BackgroundTyrosine Kinase Inhibitors (TKIs) are drugs that cause significant adverse reactions and interactions in patients. Prescription and dispensing of TKIs both take place in Hospital Pharmacies. Primary Care physicians (GPs) do not have very much information about either these drugs or patients on TKI treatment.PurposeTo describe a model for giving advice with recommendations about interactions and adverse reactions of TKIs, to provide support and information for PC physicians.Material and methodsPatients on TKI treatment were identified by the APD-ATHOS Prisma and Oncofarm software. The databases were searched for adverse reactions and interactions due to TKIs, together with their management. We selected the most common adverse reactions and interactions, including those that could cause the patients to consult their general practitioner. Then, we made a document with all the information and PC pharmacists established a link between this document and the Electronic Clinical History of each patient to enable GPs to identify patients who were on TKI treatment and also recommendations about their management.Results44 patients were identified (37 with imatinib, 4 with dasatinib and 3 with nilotinib). 29 adverse reactions were found (9 common to all 3 TKIs, plus 8 with dasatinib, 8 with nilotinib and 4 with imatinib). Interactions were classified into: drugs that increase or reduce the effects of TKIs and drugs whose effects and toxicity are increased or decreased by TKIs. The most significant interactions were: imatinib-simvastatin, imatinib-acetaminophen, imatinib-ibuprofen; nilotinib/dasatinib-proton pump inhibitors, nilotinib/dasatinib-histamine-2 receptor antagonists, nilotinib/dasatinib-drugs that prolong the QT interval, nilotinib/dasatinib-oral anticoagulants and dasatinib-food.ConclusionThe way of giving advice should help GPs to identify and manage frequent adverse reactions and interactions of TKIs. This process will be repeated for other oral anti-cancer drugs. Further studies are necessary to confirm the usefulness of this tool.References and/or acknowledgementsNo conflict of interest.
Background No head-to-head clinical trials have been published comparing aflibercept and bevacizumab for the neovascular form of age-related macular degeneration (AMD). Adjusted indirect comparisons may provide useful information on the relative efficacy of competing interventions. Purpose To compare the efficacy of aflibercept and bevacizumab for the treatment of wet AMD using an adjusted indirect comparison. Materials and methods PubMed was searched for randomised controlled trials (RCTs) comparing aflibercept or bevacizumab with ranibizumab. Selection criteria were: 1) phase III RCTs; 2) intravitreal aflibercept 2.0 mg (every two months after three consecutive monthly doses) versus monthly intravitreal ranibizumab 0.5 mg; 3) monthly intravitreal ranibizumab 0.50 mg versus monthly intravitreal bevacizumab 1.25 mg; 4) patients included with active choroidal neovascularisation secondary to AMD and 5) similar duration and methodology. A meta-analysis of RTCs comparing aflibercept versus ranibizumab and bevacizumab versus ranibizumab was performed. Odds ratios and 95% confidence intervals for dichotomous data were calculated by Mantel-Haenszel’s method. An adjusted indirect comparison by Bucher’s method using the ITC software from Canadian Agency for Drug Technologies in Health was done, with ranibizumab as a common comparator. The endpoint was the proportion of patients who improved by ≥15 ETDRs letters at 52 weeks. Results Two RCTs comparing aflibercept with ranibizumab (VIEW-1 and VIEW-2) and two RTCs comparing bevacizumab versus ranibizumab (CATT-1 and CATT-2) met the inclusion criteria. Meta-analysis showed no significant difference between aflibercept and ranibizumab (ARR:1.50% [-3.79 to 6.73]) or bevacizumab and ranibizumab (ARR: 20% [-9.0 to 4.0]). The adjusted indirect comparison didn’t show a statistically significant difference between aflibercept and bevacizumab (ARR: 3.0% [-4.90 to 10.90]). Conclusions Notwithstanding the limitations of an adjusted indirect comparison, no significant differences were found between aflibercept and bevacizumab in AMD. Until head-to head trials are available, adjusted indirect comparisons based on trial data could be relevant to guide therapeutic choices. No conflict of interest.
Background Oral chemotherapy agents are medications that were dispensed in pharmacies usually but since the entry into force of an order regional president in January 2011 became hospital dispensing. Purpose To analyse the economic and healthcare impact of the inclusion of oral chemotherapy agents in a outpatient dispensing unit. Materials and methods The study period runs from 23th January to 30th September, 2011. During this period, 16 chemotherapy agents have been acquired and dispensed in our unit: anagrelide, capecitabine, cyclophosphamide, chlorambucil, dasatinib, erlotinib, gefitinib, hydroxyurea, imatinib, lapatinib, melphalan, sorafenib, sunitinib, nilotinib, tretinoin, temozolomide. For the economic analysis estimates the cost of which has led to the introduction of oral chemotherapy compared to other outpatient dispensations of haematology, oncology and urology, which are the units that consume such medicines data were obtained through the computer application outpatient dispensing (DIPEX) and management software (Sinfhos), was also evaluated consumption of each active ingredient included. Results During this period, the number of patients who where dispensed oral chemotherapy were 388; it's means the 26,7% of patients attending in the outpatient unit. Consumption in this period for each area not including the dispensing of oral chemotherapy was: Haematology: 691,586.9€; Oncology: 280,038.23€; Urology: 27,754.74 € and consumption at the same time and each area including the dispensing of oral chemotherapy was: Haematology: 1,428,089.71€; Oncology: 907,203.66€; Urology: 96,641.97€. Representing an increase of 48.42% in consumption of Haematology, a 30.86% in Oncology and a 28.72% in Urology. The most dispensed drugs were: capecitabine 12,74%, dasatinib 9,48%, erlotinib 12,28%, imatinib 25,21%, lapatinib 5,25% and sunitinib 10,13%. Nobody was joined the staff to reinforce the outpatient unit. Conclusions 16 new oral chemotherapy agents were acquired during this period, this has meant an overall increase in consumption of 243.43%, The drug is highest cost was imatinib. The number of patients increased by 26,7%, a very important increase of work without increase in the staff budget.
BackgroundBiological therapies (BT) allowed a better control of disease activity in patients with Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA); however, its high cost may be a limitation to widespread use. It seems reasonable to implement a dose adjustment strategy in selected patients that achieve and maintain remission or low activity.Objectives1. To analyze the dose adjustment (DA) strategies used with different BT and the clinical outcome assessed by DAS28 in RA and PsA patients in biological treatment followed by second level Hospital Rheumatology Unit. 2. Determine the associated economic impact.MethodsAn observational, longitudinal, retrospective and descriptive study by reviewing medical records (from January 2013-January 2015) of patients with RA and PsA on BT, that achieve and maintain clinical remission (DAS28 <2.6) or minimal clinical activity (DAS28 2.6-3.2) for at least 6 months under DA were reviewed. Demographic data, duration of the disease before the use of BT, time of biologic in adjusted doses, clinical evaluation pre and post-optimization by DAS28 (at 6 month) and therapeutic strategies are discussed. DA strategies were: adalimumab (ADA) 40 mg/ 21 days, etanercept (ETN) 25 mg every week, ETN 50 mg every 10 days or every 15 days, certolizumab pegol (CTZ) 200 mg every 4 weeks, abatacept (ABT) 500 mg every 6 weeks and infliximab (IFN) 3 mg/kg every 10 weeks. Annual costs of each treatment were estimated based on the Spanish public ex-factory prices of each drug (€ 494.61 for 40 mg of ADA, € 227.81 for 50 mg of ETN, € 113.90 for 25 mg of ETN, € 455.99 for 200 mg of CTZ, € 322.10 for 250 mg of ABT IV and € 515.90 for 100 mg of IFN). Statistical analysis was performed using IBM SPSS version 20.0 program.ResultsFrom 279 patients with RA and PsA were on biological treatment, 57 (20.43%) were undergoing therapeutic adjustment. 37 (64.9%) were RA and 20 (35.1%) PsA. 36 (63.2%) were women. Mean age was 54±13 years. The mean duration of disease prior to the beginning of biologic treatment was 7.2±5.7 years. The mean time with BT standard dose was 63.7±31 months; the average time on adjusted doses was 13.3±9.9 months. Doses adjustment strategies were: ADA 40 mg every 21 days (24/42,1%), ETN 25 mg every week (21/36,8%), ETN 50 mg every 10 days (3/5,3%) or every 15 days (5/8,8%), CTZ 200 mg every 4 weeks (1/1, 8%), ABT 500 mg every 6 weeks (1/1,8%) and INF 3 mg/kg every 10 weeks (2/3,5%). Before DA, fifty (87.7%) patients were in DAS28 remission and seven (12.3%) in low DAS28 activity. Six months after, 48 (84,2%) continued to be in clinical remission, 3 (5.3%) in low activity, 4 (7%) in moderate activity and 2 (3.5%) in high DAS28 activity. Six patients (10.5%) needed start over the standard dose of the drug. Table shows the estimated cost per patient and year of each drug and dose pattern. Economic impact and associated savings are also showed.ConclusionsA high percentage of RA or PsA patients in sustained remission or low disease activity after standard biological treatment remain clinically co...
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