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Understanding breast cancer survivors' perspectives is critical to personalizing endocrine therapy (ET) in the adjuvant setting. A nationwide survey among breast cancer survivors was proposed in France, in collaboration with patient advocacy organizations, to assess their perspectives on personalizing ET and developing dedicated informative tools. This survey explored patients' preferences regarding ET intake schedule, formulation, presentation (color, taste, shape, size, design, and packaging), combination with agents targeting ET-related adverse events, and a mobile application to support them during ET. Of the 1103 individuals who started the survey, 939 (85.1%) were eligible for enrollment and completed the survey. The majority of the participants considered that a personalized ET should take into consideration the intake schedule (n = 974, 90.7%) and swallowable tablet formulation (n = 606, 64.5%), without a preference for ET presentation (n = 619; 65.9%). The majority of the participants expressed a willingness to participate in a potential clinical trial evaluating the combination of ET with agents targeting ET-related adverse events at the start of ET (n = 752, 80.1%) or in the case of major ET-related adverse events (n = 778, 82.8%). The primary considerations were to have an uncompromised ET efficacy and a guaranteed reduction of adverse events. Last, a dedicated mobile application was considered helpful by 665 participants (70.8%). Informative tools should focus on the recommendations for dealing with adverse events (n = 593, 63.2%), the impact on the patient's daily life (n = 515, 54.9%), benefits (n = 504, 53.7%), and adverse events (n = 494, 52.6%) of ET. This survey paves the way for multimodal strategies that can include a personalized ET (e.g., ET in combination with agents targeting ET-related adverse events) and dedicated mobile applications to ultimately improve adherence.
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Breast cancer is the most frequently diagnosed cancer in women worldwide, and non-adherence to adjuvant hormonotherapy can negatively impact cancer recurrence and relapse. Non-adherence is associated with side effects of hormonotherapy. Pharmacological strategies to mitigate the side effects include coadministration of antidepressants, however patients remain non-adherent. The aim of this work was to develop medicines containing both hormonotherapy, tamoxifen (20 mg), along with anti-depressants, either venlafaxine (37.5 or 75 mg) or duloxetine (30 or 60 mg), to assess the acceptability and efficacy of this personalised approach for mitigating tamoxifen side effects in a clinical trial. A major criterion for the developed medicines was the production rate, specified at minimum 200 dosage units per hour to produce more than 40,000 units required for the clinical trial. A novel capsule filling approach enabled by the pharmaceutical 3D printer M3DIMAKER 2 was developed for this purpose. Firstly, semi-solid extrusion 3D printing enabled the filling of tamoxifen pharma-ink prepared according to French compounding regulation, followed by filling of commercial venlafaxine or duloxetine pellets enabled by the development of an innovative pellet dispensing printhead. The medicines were successfully developed and produced in the clinical pharmacy department of the cancer hospital Gustave Roussy, located in Paris, France. The developed medicines satisfied quality and production rate requirements and were stable for storage up to one year to cover the duration of the trial. This work demonstrates the feasibility of developing and producing combined tamoxifen medicines in a hospital setting through a pharmaceutical 3D printer to enable a clinical trial with a high medicines production rate requirement.
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Neoplasias da Mama , Cloridrato de Duloxetina , Medicina de Precisão , Impressão Tridimensional , Tamoxifeno , Cloridrato de Venlafaxina , Tamoxifeno/administração & dosagem , Cloridrato de Duloxetina/administração & dosagem , Humanos , Medicina de Precisão/métodos , Cloridrato de Venlafaxina/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Feminino , Antidepressivos/administração & dosagem , Composição de Medicamentos/métodos , Antineoplásicos Hormonais/administração & dosagemRESUMO
In oncology, the place of patients has a natural and strong legitimacy. Cancer is a common disease, with many singularities but also common features between pathologies, with issues ranging from prevention to possible palliative phases or post-cancer, and conducive to both individual and collective decision-making processes. Patient engagement is now essential at all levels of the healthcare system, from simple information to real involvement (co-construction). For 20 years, Gustave-Roussy, a comprehensive cancer centre in Villejuif, has implemented specific reflection and actions, embodied by the creation of a patients and caregivers committee and complemented by an institutional steering body that illustrates the transformation of "working for" into "working with". At the level of direct care, the main works promoted concern shared-decision-making between patient and professional and accompanying patients. At the institutional level, we find the expertise of hospital projects or services, the development of institutional documents (information and advance directives form, etc.), and internal evaluation (audit). At the political level, participation in Unicancer's patient-experience working group has allowed for a better coordinated deployment with other centers. Unicancer has developed a lexical guide defining patient resources, peer helpers, trainers, evaluators and coordinators. This partnership approach is beneficial for patients, their loved ones, caregivers, and must be amplified and give rise to new research work.
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Institutos de Câncer , Cuidadores , Tomada de Decisão Compartilhada , Neoplasias , Participação do Paciente , Humanos , Institutos de Câncer/organização & administração , Neoplasias/terapia , Neoplasias/psicologia , França , Cuidadores/psicologiaRESUMO
Temozolomide (TMZ) is part of the therapeutic armamentarium used in managing pediatric cancers; however, available oral forms (capsules) are not adapted for use in children. Our aim was to assess the dose accuracy and stability of TMZ using capsule contents mixed with food compared with a novel, ready-to-use liquid formulation specifically developed for children (Ped-TMZ, brand name KIZFIZO). Dose accuracy and TMZ stability testing were performed with TMZ capsule contents (90 mg) mixed with food vehicles (apple juice, apple sauce, cream, milk, and mashed potatoes) and compared to an equivalent dose of Ped-TMZ. Acceptance criteria were predefined for TMZ (95.0-105.0%) and its degradation product amino-imidazole-carboxamide (AIC; <1%) content. The delivered dose was significantly higher using Ped-TMZ (96.6 ± 1.2%) and within the predefined criteria for TMZ content, whereas it was systematically under the lower specifications of 95% using capsule-derived preparations with apple juice (91.0 ± 1.5%) and apple sauce (91.6 ± 1.4%), respectively (p < 0.0001). In chemical stability tests, the four food vehicles (apple sauce, cream, milk, mashed potatoes) had a significant effect on TMZ stability (p = 0.0042), and the AIC significantly increased with time in three of the four vehicles (p < 0.0001). Only 1/72 of preparations from capsules met the predefined acceptance criteria, whereas Ped-TMZ showed no TMZ loss, and the AIC remained within specifications. In conclusion, mixing TMZ capsule content with food may result in significant underexposure, possibly even greater in routine practice, as complete food intake by the child is unlikely.
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Glioblastoma is one of the most common and aggressive forms of brain tumor, a rare disease for which there is a great need for innovative therapies. ONC201, a new drug substance, has been used in a compassionate treatment program where the choice of dosage form and regimen have yet to be justified. The prior knowledge needed to anticipate ONC201 stability problems has recently been partially addressed, by (i) showing that ONC201 is sensitive to light and oxidation and (ii) identifying the molecular structures of the main degradation products formed. The aim of the work presented here was to improve our understanding of the degradation pathways of ONC201 using data from ab initio calculations and experimental work to supplement the structural information we already published. The C-H bonds located αto the amine of the tetrahydropyridine group and those located alpha to the imine function of the dihydroimidazole group exhibit the lowest bond dissociation energies (BDEs) within the ONC201 molecule. Moreover, these values drop well below 90 kcal.mol-1 when ONC201 is in an excited state (S1; T1). The structures of the photoproducts we had previously identified are consistent with these data, showing that they would have resulted from radical processes following the abstraction of alpha hydrogens. Concerning ONC201's sensitivity to oxidation, the structures of the oxidation products matched the critical points revealed through mapped electrostatic potential (MEP) and average local ionization energy (ALIE). The data obtained from ab initio calculations and experimental work showed that the reactivity of ONC201 to light and oxidation conditions is highly dependent on pH. While an acidic environment (pH < 6) contributes to making ONC201 quantitatively more stable in solution in the face of oxidation and photo-oxidation, it nevertheless seems that certain chemical groups in the molecule are more exposed to nucleophilic attacks, which explains the variation observed in the profile of degradation products formed in the presence of certain antioxidants tested. This information is crucial to better understand the stability results in the presence of antioxidant agents and to determine the right conditions for them to act.
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INTRODUCTION: Following the 2005 decree on securing the medicine supply chain, the production of "chemotherapies", anticancer drugs (cytotoxic, cytostatic, immunotherapy), was centralised within hospital pharmacies. To cope with increasingly growing activities, pharmacies are moving towards robotisation. This work offers feedback from four French sites pioneers in robotic production. MATERIAL AND METHOD: A review of the literature was carried out on the PubMed and Google Scholar scientific databases and GERPAC publications relating to the robotic production of chemotherapy preparations. This review allowed to select 25 articles. RESULTS: The robotisation of the production of "chemotherapies" requires infrastructural prerequisites, a reengineering of the manufacturing process and the patient journey. This impacts all the parties involved in this complex process. The "cobotisation" concept or collaborative robotics must be anticipated by the teams. Robotisation is an institutional decision, which must be owned by the pharmaceutical team and endorsed by the medical team and management. DISCUSSION/CONCLUSION: For reasons of optimisation, safeguarding and management of human resources, a large number of centres get equipped with robotic systems. Robotic preparation should extend to other non-hazardous preparation, as it is already the case in other countries. This strategic view should be carried out today to anticipate problems, ensure safety and improve the healthcare quality.
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Antineoplásicos , Farmácias , Robótica , Humanos , Antineoplásicos/química , HospitaisRESUMO
PURPOSE: Kinase inhibitors (KI) and antibodies targeting the VEGF pathway are approved in a broad spectrum of cancers and associated with an increased risk of bleeding and thromboembolic events (TE). The use of direct oral anticoagulants (DOACs) apixaban and rivaroxaban is increasing in cancer patients, but limited data are available for patients receiving anti-VEGF agents. METHODS: To assess safety of DOAC with concomitant anti-VEGF agents, a retrospective chart review of all patients receiving concomitantly DOAC and anti-VEGF agents was performed from 2013 to 2020 in our center. Data on demographics, safety, and time on treatment were collected. Main outcome was safety (bleeding and thromboembolic events). RESULTS: Of 92 patients (median age 66 years (IQR: 59-72)), 40 were treated with KI and 52 with bevacizumab. The most frequent primary tumor sites were colon/rectum (24%), kidney (21%), ovary (13%), lung (11%), soft tissue sarcoma (10%), and thyroid (9%); 2% had brain metastases. Apixaban 5 mg bid (n = 41) or rivaroxaban 20 mg daily (n = 51) were given for TE (65%), atrial fibrillation (32%), or other indications (3%). The median duration of concomitant treatment was 4.8 months (95%CI: 0.7-50.0) with bevacizumab and 11.7 months (95%CI: 0.1-53.8) with KI. Grade ≥ 3 bleeding events occurred in 5 patients (5%): 4 patients receiving bevacizumab (one grade 5 upper digestive tract bleeding and three grade 3 rectal or vaginal hemorrhages) and 1 patient under cabozantinib for kidney cancer with endobronchial metastasis (grade 3 hemoptysis). Grade ≥ 3 TE occurred in 8 patients (9%): 7 patients receiving bevacizumab (including one grade 5 pulmonary embolism), and one patient receiving sunitinib (grade 3 pulmonary embolism). Median time-to-event (bleeding or thrombotic event) was not reached (NR) (95%CI: 76.9-NR) for KI and 86.9 months (95%CI: 42.9-148.0) for bevacizumab. CONCLUSIONS AND RELEVANCE: In our experience, the use of DOAC was safe in selected patients treated with KI, but unclear with bevacizumab. More data are needed to endorse guidelines in this specific group of patients.
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Neoplasias , Embolia Pulmonar , Feminino , Humanos , Idoso , Rivaroxabana/efeitos adversos , Estudos Retrospectivos , Dabigatrana/efeitos adversos , Anticoagulantes/efeitos adversos , Bevacizumab/efeitos adversos , Administração Oral , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Neoplasias/tratamento farmacológicoRESUMO
BACKGROUND: Imatinib is a protein-tyrosine kinase inhibitor which is currently only commercially available as a tablet dosage form in the strength of 100mg and 400mg. The elaboration of new oral liquid formulations is suitable in pediatrics and for patients who have difficulties to swallow, notably in the absence of commercial forms. This enables the adaptation of dosage and secure the administration. OBJECTIVES: The formulation of an oral pediatric solution of imatinib at a concentration of 30 mg/mL and the evaluation of its stability for the treatment of pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia. METHODS: The physicochemical stability parameters: appearance, pH, osmolality, and drug content of formulation were evaluated for 30 days when stored at 2-8°C. Concentration of solution was measured with a validated method using high performance liquid chromatography (HPLC) coupled with an absorbance UV detector. Equally, microbiological stability was performed. RESULTS: The remaining imatinib concentration was at least 95% of the initial concentration after 30 days stored in fridge temperature. No changes were observed regarding the physical properties of the formulation during the study period. CONCLUSIONS: The stability study showed that the imatinib oral solution at a concentration of 30 mg/mL provides an alternative option at the commercial tablet dosage forms for pediatric patients and patients who have difficulties to swallow.
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Pediatria , Administração Oral , Criança , Estabilidade de Medicamentos , Humanos , Mesilato de Imatinib , Suspensões , ComprimidosRESUMO
BACKGROUND: The COVID-19 pandemic has aggressively reached the most vulnerable, not only the elderly but also patients with chronic conditions such as cancer. In this study, we present the outlines of ethical thinking and the measures implemented to try to respect our basic values of care, in the specific environment of an oncology hospital. METHODS: Our ethics committee created an ethical watch system based on 24/7 shifts to assist practitioners in their daily decisions. We discuss the challenges faced by patients with cancer during the pandemic, such as access to critical care and ethical dilemmas in the context of resource scarcity, as well as the issue of isolation of patients. We also debate the restrictions in access to oncology care in a health context strongly 'prioritised' against COVID-19. RESULTS: In all areas of an ethical dilemma, either for sorting out access to critical care or for the dramatic consequences of prolonged isolation of patients, our common thread was our attempt to protect, whenever possible, the principles of deontological ethics by strictly resisting utilitarian pressure. Respecting democratic health decision-making processes is a cornerstone of ethically relevant decisions, including in the context of a sanitary crisis. CONCLUSION: The role of an ethics committee related to real-life situations includes not only a reflexive perspective in respect of fundamental principles, but also the help to enlighten and resolve ethical dilemmas in complex clinical situations. This ethical watch team assists physicians in decision-making, promoting the supportive and palliative dimension of care with a holistic approach.
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COVID-19 , Neoplasias , Humanos , Idoso , Pandemias , Neoplasias/terapia , Oncologia , Cuidados PaliativosRESUMO
A novel coronavirus, SARS-CoV-2, was first reported as a respiratory illness in December 2019 in Wuhan, China. Since then, the World Health Organization (WHO) Emergency Committee declared a global health. COVID-19 has now spread worldwide and is responsible of more than 472,216 persons, out of 9,100,090 officially diagnosed worldwide since 23 of June. In the context of cancer patients, COVID-19 has a severe impact, regarding pulmonary infection but also cancer treatments in this fragile and immunocompromised population, and ICU admission for cancer patients in the context of COVID-19 requires ethical and clinical consideration. In our cancer center, intensivists, oncologists, pharmacists, and hospital administrators had to prepare for a substantial increase in critical care bed capacity (from 10 ICU beds, 6 medical intensive care beds, and 12 surgical intensive care beds, bed capacity was increased to 28 medical intensive care beds with ventilating capacity) and to adapt infrastructure (i.e., ICU beds), supplies (i.e., drugs, ventilators, protective materials), and staff (i.e., nurses and medical staff). Overall, thirty-three COVID-19 patients were admitted in our ICU, 17 cancer-free and 16 with cancer, and 23 required mechanical ventilation, resulting in 4 deaths (of them two patients with cancer). We report here management of a dedicated intensive care unit of a cancer center during the COVID-19 infection pandemic, considering resource allocation and redistribution of healthcare workers.
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Betacoronavirus , Infecções por Coronavirus/complicações , Unidades de Terapia Intensiva , Neoplasias/terapia , Pneumonia Viral/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19 , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/epidemiologia , Pandemias , SARS-CoV-2 , Adulto JovemRESUMO
BACKGROUND: Pharmacists have been involved in the care of transplant recipients for several decades, and a growing body of literature shows the beneficial effects of clinical pharmacist care on important outcomes for these patients. OBJECTIVES: The primary objective was to describe the roles and impacts of pharmacists in a solid organ transplant setting. The secondary objective was to describe and rate the pharmacists' interventions. DATA SOURCES: Three databases-PubMed, Embase, and Evidence-Based Medicine Reviews-were searched from January 1, 1990, to June 16, 2015. STUDY SELECTION AND DATA EXTRACTION: All studies addressing the roles of pharmacists and the impacts of clinical pharmacy services on the care of solid organ transplant recipients were considered. Only studies providing a statistical analysis were included. Design, setting, sample size, patient characteristics, pharmacists' interventions, study bias, and outcomes were extracted for analysis. DATA SYNTHESIS: Four randomized controlled trials, 4 cohort studies, 3 pre-post studies, and 1 quasi-randomized controlled trial were included in the review, representing a total of 1837 patients. Of the 12 studies included, 8 specifically focused on renal transplant, and 1 each focused on liver, lung, abdominal organ, and general solid organ transplant. The pivotal pharmacist activities leading to the main patient outcomes were medication counselling (n = 8 studies), medication reconciliation (n = 5), and reviewing and optimizing drug therapy (n = 3). Improvements to medication adherence (n = 6 studies), morbidity (n = 4), costs (n = 2), and medication errors (n = 2) were reported. CONCLUSION: Currently available evidence suggests that pharmacists can improve patient outcomes in the solid organ transplant setting. Adherence, morbidity, costs, and medication errors were identified as the main outcomes that were improved by pharmaceutical interventions. Transplant programs need to invest more in this resource.
CONTEXTE: Les pharmaciens participent aux soins des greffés depuis plusieurs décennies et un nombre croissant de publications révèlent les effets bénéfiques des soins prodigués par les pharmaciens cliniciens quant aux résultats thérapeutiques importants pour ces patients. OBJECTIFS: L'objectif principal était de décrire les rôles des pharmaciens et leurs influences par rapport aux greffes d'organes solides. L'objectif secondaire était de décrire et d'évaluer les interventions des pharmaciens. SOURCES DES DONNÉES: Les bases de données PubMed, Embase et Evidence-Based Medicine Reviews ont été interrogées pour la période allant du 1cr janvier 1990 au 16 juin 2015. SÉLECTION DES ÉTUDES ET EXTRACTION DES DONNÉES: Toutes les études abordant les rôles des pharmaciens et l'influence des services de pharmacie clinique sur les soins des receveurs d'organes solides ont été prises en considération. Seules les études présentant des analyses statistiques ont été retenues. Le plan d'étude, le contexte, la taille de l'échantillon, les caractéristiques des patients, les interventions des pharmaciens, les biais et les résultats thérapeutiques ont servi à l'analyse. SYNTHÈSE DES DONNÉES: Quatre études contrôlées à répartition aléatoire, 4 études de cohorte, 3 études avant-après et 1 essai comparatif à répartition quasi-aléatoire ont été retenus pour l'analyse, ce qui représentait au total 1837 patients. Parmi les 12 études retenues, 8 abordaient spécifiquement la greffe rénale et chacune des 4 autres concernait respectivement une greffe hépatique, une greffe pulmonaire, une greffe d'organe abdominal et une greffe d'organe solide. Les activités clés des pharmaciens menant aux principaux résultats thérapeutiques étaient les conseils sur les médicaments (n = 8 études), l'établissement du bilan comparatif des médicaments (n = 5) ainsi que l'examen et l'optimisation de la pharmacothérapie (n = 3). On a constaté des améliorations des taux d'observance pharmacothérapeutique (n = 6 études), des taux de morbidité (n = 4), des coûts (n = 2) et des taux d'erreurs de médicaments (n = 2). CONCLUSION: Les données probantes disponibles laissent croire que les pharmaciens peuvent améliorer les résultats thérapeutiques en ce qui concerne les greffes d'organes solides. Les taux d'observance pharmacothérapeutique, les taux de morbidité, les coûts et les taux d'erreurs de médicaments ont été désignés comme les résultats principaux qui ont été améliorés par les interventions pharmaceutiques. Les programmes de greffe doivent investir davantage dans cette ressource.
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PURPOSE: This study aimed at exploring the prevalence of self-reported antenatal and postnatal depressive symptoms by severity across multiple countries and the association between antidepressant treatment in pregnancy and postnatal symptom severity. MATERIALS AND METHODS: This was a multinational web-based study conducted across 12 European countries (n=8069). Uniform data collection was ensured via an electronic questionnaire. Pregnant women at any gestational week and mothers of children with <1 year of age could participate. We used the Edinburgh Postnatal Depression Scale (EPDS) to measure the prevalence of antenatal and postnatal depressive symptoms according to severity, which were corrected by survey weight adjustment (descriptive analysis). Within mothers with a psychiatric disorder (n=173), we estimated the association between antidepressant treatment in pregnancy and postnatal depressive symptom severity, as standardized EPDS mean scores, via the inverse probability of treatment weight (association analysis). RESULTS: In the descriptive analysis (n=8069), the period prevalence of moderate-to-very severe depressive symptoms was higher in the western and eastern regions relative to the northern region, both in the antenatal period (6.8%-7.5% vs 4.3%) and in the postnatal period (7.6% vs 4.7%). One in two mothers with psychiatric disorders used an antidepressant in pregnancy (86 of 173). In the association analysis, women medicated at any time during pregnancy (adjusted ß=-0.34, 95% confidence interval [CI] =-0.66, -0.02) had a significant postnatal symptom severity reduction compared with the nonmedicated counterpart. This effect was larger (ß=-0.74, 95% CI =-1.24, -0.24) when the analysis was restricted to mothers within 6 months after childbirth. CONCLUSION: The prevalence of self-reported antenatal and postnatal depressive symptoms differs across European countries. Among women with psychiatric disorders, those who had been on treatment with antidepressants during pregnancy were less likely to report postnatal depressive symptoms, particularly within the 6-month period after childbirth, compared with the nonmedicated counterpart.
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The hospital-community interface represents a real challenge in the care of elderly people. A lack of coordination and communication is the main obstacle to ensuring the fluidity of this pathway. On a definite territory, a new hospital-community liaison sheet was developed as the result of a collaborative approach and then evaluated. This simple, useful and effective cross-professional tool, is the first step towards improving communication between these two universes.
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Serviços de Saúde Comunitária/organização & administração , Hospitais Comunitários , Alta do Paciente , Transferência de Pacientes/organização & administração , Melhoria de Qualidade/organização & administração , Idoso , Idoso de 80 Anos ou mais , França , Humanos , Comunicação Interdisciplinar , Colaboração Intersetorial , Auditoria de EnfermagemRESUMO
OBJECTIVES: The objectives of this study were to describe drug use during pregnancy in a context of acute and chronic diseases during pregnancy. An additional aim was to analyze the maternal socio-demographic and lifestyle factors associated with medication use in pregnancy. METHODS: Cross-sectional, web-based descriptive study conducted among French women using a 33-item web-based questionnaire. Multiple logistic regression analyzes were performed to assess the association between socio-demographic/lifestyle factors and medication use in pregnancy. RESULTS: A total of 374 women completed the questionnaire. Of these, 75.1% (n=280) and 12.6% (n=47) used medication for treatment for acute and chronic diseases, respectively. A total of 68.9% (n=258) of women surveyed have deliberately avoided taking non-prescribed drugs when they were pregnant. Non-users of folic acid were less often taking medications (78.9%) than folic acid users (89.5%) OR=0.44 [0.24; 0.79]. CONCLUSION: More than eight out of ten women have taken medication during pregnancy especially analgesics. The maternal socio-demographic and lifestyle factors do not seem to impact on the use of medication during pregnancy.
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Background Medication reconciliation (MedRec) at discharge is a cumbersome but necessary process to reduce the risk of medication errors at transitions of care. The main barriers to implementing such a process are the large number of professionals involved and a lack of collaboration among caregivers. Objective This study was designed to assess the need for a medication reconciliation form at discharge in an orthopaedic surgical ward. Setting The study was conducted in the orthopaedic surgery ward among inpatients at a 407-bed French teaching hospital. Method We first performed a retrospective audit to evaluate the quality of discharge medication information in the medical record, after which a 5-week prospective study was conducted in 2013. All patients admitted to the orthopaedic surgery unit who had at least two chronic diseases and three medications underwent MedRec at discharge. We designed a Best Possible Medication at Discharge List (BPMDL) to be completed by hospital staff and transmitted to community caregivers. Mean outcome measures We assessed the completeness of medication information in the medical records, discrepancies between medications noted on the BPMDL and those prescribed on the discharge order, and the value of the BPMDL for stakeholders. Results Thirty patients were included in the study. Only 4 % of medical records contained a discharge summary with complete medication information. In 67 % of cases, treatment discontinuations at admission were justified, and medications were reintroduced before discharge, while 107 treatments (45 %) were added but not prescribed on discharge orders. Discontinuations prior to discharge were justified in 60 % of cases (treatments were ended or supportive treatment was required during hospitalization). An average of 2.1 treatments were prescribed on discharge orders (vs. 9.4 prescribed on the BPMDL). Patients, general practitioners (GP), and physicians in long-term care settings (PLTCS) rated the format, content, and readability of the BPMDL as satisfactory, and it was found to be of value for patients and PLTCS to support medication information. Because of the very low response rate among GP (10 %), we were unable to determine their satisfaction with the MedRec discharge process. Conclusion The transmission of patient medication information at discharge is often lacking. As such, the BPMDL appears to have value to both patients and community health providers. Because this study was conducted within a single surgical unit, further study in other surgical wards is needed to assess generalizability.
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Continuidade da Assistência ao Paciente , Erros de Medicação/prevenção & controle , Reconciliação de Medicamentos/métodos , Ortopedia/métodos , Idoso , Feminino , Registros de Saúde Pessoal , Humanos , Masculino , Alta do Paciente , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Estudos RetrospectivosRESUMO
BACKGROUND: Antibiotic dosing in neonates varies between countries and centres, suggesting suboptimal exposures for some neonates. We aimed to describe variations and factors influencing the variability in the dosing of frequently used antibiotics in European NICUs to help define strategies for improvement. METHODS: A sub-analysis of the European Study of Neonatal Exposure to Excipients point prevalence study was undertaken. Demographic data of neonates receiving any antibiotic on the study day within one of three two-week periods from January to June 2012, the dose, dosing interval and route of administration of each prescription were recorded. The British National Formulary for Children (BNFC) and Neofax were used as reference sources. Risk factors for deviations exceeding ±25% of the relevant BNFC dosage recommendation were identified by multivariate logistic regression analysis. RESULTS: In 89 NICUs from 21 countries, 586 antibiotic prescriptions for 342 infants were reported. The twelve most frequently used antibiotics - gentamicin, penicillin G, ampicillin, vancomycin, amikacin, cefotaxime, ceftazidime, meropenem, amoxicillin, metronidazole, teicoplanin and flucloxacillin - covered 92% of systemic prescriptions. Glycopeptide class, GA <32 weeks, 5(th) minute Apgar score <5 and geographical region were associated with deviation from the BNFC dosage recommendation. While the doses of penicillins exceeded recommendations, antibiotics with safety concerns followed (gentamicin) or were dosed below (vancomycin) recommendations. CONCLUSIONS: The current lack of compliance with existing dosing recommendations for neonates needs to be overcome through the conduct of well-designed clinical trials with a limited number of antibiotics to define pharmacokinetics/pharmacodynamics, efficacy and safety in this population and by efficient dissemination of the results.