J.F. Marín Pozo, B. Oya Álvarez de Morales, I. Caba Porras, J. Aranda García
{"title":"Study into the use of cetuximab in metastatic colorectal cancer in a third level hospital","authors":"J.F. Marín Pozo, B. Oya Álvarez de Morales, I. Caba Porras, J. Aranda García","doi":"10.1016/S2173-5085(09)70072-3","DOIUrl":"10.1016/S2173-5085(09)70072-3","url":null,"abstract":"<div><h3>Objectives</h3><p>In this study we will analyse the use of cetuximab in the treatment of metastatic colorectal cancer (MCC) in a third level hospital. We will establish the usage conditions in our centre in keeping with those approved in current technical records. We will also record the treatment duration under the different usage conditions and use the information available in material that has been published to date.</p></div><div><h3>Methods</h3><p>An indication-prescription study of cetuximab in MCC was carried out on all patients treated with cetuximab for colorectal cancer in the period between 2004 and 2007 in our hospital. The number of prescriptions that do not fit the approved recommendations for cetuximab in MCC treatment (and why they do not fit) is determined. Descriptive statistical analysis was carried out for the different variables collected, and a Kaplan-Meier analysis was carried out for the treatment duration variable, so as to determine whether there is a difference in effectiveness for the common uses in our hospital.</p></div><div><h3>Results</h3><p>Data was recorded for 74 patients treated with cetuximab. The average cost per patient was €14 399 and on average, 15.3 dosages were administered per patient. The average initial dosage was 710<!--> <!-->mg with an average dosage of 446<!--> <!-->mg after that. The average duration of the treatments was 15.4 weeks. cetuximab was administered to 7 patients as first-line treatment and to 32 patients who had not used irinotecan previously. Irinotecan was not associated with cetuximab treatment in 9 patients, and it was used in 14 patients resulting in a negative outcome for the EFGR test. Treatment duration was longer in the case of its use as first-line treatment (27.7 weeks), if irinotecan had not been used before (23.3 weeks), if irinotecan was used (20.5 weeks) and in patients with positive EFGR results (19.6 weeks.) The median treatment duration, under the different conditions, was less than the average but with no major differences between them. 70.3% of prescriptions did not fit with the data sheet.</p></div><div><h3>Conclusions</h3><p>The use of cetuximab under different conditions to those approved on the technical data sheet creates an increase in the number of patients treated and a longer duration of the treatments which implies an increase in intake. The average and the mean treatment times for the usage conditions found did not present any significant statistical differences. There are a small number of patients who benefit from this treatment which can be seen by the large average, in comparison with the mean, without any of the conditions in which the analysis was carried out seeming to determine a higher response. The treatment duration in our study was similar to the durations recorded in relevant literature for these usage conditions.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 2","pages":"Pages 72-79"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70072-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I. Pérez Rodrigo , R. Albornoz López , M. Soto Rojas , I. Fernández García , V. Torres Degayón
{"title":"Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix","authors":"I. Pérez Rodrigo , R. Albornoz López , M. Soto Rojas , I. Fernández García , V. Torres Degayón","doi":"10.1016/S2173-5085(09)70075-9","DOIUrl":"10.1016/S2173-5085(09)70075-9","url":null,"abstract":"<div><h3>Objective</h3><p>To assess the effectiveness and safety of the use of erlotinib in the treatment of refractory cervical cancer after retrospective analysis of 2 clinical cases.</p></div><div><h3>Methods</h3><p>The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150<!--> <!-->mg/day until June 2008. The pharmacy dispensing records were also assessed to evaluate adherence to treatment. Progression-free survival was assessed and adverse reactions were recorded in the medical records.</p></div><div><h3>Results</h3><p>Three patients with recurrent, advanced cervical cancer were candidates for treatment with erlotinib, 2 of whom were only starting treatment. In both cases, the women had previously received between 3 and 4 different treatment lines. Progression-free survival was 6 months and 4 months in each case. The adverse reactions to the treatment were slight.</p></div><div><h3>Conclusions</h3><p>Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects. However, these results need to be corroborated in the clinical studies field on a wider section of the population.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 2","pages":"Pages 96-99"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70075-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M.C. Conde García , M.A. Fernández Feijoo , M.A. Calleja Hernández
{"title":"Study of rituximab efficacy, cost, safety, and compliance of its package leaflet in a tertiary hospital","authors":"M.C. Conde García , M.A. Fernández Feijoo , M.A. Calleja Hernández","doi":"10.1016/S2173-5085(09)70094-2","DOIUrl":"10.1016/S2173-5085(09)70094-2","url":null,"abstract":"<div><h3>Introduction</h3><p>The appearance of monoclonal antibodies, and specifically, rituximab, has provided a new approach to treating non-Hodgkin's lymphomas and rheumatoid arthritis. The purpose of this study is to analyse whether this drug is used according to its package leaflet in clinical practice, evaluate the treatment's efficacy, and determine its cost.</p></div><div><h3>Methods</h3><p>Ambispective, observational single-centre study of medication use set up as a prescription evaluation for the indication of rituximab in a tertiary hospital between March 2003 and December 31, 2007.</p></div><div><h3>Results</h3><p>Eighty-two of the 221 patients who were treated (37.1%) received the drug for a condition that does not appear in the package leaflet. Fifty-one point one percent and 27.5% of response and progression were registered for approved diagnoses and 34.9% and 47% for nonapproved diagnoses; the death rate was 25.3% and 41.5% respectively. The mean cost per treatment episode was the highest for idiopathic thrombocytopaenic purpura (#euro11 683), whilst the highest treatment cost per patient was associated with follicular lymphoma (€15 940).</p></div><div><h3>Discussion</h3><p>We found that the main cause of the high rate of non-compliance with the package leaflet is patient lack of response to standard treatments, together with clinical practice guides that support the use of rituximab for conditions other than those for which it is indicated. Nevertheless, most of the clinical trials evaluating the efficacy of rituximab for these unauthorised diagnostic profiles have poor methodology, are in phase II, are open studies, have low patient numbers, or in some cases, are not comparative.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 6","pages":"Pages 305-311"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70094-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Fernández-Lobato , M.S. Díaz-Carrasco , A. Pareja , M. Marín , N. Vila , A. de la Rubia
{"title":"Therapeutic use and profile of toxicity of the FOLFOX4 regimen","authors":"B. Fernández-Lobato , M.S. Díaz-Carrasco , A. Pareja , M. Marín , N. Vila , A. de la Rubia","doi":"10.1016/S2173-5085(09)70074-7","DOIUrl":"10.1016/S2173-5085(09)70074-7","url":null,"abstract":"<div><h3>Introduction</h3><p>Since the publication of the MOSAIC test results in 2004, the FOLFOX4 regimen has been established as an adjuvant treatment which is recommended in stage III colorectal cancer. The aim of this study is to assess the use of this regimen in our field and to describe its toxicity.</p></div><div><h3>Methods</h3><p>Descriptive study of treatments with FOLFOX4 prescribed between April 2005 and March 2007. The data was obtained from the Farhos Oncología® programme and clinical records. The following data was collected: age, gender, diagnosis, stage of the illness (TNM classification), and adverse reactions, expressing severity according to Common Toxicity Criteria 2.0.</p></div><div><h3>Results</h3><p>The FOLFOX4 regimen was prescribed for 39 patients (24 men and 15 women) with an average age of 59. The diagnoses were: 28 colon cancer (4 stage II, 17 stage III, and 7 stage IV), 10 rectal cancer (1 stage II, 4 stage III, and 5 stage IV), and 1 stage IV gastric cancer. The most frequent adverse reactions were peripheral neuropathy (82%), neutropaenia (56.4%), and diarrhoea (53.9%). When the study was completed, 9 patients continued active treatment with the regimen (average, 6.8 cycles). Of the 30 remaining patients only 16 people completed the 12 planned cycles. Forteen patients stopped their treatment (average, 8.1 cycles) due to toxicity in 10 cases, clinical progression in 3 cases, and 1 patient died. Of the total 368 cycles administered, 68 suffered administration delays and 22 had the dosage reduced.</p></div><div><h3>Conclusion</h3><p>The use of the FOLFOX4 regimen has been adjusted to uses with some solid scientific evidence, but its toxicity has limited its use and has made administering the planned dosage levels difficult.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 2","pages":"Pages 89-95"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70074-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77806180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Gaspar , M. Caja , I. Romero , L. Moreno Royo , A. García-Vivó , V. Tudela , M. Piquer
{"title":"Establishment of a quality indicator for pharmaceutical care","authors":"M. Gaspar , M. Caja , I. Romero , L. Moreno Royo , A. García-Vivó , V. Tudela , M. Piquer","doi":"10.1016/S2173-5085(09)70093-0","DOIUrl":"10.1016/S2173-5085(09)70093-0","url":null,"abstract":"<div><h3>Objective</h3><p>To establish a quality indicator for pharmaceutical care in an integral system for personalised medication dispensing (ISPMD) with electronic prescription.</p></div><div><h3>Methods</h3><p>Descriptive transversal study. Period: 2007. On a daily basis, we revised the pharmaceutical treatment of patients admitted to hospital units with ISPMD. Study variables: a) suitability of pharmaceutical interventions: important or very important; b) acceptance of those interventions. The LASER® method was used to identify patients with improvement opportunities.</p></div><div><h3>Results</h3><p>In absolute terms (mean [SD]): important pharmaceutical interventions, 26.6 (14.8); very important, 31.5 (24.6); acceptance, 57.5 (25.9). Percentages (95% CI): pharmaceutical interventions: important, 33.7 (9.3–58.0); very important, 39.80 (17.7–62.2); acceptance, 72.6 (64.7–80.5).</p></div><div><h3>Conclusions</h3><p>Implementation of the quality indicator for pharmaceutical care allowed us to evaluate the clinical significance and the acceptance rate of the pharmaceutical care being provided.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 6","pages":"Pages 296-304"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70093-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73758100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Vázquez Hernández , M.F. Hurtado Gómez , J.R. Blanco
{"title":"The influence of alternative medicine in highly active antiretroviral treatment","authors":"M. Vázquez Hernández , M.F. Hurtado Gómez , J.R. Blanco","doi":"10.1016/S2173-5085(09)70066-8","DOIUrl":"10.1016/S2173-5085(09)70066-8","url":null,"abstract":"<div><h3>Objective</h3><p>Over the last few years, there has been a notable increase in the use of alternative medicine by the general population. The aim of this study is 2-fold. Firstly we will analyse the incidence of the use of medicinal plants in patients with HIV undergoing Highly Active Anti-Retroviral Therapy (HAART). Secondly, with the help of existing bibliographic information, we want to study the existence of possible interactions.</p></div><div><h3>Material and method</h3><p>We carried out a prospective study with a targeted interview (October to December 2007) on consenting patients with HIV undergoing HAART treatment.</p></div><div><h3>Results</h3><p>Of the 193 patients that agreed to take part in the survey, 16.6% confirmed they used alternative medicinal therapies. In 46% of the cases there was a potential interaction with the effectiveness of HAART. Forty-six percent of the potential interactions were in the case of the patients who used grapefruit as an alternative medicine, 21% in the case of patients using thistle and Echinacea respectively, 4% for those using omega-3, Chinese herbs, and ginseng.</p></div><div><h3>Conclusion</h3><p>There is a significant use of natural products by these groups of patients, of which a significant percentage interact with HAART. A better understanding of the possible interactions with HAART and improved information offered to patients with HIV is needed.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 1","pages":"Pages 31-36"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70066-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80078963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M.V. Gil-Navarro , R. Muñoz-Corte , M. Herrero Romero , M.D. Santos Rubio , E. Cordero Matía , J. Bautista Paloma
{"title":"Work of a multidisciplinary team in the control of the prescription of ertapenem","authors":"M.V. Gil-Navarro , R. Muñoz-Corte , M. Herrero Romero , M.D. Santos Rubio , E. Cordero Matía , J. Bautista Paloma","doi":"10.1016/S2173-5085(09)70069-3","DOIUrl":"10.1016/S2173-5085(09)70069-3","url":null,"abstract":"<div><h3>Objective</h3><p>To determine the effectiveness of the intervention of a multidiscipline antimicrobial control group in the correct prescription of Ertapenem.</p></div><div><h3>Method</h3><p>A 4-month long, prospective study into prescriptions for ertapenem was carried out in a third-level hospital. Assessment into the degree of suitability of each prescription according to the infections commission usage criteria. In the situation where prescriptions were not suitable, recommendations were given and acceptance of this was recorded. The effectiveness of the antimicrobial treatment used was assessed and treatment was considered effective when there was remission of the signs and symptoms of the infection when the treatment was completed. The treatment was considered to have failed when the signs and symptoms of infection persisted or progressed, requiring the addition of another antimicrobial agent, changing antibiotics or the prolongation of the treatment for longer than 2 weeks. Lastly, the differences in the average length of stay and the duration of the antibiotic treatment between groups were analysed.</p></div><div><h3>Results</h3><p>Forty-eight prescriptions were assessed. The usage criterion was adequate in 48% of cases, with 78% effectiveness in this group. In the cases where the prescription was not adequate, but a change in prescription was accepted, the effectiveness was 92%, with 55.5% of those cases not accepting recommendation for change. The average stay was higher in this last group (P=.07). The duration of the antibiotic treatment in the patients who accepted the change in prescription was significantly less than in those who did not accept it (2 vs 7.4 days, P<.0001).</p></div><div><h3>Conclusions</h3><p>The control of ertapenem prescriptions by a multidisciplinary group was effective.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 1","pages":"Pages 48-52"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70069-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84498706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Santamaría-Pablos , C. Redondo-Figuero , M.I. Baena , M.J. Faus , R. Tejido , O. Acha , F.J. Novo
{"title":"Negative results related to drugs required in hospitalisation","authors":"A. Santamaría-Pablos , C. Redondo-Figuero , M.I. Baena , M.J. Faus , R. Tejido , O. Acha , F.J. Novo","doi":"10.1016/S2173-5085(09)70064-4","DOIUrl":"10.1016/S2173-5085(09)70064-4","url":null,"abstract":"<div><h3>Objective</h3><p>To assess the prevalence of negative clinical outcomes associated with medication as a cause of hospital admission and to determine their characteristics (types, categories, avoidability, severity, and the drug groups involved). To determine possible risk factors related to the appearance of this problem.</p></div><div><h3>Method</h3><p>An observational study carried out over a 3 month period in a department of the university hospital, 163 patients were selected at random. The information obtained from the patient interview, the revision of clinical records and clinical sessions were used to then identify negative clinical outcomes using the Dader method.</p></div><div><h3>Results</h3><p>In 27 cases (16.6%; 95% confidence interval [CI], 1.6–23.0), negative clinical outcomes associated with medication were considered to be the main cause of hospital admission. The most frequent negative clinical outcomes associated with medication were untreated health problems, non-quantitative ineffectiveness, and quantitative safety problems respectively. The overall prevalence of preventable admissions due to negative clinical outcomes associated with medication was 88.9%; (95% CI, 71.9–96.1). With regards to severity, 74.1% (95% CI, 55.3–86.1) of the total admissions were moderate. The most common drugs implicated in hospital admissions were: antibacterial for systemic use, cardiovascular, and non steroidal anti-inflammatory agents. Apart from age, no other factors were found for hospital admissions due to negative results associated with medication.</p></div><div><h3>Conclusions</h3><p>Negative clinical outcomes associated with medication as cause of hospital admission are a prevalent problem and most of them are avoidable with pharmacotherapeutic follow-up.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 1","pages":"Pages 12-25"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70064-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81955980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Ramírez Herráiz , N. Garrido Peño , R. Díez Fernández , A.M. Iglesias Bolaños , M. Arteta Jiménez
{"title":"Comparison of two formulae for the calculation of glomerular filtration in the dosage of zoledronic acid","authors":"E. Ramírez Herráiz , N. Garrido Peño , R. Díez Fernández , A.M. Iglesias Bolaños , M. Arteta Jiménez","doi":"10.1016/S2173-5085(09)70065-6","DOIUrl":"10.1016/S2173-5085(09)70065-6","url":null,"abstract":"<div><h3>Objective</h3><p>To validate the use of a formula that does not require the patient's weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid.</p></div><div><h3>Method</h3><p>Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using 2 different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient's weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the 2 measurements using the t Student-Fisher (t test).</p></div><div><h3>Results</h3><p>The t test provided a t test value of t<!--> <!-->=<!--> <!-->−3.366, with 112 degrees of freedom and a degree of bilateral importance of P<!--> <!-->=<!--> <!-->.001. The difference between both measurements was d<!--> <!-->=<!--> <!-->−0.051[0.162]) and the confidence interval was 95%, −0.082 to −0.021. From the data obtained in the t test, the degree of bilateral importance (P=.001 <.05) indicated that the results of the test were statistically significant.</p></div><div><h3>Conclusions</h3><p>The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient's weight is not available.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 1","pages":"Pages 26-30"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70065-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56619130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}