Cancer outpatients during the COVID-19 pandemic: what Oncoral has to teach us about medical drug use and the perception of telemedicine.

PURPOSE: The COVID-19 pandemic has disrupted healthcare access and telemedicine has been widely deployed. The aim of this study is to assess the impact of this health crisis on treatment consumption and telemedicine development in outpatients treated by oral anti-cancer agents and followed by the Oncoral hospital/community multidisciplinary program where continuity care is maintained by a pharmacist/nurse pair. METHODS: A prospective monocentric study was conducted among cancer patients who received Oncoral telephone follow-up during the 1st lockdown in France using a 56-item questionnaire which covered sociodemographic data, patient medication management, and telehealth. RESULTS: 178 patients received Oncoral follow-up during the 1st lockdown and 67.4% responded to the questionnaire. During lockdown, 9.2% of patients took medication or CAM for fatigue, 6.7% for mood alteration, 10.8% for sleep disorder, 11.7% for stress and anxiety, and 12.5% to get more energy. Homeopathy consumption was triggered by the pandemic. Habits about getting drugs from the pharmacy changed significantly (p < 0.001), while other treatment habits did not. 83% of patients were satisfied by the telephone follow-up established, 69% would be in favor of repeating this in case of a new epidemic wave. Those most in favor of using telemedicine seemed to be the youngest (p < 0.001), with several dependent children (p < 0.007), high school degree or higher education (p = 0.023), and in work (p < 0.001). CONCLUSION: Health system reorganization enables to limit the impact of the crisis on patients' drug use in oncology care. Telemedicine is a promising public health tool.

Real-life drug-drug and herb-drug interactions in outpatients taking oral anticancer drugs: comparison with databases.

PURPOSE: Due to polypharmacy and the rising popularity of complementary and alternative medicines (CAM), oncology patients are particularly at risk of drug-drug interactions (DDI) or herb-drug interactions (HDI). The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drug. METHOD: All prescribed and non-prescribed medications, including CAM, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis. RESULTS: 294 patients were included, with a mean age of 67 years [55-79]. The median number of chronic drugs per patient was 8 [1-29] and 55% of patients used at least one CAM. At least 1 interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%). CONCLUSION: Potentially clinically relevant drug interaction were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety.

Thromboembolic events and thromboprophylaxis associated with immunomodulators in multiple myeloma patients: a real-life study.

PURPOSE: The aim of this study is to assess international guidelines implementation concerning thromboprophylaxis strategy in myeloma patients treated with immunomodulatory drugs. METHODS: This retrospective study includes multiple myeloma patients treated with immunomodulatory drugs between 2014 and 2017 in the Hematology department of a teaching hospital (Hospices Civils de Lyon, France) and followed by the multidisciplinary care plan for cancer outpatients ONCORAL (ONCological care for outpatients with ORAL anticancer drugs). Data from immunomodulatory drugs administration, thromboprophylaxis strategy and thrombotic events were collected from medical files. Adherence to 2010 International Myeloma Working Group (IMWG) guidelines was assessed. RESULTS: 213 patients received at least one immunomodulatory drug: lenalidomide (60.9%), pomalidomide (24.0%) and thalidomide (15.1%). About two third of treatment lines (66.2%) were in accordance with IMWG recommendations. Among the others, 30.5% and 69.5% had thromboprophylaxis, respectively, superior or inferior to IMWG recommendations. 37 venous thrombotic events and 4 arterial thromboembolisms (one patient experienced both a stroke and deep venous thrombosis simultaneously) were reported. CONCLUSION: Thromboprophylaxis was systematically performed in myeloma patients treated with immunomodulatory drugs in this real-life retrospective cohort. However, the choice of anticoagulant or anti-platelet agent remains debatable, as adherence to existing guidelines was variable.

Management of adults and children receiving CAR T-cell therapy: 2021 best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association (EHA).

BACKGROUND: Several commercial and academic autologous chimeric antigen receptor T-cell (CAR-T) products targeting CD19 have been approved in Europe for relapsed/refractory B-cell acute lymphoblastic leukemia, high-grade B-cell lymphoma and mantle cell lymphoma. Products for other diseases such as multiple myeloma and follicular lymphoma are likely to be approved by the European Medicines Agency in the near future. DESIGN: The European Society for Blood and Marrow Transplantation (EBMT)-Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association collaborated to draft best practice recommendations based on the current literature to support health care professionals in delivering consistent, high-quality care in this rapidly moving field. RESULTS: Thirty-six CAR-T experts (medical, nursing, pharmacy/laboratory) assembled to draft recommendations to cover all aspects of CAR-T patient care and supply chain management, from patient selection to long-term follow-up, post-authorisation safety surveillance and regulatory issues. CONCLUSIONS: We provide practical, clinically relevant recommendations on the use of these high-cost, logistically complex therapies for haematologists/oncologists, nurses and other stakeholders including pharmacists and health sector administrators involved in the delivery of CAR-T in the clinic.

Sodium thiosulfate protects from renal impairement following hyperthermic intraperitoneal chemotherapy (HIPEC) with Cisplatin.

BACKGROUND: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been shown to provide benefits in the management of peritoneal metastasis. Cisplatin (CDDP) is one of the most frequently used drugs for peritoneal infusion. A major restriction is that CDDP causes renal toxicity and acute renal failure, sometimes leading to chronic renal failure. The aim of the present study was to assess the impact of sodium thiosulfate (ST) in preventing renal impairment (RI) following HIPEC with CDDP. METHODS: This prospective study assessed the RI rates for all patients who underwent HIPEC with CDDP during two successive periods: without ST (nST Period; from November 2016 to September 2017) and with ST (ST Period; from October 2017 to March 2018). During the ST Period, patients received an ST infusion at 9 mg/m2 prior to HIPEC and at 12 mg/m2 at the end of the procedure. RI was defined by postoperative serum creatinine >1.6 times elevation of baseline value. The impact of ST treatment was evaluated by comparison of the RI rates between the two periods. RESULTS: During ST Period, none of 38 patients (0%) developed RI versus 11/35 patients (31.4%) during the nST Period (p < .005); 2 of whom required definitive hemodialysis. Baseline characteristics, background circumstances, indications and laboratory parameters before HIPEC were comparable between the two groups, as well as CDDP dose use during HIPEC. CONCLUSION: ST appears to be an effective drug for the prevention of the renal toxicity of CDDP used for HIPEC and should be used for all such procedures.

[Feedback on clinical oncology pharmacy]. / Retour d'expérience en pharmacie clinique oncologique.

The rising of oral anticancer therapies let more and more patients to be cared at home and improve their quality of life. However the toxicities of these drugs and the distance with health professionals imply that the patient needs to be more autonomous with respect to his treatment. Patients through therapeutic education programs allows them to manage side effects, to be more observant and then to subsequently benefit from the treatment. We report here, oncology clinical pharmacists experiences in some health facilities in France, presented at the 1st day of clinical oncology pharmacy (December 2017, Marseille).

Stability Study of [18F]Fludeoxyglucose and [18F]Fluorocholine in Different Medical Devices for Intravenous Administration.

OBJECTIVE: The present study had determine the impact of prolonged storage in a cartridge or syringe on the quality of the [18F]-radiopharmaceuticals used in our center [18F]fludeoxyglucose and [18F]fluorocholine). [18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multidose flasks. When the change of packaging must be made extemporaneously for the preparation of patient unit doses in a syringe or cartridge, this is under the responsibility of radiopharmacists. As drug quality in medical devices (syringe or cartridge) is not evaluated during the marketing authorization of such radiopharmaceuticals, an evaluation of drug stability in such devices seems interesting. In addition, if there are difficulties in patient care (placement of the catheter, lack of personal, etc.) or equipment problems (technical issue with the automated dispenser delaying the delivery of the prepared dose), the contact time of [18F]-radiopharmaceuticals with the medical devices (cartridge or syringe) increases. METHODS: Appearance, pH, radiochemical purity, sterility and endotoxin tests were made according the current European Pharmacopoeia. Adsorption tests were made according the literature. RESULTS: There was no drug absorption of [18F]fludeoxyglucose or [18F]fluorocholine after 1.5h, which may be related to their hydrophilic nature. No drug radiolysis was observed even after dilution of the radiopharmaceuticals (appearance, pH, and radiochemical purity were unchanged). No impurity from medical devices (cartridge or syringe) was observed, and microbiological aspects remained in specification of the current European Pharmacopoeia. CONCLUSION: These radiopharmaceuticals repackaged in plastic medical devices retained their quality after dispensing and prolonged storage.

[Impact of pharmaceutical interventions on antibiotic therapy of urinary tract infections in rehabilitation center]. / Impact des interventions pharmaceutiques sur l'antibiothérapie des infections urinaires en service de soins de suite et de réadaptation.

BACKGROUND: The aim of this study was to assess the impact of medico-pharmaceutical partnership on the quality of antibiotic treatment in urinary tract infection (UTI) within rehabilitation center. MATERIAL: All antibiotic prescriptions were validated by the pharmacist at the start of treatment and twice a week. All patients with symptomatic urinary tract infection between January 1, 2014 to December 31, 2015 were included in this study. Addition to awareness among specifiers to promoting the appropriate use of antibiotics, the pharmacist suggested pharmaceutical interventions (PI) in order to improve the quality of antibiotic treatments. At the same time, 3 quality indicators (QI) were followed: duration, dosage, antibiotic susceptibility. The compliance rates of this 3 QI allowed to assess the quality of the antibiotic treatment in urinary tract infection. RESULTS: The study population included 154 patients corresponding to 252 UTI. Sixty-eight PI were made by pharmacist about urinary tract infection treatment (overdosage or under-dosing, duration unknown, inadequate route of administration). These QI achieved 96.4% compliance with duration, 98.8% compliance with dosage and 99.2% with the antibiotic susceptibility. CONCLUSION: This study allowed showing the medico-pharmaceutical impact on the quality of antibiotic treatments in UTI. The awareness among specifiers with a daily validation of prescription by the pharmacist allowed to improve urinary tract infections care in rehabilitation center. LEVEL OF EVIDENCE: 4.

Comparative toxicities of 3 platinum-containing chemotherapy regimens in relapsed/refractory lymphoma patients.

Optimal salvage chemotherapy regimen for patients with relapsed or refractory Hodgkin and non-Hodgkin lymphoma remains unclear but often based on platinum regimens. This retrospective study assesses in real life the toxicities profiles of patients with relapsed or refractory lymphoma treated with DHA (dexamethasone, high dose aracytine cytarabine) plus platinum salt (dexamethasone-High dose aracytine (cis)platin (DHAP), dexamethasone-High dose aracytine carboplatin (DHAC), or dexamethasone-High dose aracytine Oxaliplatin (DHAOX)), from February 2007 to May 2013 in 2 French hospitals. Toxicities were recorded from medical files and assessed according to the National Cancer Institute Common Toxicity Criteria version 3.0. Potential risk factors of renal insufficiency were tested by univariate analyses. A total of 276 patients were treated: 168 with DHAP (60.9%), 79 with DHAOX (28.6%), and 29 with DHAC (10.5%). Rituximab was associated in 80.1% of patients (n = 221). Renal failure was reported in 97 patients, mainly with cisplatin regimen (86.6%) leading to 8.9% grade III to IV renal failure (P = .001). Renal insufficiency was reversible in most patients but remained persistent in 24, with all of them being treated with DHAP except 1. Cisplatin-based regimen (50.0% versus 12.0%, P < .05) and female (44.6% versus 29.7%, P < .05) appeared to be at higher risks of renal failure. Platinum cumulative dose is a significant risk factor of nephrotoxicity. Hematologic toxicity was more frequent with carboplatin and cisplatin with at least 1 event (all toxicity grade) respectively in 79.3% and 71.4% of patients treated (P < .005). Auditory toxicity was mainly reported with cisplatin (n = 19; 4 grade I-II and 15 grade III-IV). Oxaliplatin was implicated in 77.6% of neurotoxicity (n = 59), mainly moderate (grade I-II). In conclusion, DHAOX and DHAC regimens have more favorable toxicity profile than DHAP regimen. Their lack of renal toxicity makes them attractive regimens, which may be interesting for patients eligible for autologous stem cell transplantation. Nevertheless, these results have to be confirmed by the therapeutic efficacy of these 3 regimens.

[Drug management of prisoners: Role of the pharmaceutical staff to ensure patient safety]. / Prise en charge médicamenteuse en milieu carcéral : contribution de l'équipe pharmaceutique à la sécurité des patients.

OBJECTIVES: In the prisons of Lyon, drug management of inmates implies cooperation between general practitioners, psychiatrists and pharmacists. All the medical prescriptions are reviewed by the pharmacists of the medical unit. The aim of this work was to synthesize the pharmaceutical interventions performed and show the implication of the pharmaceutical staff in detecting and handling prescribing errors. METHODS: Pharmaceutical interventions performed between the 1st of June 2012 and the 31st December 2014 and entered in the Act-IP(®) database (SFPC) were retrospectively analyzed. RESULTS: Among the 18,205 prescriptions reviewed, 4064 (22.3%) had a prescription error. The main problems encountered were by decreasing order of frequency: missing monitoring (15% of the interventions), lack of compliance (13%), over dosage (10%), lack of conformity with recommendations or consensus (8%). Interventions were accepted in 78% cases. Most prescribing errors implied medications of the central nervous system. Among the interventions, 8% were initiated by pharmacy technicians, mainly lack of compliance. CONCLUSIONS: The pharmaceutical interventions reported reflected actions of securisation initiated by the pharmacists in cooperation with physicians: monitoring of patients taking antipsychotic medications or benzodiazepines maximal dosages. Besides, in this population with a high prevalence of psychiatric comorbidities and important suicide rate, detection of patients with default of compliance is one of the keys for drug optimization among these patients as it is an explanation for therapeutic failure.

New treatments for cutaneous metastatic melanoma: MAPK pathway-targeted and immune based therapies.

Increasing knowledge on cellular biology has permitted rapid changes in the treatment of metastatic melanoma. Until 2011, dacarbazine was the gold standard treatment at our disposal. In 2011 the treatment landscape changed dramatically with the approval by the FDA of ipilimumab and vemurafenib. These drugs use two new therapeutic approaches: immunomodulation and the targeting of mutated cellular pathways in tumor cells. These two drugs, used as single agents have shown important increases in overall survival, unseen before in patients with advanced melanoma, but are limited by their toxicities and the appearance of acquired resistances. In this article, we review new therapeutic options in pathway-targeted -with the arrival of MEK inhibitors - and immune based melanoma therapies -with the arrival of anti-PD1 and anti-PDL1- as well as new therapeutic strategies developed to overcome acquired resistance and diminish drug toxicities.

EPICC study: evaluation of pharmaceutical intervention in cancer care.

WHAT IS KNOWN AND OBJECTIVES: In cancer care, clinical pharmacists contribute to improving prevention and management of drug-related problems (DRPs). The 3-year EPICC study (Evaluation of Pharmaceutical Intervention in Cancer Care) aimed to collect and analyse pharmaceutical interventions (PIs) in oncology. METHODS: The free online version of the French Society of Clinical Pharmacy (SFPC) coding system, ACT-IP, was used, supplemented by a standardized dedicated cancer-care decision tree. RESULTS: A total of 29,589 medication orders (77,004 anticancer drug preparations) were analysed. Eight hundred and ninety-four PIs were recorded. ACT-IP identified 54·1% of DRPs as concerning over- or underdosage. The standardized dedicated cancer-care decision tree identified the three principal causes of dosage problems: 50·2% due to miscalculation, 20% to omission of dose adjustment and 12% to poor choice of antineoplastic regimen. About 13·8% of DRPs were adverse effects and 3·9% were drug-drug interactions. The decision tree showed that 22% of adverse events could be circumvented by a switch within the same drug family and 72% of drug-drug interactions would have led to increased neoplastic toxicity. DISCUSSION: Pharmaceutical analysis of prescription forms contributes to medication safety in cancer care, and the present dedicated decision tree highlights additional information about DRPs and PIs. The DRP rate (3% of prescriptions) was consistent with the literature. The pharmacist has a role to play in optimizing the management of patients with cancer in terms of dose adjustment, drug toxicity management, improvement of administration and drug-drug interactions. WHAT IS NEW AND CONCLUSION: This study, highlighting PIs in cancer care, is the first of this scale in terms of number of prescriptions analysed (nearly 30 000). Results demonstrated the specificity of DRPs and PIs for patients with cancer and the value of a dedicated coding system in cancer care.

SIMMEON-Prep study: SIMulation of Medication Errors in ONcology: prevention of antineoplastic preparation errors.

WHAT IS KNOWN AND OBJECTIVE: Medication errors (ME) in oncology are known to cause serious iatrogenic complications. However, MEs still occur at each step in the anticancer chemotherapy process, particularly when injections are prepared in the hospital pharmacy. This study assessed whether a ME simulation program would help prevent ME-associated iatrogenic complications. METHODS: The 5-month prospective study, consisting of three phases, was undertaken in the centralized pharmaceutical unit of a university hospital of Lyon, France. During the first simulation phase, 25 instruction sheets each containing one simulated error were inserted among various instruction sheets issued to blinded technicians. The second phase consisted of activity aimed at raising pharmacy technicians' awareness of risk of medication errors associated with antineoplastic drugs. The third phase consisted of re-enacting the error simulation process 3 months after the awareness campaign. The rate and severity of undetected medication errors were measured during the two simulation (first and third) phases. The potential seriousness of the ME was assessed using the NCC MERP(®) index. RESULTS AND DISCUSSION: The rate of undetected medication errors decreased from 12 in the first simulation phase (48%) to five in the second simulation phase (20%, P = 0.04). The number of potential deaths due to administration of a faulty preparation decreased from three to zero. Awareness of iatrogenic risk through error simulation allowed pharmacy technicians to improve their ability to identify errors. WHAT IS NEW AND CONCLUSION: This study is the first demonstration of the successful application of a simulation-based learning tool for reducing errors in the preparation of injectable anticancer drugs. Such a program should form part of the continuous quality improvement of risk management strategies for cancer patients.

[Massive transfusion: analysis of practices according to available medical devices]. / Transfusion massive : analyse des pratiques en fonction des dispositifs médicaux disponibles.

INTRODUCTION: An assessment of practices and available medical devices during the treatment of a massive haemorrhage has been realised in the shock unit of our hospital. MATERIAL AND METHODS: Parameters influencing transfusion flow rate have been identified. Medical devices and equipment to accelerate the flow rate were analyzed on the basis of manufacturers' data and users opinion in relation with their practices. RESULTS: The system, from blood bags to venous access, influences flow rate: red blood cell viscosity, catheter and pressure gradient. Three types of acceleration systems are available: accelerated transfusion set, pressure cuff with a gravity blood IV set and fast-flow fluid warmers. Their benefits and disadvantages are presented and discussed. DISCUSSION: Maximum flow rates noted by manufacturers are not the real values because some parameters such as venous catheter diameter (limitative factor) and the red blood cell viscosity (diluted or not) are not considered. The choice of an infusion system is mainly based on the technical capacities (flow rate fluctuations, pressure gradient on blood bags, warming, air purging), practical modalities of use (medical devices and assembly) and cost. The pressure cuff with transfusion gravity set should be limited to non-critical situations or during the assembly of the fast flow fluid warmers (but no warming fluids, no air embolism prevention). The accelerated transfusion set is not the best option for a shock unit because it needs an operator permanently. The fast-flow fluid warmers are recommended for all types of massive haemorrhages, they are more secure but they require a long time to be assembled.

[The radiopharmacy end?]. / La fin de la radiopharmacie ?

In France, radiopharmaceuticals preparation and dispensation are made under the responsibility of a pharmacist. This last one made a pharmaceutical over-specialization in the field of the medical use of radioelements. However, a flaw in the French law allows nuclear medicine units to avoid the presence of the radiopharmacist decreasing so the quality and the safety of the care brought to patients. This article aims at looking for legal solutions to maintain these quality and safety by the empowerment of the radiopharmacist statute while taking into account economic aspects.

Suspicion of drug-drug interaction between high-dose methotrexate and proton pump inhibitors: a case report - should the practice be changed?

We report a case of a potential drug-drug interaction in a woman treated by a first injection of high-dose methotrexate for a T-lymphoblastic lymphoma. Valaciclovir, fluoxetine and pantoprazole were given concomitantly. A methotrexate overdosage was shown at 36 h after infusion associated with a severe renal failure. Alkaline hyperhydration, folinic acid and carboxypeptidase G2 were given. Prescription analyses by pharmacists and literature research have permitted us to suggest that a drug-drug interaction between methotrexate and proton pump inhibitors (PPI) was responsible for this renal failure. Several mechanisms of interaction were suggested and might be related to the inhibition of renal methotrexate transporters by PPI, an increase in the methotrexate efflux to the blood by an upregulation of multidrug resistance protein 3 by PPI or genetic polymorphisms. This case shows that pharmacists can help physicians to optimize patient treatment: they consensually decided on the systematic discontinuation of PPI or a switch to ranitidine when patients were treated by high-dose methotrexate.

Oral anticoagulant treatment - evaluating the knowledge of patients admitted in physical medicine and rehabilitation units.

INTRODUCTION: While numerous therapeutic education programs exist in physical medicine and rehabilitation (PM&R), they rarely concern pharmacological treatments. Nevertheless, drugs prescribed during a hospital stay can have a significant risk of adverse events. Vitamin K antagonists (VKA) are among them. OBJECTIVE OF THE STUDY: To assess patients' knowledge on their oral anticoagulant treatment before their hospital discharge. METHODS: Fifty patients were enrolled in this prospective, monocenter study. Their level of knowledge was assessed by a semi-structured interview between the pharmacist and the patients and/or their caregivers. RESULTS: Seventy percent of patients were able to give the name of the drug they were taking, 82% could explain its effect and finally, 24% of patient knew their INR target values. Twenty-two percent of patients were able to describe the symptoms in case of overdose and what to do in that case. Forty percent of patients were aware of food interactions and 60% of self-medication risks. The patient's knowledge and behavior acquired during their hospital stay are not enough to guarantee a safe treatment management upon discharge. Based on this study, therapeutic patient education sessions were implemented. CONCLUSION: These results suggest that specific drug therapy management sessions should be developed as part of PM&R's therapeutic education programs for patients.

[Platinum salts hypersensitivity]. / Hypersensibilité aux sels de platine.

It become usually after 4 to 8 courses of treatment. A long platin free interval is an increased risk of reaction. Clinical manifestations are various and can be separate in light to mild or severe reactions. Diagnose is retrospective with results of skin test. Prick test and IDR (using sequentially diluted platin salt and delayed reading) are the most available, essentially in case of acute reaction (<2h after injection of platin salt). IDR realized 30 min before injection of platin salt can be a good predictive test of hypersensitivity reaction. Management of this adverse effect depends on clinical manifestation: light to mild: careful re-introduction with a desensitization protocol; severe: no re-introduction. If it's necessary, careful replacement by another platin salt can be possible, eventually in accordance with results of IDR to all platinum salt.

Quantitative determination of endotoxins released by bacterial biofilms.

Residual endotoxins, commonly associated with bacterial biofilms colonizing reusable medical devices have been associated with pyrogenic reactions in patients. We have used a quantitative, sensitive and reproducible kinetic chromogenic adaptation of the Limulus Amebocyte Lysate assay to assess endotoxin recovery from an in-vitro bacterial biofilm. The 'recovery method' was based on a combination of physical treatment (vortexing and sonication) and chemical treatment (immersion in recovery solution). Five recovery solutions were investigated. The recovered endotoxin was greater when the biofilm was treated with a 1% SDS solution. The sensitive and reproducible method we have developed should allow the recovery and measurement of biofilm bacterial endotoxins on implanted and colonized medical devices. Moreover, the amount of endotoxin was sufficient (> 1000 endotoxin units/cm2 of substrate) to enable a substantial reduction by sterilization processes, the efficiency of which on biofilm endotoxins has yet to be proven.