No evidence of clinical efficacy of oxomemazine in cough, according to a systematic review.

PURPOSE: Cough is a prevalent symptom driving patients to seek medical attention in general practice. Despite its widespread use, the clinical efficacy of oxomemazine, the second most reimbursed molecule in France for symptomatic cough treatment, remains uncertain. This study aims to systematically evaluate the clinical efficacy of oxomemazine in cough. METHODS: A systematic literature review with meta-analysis of randomized controlled trials (RCTs) was conducted according to the Rebuild the Evidence Base (REB) protocol. Clinical trials comparing the efficacy of oxomemazine versus placebo or active comparator in cough were searched for. Trials with insufficient data were excluded. Searches were conducted across major databases (Medline, Cochrane Central Register of Controlled Trials, and Embase) and trial registries (World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov). RCTs comparing oxomemazine versus placebo or active comparators in cough were sought. Risk of bias was assessed using the Cochrane Collaboration's RoB2 tool. The protocol was preregistered on PROSPERO under the number CRD42022345496 (15). This study received no funding. RESULTS: No RCTs were at low risk of bias. Therefore, no meta-analysis was conducted, in accordance to the pre-specified protocol. CONCLUSIONS: This systematic review highlights the lack of evidence regarding the efficacy of oxomemazine in cough treatment and underscores the need for further well-designed clinical trials to inform its clinical utility in primary care settings.

What competencies are needed to develop collaboration between general practitioners and pharmacists through initial interprofessional training? An analysis of training needs through a qualitative occupational didactic approach.

BACKGROUND: Collaborative practice in primary health care increases care quality and security. In France, primary health care professionals increasingly work together. The link between general practitioners (GPs) and community pharmacists (CPs) is an important element. Nevertheless, effective collaboration between GPs and CPs is difficult to develop and formalize. Interprofessional education has been identified as a necessary step to prepare "collaborative practice-ready professionals". We aimed to identify the interprofessional training needs of last-year GP and CP students to develop interprofessional collaborations. METHOD: We conducted an analysis of training needs using a method inspired by occupational didactics. We collected data through individual semidirective interviews with CPs and GPs in 2022. At each stage we aimed to identify the elements of the occupational didactics to deduce the training needs in the form of a frame of reference: apparent competencies, emblematic situations and acting characteristics. We conducted an initial deductive thematic analysis to identify the apparent competencies of the two professions, the emblematic situations in which these competencies are used, and the acting characteristics used in these situations. We made an inductive categorization to define the collaborative competence and the families of situations and to model the actions of this GP-CP collaboration. RESULTS: We defined the competency "to collaborate effectively in an interprofessional setting in order to respond to care issues in one's territory" expressed in various professional situations. We described it by three capacities based on two interacting dynamics: one-off exchanges and structured collaborations. Various communication tools facilitate the implementation of these interactions. We modeled the actions of the GP-CP collaboration in the form of a conceptual map. CONCLUSION: The collaboration between the CP and the GP implements a competency that could be integrated into their professional referential. This competency, entitled "collaborating effectively in interprofessional settings to respond to care issues in one's territory", is expressed in a variety of professional situations. It is based on two parallel and interacting dynamics: one-off exchanges and a dynamic of lasting collaboration. This study thus lays the groundwork for the development of this collaborative skill among general practice and pharmacy residents.

Patients' acceptance of less blood pressure measurement in consultation: a cross-sectional study in general practice.

PURPOSE: Blood pressure (BP) is measured at almost every general practitioner (GP) consultation in the region of Auvergne, France. A 2018 qualitative study shows that GPs measure BP to satisfy patients, whereas patients declare themselves indifferent to the absence of the measurement. The objective was to validate the results of a qualitative study, to quantitatively assess patient satisfaction when BP is not measured, and to study the factors associated with the degree of patient satisfaction. METHODS: This was a quantitative observational study conducted using self-questionnaires among patients in medical practices in Auvergne. RESULTS: Four hundred and ninety-two questionnaires were evaluated in 20 medical practices. Sixty percent of patients had indifferent or favorable feelings in the absence of BP measurement. In bivariate analysis, young age, male sex, absence of pathology, and low frequency of visits were associated with indifferent or favorable feelings in the absence of BP measurement. In multivariable analysis, a history of hypertension and psychiatric history were associated with unfavorable feelings. The intraclass correlation coefficient for practice-related variability was 5.6%. Patients' susceptibility to having particularly favorable or unfavorable feelings could be related to their GP (physician effect). CONCLUSION: The hypothesis put forward in the qualitative study is confirmed: the majority of patients are in favor of or indifferent to the absence of BP measurement in general practice. General practice could be more efficient by measuring BP less frequently and better.

Benefits and adverse effects of ACE inhibitors in patients with heart failure with reduced ejection fraction: a systematic review and meta-analysis.

PURPOSE: Angiotensin-converting enzyme (ACE) inhibitors are part of first-line treatment for reduced ejection fraction heart failure (HFrEF). The aim was to assess the benefits and adverse effects of ACE inhibitors in HFrEF with a focus on important patient outcomes. METHODS: A systematic review of double-blind randomized clinical trials (RCTs) and comparison of ACE inhibitors versus placebo, in HFrEF patients published in French or English. Searches were undertaken of Medline, Cochrane Central, and Embase. The primary outcomes were all-cause mortality and adverse events. RESULTS: From 636 articles analysed, 11 were included (13,882 patients). For all-cause mortality (5 RCTs, 9277 patients), the number needed to treat (NNT) to avoid one death at 6 months was 50 (33-107). The NNT to prevent one death at 12 months (6 RCTs, 13,016 patients) was 63 (35-314). Under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the evidence was of moderate quality. The number needed to harm was 12 (10-15) for cough, 20 (14-31) for hypotension, 23 (17-36) for dizziness, 31 (23-47) for hyperkalaemia, and 49 (30-121) for increased creatinine levels. The quality of evidence was moderate for these criteria except for cough (low quality of evidence). CONCLUSION: This review focuses on clinical elements necessary in a shared decision-making process. In practice, general practitioners will be able to use these data to discuss ACE inhibitor treatment with HFrEF patients. This study was registered in the PROSPERO registry under the reference number CRD42018096930.

Correction to: Efficacy of phloroglucinol for the treatment of pain of gynaecologic or obstetrical origin: a systematic review of literature of randomised controlled trials.

The correct presentation of the Author names are shown in this paper.

Precipitating factors of heart failure decompensation, short-term morbidity and mortality in patients attended in primary care.

OBJECTIVE: To evaluate the precipitating factors for heart failure decompensation in primary care and associations with short-term prognosis. Design Prospective cohort study with a 30-d follow-up from an index consultation. Regression models to determine independent factors associated with hospitalisation or death. SETTING: Primary care in ten European countries. Patients Patients with diagnosis of heart failure attended in primary care for a heart failure decompensation (increase of dyspnoea, unexplained weight gain or peripheral oedema). MAIN OUTCOME MEASURES: Potential precipitating factors for decompensation of heart failure and their association with the event of hospitalisation or mortality 30 d after a decompensation. RESULTS: Of 692 patients 54% were women, mean age 81 (standard deviation [SD] 8.9) years; mean left ventricular ejection fraction (LVEF) 55% (SD 12%). Most frequently identified heart failure precipitation factors were respiratory infections in 194 patients (28%), non-compliance of dietary recommendations in 184 (27%) and non-compliance with pharmacological treatment in 157 (23%). The two strongest precipitating factors to predict 30 d hospitalisation or death were respiratory infections (odds ratio [OR] 2.8, 95% confidence interval [CI] (2.4-3.4)) and atrial fibrillation (AF) > 110 beats/min (OR 2.2, CI 1.5-3.2). Multivariate analysis confirmed the association between the following variables and hospitalisation/death: In relation to precipitating factors: respiratory infection (OR 1.19, 95% CI 1.14-1.25) and AF with heart rate > 110 beats/min (OR 1.22, 95% CI 1.10-1.35); and regarding patient characteristics: New York Heart Association (NYHA) III or IV (OR 1.22, 95% CI 1.15-1.29); previous hospitalisation (OR 1.15, 95% CI 1.11-1.19); and LVEF < 40% (OR 1.14, 95% CI 1.09-1.19). CONCLUSIONS: In primary care, respiratory infections and rapid AF are the most important precipitating factors for hospitalisation and death within 30 d following an episode of heart failure decompensation. Key points Hospitalisation due to heart failure decompensation represents the highest share of healthcare costs for this disease. So far, no primary care studies have analysed the relationship between precipitating factors and short term prognosis of heart failure decompensation episodes. We found that in 692 patients with heart failure decompensation in primary care, the respiratory infection and rapid atrial fibrillation (AF) increased the risk of short-term hospital admission or death. Patients with a hospital admission the previous year and a decompensation episode caused by respiratory infection were even more likely to be hospitalized or die within 30 d.

Efficacy of vitamin C for the prevention and treatment of upper respiratory tract infection. A meta-analysis in children.

PURPOSE: Upper respiratory tract infection (URTI) is a common infection in children, generally caused by viral respiratory infection. Vitamin C is currently proposed as prophylaxis for URTI. The purpose of this study was to assess the effectiveness of vitamin C administration in children for the prevention and reduced duration of URTI through a systematic literature review. METHODS: Review of the literature conducted between October 2017 and January 2018 in the main medical databases (CENTRAL, Medline and Embase) and by a gray literature approach. The selection criteria were: double-blind randomized controlled trials (RCTs) comparing vitamin C use to placebo in children aged 3 months to 18 years without chronic infection. Efficacy was assessed in terms of incidence, duration and severity of symptoms of URTI. A meta-analysis was conducted where possible. RESULTS: Eight RCTs, including 3135 children aged 3 months to 18 years, were selected. Quantitative analysis showed no difference between vitamin C administration and placebo (odds ratio = 0.75, 95% CI [0.54-1.03], p = 0.07, I2 = 74%). Vitamin C administration was found to decrease the duration of URTI by 1.6 days (standardized mean differences = -0.30 [-0.53; -0.08], p = 0.009, I2 = 70%). Children under 6 years of age benefit from more effective vitamin C supplementation associated with echinacea. No serious adverse events were reported. CONCLUSIONS: Although no preventive effects were found, vitamin C intake reduced the duration of URTI. Considering the frequency of URTI, the inappropriate prescription of antibiotics, and the safe nature of vitamin C, its supplementation is justified, especially in children under 6 years of age and those who present a high frequency of URTI. There is a sound rationale for further trials with greater statistical power among children of this age.

Efficacy of acetylleucine in vertigo and dizziness: a systematic review of randomised controlled trials.

PURPOSE: To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness). METHODS: Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and ClinicalTrials.gov databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo. RESULTS: Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness. CONCLUSION: There is no solid evidence of the efficacy of acetylleucine in vertigo/dizziness. Given its frequent prescription and the cost generated for the French social security system, high-quality randomised trials should be carried out to assess its efficacy.

Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo.

AIM: Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo. METHODS: A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint. Studies concerning obstetric or gynaecologic-related pain were not included. RESULTS: Three RCT were included and then analysed for risk of bias and meta-analysed. Only one RCT found that phloroglucinol was superior to placebo, although with a high risk of bias. The meta-analysis found a risk ratio of 1.10 (95% CI 0.95, 1.27) with no statistical significance. DISCUSSION: There is insufficient data to justify the wide-spread prescription of phloroglucinol for alleviating abdominal pain.

How are patients with heart failure treated in primary care?
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OBJECTIVE: The aim of this study was to assess the adherence of general practitioners (GPs) to guidelines in patients with heart failure with reduced ejection fraction (HFrEF) and to describe GPs' prescribing behavior regarding patients with heart failure with preserved ejection fraction (HFpEF). MATERIALS AND METHODS: Cross-sectional study as part of the ETIC trial. Five classes of drugs were described: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs); ß-blockers (BBs); mineralocorticoid receptor antagonists (MRAs); diuretics (thiazide or loop diuretics); and digoxin. RESULTS: 178 patients were studied: their mean age was 73.5 years (± 10.6). Of the 128 patients with HFpEF, 81.3% received ACEIs or ARBs, 63.3% received BBs, 13.3% received MRAs, 75.8% received diuretics, and 12.5% received digoxin. Of the 50 patients with HFrEF, 84% received ACEIs or ARBs, 74% received BBs, 20% received MRAs, 76% received diuretics, and 2% received digoxin. 25% of the patients were given a drug in accordance with the recommendations for drug class but not a drug authorized for the HFrEF indication. Among the patients with HFrEF who were treated in accordance with the recommendations, target doses were achieved in 1/3 given ACEIs/ARBs, 1/4 given BBs, and 1/2 given MRAs. Only 6% of the patients had a perfect Global Adherence Indicator-3 (GAI-3) with all target doses achieved. CONCLUSION: Several drugs were prescribed even though they were not recommended, and few patients were treated optimally. It seems to be necessary to develop a pragmatic tool to help GPs and cardiologists in optimizing treatment.
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Cannabis and Young Users-A Brief Intervention to Reduce Their Consumption (CANABIC): A Cluster Randomized Controlled Trial in Primary Care.

PURPOSE: Brief intervention to reduce cannabis is a promising technique that could be adapted for use in primary care, but it has not been well studied in this setting. We tested the efficacy of a brief intervention conducted by general practitioners among cannabis users aged 15 to 25 years. METHODS: We performed a cluster randomized controlled trial with 77 general practitioners in France. The intervention consisted of an interview designed according to the FRAMES (feedback, responsibility, advice, menu, empathy, self-efficacy) model, while the control condition consisted of routine care. RESULTS: The general practitioners screened and followed up 261 young cannabis users. After 1 year, there was no significant difference between the intervention and control groups in the median number of joints smoked per month among all users (17.5 vs 17.5; P = .13), but there was a difference in favor of the intervention among nondaily users (3 vs 10; P = .01). After 6 months, the intervention was associated with a more favorable change from baseline in the number of joints smoked (-33.3% vs 0%, P = .01) and, among users younger than age of 18, smoking of fewer joints per month (12.5 vs 20, P = .04). CONCLUSIONS: Our findings suggest that a brief intervention conducted by general practitioners with French young cannabis users does not affect use overall. They do, however, strongly support use of brief intervention for younger users and for moderate users.

Quality of qualitative studies centred on patients in family practice: a systematic review.

BACKGROUND: Qualitative research is often used in the field of general medicine. Our objective was to evaluate the quality of published qualitative studies conducted using individual interviews or focus groups centred on patients monitored in general practice. METHODS: We have undertaken a review of the literature in the PubMed and Embase databases of articles up to February 2014. The selection criteria were qualitative studies conducted using individual interviews or focus groups, centred on patients monitored in general practice. The articles chosen were analysed and evaluated using a score established from the Relevance, Appropriateness, Transparency and Soundness (RATS) grid. RESULTS: The average score of the 52 studies chosen was 28 out of 42. The criteria least often present were the description of the patients who chose not to participate in the study, the justification of the end of data collection, the discussion of the influence of the researchers and the discussion of the confidentiality of the data. The criteria most frequently described were an explicit research question, justified and in relation to existing knowledge, the agreement of the ethical committee and the presence of quotations. The number of studies and the score increased from year-to-year. The score was independent of the impact factor of the journal. CONCLUSIONS: Even though the qualitative research was published in reviews with a low impact factor, our results suggest that this research responded to the quality criteria of the RATS grid. The evaluation scored using RATS could be useful for authors or reviewers and for literature reviews.

Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial.

BACKGROUND: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care. RESULTS: This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively. CONCLUSIONS: Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary. TRIAL REGISTRATION: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov ( REGISTRATION NUMBER: NCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé; REGISTRATION NUMBER: 2009-A01142-55).

Attitudes of family physicians towards adolescent cannabis users: a qualitative study in France.

BACKGROUND: GPs are the health professionals most frequently consulted by adolescents. However, discussion between GPs and adolescents regarding cannabis use does not occur spontaneously. OBJECTIVE: To identify obstacles to the identification and management of cannabis use by adolescents based on GPs' experiences. METHODS: We conducted a qualitative study using focus groups of GPs from the Auvergne area (France). The GPs were selected according to descriptive and strategic variables. Three researchers--an anthropologist, a psychiatrist with expertise in addiction and a GP--performed a thematic analysis. RESULTS: Twenty-four GPs participated in three consecutive focus groups. The GPs were aware of the health risks of cannabis, yet ambivalent about its use by adolescents. The GPs also reported a lack of patient questioning during consultation. The obstacles to the identification and treatment of cannabis use by adolescents identified included lack of GP knowledge about cannabis (e.g. consumption patterns and laws); difficulties in addressing the issue with adolescents, evaluating adolescents' consumption and its impact and proposing support and follow-up and the presence of parents. The GPs were aware that their role lies at the intersection between the medical, personal, familial and social fields. CONCLUSION: Despite these barriers, GPs are willing to ask adolescents about their cannabis use. An adolescent's awareness, environment and receptiveness favour a sustainable therapeutic relationship. Brief intervention is a tool that may be of assistance in this relationship and allow GPs to take the initiative.

Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial.

BACKGROUND: Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care. METHODS: A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs. DISCUSSION: This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training. TRIAL REGISTRATION: ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].

Prescription-free consultation in France and Europe: Rates' evolution, physicians' and patients' perceptions from 2005 to 2019, a systematic review.

BACKGROUND: In 2005, the rate of prescription-free consultations in Europe varied widely: 57% in the Netherlands, 28% in Germany, 17% in Spain and 10% in France. OBJECTIVES: To assess the number of prescription-free consultations in European countries since 2005 and to analyse the perceptions of patients and general practitioners (GPs). METHODS: This was a systematic review of the literature from 2005 to 2019, including both quantitative and qualitative studies on prescription-free consultations. RESULTS: Of 13,380 studies, 28 were included. The rates of prescription-free consultations were 30% in Belgium, 41% in Slovenia, 47% in the UK and 22% in France, according to the most recent figures. Swedish GPs estimated their prescription-free consultation rate at 70%. The only significant factor that decreased the number of prescription-free consultations was laboratory visits. According to the qualitative data, the main constraint was lack of time; the main facilitating factor was a shared medical decision. CONCLUSION: Medical visits decreased the number of prescription-free consultations. According to qualitative studies, the main barrier was lack of time. The countries with the highest drug consumption levels were those with the lowest number of prescription-free consultations. Achieving prescription-free consultations to combat overmedication and for the quality of care and the environment is a priority. To understand and analyse consultations without prescriptions, a quantitative observational study was launched in France in 2020.

Prescription-free consultation: A cross-sectional study in general practice.

PURPOSE: In 2005, 10% of consultations in France ended without a prescription. In 2019, a review of the literature found 30 to 70% of prescription-free consultations in Northern Europe and 10 to 22% in Southern Europe and underlined the scarcity of quantitative data. Different factors contribute to this heterogeneity, such as product availability and status, modes of management, distribution channels, clinical practice recommendations, public policies targeting certain classes, etc. The main objective of our study was to quantify the rate of prescription-free consultations in general practice in France in 2021. The secondary objective was to characterize prescription-free consultations and analyze their determinants. METHODS: This was a quantitative observational study conducted using self-questionnaires among patients in medical practices in Auvergne. RESULTS: Out of 540 questionnaires, the rate of prescription-free consultations was 24% (95% CI [20.11-27.41]). Prescription-free consultations were for prevention, administrative problems, and gestures. The limiting factors are "feeling a need for a medication" (OR=0,006), "not knowing if a medication is needed" (OR=0.11) and "consultations for acute reasons" (OR=0.33). CONCLUSION: Acute consultations limit prescription-free consultations. General practitioners (GPs) probably overestimate patients' expectation of drug prescription. The French GP must be supported in their decision to not prescribe drugs. This is a long-term investment of time, to educate patients and avoid new consultations for acute reasons. A tool to help doctors manage non-prescription during acute consultations will be created in a future study in France.

Pediatric pharmaceutical interventions in self-medication: a descriptive study in community pharmacies.

BACKGROUND: The practice of self-medication is common but not without risk, especially for vulnerable populations such as the pediatric population. Community pharmacists have an important role of vigilance in dispensing drugs available without a medical prescription, with the possibility of carrying out a Pharmaceutical Intervention (PI) if necessary. The aim of our study was to characterize the Pediatric Pharmaceutical Interventions (PPIs) in self-medication carried out during a spontaneous request for a drug at the community pharmacy. METHODS: We conducted a descriptive study in 139 pharmacies in the Auvergne-Rhône-Alpes region (France). Data were collected from students under the supervision of internship masters in the pharmacy, using the validated GIPAMED (GrId for PhArmaceutical Self-MEDication interventions) notification grid, the first week of each month, from February to May for five years (2017 to 2021). Collected data were entered on a secure university platform. RESULTS: Of the 3,552 PIs collected, 8,3% (n = 286) were PPIs. Of these PPIs, 35% (n = 100) was generated by requests for optional prescription drugs contraindicated by the pathophysiological condition, 28.3% for drugs requiring a prescription and 20.6% for over the counter drugs not indicated by the symptomatology. Finally, 10% of requests required a referral for a medical consultation. Four Anatomical Therapeutic Chemical (ATC) classes accounted for more than 90% of the requests: respiratory system (39.5%), alimentary tract and metabolism (19.2%), nervous system (11.5%), and musculoskeletal system (10.8%). The most common drugs generating PPIs were: ibuprofen, oxomemazine and combination camphor/essential oils, mainly due to age-related or weight-related contraindication. Paracetamol also generated PPIs frequently, mainly due to problems with drug compliance and more precise infra-therapeutic doses. When these PPIs were dispensed, the pharmacist's proposed solutions were accepted in 94.8% (n = 271) of the cases. CONCLUSIONS: The community pharmacist has an important role in providing information about medicines and their correct use to patients. Our research shows that this attention benefits vulnerable populations, such as children, even for drugs that are widely used (e.g. paracetamol and non-steroidal anti-inflammatory drugs) or active substances for which there are age-related or weight-related contraindications (e.g. antitussives, camphor combinations).

Project rebuild the evidence base (REB): A method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.

Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomised clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment based on patient-important outcomes. The aim of project rebuild the evidence base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome: 1) a meta-analysis based on RCTs with a low risk of bias overall; 2) an evaluation of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorized in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting RCTs and their meta-analysis to produce quality data for general practitioners to focus on risk-benefit assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.