Clinical Relevance of Routine Monitoring of Patient-reported Outcomes Versus Clinician-reported Outcomes in Oncology.

The National Cancer Institute Common Terminology Criteria for Adverse Events classification is the standard classification used by the physicians in oncology for reporting adverse events. This classification has evolved over the last years according to the emergence of new therapies. Reporting symptoms, quality of life (QoL) and toxicities via patient-reported outcomes (PROs) in clinical practice is not yet a standard of care, nevertheless many studies have been conducted recently to assess feasibility and impact of routine monitoring of PROs, which should enable for better management of toxicities and earlier detection of disease progression in a more patient-centered health care delivery system. The aim of this article was to discuss the advantages and limitations of both approaches, clinicians-reported outcomes and PROs. Growing evidence supports that the routine collection of PROs leads to improvement of QoL and overall survival of cancer patients.

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Final validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation finale.

An initial validation of a standardized pharmaceutical counselling guide was carried out in a previous study to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. The main objective of this work was the final validation of this guide with 10 naive patients. The main secondary objectives were to assess for the patient the evolution of knowledge about the treatment, understanding of the purpose of the pharmaceutical counselling, adherence to the tools. Each patient completed a self-administered questionnaire: before and after the first pharmaceutical counselling. The primary endpoint was the average success rate per question after the pharmaceutical counselling (a value of ≥ 90% validated knowledge acquisition). Secondary judgement criteria were: change in average success rates per patient and question, rate of reformulation of the objective of the pharmaceutical counselling, response rate to presentation questions, readability and understanding. No average success rate per question after the pharmaceutical counselling was statistically less than 90%. The average success rates per patient before and after the pharmaceutical counselling were 78.9±13.7% vs 96.1±3.9% (P=0.01). The average success rates per question were different for 4 questions. All patients were able to reformulate the objective of the pharmaceutical counselling and validated the presentation, readability and understanding of the documents. This study led to the final validation of the pharmaceutical counselling guide.

[Medico-economic benefits of subcutaneous formulations of trastuzumab and rituximab in day hospitalisation (SCuBA Study)]. / Bénéfices médicoéconomiques des formes sous-cutanées de trastuzumab et de rituximab en hospitalisation de jour (étude SCuBA).

INTRODUCTION: New pharmaceutical forms of trastuzumab and rituximab which can be administered by the subcutaneous route have been developed recently. For day hospitalisation units, these can be used in simpler treatment protocols than previous intravenous formulations. The objective of this study was to evaluate the medical and economic consequences of switching to subcutaneous formulations of trastuzumab and rituximab. METHODS: Thirty-six day care units in 30 hospitals or clinics participated in this observational study. Data were collected on the capacity of the units, the number of chemotherapy sessions implemented, the duration of occupation of a chair and the production capacity of the unit pharmacy. The number of additional sessions made possible by the use of subcutaneous forms in 2016 was determined and the associated gain in earnings calculated using national tariffs. RESULTS: Compared to the intravenous route, the mean duration of occupation of a chair was reduced by 56.1 % for a session of subcutaneous trastuzumab and by 73.8 % for a session of subcutaneous rituximab. The mean number of additional sessions made possible by the use of subcutaneous treatments was 242 [168-316] sessions by year by unit, corresponding to 2.7 % [1.9 %-3.4 %] of the total number of chemotherapy sessions in the unit. The corresponding gain in annual earnings was € 111 388. DISCUSSION: Switching the route of administration from the intravenous to the subcutaneous route is a useful strategy to address the increase in activity of day hospitalisation units. This allows an increase of 2.7 % in the total number of chemotherapy sessions in the unit. In most of the participating units, there was room for further optimization of activity, potentially to reach 4.2 % of the total number of sessions.

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Initial validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation initiale.

The safety of the community treatment with oral anticancer therapies is a strong theme of the cancer plan 2014-2019. The objective of this study was to develop a Pharmaceutical Counseling Guide to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. A multidisciplinary professional working group selected a list of relevant medication adherence-related items that served as the framework for the design of the pharmaceutical counseling support materials in patient-accessible language. The readability, understanding and memorization of the information were validated in ten patients treated for myeloma. Twelve items were selected for treatment information (5 items), treatment planning (5 items), and adverse drug effects (2 items). A pharmacist guide, a patient guide, a medication schedule, and three self-questionnaires to evaluate medication knowledge and understanding of patients were developed. The patient test resulted in changes in these documents. This study carried out the initial validation of documents to standardize the pharmaceutical counseling for patients treated for myeloma so that it can be reproduced from one patient to another regardless of the pharmacist, by standardizing the information issued. This study needs to be completed by a final validation in myeloma patients, free from oral anticancer therapies.

[Chemotherapy for colorectal cancer: Pragmatic assessment of prescription changes and relative dose intensity]. / Chimiothérapies dans le cancer colorectal : étude pragmatique des modifications de prescription et de dose intensité.

INTRODUCTION: Chemotherapy induced toxicities can generate changes in prescribing and relative dose intensity which have an impact on therapeutic efficacy. METHOD: This is a prospective observational study performed in hepato-gastroenterology department for 6 months. All patients treated for colorectal cancer and beginning a protocol with at least one parenteral drug have been included. RESULTS: Among the 48 patients enrolled, 85.4% of them had at least one prescription change, which concerned 30.3% of 238 cycles. Of the 766 analyzed prescription lines, 16.6% of them were postponed and/or 6.7% had modified dosage and/or 5.6% were stopped prematurely. Grades 2 to 4 adverse reactions were responsible for at least one change prescribing to 64.6% of patients and 17.6% of cycles. Toxicity induced prescription changes were mainly due to clinical toxicities (79.3%). The rate of patients with a relative dose intensity greater than 70% was 92.9% in adjuvant state, 66.7% and 62.5% in metastatic state first line and second and subsequent line. CONCLUSION: High-grade clinical toxicities are the main chemotherapy prescription change pattern in colorectal cancer. Knowledge of toxicities before the patient's arrival is expected to target patients for which the drug preparation can be anticipated and for which a cycle postponement, dose adjustment or discontinuation is necessary.

Compatibility of ondansetron hydrochloride and methylprednisolone sodium succinate in multilayer polyolefin containers.

PURPOSE: The compatibility of ondansetron hydrochloride and methylprednisolone sodium succinate in 5% dextrose injection and 0.9% sodium chloride injection was studied. METHODS: Test solutions of ondansetron hydrochloride 0.16 mg/mL and methylprednisolone sodium succinate 2.4 mg/mL were prepared in triplicate and tested in duplicate. Total volumes of 4 and 2 mL of ondansetron hydrochloride solution and methylprednisolone sodium succinate solution, respectively, were added to 50-mL multilayer polyolefin bags containing 5% dextrose injection or 0.9% sodium chloride injection. Bags were stored for 24 hours at 20-25 degrees C and for 48 hours at 4-8 degrees C. Chemical compatibility was measured with high-performance liquid chromatography, and physical compatibility was determined visually. RESULTS: Ondansetron hydrochloride was stable for up to 24 hours at 20-25 degrees C and up to 48 hours at 4-8 degrees C. Methylprednisolone sodium succinate was stable for up to 48 hours at 4-8 degrees C. When stored at 20-25 degrees C, methylprednisolone sodium succinate was stable for up to 7 hours in 5% dextrose injection and up to 24 hours in 0.9% sodium chloride injection. Compatibility data for solutions containing ondansetron hydrochloride plus methylprednisolone sodium succinate revealed that each drug was stable for up to 24 hours at 20-25 degrees C and up to 48 hours at 4-8 degrees C. CONCLUSION: Ondansetron 0.16 mg/mL (as the hydrochloride) and methylprednisolone 2.4 mg/mL (as the sodium succinate) mixed in 50-mL multilayer polyolefin bags were stable in both 5% dextrose injection and 0.9% sodium chloride injection for up to 24 hours at 20-25 degrees C and up to 48 hours at 4-8 degrees C.

Standardized order form for investigational drugs: effect on completeness of the prescription.

AIM: To compare completeness and quality of orders written before and after introduction of a preprinted medication order form for investigational drugs. Completeness of physician's orders for investigational drugs was compared during two successive periods: before and after implementation of a preprinted form for these orders. METHOD: Orders were checked for six elements: pharmaceutical company's identity, protocol's name, patient's identity (i.e., initials), investigator's signature, order's date, and drug designation. Each element was categorized according to three quality criteria: mistake (wrong information), omission, or imprecision (incomplete information). A total of 536 orders were evaluated corresponding to 268 orders and to 4824 quality criteria in each period. RESULTS: During the baseline study, 228 (85%) problematic prescriptions were detected. Of the 4824 quality criteria evaluated, 422 (8.7%) errors were recorded. Common types of errors were omission of pharmaceutical company's identity, mistaken protocol name, and omission of patient's identity. After the introduction of the order form, 13 (4.9%) prescriptions contained errors. Fifteen (0.3%) quality criteria were not in conformity with the standard. The common types of errors were omission of patient's identity and order date. Physician's orders for investigational drugs are more complete when they use a preprinted prescription form than when they use traditional orders. CONCLUSION: The introduction of a preprinted order form for investigational drugs prevents potential medication errors and contributes to patients' safety.