Background Conversion from intravenous (IV) to oral treatment has many advantages, such as avoiding the adverse events attributed to IV treatment and using less costly drugs. It is also more comfortable, requires fewer human resources and it potentially shortens the length of hospital stay. However it is very important not to have any contraindication for oral treatment. The drugs involved must have excellent bioavailability following oral administration. Purpose To evaluate the results of a pharmaceutical intervention on switching sequentially from IV to oral antibiotics. Materials and methods Prospective and comparative study, carried out over 3 months (between March and May 2012); consisted of a phase of observation and another phase of intervention. We collected demographic data, diagnosis, antibiotic dosage and treatment duration, signs and symptoms related to the infection improving and oral tolerance to medicines and nutrition. We selected all the patients on IV treatment with levofloxacin, ciprofloxacin, metronidazole and clindamycin. Over the intervention phase and after 48–72 h of the intravenous treatment, we consulted the physician for approval to switch to the oral drug. Statistical analysis was performed using SPSS 19.0 Results 140 patients were involved. 44 in the observation phase and 96 in the intervention phase. Mean age was 72.8 (95% CI 66.0–79.6) and 71.8 years old (95% CI 68.5–75.7) respectively. Main diagnoses were divided into these infections: respiratory, gastrointestinal, urinary tract and other. During observation phase these were as follows: respiratory 24 (54.5%), gastrointestinal 10 (22.7%), urinary tract 2 (4.5%) and other 8 (18.1%). During intervention phase the numbers were: 45 (46.8%), 21 (21.8%), 6 (6.25%) and 24 (25%) respectively. In the observation phase, IV treatment duration was 6.5 days (interquartile range, 3–11) and it reduced to 4 days (interquartile range, 3–9) in the intervention phase (p = 0.068). A tendency was seen in the number of days of IV administration to decrease. Conclusions Pharmaceutical intervention reduces length of IV treatment. Therefore, a pharmacist-managed intravenous to oral step down system may be a good tool to reduce costs and potential adverse events attributed to IV treatment. This could be an example of the importance of pharmaceutical care in hospitalised patients. No conflict of interest.
Background Telaprevir is one of the new drugs for chronic hepatitis C genotype 1. As it is a new drug is necessary to be aware of the emergence of new adverse reactions that may not be included in the SPC. Purpose To investigate possible severe adverse reactions not mentioned in telaprevir’s SPC. Materials and methods Descriptive and retrospective clinical case. Data were obtained by review of the patient medical history, Savac and Selene software and laboratory data. Results Fifty-seven-year-old male with HCV genotype 1a/1c. It was decided to start his first treatment for hepatitis C with ribavirin (RBV) 400 mg/12 h, Peg-interferon (P-INF) alfa 2a 180 mcg/week and telaprevir 750 mg/8 h. In week 8 of treatment he was admitted with symptomatology compatible with pancreatitis. Amylase 1888 IU/L appeared in laboratory data. Absolute diet, analgesic and antiemetic measures were established. The patient was discharged a week after admission with an amylase of 173 IU/L. The next day he was admitted with an amylase of 3406 IU/L and the same symptoms. Telaprevir was suspended (week 9 of treatment) in case it could be the cause, and he continued with P-INF and RBV. The patient was discharged 5 days later with an amylase of 365 IU/L. The Karch-Lasagna modified algorithm established as “possible” the relationship between pancreatitis and telaprevir. Conclusions A MEDLINE search was performed on 17.01.13 with the words “telaprevir” “pancreatitis” “abdominal pain” or “amylase” and we did not find any results that evidenced pancreatitis caused by telaprevir. A temporal association existed between drug use and pancreatitis symptoms as well as between telaprevir suspension and the patient’s improvement. Therefore, we concluded that telaprevir could have caused acute pancreatitis in this patient. No conflict of interest.
Background In renal failure, alteration in the pharmacokinetics increases the frequency of overdoses. Purpose To evaluate pharmaceutical care using a computer programme for drug dose adjustment in renal failure. Materials and Methods The study period lasted from September 2011 to January 2012 (inclusive), in a 420-bed hospital. Every day creatinine values over 130 mmol/l were filtered. Treatment was reviewed and we obtained creatinine clearance values (Crockcoft & Gault) of selected patients. After consulting the drug dose adjustment on the sheet and in Micromedex, a report was sent with the pharmaceutical recommendation. ResultsThere were 68 interventions for the 2147 patients studied: Internal Medicine (34) Cardiology (1), Short Stay Unit (5), Orthopaedics (7), Urology (5), Haematology (7) Surgery (5), Neurology (1), Intensive Care Unit (ICU) (2) Oncology (1). 55.9% of notifications were for changes in the dose of enoxaparin (38), 11.8% of amoxicillin-clavulanic acid (8), piperacillin-tazobactam 14.7% (10), 8.8% levofloxacin (6), 2.9% meropenem (2), 2.9% ciprofloxacin (2), 1.5% imipenem (1) and 1.5% aztreonam (1). The proportion of suggested changes accepted was 58.8% (40). 5.9% (4) discontinued treatment, 5.9% (4) were discharged and 29.4% (20) not changed. Of the latter, five were for changes in the pattern of enoxaparin in trauma patients, another 5 from Internal Medicine and 2 more from Haematology and ICU. The rest of them were changes in the pattern of antibiotics (imipenem 1, 2 levofloxacin, 1 meropenem, 1 ciprofloxacin, piperacillin-tazobactam 3) that were given out in the different services. Conclusions A high percentage of doctors followed the recommendations. Part of the unaccepted tally corresponds to trauma patients whose prophylactic regimen of enoxaparin (40 mg/24 h) was not modified due to the service criteria. Some of the antibiotic prescriptions were not changed because of the severity of the patient’s illness (1 levofloxacin and 1 Internal Medicine Meropenem Imipenem Oncology and 1). The rest were rejected without explanation. No conflict of interest.
Background Gefitinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-TK activating mutations. Purpose To evaluate the effectiveness and safety of gefitinib in patients with NSCLC from a general hospital and compare it to the results of published studies (IPASS, INTEREST and ISEL). Materials and methods A retrospective observational study was made of patients with NSCLC treated with gefitinib between January 2012 and September 2013. Study variables: age, sex, smoking, histology, stage, EGFR mutation, ECOG functional status, treatment line, tumour response rate based on the Response Evaluation Criteria in Solid Tumours (RECIST), progression-free survival (PFS) and toxicity. Data source: SELENE software application and clinical records. Results 6 patients (83.33% women) with a mean age of 70.17 years (range 58–73) were evaluated. 5 were non-smokers (83.33%), while 1 was an ex-occasional smoker (16.67%). All of the tumours were mutated EGFR adenocarcinomas: stage IV (66.67%) and stage IIIB (33.33%). The ECOG score was ≤2. 3 patients (50.00%) started gefitinib 250 mg/day as first line therapy, 2 as second line treatment (33.33%), and 1 as third line treatment (16.67%). All patients showed clinical improvement (lessened dyspnoea and cough), and the first radiological study, based on the RECIST criteria, showed 5 patients to have a partial response (83.33%), while 1 presented stable disease (16.67%). The median PFS was 10 months (range 4–18) (1 patient who abandoned after 4 months due to unknown reasons was excluded). 4 patients continued with the treatment at the end of the study (66.67%). The following side effects (AEs) were observed: grade (G)1–2 diarrhoea (26.67%), G1 asthenia (20.00%), G1–2 acne (20.00%), moderate ALAT elevation (13.33%), G1 mucositis (6.67%), G1 anorexia (6.67%) and G1 conjunctivitis (6.67%). All of these effects were manageable without the need for dose reduction, except ALAT elevation, which required treatment discontinuation for 7 days. Conclusions Gefitinib showed similar efficacy to published studies. AEs were those described, well tolerated and all reversible. Owing to the small sample size it would be necessary to obtain a larger sample to draw definitive conclusions. No conflict of interest.
Background Bendamustine is approved in Spain for the treatment of chronic lymphocytic leukaemia (CLL), Non Hodgkin Lymphoma (NHL) and multiple myeloma (MM). The most frequent adverse reactions are haematological. Usually patients require supportive treatment with granulocyte colony-stimulating factors (G-CSF) for neutropenia and erythropoietins for anaemia. Purpose To describe the approach to neutropenia and anaemia caused by bendamustine in patients diagnosed with NHL, CLL and MM in our Hospital Materials and MethodsDescriptive and retrospective study of patients treated with bendamustine between November 2008 and February 2012 in our hospital. We collected data on age, sex, diagnosis, neutrophils count and haemoglobin before treatment and after receiving bendamustine, the proportion of patients requiring G-CSF (filgrastim or pegfilgrastim) or erythropoietins (darbepoetin alfa). Average number of G-CSF and erythropoietins doses. ResultsA total of 38 patients received bendamustine, of whom 13 were women and 25 were men, with a mean age of 67 years old. 28 patients were diagnosed with NHL, 4 with MM and 6 with LLC. Before treatment, the neutrophils count was 4,846/mm³ and haemoglobin 11.7 g/dL. Later these figures were 2,440/mm³ for neutrophils and haemoglobin 11 g/dl. 73.7% of patients required G-CSF and 10.5% erythropoietins. The median number of doses of G-CSF and darbepoetin alfa respectively were 6 and 2.5. Conclusions Bendamustine appears well tolerated. Supportive treatment with G-CSF is required in the majority of patients to maintain neutrophil count. This is not the case for anaemia, which occurs less frequently, requiring less rescue treatment. However these patients require close monitoring during treatment. No conflict of interest.
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