Economic Study of 2-Stage Exchange in Patients With Knee or Hip Prosthetic Joint Infection Managed in a Referral Center in France: Time to Use Innovative(s) Intervention(s) at the Time of Reimplantation to Reduce the Risk of Superinfection.

Objective: Chronic prosthetic joint infections (PJI) are serious complications in arthroplasty leading to prosthesis exchange and potential significant costs for health systems, especially if a subsequent new infection occurs. This study assessed the cost of chronic PJI managed with 2-stage exchange at the Lyon University Hospital, CRIOAc Lyon reference center, France. A threshold analysis was then undertaken to determine the reimbursement tariff of a hypothetical preventive device usable at the time of reimplantation, which possibly enables health insurance to save money according to the risk reduction of subsequent new infection. This analysis was also performed for a potential innovative device already available on the market, a dual antibiotic loaded bone cement used to fix cemented prosthesis that releases high concentrations of gentamicin and vancomycin locally (G+V cement). Method: Patients >18 years, admitted for a hip or knee chronic PJI managed with 2-stage exchange, between January 1, 2013, and December 31, 2015, were retrospectively identified. Following, resource consumption in relation to inpatient hospital stay, hospitalization at home, rehabilitation care, outpatient antibiotic treatments, imaging, laboratory analysis, and consultations were identified and collected from patient records and taken into account in the evaluation. Costs were assessed from the French health insurance perspective over the 2 years following prosthesis reimplantation. Results: The study included 116 patients (median age 67 y; 47% hip prosthesis). Mean cost of chronic PJI was estimated over the 2 years following prosthesis reimplantation at €21,324 for all patients, and at €51,697 and €15,745 for patients with (n = 18) and without (n = 98) a subsequent new infection after reimplantation, respectively. According to the threshold analysis the reimbursement tariff (i) should not exceed €2,820 for a device which can reduce the risk of a new infection by 50% and (ii) was between €2,988 and €3,984 if the G + V cement can reduce the risk of a new infection by 80% (this reduction risk is speculative and has to be confirmed by clinical trials). Conclusion: This study revealed that chronic PJI requiring a 2-stage revision is costly, with significant costs in relation to the reimplantation procedure (about 15 k€). However, following reimplantation the rate of subsequent new infection remained high, and the cost of reimplantation following a new infection is considerable, reaching 50k€ per patient. These first cost estimates of managing chronic PJI with 2-stage exchange in France underline the economic interest of preventing new infections.

[Assessing nurses' knowledge of insulin administration and the impact of the introduction of concentrated insulins.] / Évaluation des connaissances des personnels soignants sur les pratiques d'administration de l'insuline et impact de l'introduction des insulines à forte concentration.

Insulin is a high-risk medication, and even slight changes in blood levels can lead to serious side effects or can even result in death. Error in administering drugs is one of the main causes of over- or under-dosing, and the recent introduction of concentrated insulins (CI) has increased this risk. We assessed nurses' knowledge of these CI, their beliefs about the "insulin unit" (IU), and the impact that this knowledge had on the risk of making medication errors. A direct interview survey was conducted in eight departments of medicine and surgery in a university hospital. Sixty-eight nurses and midwives were interviewed. Twenty-six percent of them had already encountered a CI prescription and only 51.5 percent correctly defined the notion of IU. Only 18 percent responded correctly to a practical case of a CI prescription, whilst 35 percent multiplied the dose by two and 24 percent divided it by two. Sixty percent indicated that they regularly use a U-100 graduated insulin syringe to withdraw insulin from the pen. Insulin administration errors related to this misuse, which are very well documented in the literature, are linked to nurses' lack of knowledge about the true definition of IU. These administration errors have increased with the introduction of concentrated insulins.

[Number and nature of drug interactions concerning antineoplastic drugs]. / Estimation du nombre et de la nature des interactions médicamenteuses concernant les médicaments anticancéreux.

Antineoplastic drugs are prone to drug-drug interactions. Cancer patients often receive multiple concurrent medications and health care professionals are not always aware that patients are also taking others treatments. The aim of this study was to assess the number of drug-drug interactions of antineoplastic drugs used in solid tumours and to find out and collect recommendations for each of them. We performed a bibliographic search from the Vidal dictionary, the "thesaurus de l'Afssaps", the "dossier du CNHIM" and from literature of scientific journals. For the 40 antineoplastic drugs studied, 726 drug-drug interactions were identified; 186 from the Vidal dictionary, 356 from scientific literature and 184 from others bibliographic sources. The most frequently involved antineoplastic drugs are ifosfamide, paclitaxel and erlotinib. The ATC groups of associated drugs are antiinfectives for systemic use, alimentary tract and metabolism and nervous system. Antiretrovirals are prone to drug interactions with antineoplastic drugs, particularly ritonavir, tipranavir and efavirenz. 7 contraindications and 15 unadvised associations were held. For 58% of interactions, no management recommendation was specified in the bibliographic source. Healthcare professionals must be aware that the Vidal dictionary gave information for only 26 % of registered drug-drug interactions. Our database gather in one document drug-drug interactions that come from different bibliographic sources. The setting of this database is part of the multidisciplinary caring of cancer patient. Drug-drug interaction is a field which for physicians and pharmacists should developed collaboration for patient care.

Paclitaxel hypersensitivity reactions: assessment of the utility of a test-dose program.

UNLABELLED: Several studies have suggested the usefulness of a test dose of paclitaxel to reduce the incidence of hypersensitivity reactions and the resulting cost of drug wastage. The aim of this study was to assess the utility of implementing such a test dose. METHOD: We retrospectively reviewed the medical charts of patients who had received one or two courses of single-agent paclitaxel or a combination chemotherapy regimen to calculate hypersensitivity reaction incidence and the cost of drug wastage. Thereafter, a paclitaxel test-dose program was routinely implemented during the first and second cycles of paclitaxel treatment for all patients. Hypersensitivity reaction incidence and drug wastage cost were again assessed. RESULTS: Before the routine use of a test dose, 162 patients received one or two paclitaxel infusions alone or in combination therapy from January 1, 1997 to February 28, 2003. Ten (6.2%) patients experienced a hypersensitivity reaction; one of them was severe. After implementation of the test-dose program, 130 patients received 244 test doses (12 mg paclitaxel/10 mL normal saline) with an intensified premedication regimen at the first and second cycles of chemotherapy from June 28, 2003 to March 2, 2005. Three patients (2.3%) experienced a minor hypersensitivity reaction, one immediately after the test dose and two during infusion of the full dose despite a well-tolerated test dose. Thus, the negative predictive value of the test dose was 98.4%. The overall incidence of hypersensitivity reactions experienced during the first or second cycle of paclitaxel chemotherapy decreased about 63% compared with the incidence before implementation of the test dose (P < 0.20). The test-dose program resulted in a 29% increase in the cost of chemotherapy (approximately 6100 dollars for 130 patients). CONCLUSION: To our knowledge, this is the largest study ever reported to test the potential cost-saving benefit of the implementation of a paclitaxel test-dose program to prevent hypersensitivity reactions. The results suggest that the routine use of a test dose is not a cost-effective measure.

[Patients' and physicians' perceptions on participation in a clinical trial: results on a survey in a French hospital]. / Perception des essais cliniques par les patients et les investigateurs : enquête à l'hôpital Neuro-Cardiologique de Lyon.

OBJECTIVES: We report the first survey on French physicians and patients participating to assess motivations prior enrolment and benefits and constraints perceived after participation. METHOD: Twenty physicians were interviewed and 37 patients completed a questionnaire during clinical study participation. RESULTS: If the main patient's motivation is altruistic, physician wish their own patient feel better. After participation, patient is satisfied with being part of a research effort and contributing to medical science. Effect of trial treatment on physical well-being seems less pronounced. Main constraint is the randomisation to placebo group. For physicians, the main benefit is getting research experience and training. Main constraints are logistical. Otherwise, perceptions on the same clinical trial depend on participant. In fact, physician usually overestimates constraints of clinical trial for patient. CONCLUSION: The knowledge of patients and physicians perceptions of clinical trials and its taking into account should probably reduce difficulties in the recruitment in France.

[Perceptions of patients and physicians involved in clinical trials: an overview of the literature]. / Perception des essais cliniques par les patients et les investigateurs: revue bibliographique (1re partie).

UNLABELLED: OBJECTIVE - METHOD: The purpose of this review is to explore the expectations of patients and physicians prior to participate to a clinical trial and their positive or negative experiences after participating. A systematic review of Medline database from 1966 to 2005 identified 79 papers reported patients and physicians perceptions of clinical trials (only 3 in French), whom 27 English surveys conducted on patients and physicians. RESULTS: If primary patients' motivation for enrolment was altruistic, physicians wish to help their patient. After enrolment, the most perceived positive benefit for patients and physicians are, respectively, the emotional improvement and the greater opportunity for personal benefit offered to enrolled patients. Most physicians' negative experience included logistical difficulties while patients are unease with randomisation and often uncomfortable with medical procedures. Unlike patients, all physicians' expectations seem to be fulfilled. CONCLUSION: The knowledge of patients' and physicians' perception of participation may improve recruitment in clinical trials.

Pheochromocytoma unmasked by amisulpride and tiapride.

OBJECTIVE: To describe the unmasking of pheochromocytoma in a patient treated with amisulpride and tiapride. CASE SUMMARY: A 42-year-old white man developed acute hypertension with severe headache and vomiting 2 hours after the first doses of amisulpride 100 mg and tiapride 100 mg. Both drugs were immediately discontinued, and the patient recovered after subsequent nicardipine and verapamil treatment. Abdominal ultrasound showed an adrenal mass, and postoperative histologic examination confirmed the diagnosis of pheochromocytoma. DISCUSSION: Drug-induced symptoms of pheochromocytoma are often associated with the use of substituted benzamide drugs, but the underlying mechanism is unknown. In our case, use of the Naranjo probability scale indicated a possible relationship between the hypertensive crisis and amisulpride and tiapride therapy. CONCLUSIONS: As of March 24, 2005, this is the first reported case of amisulpride- and tiapride-induced hypertensive crisis in a patient with pheochromocytoma. Physicians and other healthcare professionals should be aware of this potential adverse effect of tiapride and amisulpride.