Clinical pharmacy as a guarantee of safety in times of crisis: evolution and relevance of the continued presence of clinical pharmacists in frontline medical units during the first wave of COVID-19.

BackgroundThe COVID-19 pandemic has had a major impact on the organisation of health services worldwide. In the first wave, many therapeutic options were explored, exposing patients to significant iatrogenic risk. In a context in which patient management was not well defined by clear recommendations and in which healthcare professionals were under great stress, was it still relevant to maintain pharmaceutical care or did it bring an additional factor of disorganisation? OBJECTIVE: The aim of our study was to compare the relevance of pharmaceutical care practices before and during the COVID-19 crisis. METHODS: A retrospective, comparative, observational analysis was conducted in two medical units in a French university hospital that were receiving patients with COVID-19 and benefiting from pharmaceutical care prior to the crisis. This study compared clinical pharmacy performance between two 1.5-month periods before and during the COVID-19 crisis. Performance was assessed according to the CLEO scale, rating the clinical, economic and organisational impacts of the accepted pharmaceutical interventions (PIs) performed in these units. RESULTS: Of the 675 accepted PIs carried out in the two medical units over the entire study period, PIs performed during the COVID-19 period had a greater significant clinical impact (72% vs 56%, p˂0.0001), a more positive economic impact (38% vs 23%, p˂0.0001) and a more favourable organisational impact (52% vs 20%, p˂0.0001) than those performed prior to the COVID-19 period. CONCLUSIONS: The health crisis generated important changes in care practices. Our study demonstrates the sustained relevance of pharmaceutical care during a health crisis. This local experience confirms the major interest in improving the integration of pharmaceutical expertise within French healthcare teams.

Evidence-Based Pharmaceutical Care in Community Pharmacies: A Survey of 595 French Pharmacists.

We assessed the use of evidence-based practice (EBP) among pharmacists working in community pharmacies in France and the factors linked to this practice. During 3 months in 2018, an online survey was sent to over 7000 active pharmacists and posted on pharmacists' social media sites. In total, 595 pharmacists completed the questionnaire. The responders were on average younger than the general population of community pharmacists. The 40-item questionnaire described four fictional clinical cases reflecting typical situations (conventional medicine and complementary and alternative medicine) encountered daily by community pharmacists. Multiple-choice responses were proposed and scored according to whether they reflected EBP. A high total score indicated behaviour in line with EBP. We observed 344/595 participants with a positive EBP score (57.8% [53.7-61.8%]). Univariate and multivariate analyses were used to evaluate factors that might explain adherence to EPB (the pharmacy's characteristics, the pharmacist's status, the mode of continuing education and sources of information). The majority relied on pharmaceutical industry and other biased and/or non-evidence-based sources, particularly concerning information on homeopathic products. The consultation of independent reviews, health agency recommendations and peer-reviewed scientific journals was associated with evidence-based decisions. In contrast, reliance on pharmaceutical industry documents, personal experience and informal handbooks was linked to lower EBP scores. The level of EBP use by French community pharmacists needs to be improved to ensure that good-quality, science-based advice is given to customers.

Information and Communication Technologies in Lung Transplantation: Perception of Patients and Medical Teams.

Optimal therapeutic management is a major determinant of patient prognosis and healthcare costs. Information and communication technologies (ICTs) represent an opportunity to enhance therapeutic management in complex chronic diseases, such as lung transplantation (LT). The objective of this study was to assess the preferences of LT patients and healthcare professionals regarding ICTs in LT therapeutic management. A cross-sectional opinion survey was conducted among lung transplant patients and healthcare professionals from the French lung transplantation centers. Five ICTs were defined (SMS, email, phone, internet, and smartphone application) in addition to face-to-face communication. An unsupervised approach by Principal Component Analysis (PCA) identified lung transplant patient profiles according to their preferences for ICTs. Fifty-three lung transplant patients and 15 healthcare professionals of the French LT centers were included. Both expected ICTs for treatment management and communication. Phone call, face-to-face, and emails were the most preferred communication tools for treatment changes and initiation. PCA identified four ICTs-related profiles ("no ICT", "email", "SMS", and "oral communication"). "Email" and "oral communication" profiles are mainly concerned with treatment changes and transmission of new prescriptions. The "SMS" profile expected reminders for healthcare appointments and optimizing therapeutic management. This study provides practical guidance to enhance LT therapeutic management by ICT intervention. The type of ICT used should take into account patient profiles to improve adherence and thereby the prognosis. A combination of strategies including information, education by a multidisciplinary team, and reminders is a promising approach to ensure an optimal management of our patients.

Successful Training of Patients to Intervene in Health Education and Clinical Research at Grenoble Patient School.

The primary goal of patient and public involvement (PPI) in healthcare is to improve individual and population health outcomes. This study reports on the successful training of patients to be involved in patient education as peers and clinical research at Grenoble Patients' School (GPS). GPS was founded by patients as an independent association to train patients to the above objectives tasks. The training team was multi-professional and included expert PPI who were part of the professional team. Medical faculty members and 45 patients, 59% females, 52 ± 6.4 years old, trained between 2016 and 2017, showed high satisfaction at the end of the training courses. Almost all the trained patients were involved as peer educators and 4 were involved in clinical research projects at different stages under the guidance of medical teams. Patient involvement at GPS provided strong benefits to trainees and had some impact on education and obtaining research grants. The outcome of this patient training program resulted in the creation of a Patients' Department within the Medical and Pharmacy Schools at the Université Grenoble Alpes in 2020, https://medecine.univ-grenoble-alpes.fr/departements/departement-universitaire-des-patients/.

Gout and Levodopa: An unknown adverse effect?

We report the case of a 77-year-old man with Parkinson's disease (PD) who experimented for the first time gout crisis after the initiation of levodopa. Levodopa was withdrawn, and colchicine and allopurinol were initiated to treat the gout crisis. Because of PD progression, levodopa was reintroduced, and the patient presented relapse of gout flare. To further explore the association between gout and levodopa, we extracted and synthetized all Individual Case Safety Reports of gout associated with levodopa in the World Health Organization pharmacovigilance database, VigiBase® , up to April 2021. 43 cases of gout were reported in VigiBase® with drugs from N04BA ATC class. Levodopa was suspected in fifteen cases among which improvement was noticed in six cases (two after levodopa withdrawal, two despite treatment continuation, and two cases lacking details about action taken with levodopa); three cases did not recover; in the remaining six cases, evolution was not known. "Hyperuricemia" was not mentioned in the Summary of Product Characteristics of medicine containing levodopa; however, "abnormality biologics test with uric acid" was mentioned. Despite few cases of recovery after reduced doses of levodopa, the above-described case of positive reintroduction was an argument in favor of the role of levodopa in gout flare. This study highlights a potential association between levodopa and gout through an analysis of the cases reported in the WHO pharmacovigilance database.

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 evaluation of pharmacists' interventions on multidisciplinary lung transplant outpatients' management: results of a 7-year observational study.

OBJECTIVES: Lung transplant (LT) recipients require multidisciplinary care because of the complexity of therapeutic management. Pharmacists are able to detect drug-related problems and provide recommendations to physicians through pharmacists' interventions (PIs). We aimed at assessing the clinical impact of PIs on therapeutic management in LT outpatients. DESIGN: Data were collected prospectively from an LT recipients cohort during 7 years. A multidisciplinary committee assessed retrospectively the clinical impact of accepted PIs. SETTING: French University Hospital. PARTICIPANTS: LT outpatients followed from 2009 to 2015. PRIMARY OUTCOME MEASURES: Clinical impact of PIs performed by pharmacists using the CLEO tool and the Pareto chart. RESULTS: 1449 PIs led to a change in patient therapeutic management and were mainly related to wrong dosage (39.6%) and untreated indication (19.6%). The clinical impact of PIs was 'avoids fatality', 'major' and 'moderate', in 0.1%, 7.0% and 57.9%, respectively. Immunosuppressants, antimycotics for systemic use and antithrombotic agents had the greatest clinical impact according to the Pareto chart. PIs related to drug-drug interactions (10%) mainly had a moderate and major clinical impact (82.3%, p<0.0001). CONCLUSION: Clinical pharmacists play a key role for detecting drug-related problems mostly leading to a change in therapeutic management among LT outpatients. Our study provides a new insight to analyse the clinical impact of PIs in order to target PIs which have most value and contribute to patient care through interdisciplinary approach.

Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial.

Background Pulmonary hypertension is a rare, chronic and life-threatening group of diseases. Recent advances in pulmonary hypertension management prolong survival and improve quality-of-life. However, highly complex drug therapy enhances the risk of drug-related problems. Objective To assess the impact of involving clinical pharmacists in the collaborative care of pulmonary hypertension patients. Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension. Methods This prospective multicenter randomized controlled trial included incident pulmonary hypertension patients who were followed-up for 18 months. Randomization using an adapted Zelen method allocated patients to collaborative care (n = 41) or usual care groups (n = 51). A collaborative care program involving clinical pharmacists was developed through a close partnership between with physicians, nurses and pharmacists. Besides usual care, the program includes regular one-to-one interviews between the pharmacist and the patient. These interviews had following objectives: to perform an exhaustive medication history review; to identify the patient' needs, knowledge and skills; to define educational objectives and to provide patients with relevant information when needed. Following each interview, a standardized report form containing the pharmacist's recommendations was provided to physicians and nurses and discussed collaboratively. An ancillary economic analysis was performed. Main outcome measure Number of drug-related problems and their outcomes. Results The number of drug-related problems was not significantly different between groups (1.6 ± 1.5 vs. 1.9 ± 2.4; p = 0.41). More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01). Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life were not statistically different between groups. Collaborative care decreased costs of drug-related hospitalizations. Conclusion Including clinical pharmacists in the multidisciplinary care of hospitalized patients with pulmonary hypertension improved the outcome of drug-related problems and reduced the costs of related hospitalization. However, we observed no efficacy on medication errors, clinical outcomes or medication adherence. Clinical Trial Registration ClinicalTrials.gov Identifier NCT01038284.

Effectiveness of a multicomponent pharmacist intervention at hospital discharge for drug-related problems: A cluster randomised cross-over trial.

AIMS: The aim of this study was to assess whether a pharmacist intervention associating medication reconciliation at discharge with a link to the community pharmacist reduces drug-related problems (DRP) in adult patients during the 7 days after hospital discharge in 22 university or general hospitals in France. METHODS: We conducted a cluster randomised cross-over superiority trial with hospital units as the cluster unit. The primary outcome was a composite of any kind of DRP (prescription/dispensation, patient error or gap due to no medication available) during the 7 days after discharge, assessed by phone with the patient and community pharmacist. Among secondary outcomes, we studied self-reported unplanned hospitalisations at day 35 after discharge and severe iatrogenic problems. RESULTS: A total of 1092 patients were enrolled in 48 units (538 in the experimental periods and 554 in the control periods). Three patients refused to have their data analysed and were excluded from the analyses. As compared with usual care, the pharmacist intervention led to a lower proportion of patients with at least one DRP (44.0% vs 50.6%; odds ratio [OR] 0.77, 95% confidence interval [CI] 0.61-0.98) and severe iatrogenic problems (5.2% vs 8.7%; OR 0.57, 95% CI 0.35-0.93) but no significant difference in unplanned hospitalisations at day 35 (5.8% vs 4.5%; OR 1.46, 95% CI 0.91-2.35). CONCLUSION: Medication reconciliation associated with communication between the hospital and community pharmacist may decrease patient exposure to DRP and severe iatrogenic problems but not unplanned hospitalisation. However, this intervention could be recommended in health policies to improve drug management.

Does dissatisfaction with physicians lead patients to alternative practitioners?

OBJECTIVES: To test the dissatisfaction hypothesis by focusing on the use of CAM practitioners by low back pain patients. Moreover, we have distinguished between the complementary use and the alternative use of a CAM practitioner to medical care. METHODS: We conducted a cross-sectional study of a sample of 2,056 adults living in metropolitan France. RESULTS: The likelihood of the alternative use of a CAM practitioner decreased with increasing satisfaction with the general practitioner (OR: 0.990, 95% CI 0.984-0.996). The likelihood of the complementary use of a CAM practitioner (excluding osteopaths) decreased with increasing satisfaction with medical care (OR: 0.984, 95% CI 0.972-0.996). CONCLUSIONS: Our results support the dissatisfaction hypothesis to explain the use of CAM practitioners for low back pain, whether this use is alternative or complementary to medical care. However, concerning the complementary use, our study shows that this hypothesis is invalid for osteopaths.

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.

Do compensatory health beliefs predict behavioural intention in a multiple health behaviour change context? Evidence in individuals with cardiovascular diseases?

Multiple health behaviour change (MHBC) represents one of the best ways to prevent reoccurrence of cardiovascular events. However, few individuals with cardiovascular diseases engage in this process. The present study examined the role of compensatory health beliefs (CHB; i.e., belief that a healthy behaviour compensates an unhealthy one) as a drag to engagement in this process. Some studies have shown that CHBs predict intention to engage in healthy behaviours, but no study has investigated CHBs in individuals who actually need to change multiple health behaviours. The goal was to better understand the role of CHBs in intentions formation process among individuals with cardiac diseases in an MHBC context. One hundred and four patients completed a questionnaire at the beginning of their cardiac rehabilitation program. Results showed that: (1) CHBs negatively predicted intentions (2) but only for participants with high self-efficacy or low risk perception; (3) CHBs predictions differed depending on the nature of the compensating behaviour, and were more predictive when medication intake was the compensating one. Findings only partially confirmed previous research conducted on healthy individuals who were not in an MHBC process, and emphasized the importance of considering CHBs for individuals in this process.

The ABC taxonomy for medication adherence translated into French and German.

AIMS: We translated the ABC adherence taxonomy (i.e. 7 terms and their corresponding definitions) published by Vrijens et al. (2012) into French and German without changing the original meaning with the aim to promote a standardised taxonomy for medication adherence to French- and German-speaking researchers and clinicians. METHODS: A Delphi survey was performed. To generate round 1, we identified French and German synonyms for the 7 adherence terms through a literature search in PubMed. Investigators translated the original English definitions into French and German. Panellists were members of ESPACOMP-the International Society for Patient Medication Adherence; experts suggested by ESPACOMP members and first authors of medication adherence publications in French and German. Google forms were used to create online questionnaires. Delphi rounds were performed until consensus was reached. The consensus was defined according to the acceptance rate as moderate consensus (50-75%), consensus (>75-95%), and strong consensus (>95%). RESULTS: The literature search resulted in 4-6 (French) and 4-7 (German) items per English term. Delphi rounds were launched between November 2016 and April 2018. Three rounds sufficed to reach consensus on all terms and definitions from 26 French-speaking and 25 German-speaking panellists. Preferred terms for medication adherence are adhésion médicamenteuse (82%) in French and Medikamentenadhärenz (88%) in German. CONCLUSION: The use of a common terminology for medication adherence with translations in French and German will contribute to standardise the vocabulary, to harmonise research projects and ultimately ease comparison of study results among researchers and clinicians.

Développement, validation et fiabilité d'un questionnaire pour l'évaluation du recours aux thérapeutes alternatifs : QuERTA.

INTRODUCTION: The objectives of this work were: 1) to develop and validate a questionnaire to understand several dimensions of the use of CAM practitioners in France and 2) to evaluate the test-retest reliability of each of its items. PURPOSE OF RESEARCH: Development and validation (face validity): A questionnaire was created and then analyzed by 7 experts, including 3 social scientists. Before finalization, the questionnaire was tested on a sample of 43 individuals via cognitive interviews. Test-retest reliability: 322 individuals completed the questionnaire twice (at least 9 days apart). The reliability of the 107 categorical variables that compose the questionnaire was assessed by unweighted Gwet's AC1 coefficient. RESULTS: A short and clear questionnaire, suitable for collecting the targeted information, was methodically developed. In total, excluding descriptive items characterizing the population, the questionnaire includes 114 items, 107 of which are closed and 7 open. 107 of these items are conditional. The average filling time was less than 3 minutes. Of the 107 categorical items, 1 item was associated with moderate test-retest reliability, 9 items with good reliability and 97 with very good reliability. CONCLUSION: A reliable and valid questionnaire to evaluate the use of CAM practitioners in France is available. It may allow the collection of data necessary to assess the public health issue that this phenomenon represents.

Proposal for a Global Adherence Scale for Acute Conditions (GASAC): A prospective cohort study in two emergency departments.

BACKGROUND: Adherence in the context of patients with acute conditions is a major public health issue. It is neglected by the research community and no clinically validated generic scale exists to measure it. OBJECTIVE: To construct and validate a Global Adherence Scale usable in the context of Acute Conditions (GASAC) that takes into account adherence both to advice and to all types of prescriptions that the doctor may give. To measure adherence and to study its determinants. MATERIALS AND METHOD: We based the construction of the GASAC questionnaire on a theoretical model and a literature search. Then, between 2013 and 2014, we validated it in a prospective observational study in two hospital emergency departments. Patients were contacted by phone about one week after their consultation to answer several questionnaires, including GASAC and the Girerd self-administered questionnaire about medication adherence as a control. RESULTS: GASAC consists of four adherence subscales: drug prescriptions; blood tests/ radiography prescriptions; lifestyle advice and follow-up instructions. An analysis of the 154 sets of answers from patients showed that the GASAC drug subscale had satisfactory internal coherence (Cronbach's alpha = 0.78) and was correlated with the Girerd score, as was GASAC as a whole (p<0.01). The median score was 0.93 IQR [0.78-1] for a maximum value of 1 (n = 154). In multivariaable analysis, infection was more conducive of good adherence (cut off at ≥ 0.8; n = 115/154; 74.7% [67.0-81.3]) than trauma (OR 3.69; CI [1.60-8.52]). The Doctor-Patient Communication score (OR 1.06 by score point, CI [1.02-1.10]) also influenced adherence. CONCLUSIONS: GASAC is a generic score to measure all dimensions of patient adherence following emergency departments visits, for use in clinical research and the evaluation of clinical practice. The level of adherence was high for acute conditions and Doctor-Patient Communication was a major determinant of adherence.