations of practitioner performance. New methods for routine screening of performance are required and the use of administrative data for measuring performance on quality of care indicators has been suggested as one attractive option. Preliminary studies have shown that community pharmacy claims databases contain the information required to operationalize quality of care indicators. The purpose of this project was to determine the feasibility of routine use of information from these databases by regulatory authorities to screen the quality of care provided at community pharmacies. METHODS: Information from the Canadian province of Quebec's medication insurance program provided data on prescriptions dispensed in 2002 by more than 5000 pharmacists in 1799 community pharmacies. Pharmacy-specific performance rates were calculated on four quality of care indicators: two safety indicators (dispensing of contra-indicated benzodiazepines to seniors and dispensing of nonselective beta-blockers to patients with respiratory disease) and two effectiveness indicators (dispensing asthma or hypertension medications to non-compliant patients). Descriptive statistics were used to summarize performance. RESULTS: Reliable estimates of performance could be obtained for more than 90% of pharmacies. The average rate of dispensing was 4.3% (range 0 - 42.5%) for contra-indicated benzodiazepines, 15.2% (range 0 - 100%) for nonselective beta-blockers to respiratory patients, 10.7% (range 0 - 70%) for hypertension medications to noncompliant patients, and 43.3% (0 - 91.6%) for short-acting beta-agonists in over-use situations. There were modest correlations in performance across the four indicators. Nine pharmacies (0.5%) performed in the lowest quartile in all four of the indicators, and 5.3% (n = 95) performed in the lowest quartile on three of four indicators. CONCLUSIONS: Routinely collected pharmacy claims data can be used to monitor indicators of the quality of care provided in community pharmacies, and may be useful in future to identify underperforming pharmacists, measure the impact of policy changes and determine predictors of best practices.

Doctor scores on national qualifying examinations predict quality of care in future practice.

OBJECTIVES: This study aimed to determine if national licensing examinations that measure medical knowledge (QE1) and clinical skills (QE2) predict the quality of care delivered by doctors in future practice. METHODS: Cohorts of doctors who took the Medical Council of Canada Qualifying Examinations Part I (QE1) and Part II (QE2) between 1993 and 1996 and subsequently entered practice in Ontario, Canada (n = 2420) were followed for their first 7-10 years in practice. The 208 of these doctors who were randomly selected for peer assessment of quality of care were studied. Main outcome measures included quality of care (acceptable/unacceptable) as assessed by doctor peer-examiners using a structured chart review and interview. Multivariate logistic regression was used to determine if qualifying examination scores predicted the outcome of the peer assessments while controlling for age, sex, training and specialty, and if the addition of the QE2 scores provided additional prediction of quality of care. RESULTS: Fifteen (7.2%) of the 208 doctors assessed were considered to provide unacceptable quality of care. Doctors in the bottom quartile of QE1 scores had a greater than three-fold increase in the risk of an unacceptable quality-of-care assessment outcome (odds ratio [OR] 3.41, 95% confidence interval [CI] 1.14-10.22). Doctors in the bottom quartile of QE2 scores were also at higher risk of being assessed as providing unacceptable quality of care (OR 4.24, 95% CI 1.32-13.61). However, QE2 results provided no significant improvement in predicting peer assessment results over QE1 results (likelihood ratio test: chi(2) = 3.21, P-value((1 d.f.)) = 0.07). CONCLUSIONS: Doctor scores on qualifying examinations are significant predictors of quality-of-care problems based on regulatory, practice-based peer assessment.

Effect of an Electronic Medication Reconciliation Intervention on Adverse Drug Events: A Cluster Randomized Trial.

Importance: Adverse drug events (ADEs) account for up to 16% of emergency department (ED) visits and 7% of hospital admissions. Medication reconciliation is required for hospital accreditation because it can reduce medication discrepancies, but there is no evidence that reducing discrepancies reduces ADEs or other adverse outcomes. Objective: To evaluate whether electronic medication reconciliation reduces ADEs, medication discrepancies, and other adverse outcomes compared with usual care. Design, Setting, and Participants: This cluster randomized trial involved 3491 patients who were discharged from 2 medical units and 2 surgical units at the McGill University Health Centre, Montreal, Quebec, Canada, between October 2014 and November 2016. Data analysis took place from July 2017 to July 2019. Intervention: The RightRx intervention electronically retrieved community drugs from the provincial insurer and aligned them with in-hospital drugs to facilitate reconciliation and communication at care transitions. Main Outcomes and Measures: The primary outcome was ADEs in 30 days after discharge. Secondary outcomes included medication discrepancies, ED visits, hospital readmissions, and a composite outcome of ED visits, readmissions, and death up to 90 days after discharge. Results: Of 4656 eligible patients, 3567 (76.6%) consented to participate (2060 [57.8%] men; mean [SD] age, 69.8 [14.9] years). Overall, 76 patients died during the hospital stay, so 3491 patients were included in the analysis. There was no significant difference in the risk of ADEs between intervention and control groups (76 [4.6%] vs 73 [4.0%]; OR, 0.97; 95% CI, 0.33-1.48), ED visits (433 [26.2%] vs 488 [26.6%]; OR, 0.83; 95% CI, 0.36-1.42), hospital readmission (170 [10.3%] vs 261 [14.2%]; OR, 0.22; 95% CI, 0.06-1.14), or the composite outcome (447 [27.0%] vs 506 [27.6%]; OR, 0.75; 95% CI, 0.34-1.27) at 30 days. Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57). Changes made to community medications (OR, 1.05; 95% CI, 1.01-1.10) and new medications (OR, 1.09; 95% CI, 1.01-1.18) were significant risk factors for ADEs. Conclusions and Relevance: Electronic medication reconciliation reduced medication discrepancies but did not reduce ADEs or other adverse outcomes. Hospital accreditation should focus on interventions that reduce the risk of adverse events for patients with multiple changes to community medications. Trial Registration: ClinicalTrials.gov identifier: NCT01179867.

A randomized trial of the effectiveness of on-demand versus computer-triggered drug decision support in primary care.

OBJECTIVES: Prescribing alerts generated by computerized drug decision support (CDDS) may prevent drug-related morbidity. However, the vast majority of alerts are ignored because of clinical irrelevance. The ability to customize commercial alert systems should improve physician acceptance because the physician can select the circumstances and types of drug alerts that are viewed. We tested the effectiveness of two approaches to medication alert customization to reduce prevalence of prescribing problems: on-physician-demand versus computer-triggered decision support. Physicians in each study condition were able to preset levels that triggered alerts. DESIGN: This was a cluster trial with 28 primary care physicians randomized to either automated or on-demand CDDS in the MOXXI drug management system for 3,449 of their patients seen over the next 6 months. MEASUREMENTS: The CDDS generated alerts for prescribing problems that could be customized by severity level. Prescribing problems included dosing errors, drug-drug, age, allergy, and disease interactions. Physicians randomized to on-demand activated the drug review when they considered it clinically relevant, whereas physicians randomized to computer-triggered decision support viewed all alerts for electronic prescriptions in accordance with the severity level they selected for both prevalent and incident problems. Data from administrative claims and MOXXI were used to measure the difference in the prevalence of prescribing problems at the end of follow-up. RESULTS: During follow-up, 50% of the physicians receiving computer-triggered alerts modified the alert threshold (n = 7), and 21% of the physicians in the alert-on-demand group modified the alert level (n = 3). In the on-demand group 4,445 prescribing problems were identified, 41 (0.9%) were seen by requested drug review, and in 31 problems (75.6%) the prescription was revised. In comparison, 668 (10.3%) of the 6,505 prescribing problems in the computer-triggered group were seen, and 81 (12.1%) were revised. The majority of alerts were ignored because the benefit was judged greater than the risk, the interaction was known, or the interaction was considered clinically not important (computer-triggered: 75.8% of 585 ignored alerts; on-demand: 90% of 10 ignored alerts). At the end of follow-up, there was a significant reduction in therapeutic duplication problems in the computer-triggered group (odds ratio 0.55; p = 0.02) but no difference in the overall prevalence of prescribing problems. CONCLUSION: Customization of computer-triggered alert systems is more useful in detecting and resolving prescribing problems than on-demand review, but neither approach was effective in reducing prescribing problems. New strategies are needed to maximize the use of drug decision support systems to reduce drug-related morbidity.

Detection of adverse drug events and other treatment outcomes using an electronic prescribing system.

BACKGROUND: Current pharmacosurveillance methods do not provide timely information on drug safety and effectiveness. Real-time surveillance using electronic prescribing systems could address this problem; however, the data collected using these systems has not been validated. We investigated the accuracy of using orders for drug discontinuation and dose change in an electronic prescribing system as a potential source of information for drug safety and effectiveness. OBJECTIVES: To determine the accuracy of an electronic prescribing and drug management system in documenting orders for discontinuation and dose changes of prescription drug treatment, and in identifying the reasons for the drug discontinuation and dose change. STUDY DESIGN AND SETTING: We prospectively assessed the accuracy of electronic prescription orders for drug discontinuation and dose change by comparing them with treatment changes documented by physician-facilitated medical chart review (gold standard). Validity was evaluated in 620 patients of 22 community-based primary care physicians in addition to the reasons for these treatment changes. RESULTS: A total of 141 (41.7%) drug discontinuation orders and 197 (58.3%) changes in drug doses were identified by chart review, the majority of which were for cardiovascular and CNS drugs. Ineffective treatment (30.8%), adjusting dose to optimize treatment (25.1%) and adverse drug reactions (21.9%) were the most common reasons for treatment change. The sensitivity of the electronic prescribing system in identifying physician-initiated drug discontinuations and dose changes was 67.0% (95% CI 54.1, 77.7) and the specificity was 99.7% (95% CI 99.5, 99.9). The positive and negative predictive values of electronic treatment discontinuation and change orders were 97.3% (95% CI 95.6, 98.7) and 95.8% (95% CI 92.9, 97.7), respectively. CONCLUSION: An electronic prescribing and drug management system documents drug discontinuation and dose-change orders with high specificity and moderate sensitivity. Ineffective treatment, dose optimization and adverse drug reactions were the most common reasons for drug discontinuation or dose changes. The electronic prescribing system offers a new method for augmenting pharmacosurveillance.

The impact of electronic prescribing on the professionalization of community pharmacists: a qualitative study of pharmacists' perception.

PURPOSE: To understand how the technology of electronic prescription (e Rx) can transform the community pharmacist's role through its effects on professionalization. We define professionalization as a pharmaceutical practice centred on clinical activities and made possible by the establishment of professional pharmaceutical services. METHODS: We asked 12 community pharmacists who had participated in an e Rx pilot project in the Canadian province of Quebec to fill out a qualitative survey on their experience. We then analyzed the pharmacists' perceptions of this new technology using a conceptual framework based on the Davenport typology that presents an exhaustive list of mechanisms, specific to Information Technologies, and thus e-Rx, that can potentially modify information management process and then the role of pharmacists. RESULTS: The pharmacists identified five main mechanisms by which e Rx could affect the professionalization of community pharmacists: analytical capabilities of the pharmacist and physician, dissemination of knowledge, integration of process tasks, process automation and elimination of intermediaries. These mechanisms can assist pharmacists in exercising their professional judgement by improving the quality of available information and facilitate the execution of prescriptions by improving the quality of orders. E Rx technology can also strengthen pharmacists' credibility as medication specialists in the eyes of both patients and physicians. Thus, e Rx can become a collaborative technology to the extent that it improves collaboration between community pharmacists and prescribing physicians. However, the potential benefits of this technology would appear to depend on its characteristics and how prescribing physicians use it. CONCLUSIONS: E-Rx proposes ways of working and communicating that were previously unimaginable. These new possibilities pave the way for transformations that can significantly increase the professionalization of community pharmacists. The results of this study indicate that community pharmacists have a favourable opinion of e Rx, believing it can be an ally in their professionalization.

What is in your wallet? A cluster randomized trial of the effects of showing comparative patient out-of-pocket costs on primary care prescribing for uncomplicated hypertension.

BACKGROUND: Drug expenditures are responsible for an increasing proportion of health costs, accounting for $1.1 trillion in annual expenditure worldwide. As hundreds of billions of dollars are being spent each year on overtreatment with prescribed medications that are either unnecessary or are in excess of lowest cost-effective therapy, programs are needed that optimize fiscally appropriate use. We evaluated whether providing physicians with information on the patient out-of-pocket payment consequences of prescribing decisions that were in excess of lowest cost-effective therapy would alter prescribing decisions using the treatment of uncomplicated hypertension as an exemplar. METHODS: A single-blind cluster randomized trial was conducted over a 60-month follow-up period in 76 primary care physicians in Quebec, Canada, and their patients with uncomplicated hypertension who were using the MOXXI integrated electronic health record for drug and health problem management. Physicians were randomized to an out-of-pocket expenditure module that provided alerts for comparative out-of-payment costs, thiazide diuretics as recommended first-line therapy, and tools to monitor blood pressure targets and medication compliance, or alternatively the basic MOXXI system. System software and prescription claims were used to analyze the impact of the intervention on treatment choice, adherence, and overall and out-of-pocket payment costs using generalized estimating equations. RESULTS: Three thousand five-hundred ninety-two eligible patients with uncomplicated hypertension were enrolled, of whom 1261 (35.1%) were newly started (incident patient) on treatment during follow-up. There was a statistically significant increase in the prescription of diuretics in the newly treated intervention (26.6%) compared to control patients (19.8%) (RR 1.65, 95% CI 1.17 to 2.33). For patients already treated (prevalent patient), there was a statistically significant interaction between the intervention and patient age, with older patients being less likely to be switched to a diuretic. Among the incident patients, physicians with less than 15 years of experience were much more likely to prescribe a diuretic (OR 10.69; 95% CI 1.49 to 76.64) than physicians with 15 to 25 years (OR 0.67; 95%CI 0.25 to 1.78), or more than 25 years of experience (OR 1.80; 95% CI 1.23 to 2.65). There was no statistically significant effect of the intervention on adherence or out-of-pocket payment cost. CONCLUSIONS: The provision of comparative information on patient out-of-pocket payments for treatment of uncomplicated hypertension had a statistically significant impact on increasing the initiation of diuretics in incident patients and switching to diuretics in younger prevalent patients. The impact of interventions to improve the cost-effectiveness of prescribing may be enhanced by also targeting patients with tools to participate in treatment decision-making and by providing physicians with comparative out-of-pocket information on all evidence-based alternatives that would enhance clinical decision-making. TRIAL REGISTRATION: ISRCTN96253624.

Improving patient safety and efficiency of medication reconciliation through the development and adoption of a computer-assisted tool with automated electronic integration of population-based community drug data: the RightRx project.

Background and Objective: Many countries require hospitals to implement medication reconciliation for accreditation, but the process is resource-intensive, thus adherence is poor. We report on the impact of prepopulating and aligning community and hospital drug lists with data from population-based and hospital-based drug information systems to reduce workload and enhance adoption and use of an e-medication reconciliation application, RightRx. Methods: The prototype e-medical reconciliation web-based software was developed for a cluster-randomized trial at the McGill University Health Centre. User-centered design and agile development processes were used to develop features intended to enhance adoption, safety, and efficiency. RightRx was implemented in medical and surgical wards, with support and training provided by unit champions and field staff. The time spent per professional using RightRx was measured, as well as the medication reconciliation completion rates in the intervention and control units during the first 20 months of the trial. Results: Users identified required modifications to the application, including the need for dose-based prescribing, the role of the discharge physician in prescribing community-based medication, and access to the rationale for medication decisions made during hospitalization. In the intervention units, both physicians and pharmacists were involved in discharge reconciliation, for 96.1% and 71.9% of patients, respectively. Medication reconciliation was completed for 80.7% (surgery) to 96.0% (medicine) of patients in the intervention units, and 0.7% (surgery) to 82.7% of patients in the control units. The odds of completing medication reconciliation were 9 times greater in the intervention compared to control units (odds ratio: 9.0, 95% confidence interval, 7.4-10.9, P < .0001) after adjusting for differences in patient characteristics. Conclusion: High rates of medication reconciliation completion were achieved with automated prepopulation and alignment of community and hospital medication lists.

Physician scores on a national clinical skills examination as predictors of complaints to medical regulatory authorities.

CONTEXT: Poor patient-physician communication increases the risk of patient complaints and malpractice claims. To address this problem, licensure assessment has been reformed in Canada and the United States, including a national standardized assessment of patient-physician communication and clinical history taking and examination skills. OBJECTIVE: To assess whether patient-physician communication examination scores in the clinical skills examination predicted future complaints in medical practice. DESIGN, SETTING, AND PARTICIPANTS: Cohort study of all 3424 physicians taking the Medical Council of Canada clinical skills examination between 1993 and 1996 who were licensed to practice in Ontario and/or Quebec. Participants were followed up until 2005, including the first 2 to 12 years of practice. MAIN OUTCOME MEASURE: Patient complaints against study physicians that were filed with medical regulatory authorities in Ontario or Quebec and retained after investigation. Multivariate Poisson regression was used to estimate the relationship between complaint rate and scores on the clinical skills examination and traditional written examination. Scores are based on a standardized mean (SD) of 500 (100). RESULTS: Overall, 1116 complaints were filed for 3424 physicians, and 696 complaints were retained after investigation. Of the physicians, 17.1% had at least 1 retained complaint, of which 81.9% were for communication or quality-of-care problems. Patient-physician communication scores for study physicians ranged from 31 to 723 (mean [SD], 510.9 [91.1]). A 2-SD decrease in communication score was associated with 1.17 more retained complaints per 100 physicians per year (relative risk [RR], 1.38; 95% confidence interval [CI], 1.18-1.61) and 1.20 more communication complaints per 100 practice-years (RR, 1.43; 95% CI, 1.15-1.77). After adjusting for the predictive ability of the clinical decision-making score in the traditional written examination, the patient-physician communication score in the clinical skills examination remained significantly predictive of retained complaints (likelihood ratio test, P < .001), with scores in the bottom quartile explaining an additional 9.2% (95% CI, 4.7%-13.1%) of complaints. CONCLUSION: Scores achieved in patient-physician communication and clinical decision making on a national licensing examination predicted complaints to medical regulatory authorities.

Determinants of community pharmacists' quality of care: a population-based cohort study using pharmacy administrative claims data.

OBJECTIVE: To determine if a prototype pharmacists' services evaluation programme that uses linked community pharmacy claims and health administrative data to measure pharmacists' performance can be used to identify characteristics of pharmacies providing higher quality of care. DESIGN: Population-based cohort study using community pharmacy claims from 1 November 2009 to 30 June 2010. SETTING: All community pharmacies in Quebec, Canada. PARTICIPANTS: 1742 pharmacies dispensing 8 655 348 antihypertensive prescriptions to 760 700 patients. PRIMARY OUTCOME MEASURE: Patient adherence to antihypertensive medications. PREDICTORS: Pharmacy level: dispensing workload, volume of pharmacist-provided professional services (eg, refusals to dispense, pharmacotherapy recommendations), pharmacy location, banner/chain, pharmacist overlap and within-pharmacy continuity of care. Patient level: sex, age, income, patient prescription cost, new/chronic therapy, single/multiple antihypertensive medications, single/multiple prescribers and single/multiple dispensing pharmacies. Dispensing level: prescription duration, time of day dispensed and antihypertensive class. Multivariate alternating logistic regression estimated predictors of the primary outcome, accounting for patient and pharmacy clustering. RESULTS: 9.2% of dispensings of antihypertensive medications were provided to non-adherent patients. Male sex, decreasing age, new treatment, multiple prescribers and multiple dispensing pharmacies were risk factors for increased non-adherence. Pharmacies that provided more professional services were less likely to dispense to non-adherent hypertensive patients (OR: 0.60; 95% CI: 0.57 to 0.62) as were those with better scores on the Within-Pharmacy Continuity of Care Index. Neither increased pharmacists' services for improving antihypertensive adherence per se nor increased pharmacist overlap impacted the odds of non-adherence. However, pharmacist overlap was strongly correlated with dispensing workload. There was significant unexplained variability among pharmacies belonging to different banners and chains. CONCLUSIONS: Pharmacy administrative claims data can be used to calculate pharmacy-level characteristics associated with improved quality of care. This study supports the importance of pharmacist's professional services and continuity of pharmacist's care.

The development and evaluation of an integrated electronic prescribing and drug management system for primary care.

OBJECTIVE: To develop and evaluate the acceptability and use of an integrated electronic prescribing and drug management system (MOXXI) for primary care physicians. DESIGN: A 20-month follow-up study of MOXXI (Medical Office of the XXIst Century) implementation in 28 primary care physicians and 13,515 consenting patients. MEASUREMENT: MOXXI was developed to enhance patient safety by integrating patient demographics, retrieving active drugs from pharmacy systems, generating an automated problem list, and providing electronic prescription, stop order, automated prescribing problem alerts, and compliance monitoring functions. Evaluation of technical performance, acceptability, and use was conducted using audit trails, questionnaires, standardized tasks, and information from comprehensive health insurance databases. RESULTS: Perceived improvements in continuity of care and professional autonomy were associated with physicians' expected use of MOXXI. Physician speed in using MOXXI improved substantially in the first three months; however, only the represcribing function was faster using MOXXI than by handwritten prescription. Physicians wrote electronic prescriptions in 36.9 per 100 visits and reviewed the patient's drug profile in 12.6 per 100 visits. Physicians rated printed prescriptions, the current drug list, and the represcribing function as the most beneficial aspects of the system. Physicians were more likely to use the drug profile for patients who used more medication, made more emergency department visits, had more prescribing physicians, and lower continuity of care. CONCLUSION: Primary care physicians believed an integrated electronic prescribing and drug management system would improve continuity of care, and they were more likely to use the system for patients with more complex, fragmented care.

Optimising the changing role of the community pharmacist: a randomised trial of the impact of audit and feedback.

OBJECTIVE: To evaluate the impact of comparative performance feedback to community pharmacists on provision of professional services and the quality of patients' medication use. DESIGN: Randomised, controlled, single-blind trial. SETTING: All 1833 community pharmacies in the Quebec province, Canada. PARTICIPANTS: 1814 pharmacies not opting out and with more than 5 dispensings of the target medications during the 6-month baseline were randomised by a 2×2 factorial design to feedback first for hypertension adherence (907 control, 907 intervention) followed by randomisation for asthma adherence (791 control, 807 intervention). 1422 of 1814 pharmacies had complete information available during the follow-up for hypertension intervention (706 intervention, 716 control), and 1301 of 1598 had the follow-up information for asthma (657 intervention, 644 control). INTERVENTION: Using provincial billing data to measure performance, mailed comparative feedback reported the pharmacy-level percentage of dispensings to patients non-adherent to antihypertensive medications or overusing asthma rescue inhalers. PRIMARY AND SECONDARY OUTCOME MEASURES: The number of hypertension/asthma services billed per pharmacy and percentage of dispensings to non-adherent patients over the 12 months post intervention. RESULTS: Feedback on the asthma measure led to increased provision of asthma services (control 0.2, intervention 0.4, RR 1.58, 95% CI 1.02 to 2.46). However, this did not translate into reductions in patients' overuse of rescue inhalers (control 45.5%, intervention 44.6%, RR 0.99, 95% CI 0.98 to 1.01). For non-adherence to antihypertensive medications, feedback resulted in no difference in either provision of hypertension services (control 0.7, intervention 0.8, RR 1.25, 95% CI 0.86 to 1.82) or antihypertensive treatment adherence (control 27.9%, intervention 28.0%, RR 1.0, 95% CI 0.99 to 1.00). Baseline performance did not influence results, and there was no evidence of a cumulative effect with repeated feedback. CONCLUSIONS: Comparative pharmacy performance feedback increased the provision of asthma pharmacists' services but did not improve the performance on medication-use measures. Billing data can be used to evaluate the impact of billable services rendered by pharmacists on the quality of patients' medication use.

Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study.

BACKGROUND: In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. OBJECTIVES: The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. METHODS: A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University-affiliated hospitals, the Royal Victoria Hospital and St. Mary's Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. RESULTS: This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. CONCLUSION: This study will offer an opportunity to verify the feasibility of integrating an eHealth tool that aims to improve the long-term management of breast cancer in a high-risk population by allowing more timely intervention to prevent or rapidly address AET discontinuation.

Association of Off-label Drug Use and Adverse Drug Events in an Adult Population.

IMPORTANCE: Off-label use of prescription drugs has been identified as an important contributor to preventable adverse drug events (ADEs) in children. Despite concerns regarding adverse outcomes, to date, no systematic investigation of the effects of off-label drug use in adult populations has been performed. OBJECTIVE: To monitor and evaluate off-label use of prescription drugs and its effect on ADEs in an adult population. DESIGN, SETTING, AND PARTICIPANTS: A cohort of 46,021 patients who received 151,305 incident prescribed drugs was assembled from primary care clinics in Quebec, Canada, using the Medical Office of the XXIst Century electronic health record, which supports documentation of treatment indications and treatment outcomes. Prescriptions dispensed from January 1, 2005, through December 30, 2009, were followed up from the date of the prescription to the date the drug use was discontinued, the end of treatment, or the end of follow-up (December 30, 2010). Data were analyzed from January 5, 2012, to March 15, 2015. EXPOSURES: Off-label prescription drug use with and without strong scientific evidence. MAIN OUTCOMES AND MEASURES: Adverse drug events in off-label use with and without strong scientific evidence. Analysis used multivariate marginal Cox proportional hazards regression for clustered data with the drug as the unit of analysis. RESULTS: A total of 3484 ADEs were found in the 46,021 study patients, with an incidence rate of 13.2 per 10,000 person-months. The rate of ADEs for off-label use (19.7 per 10,000 person-months) was higher than that for on-label use (12.5 per 10,000 person-months) (adjusted hazard ratio [AHR], 1.44; 95% CI, 1.30-1.60). Off-label use lacking strong scientific evidence had a higher ADE rate (21.7 per 10,000 person-months) compared with on-label use (AHR, 1.54; 95% CI, 1.37-1.72). However, off-label use with strong scientific evidence had the same risk for ADEs as on-label use (AHR, 1.10; 95% CI, 0.88-1.38). The risks for ADEs were higher for drugs approved from 1981 to 1995 (14.4 per 10,000 person-months; AHR, 1.62; 95% CI, 1.45-1.80) and for those used by women (14.3 per 10,000 person-months; AHR, 1.17; 95% CI, 1.06-1.28), patients receiving 5 to 7 drugs (12.1 per 10,000 person-months; AHR, 3.23; 95% CI, 2.66-3.92), and patients receiving cardiovascular drugs (15.9 per 10,000 person-months; AHR, 3.30; 95% CI, 2.67-4.08) and anti-infectives (66.2 per 10,000 person-months; AHR, 6.33; 95% CI, 4.58-8.76). Patients with a 1-unit increase in the continuity of care index had a 19% increase in ADEs (AHR, 1.19; 95% CI, 1.12-1.26). CONCLUSIONS AND RELEVANCE: Off-label use of prescription drugs is associated with ADEs. Caution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence. Future electronic health records should be designed to enable postmarket surveillance of treatment indications and treatment outcomes to monitor the safety of on- and off-label uses of drugs.

Evaluating the impact of an integrated computer-based decision support with person-centered analytics for the management of asthma in primary care: a randomized controlled trial.

BACKGROUND: Computer-based decision support has been effective in providing alerts for preventive care. Our objective was to determine whether a personalized asthma management computer-based decision support increases the quality of asthma management and reduces the rate of out-of-control episodes. METHODS: A cluster-randomized trial was conducted in Quebec, Canada among 81 primary care physicians and 4447 of their asthmatic patients. Patients were followed from the first visit for 3-33 months. The physician control group used the Medical Office of the 21st century (MOXXI) system, an integrated electronic health record. A custom-developed asthma decision support system was integrated within MOXXI and was activated for physicians in the intervention group. RESULTS: At the first visit, 9.8% (intervention) to 12.9% (control) of patients had out-of-control asthma, which was defined as a patient having had an emergency room visit or hospitalization for respiratory-related problems and/or more than 250 doses of fast-acting ß-agonist (FABA) dispensed in the past 3 months. By the end of the trial, there was a significant increase in the ratio of doses of inhaled corticosteroid use to fast-acting ß-agonist (0.93 vs. 0.69: difference: 0.27; 95% CI: 0.02-0.51; P = 0.03) in the intervention group. The overall out-of-control asthma rate was 54.7 (control) and 46.2 (intervention) per 100 patients per year (100 PY), a non-significant rate difference of -8.7 (95% CI: -24.7, 7.3; P = 0.29). The intervention's effect was greater for patients with out-of-control asthma at the beginning of the study, a group who accounted for 44.7% of the 5597 out-of-control asthma events during follow-up, as there was a reduction in the event rate of -28.4 per 100 PY (95% CI: -55.6, -1.2; P = 0.04) compared to patients with in-control asthma at the beginning of the study (-0.08 [95% CI: -10.3, 8.6; P = 0.86]). DISCUSSION: This study evaluated the effectiveness of a novel computer-assisted ADS system that facilitates systematic monitoring of asthma control status, follow-up of patients with out of control asthma, and evidence-based, patient-specific treatment recommendations. We found that physicians were more likely to use ADS for out-of-control patients, that in the majority of these patients, they were advised to add an inhaled corticosteroid or a leukotriene inhibitor to the patient s treatment regimen, and the intervention significantly increased the mean ratio of inhaled corticosteroids to FABA during follow-up. It also reduced the rate of out-of-control episodes during follow up among patients whose asthma was out-of-control at the time of study entry. Future research should assess whether coupling patient-specific treatment recommendations, automated follow-up, and home care with comparative feedback on quality and outcomes of care can improve guideline adoption and care outcomes. CONCLUSIONS: A primary care-personalized asthma management system reduced the rate of out-of-control asthma episodes among patients whose asthma was poorly controlled at the study's onset.