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GOT18-0018. Impact of Clinical Pharmacist Analysis to Clinical Decision-Making for Drug Therapy Management in the Hospital Care Setting Background
A deeper understanding of pharmacist clinical decision-making should provide the influence that pharmacists have on patient health care, should guide pharmacy policy and education, should contribute to educating less experienced pharmacists on decision-making processes, should promote more interprofessional work, and should encourage pharmacist decision-making toward the wisest selections of patients’ medication therapy.
Purpose
The overarching objective of this research study was to document drug therapy decision-making processes of clinical pharmacists in the hostital care setting. The specific aims of this study were to examine the current clinical decision-making of clinical pharmacists in the context of the hospital care clinic setting, to compare and contrast pharmacist clinical decision-making with current decision-making models.
Material and methods
We used a quasi-randomized design to evaluate a quality improvement project in three hospitals in Kazakhstan. Three audio-taped data collection methods of participant observation and semi-structured interview were utilized and exactly transcribed to provide textual data for analysis. Thematic analysis provided emerging themes of clinical pharmacist-led medication and clinical decision-making which were further subdivided into subsuming themes after much reflection and interpretation of the entire study data.
Results
Other health professions have identified experienced clinical decision-aking to encompass the Decision Analysis, intuition and pattern recognition. Clinical pharmacists’ clinical decision-making processes are considered in light of other health professionals’ decision-making techniques; however the results show that clinical pharmacists use a different model of clinical decision-making using constant dialogue between two different types of knowledge (objective and context-related). The analysis suggests that the enabling factors and barriers to clinical decision-making are unique for each context. The availability of time to spend with patients and the effort in consulting with other health professional colleagues have enabled clinical pharmacists to ensure more patientcentered decisions in the general hospital care clinic setting.
Conclusion
This research study demonstrated significant similarity between clinical pharmacists’ and other health professionals’ experienced clinical decision-making. The cross-communication between different health professions may further improve decision-making processes and collaborative practice agreements. This study provides evidence for better understanding of the current clinical pharmacy practice, which may further expand the success of clinical pharmacists’ contributions to improving patient care.
References and/or Acknowledgements
N/a
Conflict of Interest No conflict of interest
GOT18-0027. USING QUALITY IMPROVEMENT METHODOLOGY TO IMPLEMENT A PHARMACIST- LED MEDICINES RECONCILIATION SERVICE Background
Improving the quality and safety of health care services remain a priority reflected in national strategy and reforms. The purpose of a quality improvement project is to implement evidence based standards to improve outcomes in clinical care or processes which are measurable and sustained over time.
Provision of medicines reconciliation (MR) is an international healthcare priority. MR is one of the World Health Organisation’s (WHO) High 5s patient safety priorities. This is reflected nationally through MR inclusion in national health service policies and guidelines.
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Pharmacists are the preferred profession internationally for undertaking MR, however, it is recognised that this is a resource intensive activity.
Purpose
To utilise quality improvement methodologies to implement and measure a pharmacist-led MR service.
Material and methods
• Drugs and Therapeutics Committee assessment of the strategic MR requirements. • Business case and service scoping document development for Chief Executive Officer (CEO) evaluation • Appointment of a dedicated MR pharmacist • Stakeholder engagement pre-implementation. • Identification of Key Performance Indicators for measurement and review to ensure on-going evaluation
Results
CEO approval was obtained for phased implementation of a pharmacist-led MR service. The MR service commenced in July 2016 with one dedicated MR pharmacist. The service is modelled on WHO Guidance which specify; - The priority patient cohort; Patients aged ≥ 65 years admitted through the Emergency Department. - Service measures, sampling criteria and targets to quantify service capacity and quality.
Conclusion
MR services are recognised to improve medication and patient safety. MR is a priority practice in the hospital's strategy and reforms. A quality improvement MR project was proposed. Phase one of a resourced pharmacist-led MR service was implemented in 2016.
Service quality and expansion requirements are assessed using internationally recognised measures to enable on-going review of service performance.
References and/or Acknowledgements
[i] Health Service Executive (2015) National Service Plan 2015
[ii] Stausmire, J. (2006). Quality Improvement or Research Worksheet. Health Care, 34(6).
[iii] World Health Organisations High 5 Medication Reconciliation Project.
[iv] Health Information and Quality Authority; Guidance for Health and Social Care Providers, Principles of Good Practice in Medicines Reconciliation, May 2014.
[vi] Integrated Care Guidance: A Practical Guide to discharge and transfer from hospital, Jan 2014.
[viii] ASHP statement on the Pharmacist’s Role in Medication Reconciliation, 2013.
Conflict of Interest No conflict of interest
GOT18-0030. PRODUCTS IN KNEE PROSTHESIS: A SISTEMATIC REVIEW Background
Purpose
To realize a review of knee arthroplasty, and to identify and summarize the characteristics of the different prosthetic components involved.
Material and methods
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A search of electronic databases was performed until March 2017, to identify randomized clinical trials, cohort studies, cases and controls studies, case series, clinical practice guidelines, systematic reviews or evaluation reports of health technologies on Knee Arthroplasty. Inclusion criteria: studies that represented the original investigation, ≥ 18 years, any diagnosis of knee arthroplasty indication, partial or complete replacement without establishing fixation technique and with or without comparator. Exclusion criteria: authors declare that they have competing interests. A total of 653 studies were identified, of which 15 primary studies were selected for analysis.
Results
Knee prosthesis components are: tibial, femoral and patellar. They can be used alternately with or without cement depending on patient characteristics, age and bone quality. Partial arthroplasties may be unicompartmental or patellofemoral.All implants used in knee arthroplasty must meet: biocompatibility, resistance to mechanical stresses, friction and corrosion. Materials: Ultra high molecular weight and crosslinked polyethylenes: very high degree of hardness and resistance to friction, used for most tibial inserts. Cobalt, vanadium or titanium alloys known as Ti6AI4V: used for femoral components. Chromium-cobalt and titanium alloys: used for some tibial components. Polymethylmethacrylate: the so-called bone cement with which the femoral and tibial components are placed.Vitallium (30% chromium + 7% molybdenum and a mixture of cobalt, nickel and other materials): for joint surfaces of the knee. Zirconium implants: They are made of a metal that has gone through a process that allows the metal to absorb oxygen, creating a ceramic surface. They can potentially last up to 20 or 25 years and also metal allergic personnel can use them.
Conclusion
Considerable advances in the understanding of knee kinematics over the last decades have led to improvements in the design of prosthetic knee implants and an explosion in the number of options for each scenario. Current trends show a growing direction on appropriate timing of arthroplasty, coupled with improved prosthesis designs as the respect for the set of intrinsic stabilizing structures increases, along with finding the right balance between design and the anatomical kinematic functionality.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0089. USE OF DALBAVANCIN AS A CONSEQUENCE OF HEMATOLOGICAL TOXICITY DUE TO LINEZOLID IN A PATIENT WITH PROSTHETIC INFECTION AORTOILIAC Background
Dalbavancin has been approved for the treatment of acute bacterial skin infection and skin related structures in adults. Infections of the skin and soft tissue infections are one of the most prevalent both in the community and in hospitals infections. Actually, the medical literature doesn't contemplate the use of this antibiotic outside of this indication.
Purpose
To evaluate the efficacy and safety of dalbavancin in a patient with prosthetic infection aortoiliac
Material and methods
The information was obtained across of dispense program outpatient (Dominion®) from where collected all patient evolution. We did track of every medical consultation (analytical controls of blood and blood cultures) in a total period of 13 weeks. The primary efficacy and safety variables were defined as: the absence of infection (negative blood cultures) and the absence of adverse events grades CTCAE (Common Terminology Criteria for Adverse Events) II or higher, respectively.
Results
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We report a patient of 80 years old with a prosthetic infection aortoiliac caused by Escherichia coli, Enterococcus faecalis and Enterococcus faecium, in treatment with Amoxicillin/Clavulanic acid (1 g three times a day) combined with Linezolid (600 mg twice a day). After nine weeks, Linezolid was discontinued as a consequence of hematological toxicity (Hemoglobin 4g/dL). For that reason the clinical infection unit decided to begin a combination therapy with Amoxicillin/Clavulanic acid in combination with Dalbavancin (One dose of 1000 mg followed by 500 mg weekly for 4 weeks). After the first week of treatment hemoglobin returned to normal values and in the fourth week of treatment blood cultures were negative. During the study period no systemic side effects forced to discontinue treatment with Dalbavancin was observed. At the end of treatment with Dalbavancin, the patient continues with maintenance treatment with Amoxicillin/Clavulanic acid.
Conclusion
This study shows that treatment employed with Dalbavancin in this patient with a different infection than indicated by the data sheet of the drug, has been used effectively and safe in the prosthetic infection aortoiliac.
References and/or Acknowledgements
To my pharmacists colleagues
Conflict of Interest No conflict of interest
GOT18-0136. IDARUCIZUMAB IN THE MANAGEMENT OF MASSIVE HEMORRHAGE BY DABIGATRAN: A CASE REPORT Background
The use of anticoagulants is associated with the risk of bleeding and life-threatening bleeding complications.Bleeding is especially worrying when direct oral anticoagulants (DOACs) are taken.There is less experience in reversing its activity. Idarucizumab is a humanized monoclonal antibody that binds to dabigatran with high affinity, neutralizing its anticoagulant effect.
Purpose
To evaluate the clinical efficacy of idarucizumab as a dabigatran specific antidote.
Material and methods
Retrospective observational study to review the use of idarucizumab in a patient with massive intracranial hemorrhage associated with the use of dabigatran.Data were extracted from electronic medical records, Pubmed® and Uptodate®
Results
A 78 year-old elder male from the United Kingdom. There is not knowledge of drug allergies. Personal history of diabetes mellitus, dyslipidemia, atrial fibrillation, and ischemic heart disease. Usual treatment with metformin, furosemide, losartan, carvedilol, simvastatin and dabigatran. He went to the Emergency Department (ED) due to decay with left hemiparesis and respiratory distress, with cerebral infarction of probable cardioembolic etiology and hemorrhagic transformation and impairment of renal function (Serum Creatinine 1.8 mg/dL). The prothrombin time was (PT) 89% and the partially activated thrombin time (PATT) 32.5sec. Last intake of dabigatran 150mg is unknown. The anticogulant effect is reversed with idarucizumab, two 2.5g vials in consecutive intravenous infusion (total dose 5g). At 24 and 48h, respectively, PT 74 and 68% and PATT a 28 and 24sec. Unfavorable evolution with cerebral edema and pulmonary edema with fatal outcome.
Conclusion
Idarucizumab is the first specific antidote for DOACs approved in the management of severe bleeding and urgent surgery in patients with dabigatran.The use of DOACs in elderly patients and deterioration of renal function increase the risk of bleeding.There is no scientific evidence that recombinant blood products (prothrombin complex) act as antidotes in DACOs by recovering hemostasis.The lack of efficacy of Idarucizumab is associated with progression of the bleeding and comorbidity of the patient.The location of
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bleeding and degree of injury, as well as concomitant diseases and treatments, may have a higher effect on the prognosis of bleeding than the possibility of rapidly neutralizing the anticoagulant.
References and/or Acknowledgements
no conflict of interest
Conflict of Interest No conflict of interest
GOT18-0157. Opioid rotation in pediatrics: A conversion chart for children older than 1 year Background
Opioids are widely used for acute pain management in pediatrics after surgery, for sedation on the intensive care unit, and chronic pain management in palliative care and many other conditions. In some patients, it is necessary to change the opioid during therapy, due to tolerance development or due to side effects. Although conversion tables for adults are well established, they are not readily available for pediatric use.
Purpose
To simplify the process of opioid rotation in pediatrics, an opioid conversion chart with easily memorable conversion factors should be generated.
Material and methods
A literature search was performed to collect conversion factors and equivalent doses of opioids with different application routes. We searched specifically for conversion factors in pediatrics. Except for Oxycodone and Remifentanil, for all other opioids in our chart conversion factors for pediatric patients were found. Data for adults were used for these two substances. For all conversion factors experts confirmed their adequacy for clinical use in pediatrics. The conversion factors were rounded up to whole numbers, which was considered reasonably based on long-term experience in pediatric pain management.
Results
This conversion chart is now part of a drug information document about opioid dosing in children older than 1 year in our hospital. For every substance, starting doses were set according to our in-hospital guidelines and based on clinical experience. When necessary, details about the therapy with the individual substance were added. For illustration purposes, a sample calculation of the change from oral Morphine to oral Oxycodone was included.The immature metabolism in children younger than 1 year makes the opioid action often unpredictable. Therefore we restrict the use of the chart for children older than 1 year and in younger children specialists in pain management should be consulted.
Conclusion
Our opioid conversion chart, with easily memorable conversion factors and starting doses, supports all healthcare professionals in pediatric pain management with opioids and may also help to reduce critical incidences due to mistakes in calculation. This is the first time an opioid conversion chart is established for pediatric purpose.
References and/or Acknowledgements
Thanks to PD Dr. Bergsträsser and Dr. Thomas for their contribution to this work.
Conflict of Interest No conflict of interest
GOT18-0217. CEFTAZIDIME POPULATION PHARMACOKINETICS IN CRITICALLY ILL PATIENTS: EFFECT OF SEPSIS GRADE AND RENAL FUNCTION ON DOSING REQUIREMENTS Background
Appropriate antibiotic dosing is required from the early phase of sepsis but altered pharmacokinetics described in critically ill patients may result in insufficient antibiotic dosing
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Purpose
This study aimed to assess the pharmacokinetics of ceftazidime in the early phase of sepsis in critically ill patients, to identify sources of variability and to evaluate different dosing regimens.
Material and methods
we conducted a prospective study in intensive care units (ICU) of a Tertiary University Hospital. Inclusion criteria were: ICU admission; diagnosis of sepsis, severe sepsis or septic shock and indication for ceftazidime. Exclusion criterion: requirement of renal replacement therapies. Patient’s demographics were obtained from clinical records. Non-linear effects modeling was performed using NONMEM®v7.3 following a three-step strategy: basic model selection, covariate inclusion and final model selection. Afterwards, Monte Carlo simulations were conducted considering different scenarios: short bolus infusion (BI), different extended infusions (EI) or continuous infusion (CI). Different regimens were simulated among patients with varying creatinine clearance (CrCL) and sepsis grades. A loading dose (LD) of 1g over 30 min was included before every EI and CI. Then, we calculated the percentages of patients (probability of target attainment: PTA) with trough concentrations (C trough ) above minimum inhibitory concentration, taking EUCAST susceptibility endpoints for ceftazidime as references. Our PTA cut off percentage was set to 90%.
Results
Thirteen patients were enrolled. Patients’ mean age was 61±17.6 years. 2 patients were diagnosed of sepsis, 8 of severe sepsis and 3 of septic shock. The model that described the data best was two- compartment linear model characterized by population CL, V (central volume), Vss (steady-state volume) and Q (intercompartmental CL) with interindividual variability on CL and V. Age, weight and CrCL were identified as significant modifiers of drug clearance. Grade of sepsis showed a significant influence on volume. PTA was below our target of 90% among sepsis grades for the BI regimen.
Conclusion
Our study demonstrates the reliable need of a LD to achieve early optimal drug concentrations when treating septic patients. Regarding dosing regimens, we have found that 1-2g every 8-12h in a 4h EI and 6g/day as a CI were the best regimens depending on patients’ CrCL and sepsis grade.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0323. AWARENESS AND WILLINGNESS TO USE HIV PRE-EXPOSURE PROPHYLAXIS AMONG MEN WHO HAVE SEX WITH MEN PARTICIPATING IN THE WORLD PRIDE EVENT Background
Consistent use of pre-exposure prophylaxis (PrEP) reduces HIV sexual transmission among men who have sex with men (MSM). World pride is a major event celebrating lesbian, gay, bisexual, and transgender (LGBT) culture and pride.
Purpose
To understand awareness of, use or interest in using PrEP among MSM attending World Pride 2017
Material and methods
A street-based intercept survey was conducted. Interviewers randomly approached attendees and asked them to participate in a brief anonymous survey which included: socio-demographic data, PrEP awareness, use or readiness to use it, self-perceived risk of HIV infection and chemsex or condomless anal sex practice in the last six months. Participants were recruited during World pride event. Attendees were eligible if they were male, at least 18 years old. Participants were given the option of being interviewed or completing the survey themselves.
We examined factors associated with awareness of PrEP and use or personal interest in using PrEP using chi-squared statistics.
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Results
Eighty-four men participated in the survey. 97.6% were <50 years-old. 83% european. 48% had stable partner and 32% had more than seven different sexual partners in the last 6 months. 8.3% were bisexual. 7.5% were HIV-positive. Regarding risk behavior, in the last 6 months: 52.4% had condomless anal sex, 27.4% had any sexually transmitted infection and 27.4% had participated in 'chemsex†sessions.
Most MSM were aware of PrEP (79.8%); Cited sources of information were: friends (44%), internet/social networks and media (36%), health professionals (25%) and associations (17%).
72.6 % of MSM would like to use PrEP but only 6% had used it before.
The proportion of men who had heard of PrEP was significantly higher among men with more than 7 partners in the last 6 months (92.6% vs 73.7%;p=0.04) and no stable partner (88.6% vs. 70%; p=0.03). No factors were associated with the use or willingness to use PrEP but there was a trend among chemsex sessions participants (13.1% vs 3.3% use PrEP;p=0.09)
Conclusion
Awareness of PrEP was common among MSM attending to world pride event but PrEP use was limited. Most participants would be willing to take PrEP in the future.
References and/or Acknowledgements
None
Conflict of Interest No conflict of interest
GOT18-0346. ANTIMICROBIAL THERAPY OPTIONS AGAINST CARBAPENEM-RESISTANT ENTEROBACTERIACEAE Background
The development of antimicrobial resistance among gram-negative pathogens has been progressive and relentless. Carbapenem-resistant Enterobacteriaceae, especially Klebsiella pneumoniae (kpc), are the newest threat in nosocomial infections, where classic antimicrobial agents are no longer useful, resulting in poor treatment outcomes.
Purpose
To evaluate and characterize kpc infections and their treatment options in our hospital.
Material and methods
An epidemiological, observational and retrospective nine months study was conducted in an 800-bed hospital from January to September 2017. All patients with kpc infection were identified using microbiological online data and clinical data was collected from online clinical records from Soarian Siemens and Pharmacy online systems Hosix. All data was analyzed using Microsoft Excel software.
Results
We identified 19 patients with kpc infections, mostly male and over 75 years of age. Most of them were surgical in-patients (65%) and the main sites of infection were urinary tract (N=8; 42%) and bloodstream (n=4; 21%). The laboratory resistant pattern findings showed that 26,3% (N=5) of the kpc-isolates were resistant to all antimicrobials, 26,3% (N=5) were susceptible only to tigecycline and 21% (N=4) was susceptible only to amikacin, gentamycin and tigecycline. In all patients, tigecycline was the main therapeutic option. Patients were treated, in average, for 11,5 days. Nevertheless, about 47% of the patients infected with kpc died, mostly the ones in end stages staying in surgical wards.
Conclusion
We concluded that kpc infections were mainly in surgical in-patients and in those over 75 years old, representing two risk factors for kpc infection in our hospital. Also, most of the kpc isolates were resistant to all antimicrobials or susceptible only to one antimicrobial tigecycline. Although some case reports have shown favorable outcomes, tigecycline is not a suitable choice for the treatment of urinary tract infections,
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the main site of infection in our study, possibly contributing to poor treatment outcomes. Once as our study demonstrated, treatment options for kpc infections were very limited and, more and more, prevention strategies and antimicrobial stewardship are crucial to prevent transmission and possible kpc outbreaks.
References and/or Acknowledgements
No Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0354. SMOKING CESSATION INTERVENTION IN THE HOSPITAL PHARMACY - IMPLEMENTATION OF THE TELEPHONE COUNSELLING SUPERVISION Background
Smoking cessation intervention is one of the support pharmaceutical services for in- and/or outpatients. Pharmacists can recommand the optimal therapy and ensure the engagement of patients in the cessation proces. The long-term effect of these services should be controlled.
Purpose
To perform a smoking cessation intervention provided by a hospital pharmacist. To implement the telephone counselling supervision for checking the non-smoking status when patients finish the smoking cessation intervention plan.
Material and methods
The telephone counselling supervision calls were applied to the group of the patients who have visited consultation centre in the hospital pharmacy because of smoking cessation in 2016 and 2017. Smoking cessation intervention consisted of at least 4 sessions during 3 months. Smoking cessation was chemically verified each visit by exhaled carbon monoxide. Patients were contacted after a half year and longer after the ending of interventions.
Results
Total number of the patients group was 26 (male/female 17/9) who have visited the consultation centre in period 2016 - 2017. Patients used during the cessation varenicline (n=7;27%) or nicotine substitution therapy (n=19; 73%). By ending of the intervention all patients didn´t smoke, 15 of them (58%) continued with occasional using of nicotine substitution therapy (NST). During October 2017, all patients were contacted by telephone call, 5 of them were not accesible. 12 patients haven´t still smoked, 3 of them have used NST occasionally. Number of still-smokers is 9, but all of them want to repeat the cessation intervention, according to the telephone councelling supervision.
Conclusion
Smoking cessation interventions have been provided in the hospital pharmacy for 2 years. During this period, 26 patients visited the intervertions. All patients were then contacted by telephone councelling in October 2017. After 6 months or longer, 12 patients (48%) haven´t still smoked. Smokers (n=9; 35% ) like to continue with smoking cessation intervention in our pharmacy. Telephone councelling seems to be a good tool for improvement of motivation, and also suitable tool for the long-term feed-back. Although the number of smoking cessation consultations is not high, the results show the right choise of counselling tools (intervention and telephone supervision).
References and/or Acknowledgements
None
Conflict of Interest No conflict of interest
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GOT18-0374. PRACTICAL DIFFERENCES BETWEEN LUTEINISING HORMONE-RELEASING HORMONE AGONISTS IN PROSTATE CANCER: THE PHARMACIST’S ASSESSMENT Background Over the last 70 years, androgen deprivation therapy (ADT) with luteinising hormone-releasing hormone (LHRH) agonists has established itself as the standard of care for men with advanced/metastatic prostate cancer (PCa). However, European guidelines for the management of PCa do not differentiate between LHRH analogues in their recommendations for the treatment of men with advanced/metastatic disease. Purpose Clear differences in efficacy, safety or tolerability between available LHRH agonists are lacking, so pharmacists must look to practical differences between formulations when selecting therapy for their patients. Moreover, as the economic burden of PCa rises alongside earlier diagnosis, longer treatment duration and improved survival, differences between LHRH agonists in associated treatment costs must also be considered. Material and methods A review was conducted to summarise information on the different LHRH agonist formulations currently available and offer insight into their relative benefits and disadvantages from the viewpoint of physicians, nurses and pharmacists 1; here, we present the pharmacist’s assessment. Results One practical aspect that differentiates LHRH analogues is the need for specific storage conditions. Leuprorelin acetate and goserelin acetate solid implants are stable at room temperature and can be used at any time, whereas powder and microsphere formulations have specific storage and/or handling constraints and must be reconstituted. Differences in injection intervals for LHRH agonists may have economic implications, with less-frequent 3- or 6-monthly dosing potentially providing cost savings due to lower resource utilisation versus 1-monthly dosing. Use of the leuprorelin acetate implant in PCa patients may lead to substantial cost and time savings, compared with the most commonly used alternative 1- and 3-month LHRH agonist preparations, including the goserelin acetate implant, leuprorelin acetate microsphere injection and leuprorelin acetate powder for reconstitution. The System of Objectified Judgement Analysis (SOJA) method is also a means of assisting pharmacists in selecting the most appropriate treatment for PCa patients. Conclusion Practical and potential cost differences exist between the different LHRH agonist preparations available. Pharmacists should be aware of and carefully consider these differences when selecting treatments for their PCa patients. References and/or Acknowledgements 1Meani D et al. Ther Adv Urol 2017;accepted
Conflict of Interest Conflict of interest Corporate sponsored research or other substantive relationships: Robert Janknegt currently has no conflicts of interest but has received in the past research grants from Sandoz, Holzkirchen, Germany and Bayer-Pharma, Berlin Germany. Mladen Solarić received honoraria from Abbot Nutrition, Kent, UK and is a consultant of regional offices for, as well as received honoraria from, Astellas Pharma, Surrey, UK Sanofi, Paris, France Janssen, Hrvatska, Croatia Sandoz International GmbH, Holzkirchen, Germany and Bayer-Pharma, Berlin Germany. Harri Visapää no conflicts of interest to declare. Sandoz International GmbH funded medical writing assistance for the development of this abstract.
GOT18-0378. COMPLETE RESPONSE WITH NIVOLUMAB IN HODGKIN'S LYMPHOMA: A CASE REPORT Background
Nivolumab is a humanized immunoglobulin gamma-4 kappa anti-programmed cell death 1 monoclonal antibody. It is currently approved in Europe in monotherapy for adult patients with relapsed or refractory classic HL after both autologous hematopoietic stem cells transplantation (HSCT) and brentuximab vedotin treatment.
Purpose
To describe the safety and efficacy of Nivolumab treatment in a patient with HL.
Material and methods
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A retrospective observational study of the use of nivolumab in a patient diagnosed with HL was conducted obtaining information from electronic clinical history (DIRAYA®) and the pharmacy service managing software (ATHOS-PRISMA®).
Results
A 22-year-old woman presented in 2014 Hodgkin's Lymphoma stage II-B with bulky disease. She had previously recived the following treatments: - ABVD x 6 cycles, after which supradiaphragmatic progression is evidenced. - ESHAP x 2 cycles, but as adenopathic left laterocervical conglomerate persisted, switched to IGEV scheme. - IGEV x 3 cycles, but evidenced tumor progression. - Brentuximab x 6 cycles, after which progression of the disease is objectified. - Mini BEAM x 2 cycles. - CMOPP and CEP (1 cycle both), without response. In February 2016 positron emission tomography computed tomography (PET/CT) showed lung involvement. Nivolumab was therefore prescribed at 3 mg/kg intravenously every 2 months. Although the patient was previously treated with brentuximab, HSCT therapy was not received so nivolumab was considered off-label indication in this case. First complete response was verified after 25 cycles of treatment with nivolumab, and remained 3 months later (cycle number 33). During treatment with nivolumab the following adverse reactions were described: controlled with medication neutropenia, occasional leg cramps, and moderate headache and dry skin. Finally, nivolumab was interrupted due to accumulative infectious risk and HSCT was proposed.
Conclusion
Nivolumab has proved to be effective in this patient with HL. Although this patient has been very pretreated, nivolumab’s toxicity profile resulted to be well tolerated and it has provided her very good life quality during 1 year and a half.
References and/or Acknowledgements
No references
Conflict of Interest No conflict of interest
GOT18-0396. TAMOXIFEN USE IN ENCAPSULATING PERITONEAL SCLEROSIS – A CENTER EXPERIENCE Background
Encapsulated peritoneal sclerosis (EPS) is characterized by peritoneal fibrosis, bowel encapsulation and obstruction. EPS is a rare and serious complication of peritoneal dialysis (PD), for which there is no specific approved therapy. EPS risk factors are: time on PD greater than 5 years, overexposure to hypertonic glucose solutions, acquired ultrafiltration failure and two or more peritonitis. Various cytokines and growth factors are involved in this fibrosis and angiogenesis process, like TFG- beta. Tamoxifen has an antifibrotic effect that seems to be related to decreased TGF-beta activity and inhibition of angiogenesis. Due to scarce international literature with data from clinical practice, we consider relevant to evaluate the use of this drug, contributing to a rational and safe drug use.
Purpose
To describe and to characterize the standard use of tamoxifen regarding the treatment and prophylaxis of EPS.
Material and methods
All outpatients with tamoxifen dispensing documentation, for treatment or prophylaxis of EPS, were included in this descriptive, observational and retrospective study, between January 2011 and December 2016. All information was obtained by consulting hospital records, as well as contacting an attending physician.
Results
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During the research, 17 patients performed therapy with tamoxifen (prophylaxis (n=10) and treatment (n=7)). 58.8% (n=10) of the patients were male. The tamoxifen doses of 20 mg/day was prescribed to 88% (n=15) of the patients, with the average treatment duration of 7.6 months. The average DP time when initiating the treatment with tamoxifen was 64 (23-109) months; 76.5% (n=13) were on automatized DP; 70% of the high risk patients were undergoing PD with hypertonic solutions. None of the patients on prophylaxis developed EPS. Of the 7 patients with ongoing treatment, 3 were transplanted, 3 were in hemodialysis and 1 remained in PD. No suspected adverse drug reaction was reported concerning the use of tamoxifen in this indication.
Conclusion
EPS is a rare and dangerous complication for patients undergoing long-term PD. Like the published studies, we consider the potential benefit of the use of tamoxifen in the treatment and prophylaxis of EPS. However, to support this drug use, more prospective, randomized studies should be performed.
References and/or Acknowledgements
NA
Conflict of Interest No conflict of interest
GOT18-0408. TOPICAL AZITHROMYCIN FOR THE PROPHYLAXIS OF POSTOPERATIVE ENDOPHTHALMITIS IN CATARACT SURGERY Background
Cataract extraction with intraocular lens implantation is the most commonly performed surgical procedure in the elderly population over the world. Infectious postoperative endophthalmitis (IPOE) is the most dreaded complication of cataract surgery. Topical antibiotics (AB) role in the prophylaxis of IPOE is controversial. Recent studies reveal that the overall rate of intravitreal injection-related endophthalmitis is greater with the use of topical AB given immediately after the injection compared with no AB.
Purpose
To assess whether administration of topical azithromycin immediately following intracameral injection of cefuroxime reduced the risk of endophthalmitis in patients undergoing cataract surgery.
Material and methods
A retrospective observational study was performed in a 100-bed hospital, acting as a complementary centre to a tertiary 450 bed-hospital and including a random sample of patients undergoing cataract surgery between January 2010 and December 2014.
Intracameral cefuroxime (1mg/0.1ml) or vancomycin (1mg/0.1ml) in case of B-lactamic allergy was used in all procedures. Topical azithromycin eye drops were prescribed twice daily for three days, starting the day before surgery.
The following variables were collected: sex, age, origin, eye intervened, duration of surgery (in those patients whom variable was registered), comorbidities, and presence or absence of IPOE. Results
A total of 1834 patients were included. N(%): female 1060(57.8); age [median (Q1-Q3)]: 76(70-80); origin: home 1822(99.4), nursing home 12(0.6); eye intervened: right 890(48.5), left 944(51.5); duration of surgery [1551 patients(84.6%)] {minutes[median (Q1-Q3)]}: 15(12-22) comorbidities: hypertension 1168(63.7), diabetes 484(26.4), immunosuppression 24(1.3); presence of IPOE: 0(0).
Conclusion
The rate of endophthalmitis observed in our center is negligible. Coadministration of topical azithromycin after intracameral injection of cefuroxime has not provided any benefit and this practice should be avoided.
References and/or Acknowledgements
Conflict of Interest
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No conflict of interest
GOT18-0424. MEDICATION RECONCILIATION IN THE ELDERLY: EMERGENCY DEPARTMENT, ADMISSION AND DISCHARGE Background
Patients often have changes in medication orders during transitions of care: hospital admission, transfer between hospitalization units, or at discharge home. Medication reconciliation consists of obtaining the best possible medication history (BPMH) to reduce unintended discrepancies.
Purpose
To detect discrepancies between pre-admission medication lists, medication prescribed at the emergency department, during admission in a geriatric unit and at discharge.
Material and methods
Inclusion criteria were elderly patients with a hospital admission through the emergency department and hospitalized in a geriatric unit. Data were analyzed using Microsoft® Excel.
Variables collected at admission were: age, gender, number of medicines reviewed, omitted medications, unnecessary therapies and incorrect dosages or regimens in pre-admission medication list or in the transfer to geriatric unit.
Variables collected at discharge were: age, gender, number of medicines reviewed and discrepancies at discharge.
Results
The study included 16 patients (11 women and 5 men). Median age was 88 years old (73-99). A total amount of 163 medications were reconciled. In pre-admission medication list, a total of 24 unintentional discrepancies were detected (14,7%). Twelve (50%) of them due to unnecessary therapies, 6 (25%) were omitted medications, 5 (21%) were regimen errors and one (4%) was an incorrect dosage. In the transition from the emergency department to the geriatric department, 60 discrepancies were detected (48 were intentional). Main causes were: 40% regimen errors, 30% omitted medications, 15% unnecessary treatments and 15% incorrect dosages. Finally, there were 12 intentional discrepancies at discharge.
Conclusion
During the medication reconciliation process a total of 96 discrepancies were detected. Sixty-three percent occur during transition to the geriatric unit and were due to treatment adjustment. Most of the discrepancies detected at admission were caused by a lack of an updated pre-admission medication list. The most frequent discrepancy was an unnecessary therapy. Many patients could be overmedicated. To assure patient safety, to improve communication between Primary Care and hospital healthcare professionals is needed.
References and/or Acknowledgements
Pharmacy and geriatric unit staff.
Conflict of Interest No conflict of interest
GOT18-0444. SWITHCH IN SEVERE ASTHMA TREATMENT Background
Omalizumab is indicated in severe IgE-mediated asthma depending on initial dosage of IgE levels and weight and mepolizumab in severe eosinophilic asthma which a standard dose of 100 mg once a month is given. Patients with severe eosinophilic and IgE mediated asthma could to receive any of the treatments according criteria cost-effectiveness.
Purpose
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Economic Savings Assessment which implies the change of treatment from omalizumab to mepolizumab in patients with severe eosinophilic and IgE-mediated asthma.
Material and methods
Retrospective study in which patients on omalizumab treatment were selected using the Farmatools® program and analyzed the treatment regimen and whether they presented eosinophilia. The clinical history were checked to determine if there was or not eosinophilia, defined as a blood eosinophil count>300 cells/mcL in the previous 12 months (MENSA study).
Results
A total of 117 patients with severe IgE-mediated asthma on active treatment with omalizumab of which 28 (23.9%) had a regimen of 150 mg/month, 5(4.3%) 300 mg/15 days, 68(58.1%) 300 mg/month, 8(6.8%) 450 mg/month, 1(0.9%) 450 mg/15 days, 4(3.4%) 600 mg/month and 3(2.6%) 600 mg/15 days. Patients with doses> 450 mg/month of omalizumab would be candidates for change to mepolizumab being our sample of 13 patients (9.92%). Of these 13 patients, 3(23%)(dose 600 mg/15 days) had an eosinophil count <300 cells/mcL in the previous 12 months and 10(77%) had a blood eosinophil count> 300 cells/mcL in the previous 12 months meeting the criteria to classify them as suffering from severe eosinophilic IgE-mediated asthma. The annual savings according to the cost-effectiveness criteria would be 34,248.00 €/year/total patients (3,424.80 €/patient/year). The number of visits would be reduced to 78/year/6 patients with biweekly with a saving 420 €/patient/year.
Conclusion
After this study, a protocol was proposed for the use of monoclonal antibodies in the treatment of patients with IgE-mediated and eosinophilic asthma according to clinical and economic criteria, due to the high budgetary impact of these drugs.
Collaboration between the Prescribing and the Pharmacy Services is essential to optimize treatment. The Prescribing Services will be informed so they value the possibility of making the change of treatment in the selected patients.
References and/or Acknowledgements
Informe de Posicionamiento Terapéutico del Mepolizumab Agencia Española del medicamento. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT- mepolizumab-Nucala-asma_EPOC.pdf
Conflict of Interest No conflict of interest
GOT18-0454. USE OF NINTEDANIB AND PIRFENIDONE IN IDIOPATHIC PULMONARY FIBROSIS Background
Nintedanib and pirfenidone (both oral) are the only therapies currently approved for idiopathic pulmonary fibrosis (IPF) treatment.
Purpose
To describe the efficacy and safety of both drugs in IPF treatment in a tertiary hospital.
Material and methods
A retrospective, observational study was conducted, including all IPF patients on pirfenidone or nintedanib. Data regarding demographic characteristics, treatment posology and duration, efficacy based on forced vital capacity (FVC) variation and safety, expressed as reported adverse events (AE), were collected from the Assisted Electronic Prescription Programme and Electronic Health Record.
Results
27 patients were included; 20 (74.1%) were men, mean age 68.6 years (54-85). 14 (51.9%) received pirfenidone, and 13 nintedanib.
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Among patients on pirfenidone, 10 received the recommended dose of 801 mg/8h, 3 received a reduced dose (534 mg/8h) and 1 was undergoing dose titration (mean treatment duration 20 months (0.2-35)). Mean FVC (% of expected FVC according to each patient’s physiopathological characteristics) before treatment was 75.2% (1 patient not included because of lacking data on post-treatment FVC). Mean post- treatment FVC was 73.7%. Mean FVC variation was -2% (-18.7 to +9.6%). 2 patients (15.4%) experienced ≥10% FVC reduction. 8 (57.1%) reported AE, most frequently aminotransferase increase (3 patients, one of which required dose reduction to 1335 mg daily for 2 weeks), photosensitivity (2) and anorexia (2). 1 discontinued treatment due to weakness and stomach discomfort.
9 patients on nintedanib received 150 mg/12h; 3 received 100 mg/12h and 1 was on dose titration; mean treatment duration was 9.9 (0.5-28) months. Mean pre-treatment FVC was 80% (5 patients not included because of lacking data on FVC). Mean post-treatment FVC was 76.1% (mean FVC variation -5.9%; -16.2 to + 2%). 3 patients (37.5%) suffered ≥10% FVC reduction. 5 (38.4%) suffered AE, of which diarrhoea should be pointed out (4 patients). 3 patients required dose reduction to 100 mg/12h, 2 because of diarrhoea (one of which discontinued treatment) and 1 due to nausea and vomiting.
Conclusion
Nintedanib and pirfenidone are effective treatments for IPF, with a safety profile consistent with that reported in the available scientific evidence. Prospective studies are desirable to draw conclusions about comparative efficacy and safety between both drugs.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0461. BRENTUXIMAB VEDOTIN: EVALUATION OF THE CLINICAL PRACTICE IN A TERTIARY HOSPITAL Background
Brentuximab vedotine (BV) is a conjugated antibody formed by a monoclonal antibody directed against CD30.
Purpose
The aim of this abstract is to describe the effectiveness and safety of brentuximab vedotin according to the experience of its use in clinical practice.
Material and methods
Retrospective observational study from January 2015 to March 2017 of all patients who started treatment with BV in a tertiary level hospital. The variables analyzed were sex, age, diagnosis, stage of the disease, previous treatments, number of cycles of BV administered, transplant afterwards, effectiveness according to Cheson criteria (confirmed by PET) and adverse effects.
Results
Twelve patients were included. 58% of the patients were men and the median age was 42 years (range 22- 67). Diagnosis: nodular-sclerosis classical hodgkin lymphoma (10 patients), anaplastic large-cell lymphoma (1 patient )and mycosis fungoides transformed into large T-cell lymphoma (1 patient).Stage of disease: I (1/12), II (6/12), III (1/12), IV (4/12). Five patients were given BV when their disease was refractory to other treatments and 7 patients were relapsed. The median of previous cycles was 10 (range 14 - 7). The most frequent previous treatments were: ABVD (10/12), ESHAP-MINE (8/12), CHOP (5/12), GPD (5/12). The median of BV cycles received was 4 (range 1-7). In 5 patients (all of whom were diagnosed with Nodular- Sclerosis Classical Hodgkin Lymphoma) a subsequent transplant was performed: TASPE (2/5) and aloTPH (5/5). Effectiveness: Complete remission (CR) (4/12), partial remission (PR) (5/12), Progressive disease (PD) (2/12) and pending evaluation (1/12).
Adverse effects were manifested in 33.33% of patients (abdominal discomfort, erythematous lesions, grade II (reversible) peripheral sensory neuropathy and infusional reaction despite premedication. 2 patients die short time after starting treatment with BV.
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Conclusion
Brentuximab vedotin is an effective treatment in patients with nodular-sclerosis classical hodgkin lymphoma, leading to a complete or partial remission in the majority of patients undergoing such treatment. However, this drug causes a toxicity that leads to the withdrawal of this treatment in one of the patients. However, longer-term, population-based studies are needed to identify the benefit-risk balance as well as to identify population subgroups most likely to respond with the lowest rate of adverse effects.
References and/or Acknowledgements
the technical data sheet
Conflict of Interest No conflict of interest
GOT18-0481. ABOUT A CASE: COLISTIN MAGISTRAL TOPICAL PREPARATION FOR PSEUDOMONAS AERUGINOSA INFECTIONS Background
Pseudomonas aeruginosa is very common in systematic skin and soft tissue infections. Every time more strains of P.aeruginosa conduce to the apparition of resistances.
In case of local external infections, the use of topical colistin has shown to be a good therapeutic option.
Purpose
To elaborate a topical magistral preparation due to the lack of a commercialised preparation of topical colistin.
Material and methods
Observational study about a patient with an intern inframaleolar ulcer. The antibiogram of the ulcer sample showed the presence of multiresistent P.aeruginosa only sensitive to amikacin, aztreonam, ceftazidime, cefepime and colistin.
A parenteral treatment was started with ceftazidime during 30 days but there was a lack of improvement. Topical 2% colistin was requested to Pharmacy Service (PS).
The PS made a bibliographic research and elaborated a topical preparation following a risk matrix 1 proposed by Sociedad Española de Farmacia Hospitalaria to stablish the ideal conditions of conservation.
Results
A 65 years old man with diabetes mellitus type 2 with a inframaleolar ulcer required topical colistin treatment for the first time in the PS. We made a bibliographic research and the information obtained was:
• Topical preparation is not commercialised in Spain. • The usual dosage goes from 0,1 to 1% for the topical route. • The pure active ingredient is commercialised as colistin sulphate. • Colistin is water-soluble. It can be mixed in a o/w cream.
In our PS, we don’t dispose of the pure active ingredient so we used the parenteral vial of sodium colistimethate. One vial of sodium colistimethate contains 1MU which corresponds to 33 mg of pure colistin. To prepare a 0,1% colistin emulsion we need 3 vials of sodium colistimethate. We elaborated a topical preparation of 0,1% colistin o/w emulsion. The emulsion composition is: bidistilled water 60%, glycerine 10%, Neo PCL 30% and nipagin and nipasol as a conservants.
The given stability was 30 days at room temperature pending the results of the stability studies in a topaz container.
The patient improved and the antibiogram showed no growth after 40 days.
Conclusion
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• P.aeruginosa infections. • It should be used in more patients to arrive at solid conclusions on the possibilities of the use of this treatment.
References and/or Acknowledgements
-
Conflict of Interest No conflict of interest
GOT18-0483. ALIROCUMAB AND EVOLOCUMAB IN HYPERCHOLESTEROLEMIA AND MIXT DYSLIPIDEMIA Background
Up to now, statins and ezetrol were the election treatment for hypercholesterolemia and mixt dyslipidemia. Recently, alirocumab and evolocumab have appeared. They are high-cost drugs compared to the first line treatment and this illness is very common in our population. For that reason, it is important to make a follow- up of these patients.
Purpose
To evaluate the medical prescription before initiating the treatment regarding its efficacy.
Material and methods
The Pharmacy Service elaborated a check-list to evaluate the suitability of Alirocumb/Evolocumab treatments before initiating the treatment.
In this check-list, the evaluated parameters were: the indication, the adherence to the previous domiciliary treatment (statins and fibrates) and its maximum dosage, healthy lifestyles, LDL levels, risk factors (including age and sex) and the requiring service.
Results
14 patients were included, 11(85%) were women. The average age was 62±17 years old. The requests were made by: 8(57%) Endocrinology, 4(29%) Cardiology, 1(7%) Internal Medicine and 1(7%) Nephrology. All the requests were clinically indicated, 6(43%) had mixt dyslipidaemia and 8(57%) had heterozygote hypercholesterolemia. The average LDL level was 167±63 mg/dL. 13(93%) patients received statins and 1 (7%) patient did not. All patients with statins have taken the maximum tolerated dosage.
7(50%) of the treatments were approved and the other half were not. The reasons why the treatment was not indicated were: no compliance to statin treatment (43%), only being treated with one statin (29%), inadequate lifestyles (14%) and patients’ non-acceptance (14%).
3(43%) patients have already initiated the treatment: 2 patients with Alirocumab 150 mg every 2 weeks and 1 patient with Alirocumab 75 mg every 2 weeks. The average LDL levels during the follow-up at week 4 was 53±26 mg/dL.
Conclusion
Based on our results we conclude:
• It is important to realize a screening of the patients before initiating the treatment with Alirocumab and Evolocumab because most patients don’t accomplish the requirements we have stablished. • In our study, although we have a very small sample of patients, Alirocumab have shown to be effective because it reduced the LDL levels more than a 50%.
References and/or Acknowledgements
-
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Conflict of Interest No conflict of interest
GOT18-0486. Apremilast: A new oral treatment option in Psoriatic Arthritis and Psoriasis. Background
Apremilast is a small-molecule inhibitor of phosphodiesterase-4 specific for cyclic adenosine monophosphate (AMPc), this Inhibition raises intracellular levels of AMPc and decreases the expression of several inflammatory cytokines implicated in Psoriatic-arthritis and Psoriasis.
Purpose
To analyze the efficacy, safety and influence on the quality of life of the treatment with apremilast in patients diagnosed with psoriatic-arthritis (APs) and psoriasis.
Material and methods
Observational prospective study in patients with APs and psoriasis from January-September 2017 which included adult patients with APs and psoriasis in treatment with apremilast. Information was obtained through Farmatools® program, treatment`s protocols of changes and validated quality of life questionnaires (DLQI-dermatology and HAQ-rheumatology) performed during the visits pharmaceutical care after 47 days and 7 months of treatment. The followings variables were obtained: Demographic variables, biological activity for patients with APs (DAS28), causes of the beginning and medication adverse reactions (RAMs).
Results
The study was conduced in 13 patients (53.85% women;59.13 years), 7 presented APs and 6 psoriasis. All patients with APs presented a moderate-high biological activity. The reasons of initiation after failure- progression to disease modulating drugs (FAME) or biologic in APs and immunosuppressive in psoriasis were: 5 patients (38.46%) with incompatibility to the biological treatment, 4 by phobia of injectables (30.77%) and 4 for having a mild state of the disease (30.77%). The questionnaires were similar in both visits, with an average assessment of 0.833 APs and 5.33 psoriasis. All the patients presented RAMs, mainly 75% diarrheas, 65% sadness-decay and 41.67% insomnia; Most patients described a start of the slower improvement than expected. During the study, 6 patients (46.15%) suspended treatment; 5 APS and 1 psoriasis for inefficacy (66.66%) and RAMs (33.33%).
Conclusion
Apremilast had been effective in patients although the beginning of its action had been subjectively slower than observed for other treatments. Most of the patients presented diarrhea and depression . Although apremilast provides a new therapeutic option in APs and psoriasis, given these efficacy and safety results, its use should be reserved for patients with incompatibility to biological treatment, but it does not seem appropriate to select only by its oral administration.
References and/or Acknowledgements
Hospital Pharmacy Service
Conflict of Interest No conflict of interest
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GOT18-0494. ANALYSIS OF THE DATA OBTAINED AFTER INTENSIFY AN IMPLEMENTED ANTIBIOTIC STEWARDSHIP PROGRAM Background
Adequate antibiotic use influences the development of bacterial resistance, adverse events (AE) and health-care costs. Implementing antibiotic stewardship programs (ASP) for optimizing the use of antibiotics in hospitals is considered one of its strategic objectives. After implementing and creating a multidisciplinary infection team (MIT), in 2016, our hospital was one of the main consumers of antibiotics in the area, so ASP was intensified involving prescribers, prioritizing internal medicine (IM).
Purpose
To analyse the data obtained from the intensification of the ASP and to describe the method of a county hospital.
Material and methods
Retrospective study included adult patients admitted to IM treated with antibiotic therapy (AT) between May and September 2017. The following outcomes were collected: average of hospitalised patients and admitted to IM and how many with antibiotic; admitted to IM with antibiotic >48 hours. Of the latter, the new ones to check daily, and of these, without changing treatment, stop treatment, dose changes, escalation or de- escalation, switch therapy, discharge. Data were collected from electronic clinical history, hospital’s electronic prescribing software and by an automatic daily mail produced by MIT informing all pharmacists and prescribers about patients with AT >48hours.
Results
An average of 88,9 patients were hospitalised, 46,7 with antibiotic (52,5%). 33,3 admitted to IM, 19,6 with antibiotic (58,7%). 37,5% of hospitalised were to IM. 12,1 patients were under AT>48hours. 3,5 were news to check daily; 2,6 without changing treatment; 0,1 stopped treatment; 0 changed or de-escalated dosage; 0,3 escalated dose; 0,2 switched therapy and 0,2 discharged. During the period of time studied, patients hospitalised with antibiotic decreased in 7,5 patients (1%) and 6,5 (2,9%) in admitted to IM.
Conclusion
An intensified ASP contributes to involve prescribers to optimise the use of antibiotics. However, more improvements are needed about the consumption of antibiotics and more interventions could be registered in patients admitted to IM with antibiotic >72hours.
References and/or Acknowledgements
Internal Medicine Department, Infection team, Pharmacy Department
Conflict of Interest No conflict of interest
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GOT18-0498. EFFICACY AND SAFETY OF RITUXIMAB TREATMENT FOR CHILDREN WITH STEROID-DEPENDENT AND STEROID-RESISTANT NEPHROTIC SYNDROME Background
Rituximab(RTX) has been used as a rescue therapy for children with steroid-dependent (SD) and steroid-resistant(SR) nephrotic syndrome(NS). There is no evidence of the optimal regimen or duration of RTX treatment, although some patients have received up to 12 cycles.
Purpose
To evaluate the efficacy and safety of the use of RTX for the treatment of children with SDNS and SRNS in a tertiary hospital.
Material and methods
Records of patients, 1-18 years old, with SDNS and SRNS treated with RTX between August 2008-October 2017 were retrospectively reviewed. Treatment protocol for SDNS and SRNS in our hospital includes: i)boluses of intravenous(iv) methylprednisolone associated with oral prednisone and oral cyclophosphamide, ii)cyclosporine, mycophenolate mofetil and tacrolimus if no response or relapses still occure, and iii) iv rituximab 375mg/m2 if patient continues relapsing. Variables related to RTX treatment were recorded. Satisfactory response was defined as absense of relapse≥6 months after a RTX cycle and relapse-free period as time of each RTX cycle to time of relapse. Infusion related reactions were recorded to evaluate safety.
Results
Nine patients (55,6% girls, 14,9±1,3 years), 66,7%(N=6) SDNS and 33,3%(N=3) SRNS, were included (77.6%(N=7) idiopathic NS). Median age at the onset of NS and at the first RTX dose were 3,7 years (range2-16,4) and 10,9 years (5-16,9) respectively. At the time of the first RTX dose, all patients were receiving steroids and 88,9%(N=8) tacrolimus. Cyclosporine (66,7%,N=6), cyclophophamide (77,6%,N=7) and mycophenolate mofetil (88,9%,N=8) had been used previously. Median duration of treatment with RTX was 39,6 months (range14,5-105,3). Patients received a median of 2 cycles (range1-8) with a median interval between the cycles of 13,5 months (range4,2-39,7). Mean number of RTX doses per cycle was 1,2 (SD=0,4). Seven patients(77,6%) received>1 cycle. Median relapse-free period was 12,7 months (range 3,4-61,7). At 6 and 12 months after RTX administration, relapse rates were 13,8% and 46,4% respectively. Infusion-related reactions included nausea in 1 patient(2,6%).
Conclusion
Complex SDNS and SRNS children are treated with single doses of RTX, repeated on clinical relapse. Single doses of RTX seem to be effective in avoiding relapses at 6 months and relatively effective at 12 months. RTX is a safe alternative when administered to these patients.
References and/or Acknowledgements
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Conflict of Interest No conflict of interest
GOT18-0499. CLOSER TO THE PATIENT: IMPROVING PHARMACEUTICAL CARE IN RHEUMATOLOGY Background
The development of new biologic agents (BA) and the increasing number of patients in rheumatology has forced pharmacists to improve pharmaceutical care. It is therefore, necessary to have a standard operational procedure (SOP) in place that describes the prescription, reviewing, dispensing and counselling of biological therapies.
In our hospital, there is a follow-up programme for rheumatology patients with BA. Pharmacists have a key role to improve medication adherence and patients can have a better understanding of their medication. To achieve this goal, patients can either come to our outpatient consult or call in to the pharmacy department.
Purpose
To analyze pharmaceutical care and counselling over the telephone. The following data was collected: number of patient attended, number of consults made and number of consults recorded in patient's clinical history.
Material and methods
It was carried out and observational retrospective study from January 2016 to 31 August 2017. All rheumatologic patients with BA were included.
Results
A total of 301 patients with AB were attended in our Pharmacy Service: 158 in 2016 and 143 in 2017.
We received an average of 3 phone calls a week in 2016 and 5 in 2017. 11 calls were recorded in our system in 2016 and 29 in 2017. From these, 8 were recorded in patient's clinical history in 2016 and 12 in 2017. Most of the calls are related to adverse effects and administration doubts.
Conclusion
We can conclude that there is a great acceptance of pharmacist's care and counselling over the telephone and patient's concerns about adverse effects. In spite of this, transition from manual to electronic registration has to improve. Moreover, we need to regist all the information in patient's history.
Because of patient's increasing request it is necessary to assess and stablish a registration circuit so we can improve pharmaceutical care.
References and/or Acknowledgements
no references and/or acknowledgments
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Conflict of Interest No conflict of interest
GOT18-0508. LONG-TERM EFFECTIVENESS AND SAFETY OF PCSK9 INHIBITORS IN CLINICAL PRACTICE Background
PCSK9 inhibitors (alirocumab and evolocumab) are indicated in patients with hypercholesterolemia who are unable to reach LDL-cholesterol (LDL-c) goals with statins or, who are statin-intolerant. Therefore, PCSK9 inhibitors might decrease cardiovascular disease (CVD) incidence.
Purpose
Assessment of effectiveness, CVD risk reduction and safety of alirocumab and evolocumab in outpatients with hypercholesterolemia
Material and methods
A 13-month prospective descriptive study was conducted in an outpatient hospital pharmacy(September/2016-September/2017). Patients with hypercholesterolemia receiving alirocumab or evolocumab therapy for at least 12 weeks were included. Demographic, clinical and treatment-related variables, including hygienic-dietary measures, were recorded. Effectiveness at 12 weeks: median and relative reductions with respect to baseline LDL-c, proportion of patients achieving therapeutic goal (LDL-c<100mg/dL) and, the estimated 10-year CVD risk reduction at baseline and week 12, measured by the REGICOR® scale (low risk:<5%, moderate:5-9%, high:10-14% and, very high:≠¥15%) validated for use in Spanish population. Safety was assessed by registering most frequent adverse events detected during pharmacist-patient interview.
Results
Nineteen patients (57% women) with a median(IQR) of 55(50-61) years receiving alirocumab (6 patients:75mg/2weeks, 7 patients:150mg/2weeks) and evolocumab (6 patients:140mg/2weeks) were included. At baseline, 7/19 patients had a low 10-year CVD risk and 9/19 patients, a moderate risk.
Effectiveness at 12 weeks: median reduction of 104 mg/dL(84-139) and relative reduction of 64%(77.2%-52,3%) with respect to baseline LDL-c and, all (19/19) patients achieved the therapeutic goal. Considering the median reduction of 2%(1%-4%) per patient, a low 10-year CVD risk was estimated in all(19/19) patients.
Safety: Adverse events were presented in 74%(14/19) of patients. Most common adverse events were pruritus(3/19), local injection site reactions (2/19) and upper respiratory tract symptoms(10/19). The latter was detected more frequently(≥1/10) than pivotal studies(≥1/100). Alirocumab was interrupted in a patient due to a severe dermatological reaction. Only a 16%(3/19) of patients followed hygienic-dietary measures.
Conclusion
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The median and relative reductions of LDL-c in patients with hypercholesterolemia receiving alirocumab and evolocumab were similar to those obtained in pivotal trials, and all patients achieved the therapeutic goal. According to the REGICOR® scale, a low 10-year CVD risk was also achieved. A higher frequency of upper respiratory tract adverse events was detected. Pharmacist should be focus on increasing compliance of hygienic-dietary measures.
References and/or Acknowledgements
-
Conflict of Interest No conflict of interest
GOT18-0520. IMPROVEMENT IN OSTEO ARTICULAR INFECTIONS PATIENTS COMPLIANCE THANKS TO THERAPEUTIC EDUCATION Background
The osteo-articular infections (OAI) are a common type of infections, with a long and complicated treatment. The therapeutic success relies on the patient adherence. To this end, a pharmacist conducts educational interviews with patients using approved files.
Purpose
Develop the antibiotherapy councelling, with educational interviews and suitable files furnished to patient. Evaluate the satisfaction of patients.
Material and methods
1. A bibliographic search on pubmed concerning the compliance affecting factors 2. The preparation of files based on the retained items 3. A standardized satisfaction survey
Results
1. The Compliance affecting factors are:
-patient: age (n=24),
-disease (n=39) : symptom’s degree (n=14)
-treatment (n=55) : drug intake (n=31), side effects (n=38), galenic form (n=27), efficiency (n=26), duration (n=6)
The impacting factors of non-compliance are:
-An unknown drug’s availability: downtown or hospital
-A poor communication between patients and healthcare providers (n= 3)
2. An OAI global files and 6 specifics files (clindamycin, levofloxacin, linezolid, rifampicin, Sulfamethoxazole-Trimethoprim, Teicoplanine) was created to educate the patient on the use of his antibiotics.
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The general file is divided in 3 parts:
- Infection’s reminders (location, germ),
- Anbiotherapy’s specificities and issues (duration, drugs intakes, drug combination),
- Description of the 6 golden rules
All the specific sheets have the same structure:
- Drug’s mechanism of action
- Galenic form’s description and availabilities
- Side effects
- Drugs interactions
- Clinical-biological tracking
30 interviews were realized during 3 months.
50 antibiotherapy’s sheets was explained and given to patients: rifampicin (n=13), levofloxacin (n=12), clindamycin (n=10), linezolid (n=7).
100% were pleased with the interview, and have understood their treatment thanks to an available healthcare professional, who has given clear information.
The strengths (n=8): antibiotic’s information, the interlocutor availability, a good understanding of the pharmaceutical care.
The weaknesses (n=2): fear of side effects and a long term treatment.
Conclusion
Other sheets are being developed (Minocycline, ciprofloxacin, ceftazidime and amoxicillin- clavulanic acid).
A link with the retail pharmacist is intended, a secured letter will inform him that the patient has received appropriate counselling on his treatment.
The compliance analysis well after the interview is our next goal (i.e. Morisky score).
References and/or Acknowledgements
J. Anandamanoharan, Observance et médecine générale : peut-on dépister les problèmes d’observance chez les patients atteints de pathologies chroniques ?
Conflict of Interest No conflict of interest
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GOT18-0522. LARVAL DEBRIDEMENT THERAPY IN NECROTIC WOUNDS ASSESSMENT Background
Surgical debridement is the most usual clinical practice in dead tissue removal in wounds but, lately, new therapies have come up, like the usage of Lucilia sericata fly larvae.
Purpose
Usage of larval therapy in our hospital assessment, in terms of efficiency and economic impact.
Material and methods
We performed a retrospective and observational study with patient records, direct observation of the wound and Pharmacy Service drug dispensation. Data about gender and age were collected. We measured the number and type of injuries, along with size and depth. We also checked if there was superinfection and the patient’s nutritional details. Regarding the treatment, we counted the number of bags used, dose, posology and total cost of treatment.
Results
3 patients were treated with larvae therapy between 2015 and 2017. 2 of them were women and the average age was 63±17. All patients presented infected necrotic wounds. Patient number 1, who presented a necrotic wound in the supracondylar area because of an amputation, was treated of 1,5 weeks with larvae replacement every 4 days. Patient number 2 presented 2 ulcers in the sacral zone and 1 ulcer in the gluteus: all of them because of pressure. Patient number 3 presented 1 ulcer in the sacral zone due to pressure. In 2 and 3 the treatment lasted for 3 weeks, with larval replacement every 4 and 7 days. Average dose were 75 larvae units for patient number 1; 1,100 for patient number 2 and 150 for patient number 3. All patients had a significant improvement: dead tissue was removed regardless the dosage. The cost of the treatment was € 644.24 (3 bags) for patient number one, € 4,603.81 (15 bags) for patient number 2 and € 1,153.53 (3 bags) for patient number 3.
Conclusion
Larval therapy enabled significant improvement in necrotic wounds in our patients without the need of surgical debridement, regardless the dosage.
References and/or Acknowledgements
-
Conflict of Interest No conflict of interest
GOT18-0527. EFFECTIVENESS OF PROTEIN C TREATMENT FOR HEREDITARY TROMBOFILIA IN PEDIATRIC PATIENTS. ABOUT A CASE. Background
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Congenital protein C deficiency is an inherited disorder of coagulation due to a reduced level of protein C synthesis and / or activity and characterized by profound symptoms of venous thrombosis. More common in countries where consanguineous marriages are common; with a frequency of 1 / 500,000.
Purpose
- To evaluate the effectiveness of the use of protein C through the clinical parameters and progressive disappearance of clinical hematology .- Safety and cost of treatment
Material and methods
Clinical case report of an 8 month old female patient with a congenital deficiency of protein C, favored by inbreeding of her parents. Accompanied by the syndrome of Jervell-Lange-Nielsen (long QT) and various complications such as blood dyscrasia, purpura fulminans, ocular and auditory involvement. Study of the red series and the different times of thromboplastin, D dimers, protein C levels and prothrombin activity from birth, continuing the monitoring during the treatment
Results
From birth a thorough coagulation study is performed which is repeated every 3 months to monitor protein C levels, different thromboplastin times and blood biochemistry.The value of coagulation protein C has a range between 70-140%, and our patient was born with 4% levels, also altered the rest of clotting values ​​much lower than normal.After 2 months of treatment the levels of protein C increased up to 15% and at 6 months increased up to 60% even, decreasing corresponding thrombophilic and purple clinicians.
Conclusion
Protein C was found to be effective as a replacement therapy for hereditary thrombophilia due to congenital protein C deficiency, showing a clear improvement in the patient from the time of initiation of therapy. Appreciating an increase in protein C levels and a decrease in coagulation times in the blood count. However, further studies are needed to further clarify this treatment.
References and/or Acknowledgements
I acknowledgement to my partnerts and my family
Conflict of Interest No conflict of interest
GOT18-0537. BLOOD-PRESSURE LOWERING EFFECTS OF LIRAGLUTIDE Background
Glucagon-like peptide-1 receptor agonists (aGLP-1) attract much attention because of their cardioprotective effects.
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Purpose
The aim of this study was to assess the blood pressure-lowering effects of the aGLP-1 liraglutide.
Material and methods
Observational study. T2DM patients from a community endocrinology practice from January 2016 to April 2017. Primary endpoint included change in cardiovascular risk factors (blood pressure, body weight, c-LDL).
Results
83 patients were included (54.2% male). Mean age 56.76 ± 9.87 years, mean duration of T2DM 9.46 ± 5.46 years. Baseline patient characteristics were as follows: BMI 37.68 ± 6.82 Kg/m2, systolic BP (SBP) 138.80 ± 15.46 mmHg and diastolic BP (DBP) 82.87 ± 10.16 mmHg, fasting glucose 187.33 ± 55.11mg/dL, glycated hemoglobin (HbA1C) 8.62 ± 1.3%, total cholesterol 178.1 ± 35.74 mg/dL, c-LDL 97.66 ± 32.16 mg/dL, c-HDL 44.54 ± 13.78 mg/dL, triglycerides 197.64 ± 24.19 mg/dL. Mean duration of aGLP-1 5.46 ± 4.22 months. HbA1c and BMI were significantly reduced by 0.89 ± 0.03% (p<0.001) and 1.6 ± 0.5 Kg/m2 (p<0.001) respectively; SBP 6.04 ±3.35 mmHg (p<0.001), DBP 5.46 ± 4.54 mmHg (p< 0,000) and c-LDL 9,92 ± 1.66 mg/dl, (p< 0,011).
Conclusion
Treatment with the aGLP-1 liraglutide reduced SBP and DBP by 1 to 5 mmHg, BMI and c-LDL for patients with T2DM. aGLP-1 may offer an alternative therapy for these patients and will help provide extra cardiovascular benefits.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0542. EFFECTIVENESS AND SAVETY OF EVOLOCUMAB IN THE TREATMENT OF HYPERCHOLESTEROLEMIA Background
Evolocumab is the first monoclonal antibody approved by the Spanish Agency of Medicines and Sanitary Products(AEMPS) to reduce low-density lipoprotein colesterol (LDL-c) levels.
Purpose
To evaluate the efficacy and safety of evolocumab in hypercholesterolemia treatment.
Material and methods
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This was a retrospective, observational study conducted in a tertiary hospital in Madrid, Spain. All patients who started treatment with evolocumab between March-December- 2016 were included.
Measured variables: sex, age, type of hypercholesterolemia, baseline characteristics of the patients(hypertension, type 2 diabetes mellitus (DM-II), ischemic heart disease, and statins intolerance), previous hypercholesterolemia treatment, administration regimens of evolocumab, LDL-c levels at baseline and at 12 weeks of treatment, and adverse drug reactions(ADR) associated with evolocumab.
The results obtained were compared with those of the Therapeutic Positioning Report (IPT-AEMPS) of evolocumab issued by AEMPS.
Results
32 patients were included (4 were considered as drop-outs due to the lack of information)(75% men). Average age was 59±10.8 years. 53.6%(15)had polygenic hipercholesterolemia, 39.3%(11) heterozygous familial hypercholesterolemia and 7.1% (2) homozygous familial hypercholesterolemia(HFo). Baseline characteristics of the patients: intolerance to statins 67.9%(19), ischemic heart disease46.4%(13), HTA28.6% (8), DM-II 14.3%(4). Previous treatments: statins+ezetimibe50%(14), statins monotherapy17.9%(5), ezetimibe monotherapy10.7%(3) and statins+lipoprotein apheresis 7.1%(2). 14.3%(4)did not receive previous pharmacological treatment for intolerance to statins. The two patients with HFo were treated with evolocumab 420mg every fourteen days, the rest with 140mg every fourteen days.
The median of baseline c-LDL was 148,5mg/dL(125.5-173.5) and 61mg/dL(46.75-104) 12 weeks after initiation of treatment, with a reduction of 87.5 mg/dL(59%).
ADR registered were: flu-like syndrom(3.6%), muscle cramps(3.6%) and pruritus(3.6%).
Compared with the Therapeutic Positioning Report, no significant differences were observed in terms of age(59 vs 51-60 years) or presence of DM-II(14.3% vs <1%-20%). The presence of ischemic heart disease was higher in our study(46.4% vs 31%). The reduction of LDL-C with evolocumab was higher than that reported in the report(-87.5 vs - 53 to-64md/dL).
Conclusion
Evolocumab, in its short experience of use, can be considered an effective drug for the reduction of LDL-c.
The treatment is well tolerated. ADRs are mild.
The results of effectiveness obtained are better than those included in the IPT-AEMPS, but it will be necessary to confirm these data with future studies that include a higher number of patients.
References and/or Acknowledgements
Conflict of Interest
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No conflict of interest
GOT18-0548. EFFECTS OF CROSS-SEX HORMONE TREATMENT ON BODY COMPOSITION IN TRANSGENDER PERSONS Background
Cross-sex hormone treatments are used to masculinize or feminize the bodies of female-to-male (FtM) or male-to-female (MtF) transsexuals, respectively. Redistribution of fat mass is expected to occur during the first 1 to 6 months in transgender males and in the first 3 to 12 months in transgender females.
Purpose
To examine the effects of cross-gender sex hormone therapy (CHT) on body composition in transsexual men and women.
Material and methods
Observational study. 40 transsexual men and women assisted in the Gender Identity Unit of an endocrinology community practice from January to September 2017. We measured weight, body mass index (BMI) and body composition by bioelectrical impedance analysis (BIA) at baseline and after mean duration of CHT of 2 years.
Results
We evaluated 40 transsexuals, 19 male-to-female (MtF: 47.5%) and 21 female to male (FtM: 52.5%). Mean age 23.86 ± 11.25 years, mean duration of CHT of 24.7 ± 39.9 months. In MtF (68.8% oral estradiol, 31.2% estradiol transdermal patch, 83.3% cyproterone acetate), weight (Kg) and BMI (Kg/m2) increased from 72.12 ± 19.04 to 73.17 ± 19.96 (p<0.03) and from 23.8 ± 5.79 to 24.03 ± 5.85 (p=0.04) respectively; difference in body composition by BIA were also observed: fat mass (Kg) from 9.79 ± 7.62 to 12.3 ± 0.43 (p=0.03), muscle mass (Kg) 55.45 ± 9.24 to 56.05 ± 8.76 (p=0.015), body water 40.60 ± 6.75 to 41.02 ± 6.42 (p=0.04). FtM (76.9% testosterone cypionate, 23.1% testosterone undecanoate) also presented significant difference in body composition: fat mass (Kg) from 18.50 ± 3.55 to 14.14 ± 3.95 (p=0.04), muscle mass (Kg) 46.44 ± 2.27 to 49.70 ± 6.55 (p=0.026), body water 36.55 ± 5.57 to 33.77 ±1.84 (p=0.042). No significant difference in weight and BMI were observed.
Conclusion
Oral estradiol is the most frequent estrogen preparation used in transgender woman and testosterone cypionate in transgender men. Testosterone treatment in transgender males resulted in increased muscle mass and decreased fat mass. In transgender females, CHT is associated with change in fat mass redistribution although no difference in weight and BMI were observed.
References and/or Acknowledgements
Conflict of Interest
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No conflict of interest
GOT18-0550. POTENTIAL OF PHARMACOLOGICAL INTERACTION OF NIVOLUMAB Background
Nivolumab is an immunotherapeutic drug that acts on the immune system changes the profile of interactions with the habitual treatment of the most frequent comorbidities in the patients. The revision of these interactions generate question of whether it is necessary to treat certain pathologies in patients with advanced carcinoma.
Purpose
To analyze the profile of pharmacological interactions of anti-PD1 monoclonal antibody, nivolumab, with the habitual medication of patients treated with antineoplastic drug.
Material and methods
Retrospective observational study conducted in a group of patients treated with nivolumab from January 2016 to February 2017. The variable studied was the number of interactions pharmacological with long-term repercussion, classified in: decrease in efficacy (corticoids and imnunosupresores), increased risk of hemorrhage (Antiplatelet/anticoagulants) and increase in risk of developing autoimmune processes (antihistamines, NSAIDs, antibiotics, antiarrhythmics, beta-blockers, statins, anticonvulsants or antipsychotics), according to the interactions defined in the article of Champiat S.et al, “Management of inmune checkpoint blockade dysimmune toxicities: a collaborative position paper†. The data were obtained from the computer application Horus® in which the usual medication of the patient is recorded by the primary care physician
Results
We enrolled 7 patients diagnosed with advanced lung carcinoma. The average age of the study group was 63.4 years. All of them had a high number of prescriptions pharmacological in primary care with an average 9.14. The average of detected interactions was of 3.42 drugs (35.57%).The interactions detected that could decrease the efficacy were 33.3%, only an interaction was detected that increased the risk of bleeding and 62.5% increased the risk of developing autoimmune processes.
Conclusion
According to the results obtained, it is observed that nivolumab has a high potential of interaction that makes necessary the reconciliation of the medication at the beginning of the treatment because the long-term repercussions can be important and in some patients can force the suspension of the treatment, showing special attention to those interactions that enhance the development of autoimmune processes. For this reason it is essential the role of pharmacist in the revision of pharmacotherapy of patients treated with this new group of drugs.
References and/or Acknowledgements
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Nivolumab, interactions, pharmacotherapy
Conflict of Interest No conflict of interest
GOT18-0552. PROLACTIN CONCENTRATION IN MALE-TO-FEMALE TRANSSEXUAL SUBJECTS FOLLOWING CROSS-SEX HORMONE THERAPY Background
Male-to-female transsexual persons use estrogens + antiandrogens to adapt their physical bodies to the female sex. Estrogens are powerful stimulators of synthesis and release of prolactin and serum prolactin levels are usually somewhat increased following estrogen treatment.
Purpose
To determine prolactin levels and to assess the risk of development of prolactinoma in male-to-female transgender subjects following cross-sex hormone therapy (CHT).
Material and methods
Retrospective longitudinal study including all male-to-female transsexual persons assisted in the Gender Identity Unit from 2015 to 2017. Clinical and laboratory data were collected before and after a mean duration of CHT of 24 months. Radiologic examinations of the pituitary were performed in those patients whose prolactin levels persistently increase despite stable or reduced estrogen levels. Transgender individuals who receive psychotropic medications were excluded.
Results
Thirty-nine male-to-female transsexual persons were included (mean age 29.05 ± 11.63 years). 68.8% with oral estradiol mean doses 17.18 ± 5.74 mg/week, 31.2% estradiol transdermal patch mean doses 45.15 ± 36.85 mg/week and 78.3% plus cyproterone acetate mean doses 52.13 ± 22.99 mg/day. Prior to treatment, prolactin levels (PRL) were 13.97 ± 9.33 ng/ml,estradiol (E2) 43.90 ± 30.27pg/ml, testosterone (T2) 274.88 ± 215.41 ng/dL, LH 4.78 ± 5.51mUI/ml and FSH 5.16 ± 6.44 mUI/ml. After a mean follow up of 24.7 ± 35.6 months, PRL increased to 23.54 ± 14.19 ng/ml (p=0.02), E2 to 48.89 ± 24.92 pg/ml (p=0.03), T2 dropped to 111.25 ± 160.03 ng/dL (p=0.023), LH to 2.01 ± 3.42 mUI/ml (p=0.021) and FSH to 2.60 ± 4.34 mUI/ml (p=0.025). None prolactinomas were reported.
Conclusion
Transgender females treated with estrogens have elevations in prolactin levels although any case of prolactinoma was reported. Clinicians should measure prolactin levels in transsexual people and perform imaging techniques of the pituitary in those patients with high prolactin levels.
References and/or Acknowledgements
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Conflict of Interest No conflict of interest
GOT18-0553. EVALUATION OF THE EFFECTIVENESS OF ECULIZUMAB FOR UREMIC HEMOLYTIC SYNDROME IN PEDIATRIC PATIENTS. ABOUT A CASE Background
Hemolytic Uremic Syndrome (HUS) is a clinical entity defined by the triad no immune hemolytic anemia, thrombocytopenia and acute renal failure, constituting one of the most frequent causes of ARF in infancy with significant morbidity and mortality, above 5% mortality and a risk of chronic renal failure (CRF) or hypertension (hypertension) of 25%
Purpose
- Evaluate the effectiveness of eculizumab through hematological parameters such as indirect bilirubin (↑), haptoglobin (↓) and lactate dehydrogenase (LDH) (↑↑), platelets (<40,000 / mm3), and renal function (creatinine).- To evaluate the safety of treatment in pediatric patients- Cost of treatment
Material and methods
Clinical case report of a 3-year-old patient, who entered with severe respiratory and neurological clinic with underlying pathologies (....) Diagnosed with Hemolytic Uremic Syndrome
Results
The hematological values ​​of the main diagnosis in the case of SHUa of the patient, between the months of June and September, were analyzed by analytical. Showing an elevation of creatinine in 100% of the analytics, elevation of haptoglobin and Lactate dehydrogenase in the majority. Confirming together with the symptomatology that it is a Hemolytic Uremic Syndrome. From the moment that the treatment with eculizumab begins, despite remaining somewhat above the mean values, they remain stable, even lowering to levels within the range
Conclusion
In this pediatric patient, eculizumab proved to be highly effective, showing improvement in renal function, reestablishing more stable values ​​of haematological parameters and improvement of intravascular hemolysis. In addition to improving the quality of life due to tolerance to treatment in a patient of such a young age.
References and/or Acknowledgements
I acknowledgment to my partners and my family
Conflict of Interest
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No conflict of interest
GOT18-0554. CLINICAL PARAMETERS INFLUENCING CONSUMPTION OF COILS AND THEIR IMPACT ON THE BUDGET OF HOSPITAL PHARMACY Background
Intracranial aneurism treatment with embolization has become a reference technic. The costs of this technic’s medical tools present a major obstacle for some patients, especially those without medical insurance. Also, the cost of the coils is a considerable charge upon the hospital pharmacy’s budget, and an imprecise estimation of the number of coils to be used for a patient could lead to a considerable shortfall (loss of earning).
Purpose
We want to study the clinical parameters that could influence the number of coils used in intracranial aneurism embolization to insure a financial stability of the hospital pharmacy and a better accessibility of these products by patients needing them.
Material and methods
Patients who suffered an aneurism and more have been treated with embolization in two teaching hospitals between 2009 and 2015. The number of coils used and the patients’ clinical parameters has been collected from the hospital’s information system and from the patients’ medical files. The correlation between the number of coils and the other parameters has been analyzed by a univariate linear regression and then a multivariate one. The statistical analysis has been done with the software SPSS 13.0.
Results
200 patients have been admitted during the mentioned period. 88 men and 113 women; 166 showed an aneurysm rupture. 190 patients had only one aneurysm. The size of the aneurysm, its rupture or non-rupture influenced significantly the number of coils used (p<0.001). However, patient’s gender, aneurysm localization, aneurysms’ number and the aneurysm neck' size don’t influence the number of coils used. The overall cost of intervention is significantly dependent on the number of coils used (p <0.001).
Conclusion
The neuroradiologist and the hospital’s pharmacist can predict the number of coils to be used on the basis of the diagnosis and also the resulting costs based on the significantly influencing criterias and, thus, inform patients who don't have insurance of a large amount of coils to be used for the embolization and follow up closely the insured patients to ensure repayment all coils used for embolization. These results should be considered when establishing budgets of coils acquisition by hospital pharmacy.
References and/or Acknowledgements
Acknowledgements to neuroradiology team.
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Conflict of Interest No conflict of interest
GOT18-0562. FEATURES OF PATIENTS WITH INFECTIVE ENDOCARDITIS IN THE CARDIOLOGY DEPARTMENT (YAROSLAVL, RUSSIA) IN 2013-2015 Background
Infective endocarditis (IE) is a serious infectious and inflammatory disease of the endocardium, in which is affected the valvular apparatus of the heart. With infective endocarditis the mortality rate can reach 15-25%. More than a third of patients die within a year after diagnosis[1].
Purpose
To conduct epidemiological analysis of a cohort of patients with infective endocarditis in the cardiology department of the city.
Material and methods
The database of the cardiology department of emergency hospital.
Results
Patients treated with IE in 2012 - 3 people, representing 0.2% of the treated in the department, in 2013 - 4 (0.2%), in 2014 - 4 (0.6%), in 2015 - 7, 2016 - 23 (1.6%). We analyzed the pathogens and applied antibiotics in the treatment of IE in 2013, 2014 and 2015. The mean age of the patients was 57, 49.3 and 42.7 years, respectively; "rejuvenation" of patients occurred more often at the expense of drug users. The level of markers of inflammation was significantly elevated: leukocytes - 16.4, 9.37 and 7.9x10 9/l; procalcitonin - 137.9, 63.5 and 110.3; C-reactive protein - 0.09, 0.19 and 7.86 in 2013, 2014 and 2015, respectively. Positive for bacteremia was 47% of the blood samples from 15; pathogens were isolated: Enterococcus faecalis (2 samples from one patient), Staphylococcus aureus (3 samples), coagulase-negative staphylococci (CNS, 2 samples) and Candida parapsilosis (1 sample). The first selected sample of E.faecalis retained sensitivity to ampicillin, after 10 days of therapy become resistant to ampicillin. All samples Staph. aureus aureus were oxacillin-susceptible. One of the CNS samples retained sensitivity only to linezolid. In the treatment of patients with IE was used 25 schemes application of antibiotics, in 8 of which was used vancomycin, in 11 - aminoglycosides, in 5 cases they were used together.
Conclusion
IE is relatively rare in the structure of patients in the cardiology department; there is a decrease in the age of patients with IE; the prevalence of Gram (+) flora in the etiology of IE persists; frequent use of nephrotoxic drugs is noted.
References and/or Acknowledgements
1. Thuny F, Grisoli D, Collart F, et al. Management of infective endocarditis: challenges and perspectives. Lancet 2012;379:965–75.
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Conflict of Interest No conflict of interest
GOT18-0563. EVALUATION OF THE CONSUMPTION OF ANTIBIOTICS IN THE PEDIATRICS HOSPITAL Background
Antibiotics are the most commonly used drugs; this consumption is due to the frequency of infectious diseases. Bacterial resistance to antibiotics has become a major public health problem in the world with an unfavorable impact on morbidity and mortality of patients. Monitoring the consumption of antibiotics by health institutions is an important element in the control of bacterial resistance.
Purpose
Our objective was to analyze the consumption data of antibiotics by describing the consumption by families of antibiotics and to report the main pathologies consuming antibiotics.
Material and methods
This was a retrospective, descriptive study of the consumption of antibiotics in our pediatrics hospital during a period from 1 January to 31 December 2016.We used the ATC/DDD method, the volume data extracted from the pharmacy database were converted to DDD/1000 DH (Day of Hospitalization). Non parametric analysis were used to compare antibiotics consumption. Statistical analysis were performed with SPSS 13.0.
Results
During the study period, 5198 nominal prescriptions for antibiotic therapy were collected, of which 89.65% were prescribed by medical services. The total consumption of antibiotics was 2106.44 DDD/1000 DH. Consumption is dominated by the C3G class which was 1023.19 DDD/1000 DH or 48.57% of the overall consumption, followed by the penicillins class with 465.37 DDD/1000 DH (22.09%) and the aminoglycosides class with 227.29 DDD/1000DH. The most consuming pathologies of antibiotics were respectively: Pyelonephritis and urinary infections with 381.66 DDD/1000 DH (18.19% of the global consumption), pneumonia with 328.71 DDD/1000 DH (15.5%), maternofetal and neonatal infections with 200.86 DDD/1000 DH (9.53%) and prophylaxis in surgery with 183.81 DDD/1000 DH. Antibiotics consumption was different between pathologies (p < 0.001) and classes of antibiotics (p < 0.001).
Conclusion
The development of bacterial resistance, as well as the low number of new molecules and the increased use of certain classes of antibiotics, requires special attention and follow-up of this class of drugs. The periodic evaluation of the consumption of antibiotics makes it possible to monitor their evolution.
References and/or Acknowledgements
M Bouatia, A Cheikh, H Mefetah, A Barkat. Evaluation of antibacterial consumption in a paediatric hospital from 2009 to 2014. Eur J Hosp Pharm 24 (Suppl 1), A30-A30
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Conflict of Interest No conflict of interest
GOT18-0572. NEOADYUVANT TREATMENT WITH PERTUZUMAB IN BREAST CANCER. EFFECTIVENESS AND SAFETY Background
Human epidermal growth factor receptor 2 positive (HER2+) breast cancer is an aggressive form of the disease with high rates of recurrence and very low survival, it shows the need to start treatment as early as possible in order to reduce the tumor mass and analyze tumor response to treatment. For this reason treatment, with specific HER2- blocking drugs has proved to be so successful.
Purpose
To describe the results obtained with the combined use of two inhibitors HER2 (pertuzumab and trastuzumab)in the neoadjuvant treatment of HER2+ breast cancer.
Material and methods
Retrospective observational study (July 2016-July 2017) in a group of patients diagnosed with HER2+ breast cancer treated with pertuzumab as part of the neoadjuvant chemotherapeutic treatment. The main variable of efficacy: the complete pathological response (RcP) defined as the absence of residual tumor in the breast and lymph nodes. The safety variable: the rate of adverse effects associated with the use of pertuzumab. The information was obtained: medical prescriptions (Farmatools®), electronic clinical history (Selene®), analytical and anatomo-pathological reports. Demographic and clinical data were collected: Age, type of tumor, ki67, stage, lymph node involvement, hormonal receptor status (RH), chemotherapy régimen and toxicity.
Results
We enrolled 9 patients with average age of 47.6 years. All of them presented diagnosis of infiltrating ductal breast carcinoma HER2+, with a mean value of ki67 of 32%. The clinical stage of the tumor was III in 66.6% and II in 33.3%. Positive estrogen and progesterone RH were detected in 66.6%. The 83.3% have lymph node involvement. 100% RH negatives received docetaxel+carboplatin+trastuzumab(TCH)+Pertuzumab, whereas the group of patients RH positive received Adriamycin+cyclophosphamide followed by Taxane+trastuzumab+pertuzumab. The RpC was confirmed in 6 of the 9 patients. In terms of safety, the schemes were well tolerated without causing serious adverse effects(grado3-4). Mild adverse effects(grado1-2) were recorded, the most frequent being: asthenia(77.8%), mucositis(83.3%), diarrhea(33.3%) and neutropenia (16.6%).
Conclusion
Despite being a small study group, the data obtained in our patients are similar to the results of the “NeoSphere and Tryphaena†studies that show the safety and efficacy of the combination of pertuzumab and trastuzumab with different chemotherapy regimens, with a significant increase in RpC
References and/or Acknowledgements
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PERTUZUMAB, BREAST CANCER, NEOADYUVANT
Conflict of Interest No conflict of interest
GOT18-0578. BELIMUMAB: USE IN SYSTEMIC LUPUS ERITHEMATOSUS IN A SECONDARY-LEVEL HOSPITAL Background
Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulating protein, is the only approved biological agent for the treatment of systemic lupus erythematosus (SLE).
Purpose
To analyse the use and clinical efficacy of belimumab in Systemic Lupus Erythematosus in a secondary-level hospital.
Material and methods
Observational retrospective study. Data were collected from May 2012 to May 2017. The data were: number of patients, age, gender, pharmacotherapeutic (dosing, duration, previous treatments), analytical parametres (antinuclear antibody (ANA), anti-dsDNA and complement levels) and clinical parametres ( Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), adverse effects). The source used was the software for prescription and dispensation SAVAC.
Results
9 patients (100% female), median age 38 years, were included. The median number of previous line of treatment was 4. All have been treated previously with glucocorticoids. Other treatments were; Hydroxychloroquine, methotrexate, azathioprine, Rituximab, leflunomide or mycophenolate. They received Belimumab 10mg/Kg with a median duration of 32 months.
8 patients have positive ANA and anti-dsDNA before treatment with belimumab, and only one of them had negative parametres at the end of the study. The patient with negative ANA and anti-dsDNA before the therapy con belimumab, had positive parametres at the end of the study. In respect of complement levels,8 patients had low levels before treatment with belimumab and 3 patients had normal levels at the end of the study.
As for the SLEDAI-2K, 8 patiens had high activity values before therapy with belimumab, at the end of the study, this value had decreased in 4 patients, but it had increased in the other 5 patients. Besides, only a patient had low activity values at the end of the study. The most frequent adverse event was infections (33,33%). Other adverse reactions were migraine, articular pain and hypertension.
Conclusion
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Belimumab is used mostly in SLE when other standar treatments failed. In our experience, patients did not improve their analytical or clinical parametres after the treatment with belimumab. However our poblation was very small and the results are not significatives. More studies are necessary to evaluate the effect of belimumab in this patients.
References and/or Acknowledgements
Hahn BH. Belimumab for systemic lupus erythematosus. N Engl J Med. 2013;368:1528–35
Conflict of Interest No conflict of interest
GOT18-0580. VORICONAZOLE PRESCRIPTION PATTERNS AND BLOOD LEVEL VARIABILITY Background
Voriconazole exhibits nonlinear pharmacokinetics and therapeutic drug monitoring (TDM) is recommended to optimize efficacy and to avoid potential toxicities.
Purpose
To describe voriconazole prescription patterns, overdosing ranges and related adverse effects.
Material and methods
Descriptive, retrospective study of adult patients treated with voriconazole with at least one voriconazole trough blood levels (VBL) measurement between January 2014 and September 2017. VBL>5.5 mg/L are considered overdosing. Demographic data, administration route, dose, microorganisms, source of infection, reported hepatic (HF), as FA, GTP or bilirubin>ULN, and renal failure (RF), as creatinine>1.2mg/dl, VBL and time to TDM into therapy were reordered. Dichotomous data were compared using the odds ratio.
Results
19 treatment courses were included (63% men; mean age: 66±9.647 years; mean weight 67.23±10kg). In 79% courses, invasive aspergillosis was suspected. Aspergillus sp. was isolated in 12 samples (83.3%, respiratory; 16.6% osteoarticular); Scedosporium sp. was isolated in 3 patients.
73.7% intravenous (IV) courses were found as initial therapy. 71.4% weight-based doses(WD) (6 mg/kg/12h as loading dose(LD) and 4 mg/kg/12h as maintenance(MD)) and 28.6% fixed doses(FD) of 400 mg/12h followed by 200 mg/12h were observed. 28.6%.WD and 25% FD showed high VBL. Oral regimen was 400 mg/12h as LD and 200 mg/12h as MD.
In only 42% courses, VBL were measured into 4 th -7 th day of therapy. Mean time to first TDM was 11±10 days. After initial VBL, 9 patients had consecutive measurements
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every 8±3 days. Seven patients (36.8%) with VBL>5.5 mg/L were identified. Mean time of toxic VBL appearance was 13.42±5.25 days.
Hepatic toxicity was observed in 47.4% cases. 55.5% showed high VBL. There were not statistically significant differences between overdosed and non-overdosed patients. OR:5;95%CI(0.66-38.15).
In 42.3% of cases, renal toxicity was observed. 37.5% showed high VBL (>10mg/dL,66.6%). There were not statistically significant differences between overdosed and non-overdosed patients. OR:0.59;95%CI(0.08-4.39).
4 patients developed RF and HF simultaneously. There were not statistically significant differences in development of hepatic toxicity between patients with renal toxicity and those with normal renal function. OR:1.2;95%CI(0.19-7.44). Conclusion
Great variability of VBL and non-standardization TDM were found. 36.8% patients, with high VBL in the 2 nd week into therapy, were identified. Initial VBL and subsequent TDM are essential.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0581. EFFECTIVENESS OF PERTUZUMAB FOR NEOADJUVANT THERAPY IN HER2-POSITIVE BREAST CANCER Background
Approval of pertuzumab indication as neoadjuvant therapy (NAT) was based on studies where the primary variable was complete pathologic response (pCR) as a surrogate end point for long-term clinical benefit. Cortazar P meta-analysis (2014) showed an association between pCR and an improved survival.
Purpose
To analyse effectiveness outcomes in NAT of Her2-positive breast cancer at a hospital setting based on pCR rates and to determine the treatment associated costs.
Material and methods
Retrospective observational study including all Her2-positive breast cancer patients treated with pertuzumab as NAT at an oncology reference hospital, except those treated as part of a clinical trial. Study closing date was the 31st August 2017. The following data were collected: age, hormone receptors (HR) expression, combined drugs, daily dose, cumulative doses and pertuzumab use. Frecuency, mean and standard deviation (s) were calculated. We used pCR rate and partial pathological response (pPR) as primary variables.
Results
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34 patients were included with a mean age of 51 years [27-74]. All patients were treated with a combination of four cycles with pertuzumab-trastuzumab-taxane as NAT, after completing a four cycle regime of dose-dense epirubicine-cyclophosphamide. Weekly paclitaxel was the taxane chosen in 32 patients whereas every-3-weeks docetaxel was used in two patients. At the closing date time, seven patients had not been received surgery yet so pathologic response data were not available. 12 patients (35.3%) attained pCR and 15 (44.1%) pPR. Positive-HR expression rate was 76% and a 24% rate for the negative ones. According to HR expression, pCR rate was 50% for HR-negative tumours and 29.6% for HR-positive tumours. The total expenditure of pertuzumab for NAT was 364,038€, with a mean incremental cost in relation to standard regime of 10,707€/one patient (s=1,757). The incremental cost to obtain one pCR was 30,336€.
Conclusion
Effectiveness results in our population in relation to pCR rated are consistent with NeoSphere efficacy results not only from an overall point but also with the HR expression, resulting in a high incremental cost for one pCR gained. It is left to be determined whether this pCR rate is associated with a clinically relevant increased survival.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0584. EFFECTIVENESS AND SAFETY OF NIVOLUMAB IN THE TREATMENT OF NON-MICROCYTIC LUNG CANCER (NSCLC) Background
Lung carcinoma is the leading cause of cancer death globally. The mean age of onset of lung cancer ranges from 55 to 75 years, being more frequent in men than in women. Nivolumab is a human monoclonal antibody (HuMAb).
Purpose
To evaluate the effectiveness, safety and cost of treatment with nivolumab in patients with non-microcitic lung cancer.
Material and methods
- Retrospective observational study in a third level hospital.
- Inclusion criteria: patients diagnosed with locally advanced or metastatic NSCLC after previous chemotherapy who completed at least one treatment cycle until January 2017.
- Variables: Sex, age, functional status (ECOG), staging, histology, presence of EFFR / ALK mutations, previous treatment lines, number of cycles received, progression-free survival (PFS), adverse reactions (RA) and cost.
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Results
During this period, 12 patients were treated with nivolumab, 91.67% were men, with a mean age of 63 years (54-76). All had EGFR / ALK wid type and were in stage IV at the beginning of treatment. 33.33% had ECOG of 0 and 58.33% ECOG of 1. Histologically, 75% were adenocarcinoma and 25% were squamous. They received an average of three previous lines, all received taxanes and platinos. The mean of cycles with nivolumab was 9.08 and a total of 109 cycles. The most frequent adverse reactions were: asthenia(33.33%), ocular toxicity (16.67%), anemia (8.3%), muscular pain (8.3%) and rash (8.3%). Patients report good tolerance and better quality of life. Total cotes of treatments was 107,378,625 €. /span>
Conclusion
- Nivolumab has been shown to be effective in the population studied for the treatment of NMSC.
- Nivolumab has a good tolerance, with a different safety profile than conventional chemotherapy.
- The AR were described in a technical file and in no case motivated the suspension of the treatment.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
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GOT18-0597. CHRONIC SPONTANEOUS URTICARIA: OMALIZUMAB Background
The treatment of spontaneous chronic urticaria (SCU) has been based on antihistamine drugs and corticosteroids. Omalizumab for this indication has revolutionized the evolution of the disease but at a fairly high cost, so it is necessary to know if the cost-effectiveness is beneficial.
Purpose
To describe the use and effectiveness of omalizumab for the treatment of CSU and associated cost.
Material and methods
A retrospective observational study was conducted including patients who received omalizumab for CSU between October 2016 and October 2017.This hospital provide care for a population of 166.000.Review of digital medical records.Variables studied: sex, age, number of dispensations, antihistamines used, corticosteroid therapy yes/no, complete/partial improvement/no improvement and “weekly urticaria activity scale†(UAS7).
Results
7 patients are on treatment with omalizumab for SCU, all patients are women, mean age: 45.8 years (17-70). Main dermatological symptomatology: generalized hives that do not give up with conventional antihistamine and / or corticosteroid treatment for more than 1 year of evolution. 35 dispensations have been made.All patients had used: bilastine or loratadine or hydroxyzine or rupatadine or dexchlorpheniramine and corticosteroid therapy with deflazacort or prednisone.In 6 patients at the second dose the clinical improvement was complete,measured as UAS7 was found to be less than 6 (0-42) and antihistamines and/or corticosteroids were discontinued at the third dose if patients followed in complete remission. A patient had to stop the treatment because although there was improvement in the disappearance of hives but the itching was still active. The treatment is administered in day hospital to prevent reactions in the administration. The specific dose for this indication is 300 mg/28 days and associated cost has been 614,82€ per month (7.377,84€ total treatment per year).The effectiveness of treatment has reached 85.7% taking into account the UAS7 variable.In one patient it was necessary to suspend the treatment in the absence of remission of itching and other diagnoses such as eosinophilic cellulitis or Wells syndrome should be ruled out.
Conclusion
The treatment for SCU with omalizumab has proved to be very effective, but it would be crucial to know if the results (USA7 <6 points) are maintained over time despite the end of treatment.
References and/or Acknowledgements
http://www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/000606/human_med_001162.jsp&mid=WC0b01ac058001d124
Conflict of Interest No conflict of interest
GOT18-0603. EXPERIENCE WITH IDARUCIZUMAB IN REAL CLINICAL PRACTICE Background
Idarucizumab is a specific reversal agent of dabigatran. It is indicated in case of potentially fatal or uncontrolled hemorrhages and in case of invasive medical procedure or urgent surgery.
Purpose
To assess the effectiveness, safety and tolerability of idarucizumab in real clinical practice.
Material and methods
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It is a retrospective 12-month study. Patients who require the use of idarucizumab were listed.To assess the effectiveness, it was taken the percentage of reversion of anticoagulant effect after being an hour administrated to patient, by the determination of the activated partial thromboplastin time (aPTT) and the prothrombin time (PT).The effectiveness of idarucizumab was also measured through hemostasis restoration.The safety was assessed through the record of thrombotic events following by using of idarucizumab, by natremia alteration or proteinuria presence. The intolerance was determined for the appearance of anaphylactic reaction. Other data of interest were: doses of dabigatran, hemorrhagic risk factors and and time to restart dabigatran or other antithrombotic treatment.
Results
Four patients were treated with idarucizumab since it was used in our hospital: three of them with severe bleeding and, one who required urgent surgery. Three patients were male, mean age 75 ± 9 years. In all cases, last dose of dabigatran (110 mg) was within 24 hours. All patients had 2-5 hemorrhagic risk factors (mean creatinine clearance 32.6 ± 14.6 ml/min). Mean aPTT and PT before being administrated the antidote was 82 ± 21.8 seconds and 27 ± 8.4 seconds, respectively. The percentage of reversibility was 50% at a time <1 hour (an average decline of 40% aPTT and 34% PT basal).The hemostasis restoration was variable among patients(> 5 days). Idarucizumab was well tolerated, with slight increase in natremia and without proteinuria. A patient underwent a thrombotic event. Dabigatran was restarted in half of patients over two months later. Two patients died by hemorrhagic complications.
Conclusion
Idarucizumab was effective in half of patients treated, being safe in 75% of patients.It was well tolerated in all cases.A greater population is needed to assess the real impact of the use of idarucizumab.Despite this limitation, idarucizumab is the only alternative to specifically reverse the effect of dabigatran.
References and/or Acknowledgements
https://www.aemps.gob.es/cima/dochtml/ft/1151056001/FichaTecnica
Conflict of Interest No conflict of interest
GOT18-0609. IS THERE ZINC? Background
Zn is a key trace element for the functioning of the immune system. Malnutrition in the elderly population affects 20% of the old men living in their homes and 85% who live in nursing home, and they do not ingest the recommended daily amounts of Zn. This, together with drug treatments such as antacids, anti-inflammatories, anticoagulants and antidiabetics that alter intestinal absorption, leads to an increase in nutritional deficiencies. Zinc deficiency causes a decrease in the immune response with a higher probability of infections, disorders in the development of tissues such as the skin, intestinal mucosa and enterohepatic acrodermatitis, among others.
Purpose
Review the availability of zinc presentations, indicated in its deficit, and selecting at the lower cost for the treatment in elderly patients.
Material and methods
Search on drug regulatory agencies, AEMPS (Spanish Agency for Medicines and Health Products), EMA (European Medicines Agency) and FDA (Food and Drug Administration) and different providers of food supplements. From the available options, compare the cost to the patient.
Results
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There is only one specialty with zinc (Wilzin), it is not authorized by AEMPS, indicated exclusively in Wilson's disease. A foodstuff with zinc acetate, for the Zinc deficiency. An oral pharmaceutical compounding with acetate or zinc sulfate.
Zinc cost (25mg, recommended daily PRODUCT OBSERVATIONS supply) WILZIN 25mg y 50mg Medicación 0.83€ 250caps extranjera ACETATO DE ZINC 250g Fórmula Magistral 1.25€ ZINC 25mg 60caps Producto Alimenticio 0.28€ Conclusion
Due to high frequency of elderly zinc deficiency, it is under-treated. There are no drugs marketed with this indication and it is necessary to resort to the elaboration of pharmaceutical compounding or nutritional supplements to replace this therapeutic gap. None of these alternatives are financed by Social Security, which complicates the therapeutic compliance of pensioners. There is a need for a zinc supplement registered as a authorized drug by the relevant authorities for the treatment of this deficiency.
References and/or Acknowledgements
Nutritional modulation of agerelated changes in the immune system and risk of infection, Nutrition Research (2017). The Emerging Role for Zinc in Depression and Psychosis. Front. Pharmacol
Conflict of Interest No conflict of interest
GOT18-0612. THE RELATIONSHIP BETWEEN IL-6 AND TNF-ALPHA CONCENTRATION AND OUTCOME IN PATIENTS WITH AML NON M3 Background
Cytokines such as Tumor necrosis factor (TNF)-α have important role in the pathogenesis of hematologic malignancies like acute myeloid leukemia (AML) but the relationship between them and outcome in these patients is unclear.In our study we assessed the association between serum concentrations of TNF-α and Interleukin 6 (IL-6) and outcome in patients with AML non M3.
Purpose
The main aim of our study was the evaluation of relationship between pro-infammatory cytokines (IL-6 and TNF-α) and complete remission (CR) in patients with AML non-M3 and wethere it is possible to use drugs that affect these cytokines to improve the outcome in these patients.
Material and methods
Serum levels of TNF-a and IL-6 were measured in patients with AML non M3 who presented for treatment with chemotherapy regimen. Univariate and multivariate analyses were performed to test for correlations with clinical outcomes.
Results
Serum concentrations of IL-6 increased significantly on day +28 after the start of the chemotherapy regimen (P=0.021). Higher IL-6 levels were found to correlate with poorer outcome such as lower rate of complete remission (P= 0.042). TNF-α was not found to be predictive of clinical outcomes.
Conclusion
High serum IL-6 level is an poor prognostic factor for complete remission in patients with untreated AML non M3.
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References and/or Acknowledgements
Tsimberidou, A.M., Estey, E. and Wen, S. (2008) The Prognostic Significance of Cytokine Levels in Newly Diagnosed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes. Cancer Journal, 113, 1605-1613.
Tsimberidou AM, Giles FJ.(2002) TNF-alpha targeted therapeutic approaches in patients with hematologic malignancies. Expert Rev Anticancer Ther Journal;2;277-86.
Conflict of Interest No conflict of interest
GOT18-0614. EFFICACY AND ADEQUACY OF EVOLOCUMAB IN HYPERCHOLESTEROLEMIA Background
Anti-PCSK9 human monoclonal antibodies are a novel group of drugs that lower plasma levels of LDL cholesterol.
Purpose
To assess the efficacy and adequacy to the criteria of use established by the subcommittee of anti- PCSK9 antibodies.
Material and methods
All requests to start treatment issued to the anti-PCSK9 antibodies subcommittee between January 2016 until September 2017 were included. The data were obtained from the outpatient dispensing software Dipex and by review of medical records (Diraya). The criteria of use established by the subcommittee for the initiation of treatment were indication of homo or heterozygous familial hypercholesterolemia, as well as an established cardiovascular disease (ischemic heart disease, ischemic cerebrovascular disease or peripheral arterial disease), maximum doses of high-intensity statins along with 10mg of ezetimibe for at least 4 weeks and/or intolerance or insufficient response to statins. All included patients started treatment with evolocumab at doses of 140 mg every two weeks. Treatment was considered effective if the LDL reached was <70 mg/dL for very high CV risk or <100 mg/dL for high CV risk.
Results
A total of 24 applications were submitted to the subcommittee of anti-PCSK9 antibodies, of which 8 were approved (three of the patients were excluded because they had not yet started treatment), 14 were rejected and 2 were pending evaluation at the time of the study. All patients who started biological therapy were diagnosed with familial hypercholesterolemia and had a very high CV risk. Among the approved applications, 5 were in prior treatment with a rosuvastatin/ezetimibe combination 20/10mg, 1 with atorvastatin/ezetimibe 80/10 mg and 2 treatment initiations were justified by statins intolerance. At baseline, patients had a mean plasma LDL level of 176 mg/dL. The mean evolocumab duration of treatment was 11 months. Of the 5 patients, 4 achieved efficacy target during treatment (<70 mg/dl), with a mean plasma LDL of 63 mg/dl.
Conclusion
36% of evaluated applications were accepted, while 64% were rejected for not meeting the adequacy criteria. Poor adherence to prior treatment was the main cause of denial of treatment. In this study, 80% of patients who started treatment with evolocumab reached the established efficacy goal.
References and/or Acknowledgements
.
Conflict of Interest
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No conflict of interest
GOT18-0617. EXPERIENCE IN THE USE OF ABIRATERONA ACETATE AND ENZALUTAMIDE IN A THIRD LEVEL HOSPITAL Background
Metastastatic castration resistant prostate cancer (CRPCm) is one in which, despite castration levels, the Androgen Receptor remains active and continues to drive advancement. This understanding has led to the development of new drugs such as abiraterone or enzalutamide intended to reduce the production of androgens or blocking their receptor.
Purpose
To describe our experience with abiraterone acetate and enzalutamide as first-line CRPCm treatments and to compare the results of both drugs
Material and methods
Retrospective study, including 60 patients with CRPCm who started first-line treatment with abiraterone acetate (n=32) or enzalutamide (n=28) between March 2014 and June 2017.Patient baseline characteristics (age, type of metástasis, ECOG Performance Status), biochemical response (decrease in PSA value at 1 and 3 months), radiological response and toxicities of both groups were presented and compared. Data were obtained from the Diraya® database
Results
In terms of basal characteristics, bone metastases predominate in both groups, with 31.25% of lymph node metastasis in the abiraterone group (n=10) and 21.42% in the enzalutamide group (n=6). With a median follow-up of 17.5 months (3-39) for abiraterone and 11 months (3-24) for enzalutamide, abiraterone shows a decrease in PSA > 50% in the first and third months of 43.75% and 62.8% respectively, while enzalutamide achieves a decrease of 49.6% and 73%. 37.5% of patients with abiraterone and 35.71% with enzalutamidNo statistically significant differences were found between the two drugs in most of the parameters analyzed. The difference in patient characteristics and follow-up time between the two groups makes efficacy data not comparable. In our series, abiraterone and enzalutamide prove to be safe drugs.e progressed radiologically. The median survival rate free of radiological progression was 21.8 and 16.9 months, respectively. Treatment with abiraterone was discontinued at 18.75% (n=6) for arterial hypertension and in no case with enzatutamide
Conclusion
No statistically significant differences were found between the two drugs in most of the parameters analyzed. The difference in patient characteristics and follow-up time between the two groups makes efficacy data not comparable. In our series, abiraterone and enzalutamide prove to be safe drugs.
References and/or Acknowledgements
To CH Torrecárdenas
Conflict of Interest No conflict of interest
GOT18-0622. DABRAFENIB AND TRAMETINIB: AN ALTERNATIVE CHOICE IN METASTASIC MELANOMA Background
The BRAF inhibitor dabrafenib and the MEK inhibitor trametinib are indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF (V600) mutation. Combination of both drugs has shown more effectiveness and survival improvement.
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The use of these drugs was autorized in our Hospital as first line treatment for patients with mutated BRAF, and in second line for patients with no-mutated BRAF.
Purpose
To evaluate the effectiveness and tolerability of both dabrafenib and trametinib, based on the overall survival (OS) and progression free survival (PFS) in the treatment of metastasic melanoma.
Material and methods
Retrospective study that included patients receiving treatment with combination of dabrafenib and trametinib. The period of study evaluated was from the commercialization of the drugs until October 2017. The needed data was obtained from clinic electronic history Cerner Millennium and the variables were: gender, age, date of diagnosis of metastasic melanoma, number of previous lines of chemotherapy, adverse effects, progression date and death date.
Results
There were 7 men and 16 women receiving the combination. The median age was 58.0 years. The V600 BRAF was mutated in all the patients.
Most of the patients are still receiving the treatment, and only 8 stopped it. Patients who stopped the treatment were 6 due to progression and 2 due to adverse effects. The median progression free survival (PFS) is 6.37 months (range, 1.70-29.73). During the study, 6 patients died. The median overall survival is 6.93 months (range, 1.90 -29.73).
Many adverse effects appeared with this combination and 33% of the patients had to reduce dose due to toxicity. Most common side effects were: fever, dermatologic effects (such as eczema, rash, edemas), neurological toxicity (such as cephalea, confusion, dizziness, lost of memory), visuals alterations (photophobia, visual reduction) and asthenia.
Conclusion
Dabrafenib and trametinib are a good choice for treatment in patients diagnosed of metastasic melanoma with a BRAF mutation. Results of PFS and OS are lower than expected because many patients had started the treatment recently, so the time of study isn’t long enough. Toxicity is a serious condicionant to the treatment as it affects quality of patient’s life.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0626. EFFICACY AND SAFETY OF TRIFLURIDINE / TIPIRACYL IN METASTATIC COLORECTAL CANCER Background
Trifluridine / tipiracil is an oncology therapy indicated in adult patients with metastatic colorectal cancer (CCRm), that have been previously treated.
Purpose
To assess the efficacy and safety of trifluridine / tipiracil in patients with CCRm.
Material and methods
A retrospective observational study of patients with CCRm who started oral treatment with trifluridine / tipiracyl monotherapy during 2016 and until September 2017. Data were obtained from the outpatient dispensing program Dipex® and review of medical records. All patients received an initial oral dose of 35 mg / m² / dose given twice a day for days 1 to 5 and 8 to 12 of each 28-day cycle. Overall survival
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(OS) and progression-free survival (PFS) were considered as measure of efficacy, obtained by the Kaplan-Meier method and defined as the time elapsed from the start of treatment until patient’s decease, excluding those patients who had not died at the end of the study.
Results
9 patients (6 men and 3 women) were included, with a median age of 67 years. All patients had an ECOG 1 baseline functional status. Patients had received an average of 3 previous treatment lines. 6 of the patients died during the study period. Of the remaining 3, two maintain stable disease. During the treatment period with trifluridine / tipiracil, 6 patients suffered progression of the disease. The median OS was 4 months(95% IC 2,9-5,09) . The median PFS was 4.1 months(95% IC 3,4-4,59) . In 3 patients, dose reduction was necessary due to the appearance of mucositis, uncontrollable vomiting, and intense asthenia respectively, being necessary the suspension of the treatment in the latter.
Conclusion
The median SG obtained in our study is lower than that published in the pivotal study Recourse (4 vs 7.1 months). The median PFS was also lower (4.1 vs 5.3 months).With respect to the observed adverse effects, these may be comparable to those described in the technical file. The small number of patients is a limitation to our study, which could explain the differences found with the pivotal study.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-0645. ANTIBIOTICS CONSUMPTION IN PATIENTS TREATED WITH MEDICINES FOR CHRONIC OBSTRUCTIVE BRONCHOPULMONARY DESEASE Background
One of the widely used combination therapy to reduce symptoms and risks for deterioration of respiratory function of stable Chronic-obstructive-bronchopulmonary-desease (COPD) is the one of a long-acting-β2-agonist (LABA) and a long-acting-muscarinic-antagonist (LAMA). In the national territory the mortality for patients hospitalized for COPD, and in treatment with LABA/LAMA, resulted as a function of reacutizations frequency. These reacutizations determine a changing in the treatment: for infectious type reacutizations management antibiotics represent one of the therapeutic options.
Purpose
To analyze in a territorial area the use of antibiotics prescribed for infectious reacutizations in patients with COPD and value the adherence to international guidelines 'Global Chronic Obstructive Lung Disease†/GOLD.
Material and methods
The prescriptions from general medicine doctors from 1 January 2015 and 31 December 2015, in a local area (952.855 patients), regarding the registered medicines for COPD in national territory (ATC: R03AL03 and R03AL04) were extrapolated. The antibiotics prescribed to the same patients in the same period were analyzed (ATC: J01A, J01C, J01D, J01E, J01F, J01G, J01M, J01X) and also the other categories (J02A-antimycotic; J05A-direct antiviral) were considered. Every prescription was evaluated as a single cycle therapy.
Results
The patients treated with COBPD medicines were 258: 31 with vilanterol/umeclidinium and 227 with indacaterol/glycopyrronium. Between those patients, 188 (73%) have received at least one antibiotic prescription during the same year. The most prescribed category was the one of quinolones (238/669; 35,6%)-especially levofloxacin (154/669; 23%). To follow in decreasing order there were macrolides and lincosamides (128/669; 19,1%)-with azithromycin (12,2%), beta-lactam and penicillins (116/669;
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17,3%)-with amoxicillin and enzyme inhibitors (13,7%), 2nd and 3 rd generation cephalosporins (90/669; 13,4%)-with ceftriaxon (8,1%), tetracyclines (7/669; 1%)-with doxycycline (0,6%), sulfonamides and trimethoprim (6/669; 0,9%)-with the only one prescribed sulfamethoxazole and trimethoprim, aminoglycosides (4/669; 0,6%)-with the only one prescribed amikacin and in closing fosfomycin (4/669; 0,6%). Regarding antimycotics (61/669; 9,1%) the most prescribed was itraconazole (5,7%), while the only antiviral prescribed was acyclovir (15/669: 2,2%).
Conclusion
The 73% patients in treatment with medicines for COPD and who have used antibiotics have likely showed infectious reacutizations. The antibiotic therapies prescribed fall into the categories of the recommended treatment of the GOLD international guidelines.
References and/or Acknowledgements
Global-initiative-for-chronic-obstructive-lung-desease (goldcopd.org/)
Conflict of Interest No conflict of interest
GOT18-0663. Evaluation of interferon-free therapies for hepatitis C treatment of previous non- responders to triple therapy Background
Triple therapy regimens (pegylated interferon/ribavirin/boceprevir or telaprevir) nearly doubled the chances of response to the treatment of hepatitis C virus (HCV). Interferon free regimens (IFR) showed even better results with fewer side effects.
Purpose
Descriptive study assessing the outcomes of triple therapy (TRT) and IFT for HCV genotype 1 patients who failed to achieve a sustained viral response (SVR) after triple therapy.
Material and methods
Second-level hospital; 48 patients received TRT between 2011 and 2012. Twenty (42%) failed to achieve SVR. Sixteen of these were treated with IFT during the study period 01/04/2015-31/03/2017. Demographics, viral load, interleukin 28B polymorphism (ILB28), liver fibrosis, response to TRT, HIV coinfection, IFT regimen, tolerance and response were collected from the outpatient drug dispensing program and electronic medical record.
Results
Median age: 54 years (18.7 and 71.8). Three co-infected with HIV. ILB28 polymorphism: 12.5% ​​CC, 50% CT and 37.5% TT. Fibrosis: 12 patients F4, 3 F3, and 1 F2. Cirrhosis: 69%.
There were 12 partial responders, 2 null responders and 2 relapsers to TRT. Fifteen patients (94%) had adverse effects: asthenia 11, pruritus/rash 8, anemia 6, thrombopenia 6, neutropenia 3, psychiatric disorders 6 and fever and myalgia 4. In five patients treatment had to be discontinued due to intolerance (severe rash and anemia).
Median viral load at the start of IFT: 1,270,000 copies/ml (140,000-8,540,000). Treatment: sofosbuvir / ledipasvir 13; sofosbuvir / simeprevir 2; sofosbuvir / daclatasvir 1. Ribavirin was associated in 7 patients. Treatment duration: 12 weeks in 11 patients and 24 weeks in 5. Thirteen patients achieved SVR at 24 weeks post-treatment. Two patients with fibrosis reduction. Adverse reactions were mild: headache 4, asthenia 3, rash 2 and anemia 2 patients.
Three patients relapsed: one was re-treated with sofosbuvir / simeprevir / ribavirin after initial failure to sofosbuvir / ledipasvir, achieving SVR and fibrosis reduction; two other re-treatments pending.
Conclusion
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Response to the IFT was very good despite the fact that all patients had poor response prognosis, significant hepatic fibrosis (F3-F4), difficult to treat genotypes and poor response IL28 polymorphisms.
Tolerance to IFT was much better, favored by a more desirable adverse effects profile and short therapy duration. References and/or Acknowledgements
No conflict of interest.
Conflict of Interest No conflict of interest
GOT18-0671. EFFECTIVENESS AND SAFETY OF PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9 INHIBITORS IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA AND CLINICAL ATHEROSCLEROTIC CARDIOVASCULAR DISEASE Background
The proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9) alirocumab and evolocumab are monoclonal antibodies approved for the treatment of patients with familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional low-density lipoprotein (LDL) cholesterol lowering. In clinical trials, PCSK9 lower serum LDL levels by approximately 50%. PCSK9 use is limited by several factors, including cost, lack of long-term cardiovascular and safety data
Purpose
To evaluate effectiveness and safety of PCSK9 inhibitors in clinical practice.
Material and methods
Observational and retrospective study of patients who began treatment with PCSK9 between April 2016 and June 2017.A consensus document was made to adequate PCKS9 prescriptions to funded recommendations and evidence-based assessment criteria were defined for monitoring.The studied variables were: age, sex, diagnosis, previous and concomitant lipid treatment, effectiveness (total cLDL) and safety profile (adverse reactions (AR), suspension or dose reduction).The information was obtained from outpatient dispensing programme registration (Farmatools®) and computerised medical records (Selene®).
Results
21 patients were included (52,4% women), median age 61 years (range 26–78). Diagnosis: 52,4% FH, 33,3% patients ASCVD and 14,3% patients who are intolerant to statins. 71% patients received evolocumab and 29% alirocumab. Previously all patients had been treated with high-dose statins and ezetimibe. During therapy, 67% patients were treated with PCKS9 plus two lipid lowering therapies (statin and ezetimibe); 19% with PCSK9 and statin or ezetimibe and 14% with PCSK9 as monotherapy.
Mean baseline LDLc levels were 144.9 mg/dl and percentage reduction in LDLc with PCSK9 at week 12-16 was 57,5% (mean levels 61,4 mg/dl). Median follow-up 34 weeks(10-70). One patient stopped treatment due to AE at injection site with evolocumab and other related to urgent surgery. One patient referred important asthenia. No other AE was reported.
Conclusion
PCSK9 added to high-intensity statin therapy significantly reduce LDL-C in patients requiring further LDL-C reduction. Our results in clinical practice are similar to those obtained in clinical trials. Clinical pharmacy successfully implemented a clinical review process to provide a proactive patient evaluation, management of patients eligible for PCSK9 inhibitor therapy and adequate education. However, studies regarding the ability of PCSK9 to reduce mortality as well as long-term safety concerns are necessary.
References and/or Acknowledgements
None
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Conflict of Interest No conflict of interest
GOT18-0678. EFFECTIVENESS AND SAFETY OF APREMILAST IN PSORIASIS Background
Apremilast is an oral phosphodiesterase-4-inhibitor that produces a reduction of expression of proinflammatory mediators, and an increase in expression of anti-inflammatory mediators. Potential advantages of apremilast include moderate activity for both psoriasis and psoriatic arthritis and efficacy in difficult-to-treat forms of psoriasis, a good safety profile, no need of laboratory prescreening or ongoing monitoring for laboratory parameters, a potentially advantageous weight loss effect, and a convenient oral administration and dosing.
Purpose
Study the effectiveness and safety of apremilast in psoriasis.
Material and methods
Retrospective and descriptive study of all prescriptions of apremilast in psoriasis in a general hospital since May 2016 until May 2017. Demographic data, prior therapies, basal PASI, duration of treatment, PASI at 4-6 months or at the end of treatment and adverse effects (AE) were registered in an Excel file. Quantitative variables were expressed with the median and rank.
Results
17 patients, 53(28-82) years old, 10 men with a basal PASI of 4,8(1-10,8). All patients had psoriasis with involvement of the scalp and nails. Except one, all was in treatment with topical corticoids. 5(29%) were prior treated with PUVA and 9(53%) with acitretin and/or methotrexate. 6(35%) patients responded and continued with apremilast at the end of follow-up period with 18 (5-18) months of treatment. Basal PASI was 5(1-8) and at 4-6 months 1(0-4). 4 patients achieved PASI-50 and 2 PASI- 75. 11 patients suspended treatment: 1 for gastrointestinal AE, 1 for being father, 1 for own decision and 8 for lack of response (47%). In these patients treatment lasted 5(2-9) months, basal PASI was 5 (3-11) and at the end of treatment 5(2-11).
7 patients had gastrointestinal disorders and 2 headaches that resolved after several weeks of treatment, except one patient who suspended and 2 more patients had depression after 3-4 months of treatment.
Conclusion
Effectiveness in our study is low, 35% of response and 47% of lack of response. 53% of patients had AE the first weeks of treatment and 1 patient suspended because these AE. Apremilast has not been as effective as we expected in patients with mild-to-moderate psoriasis with primary involvement of scalp and nail.
References and/or Acknowledgements
No
Conflict of Interest No conflict of interest
GOT18-0685. SHARING EXPERIENCES BETWEEN COUNTRIES AS A LUNG TRANSPLANT PHARMACISTS AND NEW DEVELOPMENTS Background
Sharing experiences and knowledge between countries is one of the best ways to improve our skills as pharmacists. Spain is a leading country regarding both rate of traspants and efficiency in its
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management but the role of the pharmacist is however, less developed than it is in neighbouring european countries.
Obtaining a broadening-of-studies scholarship enabled me to train for a month in a United Kingdom hospital as a lung transplant pharmacist, which played a fundamental role in acquiring relevant skills and knowledge on the following topics:
-Immunosuppressive Treatments
-Antibiotic Treatments -Drud monitoring of Immunosuppressive Treatments -Patient counseling -Outpatients Clinic for patient education and counseling
Purpose
To implement all knowledge and skills obtained throughout the entire scholarship period as a pharmacist expert in lung transplant.
Material and methods
Granting of a scholarship and a one month stay in a monographic hospital of Tx pulmonar in the UK with a total integration in the lung transplant team.
Results
Ever since my return to Spain, the following processes have been implemented:
- Counselling patients after the transplant and before the discharge. One interview and two informative sessions are held for this purpose. The program itself is presented in the interview, as so are the informative consent and the pre-session questionnaire. In the first session the patient is provided with an introduction to the pharmacological treatment as well as some healthy post-transplant habits. The pre-informative questionnaire and the pre-session rating are handed, and the patient receives the book “Discharge information for post lung-transplanted patients†. During the second informative session the patient receives detailed information on the post-transplant medication they will need to take. On discharge day medication planning as well as the post-informative session questionnaire. After ten days from discharge the patient is surveyed via phone call on post informative sessions and the information is rated again.
- Creation of a patient-information blog detailing all the information given to the patient during counselling
Conclusion
The granting of a scholarship as a lung transplant pharmacist trainee has led to the implementation of new projects in the hospital.
Post-transplant patients are the main beneficiaries of having highly expert and trained pharmacists
References and/or Acknowledgements
no
Conflict of Interest No conflict of interest
GOT18-0686. ERIBULIN USAGE IN BREAST CANCER AFTER ITS INCLUSION IN THE FORMULARY Background
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In 2015, the Regional Committee for the Rational Use of Drugs decided the inclusion of eribulin in the formulary with specific recommendations: “patients with metastatic breast cancer who have progressed. Prior therapy must have included an anthracycline, taxane and capecitabine. ECOG 0 or 1, life expectancy ≥3 months and no brain metastases†.
Purpose
To evaluate the adequation of the eribulin prescription to the criteria established by the Committee, as well as its effectiveness and safety.
Material and methods
Observational, retrospective study of patients treated with eribulin until April 2017. The data collected were: sex, age, tumor receptors, previous chemotherapy regimens, treatment duration and reason for discontinuation, adverse events (AEs) and death date. Efficacy was measured in terms of progression- free survival (PFS) and overall survival (OS). It was checked if patients met the established criteria.
Results
Sixteen women with a median age of 55 years (35-75) were treated. All had HER2-negative disease and 15 HR-positive disease (two of them only estrogen-positive). The median of previous chemotherapy regimens was 5 (2-10). All of them had received at least one regimen based on anthracycline, taxane and capecitabine. The median duration of treatment was 31 days (1-123) and the median of administered doses 4 (1-12). Reasons for interruption were: neutropenia grade 4 (n=1), progression (n=7), and death (n=3). At the end of the follow-up period, 5 patients continued treatment with eribulin. The median PFS was 42 days (7-122) and the median OS was 20 days (11-163). The reported AEs were: neutropenia grade 4 (n=2) and grade 2 (n=1), asthenia (n=3), myalgia (n=2), neuropathy grade 1 (n=1). Dose reduction was required due to AEs in 5 patients.
Conclusion
The prescription of eribulin was adequate to the recommendations established by the Committee in 100% of the cases. The median PFS was lower compared with the pivotal study (EMBRACE). AE were similar to those reported in the literature. A larger sample size and a longer follow-up period are required to obtain robust data on the efficacy and safety of eribulin in our hospital.
References and/or Acknowledgements
Lancet. 2011 Mar 12;377(9769):914-23.
Conflict of Interest No conflict of interest
GOT18-0690. ANALYSIS OF THE USE OF PCSK9 PROTEIN INHIBITORS IN A TERTIARY CARE HOSPITAL Background
Hyperlipidemia is a well-established risk factor for developing cardiovascular disease (CD) with new treatments being necessary to reduce LDL levels when statin therapy is not tolerated or insufficient.
Purpose
To evaluate the indication, effectiveness and safety of two PCSK9 inhibitors (PCSK9-Inh), alirocumab and evolocumab.
Material and methods
A retrospective observational study including patients treated with PCSK9-Inh from October 2016 to March 2017. Analysed variables were: sex, age, diagnosis, prior statin treatments, dose regimens, treatment duration and lipid profile [LDL, HDL, total cholesterol (TC), triglycerides (TG)]. A standardized electronic application form was needed defining the following diagnoses: homozygous familial
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hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH) and non-familial mixed dyslipidemia with established CD.
The primary effectiveness endpoint was the decrease in LDL. Safety was assessed by reported adverse reactions.
Data was obtained through the prescription and validation programme SAVAC and the medical records programme (Selene).
Results
Seven patients (57.14% men) were included in the study with a median age of 44 years (range 36-65). The diagnoses were: HeFH (n=3) and mixed dyslipidemia (n=3). One patient had suspected HoFH with pending genetic result, requiring the maximum dose for HoFH due to lack of clinical response. The dosage regimens used were as described in the technical sheets for each specific indication. All patients had previously received at least two statins at their maximum tolerated doses being discontinued due to intolerance in 2 patients. All patients had taken adequate dietary measures. Five patients (71.43 %) had a history of CD. Median treatment duration was 6 months (range 1-7).
Mean levels before and after the treatment were LDL: 224.29±67.15 vs 148.80±91.38mg/dL; HDL: 46.00±17.13 vs 47.60±9.18mg/dL; CT: 293.57±64.09 vs 214.20±91.33mg/dL and TG: 275.00±375.04 vs 143.80±74.69mg/dL. There was a 33.66% reduction in LDL levels compared to baseline.
One patient reported an unclear drug-related side effect of dizziness.
Conclusion
There was a safe decrease in LDL levels, including patients without concomitant statin therapy. The most frequent indications of use were HeFH and mixed dyslipidemia, with no diferences in response to treatment. Treatment was equally effective in patients with CD.
Further studies are needed to confirm the effectiveness and safety of the use of PCSK9-Inh.
References and/or Acknowledgements
No conflict of interest
Conflict of Interest No conflict of interest
GOT18-0691. IDARUCIZUMAB USAGE IN THE EMERGENCY DEPARTMENT Background
Idarucizumab is a humanized monoclonal antibody fragment that binds to dabigatran with very high affinity (more than 300-fold higher than the affinity of dabigatran for thrombin). Idarucizumab binds both free and thrombin-bound dabigatran and rapidly reverses the anticoagulant effects of dabigatran and attenuates dabigatran-induced bleeding.
Purpose
To analyze the use of idarucizumab in the hospital Emergency Department.
Material and methods
Observational study of patients requiring administration of idarucizumab because of severe bleeding or urgent surgery. The following variables were collected: sex, age, indication, dabigatran dose, prothrombin time (PT), activated partial thromboplastin time (APTT) and fibrinogen on admission and after administration of idarucizumab. We also collected dabigatran plasma concentrations before and after antidote administration.
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Results
Idarucizumab was administered to 4 patients (50% women), with a median age of 82 years (66-83). Two of them had intracerebral hemorrhage, one bleeding with scrotal abscess, and another one required surgery after a hand trauma. The doses of dabigatran were: 150 mg/12h (n=1), 75 mg/12h (n=1) and 110 mg/12h (n=2). The parameters of each patient on admission were: PT 66%, 52%, 84%, 84%; APTT 43.7, 51.6, 41.6, 30.6 seconds; fibrinogen 363, 695, 515, 513 mg/dL; plasma concentrations of dabigatran 91.87, 289.19, 57.36, - ng/dL. After administration of idarucizumab: TP 73%, 66%, 88%, 93%; TTPA 34.4, 24.3, 29.7, 24.4 and fibrinogen 533, 706, 456, 529; plasma concentrations of dabigatran -, 1.29, 0.16, - ng/dL. In one patient, the plasma concentration of dabigatran after administration of idarucizumab was not determined. In another patient it was determined neither at admission nor after administration of the antidote, and the blood count was assessed 4 days after admission. 
All patients were able to control the hemorrhage and underwent surgery if necessary.
Conclusion
Idarucizumab can be considered an essential resource in emergency situations involving patients taking dabigatran. As a drug of high economic impact and with limited evidence about its safety profile, it seems necessary to establish strict criteria of use to avoid its irrational use in patients treated with dabigatran that show hemorrhagic symptoms.
References and/or Acknowledgements
N Engl J Med. 2015 Aug 6;373(6):511-20
Conflict of Interest No conflict of interest
GOT18-0700. COST-EFFECTIVENESS OF ADJUVANT LIRAGLUTIDE IN WEIGHT-LOSS THERAPY Background
Liraglutide use as adjuvant treatment of weight-loss was authorized by the EMA in 2016. Cost- effectiveness has not been evaluated in real clinical practice patients.
Purpose
To estimate cost-effectiveness of adjuvant liraglutide use in weight-loss therapy.
Material and methods
An observational retrospective study was carried out. Patients followed by the obesity unit department of Endocrinology who started treatment with liraglutide between January 2016 and August 2017 were selected. Efficacy was measured as the proportion of patients with loss greater or equal to 5% of baseline body weight after 12 weeks treatment (responder patients), and as the mean loss value expressed in kg. Each patient's drug costs were obtained from the corporate database for prescription billing (Farma). Cost-effectiveness was calculated for both efficacy variables. An exploratory cost- effectiveness analysis was performed based on previous pharmacotherapy for diabetes treatment.
Results
38 patients underwent liraglutide therapy during the study period. Twelve patients were excluded because they did not have an assessment of weight-loss yet. Results of 26 patients were analyzed. Mean baseline weight was 107.5kg. After 12 weeks treatment, nine patients showed response (35%), with a mean weight loss of 5.32 kg. The total cost of treatment with liraglutide was €29,704.90, resulting in a cost per responder of €3,049 and €214.78 per kg of lost weight. In the subgroup of patients whose previous treatment was metformin monotherapy, responders were 85% (six of seven patients), with a mean weight loss of 12.4kg. Total cost of treatment with liraglutide in this group was €8,842.24, with a cost per responder of €1,473.71 and €101.52 per kg of weight lost. In the group of patients previously treated with insulin, 12.5% ​​(two out of 16 patients) responded, with a total cost of €18,098.96, with a cost per responder of €9,049.48 and €480.08 per kg of lost weight.
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Conclusion
Effectiveness of liraglutide as adjuvant treatment in weight-loss is high in patients trated only with metformin and minimal in patients treated with insulin. Cost-effectiveness is six times higher in patients with previous treatment with insulin.
References and/or Acknowledgements
European Medicines Agency. Saxenda product information. Consulted: 13-10-2017.
Conflict of Interest No conflict of interest
GOT18-0705. ANALYSIS OF BEVACIZUMAB PLASMATIC CONCENTRATIONS IN THE TREATMENT OF METASTATIC COLORECTAL CANCER Background
Caulet et al.(2016) showed that metastatic colorectal cancer (mCRC) patients who have bevacizumab trough concentration above 15.5mg/L at day 14 of treatment have longer survival.
Purpose
The aim of this study is to describe and analyze plasmatic levels of bevacizumab in patients diagnosed of mCRC in a third-level hospital.
Material and methods
A single-centre, prospective, observational, study of 5 month (January-May2017). All adult colorectal cancer patients treated with bevacizumab were included. Bevacizumab minimun concentrations(C min ) were collected and determination of concentrations was carried out with SHIKARI®Q-BEVA ELISA kit.
Other collected variables were: sex, age, anthropometics caracteristics (Body Mass Index;BMI), presence of extra-hepatic metastases, concomitant quimiotherapy and recieved dose of bevacizumab.
Patients were requested to sign an informed consent for inclusion.
Results
The study included 4 patients, average age of 56.0(54-63), of which 50.0% were male. 100% of patients received FOLFIRI as concomitant quimiotherapy and the average BMI of patients were 25.7 (22.7-36.5).
All included patients had exta-hepatic metastases and the average logCEA was 1.14(-0,04-2,97). The bevacizumab dosage was 5mg/kg in all cases (average received dosage: 304.9mg).
A total of 19 determinations were carried out, with an average Ctrought of 24.02mg/L (9.4-36.1). The average minimun and maximun C min for the included patients were respectively 13.2 mg/L(6.4-32.3) and 35.2 mg/L(13.9-54.7).
50.0% of included patients did not reach a concentration higher than 15.5mg/L after the first 14 days of treatment with bevacizumab, all of them has one or more of the high risk parameters identify by Caulet et al. (2016) (elevated basal CEA, extra-hepatic metastases, and high BMI).
Conclusion
Our results are preliminary and limited by the number of patients, but indicate the existence of a high variability in the bevacizumab trough concentration. They also show that patients who didn’t reach levels above 15.5mg/L present some characteristics related by Caulet et al. with a higher elimination rate of the drug.
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The recruitment of a greater number of patients and more longer follow-up will allow us to analyze the influence of these C min in patients survival.
References and/or Acknowledgements
No conflict of interest.
Conflict of Interest No conflict of interest
GOT18-0720. RESULTS OF IMPLEMENTATION OF AN ANTIMICROBIAL STEWARDSHIP Background
Antimicrobials are drugs prescribed by all specialties and one of the most commonly used drugs in hospitals. They are the only drugs with ecological effect, reason why its administration can contribute to the appearance and dissemination of microbial resistances. All this makes it essential to establish programs for the optimization of antimicrobial use in hospitals.
Purpose
To describe the results of implementing an antimicrobial stewardship program (AMS) in a third-level hospital.
Material and methods
We have developed a computer tool capable of analyzing multitude of situations through pre- established conditions and presenting in an organized way the patients susceptible to review to improve the use of antimicrobials.
Meetings are organized twice a week and participates one Pharmacist, three infectious diseases physicians and a clinical microbiologist.
Results
From July 2015 until February 2017 we have met 101 times with the following results:
• Intervened on 943 treatments corresponding to 512 patients.
• The average duration of the antibiotic treatments was 7.9 days. (One of the criteria for reviewing treatments is to review those that have been prescribed for more than 7 days).
• Indication was mainly empirical treatments.
• Most common infections were respiratory infections, urinary infections, and skin and soft tissue infections.
• 60% of the patients had extracted cultures when they were reviewed.
• The antibiotic treatment could be optimized in 28% of patients with positive cultures. 11% because of the microorganism was resistant to the antibiotic prescribed and 17% because there was an alternative option with a narrower spectrum.
• Most of the interventions (54.4%) were suspensions of treatment for inadequate duration, promotion of sequential therapy (IV to OR), suspensions of treatments not indicated and therapeutic de-escalation to another antibiotic with narrower spectrum. 31.3% of patients rewiewed no changes were recommended.
Conclusion
The development of computer tools that detect possible interventions on antibiotic treatments is a very powerful aid to the AMS programs.
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A multidisciplinary AMS team allows the development of conditions managed in the computer tools based on microbiological, clinical and medicine based data.
References and/or Acknowledgements
Thanks to muldidisciplinary team from HUNSC
Conflict of Interest No conflict of interest
GOT18-0727. PHARMACOKINETIC VARIABLES DETERMINANT OF PLASMA CONCENTRATION OF VANCOMYCIN IN CRITICAL ILL PATIENTS Background
Critical ill patients are likely to require antibiotic treatment and Vancomycin is one of the antibiotics commonly used. For this reason, it is important to know the pharmacokinetic variables that affect the plasma concentration of these.
Purpose
To assess the pharmacokinetic variables that affect the plasma concentrations of Vancomycin in critical ill patients.
Material and methods
Retrospective observational study carry out from January to December 2016, in a tertiary hospital with 21 beds to intensive care units. The following variables were collected from the computer program GestLab®: demographic data, Vancomycin trough serum level(Cv); age (a 1: young adults (<65years) 2 and a 2: seniors (>65years)); Body mass index (BMI) (w 1: normal weight (<25kg/m ) and w 2: overweight/obesity (>25kg/m 2)); and estimated Glomerular Filtration Rate (GFR) by Cock-croft-Gault (r 1: normal GFR(>80ml/min), r 2: moderately decreased (30-80ml/min) and r 3: severely decreased (<30ml/min)).
For data analysis, the statistical program SPSS Statistics22® was used. The analyzed variables were compared using the Analysis of variance, unpaired samples t-test and Scheffé's method to multiple comparisons, when it was possible. A p-value < 0.05 was considered statistically significant.
Results
A total of 148 determinations, corresponding to 58 patients who required intensive care and that were treated with vancomycin, were recorded. Characterization of the variables of the patients included in the study: Male sex 60.3% (n=35); age= 70.5 ± 13.6 (35-90) years; Serum creatinine= 0.93±0.56 (0.33-2.83)mg/dL; GFR=99.16 ±60.05 (17.91-291.67) mL/min; BMI= 27.67±5.32 (17.6-45.3) kg/m 2, Cv= 14.2± 7.1 (1.0-42.3) mcg/mL.
Patients a 1 had significantly lower Cv than patients a 2 (7.44 mcg/mL vs. 10.82 mcg/mL; p=0.019). The average of Cv in patients with normal renal function was also significantly lower than Cv of the groups with impaired renal function (r 3-r 1=5.81mcg/mL, p=0.022; r 2-r 1=5.92, p=0.000). Nevertheless, there was no difference between sex (p=0.528) nor BMI (p=0.182).
Conclusion
Cv in critical ill patient is higher in elderly patients and in those with reduced GFR. However, in our study there is no difference in BMI categories. This may be due to the complex clinical status of patients studied and the multiple factors that influence it in the pharmacokinetics of the drug.
References and/or Acknowledgements
To my workmate. Thanks for your help.
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Conflict of Interest No conflict of interest
GOT18-0729. SECUENCIAL TREATMENT NOT INCLUDED IN DATA SHEET WITH SOMATOSTATIN AND THALIDOMIDE ANALOGUES IN INTESTINAL AGIODYSPLASIA Background
The limited response to regular treatment of intestinal agiodysplasia causes that drugs that are not legally recognised for this specific indication are occasionally required, even though the accumulated experience allows us to expect certain degree of control of the issue.
Purpose
The objective is to evaluate the results of a secuencial diagram which is based on the use of somatostatin and thalidomide analogues-both out of Data Sheet-.
Material and methods
Observational, descriptive, retrospective study in which patients under treatment with ocreotid or lanreotid(or both) and thalidomide who had been diagnosed with intestinal agiodysplasia were incuded. None of the three drugs were used concomitantly.
Checking medical history, response to treatment was rated by analysing the number of red cell concentrated transfusions, emergency room visits and hospital admissions, comparing the annual mean value of these variables within two equal periods of time: before and after the onset of treatment. Adverse events attributable to drugs were gathered, demographic parameters and number of comorbidities. Data analysis was performed with Excel2007. Results
Six patients were treated,2women and 4men, average age 84. All of them received intravenous iron therapy.
The number of comorbidities were7,8,5,6,5 and 11(median:6.5).
The mean values of annual hospital admissions before starting therapy were:1.31;0.67;1.37;0.4;0.17;1.06(median:0.83); being after treatment initiation:12.0;5.0;1.0;0.0;3.0;1.25(median:2.12).
The average number of annual emergency room visits before starting therapy were:1.62;0.72;0.87;0.6;0.29;0.88(median:0.80); being after treatment initiation:6.0;11.0;4.5;0.0;3.0;4.0 (median: 4.25).
The mean value of annual transfusions before starting therapy were:6.0;9.5;4.87;8.4;2.0;17.0(median 7.2); being after treatment initiation:76.0;28.5;20.5;58.0;15.5;15.0(median:24.25).
Adverse effects requiring thalidomide suspension in 5 patients were: thrombotic processes(two of them) and paresthesias(three of them). Conclusion
Patients who were treated following this diagram proffer a high fragility, as much because of their age as because of the comorbidity.
The results of the variables previously described show an important deterioraton and a greater transfusion dependency, once out of data sheet treatment was started. Thalidomide adverse effects required suspension of treatment in almost all the patients.
The design of this study does not allow evaluation of drug effect, because of the unknowledge of the evolution of patients under no treatment. Even so, results seem to be barely encouraging about the effectiveness of the diagram utilized for the disease control. References and/or Acknowledgements
.
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Conflict of Interest No conflict of interest
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GOT18-0739. EFFECTIVENESS AND SAFETY OF OSIMERTINIB Background
Osimertinib is a potential new standard of care for adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Approximately half of patients with NSCLC develop resistance to tyrosine kinase inhibitors such as gefitinib, erlotinib and afatinib due to the secondary mutation, EGFR-T790M
Purpose
Evaluation of effectiveness and safety of osimertinib in patients diagnosed with NSCLC and EGFR mutation (T790M).
Material and methods
A retrospective observational study of the effectiveness and safety of osimertinib in four patients diagnosed with NSCLC in which, after receiving several treatment lines, a positive T790M epidermal growth factor receptor (EGFR) mutation was confirmed. To obtain data, the clinical records and the available bibliography were reviewed. The variables studied were sex, age, ECOG at the beginning of treatment with osimertinib, number of previous treatment lines, progression-free survival (PFS), and adverse effects
Results
Four patients (2 male and 2 female) with a mean age of 64 years and ECOG 1-2 were included. In all patients, osimertinib was used after ≥2 lines of treatment, having previously confirmed the presence of a T790M mutation on biopsy. Two patients were treated with osimertinib in the second line (in the first line erlotinib and afatinib respectively); in the other two patients, osimertinib was used in ≥3 line (following progression to afatinib, cisplatin-pemetre- d, vinorelbine, nivolumab in one patient and, after cisplatin-pemetrexed, erlotinib in the other patient).
The suspension of treatment was in two patients due to progression of the disease (6 months and 3 months respectively) and in one of the patients due to a severe clinical deterioration triggered by disease progression 2 months after the beginning. The fourth patient is currently being treated (5 months) with disease stabilization.
The adverse effects observed were: dry skin and rash grade 2 (one patient) and diarrhea grade 2 (two patients) according to version 4.03 of "Common Criteria Terminology for Adverse Events, CTCAE.
Conclusion
In the recently published phase III study (AURA 3), the PFS was 10.1months, being superior to that of our patients. As for the adverse effects, all of them were of mild-moderate intensity.
References and/or Acknowledgements
""
Conflict of Interest No conflict of interest
GOT18-0741. PERFORMANCE OF CHEMOTHERAPY-TESTED GLOVES DURING SIMULATED USE: THE ROLE OF HOSPITAL PHARMACY Background
Due to their potential mutagenic and carcinogenic effects, occupational exposure to chemotherapy drugs should kept to a minimum. Utilization of personal protective-devices, especially the use of protective medical gloves, is a mainstay to avoid skin contact and thus ensure operator safety. When selecting gloves for practice, it's important to involve staff members in the product decision and ensure that the product is functional, safe and effective.
Purpose
To evaluate the best chemotherapy-tested gloves to introduce in the clinical practice.
Material and methods
The Pharmacist selected several samples of chemotherapy–tested gloves and then the staff members tried them in the clinical setting. Hospital Pharmacy Service in collaboration with Prevention and Protection Service (PPS) elaborates an evaluation score sheet about the functional characteristics of each types of gloves using a score from 1 to 4. The parameters evaluated by pharmacist in agreement with the other operators involved were flexibility, durability, comfort and gloves’ length. We tested three brands of chemotherapy gloves, divided for application use (preparation, administration and support use) and aseptic technique according to Good Manufacturing Practice and EN ISO 9001:2000. Tests were performed in each hospital unit that handling chemotherapy such as transplant unit, urology and division of oncology. The selected gloves for the test were chemo-tested, latex and powder free, made respectively by Neoprene, Vinyl or Nitrile. The minimum standard score required for the gloves’ choice was fixed to 2.5.
Results
From November 2016 to February 2017 were enrolled 35 nurses and 75 score sheets were correctly completed. The Hospital Pharmacist collected the sheets and analyzed data in Excel®; all the samples have achieved the minimum standards. The Neoprene gloves obtained the highest value (3.6 points) for the aseptic handling, while for non-sterile operating area (including administration of chemotherapy) the nurses preferred nitrile type (3.0). No cases of adverse reaction was noted.
Conclusion
The multidisciplinary team approach including pharmacists, nurses and technicians leads to a detailed analysis of the chemo-tested gloves and allowed to the selection of the best product. Consultant activities, property, classification, codification, legislation, alternative products and logistics are the working led in which Hospital Pharmacist play a relevant role in medical equipe.
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References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0763. CORONARY HEART DISEASE PATIENTS' EXPERIENCES OF MEDICATION REVIEW AND MOTIVATIONAL INTERVIEWING Background
The study Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) is a randomized controlled trial of a clinical pharmacy intervention which aims to improve cardiovascular secondary prevention treatment. The intervention includes two counselling sessions and medication review with a clinical pharmacist in an outpatient clinic. Along with the study outcomes on adherence, clinical effects and quality of life the intervention process is studied by quantitative and qualitative methods in a pre-specified process evaluation. A conceptual model of the intervention change process has been developed.
Purpose
The overall objective was to find out if patients experienced the intervention in MIMeRiC as described in the conceptual model of the intervention change process. The specific aims were to study:
• How was the patients’ reasoning about medicines affected by the intervention? • How patients were affected practically, i.e. how they take their medicines? • How did the patients perceive that their health was affected?
Material and methods
Data was collected in two focus groups and analysed by deductive qualitative content analysis. Categories for the coding in the deductive analysis were drawn from the conceptual model and included: Beliefs about medicines, attitude toward adherence, subjective norms about adherence, perceived behavioural control, skills, perceived effects of drugs, perceived side-effects of drugs, perceived general health, person centredness, environmental factors.
Results
The analysis of focus group transcripts showed that the intervention affected the participants in eight of the ten categories from the conceptual model. In specific, participants stated that it felt better with increased knowledge; knowing what medicines they are taking and why they are taking them. Some expressed a greater importance of taking their medicines after the intervention. Participants also reported that they had aquired strategies to help them remember taking their medicines. One participant stated that his mental/psychological health was improved by the consultation. Participants also expressed views about being seen as an individual, to be met with respect and to feel taken care of.
Conclusion
Patients experienced the intervention as intended. They felt more confident with their medicines and they had acquired strategies facilitating adherence. Participants also felt respected and taken care of by the intervention activities.
References and/or Acknowledgements
None
Conflict of Interest No conflict of interest
GOT18-0776. MEPOLIZUMAB FOR THE TREATMENT OF SEVERE EOSINOPHILIC ASTHMA: EXPERIENCE IN A UNIVERSITY HOSPITAL. Background
Eosinophilic asthma is a severe subtype of asthma and it represents approximately 10% of all asthma cases. The number of eosinophils is increased in blood, lung tissue, and respiratory tract.
Mepolizumab is a monoclonal antibody against interleukin 5 that inhibits eosinophilic airway inflammation and reduces the frequency of asthma exacerbations.
Purpose
To describe effectiveness and safety of mepolizumab in patients with eosinophilic asthma.
Material and methods
A retrospective study was conducted from February to September 2017, including all patients treated with mepolizumab. The following data were collected: demographic data, duration of treatment, baseline and current eosinophils level, baseline and current spirometry values (FEV1, FVC, FEVI1/FVC), adequate clinical response, hospital admissions due to asthma during the treatment, and adverse events related to mepolizumab.
Adequate clinical response was defined as at least 50% fewer asthma exacerbations requiring systemic corticosteroids or a clinically significant reduction in the continuous use of oral corticosteroids by maintaining or improving asthma control. Statistical analysis was performed using SPSS 15.0.
Results
Six patients started treatment with mepolizumab (3 men). Median age was 50 years (IQR 41-60). Median duration of treatment was 6 months (IQR 4,7-7,5).
Four patients had an adequate clinical response and two patients maintained asthma control. None had hospital admissions due to asthma during the treatment. Two patients presented adverse events (one patient had erythematous lesions and other patient had an infectious disease).
Variables Baseline levels (average) Levels after 12 weeks of treatment
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Eosinophils (x10 3 /µl) 0,8±0,2 0,1±0,8 FEV1 (%) 72,8±16,5 98,3±22,1 FEV1 (L) 2,3±1 3,1±1,4 FVC (%) 92,4±16,6 102±17,3 FVC (L) 3,3±0,9 3,7±1,2 FEV1/FVC (%) 64,9± 9,4 80±10,3 Conclusion
Clinical management of mepolizumab was adequate with a low rate of adverse events. A close monitoring is necessary because mepolizumab must be discontinued after 12 months if asthma has not responded. The number of patients was small, so a wider study should be necessary.
References and/or Acknowledgements
The authors declare no conflict of interest
Conflict of Interest No conflict of interest
GOT18-0785. OFF-LABEL USE OF RITUXIMAB IN A TERTIARY HOSPITAL Background
Rituximab is a monoclonal antibody, a type of protein, that binds to the surface of one type of white blood cell, B lymphocytes. The use of Rituximab in Spain has increased considerably since its authorization.
Purpose
Analyze the prevalence and the use of the Rituximab under conditions off-label and describe its economic impact.
Material and methods
Retrospective observational study which included all off-label Rituximab applications received at the hospital for a period of 2 years (2015-2017). According to the Spanish Agency for Medicines and Health Products, Rituximab has indications in: Non-Hodgkin's lymphoma, Chronic lymphatic leukemia, Rheumatoid arthritis, Granulomatosis with polyangeitis and microscopic polyangiitis. We registered variables such as age and sex of the patient, indication for which the drug is requested, requesting Medical Service, type of evidence, cost of treatment, and degree of authorization.
Results
There were 50 requests for Rituximab during the study period, accounting for 11.2% of the total number of off-label drugs requested. Sixty percent were women and the mean age was 40.8 years ± 22.3. The distribution of the requests according to medical services was: Neurology (30%), Child Oncology (16%), Rheumatology (16%), Nephrology (14%), Cardiology (10%), Hematology (6%), Child Nephrology (2%), Internal Medicine (2%) and Child Rheumatology (2%). The use of Rituximab in 25 different pathologies was requested. The three most common pathologies were Systemic Lupus Erythematosus (5), Multiple Sclerosis (4) and Epstein Barr Virus (4). The type of evidence found was: case series (64%), phase II (16%), phase III (10%), controlled / retrospective (6%), comparative (4%) cases. One hundred percent of applications were approved. The average cost per treatment was 5,870 euros and the total cost in the study period was 293,513 euros.
Conclusion
There are a large number of applications for the off-label use of Rituximab. Rituximab is required by different specialties, due to its utility in a large number of pathologies. The off-label use of Rituximab leads to a considerable increase in hospital pharmacy costs.
References and/or Acknowledgements
Sailler L. Rituximab off label use for difficult-to-treat auto-immune diseases: reappraisal of benefits and risks. Clin Rev Allergy Immunol. Spanish Agency of Medicines and Sanitary Use. Rituximab.
Conflict of Interest No conflict of interest
GOT18-0805. EFFECTIVENESS AND SAFETY OF AUTOLOGOUS SERUM EYE DROPS Background
Autologous serum eye drops (ASED) are a therapeutic option widely used for treatment of ocular surface diseases such as ocular ulcer (OU) and keratopathy. OU is an open sore on the cornea commonly cause by infection, corneal drying and contact lens. Keratopathy is a noninflamatory disease of the cornea.
Purpose
To assess the effectiveness and safety of ASED for treatment of OU and keratopathy.
Material and methods
Descriptive retrospective observational study of patients treated with ASED was conducted from January 2015 to September 2017. Access® database was used to record the following dates: gender, age, number of eyes treated, ASED composition and duration of treatment. For OU patients, effectiveness was defined as ulcer closure and closing time of ulcer. Fluorescein staining loss was used to evaluate effectiveness for keratopathy patients. Safety was assessed collecting adverse effects. ASED were elaborated in the sterile area of Pharmacy Service: serums obtained from blood were mixed with diluents (normal saline and ofloxacin) in adequate proportions.
Results
During the study period, 35 patients (21 presented OU and 14 keratopathy) were evaluated. There were 18 (51.4%) men and 17 (49.6%) women. Median age was 70 (23-95) years. ASED composition consisted of: 20% serum with normal saline in 7 (20%) patients and 50% serum
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with ofloxacin in 28 (80%) patients. Median duration of treatment was 3.5 (1-75) months. Ulcer closure was observed in 20/21 (95.2%) patients and median closing time of ulcer was 1 (0.2-4) month. Fluorescein staining loss occurred in 10/14 (71.4%) patients. No adverse effects associated with treatment were founded.
Conclusion
1. Almost all patients diagnosed with OU and treated with ASED presented ulcer closure. 2. More than two thirds of keratopathy patients were effective with fluorescein staining loss. 3. The ASED was well tolerated, without adverse effects founded. 4. High effectiveness and great tolerance presented ASED as an important therapeutic option for treatment of OU and keratopathy.
References and/or Acknowledgements
No conflict of interest
Conflict of Interest No conflict of interest
GOT18-0824. COMPARATIVE ECONOMIC STUDY OF MEDICINES FOR THE TREATMENT OF CROHN'S DISEASE Background
Crohn's disease is a chronic inflammatory disease that mainly affects the gastrointestinal tract. Pharmacological treatment is very varied, from classic glucocorticoids and immunosuppressants, to new biological medicines, which are very effective but with high prices.
Purpose
Our objective is to evaluate and compare the cost of different biological therapies for treatment of Crohn's disease.
Material and methods
Comparative economic study of six medicines used in Crohn's disease, these medicines are: adalimumab, innovator infliximab, biosimilar infliximab 1, biosimilar infliximab 2, vedolizumab and ustekinumab. Pricing data for each pre-filled pen or vial is obtained from Orion Logis® management program. Cost of first year and cost of successive years, according to usual dosage regimens described in the technical file, are evaluated from each therapeutic alternative. In first year of treatment, consideration will be given to induction therapy of those who require it. For those drugs that are dosed by weight, a standard weight of 70 kg will be considered. Finally we compare what it costs a first year of each medicine and what they cost the following years.
Results
Price of adalimumab during the first year of treatment is 12.756€. Innovator infliximab, biosimilar infliximab 1 and biosimilar infliximab 2, cost in the first year of treatment 9.677,5 €, 7.448 € and 7.227,5 €, respectively. Vedolizumab has a first-year treatment cost of 13.655,81€. Cost of first year of ustekinumab treatment is 12.474,36€. Costs per year of successive years of treatment of adalimumab, innovator infliximab, biosimilar infliximab 1, biosimilar infliximab 2, vedolizumab and ustekinumab are 11.055,2€, 8.295€, 6.195€, 6.384€, 11.704,98€ and € 9.504,48€, respectively.
Conclusion
At first year of treatment, the most economical therapies are biosimilars of infliximab, and the least economical therapy is vedolizumab. Adalimumab and ustekinumab have similar costs in the first year of treatment. In subsequent years of treatment, biosimilars of infliximab are the most economical therapies too, and vedolizumab is the least economical therapy. Ustekinumab has a lower cost than adalimumab in subsequent years. This study does not take into account costs of medicines administration and preparation, which could change the results.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0840. DESCRIPTIVE STUDY ON THE USE OF ANGIOTENSIN RECEPTOR BLOCKER IN A THIRD LEVEL HOSPITAL Background
Angiotensin receptor blocker(ARB) are a widely used therapeutic group. Seven ARB (losartan,irbesartan,candesartan,valsartan,olmesartan,telmisartan and eprosartan) have been marketed. Losartan, irbesartan, candesartan and valsartan are available in the Hospital's Pharmacotherapeutic Guide(HPG) of our center. Losartan is the ARB of choice based on efficiency criteria.
Purpose
The aim of this study is to analyze the use of ARB in a third level hospital.
Material and methods
A cross-sectional study was conducted in september 2017, so that all patients admitted to Units with pharmaceutical validation were selected for treatment with any ARB available in the HPG and retrospectively, a household prescription of ARB, hospital prescription, realization or not of therapeutic exchange, changes during the stay, prescribed diet.
Results
48 patients were selected, 18% of all patients admitted according. 8 had no ARB prescribed at home. 20%(n = 8) were >80 years. 72.5%(n = 29) were admitted to Surgical Services. The median stay was 12.5±13.5 days. The home-based ARB was distributed as: valsartan(10,25%), olmesartan(10,25%), losartan(9,22.5%), irbesartan(4,10%), telmisartan(4,10%), candesartan(2.5%) and eprosartan(1,2.5%). Of these, 35%(n = 14) associated with hydrochlorothiazide. On admission, the ARB prescribed were: losartan (20,50%), valsartan(11,27.5%), irbesartan(6,15%), candesartan(2,5%) and none(1, 2.5%). Of which 30%(n = 12) with hydrochlorothiazide. In 55%(n = 22) the home treatment was maintained, in 22.5%(n = 9) therapeutic interchange was performed and in 22.5%(n = 9) the treatment modifications were made by the doctor. Therapeutic exchanges were done directly by the physician in 44% and by the pharmacist in 56%, although with respect to the total was only 12.5%. In 12.5% ​​(n = 5), modifications were made during the stay, 40% in patients >80 years. The diet was recorded in 36 patients(90%), of whom 67%(n = 24) had a diet without salt.
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Conclusion
In our center the most common practice is to maintain home treatment at admission and therapeutic exchanges by the pharmacist were minority.
The ARB most prescribed at home were valsartan and olmesartan, while at admission they were valsartan and losartan, although the latter was less than expected if we consider that it's the ARB of choice according to efficiency criteria.
It's necessary to re-evaluate the ARB that should be included in the HPG.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-0852. IMPROVING INVESTIGATIONAL DRUG MANAGEMENT: AN INNOVATIVE PROCESS Background
The Good Clinical Practice guidelines establish that principal investigator can delegate the management of investigational drugs (ID) to pharmacist. In our hospital the significant increase of clinical trials assigned to Pharmacy , the several area of storage, dispensing and administration lead us to implement a new process.
Purpose
The aim of the study was to improve the process and optimise the investigational drugs management.
Material and methods
The process included the creation by Pharmacy Service of a specific form to apply for the ID request, the protocol assignment to a specific type of management, and the development of an intranet site where health care professionals have the possibility to download forms. The form was organised in 5 sections: Section A already filled in with protocol information (name, centre code, principal investigator); Section B displayed patients data (initials, patient code, treatment cycles) and treatment schedule (dose and cycles); Section C, filled out with the names of ID had to be complete with quantities and expected date of administration; Section D had to be completed with batch and expiry date. The form had to be signed by pharmacist during dispensation and countersigning for receipt. Section E reminded the type of management assigned to the protocol. According to the characteristics of storage, formulation and activities required by the protocol (IWRS, unblinded pharmacist, drug preparation) 5 types of management had been identified. ID were, depending on the case, picked up from pharmacy or delivered to the ward. The operational working methods provided that the investigator during recruitment/randomization for the first cycle and in the following cycles, sent to the pharmacy the specific form to request the ID indicating the administration date and pharmacists prepared the kit and deliver it.
Results
The procedure has now been running for three years. Data from January to June 2017 attested 60 ongoing protocols, 722 dispensations for patient, 237 drugs prepared by pharmacists and 986 in Chemotherapy preparation unit (CPU), confirmed the efficient organisation of the process
Conclusion
The introduction and development of the new procedure ensured the planning and tracking of the ID, overcoming the logistical difficulties, simplifying control, and increasing safety
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0855. EFFICACY AND SAFETY OF SORAFENIB FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA Background
Sorafenib is the standard first-line drug for advanced hepatocellular carcinoma (HCC).
Purpose
To determine the efficacy and safety of sorafenib for the treatment of HCC in our population.
Material and methods
Retrospective study in a single center. Cases of HCC patients who received sorafenib therapy from October 2008 to September 2017 were studied.
Patient demographics, treatment and disease characteristics (HCC etiology, tumor stage according to the Barcelona-Clinic-Liver-Cancer (BCLC) system and presence of portal vein thrombosis) were collected from electronic patient files. To evaluate the efficacy of sorafenib, overall survival (OS) and progression free survival (PFS) were assessed in all patients who received at least 30 days of sorafenib therapy.
Safety analysis was based on the evaluation of adverse events (AEs) and the need of dose modification.
Crude and adjusted hazard ratios (HRs) were calculated using Cox regression analysis to identify factors associated with outcome.
Results
There were included 34 patients, mostly male (88.2%), with a median age of 64.5 (44-77) years. The main etiology of HCC was alcoholic liver disease (64.7%) and 73.5% of the patients were staged as BCLC-C.
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After a median of 32 (7-250) weeks of follow-up, the median OS was 226 (46-1753) days and the median PFS was 112 (32-654) days.
The most frequent AEs during therapy were hand-food skin reaction (HFSR) (55.9%), asthenia (55.9%) and anorexia (38.2%). Fourteen (41.2%) patients presented grade 3/4 AEs. Fifteen patients (44.1%) required dose reduction due to AEsand the median time to dose reduction was 35 (7-283) days. Eight patients (23,5%) interrupted treatment because of AEs with a median duration of 22 (14-301) days.
In multivariate analysis, HFSR was associated with improved OS (HR=3.31, 95%CI=1.36-8.03) and PFS (HR=3.88, 95%CI=1.53-9.84), compared with no HFSR.
Conclusion
We observed an OS of 226 (46-1753) days and a PFS of 112(32-654) days in our population.
HFSR and asthenia were the most frequent EAs during therapy. Dose reduction due to EAs during therapy was common.
Our results suggest that HFSR is an independent predictor of longer OS and PFS in HCC patients treated with sorafenib.
References and/or Acknowledgements
Conflict of Interest No conflict of interest
GOT18-0890. WOMEN WHO USE ILLEGAL DRUGS IN A DEPRESSED SOCIAL SITUATION Background
Although the presence of socially depressed, non-legal female drug users is much less frequent, a detailed study is needed to obtain better assistance.
Purpose
To analyze the resources available to women who use illegal drugs in socially depressed situations.
Material and methods
A Review of available data on women who use non-legal drugs in socially depressed situations in the Barcelona metropolitan area was carried out. Semi-structured interviews with nurses, doctors, social workers, drug users and social educators were collected.
Results
On the basis of the discussions we can propose that women who use illegal drugs account for 15%. There are 40% of them on the street. Cocaine is usually the main drug of consumption. They are more vulnerable to drug abuse, they have more difficulties in initiating treatment for addictions (smaller family support, the fact that the treatment may mean having to abandon the course of life or the threads, the reason why the addiction would lead to the withdrawal of the substance) and to their withdrawal.
Conclusion
Homelessness favors violence against people, but especially the most vulnerable. There are not enough resources for women who use drugs and have children, after being assaulted during an active use phase and in the face of their partner's dependence on both drugs and injection, as well as the lack of resources for drug addicts.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-0896. ILLEGAL DRUG MARKET Background
Although this is an area of difficult access, there are indicators that drug market behaves like other business areas.
Purpose
It should be noted that illegal drug market follows the usual rules of legal markets and that its knowledge may lead to forms of intervention different from those previously applied.
Material and methods
Review of available data on drug use and actions against drug users in Barcelona metropolitan area. Semi-structured interviews with nurses, doctors, drug users and social educators was conducted.
Results
On the basis of the discussions we can propose that heroin and cocaine follow a characteristic import route.Since their arrival in Spain,they have suffered a process of increasing prices in the successive transactions, until reaching the small distributor already in contact with consumers.There is a good distributor, with certain professionalism, which can lead to defend its own prestige and the safety of its product, has respect for buyers, tries to avoid unfavorable reactions in the course of consumption, provides hygienic material and behaves with discretion in relation to the environment.It contrasts with the appearance of bad camels, spontaneous, with less experience in the sale and with pathogenic actions that can lead to the mistreatment of the buyer.Along various transactions there is a loss of quality, which in this area is characterized by the appearance of additives. Additives are not involved in consumer effectsThere is wholesale sale -more economic- and sale of smaller quantities. These differences also exist in different areas of the city.
Conclusion
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Tourism has made illegal drugs more expensive. There has been an increase in demand and new vendors, fewer professionals and users with fewer economic resources and less bargaining power have appeared before distributors.Barcelona is an attractive destination for active consumers, with safe points of consumption, affordable prices and an attractive extra-drugs offer. This forces us to design new actions.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-0898. Imported pathology cases in pediatric age: malaria Background
Malaria can be a severe, potentially fatal disease and treatment should be initiated as soon as possible. Children under 5 years of age are one of the most vulnerable groups affected by malaria.
Purpose
To analyze the therapies used and adverse effects related to them in the pediatric population diagnosed with malaria in a third level hospital.
Material and methods
We collected data regarding demographic variables, prophylaxis, Plasmodium species, parasitaemia, treatment, adverse events (AE), analytical variables and length of hospital stay of two pediatric patients with malaria, admitted to the Pediatric Emergency Department in October-2016, thanks to the presence of a clinical-pharmacist in the unit and to electronic record management programmes.
Results
Two male patients were included, both Spanish, aged 2 and 6 years (mean-weight 16.8kg), the infecting species was Plasmodium falciparum . They had travelled to Guinea, without receiving pre-exposure prophylaxis and returning 15 days before hospital admission. They presented with fever, vomiting, thrombocytopenia and anemia.
The 6-year-old patient was hospitalized for 9 days (parasitaemia 6%), starting treatment with oral quinine-sulfate 200mg/8h + clindamycin 150mg/8h (2 doses), due to oral intolerance this therapy was changed to IV artesunate 60mg (4 doses). Subsequently oral treatment was restarted: atovaquone+proguanil 100/250mg/24h (3 days). Analytical data were:
• Hemoglobin on admission: 10.4g/dl (7.3g/dl on the 4th day of admission).
• Platelets on admission: 29,000/μl.
The 2-year-old patient was hospitalized for 5 days and was treated with oral atovaquone+proguanil 100/250mg/24h (3days). Analytical data were:
• Hemoglobin on admission: 9.7g/dl (8.6g/dl on the 2nd day of admission).
• Platelets on admission: 119,000/μl (80,000/μl on the 2nd day of admission).
The Pharmacy Department studied the possibility of masterly formulation in view of the swallowing difficulties presented by this patient. There were no treatment-related AE.
Conclusion
Due to the potential severity of malaria in children, treatment should be initiated early, as it conditions a better prognosis. In our study, the treatments used were effective and safe.
There are few studies and little variability of dosage forms for the pediatric population. More studies and involvement of the industry are needed to commercialize pharmaceutical forms suitable for pediatric patients.
References and/or Acknowledgements
M.GarcÃa López Hortelano,V. Fumadó,M.I. González.Actualización en el diagnóstico y tratamiento de la malaria. AnPediatr2013;78:124.e1-8- Vol.78Num.2.
Conflict of Interest No conflict of interest
GOT18-0901. THERAPEUTIC DRUG MONITORING DURING INDUCTION OF INFLIXIMAB THERAPY IN INFLAMMATORY BOWEL DISEASE Background
Therapeutic drug monitoring (TDM) of infliximab during maintenance therapy, has been proven effective. Nevertheless, much less is known about its use during infliximab induction therapy.
Purpose
To assess whether infliximab concentrations during induction therapy are associated with clinical response and short-term mucosal healing (STMH) in patients with inflammatory bowel disease(IBD).
Material and methods
We performed a prospective from October-2016 to September-2017, double-center analysis of data collected from patients with ulcerative colitis (UC) or crohn's disease(CD) who received induction therapy with infliximab. Serum samples were collected and concentrations of C-reactive protein (CRP) and albumin were measured. STMH was defined by endoscopic evaluation, and a Mayo score<1 and Harvey Bradshaw (HB)<5, in UC and CD, respectively. An endoscopic evaluation at baseline and after induction therapy was performed. Infliximab concentrations were
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evaluated at weeks 2, 6, and 14 of infliximab therapy by using an enzyme-linked immunosorbent assay using the Lisa-Tracker® analyzer. Results expressed as median (IQR) for quantitative variables and percentages for qualitative.
Results
Seven patients (3 with UC and 4 with CD) were included in the study (86% male) with age at infliximab initiation of 34 years (27–48), disease duration of 4 years (1-11) and 57% were smokers. One patient was treated with prior biologic therapy, 57% and 71% had concomitant treatment with corticosteroids and azathioprine, respectively. Before induction, 71% had an elevated CRP (>5mg/L) and 43% low albumin (<4g/L) levels. Before infliximab induction Mayo score was 5 (4-5), indicative of mild-moderate disease in all patients with UC, and HB score was 2 (2-7), indicative of mild disease in one patient with CD. After induction, 5 patients (71%) achieved STMH, one maintain mild disease and one discontinued treatment before week 6 due to fistula resection. Infliximab serum levels at weeks 2, 6, and 14 were 21.1 (16.7- 23.9), 15.7 (11.3-25.7) and 2.8 (1.6-6.2) in the patients with SMTH, and in the patient without SMTH levels were 4.0, 0.5 and 0.7.
Conclusion
After analysis of preliminary results from clinical practice, infliximab concentrations during the induction therapy seems to be related with STMH in patients with IBD. However, more extensive studies are required to confirm these results.
References and/or Acknowledgements
Thanks to gastroenterology unit.
Conflict of Interest No conflict of interest
GOT18-0946. LONG-TERM EFFICACY AND SAFETY OF ADEFOVIR DIPIVOXIL AS MONOTHERAPY IN CHRONIC HEPATITIS B PATIENTS Background
Adefovir dipivoxil (ADV) was one of the first oral nucleoside/nucleotide analogues (NAs) approved for the treatment of chronic hepatitis B (CHB). Due to its association with high rates of drug resistance, other NAs agents (tenofovir or entecavir) have become the mainstay of CHB treatment. Nevertheless, the long-term efficacy and safety of ADV in patients who are still in treatment needs to be assessed.
Purpose
To described the long-term efficacy and safety of ADV as monotheray in CHB patients, to whom the therapy is dispensed by the hospital pharmacist of a regional hospital.
Material and methods
Observational retrospective study of all patients with CHB who received ADV between 2010-2017. Data was collected from the medical records and the electronic prescribing database, including: patients and disease characteristics, adherence to the treatment, number of visits realized to the hospital pharmacy in the last 7 years, efficacy (hepatitis B virus (HBV) DNA, HBeAg seroconversion and ALT normalization time), and safety. At treatment years 1, 4 and 7, efficacy was reassessed. In every visit to the pharmacy the hospital pharmacist interviewed patients, recorded any medication-related-event and promoted adherence.
Results
During the time considered, a total of 4 patients with HBeAg-negative CHB and a HBV DNA of >2.000 UI/ml [4.240 -1.560.000] were evaluated. All of them had been receiving ADV 10 mg orally once daily during more than 7 years [7-12]. Patients visited the pharmacy a mean of 6 visits per year and had an adherence superior to the 90%. At weeks 12, 12, 24 and 28 all patients had HBV DNA<200 UI/ml, achieved HBeAg seroconversion and normalized ALT levels. Efficacy was maintained with only one case of virological rebound after one year of treatment which normalized by the next analysis. No remarkable adverse drug reactions were recorded.
Conclusion
In these long-term patients, the efficacy of ADV has been maintained with a satisfactory level of safety. The fact that each patient visits the outpatient pharmacy about 6 times a year must be considered as an essential opportunity of detecting any medication-related-event and promoting adherence.
References and/or Acknowledgements
EASL 2017 Clinical Practice Guidelines on the management of HBV. Journal of Hepatology 2017.67:370–398.
Conflict of Interest No conflict of interest
GOT18-0970. INFLUENCE OF CONTINUITY OF CARE OF RIVASTIGMINE TREATMENT IN LENGHT OF HOSPITAL STAY Background
Transdermal patch formulation of rivastigmine is not included in local hospital formulary and delay of its administration may occur during hospital admission.
Purpose
The aim of this study was to analyze the impact of continuity of care, guided by pharmacist, of transdermal rivastigmine treatment in length of hospital stay in an orthogeriatric unit.
Material and methods
We conducted an observational, descriptive and ambispective study in an orthogeriatric unit with an average of 600 patients with hip fracture per year and with a pharmacist integrated in the multidisciplinary team promoting medication reconciliation. Data collection was performed from June 2015 to November 2016.
Patient groups were classified according to if rivastigmine was given in the first 48 hours of hospital admission (group A) or if was not fulfilled its administration or was later than 48h (group B).
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We extracted from our electronic database:
-Age and gender.
-Intertrochanteric fracture or other types (anatomical classification).
-Local stratification of comorbid patients.
-Hospital stay was considered long if it was greater than 10 days.
-Incidence of delirium, acute urine retention or paralytic ileus.
Statistical analysis was performed using Fisher exact test (SPSS v23) and difference was considered statistically significant if the p-value was ≤ 0.05 (two-tailed).
Results
Twenty-five patients were included (88% women) mean age 86 years-old [74-99]. Thirteen patients were classified in group A and 12 patients in group B. Pharmacist was not present in the unit in 83% of events when rivastigmine was not administrated on the first 48 hours.
Twelve patients suffered intertrochanteric fracture (7 group A and 5 group B). Attending local stratification, comorbid condition was maximal in 80% of patients (10 in each group).
Hospital stay was large in 15% of patients of group A and 67% of patients of group B, the difference was statistically significant (p = 0,015).
Incidence in delirium, acute urine retention or paralytic ileus were similar in both groups.
Conclusion
Pharmacist promoting continuity of care of transdermical rivastigmine treatment was associated with shorter hospital stay in an orthogeriatric unit.
References and/or Acknowledgements
How to minimise the risks of medication errors with rivastigmine patches. UKMiQ&A 382.1. Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Date prepared: March 2017
Conflict of Interest No conflict of interest
GOT18-0972. ANALYSIS OF THE USE AND EFFECTIVENESS OF TWO-DRUG ANTIRETROVIRAL REGIMEN IN HIV INFECTED PATIENTS Background
Antiretroviral therapy with three drugs is the initial recommended treatment for chronic HIV infection. Simplification of treatment to regimens with fewer drugs (two-drug biterapies) may be an option in case of resistance and an alternative to improve safety, toxicity or adherence profile, and preserve drug families for later use and decrease the cost of treatments.
Purpose
To analyze the change from a three-drug antiretroviral treatment regimen (HAART) to a two-drug regimen in HIV+ patients: reason of change and effectiveness.
Material and methods
Cross sectional retrospective study of HIV-infected patients in treatment with two antiretroviral active drugs from January 2015 to March 2017. The data was obtained from medical history and Farmatools® application of external patients treatment. Effectiveness was evaluated by the viral plasmatic load(VPL) and the CD4 cells count, measured at 48 weeks. Viral load suppression(VLS) was defined as less than 50 copies/ml.
Results
A total of 49 patients were studied, with the following two-drug regimens: 7 patients with Darunavir(DRV)/Cobicistat(COBI)/Dolutegravir(DTG); 9 patients with DRV/COBI/Rilpivirina; 11 patients with DRV/COBI/Lamivudina(3TC); 3 patients with DRV/COBI/Raltegravir(RAL); 10 patients with Atazanavir(ATV)/COBI/3TC and 1 patient of the following combinations: DRV/Ritonavir/ATV, RAL/Rilpivirina, RAL/3TC, DRV/COBI/Etravirina (ETR), RAL/Lopinavir/Ritonavir, RAL/ETR, ATV/COBI/ETR, RAL/ATV, DTG/3TC. The reasons for the change to two-drug regimen were the following: 18 patients were determined by drug resistence tests, 6 due to side effects of previous HAART and 25 for simplification of their antiretroviral treatment. Of the patients who changed for simplification, 24 remained undetectable at 48 weeks. Of all patients with resistance to previous treatment, 16 presented VLS at 48 weeks. All patients with intolerance to previous treatment presented VLS at 48 weeks. 46 patients showed VLS (94% <20 copies/mL, 5 patients had 20–50 copies/mL) at the end of the study, and therefore maintained effectiveness was demonstrated. The mean CD4+ were 510 cells/microliters (range 88–1602) at 48 weeks.
Conclusion
1.The main two-drugs regimens used were DRV/COBI/3TC and ATV/COBI/3TC. 2.The main reasons for the HAART exchange to two-drug regimen were drug resistence tests and simplification of the antiretroviral treatment. 3.The change to a treatment with two active antiretroviral drugs seems to be, at least, as effectively as the three-drug regimen HAART.
References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-0993. USAGE PROFILE AND ASSOCIATED COST OF BOTULINUM TOXIN Background
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Botulinum toxin (BT) is a neurotoxin produced by Clostridium Botulinum. There is a large number of patients who benefit from its treatment. Despite its effectiveness and safety, the development of antibodies, side effects, as well as their high cost associated may limit its use.
Purpose
To analyze the adequacy of the use of BT to a hospital protocol and its associated cost.
Material and methods
A retrospective observational study of the use of BT during a year (2016) has been done. A protocol was designed which was structured into 3 categories: A: Authorized indications in the country; B: Non authorized indications in the country but scientifically proven; C: Non authorized indications in the country and not scientifically proven. The suitability of its use and cost by medical services and categories were analyzed.
Results
257 patients treated with TB were analyzed. Total cost: € 58,623. 165 patients were assigned to category A , and 75 and 17 to categories B and C, respectively. Cost associated by categories: A: 65%; B: 27% and C: 8%. The Neurology Service provided 76% of patients; 75% of the total cost. 67% of category A patients [35% blepharospasm (BF) and facial hemiespasm; 50% refractory chronic migraine; 8% post-stroke spasticity (PSS); 6% cervical dystonia and 1% bladder dysfunction] and 26% and 7% category B (39% occipital neuralgia; 23% tremor; 18% sialorrhea; 20% spasticity in multiple sclerosis and task-specific dystonias) and C, respectively. 17% of the patients were treated by the Rehabilitation Service. 22% of the total cost. 38% of category A patients (65% PSS and 35% spasticity associated with equine foot); 53% category B (100% myofascial pain after breast cancer intervention); and 9% category C . 4% of the patients were treated by BF by the Ophthalmology Service and 3% by primary axillary hyperhidrosis by the Dermatology Service (2% and 1% of the total cost, respectively), both category A indications.
Conclusion
The analysis of the use of BT in our hospital shows that 93% of the prescriptions are adjusted according to hospital protocol. This level of compliance reveals the importance of the role of a hospital pharmacist in the follow-up of this high-cost drug.
References and/or Acknowledgements
Noone
Conflict of Interest No conflict of interest
GOT18-0994. POST-EXPOSURE PROPHYLAXIS IN ADOLESCENTS Background
In pediatrics, the risk of sexually transmitted infections (STIs) occurs mostly in adolescents, for sexual intercourse, whether or not consenting, with infected people. Post-Exposure Prophylaxis (PEP) has shown effectiveness as a secondary measure in SITs prevention.
Purpose
To develop an action protocol for PEP in the emergency department and to design a kit as a tool for treat adolescent’s patients (≥12 years old).
Material and methods
A meeting between the Emergency, Infectious and Pharmacy Service of a teaching hospital and a systematic review of the literature and consensus guidelines for the diagnosis and treatment of STIs in adolescents was held.
Subsequently, a retrospective study was conducted from Sept-2015 to May-2017, which included 36 adolescents who requested this PEP kit.
Results
A protocol was developed according to evidence-based medicine criteria to classify the patients in order to separate them by risk groups and to treat them accordingly.
The treatment combination was designed to cover the most common or severe STIs in our environment: gonorrhea, chlamydial infection, syphilis and HIV infection. The kit designed contained medication for the emergency department, taking advantage of the availability of robotic cabinets, with a sufficient number of drugs to cover 5 days of treatment until the patient was referred to the infectious disease specialist: metronidazole 2g.orally, azithromycin 1g.orally and ceftriaxone 250mg. IM (administered in the emergency department all as a single dose); in addition to triple antiretroviral regimen combining emtricitabine/tenofovir (200/245mg) (once-daily) plus raltegravir (400mg)(twice-daily).
All patients commenced treatment within 72 hours of a risk exposure and nobody developed an STI clinic. However, in the follow-up clinical interview 81% reported nausea on the first day of treatment and 17% of them reported vomiting.
Conclusion
After the results obtained, we can state that the purposed PEP treatment seems to be effective. After its implementation, changes are purposed in order to increase their tolerance, the antiretroviral therapy by an option that allows a single daily tablet, like to delay the start of non-antiretroviral drugs to reduce the number of tablets taken in the same day, and in order to simplify the posology, like switch the antiretroviral treatment to a once- daily dose scheme.
References and/or Acknowledgements
https://www.msssi.gob.es/ciudadanos/enfLesiones/enfTransmisibles/sida/publicaciones/profSanitarios/docConsensoDiagnosticoTtoITSAdultos.pdf
Conflict of Interest
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No conflict of interest
GOT18-1000. EXPERIENCE OF PAZOPANIB IN RENAL CELL CARCINOMA. Background
Pazopanib is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Purpose
To evaluate effectiveness and safety of pazopanib in patients with metastatic or unresectable locally advanced RCC in a tertiary hospital.
Material and methods
Descriptive, retrospective, observational study in patients treated with pazopanib from January 2013 until data compilation(September 2017).
Variables included were: age, sex, prior nephrectomy, Memorial Sloan-Kettering Cancer Center (MSKCC)criteria, previous and subsequent treatment, treatment line, dose reductions, duration of treatment, discontinuation.
In terms of effectiveness, progression-free survival(PFS) were analyzed. Response was evaluated by RECIST criteria(complete response (CR), partial response (PR), stable disease (SD), progressive diasease (PD), unevaluable). Regarding to safety, adverse drugs reactions (ADRs) were reviewed.
For data compilation, we used medical records and dispensing data.
Results
33 patients were evaluated. 75.7% were male and mean age was 66.1 (36-89) years. 97% had prior nephrectomy . MSKCC criteria were specified in 57.6% patients: 9.1% low, 36.4% intermediate, 12.1% high-risk.
According to treatment line: 69.7% were first-line, 6.1% second, 12.1% fourth and 12.1% fifht. Of the 10 patients in second-line or further, previous treatments were: sunitinib, 24.2% everolimus, 24.2% axitinib, 9.1% sorafenib.
Dose reductions were registered in 30,3% due ADRs. 42,4% needed temporary discontinuation.
In terms of response 12.1% achieved CR, 21.2% PR, 30.3% SD, 15.2% PD and 21.2% unevaluable. PFS was 7 months (1-28). 51.5% are still alive and 30.3% continued therapy with pazopanib.
The most frequent AR are: 48.5% diarrhea, 48.5% asthenia, 30.3% hypertension, 27.3% anorexia, 27.3% nausea/vomiting, 18.2% dyspepsia, 18.2% hypothyroidism, 15.2% mucositis, 15.2% hand-and-foot syndrome, 15.2% transaminase elevation, 12.1% disgeusia, 9.1% hair colour changes, 9.1% cutaneous rash, 9.1% paresthesias, 9.1% venous thromboembolic events and 30.4% others.
Subsequent treatments were: 12.1% axitinib, 12.1% cabozantinib, 9.1% everolimus and 3% sunitinib.
Conclusion
Pazopanib is a therapeutic option in RCC. Among our population it supposed a delay in progression. However, the small sample size didn't allow us to draw conclusions.
ADRs notified were consistent with the most frequent specified in the Summary of Product Characteristics. References and/or Acknowledgements
.
Conflict of Interest No conflict of interest
GOT18-1012. Developing a Paediatric Electronic Prescribing System Background
One of the many benefits of electronic prescribing in secondary care is the reduction in prescribing error rates. However, implementing electronic prescribing in paediatrics, presents many challenges such as weight-based dosing. An electronic prescribing system (EPS), was acquired from a local adult secondary care hospital and developed to include a specialist paediatric drug library with clinical decision support. A smaller training team was deployed with external trainers and a multi-disciplinary project team of IT and healthcare professionals oversaw implementation.
Purpose
To develop an EPS for a tertiary care paediatric hospital.
Material and methods
The pilot was launched, on the hepatology ward, consisting of 14 beds. All patients that were treated under the hepatology medical and surgical teams were placed on the EPS.
Results
The pilot was launched in April 2017 and it bought many benefits such as alerts triggered for a prescription in the presence of an allergy or a a drug interaction.
However, an anticipated reduction in medication errors was not seen in the first 3 month period following implementation. There were many common themes from the reported incidents including:
Access: Equipment & IT system issues reported in initial go live period were quickly resolved. However, challenges remained in the evenings which resulted in the dual running of paper prescription charts and drugs charts on the EPS.
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Paediatric prescribing: Prescribing fluids by volume instead of bags, became problematic to replicate on the EPS and many medicines required more detailed clinical decision support for prescribers and administrators alike.
Pharmacy specific issues: Processes that proved effortless on drug charts and discharge prescriptions, became complex for pharmacists and technicians, as the EPS lacked the necessary features including such as noting patient's own supply and pharmacy supply.
Conclusion
Valuable lessons were learnt during the pilot that will directly impact on roll-out across the trust, many areas could be improved upon to ensure substantial progress could be made, from the pilot.
References and/or Acknowledgements
Franklin G., O’Grady K., Donyai P., Jacklin A. and Barber N. (2007). The impact of a closed-loop electronic prescribing and administration system on prescribing errors, administration errors and staff time: a before-and-after study. Qual Saf Health Care. 16. 279–84.
Conflict of Interest No conflict of interest
GOT18-1014. NEW THERAPEUTIC APPROACHES IN LUNG CANCER Background
There has been a fast evolution in the treatment of non-small cell lung cancer (NSCLC) with the discovery of different molecular alterations (e.g. EGFR, ALK), together with the appearance of target therapies such as tyrosine kinase inhibitors (TKI) and immunotherapy.
Purpose
To analyse the use of TKI, nivolumab and pembrolizumab in NSCLC, duration of treatment and tolerability.
Material and methods
Retrospective study of patients treated with TKI and nivolumab and pembrolizumab, from 2014 to 2017, with analysis of the variables age, gender, tumour classification, lines and duration of treatment and tolerability.
Results
Fifty-two patients (36 men), mean age 67 years (36-89), with adenocarcinoma (n=44), squamous cell carcinoma (n=4), mostly in stage IV, were included. They were treated with erlotinib (n=42), gefitinib (n=2), afatinib (n=1), osimertinib (n=1), crizotinib (n=5), ceritinib (n=1), alectinib (n=1), nivolumab (n=6) and pembrolizumab (n=1).
Patients with positive EGFR mutations were mainly treated with erlotinib, two with gefitinib and one with afatinib (under treatment). Erlotinib was mostly used in second line. The mean duration of treatment was 89 days (14-881). All patients reported adverse effects, mostly cutaneous, one with grade 4. The average duration of treatment with gefitinib was 357.5 days (64-651), with cutaneous toxicity in one patient. Osimertinib was used in third line, in positive T790M mutation, maintained for 320 days.
In patients with positive ALK translocation, crizotinib was used, mostly in second line. The mean duration of treatment was 100.8 days (22-335). One patient was switched to ceritinib by progression, in another to alectinib by pharmacological interaction. The duration of treatment with ceritinib was 409 days. Alectinib was discontinued due to muscle pain.
Nivolumab was used in two adenocarcinomas and four squamous. The mean duration of treatment was 115.8 days (61-145). There were adverse effects in all patients, namely colitis and immune pneumonitis. Pembrolizumab was used in 4th line, in adenocarcinoma with PD-L1 80%, maintaining treatment.
Conclusion
The most used drug was erlotinib, which is consistent with the fact that it was the first drug to be marketed. Nivolumab was the drug with the most limiting adverse effects. The new therapeutic options allow a personalized therapeutic approach in NSCLC.
References and/or Acknowledgements
Acknowledgements to pharmacy and pneumology staff.
Conflict of Interest No conflict of interest
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