CLEO: a multidimensional tool to assess clinical, economic and organisational impacts of pharmacists' interventions.

OBJECTIVES: Clinical pharmacists' interventions (PIs) are an important element in ensuring good pharmaceutical care. We aimed to develop and validate a comprehensive multidimensional tool for assessing the potential impact of PIs for daily practice of medication review. METHODS: Experts of the French Society of Clinical Pharmacy (SFPC) developed the CLinical, Economic and Organisational (CLEO) tool, consisting of three independent dimensions concerning clinical, economic and organisational impact. They were asked to analyse 30 scenarios of PIs, and re-rated 10 PIs with a washout of 1 month (internal validation). Then, seven external experts not involved in the development of the tool rated 60 scenarios collected when using the CLEO in daily practice. Inter- and intra-rater reliabilities were determined by calculation of the intra-class correlation (ICCA,1). Users' satisfaction and acceptability of the tool were assessed on a 7-level Likert scale with a 17-item questionnaire. RESULTS: For internal reliability, the inter-rater reliability for the CLEO tool was good for clinical dimensions (ICCA,1=0.693), excellent for economic dimensions (ICCA,1=0.815) and fair for organisational dimensions (ICCA,1=0.421); and the intra-rater reliability was good for clinical dimensions (ICCA,1=0.822), excellent for economic dimensions (ICCA,1=0.918) and good for organisational dimensions (ICCA,1=0.738). For external reliability, the inter-rater reliability was good for clinical dimensions (ICCA,1=0.649), excellent for economic dimensions (ICCA,1=0.814) and fair for organisational dimensions (ICCA,1=0.500). CLEO was viewed as relevant (mean±SD 4.93±1.27), acceptable (4.81±1.78), practicable (5.56±1.45) and precise (5.38±1.47). CONCLUSIONS: CLEO is a comprehensive tool assessing clinical, economic and organisational impacts of PIs which has been developed, validated and was reliable and feasible for use in routine clinical practice.

How to agree on what is fundamental to optimal teamwork performance in a situation of postpartum hemorrhage? A multidisciplinary Delphi French study to develop the Obstetric Team Performance Assessment Scale (OTPA Scale).

INTRODUCTION: The objective of this study was to develop a new interdisciplinary teamwork scale, the Obstetric Team Performance Assessment (OTPA), for the management of the post-partum hemorrhage, through consensus agreement of obstetric caregivers. The goal is to provide a reliable tool for teaching and evaluating teams in high-fidelity simulation. METHODS: This prospective study is based on an expert consensus, using a Delphi method. The authors developed the "OTPA¼ specifically related to the management of post-partum hemorrhage, using existing recommendations. For the Delphi survey, the scale was distributed to a selected group of experts. After each round of Delphi, authors quantitatively analyzed each element of the scale, based on the percentages of agreement received, and reviewed each comment. This blind examination then led to the modification of the scale. The rounds were continued until 80-100 % agreement with a median overall response score equal to or greater than 8 was obtained for at least 60 % of items. Repeated 3 times, the process led to consensus and to a final version of the OTPA scale. RESULTS: From February to October 2018, 16 of the 33 invited experts participated in four Delphi cycles. Of the 37 items selected in the first round, only 19 (51.3 %) had an agreement of 80-100% with a median overall response score equal to or greater than 8 in the second round, and a third round was conducted. During this third round, 24 of the 37 items were validated (64.9 %) and 82 of the 88 sub-items obtained 80 %-100 % agreement (93.2 %). The fourth round consisted of proposing a weighting of the different items. CONCLUSION: Using a structured Delphi method, we provided a new interdisciplinary teamwork scale (OTPA), for the management of the post-partum hemorrhage. Thus, this scale will be able to be used during high-fidelity scenarii to assess performances of various teams facing a scenari of PPH. Moreover, this scale, focusing some crucial aspects of interdisciplinary teamwork will be useful for teaching purpose.

Clinical, economic and organizational impact of pharmacist interventions on injectable antineoplastic prescriptions: a prospective observational study.

BACKGROUND: Pharmacists play a key role in ensuring the safe use of injectable antineoplastics, which are considered as high-alert medications. Pharmaceutical analysis of injectable antineoplastic prescriptions aims to detect and prevent drug related problems by proposing pharmacist interventions (PI). The impact of this activity for patients, healthcare facilities and other health professionals is not completely known. This study aimed at describing the clinical, economic, and organizational impacts of PIs performed by pharmacists in a chemotherapy preparation unit. METHODS: A prospective 10-week study was conducted on PIs involving injectable antineoplastic prescriptions. Each PI was assessed by one of the four multidisciplinary expert committees using a multidimensional tool with three independent dimensions: clinical, economic and organizational. An ancillary quantitative evaluation of drug cost savings was conducted. RESULTS: Overall, 185 patients were included (mean age: 63.5 ± 13.7 years; 54.1% were male) and 237 PIs concerning 10.1% prescriptions were recorded. Twenty one PIs (8.9%) had major clinical impact (ie: prevented hospitalization or permanent disability), 49 PIs (20.7%) had moderate clinical impact (ie: prevented harm that would have required further monitoring/treatment), 62 PIs (26.2%) had minor clinical impact, 95 PIs (40.0%) had no clinical impact, and 9 PIs (3.8%) had a negative clinical impact. For one PI (0.4%) the clinical impact was not determined due to insufficient information. Regarding organizational impact, 67.5% PIs had a positive impact on patient management from the healthcare providers' perspective. A positive economic impact was observed for 105 PIs (44.3%), leading to a saving in direct drug costs of 15,096 €; 38 PIs (16.0%) had a negative economic impact, increasing the direct drug cost by 11,878 €. Overall cost saving was 3218€. CONCLUSIONS: PIs are associated with positive clinical, economic and organizational impacts. This study confirms the benefit of pharmacist analysis of injectable antineoplastic prescriptions for patient safety with an overall benefit to the healthcare system.

Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study).

BACKGROUND: Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. METHODS: This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team's satisfaction. DISCUSSION: This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02598115 . Registered on 4 November 2015.

A Randomised Controlled Trial to Test the Effectiveness of Planning Strategies to Improve Medication Adherence in Patients with Cardiovascular Disease.

BACKGROUND: Low levels of adherence to medication prescribed to treat and manage chronic disease may lead to maladaptive health outcomes. Theory-based, easy-to-administer interventions that promote patients' effective self-regulation of their medication-taking behaviour are needed if adherence is to be maximised. We tested the effectiveness of an intervention adopting planning techniques to promote medication adherence. METHODS: Outpatients with cardiovascular disease (N = 71) were allocated to either an experimental condition, in which participants were asked to form implementation intentions and coping plans related to their treatment, or to a no-planning control condition, in which participants received no treatment. Patients also completed self-report measures of medication adherence, self-efficacy, and beliefs in medication necessity and concerns. Measures were administered at baseline and at 6-week follow-up. RESULTS: Results revealed no overall main effect for the intervention on medication adherence. Post-hoc moderator analyses revealed that the intervention was effective in patients with lower necessity beliefs compared to those with higher necessity beliefs. CONCLUSION: While current findings have promise in demonstrating the conditional effects of planning interventions, there is a need to replicate these findings by manipulating planning and beliefs independently and testing their direct and interactive effects on medication adherence.

Best practice strategies to safeguard drug prescribing and drug administration: an anthology of expert views and opinions.

BACKGROUND: While evidence on implementation of medication safety strategies is increasing, reasons for selecting and relinquishing distinct strategies and details on implementation are typically not shared in published literature. OBJECTIVE: We aimed to collect and structure expert information resulting from implementing medication safety strategies to provide advice for decision-makers. SETTING: Medication safety experts with clinical expertise from thirteen hospitals throughout twelve European and North American countries shared their experience in workshop meetings, on-site-visits and remote structured interviews. METHODS: We performed an expert-based, in-depth assessment of implementation of best-practice strategies to improve drug prescribing and drug administration. MAIN OUTCOME MEASURES: Workflow, variability and recommended medication safety strategies in drug prescribing and drug administration processes. RESULTS: According to the experts, institutions chose strategies that targeted process steps known to be particularly error-prone in the respective setting. Often, the selection was channeled by local constraints such as the e-health equipment and critically modulated by national context factors. In our study, the experts favored electronic prescribing with clinical decision support and medication reconciliation as most promising interventions. They agreed that self-assessment and introduction of medication safety boards were crucial to satisfy the setting-specific differences and foster successful implementation. CONCLUSION: While general evidence for implementation of strategies to improve medication safety exists, successful selection and adaptation of a distinct strategy requires a thorough knowledge of the institute-specific constraints and an ongoing monitoring and adjustment of the implemented measures.

Why Do Patients with Chronic Inflammatory Rheumatic Diseases Discontinue Their Biologics? An Assessment of Patients' Adherence Using a Self-report Questionnaire.

OBJECTIVE: Concerns have been raised about nonadherence behavior among patients with chronic inflammatory rheumatic diseases (CIRD) receiving biologics. This nonadherence may be caused by various factors. The main objective was to explain why patients discontinue their biologics of their own accord. METHODS: A quantitative and descriptive study was performed using a self-report questionnaire that was sent through the Internet to members of different patient associations. Sociodemographic data, medical and therapeutic history, management of biologic administration, previous experiences, and patients' beliefs and perceptions about treatment efficacy and side effects were studied to explain self-discontinuation (SD). RESULTS: A total of 581 patients answered the questionnaire between June 16, 2012, and July 4, 2012, including patients with ankylosing spondylitis (351/581, 60.4%), rheumatoid arthritis (196/581, 33.7%), psoriatic arthritis (30/581, 5.2%), and other CIRD (4/581, 0.7%). More than 1000 different biologics were described by the 581 patients, with a median of 2 lines per patient. Eighty-six patients discontinued their biologics of their own accord (14.8%). In a multivariate analysis, factors that were significantly related to SD were low level of pain, more than 1 line of biologics tried, self-administration of biologics, negative beliefs about the treatment, and a lack of medical and social support. CONCLUSION: Five predictive factors of this SD were identified, which should be assessed in routine with patients with CIRD receiving biologic treatment: pain, treatment history, self-administration of injections, negative beliefs about treatment, and a lack of perceived medical and social support.

Tools for Assessing Potential Significance of Pharmacist Interventions: A Systematic Review.

INTRODUCTION: Assessing the significance of pharmacist interventions (PIs) is essential to demonstrate the added value of pharmacists. Methods and tools for assessing the potential significance of PIs are diverse and their properties are questionable. OBJECTIVES: We aimed to systematically review the tools available to assess the potential significance of PIs. METHODS: We conducted a systematic search for English- or French-language publications from 1986 to 2013 in PubMed, PsycINFO, PASCAL, and CINAHL. Studies were screened by two independent reviewers based on inclusion/exclusion criteria and were abstracted for content, structure of tools, and validation process. RESULTS: Of 873 citations screened, 82 distinct tools were identified from 133 studies. While clinical aspects were often defined quite clearly, terminology regarding humanistic, economic, and process-related aspects of PIs was omitted, incomplete, or ambiguous in most tools. The probabilities of consequences of PIs/drug-related problems were evaluated in 20/82 tools. Few tools simultaneously measured economic, clinical, humanistic, and process-related variables. Structure of the tools varied from an implicit, mono-dimensional tool to an explicit, multi-dimensional algorithm. Validation processes were diverse in terms of quantification and number of raters, rating method, and psychometric parameters. Of 133 identified studies, there was limited evidence of validity (8/133, 6.0%), inter-rater reliability (49/133, 36.8%), and intra-rater reliability (2/133, 1.5%). CONCLUSIONS: The majority of tools focused primarily on assessing clinical aspects and failed to detect comprehensive impacts. The heterogeneity of tools and assessment processes hindered our ability to synthesize the results of evaluations. Limited results for their validity and reliability cast doubt on the credibility of this methodology for justification of the value of PIs. Recommendations for development of tools with optimal theoretical, pragmatic, and psychometric properties are proposed.

Automated drug dispensing systems in the intensive care unit: a financial analysis.

INTRODUCTION: To evaluate the economic impact of automated-drug dispensing systems (ADS) in surgical intensive care units (ICUs). A financial analysis was conducted in three adult ICUs of one university hospital, where ADS were implemented, one in each unit, to replace the traditional floor stock system. METHOD: Costs were estimated before and after implementation of the ADS on the basis of floor stock inventories, expired drugs, and time spent by nurses and pharmacy technicians on medication-related work activities. A financial analysis was conducted that included operating cash flows, investment cash flows, global cash flow and net present value. RESULTS: After ADS implementation, nurses spent less time on medication-related activities with an average of 14.7 hours saved per day/33 beds. Pharmacy technicians spent more time on floor-stock activities with an average of 3.5 additional hours per day across the three ICUs. The cost of drug storage was reduced by €44,298 and the cost of expired drugs was reduced by €14,772 per year across the three ICUs. Five years after the initial investment, the global cash flow was €148,229 and the net present value of the project was positive by €510,404. CONCLUSION: The financial modeling of the ADS implementation in three ICUs showed a high return on investment for the hospital. Medication-related costs and nursing time dedicated to medications are reduced with ADS.

Influence of intention to adhere, beliefs and satisfaction about medicines on adherence in solid organ transplant recipients.

INTRODUCTION: Nonadherence to immunosuppressive (IS) therapy is associated with poor outcomes. Identifying factors predicting poor adherence is therefore essential. The primary objective of this study was to test whether parameters of a model adapted from the theory of planned behavior, and more specifically attitudes that are influenced by beliefs and satisfaction with medication, could predict adherence in solid organ transplant patients. METHODS: Adherence was assessed with a self-reported medication adherence scale and IS blood trough concentrations over 6 months, in four transplant units. Satisfaction and beliefs were assessed using the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) and Beliefs about Medicines Questionnaire (BMQ), respectively. Theory of planned behavior was assessed with a specific questionnaire exploring intentions, subjective norms, attitudes and perceived behavioral control. Treatment characteristics and socioeconomic data were also collected. RESULTS: One hundred and fifty-three solid organ transplant patients were enrolled, including lung (n=33), heart (n=43), liver (n=42), and kidney (n=44) patients. Satisfaction and positive beliefs about medication were higher in adherent than those in nonadherent patients. Factors independently associated with an increased risk of nonadherence were negative general beliefs about medications (odds ratio [OR]=0.89 [0.83-0.97]), living alone (OR=2.78 [1.09-7.09]), heart transplantation (OR=3.49 [1.34-9.09]), and being on everolimus (OR=5.02 [1.21-20.8]). CONCLUSION: Negative beliefs toward medications were shown to be an independent risk factor of poor adherence. Therefore, the BMQ could be an effective, easy to implement tool, for use in everyday practice, to identify patients needing interventions to improve adherence to IS.

Assessing medication adherence: options to consider.

BACKGROUND: Adherence to chronic therapy is a key determinant of patient health outcomes in chronic disease. However, only about 50 % of patients adhere to chronic therapy. One of the challenges in promoting adherence is having an accurate understanding of adherence rates and the factors that contribute to non-adherence. There are many measures available to assess patient medication adherence. AIM OF THE REVIEW: This review aims to present the commonly used indirect methods available for measuring medication adherence in routine healthcare and research studies. METHOD: A literature review on medication adherence measures in patient populations with chronic conditions taking chronic medications was conducted through Medline (2003-2013). A complementary manual search of references cited in the retrieved studies was performed in order to identify any additional studies. RESULTS: Of the 238 initial Medline search results, 57 full texts were retrieved. Forty-seven articles were included as a result of the manual search. Adherence measures identified were: self-report (reported in 50 publications), electronic measures (33), pharmacy refills and claims data (26) and pill counts (25). Patient self-report, electronic measures, pharmacy refill and claims data were the most commonly used measures of adherence in research, routine practice, epidemiological and intervention studies. These methods, and their strengths and limitations have been described in this paper. CONCLUSION: A multitude of indirect measures of adherence exist in the literature, however, there is no "gold" standard for measuring adherence to medications. Triangulation of methods increases the validity and reliability of the adherence data collected. To strengthen the adherence data collected and allow for comparison of data, future research and practice interventions should use an internationally accepted, operational standardized definition of medication adherence and clearly describe the medication adherence methods used.

[From treatment history to patient follow-up: the role of the pharmacist]. / De l'historique médicamenteux au suivi du patient. Rôle du pharmacien.

Pharmacists and physicians have complementary roles. Indeed, pharmacists have specific knowledge of medications and a particular relationship with patients, especially in the community. Integration of pharmacists within medical teams, based on the North-American model, helps to ensure close collaboration founded on mutual trust and face-to-face contacts. This role of the pharmacist is appreciated by physicians, notably because it helps them to verify their prescriptions. It is essential to determine patients' relationships with their medications, through a knowledge of their treatment history. The French educational model of clinical pharmacy, based on the fifth hospital year, is inspired by this experience. The challenge is now to prove the benefits both for patients, physicians and nurses, of integrating a pharmacist within the medical team. This educational model helps to develop the pharmacist's role within the community and facilitates relationships between the hospital and the community.

Development of a pharmacist collaborative care program for pulmonary arterial hypertension.

Patients with Pulmonary Arterial Hypertension (PAH) require multidisciplinary care. Involving pharmacists in PAH multidisciplinary care teams may enhance patient education and improve medication use. We describe the implementation of a Pharmacist Collaborative Care Program (PCCP) in a PAH referral centre in Grenoble, France. Initiated in 2007, the PCCP program includes a pharmacist intervention whose goals are educational, psychosocial, and technical. During patient interviews, pharmacists make an 'educational diagnosis' and provide a patient-specific education session. Patient skills are evaluated at the end of the session. Pharmacists provide feedback to nurses and physicians through a standardized report form and discussion during medical rounds and PAH group meetings. Pharmacists re-evaluate patients' skills every 3-6 months during multidisciplinary clinical evaluations. The PCCP program for PAH is an established practice in Grenoble and may inform future patient education programs involving pharmacists in France, where legislation has recently been passed to standardize patient education.

Assessment of clinical pharmacists' interventions in French hospitals: results of a multicenter study.

BACKGROUND: The development of clinical pharmacy activities in most European countries is underway; however, data on these activities are still poorly reported. Multicenter studies are necessary to standardize and demonstrate the value of clinical pharmacy activities in these countries. OBJECTIVE: To document clinical pharmacists' daily routine interventions (PIs) to identify trends of intervention, drugs, and situations most frequently associated with drug-related problems (DRPs) and to estimate physicians' acceptance of PI. METHODS: A prospective study of PIs was conducted in 6 French hospitals. The sample consisted of 300 randomized PIs per hospital, recorded during the medication order validation process when a DRP was identified. We recorded patients' demographic characteristics, drugs involved, wards, DRP description, pharmacists' recommendations, and whether or not the recommendations were accepted by the physicians. RESULTS: A total of 38,626 medication orders were analyzed by 28 clinical pharmacists, leading to 1800 PIs (4.66 PIs per 100 medication orders). Of the 1800 PIs, 25.9% targeted psychotropic drugs, 15.9% targeted antithrombotic drugs, 15.5% targeted digestive and metabolic drugs, and 15.0% targeted cardiovascular drugs. The most commonly identified DRPs were nonconformity to guidelines or contraindication (21.3%), followed by improper administration (20.6%), supratherapeutic dose (19.2%), and drug interaction (12.6%). Nearly half (42.2%) of the pharmacists' recommendations were related to drug choice (drug switch 22.2%, drug discontinuation 16.3%, addition of a new drug 3.7%) followed by dose adjustment (23.8%), optimization of administration (21.9%; change of administration route 10.3%, administration modalities 11.6%), and need for drug monitoring (12.2%). The rate of physicians' acceptance was 73.4% (15.3% refusals, 11.3% not assessable). CONCLUSIONS: In French hospitals, pharmacists contribute to preventing DRPs during medication order validation. This study suggests that a few types of drugs and errors constitute a substantial proportion of PIs. Knowledge of the most frequent DRPs could significantly increase the efficiency of clinical PIs.

Primary angioplasty is cost-minimizing compared with pre-hospital thrombolysis for patients within 60 min of a percutaneous coronary intervention center: the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) cost-efficacy sub-study.

OBJECTIVES: This ancillary study of the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) trial sought to assess the cost-efficacy ratio of primary coronary angioplasty (PCA) and pre-hospital thrombolysis (PHT) in patients suffering from an acute myocardial infarction (AMI) (<6 h) close to (<60 min journey) a percutaneous coronary intervention (PCI) center. BACKGROUND: In the CAPTIM study, at 30 days follow-up PCA was as equally effective as PHT with rescue angioplasty if needed. The cost efficacy of these two strategies has not yet been compared. METHODS: Data were prospectively collected for 299 patients in three centers. The efficacy analysis was extended at one-year follow-up for those patients. Direct fixed and variable actual costs were assessed with a piggyback data collection. RESULTS: The one-year primary end point event-rate (death, non-fatal myocardial infarction, and stroke) was not different after PCA or PHT (14% vs. 16. 4%, p = NS). Costs were lower in the PCA group either during the in-hospital period (8,287 vs. 9,170 $, p = 0.0001) and after one-year follow-up, in relation to a higher rate of subsequent revascularizations in the PHT group (49% vs. 23%, p < 0. 01), leading to a longer hospital stay (10 vs. 9.1 days, p = 0. 03). CONCLUSIONS: After AMI in patients less than 1 h from a PCI center, PCA is as effective and less costly than a combined strategy of PHT followed by rescue angioplasty.

Opinion and behaviour of pharmacists towards the substitution of branded drugs by generic drugs: survey of 1,000 French community pharmacists.

OBJECTIVE: In 1999, a new law was introduced, giving French pharmacists the right to switch from branded to generic drugs, unless the prescriber had specified that substitution was not permitted. The purpose of this study was to assess the opinion and behaviour of community pharmacists toward substitution. DESIGN: Self-completion, postal close-ended questionnaires were filled out. SAMPLE AND SETTING: 1,000 French community pharmacists were included. RESULTS: 90% of the pharmacists were favourable to the implementation of the substitution right. 42.5% declared they systematically offered patients the generic drug, whereas 55% chose to target specific populations for substitution. The reluctance of pharmacists could be commercial ('How do I get paid for the time spent? Is it worth risking loosing a customer?'), or cultural ('How do I work this out? Who should I offer generic drugs to? What strategy should I use to offer them?'). CONCLUSION: Generic drug distribution is very recent in France and is not yet common practice. Pharmacists and patients must be informed and trained because substitution is a collaborative act. It does not depend solely on the will and experience of pharmacists.