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.

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.

[Bariatric surgery, stomas and other digestive tract reductions: Insufficient data and recommendations to adapt medicines regimens in therapeutic practice]. / Chirurgie bariatrique, stomies et autres réductions du tube digestif : trop peu de données et de recommandations pour l'adaptation des thérapeutiques médicamenteuses.

Surgery modifying digestive tract may alter drugs pharmacokinetics. To maintain concentrations of active substance in their therapeutic ranges, a dosage adjustment or change of drug may be necessary. This is particularly important when no pharmacological or pharmacodynamic parameter reflecting the medication effectiveness is easily measurable. Our objective was to gather the information and documentary tools that can guide prescription in these patients with rearranged digestive tract. We searched information on the documentary portals of French agencies, on gray literature, on MEDLINE and in the summaries product characteristics. No information was found on the website of French agencies, sparse data were identified in gray literature. Some document are discordant, most are imprecise. One hundred and ten studies or case reports referenced on MEDLINE describe 79 medications pharmacokinetics after gastrointestinal surgery. Four are not available in France. Six literature reviews were found. Four summaries of product characteristics provided information related to drug absorption. No documentary tool adapted to clinical routine exists. This unsatisfactory situation is a barrier to optimal patients care. Information is available. It is however necessary to gather under an ergonomic shape adapted to clinical routine, bringing the surgery type, pharmacokinetic changes induced and what to do about the dose adjustment.

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.

[Factors to consider in managing drug interactions in clinical practice]. / Facteurs à prendre en considération pour la gestion des interactions médicamenteuses en pratique clinique.

The huge number of drug interactions makes it impossible to memorize them all. Detecting them and preventing adverse effects requires the use of reference works or databases. There are numerous discordances between the so-called "reference" books and databases. Nonexistent and unconfirmed interactions are published. The wording of the "drug interactions" section of the summary of product characteristics (SCP) sometimes sheds very little light on the risks involved. The delay by AFSSAPS in updating its drug interaction thesaurus may present problems in clinical practice. It is essential to know the limitations of the computerized systems for detecting and reporting drug interactions.

Epidural, intrathecal pharmacokinetics, and intrathecal bioavailability of ropivacaine.

BACKGROUND: Ropivacaine is used by the epidural route for postoperative pain management with various neuraxial techniques. Given the widespread use of these techniques and the relative paucity of data on spinal disposition of local anesthetics, we evaluated through an experimental animal model, the spinal disposition of ropivacaine, allowing further studies of factors influencing their intrathecal bioavailability. METHODS: Sheep received an IV bolus dose of ropivacaine (50 mg), and 1 wk after, an intrathecal dose of ropivacaine (20 mg) followed 3 h later by epidural ropivacaine (100 mg). A simultaneous microdialysis technique was used to measure epidural and intrathecal drug concentrations after both epidural and intrathecal administrations. RESULTS: Absorption-time plots showed a large variability in the systemic absorption after both intrathecal and epidural administration, with an apparent faster systemic absorption after intrathecal administration. In the intrathecal space, the elimination clearance was around three-times higher than the distribution clearance. In the epidural space, the relative contribution of elimination and distribution to ropivacaine disposition was different, indicating a more pronounced influence of the distribution process. The intrathecal bioavailability after epidural administration was 11.1% +/- 7.6%. CONCLUSIONS: Using an animal model, we showed that drug dispositions in the intrathecal and epidural compartments are different, and that the intrathecal bioavailability of ropivacaine after epidural administration is low, and highly variable.

Validation of an instrument for the documentation of clinical pharmacists' interventions.

OBJECTIVE: To validate an instrument for documentation of clinical pharmacy interventions in French speaking hospitals in France and outside of France. METHOD: A panel of 12 French speaking clinical pharmacists (six from France; six from French speaking countries) was asked to analyse a set of 60 pharmacist's interventions on drug prescription. They used a form including (1) the identification of the drug related problems (DRPs) (10 items), (2) the pharmacist's intervention (7 items). We assessed the level of agreement between the 12 pharmacists on the test DRPs and on the interventions. MAIN OUTCOME MEASURES: Kappa coefficient of concordance was used to assess the level of agreement between experts for DRPs and interventions. We also assessed the userfriendliness of the instrument using Likert scales. RESULTS: The level of concordance observed in the validation was 0.76 for DRPs and 0.89 for the type of intervention. Eleven experts out of 12 were "very satisfied" or "satisfied" and one "not satisfied" with the tool. Ten out of the 12 experts were ready to use it in daily practise. CONCLUSION: The present instrument proposed by the French Society of Clinical Pharmacy (SFPC) is the first coding system for pharmacist's interventions with a French interface. The validation process using a standard statistical methodology helps support the external validity of our tool. The level of concordance between users can be considered as satisfactory, allowing the use of the tool in daily clinical pharmacy practise. To enhance the diffusion of the instrument and of the general process of routine documentation of interventions, a spreadsheet is provided on the French Society of Clinical Pharmacy website.