Whether patients whose catheter tip grows Staphylococcus aureus but who have no concomitant bacteraemia should receive antimicrobials remains an unresolved issue. However, a proportion of patients with catheter tips colonized by S. aureus have no blood cultures taken because of low suspicion of sepsis and the meaning of this microbiological finding is unknown. We have analysed all catheter tips growing S. aureus during a 6-year period and have selected patients without blood cultures taken 7 days before or after central vascular catheter removal. Patient's evolution was classified into good and poor outcome. Poor outcome was defined as S. aureus infection within 3 months after catheter withdrawal or death in the same period with no obvious cause. Patients with good and poor outcomes were compared to assess whether antimicrobial therapy influenced evolution. Sixty-seven patients fulfilled our inclusion criteria and five (7.4%) had a poor outcome. The administration of early anti-staphylococcal therapy had no impact on the outcome of this population (p 0.99). The only factor independently associated with a poor outcome was the presence of clinical signs of sepsis when the catheter was removed (OR 20.8; 95% CI 2.0-206.1; p 0.009). Our data suggest that patients with central vascular catheter tips colonized with S. aureus should be closely monitored for signs and symptoms of ongoing infection, but if these are not present then antimicrobial therapy does not seem justified.
Background Waldenstrom’s macroglobulinemia (MW) is an uncommon lymphoproliferative disorder of the B cells, associated with overproduction of the monoclonal component Immunoglobulin M (IgM). Purpose To analyse the treatment and outcome of patients with MW. Materials and Methods Observational, retrospective and descriptive study of all patients diagnosed with MW from 2001 to the present day. A cytostatic dispensing programme (OncoGest) and the electronic history (Selene) were used to gather the following data: gender, age, year of diagnosis, previous treatments, treatment regime, adverse reactions. The treatment response was rated according to symptom let-up and decrease in the serum IgM. Results 8 MW patients were included, their average age was 72 years old (rank: 51–82), of which 50% were male. The symptoms with which patients presented before commencing treatment included: asthenia (100%), anorexia, peripheral neuropathy (37.5%), anaemia (25%), hyperviscosity syndrome (62.5%); 40% of patients required a session of plasmapheresis. Various treatment regimens were used: Two of the patients commenced treatment with fludarabine, one started with cladribine and two with chlorambucil. Patients with fludarabine had a good response and in the other three cases the response was quite low; as a result, treatment was changed to weekly rituximab until the symptoms stopped and the IgM decreased. Three of the patients started treatment with weekly rituximab with a good response in two of the cases and one had a low response so the treatment was changed to rituximab with cladribine. All patients except one who is currently receiving rituximab and cladribine have had relapses after the first treatment. They were treated with weekly rituximab until the symptoms stopped, except in two of the cases, who currently continue with maintenance rituximab every two and three months respectively. As regards tolerance and adverse reactions, neutropenia appeared in just one patient treated with chlorambucil, the treatments were well tolerated by the remaining patients. Conclusions Various drugs are used for the treatment of MW: chlorambucil, fludarabine, cladribine and rituximab, alone or in combination. The treatment regimen the most commonly used, especially if weekly rituximab, especially for those patients that have had relapses with other treatments. Weekly rituximab is a treatment with a good response rate and is well tolerated. No conflict of interest.
Background Rituximab is used in Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL) and Rheumatoid Arthritis (RA). Moreover, it has other uses which are not included in Technical Data Sheet (TDS). Purpose To analyse the off-label-use of Rituximab and estimate the global cost of Rituximab treatment. Materials and methods Retrospective and descriptive study, in which all patients who received Rituximab between January and June, 2011, are included. The list of patients, dose and number of cycles administered were extracted from the Oncogest® program. From the electronic medical record (Selenex00AE; Siemens 5.1.0.1) the following were obtained: sex, age, diagnosis and prescribing services. The total cost was estimated by summing the sale price corresponding to the total dose for each patient. Results Number of patients: 79; Male: 54.4%; Female: 45.6%; Average age: 61.3 years (range: 16-87). In 67 patients (84.8%) the diagnosis were described in TDS: NHL 46 (52.8%), CLL 19 (24.1%) and RA 2 (2.5%). In 12 patients (15.2%) the indication was not included in TDS, among these the most frequent use was Idiopathic Thrombocytopenic Purpura (ITP) (4 patients). The departments which most frequently prescribed Rituximab were: Haematology (78.5%) and Oncology (11.4%). The average dose per chemotherapy cycle was 697 mg and the average number of cycles per patient was 3.1. The total cost of Rituximab was €408 370 and the average cost per patient was €5 169. The cost of approved treatments responded for 84% of the total cost (€342 889). DGI023 table 1 DIAGNOSIS AVERAGE COST PER PATIENT (euro, €) CLL 7 476 NHL 4 157 AR 4 800 Conclusions Rituximab was mostly used in label conditions, mainly in NHL treatment. Label use was associated with the highest cost of Rituximab. Moreover, the average cost per patient with CLL proved to be higher than all other approved uses, because the total doses administered, as well as the number of cycles, were higher. The most common diagnosis off-label-use was ITP.
Background Fingolimod has recently been authorised in our country (April 2011). It is the first orally administered disease-modifying drug that has been approved for highly active relapsing remitting multiple sclerosis. So far, only one patient has been treated with it in our hospital, so we have limited experience in its use. Purpose The case report relates to relapsing remitting multiple sclerosis (RRMS) patient with high disease activity under treatment with Fingolimod. We aim to describe the evolution of this patient during the treatment period. Materials and Methods It was an observational, six-month prospective study. The patient, a 32-year-old female, was diagnosed with RRMS in February 2004 after an episode of sensory deficits. Results At first, she was treated with interferon b-1a, which was stopped in February 2006 and switched to mitoxantrone IV. The patient continued to have several relapses during the treatment with this immunosuppressant; one of these relapses required plasma exchange therapy. Her Expanded Disability Status Scale (EDSS) worsened to 6 points. Assuming a lack of efficacy, the patient started treatment with natalizumab in April 2007. During four years of treatment with natalizumab she showed remarkable clinical improvement and did not experience any new relapses. Her EDSS improved to 2.5. After this time and due to the high risk of developing progressive multifocal leukoencephalopathy (PML), she switched to fingolimod (December 2011). Ten days after initiation, she developed a severe relapse that required hospital admission, high dose IV steroids and 3 cycles of plasma exchange therapy. Doctors concluded this relapse was in fact a rebound effect due to stopping natalizumab. In February 2012 she restarted fingolimod; one month later she developed a new relapse, treated with high dose steroids. In April and May 2012 she had two more relapses, with severe EDSS worsening and again managed with high dose steroids. In May 2012, it was decided to stop treatment with fingolimod, and despite the risk of PML (JC virus +), natalizumab was restarted. Conclusions During six months of fingolimod treatment, the patient’s condition further deteriorated (four relapses in six months), her EDSS worsened and showed a high disease activity. We conclude that the treatment was not effective in this patient. No conflict of interest.
Background The ‘Study on patient safety in primary health care’ (APEAS), published in 2008 by the Spanish Health Ministry declared that 48% of adverse events (AEs) detected in these patients were due to medicines errors (MEs). The Institute for Safe Medication Practices (ISMP) promotes the development of internal systems to report medicines-related incidents in hospitals in order to achieve effective preventative measures. PurposeTo analyse total errors in an intravenous mixing unit and establish checkpoints to prevent them. Materials and MethodsProspective observational study (August–December 2011) which included outpatients who might be exposed to an error with intravenous medicines. The variables were: Wrong drug, original prescription service, prescription type (manual or printed), who detected the error and process error (prescription, validation, preparation or administration). Errors were classified according to severity category and error type based on the taxonomies listed in ISMP Spain. The errors observed and reported by the staff involved with the process were recorded by the pharmacist. The differences between frequencies were checked with the Chi-Square statistical test. ResultsThe total error frequency (EF) was 1.27%. The drugs most frequently involved were natalizumab (2.43%), infliximab (1.23%) and intravenous immunoglobulin (1.23%). No statistically significant differences between EF of each drug and the mean frequency were detected (P = 0.94, 0.76 and 0.94). The services involved were: Gastrointestinal (2.98%), Neurology (1.57%), Rheumatology (1%), Haematology (0.15%) and Oncology (0.035%). Only in the Haematology and Oncology services were differences from the average found (P = 0.038, p = 0.001). Most failed orders were manual (67%). All incidents occurred in the prescribing process and were detected by the pharmacist during validation. No errors reached the patient (category B). In the classification by error type: 67% were incorrect date (periodicity in the cycle), 22% dosage (50% excess) and 11% in the rate of administration. Conclusions After reviewing the results we can assume that the main checkpoints where our activities should focus on are the following: incorrect date, dosage and rate of administration. A possible methodological bias can be considered because the data were collected in the pharmacy unit and all errors were prescription errors – no pharmacy or process errors. No conflict of interest.
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