[Study impacto: Descriptive analyzis of pharmacist's clinical practice in onco-hematology]. / Étude impacto : analyse descriptive des pratiques de pharmacie clinique en cancérologie.

Pharmaceutical analyses of chemotherapy prescriptions by hospital pharmacists are activities codified by regulation and rules (bon usage). The involvement of the pharmacists in clinical pharmacy activities in the oncology setting is not clearly identified, justifying the development of a mapping of these activities from a questionnaire addressed to the professionals. One hundred and seven centers have participated to this study at the national level (overall participation rate of 32.4%). More than 95% of them used a computerized ordering system and three quarter of them submit the introduction of new compounds to an analysis by the drug therapeutic committee. Prescription analysis allowed detecting around 2% of errors from the current prescription. Clinical pharmacist participates to tumor boards of onco-hematology (RCP) at a level of 46% for senior pharmacist and 42% for junior pharmacist. This involvement in the RCP allowed anticipating protocol's modification and temporary used authorization. Ninety-two percent of the senior pharmacists estimate that they highlight the risk of no reimbursement for prescription out of the guideline during RCP, resulting to a modification of the prescription for 40% of them. This level of intervention is lower with respectively 64% and 10% for the juniors. This study underlines the expert value of the clinical pharmacist dedicated to oncology setting in pre and post analysis prescriptions. It could be targeted by a prospective analysis of both clinical and pharmacoeconomics impact of these interventions.

[The PICC line, a new approach for venous access]. / Le PICC line, une nouvelle stratégie dans l'accès veineux.

Peripheral Inserted Central Catheter (PICC) line is a peripherally inserted central catheter. This implantable medical device is placed into a peripheral vein of the arm in order to obtain an intravenous central access. This device can find its use in various applications like intravenous delivery of parenteral nutrition, anticancer agents and antibiotics, as well as for blood sampling. PICC line is not widely used in medical practice because it remains largely unknown. The aim of this review is thus to introduce PICC line to the medical and scientific community. First, we will approach its insertion and maintenance of the dressing. We will then detail the benefits and drawbacks associated with its use, and finally discuss its position with regards to the other central venous access available.

The PhaSeal® system: impact of its use on workplace contamination and duration of chemotherapy preparation.

PURPOSE: The primary objective of this study was to compare the levels of environmental contamination before and after the introduction of PhaSeal® (closed-system drug transfer device) in two hospital pharmacies. Our secondary objective was to assess the impact of the device on the duration of drug preparation compared to procedures involving the use of needles and syringes. METHODS: The study involved two French hospitals, which prepared antineoplastic chemotherapy using a biological safety cabinet and an isolator. Five skilled pharmacy technicians at each hospital prepared a total of 100 chemotherapy preparations using the standard procedure and 100 using the PhaSeal® system. To control for possible contamination occurring in the course of the procedure, we used fluorescein which becomes fluorescent when exposed to UV light. To reply the second objective, we timed the duration of the different steps of the manipulation. RESULTS: Our findings showed a major reduction in the contamination of the work environment when using the PhaSeal® system for drug preparation. Reduction rates higher than 93% were obtained, whatever the type of protection used. On the duration of preparation, our results indicate that this duration would be approximately 1 h longer for the preparation of 100 samples. CONCLUSION: In conclusion, this study clearly establishes the benefit of using PhaSeal® for protecting the staff members who work with hazardous agents. It also indicates that the duration of drug preparation is not impacted by the use of the system.

Alteration of the inner surface of venous catheters by antineoplastic drugs.

Septic complications and thrombosis are frequent causes of long-term venous catheter implantation failure and tend to occur more frequently in oncology than in patients using catheters for hyperalimentation only. The purpose of this in vitro study was to study extensively the inner surface behaviour and the possible changes in their mechanical properties of various silicone and polyurethane catheters after exposure to a flow of the most common antineoplastic drugs. Silicone catheters appeared to be the best choice for cytostatic drug infusions because of their chemical stability, but the addition of an opacifier imposes a protective inner and outer layer to improve their surface properties for biocompatibility.

Energy expenditure during allogeneic and autologous bone marrow transplantation.

Resting energy expenditure (REE) was measured by indirect calorimetry during allogeneic and autologous bone marrow transplantation in order to evaluate the evolution in allogeneic and autologous recipient patients. REE values obtained with indirect calorimetry and compared with values using the Harris-Benedict formula were different. Evolution of REE during aplasia were significantly different in autologous and allogeneic recipients with an increase 11.5 ' 10.8 cent for autologous and a decrease of - 7.3 ' 8.9 cent in allogeneic bone marrow transplantation (BMT) patients. There were no differences in nutritional status and REE before BMT, at discharge and 1 month after discharge between the two groups but all patients had inflicted damage on their nutritional status at discharge from hospital after BMT. However, these patients differed because of the decrease in oral nutritional intake and an increase in the length of aplasia and hospital stay in allogeneic patients. Currently, there is no proof that recommendations for nutritional interventions or results of nutritional investigations in allogeneic BMT can be extrapolated in autologous patients. Harris-Benedict formula does not estimate the energy expenditure of patients submitted to massive chemotherapy and BMT with enough precision because of the great differences in individuals.

[Morphine therapy: evaluation of patient information]. / Thérapeutique morphinique: évaluation de l'information des patients.

Pain is frequent in the course of cancer and can have negative consequences on patients quality of life. The great majority of patients can be helped by simple treatments. The prescription of morphine (M) must be preceded by some explanations. In order to verify the reality of these explanations, a study was done in a 230 comprehensive beds Cancer Centre, with 129 patients, randomized between all the patients hospitalized. In an open questionnaire, different aspects were studied. One hundred answers were studied: 63 patients did not have M at any time: group M-; 37 patients had M (19) or have had M (18): group M+; 97% of the patients in group M+ thought that M decreased pain, for 85% patients in group M-. Morphine treatment was effective in 92% of patients M+, and not very effective in 5%; 67% of patients M- thought that M is efficient but 17% did not know; 76% of patients M+ did not worry about M; 13% worried et 11% did not know. For patients M- only 48% did not worry; 41% worried and 11% did not know. The side effect known by the patients, and spontaneously quoted were constipation (12 patients in M+ group). For 14 patients there was no problem and 2 did not know. In M- group 49 patients did not know. Only 8% of M+ group were afraid by addiction, but 44% in group M-; 97% patients M+ said that they could stop without problem against only 38% of the patients in M- group. For 16% of M+ group, the use of M had a bad signification about their disease, but 52% of M- group thought that if morphine was used in their cases, the meaning would be very bad. The differences between the two groups allow to think that the prescription of M in this study is explained, and that the patients receiving M are rather well informed. Patients with cancer but without M do not have good information and their knowledge is similar than general population. The use of recommended therapy and explanations allowed patients with M therapy to be comfortable with this prescription.

[Incidence of nosocomial infections in an cancer center: clinical and bacteriologic data]. / Incidence des infections nosocomiales dans un centre anticancéreux: données cliniques et bactériologiques.

Over a 5 month period, a study of the incidence of nosocomial infections (NI) was carried out in the Léon Bérard Oncology Center (Lyons). It comprised 1,551 patients classified in groups according to the site of origin of the underlying malignancy. The respective frequency of the different types of nosocomial infections and the responsible agents was evaluated in each group and the incidence was calculated per day of hospitalization. The overall incidence of NI was 11.29 per 1,000 patient-days, with a maximal value of 20.04 for patients suffering from lymphomas. The most frequently encountered infections were bacteremias (22.7%), followed by urinary tract infections (20.8%) and wound infections (20.5%). The most frequent causative agents of NI were Escherichia coli (25.8%), Pseudomonas aeruginosa (13.9%), Staphylococcus aureus (9.8%) and Staphylococcus epidermidis (9.8%). The latter micro-organism together with Escherichia coli were the most frequent causative agents of bacteremias. Even though cancer patients are particularly prone to developing infections, the incidence of NI could be reduced thanks to a program of control and surveillance of infectious episodes during hospitalization.

[Huriet law: application in a regional cancer centre (Centre Léon-Bérard, Lyon)]. / Loi Huriet: bilan d'application dans un centre régional de lutte contre le cancer (centre Léon-Bérard, Lyon).

Clinical research is one of the main activities in cancer centres and is submitted in France to a specific law (named "loi Huriet") which includes good clinical practices. We are now conducting a general program of quality evaluation and improvement in the regional cancer centre of Lyon (centre Léon-Bérard). Part of this program is an audit of the application of the Huriet law. Since no instrument exist for measuring this application, we have created a specific one, that attribute notation according to the different aspects of the law. Results show a good level of conformity but sometime non sufficient. There is no difference between the two studied years. Quality changes according to promoters (private or academic) and monitoring. Written procedures and specific training for the different actors are required to improve quality of clinical research with focus on the patient interest.

[Analysis of hematopoietic growth factor prescriptions in 19 french cancer centers]. / Analyse de la prescription de facteurs de croissance hématopoïétique dans 19 centres anticancéreux français. Groupe de pharmaciens de la Fédération nationale des centres de lutte contre le cancer.

Medical prescription of hematopoietic growth factors (HGF) was analysed in 19 anticancer french centers during 2 months. About 4% of anticancer chemotherapeutic cycles prescribed during this period were supported by HGF prescription. The mean duration of treatment was 8 days. Among the 755 collected prescriptions, two tumor localizations represented about 50% of the prescriptions: malignant non Hodgkin lymphomas and breast cancer. The other main localizations concerned adult or pediatric soft tissue sarcomas (18%), testicular cancer (7%) and gynecologic tumors (6%). The prescription for primary prophylaxis for febrile neutropenia remains the main use of HGF (44%). The respect of the guidelines established by the F|d|ration nationale des centres de lutte contre le cancer was analyzed. Overall, 66% of the prescriptions were in adequation with these guidelines. Whereas the consommation of HGF decreased in the 19 considered institutions, it did not reach a plateau and could decrease in institutions which are awaked to the international and national recommendations.

[Necessary harmonization of health cost assessment. Autologous peripheral blood progenitor cell transplantation in France]. / Vers une nécessaire harmonisation des évaluations de coûts en santé

BACKGROUND: The purpose of this study was to determine to what extent methods used to assess health cost affect the total cost of a therapeutic procedure. METHOD: We assessed total cost of 160 consecutive therapeutic intensification procedures using autologous blood progenitor cell transplantation, 95 for lymphoma and 65 for breast tumor. RESULTS: The average total cost of the therapeutic intensification for patients with lymphoma was 227156 francs (34630 euros), including 60720 francs (9257 euros) for mobilization, 14947 francs (22402 euros) for the treatment period and 19489 francs (2971 euros) for secondary hospitalization. The average total cost for patients with a breast tumor was 199626 francs (30433 euros), including 39269 francs (5987 euros) for mobilization, 14912 francs (22737 euros) for the treatment period, and 11215 francs (1709 euros) for secondary hospitalization. CONCLUSION: We compared our findings with those from six earlier French studies. Differences in the methodologies used focuses attention on the need for incentives for better harmonization of health cost assessment.

[Polyurethane catheters and antineoplastic chemotherapy. An experimental study]. / Cathéters en polyuréthane et chimiothérapie antinéoplasique. Etudeexpérimentale.

An in vitro study of the effect of cytotoxic drugs on polyurethane catheters was carried out. The drugs used--vincristine, doxorubicin, cisplatin and carmustine--damage the surface of silicone elastomer catheters. The irregularities produced seem to be preferential sites for thrombus formation and adhesion of bacterial microcolonies. Electron microscopy examination of the catheters dipped in the drug solutions for different time intervals revealed the appearance of different patterns of damage. The irregularities produced seemed to be less pronounced than for silicone catheters. Polyurethane was highly sensitive to doxorubicin. These changes could well have clinical repercussions. The compatibility of catheters and drugs should be routinely tested before being put on the market.

[Surface changes of intravenous catheters after antineoplastic chemotherapy]. / Modifications de surface des cathéters veineux après chimiothérapie antinéoplasique.

During long-term venous catheter implantation, septic and thrombotic complications are quite frequent. In the case reported, the failure of systemic and local antibiotic therapy during repeated septicaemia due to Bacillus cereus at the time of intensive chemotherapy led to a scanning electron microscopy study of the used silicone catheter. There were marked changes of the inner surface with a lot of cellular remains, in contrast with the usual non thrombogenic property of the silicone. An in vitro study was carried out with antitumour agents. Duration of exposure and drug concentration were identical to those used in in vivo perfusions. There were marked changes of the inner surface, which could lead to important modifications of the properties of the silicone. The damage depended on the drug. Silicone was slightly sensitive to vicristin and carmustin, but highly sensitive to cisplatin and doxorubicin. The compatibility of catheter material with the drugs used, especially for oncologic chemotherapy, must be tested systematically.

[Standards, options, and recommendations for the use of hematopoietic growth factors in oncology]. / Standards, options, recommandations pour l'utilisation des facteurs de croissance hématopoïétique en cancérologie.

Four hematopoietic growth factors have marketing approval in France: filgrastime (G-CSF), malgraostime (GM-CSF), lenograstime (glycolysated G-CSF) and erythropoietin. A standards, options and recommendations document has not yet been established for erythropoietin which is excluded from this report. Administration of hematopoietic growth factors can be proposed in five clinical situations: primary prophylaxis, secondary prophylaxis, curative care, after myeloablative chemotherapy and hematopoietic stem cell grafting, and finally mobilization of peripheral stem cells. Primary prophylaxis: excepting therapeutic trials, the use of hematopoietic growth factors is recommended for clinical situations where a significant incidence of neutropenia with fever has been reported in randomized trials and in rare cases where there is an increased risk of severe infectious complications. Hematopoietic growth factors are indispensable for increasing the quality of cytapheresis peripheral stem cell harvesting.

[Hemoperfusion on charcoal and hemodialysis in acute poisoning caused by methotrexate]. / Hémoperfusion sur charbon activé et hémodialyse dans l'intoxication aiguë au méthotrexate.

Acute methotrexate intoxication occurred in 4 patients despite adequate alkaline hyperhydration and classical folinic acid rescue. Three of these patients had no previous risk factor. Charcoal haemoperfusion with haemodialysis was promptly instituted and the methotrexate blood levels rapidly decreased, avoiding further renal damage and multisystemic involvement. Chemotherapy could subsequently be performed in 3 of the 4 patients without delay and toxicity. Charcoal haemofiltration appears to be an excellent treatment of methotrexate intoxication.

[Aprepitant for the prevention of cisplatine induced nausea and vomiting: an observational study]. / Aprépitant pour la prévention des nausées et vomissements induits par une chimiothérapie à base de cisplatine: étude observationnelle.

Aprepitant is actually recommended in the prevention of nausea and vomiting induced by high emetic risk chemotherapy using cisplatin. We performed an observational prospective study on 101 patients evaluating the efficacy of aprepitant in the clinical conditions of use of cisplatin, out of context of clinical trial. We did not perform any intervention on the choice of anti-emetic treatment by the clinicians. Data on anti-emetic treatments were collected from prescriptions by a pharmacist after prior consultation with a medical doctor. Inclusions were closed when we lay 50 patients who received aprepitant associated to standard anti-emetic treatment (ondansetron and prednisolone) and 51 patients who received standard anti-emetic treatment. We observed a significant positive effect of aprepitant in the prevention of acute (84 vs 74.4 %, P = 0.24) and delayed vomiting (84 vs 60.8%, P = 0.009). But there was not a significant difference between the two groups regarding the prevention of nausea and the rate of complete response (absence of nausea and vomiting during five days).

[Improvement of quality of practices for the preparation of cytotoxic drugs: results of a "before-after" study]. / Optimisation des procédures de manipulation des chimiothérapies anticancéreuses : impact des contrôles de contamination environnementaux.

Despite the publication of guidelines for handling antineoplastic agents, measurable amounts of these drugs are still found at various hospital sites. In this context, the French cancer network ONCORA supported the present study to assess the impact of environmental contamination controls on the quality of practices during the preparation of cytotoxic drugs. The first part of the study was conducted at five voluntary hospitals. A total of 65 wipe samples of objects and surfaces were taken in the drug preparation rooms and analyzed for the presence of 5-fluorouracil (5-FU). Measurable amounts of 5-FU were detected in 21 samples (32%). Many surfaces within Biological Safety Cabinets and isolators were found contaminated (36%). The worse results were obtained on gloves and on the outside of infusion bags. The same method was applied during the second part of the study, conducted six months after the end of the first audit. Global contamination was reduced to 17%. This study shows that appropriate handling helps decrease the number of samples contaminated, making it possible to recommend these controls for evaluating and improving the quality of practices. Since 2007, the network's laboratory has extended its activities to all French hospitals interested in this quality assurance programme.

Amphotericin B intralipid formulation: stability and particle size.

Amphotericin B remains the drug of choice for treating systemic fungal infections, although toxicity limits its clinical use. Some studies reported the use of Intralipid deoxycholate amphotericin B as an alternative delivery system. An in-vitro study was performed to assess the compatibility of deoxycholate amphotericin B in Intralipid. With two types of dilution of deoxycholate amphotericin B (in 5% dextrose and Intralipid or in Intralipid alone) the solution stability was not constant with a clear yellow precipitate. We observed an increase in the size of the particles (1.5-4-fold). In light of these results Intralipid deoxycholate amphotericin B should not be routinely administered.