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.
BackgroundThere is only limited information about the sequential use of abiraterone acetate (AA) and enzalutamide (ENZ) in metastatic castration-resistant prostate cancer (mCRPC) patients. Patients who receive AA or ENZ as first-line therapy and subsequently become resistant have only a response rate of 15% to 30% to the alternative agent as second-line treatment. That finding clearly shows that cross-resistance occurs between ENZ and AA.PurposeTo evaluate the effectiveness of ENZ after failure of AA in patients with mCRPC.Material and methodsRetrospective study including all patients with mCRPC having sequential therapy with AA and ENZ from May 2012 to October 2017. Posttreatment changes in prostate-specific antigen (PSA) and differences in the median duration treatment (MDT) with AA and ENZ were used to determine the effectiveness of ENZ. A PSA reduction <30% and/or a MDT-ENZ/MDT-AA ratio <0.3 was considered as ineffective.ResultsThe study included 16 mCRPC patients treated sequentially with AA and ENZ. Only three patients had undergone prior docetaxel therapy. MDT-AA was 15 months (range: 3–38). During AA therapy 10 (67%) achieved a>50% decline in PSA, 12 (80%) a>30% and three (20%) did not achieve any decline in PSA. Subsequent MDT-ENZ was 4 months (range: 1–12), showing a MDT ratio of 0.27. Three patients did not have PSA levels after taking enzalutamide. None of the CRPC patients who were or not initially AA-sensitive showed a>30% PSA decline while taking ENZ. The medium PSA decline after abiraterone and enzalutamide were 37% and 17.8% respectively. Of the 15 patients, 7 (46.6%) were primarily ENZ-resistant and showed a rising PSA as the best response. Median time to progression was 7 months (range: 2–12) for five of 15 patients with at least one declining PSA value while taking enzalutamide (33.3%).ConclusionAlthough the number of patients included in this study is small, ENZ therapy after AA failure shows a low activity in terms of PSA response and/or medium duration of treatment. Results would be compatible with qualifying the use of ENZ after failure to AA as ineffective. Further properly designed studies to this aim are needed.Reference and/or Acknowledgements1. J Clin Oncol2014;32:125.No conflict of interest
BackgroundBortezomib is an expensive drug with a very short stability. For subcutaneous administration each vial should be reconstituted with 1.4 mL of NaCl 0.9% (2.5 mg/mL). According to the manufacturer, reconstituted it is stable at 25°C for only 8 h. Considering the recommended dose of 1.3 mg/m2 and the amount of drug per vial (3.5 mg/1.4 mL), the loss of product during preparation may be significant. However, a study published by Walker et co-authors has shown that bortezomib is stable for up to 21 days, permitting an optimisation of costs.PurposeTo evaluate the impact of the extended stability limits of bortezomib on handling practices and the optimisation of costs.Material and methodsTwo periods were evaluated: before (January–September 2013) and after (January–September 2014) modification of the stability limits. From the individual preparation files, different parameters were recorded: number of patients and prescription lines, mean dose, theoretical residues, % of residues re-used, value of the residues re-used.ResultsSeventy patients were included, 34 in the first period and 36 in the second one. The number of prescription lines was 584 and 452 in the first and second period, respectively. The mean dose in both periods was 2.10 mg. In the first period the theoretical residues were 311.59 mL, the % of residue re-used 56.00 mL (17.9%) and the value of the re-used residues €24,137.57. For the second period, the theoretical residues were 248.39 mL, the % of residue re-used 232.4 mL (93.7%) and the value of the re-used residues €100,170.90. The cost per dose was €983 and €677 in the first and second period, respectively.ConclusionAn extended stability limit for bortezomib as compared to that recommended by the manufacturer should lead to an improvement of manufacturing processes and significant costs savings. The re-use of residues is a real strategy to contain costs.References and/or acknowledgementsNo conflict of interest
BackgroundAlthough clinical trials show low virological failures rates (<10%) for initial combination regimens of antiretroviral therapy (ART), we have observed a considerable percentage of naïve patients switching to another combination regimen.PurposeTo evaluate the switch rate among naïve patients who begin ART and to determine the reasons that led to a change in the ART regimen.Material and methodsWe conducted a retrospective observational study that included naïve HIV positive persons who initiated ART between January 2015 and January 2016 and attended the pharmaceutical care office. The main variable was persistence with treatment. Secondary variables were: demographics (age, gender); virological response (viral load), pharmacotherapeutics (initial combination regimen, new combination regimen) and reason for switching to another combination (virological failure, documented toxicity, prevention of long term toxicity, avoiding serious drug–drug interactions, simplification). Persistence rates were obtained through dispensing records of the pharmacy programme. The remaining variables were obtained from microbiology reports and the medical history of each patient.Results31 patients with an average age of 40±11 years were included. Most patients were men (90.3%). Median viral load was 23.300 (elite controller 481.000) copies/mL. The proportion of patients coinfected with hepatitis C virus was 16.1%. In all cases patients received triple therapy. More than half of patients (67.7%) began treatment with a combination regimen based on two nucleos(t)ide analogues plus an integrase inhibitor and the preferred regimen was tenofovir, emtricitabine, elvitegravir and cobicistat (58.1%). Non-nucleoside rilpivirine was used as a third drug in 25.8% of cases. Almost half of the patients switched to another treatment (48.4%). No virological failure occurred in any patient. The most common reason for changing to another regimen was documented toxicity (6). Other reasons were prevention of long term toxicity (4), simplification (4) and avoidance of serious drug–drug interactions (1).ConclusionThis study showed that a high proportion of ART regimens in naïve HIV patients were changed, even though these regimens achieved undetectable viral load. The main reason for switching was based on safety, either documented or potential toxicity. These data might help in designing pharmacist intervention programmes to improve the efficacy and safety of ART.No conflict of interest
BackgroundThe pharmaceutical care model proposed in socio-health centres (SHC) aims to provide efficient and coordinated pharmaceutical services between different levels of care. The integration of the hospital pharmacist into the multidisciplinary team improves the socio-healthcare of institutionalised elderly patients.PurposeOptimise drug therapy of institutionalised patients (residents) in a SHC through pharmaceutical intervention (PI).Material and methodsProspective and quasi-experimental pilot study without control group, which includes the residents of a SHC Exclusion criteria: patients assigned to health centres (HC) and patients without drug treatment. Residents’ pharmacotherapy were reviewed with proposals for pharmaceutical treatment modification (PI), evaluation and multidisciplinary consensus. PI types: adequate adherence to the Pharmacotherapy Guide of SHC (PGSHC) in a Health Management Area with replacement for Specialties with Better Geriatric Profile (SBGP) and the implementation of the Therapeutic Equivalents Program; dose adjustment according to recommendations in geriatric patients (chronic kidney disease, psychoactive drugs); and deprescribing (duplicates, Non-Elevated Intrinsic Value Drugs (NEIVD) and Stopp criteria (safety issues or poor prognosis). Suggestions for improvement.ResultsNumber of residents, 104. Excluded: six (three assigned to HC, three without pharmacological treatment). Of the 97 patients included, 78.4%(n=76) were assisted and 21.6% (n=21) were valid residents. Mean age: 79.5 years (range 49–99, SD: 10.3); 54.6% (n=53) were males. Pharmacological profile: number prescription drugs/chronic patients: mean: 5.3 (range 1–12, SD: 2.93); prevalence of polypharmacy (≥5 drugs): 59.8%( n=58). Total PI performed: 61; average PI/resident: 0.6; therapeutic equivalent alternative: 40.9% (n=25). Adequacy to PGSHC: 36% (n=22) with adaptation to presentations included (24.5%, n=15) and SBGP (11.4%, n=7); dose adjustment: 8.1% (n=5); deprescribing: 14.75% (n=9) with five cases of duplicity, three safety issues and one NEIVD. Substitution of drugs prescribed by equivalent alternatives of the PGSHC supposes a significant cost saving. Improvement proposals: continuous re-evaluation of patients, so the design and implementation of a Pharmacotherapy Review Programme in institutionalised elderly patients is proposed, with a personalised action plan integrated into the Comprehensive Geriatric Assessment and quantification of the economic impact.ConclusionInstitutionalised patients are chronic patients with high complexity, so it is essential to review pharmacotherapeutic practices through an attention and care shared multidisciplinary team. The incorporation of the pharmacist into the multidisciplinary team allows optimisation of the treatments with a rational use of these.No conflict of interest
BackgroundOn September 7th 2015, the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS) notified a drug safety warning (DSW) through a communication to healthcare professionals on the use of mirabegron. It showed new recommendations for its use in relation to the risk of increased blood pressure.PurposeTo detect patients under mirabegron treatment with an increased risk of hypertension. To make a notification to physicians.Material and methodsRetrospective study involving patients who were prescribed mirabegron from February–July 2015 in a health area of 450.000 inhabitants. The following data were obtained by querying the electronic prescription billing system (Microstrategy): sanitary identification number (NUHSA) of patients under mirabegron treatment, prescribers and their medical service. Furthermore, we obtained the NUHSA of patients under main therapeutic groups of antihypertensive drugs (AD) treatment: angiotensin converting enzyme inhibitors, angiotensin II-receptor antagonists and calcium antagonists. Patients under mirabegron treatment and any AD were both identified. These patients were defined as patients with increased risk of hypertension during treatment with mirabegron. We did a report that included: a summary of the DSW, an analysis of the prescribing physicians and patients with increased risk of adverse reaction (AR). This report was sent to all physicians.ResultsAfter analysing 6 months, 810 patients were treated with mirabegron. 41.5% of them (N=336) belonged to the Urology service, while the other prescriptions were evenly distributed among other services. The Urology service was considered urgent to send the report. From all the patients under mirabegron treatment, 45% (N=365) had been treated with any AD, implying a higher risk for the AR or possibility of having already had it. A report was sent by pharmacist to show data of patients under both drugs treatment and physicians prescribing mirabegron. It will help to revise the prescriptions when necessary. The report included information about other treatment options.ConclusionFive out of ten patients under mirabegron treatment can be considered as risk population for hypertension. The analysis allows prioritisation on the diffusion of information identifying patients at risk and main prescribers. Further studies would be necessary to confirm the impact of this intervention.References and/or AcknowledgementsCP-Betmiga-07-septiembre-2015.pdf. Consulted: 8/09/2015.No conflict of interest.
BackgroundTenofovir alafenamide (TAF) is a new molecule that is being replaced for TDF, the original formulation of tenofovir (TDF), because of its improved efficacy and safety profile in HIV patients.PurposeTo analyse efficacy and renal safety of TAF/FTC/EVG/cobi antiretroviral therapy (ART) in real clinical practice.Material and methodsRetrospective study including all patients who started treatment with TAF/FTC/EVG/cobi from June 2016 to May 2017. Patients were divided into two subgroups: naive and pretreated with other ARTs patients. To determine effectiveness, plasma-HIV RNA (viral load) and CD4-T-lymphocyte (CD4) cell count were measured, and to analyse renal safety, glomerular filtration rate (GFR) and urinary protein to creatinine ratio were measured at baseline and after 6 months’ treatment. Viral load <20 copies/ml was considered as effective. Renal involvement was considered if GFR <60 ml/min. Sources of information: athosPRISMA™ (patient selection) and Diraya-Clinical-Station (analytical data).ResultsNinety-eight patients were analysed, 80% were males and mean age was 46 years. Naive-subgroup: eight patients (8%). After 6 months’ treatment, six of eight patients reduced their baseline viral load to <20 copies/ml. Mean CD4 ratio increased from an average of 181 to 221 cel/µL. Mean baseline GFR decreased from an average of 115 ml/min to 107.3 ml/min (7%) after 6 months’ treatment. Urinary protein to creatinine ratio worsened in one patient and improved in another after 6 months’ treatment. The rest of the patients remained at normal levels. Pretreated subgroup: 90 patients (92%). 68 patients had <20 copies/ml at baseline and also after 6 months’ therapy. Twenty-two patients had an average of 37 500 copies/ml, and 16 of these patients reduced their viral load to <20 copies/ml after 6 months’ treatment. The average CD4 count increased from 623 to 700 cel/µL in all patients. Mean GFR at baseline was 98.5 ml/min and did not change after treatment with TAF/FTC/EVG/cobi. The urinary protein to creatinine ratio worsened in two of 90 patients and improved in six patients after 6 months’ treatment. The rest of the patients remained at normal levels. Of all analysed patients, no one had renal involvement.ConclusionTAF/FTC/EVG/cobi therapy was described to be effective and safe in both naive and pretreated patients in clinical practice.Reference and/or Acknowledgements1. European Medicines Agency. Genvoya Product Information. Consulted: 13 October 2017.No conflict of interest
adverse reactions (AR) such as aseptic meningitis (AM) are described in the product information (PI). Purpose To describe and analyse five cases of AM in patients treated with IVIg in our centre. Material and methods A literature search was conducted on the AR of IVIg. The case analysis was established using the Karch-Lasagna algorithm. Results There were five cases notified of AM in a 3 month period (80% females). Clinical manifestations included headache, fever, nausea and vomiting, and in some cases photophobia. Symptoms usually commenced within 48 hours after infusion. In all cases lumbar puncture was compatible with AM. Two patients had to be hospitalised due to AM, one of them prolonged hospitalisation.All patients received IVIg of the same brand, presentation and even some of the same batch. All of them received an individualised administration form prepared by the pharmacist including premedication information and the rate of administration of the IVIg calculated according to patient weight and PI.The Karch-Lasagna algorithm in these cases established a possible causal relationship between IVIg and the occurrence of AM.Every case reported had a neurological-based pathology: myasthaenia gravis, nystagmus, multiple mononeuropathy, Parsonage-Turner syndrome and sensitive-motor polyneuropathy. Nevertheless, in our centre the other five patients with no neurological pathology received the same presentation and batch of IVIg during the same period and did not present AM. The analysis leads us to suspect that patients with basic neurological diagnosis have a higher risk of suffering from AM.The preventive measures adopted were to reduce the speed of individualised administration and to insist that good hydration is important in preventing this adverse effect. Conclusion IVIg have demonstrated efficacy and a good safety profile in clinical trials. However, possible AR due to its use can be observed. The role of the pharmacist is important in the individualised information by patients concerning the administration of immunoglobulins. In order to reduce the incidence of AM, it is suggested to start the initial infusion at a slow rate, prehydration and premedication therapy.
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