[IMPACTCHIMIO: Development and multicentric validation of a tool for collecting pharmaceutical interventions carried out within chemotherapy reconstitution units]. / IMPACTCHIMIO : élaboration et validation multicentrique d'un outil de recueil des interventions pharmaceutiques réalisées au sein des unités de reconstitution de chimiothérapies.

OBJECTIVES: To develop and validate prospectively a specific tool for pharmaceutical interventions performed in centralized cytotoxic preparation units. METHODS: A pharmaceutical intervention is defined as a type of intervention performed in relation to a problem encountered. ImpactChimio is derived from the Act-IP® (SFPC) tool. The initial version (version 1) was developed from the pharmaceutical interventions collected over 1 year by the pilot centre. Its validation was carried out by the Delphi method via a prospective multicentric collection to assess its robustness (real life pharmaceutical interventions) and reproducibility (50 pharmaceutical interventions classified by pharmacists naive or not to the tool and study of classification divergences). RESULTS: The development of the tool (version 1) was based on the analysis of 412 pharmaceutical interventions. For its validation, 196 pharmaceutical interventions were provided by 6 centers for 5 months. The changes have been incorporated into the new versions of the tool (version 2 and version 3). Six naive and six non-naive pharmacists then tested reproducibility by reclassifying 50 selected pharmaceutical interventions into version 3. A total of 136 discrepancies (11.3 %) were found out of 1200 responses: 66 related to the problem encountered and 70 to the type of intervention. No statistically significant differences were found between naive and non-naive pharmacists. CONCLUSIONS: ImpactChimio is the first pharmaceutical interventions' specific tool for centralized cytotoxic preparation units, developed and validated by a multicentric study using the Delphi method. It makes possible to enhance the value of the analysis activity and to identify training areas for the teams.

Risk evaluation of the use of complementary and alternative medicines in cancer.

INTRODUCTION: Cancer patients use complementary and alternative medicines (CAM) to improve their well-being. Little is known about real risks. OBJECTIVE: To highlight 3 different types of axes: 1/cancer patients' perceptions concerning CAM; 2/misinformation/miscommunication about CAM; 3/CAM toxicity (direct toxicity, CAM-anticancer drugs, CAM-cancer interactions). METHOD: A questionnaire was proposed to cancer patients for 2 months. The CAM toxicity was analyzed if patients documented their drugs and CAM. RESULTS: Eighty-five patients responded: 72/85 were taking≥1CAM. In total, 95% patients were satisfied. There was an increasing CAM intake after cancer diagnosis. One hundred and seventeen different CAM were identified (63 herbs, 24 essential oils, 28 food supplements, 2 homeopathic specialities). Only 30/85 were aware CAM could interact with anticancer drugs. No other type of risk was perceived. INFORMATION SOURCES: 43/85 Internet, 38/85 general practitioner, 38/85 community pharmacist, 32/85 entourage, 25/85 other patients, 22/85 oncologist. In total, 81.3% questioned healthcare professionals (HCP) about CAM. Twelve patients noticed HCP lacked knowledge regarding CAM. The toxicity analysis was carried out for 24 patients who consumed 1 to 24CAM. In total, 133CAM were reported, including 87 different CAM. For only 43CAM/87, studies were found. All patients presented≥1risk: 14 at risk of CAM-cancer interactions, 15 of CAM-anticancer drug interactions, 21 of CAM direct toxicities. CONCLUSION: Many CAM are used by patients. The diagnosis of cancer favors their use. The risks are manifold: low perception of risk that can be induced by CAM, diverse and insecure sources of information and many potential toxicities that are not scientifically documented.

Prevalence and pathogenicity of binary toxin-positive Clostridium difficile strains that do not produce toxins A and B.

Clostridium difficile causes antibiotic-associated diarrhoea and pseudomembranous colitis. The main virulence factors of C. difficile are the toxins A (TcdA) and B (TcdB). A third toxin, called binary toxin (CDT), can be detected in 17% to 23% of strains, but its role in human disease has not been clearly defined. We report six independent cases of patients with diarrhoea suspected of having C. difficile infection due to strains from toxinotype XI/PCR ribotype 033 or 033-like, an unusual toxinotype/PCR ribotype positive for CDT but negative for TcdA and TcdB. Four patients were considered truly infected by clinicians and were specifically treated with oral metronidazole. One of the cases was identified during a prevalence study of A(-)B(-)CDT(+) strains. In this study, we screened a French collection of 220 nontoxigenic strains and found only one (0.5%) toxinotype XI/PCR ribotype 033 or 033-like strain. The description of such strains raises the question of the role of binary toxin as a virulence factor and could have implications for laboratory diagnostics that currently rarely include testing for binary toxin.