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BAR19­0020 HOW TO IMPROVE THE COMMUNICATION SKILLS OF PHARMACISTS IN HOSPITAL PRACTICE

V. ČELJO1 1hospital pharmacist, Clinical pharmacy­ University Clinical Centar ­Specialist Control drugs position, 71000 Sarajevo, Bosnia ­ Herzegovina

Background

The development of the practice of the Clinic Pharmacy from the orientation towards the drug is in the process of being directed towards the patient.

Purpose

The aim of this paper is to emphasis the role of a clinical pharmacist in a healthcare team in hospital practise and to explore the effective communication skills that could be used by a clinical pharmacist in hospital practice.

Material and methods

Research was based on an anonymous questionnaire in order to find possibilities for improving communication between pharmacists and doctors.Each questionnaire consisted of 9 topics. Most of answers in the questionnaire are rated by Likert's scale of 5 points, ranging from having communication to not having communication at all.

Results

Out of sixteen (16) hospital pharmacists who were invited to fill in the questionnaire, twelve (12) pharmacists have complted the survey with a response rate of 75%.

The data reviled that the low frequency of performing pharmacological function of a pharmacist is observed. The highest percentage of examinees 45% who communicate with doctors are in the areas where regular re­examination is required (46%) of the examinees communicate with the physician in cases when prescription is made for the wrong patient.

Discussion: According to the questionnaire, the highest percentage of pharmacists who communicate with doctors are in the subject of­2­dose and mode of use (45%) and topic 7­ logistics (46%). In topics 6­ Drug use and topics 8­ Omissioned medicine items occur where there is no communication between the physician and the pharmacists.

In order to improve the relationship between the doctors and the pharmacist, the pharmacists were asked to write a wish list.

Conclusion

Taking into account the individual roles of doctors and pharmacists in the system of health care, effective communication, trust and mutual respect are of utmost importance.

References and/or Acknowledgements

Lee E. Braund R. Tondoff J. Examining the first year of Medicines Use Review services provided by pharmacists in New Zealand.NZ Med J.2009. 122(1306):143 Sandeep N. Jasdeep G. Sukhjinder N. Ef fective collaboration between doctors and pharmacists.Articles May 2008.15

Conflict of Interest No conflict of interest

BAR19­0039 EFFECTIVENESS AND SAFETY OF CRIZOTINIB IN PATIENTS WITH ALK­POSITIVE NON­SMALL­CELL LUNG CANCER

J.C. DEL RÍO VALENCIA1, R. TAMAYO BERMEJO1, B. MORA RODRIGUEZ1, I. MUÑOZ CASTILLO1 1HOSPITAL REGIONAL UNIVERSITARIO MALAGA, PHARMACY SERVICE, MALAGA, SPAIN

Background

Rearrangements of the anaplastic lymphoma kinase (ALK) gene are present in 3 to 5% of non–small­cell lung cancers (NSCLCs).They define a distinct subgroup of NSCLC that typically occurs in younger patients who have never smoked or have a history of light smoking and that has adenocarcinoma histologic characteristics. Crizotinib is an oral small­molecule tyrosine kinase inhibitor of ALK.

Purpose

To analyze the survival impact of crizotinib on patients with ALK­positive NSCLCs and to study the safety of the drug.

Material and methods

This was an observational retrospective study carried out between July 2015­July 2018. All patients with NSCLC undergoing treatment with crizotinib were included. Patient data were taken from clinical records. Variables analyzed; demographic variables: age and sex; clinical variables: diagnosis, stage, line of treatment, dose administered, functional status (PS) according to the scale (ECOG). Others variables: smokers. Efficacy endpoints was progression­free survival (PFS) assessed by RECIST 1.1 criteria. Adverse reactions and comorbidities were assessed too. Analysis of the SLP using the Kaplan Meier curve (SPSS version 17).

Results

: 9 patients were included with rearrangements of the ALK gene. 66.66% were men, average age was 68.88±8.07 years. 66.66% had an ECOG­PS 0–1 and 66.66% were current or past smokers. NSCLC stage was III/IV in 100% of patients. About comorbidities, 44.44% suffered from high blood pressure, 33.33% diabetes, 22.22% coronary heart disease and 22.22% chronic obstructive pulmonary disease.

Patients started therapy with crizotinib in first­line 33.33% and 66.66% in second­line. Every patient started with 250 mg/12h, but the doses of four patients was reduced to 250 mg daily due to toxicity. Median PFS was 4 months, (95% confidence interval [CI] 1.1–6.9).

Adverse­reactions: digestive toxicity: 33.33% of the patients developed grade 2(G2) vomit, 33.33% had G1 asthenia, nausea and vomit. Other toxicities: G1 visual disturbances 1.11%.

Conclusion

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 1/60 05/11/2018 Rejected - S4.html In our cohort of patients with NSCLC and rearrangements of the ALK gene, crizotinib had an efficacy lower than the expected compared to other studies (7.7­10.9 months of PFS). Perhaps, it is because six started crizotinib in second­line. Further analysis with real world patients are necessary to know accurately PFS. Regarding adverse­effects, the most frequent was digestive toxicity.

References and/or Acknowledgements

No conflict of interest

Conflict of Interest No conflict of interest

BAR19­0040 ANALYSIS OF UTILIZATION AND RESPONSE OF IN MULTIPLE MYELOMA

M. SÁEZ­GARRIDO1, A. RUIZ­GÓMEZ1, A. TOMÁS­LUIZ1, P. FERNANDEZ­GARCÍA1, M. ALMANCHEL­RIVADENEYRA1, L. MENENDEZ­ NARANJO1, M.S. DÍAZ­CARRASCO1, A. ESPUNY­MIRÓ1 1HOSPITAL CLÍNICO UNIVERSITARIO VIRGEN DE LA ARRIXACA, PHARMACY , MURCIA, SPAIN

Background

Multiple myeloma (MM) is a neoplastic disease characterized by a clonal proliferation of plasma cells derived from B cells of the bone marrow. Pomalidomide in combination with dexamethasoneis used in the treatment of adult patients with this patology. It inhibits proliferation and induces apoptosis of tumor hematopoietic cells.

Purpose

To analyze the characteristics of use and response of pomalidomide in MM.

Material and methods

Retrospective observational study of all patients treated with pomalidomide in our hospital since its availability (December 2017) until 31th March of 2018. Variables collected: age, sex, type of MM, stage, treatment scheme, number of cycles received, line number of treatment with pomalidomide, response, previous treatments, progression­free survival (PFS) and overall survival (OS).

Results

During the study period, 8 patients, 5 women and 3 men were treated with pomalidomide, with a median age of 77 years (72­85).Five of them were diagnosed with MM type IgG Kappa, two with IgA Kappa and one with Bence­Jones Kappa. Seven were in stage IIIA and one in IV. Two patients started pomalidomide in 3rd line of treatment, one started in 4th, two in 5th, two in 6th and one in 7th. All started treatment according to the POMDEX scheme (Pomalidomide 4 mg/day x 21 days + Dexamethasone 40 mg/weekly, 28 day cycle) with an average of 3.25 cycles.Currently, four patients are still active (one with stable disease, two with partial response and another not evaluable). One patient remained stable with an overall survival of 5 months until refractoriness, and finally, death. One patient presented a partial response but the follow­up was lost. Two patients were death before being able to assess the response.The median PFS was 4.63 months (0.40­8.86). The median of OS was not reached.

Conclusion

The treatment with pomalidomide in our hospital is prescribed in advanced or metastatic stages of MM from the 3rd line of treatment. The SLP obtained in this study is lower than that achieved in the pivotal study, but we must take into account the shorter follow­up time, the smaller sample size and the higher median age of our patients.

References and/or Acknowledgements

I would like to express my special thanks to Laura Menendez.

Conflict of Interest No conflict of interest

BAR19­0062 ASSESMENT OF NINTEDANIB EFFICACY AND SAFETY PROFILE IN A GENERAL HOSPITAL

B. GRACIA1, A. MURGADELLA SANCHO2, A. MORALES TRIADO3, N. SAN JUAN MARTÍNEZ3 1HOSPITAL MOISES BROGGI, PHARMACY, SANT JOAN DESPI, SPAIN 2HOSPITAL MOISES BROGGI, PHARMACY, SANT JOAN DESPÍ, SPAIN 3HOSPITAL MOISÈS BROGGI, PHARMACY, SANT JOAN DESPÍ, SPAIN

Background

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with poor prognosis. The kinase inhibitor nintedanib significantly reduced the rate of decline of forced vital capacity (FVC)

Purpose

To assess the efficacy and safety of Nintedanib in IPF

Material and methods

Retrospective and observational study in patients who started nintedanib between March 2016 and December 2017. We recorded demographic variables (age, sex), start date of treatment, FVC and diffusion capacity of the lung for carbon monoxide (DLCO) at baseline, after 6 and 12 months, side effects, stop or dose reduction, hospitalizations, illness exacerbations and exitus.

Lack of efficacy was considered when FVC decreased ≥ 10 % or DLCO decreased ≥ 15%, based in pivotal trials.Results

We identified 20 patients. 7 were excluded, due to: early switch of treatment (n=3), wrong diagnosis (n=1) or exitus (n=3).

Finally 13 patients were included, all men with a mean age of 79.1 years (74­85).

At baseline FVC of the patients was between 50% and 101%, and DLCO between 23% and 66%.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 2/60 05/11/2018 Rejected - S4.html After 6 months of treatment (data from 10 patients), no patient had a reduction of FVC >10%. Regarding DLCO (data from 9 patients), 2 (22.2%) had a reduction of DLCO >15%.

After 12 months (data from 8 patients), 1 (12.5%) presented a reduction of FVC >10%, and 2 (25%)a reduction of DLCO >15%.

Twelve patients (92.3%) reported side effects. Gastrointestinal toxicity (nauseas, vomiting, diarrhea) was the most commonly reported (n=12, 92.3%), followed by weight loss (n=5, 38.5%) and hepatotoxicity (n=2, 15.4%).

7 patients (53.8%) required dose reduction, 1 (7.7%) hospitalized for a respiratory cause, and 2 (15.4%) were exitus.

Conclusion

Nintedanib has demonstrated to slow disease progression, decreasing the worsening of FVC in IPF patients. In our study, 12.5% patients obtained a reduction of FVC ≥ 10% after 12 months of treatment; so nindetanib was effective in the 87.5%.

Related to safety, we observed that 92% of patients suffered adverse events. Gastrointestinal toxicity was the most frequent, followed by weight loss and hepatotoxicity, same like the evidence published. In more than half of the patients it was necessary to reduce drug dose due to side effects.

References and/or Acknowledgements

https://www.thelancet.com/journals/lanres/article/PIIS2213­2600(18)30339­4/fulltext https://www.dovepress.com/nintedanib­evidence­for­its­therapeutic­potential­in­idiopathic­pulmon­peer­reviewed­article­CE

Conflict of Interest No conflict of interest

BAR19­0072 TOLVAPTAN IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A CASE REPORT

M. SUAREZ GONZALEZ1, E. RAMOS SANTANA1, P. DIAZ RUIZ1, C. ROMERO DELGADO2, R. MESA EXPOSITO1, M.A. NAVARRO DAVILA1, J. MERINO ALONSO1 1HOSPITAL NUESTRA SEÑORA DE CANDELARIA, FARMACIA, SANTA CRUZ DE TENERIFE, SPAIN 2HOSPITAL UNIVERSITARIO DE CANARIAS, FARMACIA, SANTA CRUZ DE TENERIFE, SPAIN

Background

Tolvaptan is a vasopressin­2­receptor antagonist. It blocks receptors in the kidneys for the hormone vasopressin.

Tolvaptan is a drug used to treat adults with autosomal dominant polycystic kidney disease (ADPKD).

ADPKD is generally a late­onset multisystem disorder characterized by bilateral renal cysts, liver cysts and an increased risk of intracranial aneurysms.

Purpose

Evaluate safety, efficacy and tolerability of Tolvaptan in a patient diagnosed with ADPKD.

Material and methods

Observational, prospective and descriptive study of a patient with ADPKD in a tertiary hospital.

The information was obtained from the Electronic Clinical History (SELENE®) and the Pharmacy Service Managing Software (FARMATOOLS®).

Results

50 years old male with ADPKD diagnosed at the age of 30 years. The patient has renal cysts of 16 cm, hypertension since 2002, creatinine 1,78 mg/dL and normal liver enzymes.

In april 2018, he started with Tolvaptan. It starts with a dose­escalation, starting with 45/15 mg in the first month. Then, the second month, the dosage increased 60­30 mg and the third month 90­30 mg at the moment.

Tolvaptan has been associated with elevations liver enzymes, so it is necessary to measure them for as long as the patient is on tolvaptan treatment.

Tolvaptan therapy increases free water clearance which can lead to dehydration, hypovolemia and hypernatremia. So, the patient has to drink water when thirsty and during the day and night if awake. Due to monitor for weight loss, hypotension and tachycardia because they may signal dehydration.

After 4 months with tolvaptan therapy, creatinine increased 2,2 mg/dL, normal liver enzymes in the blood, a little weight loss and an increase in polyuria and nocturia of 2­3 times at night with fatigue due to them. Furthermore, the size and number of the renal cysts remained constant.

Conclusion

FDA, EMA and AEMPS have approved the use of Tolvaptan as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing ADPKD.

Tolvaptan has being acceptably safe, effective and well tolerate by the patient at the moment. However, high cost treatments require correct identification in patients, so each case should be studied by a multidisciplinar team (Nephrology and Pharmacy).

References and/or Acknowledgements

Data sheet Tolvaptan, SELENE®, FARMATOOLS®

Conflict of Interest No conflict of interest

BAR19­0076 EFFECTIVENESS OF ON CROHN´S DISEASE PATIENTS

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 3/60 05/11/2018 Rejected - S4.html M. SUAREZ GONZALEZ1, P. DIAZ RUIZ1, R. MESA EXPOSITO1, E. SANTANA RAMOS1, M.M. VIÑA ROMERO1, S. HERNANDEZ ROJAS1, A. HERNANDEZ CAMBA2, J. MERINO ALONSO1 1HOSPITAL NUESTRA SEÑORA DE CANDELARIA, F ARMACIA, SANTA CRUZ DE TENERIFE, SPAIN 2HOSPITAL NUESTRA SEÑORA DE CANDELARIA, DIGESTIVO, SANTA CRUZ DE TENERIFE, SPAIN

Background

Ustekinumab is a human monoclonal attaches to two cytokines called interleukin­12 and ­23. It is a novel Crohn´s disease (CD) treatment option for patients who have failed conventional biologics with anti­Tumour Necrosis Factor (anti­TNF) (, and certolizumab) and anti­ agents ().

CD is a chronic inflammatory condition of the gastrointestinal tract with the potential to progress to a severe debilitating state.

Purpose

Evaluate the effectiveness of Ustekinumab on CD patients treated with this drug in a tertiary hospital during 2018.

Material and methods

Observational, retrospective and descriptive study of patients for CD with Ustekinumab during 2018 in a tertiary hospital.

Clinical variables collected were: previous biological treatment, fecal claprotectin (FC) pretreatment and induction Ustekinumab (week 8), C­reactive protein (CRP) pretreatment and induction Ustekinumab (week 8) and clinical response.

The information were obtained from the Electronic Clinical History (SELENE®) and the Pharmacy Service Managing Software (FARMATOOLS®).

Results

10 patients (50% men; median age 41 years) were included in the study.

9 patients were treated with Ustekinumab who had failed biologics with anti­TNF: 3 patients had inadequate response to Adalimumab, 3 patients to Infliximab and 3 patients to Infliximab/ Adalimumab.1 patient was treated with Ustekinumab who had failed biologic anti­integrin agent, Vedolizumab.

We obtained an average FC pretreatment 255,1±146,2 µg/g fecal and after induction Ustekinumab 146,2±126,8 µg/g fecal. On the other hand, we obtained an average CRP pretreatment 4,9±5,3 mg/dL and after induction Ustekinumab 1,2±1 mg/dL.

After 6 months with this therapy, the results were a decrease in FC values (41±34 %) and CRP values (52±32 %) and improvement of the general condition of the patients.

There was no adverse effect related to ustekinumab.

The side effects of the Ustekinumab were considered tolerable and manageable.

Conclusion

FDA, EMA and AEMPS have approved the use of Ustekinumab to treat the moderately to severely active CD in adults whose condition has not responded well enough to other treatments for CD or who cannot receive such treatments.

Ustekinumab improve clinical response in patients with active CD.

Studies with more patients are necessary to evaluate the efficacy and safety of Ustekinumab on CD patients.

References and/or Acknowledgements

Data sheet Ustekinumab, SELENE®, FARMATOOLS®

Conflict of Interest No conflict of interest

BAR19­0081 CLINICAL MANAGEMENT NEAR DEATH IN PATIENTS WITH SOLID TUMORS.

E. GARCÍA MARTÍN1, V. ESCUDERO VILAPLANA1, R. COLLADO BORRELL1, E. GONZÁLEZ­HABA PEÑA1, B. MARZAL ALFARO1, B. FOX2, Á. HOYO MUÑOZ1, P.A. MARTÍNEZ ORTEGA1, A. MELGAREJO ORTUÑO1, A. HERRANZ ALONSO1, M. SANJURJO SÁEZ1 1GENERAL UNIVERSITY HOSPITAL GREGORIO MARAÑON, PHARMACY DEPARTMENT, MADRID, SPAIN 2GENERAL UNIVERSITY HOSPITAL GREGORIO MARAÑON, ONCOLOGY DEPARTMENT, MADRID, SPAIN

Background

The higher incidence of the disease and new researches leads an increasing demand in health care services. Lung cancer is the most common cause of cancer death, followed by colo­rectal, pancreatic and breast cancer.

Purpose

To describe clinical management in oncology patients at the end of life. Our second objective is to assess differences according to type of tumor.

Material and methods

An observational, longitudinal and retrospective study was performed at a university hospital. We included adult patients in treatment with antineoplastic therapy during 2015­2016 and who died from inclusion to 31­July 2017.

We reviewed clinical records (HCIS®) and pharmacotherapeutic profile(Prescriplant®) of the patients. Data were recorded on REDCap®.

Statistical analysis: Univariate analyses were carried out using t tests for continuous variables and 2 analyses for categorical variables. Data were analyzed using STATA® v14.2.

Results

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 4/60 05/11/2018 Rejected - S4.html 315 patients were included (mean age:65.9 years (SD:12.6)). Lung cancer(21.0%), colo­rectal(15.9%) and breast(10.5%) were most frequent type of cancers.

87.6% of patients died at hospital in different healthcare services(50.0% Palliative Care, 34.8% Oncology, 4.7% Internal Medicine, 2.2% Radiation Oncology, 0.4% Intensive Care Unit and 8.0% others). Only the 28.0% of patients with colo­rectal cancer died in an acute unit (p=0.014) in comparison with breast(63.6%), head neck(46.4%) or lung(45.5%) tumors. There were no differences among tumors in patients who died in palliative care services.

71.9% of patients visited emergency services at least one time. The mean of visits to emergency services last month of life were higher for tumors such as: ovarian(2.2), soft tissue sarcoma (1.8), bladder (1.5),esophagus and pancreas (1.4) or head and neck, breast, skin­melanoma and lung(1.3). No differences according to the type of tumor were found.

The mean duration of follow up in hospice care was 51.1 days (range 0­2,156). There were differences(p=0.032) between colo­rectal (80.0% of patients contacted this service), head and neck (67.8%),pancreas (65.6%), breast and lung(64.6%) and stomach(47.8%) tumors.

Conclusion

Patients with cancer mostly died at hospital, frequently in Palliative Care unit, not in an acute service. Near death, patients often visited emergency services more than one time. An early hospice care follows up was frequent in colo­rectal,head and neck, pancreas, breast and lung or stomach tumors.

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­0106 Audit of antibiotic prescribing practices in the intensive care unit

F. BERDI1, N. NCHINECH1, Y. TADLAOUI1, J. IFEZOUANE1, A. BENNANA2, J. LAMSAOURI1 1MOHAMMED V MILITARY TEACHING HOSPITAL, PHARMACY POLE, RABAT, MOROCCO 2FACULTY OF MEDICINE AND PHARMACY RABAT, DEPARTMENT OF THERAPEUTIC CHEMISTR Y, RABAT, MOROCCO

Background

One of the critical acts at the hospital is the antibiotic therapy, this is due to the risk of misuse of antibiotics and it’s impact on the development of bacterial resistance and the inefficiency of antibiotics. The identification and the prevention of medication errors, especially those related to antibiotics are part of the continuous improvement of quality and safety of care

Purpose

The aim of our study is to assess the compliance of antibiotic prescriptions in order to detect possible prescription errors

Material and methods

This is a retrospective study conducted over a period of 5 months, from January to May 2018. All the antibiotic prescriptions of the two medical and surgical intensive care units were analyzed on the basis of an evaluation grid inspired by the literature

Results

235 prescriptions were analyzed, including 95 where the diagnosis was not completed and therefore no possible pharmaceutical validation. 40 prescriptions had no specified dosage. 12 prescriptions did not specify the route of administration. In 8 others, we had to change the protocol, because of the unavailability of some antibiotics. For all prescriptions, the results of the antibiogram were transmitted after 72 hours. All prescriptions have been broad­spectrum. This can be explained by the particular profile of patients admitted to the intensive care unit. According to the antibiotic therapy guide, all the antibiotic prescriptions were in accordance with the recommendations

Conclusion

The pharmacy must be involved in setting up reviews of errors related to drugs including antibiotics. The monitoring of sentinel events is an interesting way of detecting drug errors

References and/or Acknowledgements

no one

Conflict of Interest No conflict of interest

BAR19­0110 IMPLEMENTATION OF A MAJOR INTERACTION ALERTS SYSTEM IN THE PROCESSING SYSTEM

P. SIMÕES DE MOURA1, A. AZEVEDO2, R. CARVALHO2, A. ARAÚJO2, R. LIMA2, N. VARELA2, A. AGRE2 1GRUPO TROFA SAÚDE, FARMACY, TROFA, PORTUGAL 2TROFA SAUDE HOSPITAL, PHARMACY, PORTO, PORTUGAL

Background

Drug / drug interactions may alter the course of treatment of the patient, contributing to an increased risk of adverse effects or to a decrease in the therapeutic effect of a given drug. [1] Since the occurrence of interactions can occur both at the pharmacodynamic level and at the pharmacokinetics of the drugs; it is imperative to prevent the problems that may arise from drug interactions, especially those with high clinical significance, major interactions. [1,2]

Purpose

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 5/60 05/11/2018 Rejected - S4.html Raise awareness of the importance of detection / prevention of major interactions; Increase patient safety in an inpatient setting; Prevention of complications during and after hospitalization.

Material and methods

Bibliographic research of major interactions.

Results

Creation of an alert system in the system CPC (Portuguese Computer Company) Glint for Prescribing and Pharmacist; Development of a table / summary to be placed in the hospitalizations, that allows to easily identify major interactions, resulting from the concomitant use of therapeutic groups / drugs.

Conclusion

The incidence of potential pharmacological interactions in hospitalized patients is an ongoing risk. The creation of an early warning system is an effective way to identify and prevent undesirable interactions in clinical practice, thereby increasing the efficiency and safety of health care delivery.

References and/or Acknowledgements

[1] CASCORBI, Ingolf ­ Drug Interactions—Principles, Examples and Clinical Consequences. Deutsches Arzteblatt International. . ISSN 18660452. 109:33–34 (2012) 546–556.

[2] Drugs.com | Prescription Drug Information, Interactions & Side Effects ­ [Consult. 17 mai. 2018]. Disponível em WWW: .

Conflict of Interest No conflict of interest

BAR19­0114 Study and impact of biosimilars in a day hospital service.

C. TOULLIC1, M. NAVEAU2, C. GRANSARD2, C. LAFFONT2 1CENTRE HOSPITALIER BETHUNE, PHARMACY, BETHUNE BEUVR Y, FRANCE 2CENTRE HOSPITALIER BÉTHUNE, PHARMACY, BETHUNE BEUVRY, FRANCE

Background

Since 2015, bio similar has been on the drug market. Currently in our public hospital we use originator anti­TNF (Remicade®) and one type of biosimilar (Inflectra®).

Purpose

The state of play of the switch of all patients to biosimilars.

Material and methods

A one month study in a day hospital for patients currently treated with biosimilars but who have already been treated with Remicade. Verification of previous drug treatments and completion of a patient questionnaire in a care unit was done. A questionnaire for doctors and nursing staff was also carried out.

Results

41% of men and 59% of women answered the questionnaire. The most common pathologies found were ankylosing spondylitis (37%) and Crohn's disease (40%). Patients say they are at the point about their disease and their treatment to 85% but 40% admit to not knowing the term bio similar. 60% of patients were informed of the change to Inflectra® and 63% are satisfied with their treatment in terms of quality of life. However, 5 patients with rheumatological pathology received Remicade® again due to adverse reactions reported in pharmacovigilance. Prescribers believe that Inflectra® is as effective as Remicade® and that the tolerance profile is the same. Only a quarter of physicians informed patients of Inflectra® substitution. The caregivers questioned do not report any difference in the handling of Remicade® or Inflectra® vials, but have mixed feelings about the tolerance profile and effectiveness of a biosimilar. More frequent complaints are noted, including 50% asthenia but no additional adverse effects during the passage of the perfusions were found.

Conclusion

Some patients would have liked to be informed of the change to a biosimilar but the information for more than 40% of these patients makes it possible to discard any "psychological effects" related to the apprehension of the biosimilar assimilated to generic. On a financial level, the savings generated are consistent for the hospital with equal security and efficiency. Now, most patients will take biosimilar except those who will still receive Remicade®. These latter patients take both paracetamol for pain and anti­TNF alpha. However, no study was found when concurrent intake of these two molecules are taken.

References and/or Acknowledgements

https://ejhp.bmj.com/content/24/5/308

Conflict of Interest No conflict of interest

BAR19­0121 AN EVALUATION OF PATIENT SATISFACTION WITH PHARMACIST­LED ADHERENCE CLINICS FOR HEART FAILURE

G. CAMPBELL1, M. FAIRFAX1, C. THOMSON1 1GUY'S AND ST THOMAS' NHS FOUNDATION TRUST , PHARMACY, LONDON, UNITED KINGDOM

Background

There is wide variability in rates of adherence to medications for heart failure (HF) patients, and it is clear that non­adherence increases the risk of mortality and hospitalisations. Heart failure pharmacists, working within an integrated team, have introduced community­based clinics to work with patients to implement interventions to improve adherence. file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 6/60 05/11/2018 Rejected - S4.html Purpose

To evaluate patient satisfaction with pharmacist­led medication adherence clinics

Material and methods

A satisfaction questionnaire was created. A standardised letter was then sent to all patients that attended an adherence clinic between January and June 2018, and those who consented were contacted by telephone. The questionnaire responses were recorded for each individual patient along with any other comments or feedback on the service.

Results

10 patients consented to be contacted and completed the questionnaire. 8 patients (80%) were male and the mean age was 76.3 years. Common co­morbidities included hypertension (80%), ischaemic heart disease (40%), atrial fibrillation (40%) and diabetes (50%). 3 patients had had at least one hospital admission for HF in the last 6 months.

Examples of interventions made are shown in Table 1.

Table 1

Logistical No. of patients (n=10) Medicines removed 1 Medicines rationalisation 1 Dosette started 3 Behavioural Associating medicines with activity 1 HF education provided 4 HF medicines education provided 6 Other medicines education provided 2 Cognitive Referral to GP for memory review 1 Social Social services referral 1 Condition­related Oedema worsening 1 Treatment­related Review to stop medicines no longer indicated 1 Side effects identified 3

All patients (100%) were fairly satisfied or very satisfied with the service provided and said they were directly involved in decisions about their treatment. Clinic location being inconvenient was the main reason for dissatisfaction and 1 patient reported inadequate time available for the appointment.

9 patients (90%) were likely to recommend the service to family or friends.

Conclusion

Non­adherence to medication can be complex and multi­factorial. A specialist clinic is one way to engage patients in their care and provide tailored interventions to help improve adherence.

Further work needs to be undertaken to review whether improved adherence rates affect clinical outcomes for heart failure patients.

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­0213 DESIGN OF A TOOL TO OPTIMIZER THE BIOLOGICAL TREATMENT IN RHEUMATOLOGY

M. MAÑES SEVILLA1, L. CORRALES PEREZ1, E. MAROTO GARCIA1, B. BERTRAN DE LIS BARTOLOME1, C. MORIEL SANCHEZ1 1HOSPITAL UNIVERSITARIO MOSTOLES, PHARMACY DEPARTMENT, MADRID, SPAIN

Background

The optimization of biological therapies (BT) is to obtain, for each patient, therapeutic benefits with the least possible dose, improving the adherence, reducing adverse effects and helping to decrease costs for national health services.

Purpose

To design a specific tool to identify, in the electronic medical record (EMR), the rheumatology patients with BT or optimized biological therapies (OBT).

Material and methods

A multidisciplinary team formed by professionals of the Services of Pharmacy, Rheumatology and Informatics were created. First, the optimization strategies were defined based on dose reduction or spacing the interval dosing. The ideal candidate for the optimization therapy needed to have therapeutic objective for at least 6 months before the reduction with biological drug (, infliximab, adalimumab, certolizumab, , , , , , ). Two marks were designed to incorporate in the EMR:

­“B” for patients with BT.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 7/60 05/11/2018 Rejected - S4.html ­“BO” for patients with OBT.

Using the program Farmatools® electronic prescribing, Pharmacy Service identified patients with BT or OBT and incorporated the marks in the EMR.Results

The mark "B" was included in the EMR of 236 patients treated with: 22.7% etanercept; 19.2% adalimumab; 14% golimumab; 12.7% certolizumab; 8.7% secukinumab; 8.3% infliximab; 5.7% abatacept; 4.4% tocilizumab; 2.6% baricitinib; 1.7% tofacitinib. The mark "BO" was included in the HCE of 63 patients: 20.6% etanercept; 54% adalimumab; 2.6% golimumab; 1.6% certolizumab; 22.2% infliximab. In 87.3% optimization was done by spacing the interval dosing and by 14.5% the dose was reduced. All patients with OBT have therapeutic objective for at least 6 months. Limitation: Due to the recent implantation, we do not know the impact of this tool in the optimization of treatments.

Conclusion

This tool allows to know at present that patients are in treatment with biological drugs susceptible to be optimized. It also allows to obtain which are the patients with OBT to monitoring them. This model can be extrapolated to any other health institution.

References and/or Acknowledgements

NO

Conflict of Interest No conflict of interest

BAR19­0127 PHARMACEUTICAL CONSULTATION IN OUTPATIENTS UNDER HAART AS PREDICTIVE FACTOR IN ADHERENCE TO TREATMENT

I. RATÃO1, V. BARRADAS1, F. DIMAS1 1CENTRO HOSPITALAR BARREIRO MONTIJO, PHARMACY , BARREIRO, PORTUGAL

Background

Factors such as adherence, pharmacological effectiveness and tolerance contribute to response to initial HAART. The risk of virological failure associated with antiretroviral resistance increases adherence decreases.

Purpose

Evaluation role of Hospital Pharmacist (HP) in optimization and therapeutic management of outpatients (pts) under HAART.

Material and methods

Retrospective observational analysis of patients followed at Pharmaceutical Consultation for Therapeutic Adherence (PCTA) from October 2017 to September 2018, evaluating % of adherence by indirect method of counting remaining medication.

Analyzed data: Gender, age, initial HAART, initial viral load (VL), Abacavir sensitivity test (HLA), concomitant drugs, interactions (DI), adverse effects (AE), HAART change, VL at 1, 3 and 6th month PCTA.

Results

210 PCTA were performed at 43 pts referenced by physician for the need to integrate into the PCTA.

76.7% (43pts) were tested for HLA. Only 16 of them changed to HAART containing ABV / 3TC.

41.86% have concomitant drugs. One patient with potential DI. 16 of them reported AE related to HAART. Those who reported AE, 35.3% were eligible for pharmaceutical intervention.

VL at 1 month 18.6% have no evaluation. At the 1st month, was undetectable VL (undVL) at 42.8%. 32 pts that could be reevaluated at the 3rd month, 75% evaluated the VL: 15 pts have undVL (10 pts maintained the undVL and 5 reached). 21 pts that could be assessed on the VL at 6 months, 61.9% evaluated VL: 9 pts have undVL (6 pts maintained undVL, 3 reached) and 1 was no longer undetectable. At the period of the study, 85.7% pts presented undVL.

35 pts are eligible for adherence evaluation: 37.1% reached 100%; 45.7% between 85% and 99%; 11.4% between 50 and 84%, and 5.7% below 49%.

Conclusion

Majority of pts in PCTA have a good adherence to therapy (82.8%), being reflected in undVL.

Follow­up of pts in PCTA allows us to know the adherence of patients in order to determine the causes of non­adherence and thus to design, in a multidisciplinary team, strategies to increase adherence to treatment and improve the results of HAART, thus validating the fundamental role of HP.

References and/or Acknowledgements

Antón Torres, R. et al­ Adhesión al tratamiento antirretrovírico en pacientes VIH+. Farm Hosp 2000 ; 24(6):377­382

Conflict of Interest No conflict of interest

BAR19­0155 FOR THE TREATMENT OF THE IDIOPATHIC PULMONARY FIBROSIS: AN ITALIAN HOSPITAL EXPERIENCE

F. FERRANTE1, G. POLITO1, L. RICCI1 1OSPEDALE "F. SPAZIANI", U.O. FARMACIA, FROSINONE, IT ALY

Background

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 8/60 05/11/2018 Rejected - S4.html Idiopathic pulmonary fibrosis(IPF) is a severe pulmonary disease with few therapeutic alternatives and characterized by a progressive decline in lung function. Pirfenidone is a tyrosine kinase inhibitor that has been approved for the clinical treatment in mild to moderate IPF in adults.

Purpose

The aim of this study was to evaluate the effectiveness and safety of pirfenidone in patients with mild to moderate IPF over 12 months follow­up period.

Material and methods

A retrospective study was conducted in patients receiving treatment with pirfenidone from January 2017 to December 2018. Clinical data were collected from the web­based register of Italian Medicines Agency. The measured variables were: Age; sex; gravity of the pathology; forced vital capacity(FVC, %), diffusion capacity of the lungs(DLco, %), before and after the treatment was initiated. The main outcome evaluated the variation of FVC from basal levels, considering it a positive response to the treatment if FVC did not decrease more than 10%. The presence of adverse reactions were reviewed to assess safety.

Results

We enrolled 25 patients receiving pirfenidone 2403 mg daily. 88% of patients were male, with a mean age of 71 ± 8 years. 56% and 44% of patients had a moderate and mild pathology, respectively. The initial medium FVC was 76 ± 11% and the medium DLco was 50 ± 11%. After the treatment, we had a medium FVC of 81 ± 15% and a medium DLco of 50 ± 13%. As results, 36% of treated patients had improvement of FVC >10%, and 72% of treated patients had improvement of FVC >5%, statistically significant (Z=­2,747; ρ<0,006). 28% of treated patients had improvement of DLco>15%. 14 patients had adverse reaction and the most frequent was dyspepsia (36%), followed by rush (25%); other less frequent were headache (8,4%) and diarrhea (8,4%).

Conclusion

Pirfenidone has shown benefit in decreasing progression of IPF and showed effectiveness and safety profiles similar to those of other studies. On the other hands, the adverse reactions were mild but the rate of occurrence was high. Studies with a broader population of patients should be carried out to assess whether the balance between efficacy and safety is suitable.

References and/or Acknowledgements

­

Conflict of Interest No conflict of interest

BAR19­0183 DEVELOPMENT OF A COLOR SYSTEM TO AID PRESCRIBING OF BIOLOGICAL THERAPIES

E. GARCÍA LOBATO1, J. REIS­PARDAL2, C. GARCÍA LOBATO3, M. FERRIS VILLANUEVA1, C. REDONDO GALÁN1, C. BONILLA GALÁN4, D. BRIEGAS MORERA4, M.J. IZQUIERDO PAJUELO4, S. MARTÍN CLAVO1, J.F. RANGEL MAYORAL1 1UNIVERSITY HOSPITAL COMPLEX OF BADAJOZ, HOSPITAL PHARMACY, BADAJOZ, SPAIN 2HOSPITAL ORTOPÉDICO DE SANTANA­ SANTA CASA DA MISERICÓRDIA DE LISBOA, SERVIÇOS F ARMACÊUTICOS, LISBOA, PORTUGAL 3UNIVERSITY HOSPITAL COMPLEX OF BADAJOZ, ENDOCRINOLOGY AND NUTRITION, BADAJOZ, SPAIN 4SERVICIO EXTREMEÑO DE SALUD, SUBDIRECCIÓN DE GESTIÓN FARMACÉUTICA, MÉRIDA, SPAIN

Background

The use of biological therapies has had a great economic impact on hospital budgets, and prescribers want to know the costs of treatments they prescribe. With that in mind, a color system was created and presented at the Biological Therapies Commission of our hospital to allow the easy identification of treatments costs.

Purpose

To carry out an economic analysis of biological treatments used in different pathologies, and to elaborate a useful and aiding color system to guide prescribers in the decision­making process.

Material and methods

We made a list of all the hospital­restricted biological drugs available in our hospital. For each drug, we identified in the Summaries of Product Characteristics, officially approved indications and corresponding dosing regimens. The unit cost of each drug was recorded according to the information provided in BOTPLUS. Then, by applying a value­added tax of 4%, we calculated the cost per dose. The number of doses per year was also calculated and finally the patient cost per year was obtained. For each indication drugs were sorted from the lowest to the highest patient cost per year and those of lower cost were presented in green, those of intermediate cost were presented in yellow­orange and those of higher cost were presented in red. Within each color, drugs were presented in different tonalities according to the total patient cost per year.

Results

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 9/60 05/11/2018 Rejected - S4.html

Conclusion

This color system represents a tool to aid prescribers’ decision­making when selecting biological therapies. It is deemed necessary that prescribers evaluate the most appropriate treatment for each patient, taking into account criteria of effectiveness, efficiency and safety.

The use of biosimilar instead of biological reference drugs can save up to 2810 euros, so prescribers should also considered the use of these drugs when treating patients.

References and/or Acknowledgements

1. Base de datos del Consejo General de Colegios Oficiales de Farmacéuticos (BOT). Disponible online en: http://www.portalfarma.com

Conflict of Interest No conflict of interest

BAR19­0582 IMPROVING COMMUNICATION BETWEEN HOSPITAL AND COMMUNITY PRACTITIONERS : IMPLEMENTATION OF AN AUTOMATIC PHARMACEUTICAL LETTER OF HOSPITAL DISCHARGE.

J. SALGUES1, M. COSSON1, L. LOHAN­DESCAMPS1, A. QUINTARD1, D. ROSANT1, I. ROCH­TORREILLES1, A. MARIA2, R. GOULABCHAND2, A. LE QUELLEC2, C. BREUKER1 1UNIVERSITY HOSPITAL CENTER OF MONTPELLIER, PHARMACY UNIT, MONTPELLIER, FRANCE 2UNIVERSITY HOSPITAL CENTER OF MONTPELLIER, INTERNAL MEDICINE UNIT, MONTPELLIER, FRANCE

Background

To improve continuity of care at hospital admission and discharge and to decrease medication errors (MEs) pharmaceutical care programs are developed. The causes of these MEs are multi­factorial, such as the patient’s inability to accurately recall his medication use or incomplete transfer of information between healthcare settings.

Purpose

Develop an automated pharmaceutical letter of hospital discharge (APL) to improve the transition of patients from hospital discharge to community setting.

Material and methods

We conducting this prospective study in an internal medicine from June to August 2017. The pharmaceutical team (PT) included 1 resident and 1 student of pharmacy. All patients admitted to the unit were included in the study, except inter­hospital patient transfert. APL was developed on the DxCare (Medasys®) software. APL is automatically edited at patient discharge at the end of medication reconcilation process. Firstly, we conducted a test phase of 6 weeks in order to check the process (edition without sending). Secondarily, we conducted the operational phase (edition, explanation to patient and sending to community practitioners including community pharmacist).

Results

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 10/60 05/11/2018 Rejected - S4.html During the test phase, 51 APL were edited and 100% were correcte. 95 patients were included in the operational phase (40% of male, mea nage of 63 years old and average length of stays of 12 days). 53 (56%) patients had APL. The mean cause of non­realization of the letter were discharge in non­working hours (n=14, 15%), lack of treatments informations (n=16, 17%) or unavailability of PT (n=12, 12%). Regarding the 36 APL edited for patients returning at home, 32 (89%) were given and explained, 19 (53%) were sent within 24 hours to pharmacist and 32 (89%) to general practitioner. 12 patients refused to send the APL to their pharmacist and 5 could not deliver an agreement. Regarding the 17 APL edited for patients transferred to another health center, 8 (47%) were given and explained and 17 (100%) were sent to a health center within 24 hours.

Conclusion

This study was successfuly extended to another internal medicine unit. The impact and value­added of this APL were evaluated in another study with the satisfaction of patients, pharmacists and general practitioner.

References and/or Acknowledgements https://www.ncbi.nlm.nih.gov/pubmed/28007439

Conflict of Interest No conflict of interest

BAR19­0211 HOSPITAL PHARMACIST IN IDIOPATHIC PULMONARY FIBROSIS PHARMACEUTICAL CONSULTING

A.P. ALMEIDA SERRA FERNANDES1, V. BARRADAS1, F. DIMAS1 1CHBM HOSPITAL, PHARMACY, BARREIRO, PORTUGAL

Background

Idiopathic Pulmonary Fibrosis (IPF) is a chronic, relentlessly progressive, fibrotic disease of lower respiratory tract, typically affects adults over 40 years of age. The Pharmaceutical Consultation (PC) arises from the need to monitor the therapeutic and adverse effects (AE), costs and promotion of adherence.

Purpose

Characterization the outpatients (pts) with IPF followed in PC and evaluation of the role of the Hospital Pharmacist (HP) in optimization/management of therapy.

Material and methods

Retrospective observational analysis of pts followed in PC from February 2016 to September 2018.

Evaluation of adherence (%) by indirect method of counting the remaining medication.

Data analyzed: Gender,age,therapeutic regimen,concomitant drugs and drug interactions (DI),AE,adherence and cost treatment.

Results

Were performed 249 PC at 21 pts followed since 2016. One patient followed in PC, maintaining treatment since August 2016 to present date (Total: 32 PC).

Mean age 70.8 years (range: 47­83 years).

Pts under treatment are evenly distributed among the 2 gender.

One of the 21 pts followed left treatment, and 6 pts passed away.

Therapeutic regimens:52.4% Nintedanib;47.6% Pirfenidone.

All pts have more than 5 concomitant drugs, including corticosteroids and immunomodulators, without relevant DI with IPF drugs.

The most frequent AE is diarrhea (All pts). In 2 pts (9.52%) under Nintedanib, dose adjustment/reduction was done. Photosensibility occurred on a patient under Pirfenidone, controlled with application of sun protection.

All pts have good therapeutic adherence (> 85%).

Monthly treatment cost (14 pts in treatment): € 12,612.60 (Nintedanib);€ 12,373.5 (Pirfenidone).

Minimum time/PC:30min. Total time spent on 249 PC: 124.5 hours.

Conclusion

Patient follow­up in PC, allow HP play more patient oriented role, integrated in multidisciplinary team, in order to manage the therapeutic regimen as prescribed.

Discontinuation of 1 patient’s therapy was motivated by persistence of AE, high weight loss and lack family support.

Time spent in PC by giving information to patient (verbal/written information­leaflet), with therapeutic advice of IPF drugs as well as the support therapy for prevention/treatment of AE, allows HP promote adherence and quality improvement patients life, being the link between them and their doctor, contributing to the increase patient’s security/confidence.

References and/or Acknowledgements

F. Soares Pires et al – Fibrose pulmonar Idiopática: apresentação clínica, evolução e fatores de prognóstico basais numa coorte portuguesa. Revista Portuguesa de Pneumologia. 2013;19 (1):19­27

Conflict of Interest No conflict of interest

BAR19­0212 INTEGRATION OF AN INVESTIGATIONAL DRUG MANAGEMENT SOFTWARE SYSTEM IN A DRUG AUTOMATED STORAGE AND DISPENSING SYSTEM

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 11/60 05/11/2018 Rejected - S4.html A.I. PLANO SÁNCHEZ1, E. LÁZARO LÓPEZ1, A. RODRÍGUEZ FERRERAS1, A. ARIAS MARTÍNEZ1, A. PIERAS LÓPEZ1, I. ZAPICO GARCÍA1, M. ALAGUERO CALERO2, J. MÉNDEZ­CASTRILLÓN RODRÍGUEZ1, A. LOZANO BLÁZQUEZ1 1HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS, HOSPITAL PHARMACY, OVIEDO, SPAIN 2HOSPITAL UNIVERSITARIO CENTRAL DE STURIAS, HOSPITAL PHARMACY, OVIEDO, SPAIN

Background

Number of clinical trials (CT) has increased during the last years; therefore the workload in the Clinical Trials Pharmacy Area has considerably increased. Standardized working protocols and tools are required to establish a continuous quality control system. The Automated Dispensing Systems (ADS) help us with the drug management.

Purpose

To describe the experience of the integration between the CT management software and ADS in the CT´s area. Collecting and analyzing the activity, advantages and incidents during the first three months.

Material and methods

This is an observational and cross sectional study. Data were obtained from the integration with an ambient temperature ADS between January­ March 2018. The entire CT was updated in the new version software program putting all the investigational drugs into the ADS. The errors and incidents were noted using the application’s tools.

Results

At the beginning of the study there were 153 active CT (47% from Oncology service, 18% Hematology, 9% Digestive, 6% Cardiology and the rest part of other services). All the CT protocols were introduced in the new version of management program followed by the introduction of the drugs in the ADS. It was assigned an identification label in each drawer containing: protocol code, drug name and specific internal code. Each drug was identified by CT´s name, active pharmaceutical ingredient, batch number, date of expiry and kit number. The filling process was completed in three weeks (rate of ADS occupation was 42.8%).The main advantages were the safety to dispensing, the efficient management of physical space and the record of all transactions. The mostly incidents were errors about overfilling and underfilling and errors in the location. At the end of the study, there were 155 active CT, 417 samples were in the ADS. 337 investigational drugs belonged to Oncology and Hematology Services. 284 dispensations and 73 preparations of intravenous mixtures were made.

Conclusion

The integration of ADS in CT´s area with the management software program enables us to optimize the space increasing security about the dispensation and reception of the medicines in the CT area where activity is growing up everyday.

References and/or Acknowledgements

.No conflict of interest.

Conflict of Interest No conflict of interest

BAR19­0218 MULTIDISCIPLINARY CONSENSUS ON THE DESIGN OF A DERMATOLOGICAL FORMULARY FOR THE STANDARDIZATION OF PHARMACEUTICAL COMPOUNDING IN A TERTIARY HOSPITAL PHARMACY

J. CORDERO RAMOS1, C. DONOSO RENGIFO1, M. MOYA MARTIN1, L. RENDÓN DE LOPE1, M. MURILLO IZQUIERDO1, C. CASTILLO MARTIN1, M.D. ALVARADO FERNÁNDEZ1, L. JIMENÉZ GUERRERO1, M. VÁZQUEZ REAL2, I. CASTAÑEDA MACÍAS1, M. CAMEÁN FERNÁNDEZ1 1HOSPITAL VIRGEN MACARENA, PHARMACY , SEVILLE, SPAIN 2HOSPITAL NUESTRA SEÑORA DE GUADALUPE, PHARMACY, SAN SEBASTIAN DE LA GOMERA, SPAIN

Background

Following a former collaboration between dermatologists and pharmacists which main aim was to develop new pharmaceutical compounding, a multidisciplinary group drafted an official document with the aim of reducing the existing variability when prescribing master formulas per se but also to decrease mistakes among dermatologists themselves.

Purpose

The following goals were aimed: i) assessing which are the main dermatological pathologies that require master formulas (MF),ii) tailoring a catalog of MF preparations according to the specific pathologies above metioned (i).iii)Designing patient information leaflets for the MF.

Material and methods

Five different activities were carried out: A sytematic review of dermatological pathologies that require MF as their main therapeutic arsenal. The availability of their commercialized pharmaceutical compounding was taken into account. Selection of new formulas and a review of existing MF(dermatologists and pharmacists). Worksheets update of the existing MFs already included in the hospital formulary and creation of non­existent ones (novel MFs),Updating of information leaflets for patients(dermatologists and pharmacists). Prediction of novel FMs viability (pharmacists).

Results

The pathologies evaluated were: hyperkeratosis, dermal inflammatory pathology, inflammatory pathology of the oral mucosa, scalp dermatitis, seborrheic pathology, tinea, infected ulcer, scabies, pediculosis, superinfected and candidiasic intertrigo, alopecia areata, psoriasis, hemangioma infantile, ichthyosis, hidradenitis suppurativa, erythema nodosum and angiofibromas. The new formulary covered a total of 36 MFs, 83% of which were topical(61% were semi­solid and 22% liquid creams / gels). Regarding oral administration formulas, 8% were solid and 8% liquid). Patient leaflets included the following information: indication, schedule and posology, most frequent adverse effects, general and specific precautions (children, pregnant and breastfeeding), interactions, conservation and expiration.

Conclusion

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 12/60 05/11/2018 Rejected - S4.html It seems that the requirement of pharmaceutical compounding when treating dermatological pathologies is highly common.Defining a proper formulary which embrace all MFs available in a hospital is essential in order to enable efficient treatments. Hospital formulary provides shortening prescription time, and it proves to help reducing the possible variability when prescribing. On the other hand, patient information brochures boost the efficacy of the treatment as it can be used as a reliable source of information which provides an adequate explanation of how to use the MF and which precautions need to be followed.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0411 REGORAFENIB IN HEPATOCELLULAR CARCINOMA. TWO CASE REPORT.

J. CORDERO RAMOS1, L. RENDÓN DE LOPE1, Ú. BAÑOS ROLDÁN1, C. CASTILLO MARTIN1, M.D. ALVARADO FERNÁNDEZ1, M. MURILLO IZQUIERDO1, L. JIMÉNEZ GUERRERO1, M. VAZQUEZ REAL2, I. CASTAÑEDA MACÍAS1, C. DONOSO RENGIFO1 1HOSPITAL VIRGEN MACARENA, PHARMACY, SEVILLE, SPAIN 2HOSPITAL NUESTRA SEÑORA DE GUADALUPE, PHARMACY, SEVILLE, SP AIN

Background

Over the past ten years, sorafenib, has been the only systemic agent approved for first­line treatment of patients with unresectable hepatocellular carcinoma (HC). In 2016, the RESORCE trial showed regorafenib having a survival benefit in HC patients after first­line treatment with sorafenib.

Purpose

To describe the efficacy and safety experience of regorafenib used in HC patients after first­line treatment with sorafenib.

Material and methods

Retrospective observational study including two patients with HC who started treatment with regorafenib after first­line treatment with sorafenib between July 2018 and September 2018 was carried out.

The following variables were collected: sex, age, hepatitis C virus (VHC) infection, the Eastern Cooperative Oncology Group scale (ECOG) and date of diagnosis.

Progression­free survival and adverse effects (AEs) were recorded to evaluate effectiveness.

Results

Our study included two patients (both male) with a mean age of 61,5. Both cases did not present metastatic illness and they had being treated with sorafenib as the prior line.

Patient 1 is a 70 years­old man who had presented VHC infection. He had a HC of 25 months of evolution and a Child Pugh score of 5 (A rank). He received a regorafenib dose of 160mg for six months (six cycles) and until now he has not showed evidence of progression, ECOG or Child Pugh score increase.

Patient 2 is a 53 years­old man with a HC of 12 months of evolution and a Child Pugh score of 5 (A rank). He started receiving 160mg of regorafenib three months ago. Until the date of this study, he has not showed evidence of progression, ECOG or Child Pugh score increase.

Although the patient’s HC was completely stable, some AEs appeared along the treatment period. Patient 1 presented diarrhea G1, bradypsychiaand, asthenia G1. Patient 2 presented erythema G2 in month two, after that the dose was reduced to 80mg/daily, but it was insufficient and the dose had to be reduced again.

Conclusion

In our cases, regorafenib seemed to be effective and safe in patients with HC prior treated with sorafenib. Further investigations with more patients will be needed to assess these results

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0270 Pharmaeconomic analysis of emicizumab as the treatment of congenital hemophilia A in a patient with inhibitors against factor VIII

J. JUAN CARLOS1, M.F. MARTINEZ­GARCIA2, M. FERNANDEZ­CABALLERO2, Á.G. ARÉVALO1, M. LARROSA­GARCÍA1, P. LALUEZA­BROTO1, A. SANTAMARIA­ORTIZ2, M.Q. GORGAS­TORNER1 1HOSPITAL UNIVERISTARIO VALL D'HEBRON, PHARMACY , BARCELONA, SPAIN 2HOSPITAL UNIVERISTARIO VALL D'HEBRON, UNIDAD DE HEMOFILIA, BARCELONA, SP AIN

Background

The treatment of patients with hemophilia A with inhibitors have been based on conventional inmune tolerance induction (ITI) treatment with high doses of FVIII, bypass agents activated prothrombin complex concentrate (aPCC) and recombinant factor VIIa (rFVIIa). Emicizumab, a humanized immunoglobulin IgG4 antibody administered subcutaneously that mimics the effect of activated factor VIII (FVIIIa) has been approved recently as treatment of this condition. Emicizumab showed a decrease of annual bleeding rate compared to bypass agents in pivotal analysis; however, its cost is high and it is not marketed in our region, so compassionate use is the only option to prescribe it in a patient non­responder to conventional ITI treatment

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 13/60 05/11/2018 Rejected - S4.html Purpose

The aim of this study was to carry out a cost­minimization analysis of emicizumab in a 16 years­old patient with severe hemophilia A with inhibitors who was treated with high doses of FVIII and bypass agents (rFVIIa and aPCC) without achieving a good response

Material and methods

The two­year cost of emicizumab was estimated considering a 3 mg/kg dose per week during the first month, followed by 1.5 mg/kg per week during 23 months for a patient with hemophilia A, who weighed 57 kg. The two­year­cost of previous treatment was estimated considering rFVIIa prophylactic daily doses, high doses of plasma derived FVIII and high doses of rFVIIa and aPCC because of two life threatening bleeding events ; all of them adjusted to weight.

Results

The total cost of his previous treatment was 1,170,742 € (891,562 € for rFVIIa; 147,420 € for high doses of plasma derived FVIII and 131,760 € for aPCC). The total cost of emicizumab was 1,291,596 €. The two years incremental cost was 120,854 €, which represents an increase of 10%. Compassionate use was requested for this treatment; subsequently, during the three­months follow­up there was a good compliance to the treatment with no severe adverse events and no bleedings reported

Conclusion

The use of emicizumab in this patient successfully prevented hemorrhagic episodes without involving a significant cost increase.

References and/or Acknowledgements

1­ Oldenburg J. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809­818. doi: 10.1056/NEJMoa1703068.

ORCID first Author: JC Juarez­Gimenez https://orcid.org/0000­0001­5859­986X

Conflict of Interest No conflict of interest

BAR19­0224 ABSENCE OF GENDER BIAS IN THE PRESCRIPTION AT HOSPITAL DISCHARGE

M.A. GAYOSO RODRIGUEZ1, A. HIDALGO BALSERA2, N. CORRAL BLANCO3 1HOSPITAL VALLE DEL NALÓN, SERVICIO DE FARMACIA, ASTURIAS, SPAIN 2SCHOOL OF MEDICINE, FARMACOLOGÍA, ASTURIAS, SPAIN 3FACULTY OF MATHEMATICS, STATISTICS, ASTURIAS, SPAIN

Background

Most studies have focused on demonstrating inequalities between sexes regarding healthcare, especially concerning accessibility and the effort made to diagnose and treat patients.

Purpose

To determine if prescribing medications at hospital discharge incurs gender bias.

Material and methods

A retrospective analysis was conducted using one­year hospital discharge database excluding patients under 15 and obstetric pathology. Pharmacological therapy collected as active principles following anatomical­therapeutic­chemical classification (ATC), diagnoses according to International Statistical Classification of Diseases (ICD­9), socio­demographic factors and other variables were included. The comparison between categorical variables was performed with Chi­square test and, to assess the relationship between binary variables, odds ratio (OR) was used.

Results

Out of the 4683 patients analyzed, 94% had medication prescribed being three the most frequent number of drugs received. A median of five and six drugs were found in men and women respectively (p=0.0001). In men aged 45­64, subgroups "C01", "C07" and "C09" (OR=0.49; 0.63 and 0.75; p<0.05) predominated, while "C10 "(OR=0.61; p<0.05) prevailed in those aged 65­74. In women ≥65, a greater consumption of "C03" and "C08" was observed (OR= 1.93; 1.91; p<0.05). Among women ≥45, there was an increased risk in the use of "N02", "N05", "N06” (OR= 1.55; 2.03 and 2.44; p<0.05). The "B03" was associated to men, especially in the group aged between 45­64 (OR=0.75; p<0.05); the association of two or more antithrombotics was more frequent among males aged 45­74 (OR=0.45 and 0.48; p<0.05). The pharmacological therapy prescribed according to the main diagnosis and clinical guidelines suggests absence of gender bias both among professionals (p=0.582) and the patients to whom it is addressed (p=0.89). We haved observed a large dispersion of additional complaints to the reason for admission (3.08±2.72), with the burden of disease being higher in men, except young ones (p<0.05).

Conclusion

Although the amount of drugs increases with age, once adjusted by sex and age group, there are statistically significant differences between sexes although not clinically relevant. The differences found in the prescription can be explained by the unequal distribution of the prevalence of diseases in both sexes, without having been able to identify deviations due to gender.

References and/or Acknowledgements

k

Conflict of Interest No conflict of interest

BAR19­0240 DEPRESCRIBING CHOLINESTERASE INHIBITORS AND MEMANTINE IN SEVERE END­STAGE ALZHEIMER´S DISEASE

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 14/60 05/11/2018 Rejected - S4.html E. RODRIGUEZ JIMENEZ1, S. RODRIGUEZ ALCOBENDAS2, R. CIFUENTES CACERES2, M. MARTINEZ CAMACHO1, D. GARCIA MARCO3, P. MOYA GOMEZ4 1HOSPITAL VIRGEN DEL VALLE, HOSPITAL PHARMACY, TOLEDO, SPAIN 2RESIDENCIA DE MAYORES BENQUERENCIA, OCCUPATIONAL THERAPY , TOLEDO, SPAIN 3HOSPITAL NACIONAL DE PARAPLEJICOS, HOSPITAL PHARMACY, TOLEDO, SPAIN 4HOSPITAL VIRGEN DE LA SALUD, HOSPITAL PHARMACY, TOLEDO, SPAIN

Background

Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, are used to Alzheimer’s disease (AD). These drugs come with both potential benefits and risks, and those benefits and risks can change over the time, such as in severe, end­stage Alzheimer’s disease (SESAD). Therefore, appropriate use of Cholinesterase inhibitors and memantine involves both prescribing and deprescribing them for individuals where the risks outweigh the benefits.

Purpose

To avoid long­term use of the SESAD treatment in a long term care elderly center. Deprescribing SESAD treatment. To observe if any complication appears during withdrawing, and medication re­initiation if worsening of condition appears after withdrawal.

Material and methods

An observational study was carried during 6 months in a long term care elderly center. The stages of the study were the following:

1. 1. Geriatric evaluation of AD patients to select the SESAD patients 2. 2. Family information about deprescribing 3. 3. Recommended health care professionals for deprescribing: tappering and then stop. Step down the ChEIs dose through available dose forms every 4 weeks to lowest available dose, followed by discontinuation. Step down the meantime dose in 5 mg every week to stop 4. 4. Close periodic monitoring every four weeks and medication 5. 5. Re­initiation if worsening appears after withdrawal

The scales used to geriatric assessment, were: GDS for clinical evaluation, MMSE for cognitive assessment and FAST for funcional assessment. The scores for SESAD were: GDS=7, MMSE <6, FAST >7c.

Results

A geriatric evaluation was carried out in 31 subjects with AD. The age values were between 84 and 93 years. The majority were women (3 men and 28 women). There were 4 (12.90%) subjects with SESAD, all of them women. Deprescribing consists of: Withdrawal of Donepezil 10 mg, one subject; withdrawal of Rivastigmina patch 9.5 mg and Memantina 20 mg another subject and in the two latest Memantina 20 mg was withdrawal. After deprescribing there were no complications

Conclusion

In SESAD patients, deprescribing should be considered. Tappering and deprescribing were conducted in collaboration with the carers/family and relevant healthcare professionals. Monitoring is necessary and medication re­initiated if the individual evidences clear worsening of condition after withdrawal.

References and/or Acknowledgements

http://sydney.edu.au/medicine/cdpc/resource/deprescribing­guidelines.php

Conflict of Interest No conflict of interest

BAR19­0802 REAL WORLD EVIDENCE (RWE) AND GOVERNANCE OF INNOVATION IN ONCOLOGICAL AND ONCO­HAEMATOLOGICAL FIELD: CREATION OF AN EXPERIMENTAL LABORATORY OF PHARMACOUTILIZATION IN THE HOSPITAL PHARMACY

G. FAZZINA1, C. NADA1, V. TAGINI1, M. DI MAIO2, M.C. AZZOLINA3, A. GASCO1 1MAURIZIANO HOSPITAL, HOSPITAL PHARMACY, TURIN, ITALY 2MAURIZIANO HOSPITAL, ONCOLGY UNIT, TURIN, ITALY 3MAURIZIANO HOSPITAL, HEALTH MANAGEMENT UNIT, TURIN, IT ALY

Background

RCTs are the most reliable tool to generate evidence on the efficacy of drugs. However, the long duration of many therapies or the incomplete adherence of patients to medical recommendations, also considering the increasing frequency of oral therapies, can generate a discrepancy between the evidence generated in the controlled environment (efficacy), and their actual impact in the real world (effectiveness). Wherefore, the RCTs are not always suf ficient to describe the real impact of care in clinical practice.

Purpose

This Project, conducted in a multidisciplinary context, intends to set up an experimental Laboratory of Pharmacoutilization in the oncological and onco­haematological field, with the aim of defining a methodology that produces RWE, to be combined with RCTs, through the analysis of local Real World Data (RWD).

Material and methods

The Project is achievable through the following phases: 1. centralization of all parenteral onco­haematological therapies, to garantee safety/quality standards; 2. implementation of the counseling activity of all oral onco­haematological therapies, in order to avoid that any therapeutic failures derive from suboptimal compliance, rather than from a real ineffectiveness of the drugs; 3. definition and development of a Data Base for the collection and analysis of the local pharmacoutilization data (R WD).

Results file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 15/60 05/11/2018 Rejected - S4.html The Laboratory will be able to represent an innovative point of view on drug therapies: here, efficacy­data (EBM­supported) are integrated with those of effectiveness (RWD­supported), offering information for the optimization of therapeutic choices. The data thus obtained can be combined with data from other Centers, in order to increase the solidity and generalization of the information.

Conclusion

The RWE allows to continue to study the benefit­risk profile of drugs and to improve their understanding of relative value, in comparison with the avaible therapeutic alternatives, configuring itself as an opportunity to acquire new information, for example to improve kwoledge on the safety and efficacy profile and to acquire additional information on population subgroups that have not studied in clinical trials. In the experimental Pharmacoutilization Laboratory, the relationship between pharmacist and clinician can consolidate and, with a view to global sustainability, the conditions can be created to promote a more effective allocation of avaible resources.

References and/or Acknowledgements

Melazzini M, Dagli studi clinici alla pratica medica. AIFA Editorial 06/04/2017

Conflict of Interest No conflict of interest

BAR19­0274 COORDINATED PHARMACEUTICAL CARE AROUND THE PATIENT.

A.M. JUANES BORREGO1, M. HERNANDEZ2, M.T. BARRERA3, O. CARRASCOSA3, J. RUIZ4, E. CLOT5, R. LOPEZ6, M. LESTON7, L. PUERTA8, C. MESTRES9, M.A. MANGUES1 1HOSPITAL DE SANT PAU I LA SANT A CREU, PHARMACY, BARCELONA, SPAIN 2GRUP MUTUAM / BLANQUERNA HEALTH SCIENCE_ RAMON LLULL UNIVERSITY , PHARMACY, BARCELONA, SPAIN 3HOSPITAL DOS DE MAIG, PHARMACY, BARCELONA, SPAIN 4HOSPITAL DE SANT PAU I LA SANT CREU, PHARMACY, BARCELONA, SP AIN 5HESTIA PALAU SOCIOSANITARI, PHARMACY, BARCELONA, SPAIN 6FUNDACIÓ PUIGVERT, PHARMACY, BARCELONA, SPAIN 7INSTITUT CATALA DE LA SALUT ICS, PHARMACY, BARCELONA, SP AIN 8GRUP MUTUAM, PHARMACY, BARCELONA, SPAIN 9BLANQUERNA HEALTH SCIENCE. UNIVERSITY RAMON LLULL, HEAL TH SCIENCES, BARCELONA, SPAIN

Background

Pharmaceutical care (PC) is an effective tool to minimize Drug related­health problems (DRP)(1). Working collaboratively in our area give us the opportunity to maximize PC.

Purpose

To optimize in terms of health results and resources consumption was created a group with the main objective of establish a coordinated PC program including all clinical pharmacy services in our area. Shared priority objectives:

­Analyze DRP that generate consultation in the Emergency Department (ED) of acute hospitals.

­Implement measures for secondary and primary prevention of DRPs.

­Consensus on pharmacotherapeutic equivalents guides and protocols.

Material and methods

Group creation June­2017 involving ten institutions (acute hospitals, intermediate and primary care) represented by 19 clinical pharmacist. The patient receives PC and seamlessly in their trajectory in the public health system, ensuring home medication conciliation and pharmacotherapeutic follow­up.

Four meetings have been held and the Strategic Plan has been defined in 5 strategic lines (SL).

SL1.PC model. Implement secondary and primary prevention measures of DRPs PSMs that generate consultation in the ED. Consensus common care protocols.

SL2.Coordination and synergies. Develop all the coordination activities of the group (meetings and annual report). Establish synergies with other welfare pharmacy working groups and scientific societies.

SL3.Communication. Disseminate and exchange information of interest related to the PC.

SL4.Training and teaching PC.

SL5.Research PC.

Results

Current status:

LE1.Detection and registration of DRPs has been developed in the ED of the three acute hospitals. Three therapeutic groups’ equivalents have been reviewed and unified.

LE2.Calendar of quarterly meetings has been defined.

LE3.Shared folder were created to exchange information. Twitter account was created.

LE4.Shared monographic sessions monthly. Organize annual conference to show clinical and social impact of DRPs (First realized April 2018).

SL5.Two clinical trials are currently underway at the two acute care hospitals in our health area, in collaboration with ED. Led by group pharmacists, focusing in DRP detection and prevention.

Conclusion

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 16/60 05/11/2018 Rejected - S4.html In a short time the formation of the group has been achieved including all the levels of care of the Clinical Pharmacy in our area. A strategic plan has been agreed upon that includes different phases and aspects to achieve the objectives.

References and/or Acknowledgements

1.Patel P, Zed PJ. Drug­related visits to the emergency department: how big is the problem? Pharmacotherapy.2002 Jul;22(7):915–23.

Conflict of Interest No conflict of interest

BAR19­0275 EFFECTIVENESS AND SECURITY OF SECUKINUMAB IN THE TREATMENT OF ANCHILOSANTE SPONDYLITIS

E. TEJEDOR1, B. TAUSTE HERNANDEZ1, S. CAÑIZARES PAZ1, E. VELASCO MARTINEZ1, F. VERDEJO RECHE1, F. SIERRA GARCIA1 1COMPLEJO HOSPITALARIO TORRECÁRDENAS, PHARMACY, ALMERIA, SPAIN

Background

Ankylosing spondylitis (AS) is a chronic inflammatory disease manifested by back pain and progressive spinal stiffness

Purpose

To assess the efficacy and safety of secukinumab in the treatment of ankylosing spondylitis.

Material and methods

Retrospective observational study, where patients treated with secukinumab were included. From the clinical history program (Diraya®) and the outpatient program (Dominion­FarmaTools ®). The following variables were collected; age, sex, BASDAI (Bath ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (Ankylosing Spondylitis Quality of Life questionnaire), EVA (Visual Analog Pain Scale),PCR (C reactive protein),ESR (Globular Sedimentation Rate), and adverse reactions. Efficacy was assessed by reducing BASDAI, VSG and PRC values. Safety was assessed by the appearance of adverse effects.

Results

We included 20 patients, 14 men (70%) and 6 women (30%),with an average age of 42 years (34­64) at the time of the study. 33% of patients were treated in combination with a DMARD (disease modifying drugs), and 100% had received prior treatment with agents anti­TNF­α, having suspended it due to intolerance or lack of response. For the study, a mean value of BASDAI was observed at the beginning of 7.1, the mean value of ESR at the beginning was 31.3 and the average value of PCR at the beginning was 1.1, with these values we can say that are patients with spondylitis actively. After 6 months of treatment with secukinumab, the mean value of BASDAI was 5.5 (decrease 21.8%), VSG was 18.5 (decrease 59%) and CRP was 0.3 (decrease 29.1%); this improvement of at least 20% of the main variables indicates that the patients were responders. On the other hand, comment that 4 patients (20%) had adverse reactions, most were mild or moderate (thrush, conjunctivitis, rhinitis, digestive symptoms)

Conclusion

Based on the results available to date, secukinumab is an effective alternative for the treatment of patients with ankylosing spondylitis, and due to the low incidence of adverse reactions we can say that it´s a safe drug. Secukinumab is a good alternative for patients previously treated with biologics.

References and/or Acknowledgements

Assessment and treatment of ankylosing spondylitis in adults. David T Yu. 2018

Conflict of Interest No conflict of interest

BAR19­0277 JUSTIFICATION OF ANTIBIOTICS RESTRICTED BY THE DIFFERENT UNITS OF CLINICAL MANAGEMENT, A THIRD LEVEL HOSPITAL IN DURING 2017.

E. TEJEDOR1, B. FRANCO SANDAR1, D. FERNANDEZ GINES1, E. ELVIRA LADRON DE GUEVARA1, E. VELASCO MARTINEZ1, F. VERDEJO RECHE1, F. SIERRA GARCIA1 1COMPLEJO HOSPITALARIO TORRECÁRDENAS, PHARMACY , ALMERIA, SPAIN

Background

Antimicrobial stewardship consists of systematic measurement and coordinated interventions designed to promote the optimal use of antibiotic agents, including their choice, dosing, route, and duration of administration

Purpose

Analyze the justification of the antibiotic prescription (ATB) of a tertiary hospital during 2017

Material and methods

Retrospective observational study of the prescription of antibiotics in a tertiary hospital with a total of 590 beds assigned to the unit dose dispensing system.

Criteria for inclusion: patients admitted to the hospital, at least one day, who were prescribed a restricted antibiotic during their stay in 2017.Results

During the study period, a total of 972 antibiotic justification methods were recognized from January 2017 to December 2017, of which 544 (55.96%) were justified. The analyzed services were those in which hospital admissions are included: anesthesia, cardiology, general surgery, digestive, hematology, internal medicine, neurology, nephrology, oncology, traumatology, pediatrics, intensive care unit. The service that has most justified its prescriptions of antibiotics was medicine and infectious with a percentage of 90%; and on the other hand, the services that least justified their prescription were those corresponding to the surgical area, such as general surgery with 42.75%

Conclusion

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 17/60 05/11/2018 Rejected - S4.html This study shows the importance Pharmaceutical interventions detecting potential drug­related problems adjusting patient treatment, the full­time pharmacist would optimize pharmacotherapy for all patients, producing added value to safety and treatment efficacy and ensuring rational drug use.

References and/or Acknowledgements

Antimicrobial stewardship in hospital settings. Marisa Holubar, MSStan Deresinski . 2018

Conflict of Interest No conflict of interest

BAR19­0355 EVIDENCE ON THE USE OF TRIFLURIDINE/TIPIRACIL IN METASTATIC COLORECTAL CANCER

L. RENDÓN DE LOPE1, J. CORDERO RAMOS1, M. MURILLO IZQUIERDO1, M.D. ALVARADO FERNÁNDEZ1, I. CASTAÑEDA MACIAS1, Ú. BAÑOS ROLDÁN1, M.C. DONOSO­RENGIFO1, M.L. MOYA MARTÍN1 1HOSPITAL UNIVERSITARIO VIRGEN MACARENA, PHARMACY, SEVILLE, SP AIN

Background

Trifluridine/tipiracil (TAS102) is approved for adult pacients with metastatic colorectal cancer (mCRC) who have previously tested based on fluoropyrimidine, oxaliplatin or irinotecan, anti­VEGF and anti­EGFR agents. The references published so far supports the efficacy of this treatment.

Purpose

To evaluate the efficacy and safety of trifluridine/tipiracil in pacients with mCRC (stage IV) from a tertiary hospital.

Material and methods

A retrospective observational study was realized. Twenty­four patients who started treatment between September 2017 and September 2018. The variables included was: sex, age, performance status (ECOG) when starting treatment and ECOG at the end of the study, KRAS mutation (native or positive), number of line of treatment, number of cycles with trifluridine/tipiracil, adverse effects (AEs), need for dose reduction, progression­free survival (PFS), overall survival (OS) and date of exitus. Data were obtained from digital medical records and e­prescribing program.

Results

Twenty­four patients were included; 87.5% of whom were male, with an average of 66.6 ± 8,7 years. 66,7% showed KRAS mutation. None patient showed improvement of ECOG, however, 33,3% kept the ECOG and 66,7% suffered an increase of ECOG during treatment. They had received a median of 3 lines of prior treatment and a median of 3 cycles of trifluridine/tipiracil. Eleven (45,8%) patients progressed despite the treatment and six (25%) died.

Thirty­four AEs were recorded among the 24 patients, being asthenia the most frequent (29,4%) followed by neutropaenia (11,8%) and diarrhoea (11,8%). Eight (33,3%) patients needed dose reduction and one of them had to discontinued due to AEs.

The PFS calculated was 3,5 ± 3,1 months; 13 patients did not present a progression, until the moment of the study, with an average of PFS of 5 ± 2,4 months. The OS resulted was 3,3 ± 2,4 months.

Conclusion

TAS102 shows a controllable security profile. In terms of efficacy, this treatment does not show improvement in patient's performance status. However, futher studies to compare TAS102 with other alternatives.

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­0324 EXPERIENCE WITH DARATUMUMAB IN MULTIPLE MYELOMA

L. YUNQUERA ROMERO1 1HOSPITAL VITHAS XANIT INTERNACIONAL, PHARMACY , BENALMÁDENA, SPAIN

Background

Daratumumab is an anti­CD38 used to treat adults with multiple myeloma (MM). It is approved in combination with the bortezomib, melphalan and prednisone (VISTA regimen) in patients with newly diagnosed MM not eligible for autologous stem cell transplant (ASCT); or in combination with dexamethasone plus or bortezomib in pretreated patients. It is also used as monotherapy for relapsed and refractory MM, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMID) with disease progression.

Purpose

To analyze the use, safety and cost of daratumumab in patients with MM.

Material and methods

Observational, retrospective study of all patients treated with daratumumab from June 2016 to April 2018. Variables studied: sex, age, previous treatments and refractoriness, ASCT, prescribed dose, number of doses received and duration of treatment, response, adverse effects, average cost.

Results

4 patients were included, 50% women. Mean age 80.5(72­87) years. Patients had received a median of 4 prior lines of therapy. None of the patients had previously received an ASCT. 75% received VISTA regimen as first­line therapy. Other previous treatments: bortezomib (100%), lenalidomide (75%), pomalidomide(50%) and carfilzomib(25%). At baseline, 100% of the patients were refractory to previous therapy: 75% to PI and IMID, 100% to alkylating agents, 50% to pomalidomide and 25% to carfilzomib. 100% of the patients received daratumumab in combination. All patients received file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 18/60 05/11/2018 Rejected - S4.html a standard dose at 16 mg/kg. Average dose received was 1313 mg. Doses received: 12.5±6.6. Treatment duration: 4.6±2.7 months. 3 patients progressed during treatment; one of them received a later line of treatment, and all of them were exitus at the time of the study. 1 patient continues with daratumumab with good response. Adverse reactions described were included in the product information as very frequent (pneumonia, upper respiratory tract infection, cough, fever, fatigue, peripheral edema, infusion related reactions). Average cost of each dose: 7998.32€; average treatment cost: 99.979€.

Conclusion

Daratumumab was used in our hospital according to licensed indications. Registered adverse effects were described in the product information as very frequent, in all cases. However, more studies with a larger sample size are needed to assess the efficacy, safety and costs of daratumumab.

References and/or Acknowledgements

None

Conflict of Interest No conflict of interest

BAR19­0342 STATE OF PRATICE OF USING MELATONIN LP 2MG IN GERIATRIC FCR (FOLLOW­UP CARE AND REHABILITATION)

O. DIABY1, C. BRUN2, H. BARRETEAU3, V. BLOCH4, V. DUCASSE5, M. VEYRIER6 1HOPITAL FERNAND WIDAL, PHARMACY, PARIS, FRANCE 2HOPITAL FERNAND WIDAL, MEDECINE GERIATRIC, PARIS, FRANCE 3HOPITAL LARIBOISIÈRE, PHARMACIE, PARIS, FRANCE 4HOPITAL LARIBOISIÈRE­FERNAND WIDAL, PHARMACY , PARIS, FRANCE 5HOPITAL LARIBOISIÈRE­FERNAND WIDAL, MEDECINE GERIATRIC, PARIS, FRANCE 6HOPITAL FERAND WIDAL, PHARMACY, PARIS, FRANCE

Background

Melatonin is a hormone involved in circadian rhythms. 2mg Melatonin Long Release (MLR) is available for insomnia in people over 55 years.

Purpose

Realization of prescription ‘state of MLR in geriatric service.

Material and methods

Retrospective study. For patients who benefited from MLR from 02/2017 to 08/2018, information was collected in the prescription software and the medical record: age, sex, height, weight, BMI, dose and duration, benzodiazepine (BZD) treatment at entry and exit, comorbidities (dementia, stroke). Continuation of the treatment was objectified thanks to pharmacy.

Results

Over 18 months, 31 patients (13 women, 18 men) mean 86 years had MLR. The dosage and mean duration was 2.4 mg for 45 days. No significant influence of age, number and type of comorbidities, BMI, sex was found on the prescribed dosage.The most common comorbidities were dementia (42%) and stroke history (34%).

For 39%, 32%, 29% of the MLR patients were: stopped the day before exit, during the stay and continued at the exit. For these last ones, 22% (n = 2) consistently went at the pharmacy and 33% (n = 3) only the first month.

71% (n = 22) of patients had a BZD at entry and 42% at exit (n = 13). 66% (n = 6) of patients benefited at the end of a co­prescription of MLR and BZD.

The MLR is often stopped the day before leaving the hospital, and during the stay due to partial response or inefficiency. Only 22% of patients continue to receive MLR outside hospital. This can be explained by the cost or the misuse. The MLR has a chronobiotic action on the circadian rhythm and a soporific action. The chronobiotic action may cause, when taking too early or late compared to the usual bedtime, a delay or a phase advance of sleep.

The patient or the clinician may then think that this is due to inefficiency or a partial response.

Conclusion

MLR may be interesting for elderly with insomnia associated with a history of stroke or dementia. Nevertheless, no recommendation of good use exists yet. For now, because of its cost and its use, the MLR seems difficult to use.

References and/or Acknowledgements file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 19/60 05/11/2018 Rejected - S4.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4069047/ https://www.ncbi.nlm.nih.gov/pubmed/19171948 https://www­ncbi­nlm­nih­gov.frodon.univ­paris5.fr/pmc/articles/PMC4648706/pdf/nihms713707.pdf https://academic.oup.com/jcem/article/95/7/3325/2596406

Conflict of Interest No conflict of interest

BAR19­0359 EFFECTIVENESS AND COST OF GEFITINIB IN ADVANCED/METASTATIC NON­SMALL CELL LUNG CANCER

P. SELVI1, O. MONTERO­PEREZ1, A. PELAEZ­BEJARANO1, D. YAÑEZ­FERIA1, I. CARRION­MADROÑAL1, E. SÁNCHEZ­GÓMEZ1 1HOSPITAL JUAN RAMÓN JIMÉNEZ, PHARMACY, HUELVA, SPAIN

Background

Gefitinib is one of the drugs used in patients diagnosed with non­small cell lung cancer (NSCLC) with activating EGFR mutation, with an elevated economic cost.

Purpose

To analyse the effectiveness and cost of gefitinib in advanced/metastatic NSCLC.

Material and methods

A retrospective descriptive study covering the period from January 2013 to June 2018 of advanced/metastatic non­small cell lung cancer patients starting treatment with gefitinib between January 2013 and January 2017 was performed. Parameters collected were: age, sex, smoking history, previous chemotherapy, EGFR status, progression­free survival (PFS) and economic spending. Data were collected from the Electronic Prescription Software Prisma® and the program of electronic patient records Diraya® and afterwards, organized in an Excel® base design for this study.

Results

A total of 23 patients with a median age of 68 years, 69,9% women, 65,2% chemotherapy­naive and 34,8% chemotherapy­treated were included. 50% were non­smokers and 38,9% were ex­smokers. Regarding the tumour, 73,9% presented adenocarcinoma, 17,4% large­cells and 8,7% epidermoid. 90% presented metastasis.

Regarding the EFGR mutation; 52,2% presented mutation, 8,7% did not present mutation and in 39,1% the status was unknown.

The mean PFS was 8,1 months with a 39,1% of 1­year­ progression­free survival. However, no difference was found between the group of chemotherapy­naive patients (8 months PFS) and chemotherapy­treated patients (7,2 months of PFS) (p>0,05) or the patient with adenocarcinoma (10,4 PFS) and no­adenocarcinoma (7,1 PFS) (p>0,05).

The cost of treatment/patient was 24.662€ and the total expenditure was 567.224€ (0,4% of the total pharmacy service budget).

Conclusion

The data of 8,1 months of PFS were different from the published in the Gefitinib pivotal trials. IPASS (chemotherapy­naïve) and INTEREST (pre­ treated) showed data of 5,7 and 2,2 months of PFS. However, it is similar to the population EFGR positive of these trials, which was 9,5 and 7 months of PFS. This could be on account of the low proportion of EFGR negative in our study and makes us think that those patients with the EFGR status unknown would be mostly positive.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0384 CONSOLIDATION OF A NUTRITIONAL SUPPORT TEAM THROUGH THE ESTABLISHMENT OF A PAPERLESS CIRCUIT TO REQUEST THE START OF NUTRITIONAL SUPPORT

L. VALLEZ VALERO1, P. TABERNER BONASTRE2, B. MARTINEZ CASTRO1, M. MARTINEZ SOGUES1, M. GILABERT SOTOCA1, E. MEDINA PERALTA1, J.A. SCHOENENBERGER ARNAIZ1 1HOSPITAL UNIVERSITARIO ARNAU DE VILANOVA DE LLEIDA, HOSPIT AL PHARMACY, LLEIDA, SPAIN 2HOSPITAL UNIVERSITARIO SANTA MARIA, HOSPITAL PHARMACY, LLEIDA, SPAIN

Background

In the hospital, the indication and type of nutritional support (NS) were decided by the medical team and parenteral nutrition (PN) was prepared by the pharmacy service. However, sometimes, the requested support was not the most appropriate for clinical situation and the reception of prescription was not carried out within the established hours, which delayed the start of NS.

Purpose

Establish an efficient circuit for non­critical adult patients that includes a multidisciplinary nutritional support team (MNST) who guarantees the supply of PN that best suits their clinical situation and ensure that the team communicates fluidly and efficiently.

Material and methods

In January­2012 was stablished a MNST with the more qualified specialists in NS. A protocol was elaborated to establish the responsibilities of each member and a circuit for the request of NS was included.

Results

The MNST was established consisting of endocrinologists, hospital pharmacists and dieticians­nutritionists. Hospital pharmacists and endocrinologists would be in charge of the PN. They meet daily to decide the most appropriated formulation.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 20/60 05/11/2018 Rejected - S4.html The protocol defined the need of a prescriptor interconsultation (IC) through the computerized medical history program.

To let the physicians know, an informative note was sent notifying the withdrawal of paper applications and the need to make an interconsultation to the MNST.

The protocol was implemented in January­2012. In January, 4 IC were done, reaching 39 in February. The average of IC in the years 2012, 2014 and 2017 was 38, 48, 47 respectively/monthly.

The main benefit for the patient is that PN is administered earlier and it adapts better to their clinical needs. For the clinicians the circuit is simple, comfortable and agile.

Conclusion

The fact that since the system was implemented the number of IC was high shows the great effort of the MNST to make this system work.

Collaboration with other clinicians always improves the selection of the most appropriate treatment. The establishment of a circuit that streamlines the processes for both doctors and pharmacists always facilitates the adherence of those involved.

The use of IC has led to clinicians using this route to request the collaboration of the pharmacist in other issues such as drug­monitoring.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0406 EFFECTIVENESS OF REGORAFENIB AFTER TRIFLURIDINE/TIPIRACIL­LINE FOR REFRACTORY METASTATIC COLORECTAL CANCER

J. CORDERO RAMOS1, L. RENDÓN DE LOPE1, Ú. BAÑOS ROLDÁN1, M. MURILLO IZQUIERDO1, C. DONOSO RENGIFO1, C. CASTILLO MARTIN1, I. CASTAÑEDA MACÍAS1, L. JIMÉNEZ GUERRERO1, M. VAZQUEZ REAL2, M.D. ALVARADO FERNÁNDEZ1 1HOSPITAL VIRGEN MACARENA, PHARMACY, SEVILLA, SPAIN 2HOSPITAL NUESTRA SEÑORA DE GUADALUPE, PHARMACY, SAN SEBASTIÁN DE LA GOMERA, SPAIN

Background

Regorafenib and trifluridine/tipiracil (TAS­102) are indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) refractory to standard therapy. Little evidence exists about the use of regorafenib in mCRC refractory to TAS­102.

Purpose

To study the effectiveness and safety of regorafenib in patients with advanced mCRC refractory to TAS­102 in real clinical practice.

Material and methods

A retrospective observational study including all patients with mCRC who started treatment with regorafenib after TAS­102 between January 2018 and September 2018 was carried out. The following variables were collected: sex, age, KRAS­mutation, the Eastern Cooperative Oncology Group scale (ECOG) at the beginning of treatment, number of previous lines and adverse effects (AEs). Median progression­free survival (PFS) and overall survival (OS) were recorded to evaluate effectiveness. Differences in survival were evaluated with the Kaplan­Meier test.

Results

Our study included 4 patients (3 women) with a mean age of 50,9 (45­61). They presented an ECOG 1 in all cases and they had received at least 4 prior lines and a maximum of 7 for mCRC. All of them presented a KRAS­mutation but one. The median PFS was 4. 33 (3–9) months and one patient died after 3 months of being treated. Treatments were discontinued in 3 of those patients following disease progression or patient’s death and none of them because of toxicity. The AEs related to regorafenib were asthenia (n=3), neutropenia (n=3), infection (n=3), edema (n=1), nausea (n=1), constipation (n=1), bleeding (n=1) and anorexia (n=1). Despite the number of AEs, only in one case they reach a grade 3. In this case, asthenia was de AE grade 3 presented

Conclusion

We had found regorafenib after TAS102 with a modest effectiveness (PFS 4. 33 months) and a tolerable toxicity for patients with refractory mCRC. Similar results have been found in other study already published (1) where they conclude a median PFS of 3,7 months in 10 Asian patients treated with regorafenib after TAS102. Further investigations with more patients will be needed to assess these results.

References and/or Acknowledgements

Tanaka A, et al. Retrospective study of regorafenib and trifluridine/tipiracil efficacy as a third line or later chemotherapy regimen for refractory metastatic colorectal cancer.2018;6589–97.

Conflict of Interest No conflict of interest

BAR19­0433 PHARMACEUTICAL CARE IN A PUBLIC NURSING HOME DURING THE PERIOD OF 2015 – 2017

M.B. DE­LA­NOGAL­FERNANDEZ1, V. MARTINEZ­FERNANDEZ1, M. NOGUEROL­CAL1, H. CASAS­AGUDO1, S.D.C. VAZQUEZ­TROCHE1, B.C. LOPEZ­VIRTANEN1, J.A. VALDUEZA­BENEITEZ1, M. RODRIGUEZ­MARIA1 1HOSPITAL EL BIERZO, HOSPITAL PHARMACY, PONFERRADA, SPAIN

Background

The integration of the hospital pharmacy service with the public residential care home of our area was in 2011. There are 204 places in this nursing home.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 21/60 05/11/2018 Rejected - S4.html Purpose

Description of the pharmaceutical interventions registered during 3 years in a fully assisted public residential care home, indicating the most frequent therapeutic groups and principle active ingredients as well as the medication which produces a greater economic impact.

Material and methods

An ambispective study of the pharmaceutical interventions realized from January 2015 until December 2017 was registered based on the 4thConsesus of Granada.

For the analysis of the therapeutic groups, principle active ingredients and the Pareto diagram, there are the Unidosis management modules, economic management and the statistical exploitation of the FarmaTools programme.

Results

A total of 638 pharmaceutical interventions were registered with a monthly patient average of 191.

The majority of the treatments were used on admission of the resident to the care home or when there was a modification in their treatment.

The order of frequency was:Therapeutic equivalents (adaptation to the hospital guidelines), inappropriate dosis/instructions/ duration, duplicates, interactions and contraindications.

The therapeutic groups implicated in the order of frequency were: antiulcer agents, anti­inflammatories, antirheumatic agents and painkillers, antibiotics, antidepressants, diuretics and benzodiazepines.

The most frequent active principles were: proton­pump inhibitors, serotonin reuptake inhibitors, NSAIDs, digoxin, hydroxyzine, diazepam and furosemide.

The medications that have supposed a greater economic impact have been: Vildagliptin/metformin, lactulose, Buprenorphine patches, Sodium phosphate enemas, Memantine, Valsartan and Clormethiazole (these 7 drugs have supposed 25% of the total cost).

Conclusion

The development of a pharmaceutical care programme implies an improvement in the efficiency and safety of treatments in the nursing home of the area in the last 3 years.

References and/or Acknowledgements

Deprescribing. European Journal of Hospital pharmacy. January 2017. Volumen 24. Issue 1 https://ejhp.bmj.com/content/24/1/1

Conflict of Interest No conflict of interest

BAR19­0443 UREA AS THERAPEUTIC ALTERNATIVE TO TOLVAPTÁN IN THE TREATMENT OF HYPONATREMIA ASSOCIATED WITH SYNDROME OF INADEQUATE SECRETION OF ADH

A. FERRER MACHÍN1, I. PLASENCIA GARCÍA1, P.M. GARCÍA GARCÍA2, J. MERINO ALONSO1 1HOSPITAL UNIVERSITARIO NUESTRA SEÑORA LA CANDELARIA, PHARMACY SERVICE, SANT A CRUZ DE TENERIFE, SPAIN 2HOSPITAL UNIVERSITARIO NUESTRA SEÑORA LA CANDELARIA, NEPHROLOGY SERVICE, SANTA CRUZ DE TENERIFE, SPAIN

Background

Hyponatremia is the most common electrolyte disorder in hospitalized patients. It is defined as a serum sodium concentration less than 135 mmol/L. The causes are multiple among which is the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). In this case, water restriction is the mainstay of treatment and if no improvement is observed, vasopressin receptor antagonists, such as Tolvaptan, are a therapeutic alternative, although there are other options such as Urea.

Purpose

To describe how the exchange of tolvaptan for urea in a patient with severe hyponatremia due to SIADH allows sodium levels to be maintained more stable.

Material and methods

Observational, retrospective and descriptive study of a patient with SIADH in a third­tier hospital.

The information has been obtained from the electronic clinical history (SELENE®) and the pharmacy service managing software (FARMATOOLS®).

Results

A 60­year­old woman with no known allergies to drugs and no toxic habits.

The patient was admitted to the hospital for hypervolemic hypoosmolar hyponatremia of 116 mEq/L, with plasma osmolality of 270 mOsm/kg, urinary sodium of 9 mmol/L and urine osmolality of 980 mOsm/kg.

As a first step, oral sodium and saline solution with 20% NaCl ampoules was started. After several days of irregular control and suspicion of SIADH, treatment with tolvaptan is started but adequate sodium control is not achieved. Then, medical team a change of therapeutic strategy. It was decided to suspend the tolvaptan and begin with the oral administration of urea (Urea NM). With tolvaptan the mean sodium levels were 121.1±5.9mEq/L, and with great variability. However, better control of sodium was achieved with urea, with a slow but stable rise, reaching a mean level of 126.1±6.6mEq/L.

Conclusion

The administration of oral urea supposed a better control of the sodium levels in this patient, compared to the previous administration of tolvaptan, achieving a slower, progressive and stable sodium ascent, and providing greater security to our patient, and also, with cost reduction.

References and/or Acknowledgements

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 22/60 05/11/2018 Rejected - S4.html .

Conflict of Interest No conflict of interest

BAR19­0456 THE USE OF CLINICAL PHARMACOKINETICS IN THE DESIGN AND CONTROL OF MEDICAL PRESCRIPTION

G. QUINONEZ1, G. QUINONEZ1 1UNIVERSITY OF BAJA CALIFORNIA, P AHRMACOLOGY AND BIOPHYSICS, TIJUANA, MEXICO

Background

This work presents an alternate form of dosage of a aminoglycoside , safer and more effective form, based on the use of the Fuller­Goldman method, which is useful for designing dosing regimens in drugs that have a high potential for the development of adverse reactions and a narrow therapeutic window.

Purpose

To readjust doses analyticaly . Analyzing data obtained of plasmatic concentration. These gave place to;

Use of a kinetic method. Validate an analytical method in the analysis of the sample. Kinetic studies on patients and individualize therapy. Creation of its Individual therapeutic regimen. Obtain kinetic parameters for aminoglycosides in Mexican patients

Material and methods

The study group was formed by convenience since you couldn't predict the number of patients who would be hospitalized In The State Hospital. It was carried out in 14 adult patients, 11 female and 3 male, with diferent diagnosis. Creatinine clearance and renal function were determined using the Crockfort­Gault nomogram.

We used a immunoassay method (EMIT) which is a homogeneous technique, its principle is based on the competence of the drug with the enzyme glucose­6­Phosphatase dehydrogenase. The activity of the enzyme Nicotine Adenine Dinucleotide oxidized in to the reduced form results in the change in the absorbance which is measured spectrophotometricalResults

We found that 65% of the patients had concentrations that fell within recommended levels (2 – 4.9 mcg/ml) for the pathologies encounter in the study. In these cases the patients had a volume of distribution between 12 to 16 L/Kg.

35% did not reach plasmatic concentrations in stationary state because they presented an atypical pharmacokinetic parameter.

Conclusion

This pharmacokinetic method is an excellent guide for the designing of individual regimen of dosification in a scientific way. Its predictive power is very acceptable for pharmacologic agents that have a very narrow therapeutical window and a high potential for producing toxic side effects.

The data from the plasmatic concentrations at steady state for gentamycin, 65% of patients their values obtained where the ideal therapeutic ranges for the diseases found.

References and/or Acknowledgements

1. Avent ML, Rogers BA, Cheng AC, Paterson DL. Current use of aminoglycosides: indications, pharmacokinetics and monitoring for toxicity. Internal Medicine Journal, 2011; 41(6): 441–449.

Conflict of Interest No conflict of interest

BAR19­0496 EVALUATION OF MULTIPLE SCLEROSIS COMITEE AND THE PHARMACEUTICAL ROLE IN CHANGES OF TREATMENTS.

J.L. ORTIZ LATORRE1, E. SÁNCHEZ YAÑEZ1, I. MOYA CARMONA1, J.M. FERNÁNDEZ OVIES1 1HOSPITAL VIRGEN DE LA VICTORIA, PHARMACY, MALAGA, SPAIN

Background

Since February 2017 is started in our Center a local MS comitte formed by neurologist and hospital pharmacist to evaluate the new treatments

Purpose

To evaluate the activity of the local MS comitee and to describe therapy changes, cause of them and the time between two lines of treatment

Material and methods

Retrospective, observational study that includes new MS treatments since February 2017 to April 2018. The variables studied were: type of request (naïve patients or changes of treatment), pharmaceutical intervention (yes or no), exchange rate (interclass, de­escalated and escalated), reason for the change and the time between two treatments lines.

Data were obtained from a specific database created by local MS comitee and from outpatient application.

Results

During the study period, 54 requests were made. 37% naïve patients and 63% changes of treatment. The pharmacist made 7 interventions to propose a more efficient alternative ( vs oral treatments). All of them were accepted. The exchange rates were: interclass (58`9 %),

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 23/60 05/11/2018 Rejected - S4.html escalated to a second line (29`4%) and de­escalated (11`7%).

In the other hand the reasons for the change were: adverse effects (50%), progression of the disease (44`1%) and request of the patients (5´9%).

In cases where changes of treatments were by progression of the disease, local MS comitee decided escalated to a second line in 69% of the cases and when the changes of treatments were by side effects, in 70% of cases decided an interclass change.

The time elapsed between two treatment lines was 25`9 months when the change was interclass and 14 months when the change was escalated to a second line.

Conclusion

The beginnings of treatment evaluate by local MS comitee were adjusted to the guidelines of the Community. The pharmaceutical interventions were destined to improve the efficiency of the treatments.

With regard to therapy changes, it was decided mainly interclasses change if the reason was the adverse effects and escalated to a second line if the reason of the change was progression of the disease.

Finally the time between two treatment lines was longer when a interclass change was made than when a escalated change was made

References and/or Acknowledgements

No conflict of interest

Conflict of Interest No conflict of interest

BAR19­0500 PHARMACEUTICAL INTERVENTION DURING STROKE THERAPEUTIC EDUCATION

M. STRUMIA1, A.L. BOURGEOIS1, C. DURAN1, Y. HAKIMI1, C. TRAVÈRE2, M. BARBIEUX­GUILLOT2, C. LABORDE1 1CHU DE TOULOUSE, PÔLE PHARMACIE, TOULOUSE, FRANCE 2CHU DE TOULOUSE, SERVICE DE NEUROVASCULAIRE, TOULOUSE, FRANCE

Background

Therapeutic education programs allow patients to improve their knowledge and qualifications. A nurse of therapeutic education suggests this type of program to patients who had a stroke. The pharmacist participates in educational diagnosis and workshop about therapeutics. During the educational diagnosis, pharmacist did a drug review highlighted potential problem. Throughout this program, pharmacist can suggest prescription’s improvements to doctor by letter signed by pharmacist and neurologist. It is the pharmaceutical intervention (PI).

Purpose

One year after the beginning of stroke therapeutic education program, we analysed the becoming of PI.

Material and methods

Between 3 and 19 months after workshop, pharmacist called patients who need PI to find out if doctor had accepted them. PI were classified by the validated scale of the “Société Française de Pharmacie Clinique” according to the type of problem and intervention.

Results

We included in educational diagnosis and therapeutics workshop 38 patients. The median age was 63.5 years [22;86].

Nine patients (26.3%) were concerned by PI (n=14), with on average 1.6 PI by patient. The main problem described was “adverse drug reaction” (42.9%) with statin use. The other problems were contraindication (21.4%), non­indicated drug (14.3%), poor choice of galenic (14.3%) and under­ dosing (14.3%). Interventions were switch (50.0%) or stop (28.6%), optimization of drug administration (14,3%) and therapeutic follow­up (7.1%).

Eight PI were accepted by doctor (57.1%).

About PI declined (n=3), either patient did not feel the side effect or doctor deemed PI useless. But, for one of patient who needed PI about poor choice of galenic formulation, even if doctor refused PI, the patient follows the recommendations of pharmacist.

For 3 PI, we were unable to evaluate becoming: one patient refused 2 PI and stopped their treatment, one patient did not see their doctor in the period.

Conclusion

Therapeutic education can be a way for a revaluation of the prescription according to the need of the patients and the literature were very poor about this subject. The period between the suggestion of PI and patient calling were different for each patient, and we did not discuss with doctor directly.

References and/or Acknowledgements

Alami, Therapeutic education of the patient: The role of the hospital pharmacist, EJHP 2016

Conflict of Interest No conflict of interest

BAR19­0497 EVALUATION OF THE EFFECTIVENESS AND SAFETY OF PIRFENIDONE IN IDIOPATHIC PULMONARY FIBROSIS

E.G. FERNÁNDEZ LÓPEZ1, M.P. DIAZ RUIZ1, M. SUAREZ GONZALEZ1, E. RAMOS SANTANA1, R. MESA EXPOSITO1, E. TEVAR ALFONSO1, E. GOMEZ MELINI1, J. MERINO ALONSO1 1HOSPITAL NUESTRA SEÑORA DE CANDELARIA, HOSPIT AL PHARMACY, SANTA CRUZ DE TENERIFE, SPAIN

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Background

Idiopathic pulmonary fibrosis (IPF) is a devastating disease with rare incidence but high mortality. Patients with IPF have a median survival of about 2­5 years. Pirfenidone is an antifibrotic agent that has shown clinical benefit in mild to moderate IPF in clinical trials.

Purpose

To evaluate the effectiveness and safety of pirfenidone in patients with IPF.

Material and methods

Retrospective observational analysis of the use of pirfenidone in our hospital from 2016 to september 2018 was conducted.Variables included: sex, age and tobacco habit. The evolution of respiratory function tests (PFR) such as forced expiratory volume (FEV), forced vital capacity (CVF), lung carbon monoxide transfer capacity (DLCO) before and after the treatment was analyzed. We also confirm the presence of non obstructive pattern FEV1/CVF > 0.7. The effectiveness was evaluated by the proportion of patients who had a decline of ≥10% in the FVC in an interannual period or less (the most important predictor of mortality in IPF). The occurrence of adverse events was reviewed.

Results

Seven patients with moderate IPF were included. 57% were male and 43% female. The median age was 72 years (64­81). 57% had been smokers. PFR and effectiveness were analyzed: FEV increased in two patients, decreased in three and remained stable in two. DLCO increase in two patients, decreased in one, remained stable in two and results of two patients were not available . All patients had a ratio FEV / FVC > 0.7 Three patients had a reduction < 10% in CVF, three were stable and one had a reduction > 10%. The initial dose of pirfenidone coincides with that described in the data sheet: one capsule / 8h (801 mg / day), gradually increasing to 3 capsules / 8h (2,403mg / day). 56% presented adverse effects: gastrointestinal (34%), mild liver disorders (11%) and weight loss (11%).

Conclusion

Pirfenidone has shown to decrease the deterioration of CVF in patients with IPF. We had a good response in 86% of patients, with a lack of efficacy (reduction of CVF> 10%) in one patient. The rate of adverse effects was high, although none required adjustment of dose.

References and/or Acknowledgements

Acknowledge the help provided by the pharmacy members.

Conflict of Interest No conflict of interest

BAR19­0516 USE OF MEDICINES FOR HOSPITAL USE IN HEALTH CARE CENTERS

S.M. SANZ RODRÍGUEZ1, A. REPILADO ALVAREZ1, R. SANABRIAS FERNANDEZ DE SEVILLA1, M. CALVO SALVADOR1, V. SAAVEDRA QUIRÓS1, A. SANCHEZ GUERRERO1 1HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, SER VICIO DE FARMACIA HOSPITALARIA, MADRID, SPAIN

Background

Socio­health care for the fragile elderly polymedicated has increased in recent years, adapting to the needs of today's society.

In October 2016, the Institutionalized Patient Care Unit (UAPI) was opened to take care of these patients, which reduced the time spent in the emergency room and encouraged the humanization of urgent hospital healthcare.

Another fundamental aspect is to agree with the medical services of residences on the pharmacological treatments and hens, distributing by our hospital avoiding the unnecessary movement of the patient to the hospital.

Purpose

Analyze and elaborate information for the safe use of medicines for hospital use in the Health Centers of our Health Care Area.

Material and methods

Retrospective study of the use of medication for hospital use in socio­sanitary centers from October 2016 to March 2018 through coordination with the UAPI or institutionalized patients discharged.

Based on the data obtained through the Farmatools computer application, the following variables were analyzed: age, sex, drugs dispensed and number of dispensations.

We wrote 8 information sheets and a table with 49 records of the characteristics of intravenous medication to ensure the safe administration of these drugs by specialists.

Results

Since October 2016 to March 2018, 148 patients with an average age of 87 years, of which 69.60% were women, received hospital medication from the Pharmacy Service to complete their treatment in social health centers.

Monotherapy occurred in 87.84% of the patients, while the remaining 12.16% received tow or more drugs. Single dispensation of treatment occurred in 95.27% of the patients, whereas only 4.73% were dispensed two or more times the same drug on different dates. Intravenous antibiotics were the most frequently used (73.65%): amoxicillin / clavulanate (31.20%), ceftriaxone (26.60%) and ertapenem (22.02%).

Conclusion

The creation of a new area in Emergency Department: UAPI favours the integration of the pharmacist in this service who provides a better pharmacological control of the patient and collaborates in the information and administration of treatments through the creation of information sheets

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 25/60 05/11/2018 Rejected - S4.html and guides of quick access of the characteristics of intravenous medication administration.

References and/or Acknowledgements

This work has been carried out thanks to the coordination between the pharmacy and emergency services.

Conflict of Interest No conflict of interest

BAR19­0544 REAL­LIFE EXPERIENCE OF ERIBULIN IN PATIENTS WITH ADVANCED LIPOSARCOMA

H. RODRÍGUEZ RAMALLO1, R. JIMÉNEZ GALÁN1, N. BÁEZ GUTIÉRREZ1, S. FLORES MORENO1, L. ABDELKADER MARTIN1, M.D. VEGA COCA1, M. MUÑOZ BURGOS1 1HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO, PHARMACY, SEVILLA, SPAIN

Background

Eribulin was approved in April 2016 by European Medicines Agency for treatment of patients with unresectable or metastatic liposarcoma who have progressed with prior anthracycline­containing treatment.

Purpose

To evaluate effectiveness and safety of eribulin in real­world patients with advanced liposarcoma.

Material and methods

Observational retrospective and single­centre study that included patients who received treatment with eribulin for advanced liposarcoma from June 2016 to August­2018. Variables collected were: gender, age, basal Eastern Cooperative Oncology Group performance status (ECOG), prior lines of treatment, number of cycles, progression and death date, adverse events (AE), treatment discontinuation and dose reductions.

Response rate was assessed by computed tomography. Progression free survival (PFS) was measured from time of beginning treatment with eribulin to date of first progression or death from any cause. PFS was calculated by Kaplan­Meier analysis. Data analysis was performed using the statistical package SPSS 21.0 for Windows. Clinical data were obtained from clinic electronic history and corporate prescription software Farmis Oncofarm®.Results

We included 13 patients, 9 men and 4 women with a mean age of 59.7 years range (40.6­80.7). Seven patients had ECOG 0, four patients ECOG 1 and two patients ECOG 2. Eribulin was provided as second, third and fifth line chemotherapy in seven, two and one patients, respectively. The remaining three patients received it as first line due to contraindication to anthracyclines. Median number of cycles was 3 (range 1­9).

Complete response was not achieved in any patient; partial response and stable disease were recorded in one and four patients, respectively. The remaining patients showed progression disease. Median PFS was 2 months (95% CI 0.95­3.04). AE occurred in 6 patients. Most frequent AE were gastrointestinal (30.8%), neurotoxicity (15.4%) and neutropenia (7.7%). No patient discontinued treatment by toxicity and no dose reductions were necessary.Conclusion

The effectiveness of eribulin on real­world patients was modest. PFS values were lower than published in the literature. Eribulin showed an acceptable toxicity profile; more than half of patients showed no AE and no patient required dose reduction. Studies with larger sample size are needed to determine real­life effectiveness of eribulin.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0553 EFFECTIVENESS OF BECLOMETHASONE SOLUTION FOR MANAGEMENT OF GASTROINTESTINAL GRAFT­VERSUS­HOST DISEASE

H. RODRÍGUEZ RAMALLO1, N. BÁEZ GUTIÉRREZ1, M. LADRÓN DE GUEVARA GARCÍA1, M. MUÑOZ BURGOS1 1HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO, PHARMACY, SEVILLA, SPAIN

Background

Gastrointestinal graft­versus­host disease (GI­GVHD) is a severe complication frequently presented after allogeneic stem­cell transplantation. A common approach for the treatment of GI­GVHD has been high doses of systemic corticosteroids (SCS) often combined with systemic . Oral beclomethasone dipropionate (BDP) is a topically active corticosteroid with low systemic bioavailability; it has shown efficacy and safety as monotherapy or in combination with SCS.

Purpose

To evaluate the effectiveness of formulated BDP 0.5 mg/ml corn oil solution for the treatment of GI­GVHD.

Material and methods

Retrospective observational study of acute myeloid leukemia patients who after allogeneic stem­cell transplantation were treated with BDP solution within 2013­ 2017.

Data collected: demographics, GI­GVHD confirmed by biopsy, dose and posology, treatment duration, concomitant use of SDS, partial/total withdraw of SDS using BDP, response to treatment, survival at 200 days after transplantation.

The information was obtained from the corporate prescription program Athos Prisma® and from the Diraya® clinical station.

Results

Clinical data was obtained for 39 patients (53.8% female, average age 37 years, median age 41 years) 5 patients were treated up to 3 different occasions with BDP. file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 26/60 05/11/2018 Rejected - S4.html GI­GVHD was confirmed on 44.4% of patients by biopsy, the rest were treated based on symptomatology.

Patients were treated with 2 mg of BDP administered every 6h (60%), 8h (35.6%), 12h (4.4%). Median BDP treatment duration: 153 days (range 2­ 1431).

68.9% of patients were treated with SDS + BDP (33.3% stopped requiring SDS, 22.2% reduced the dose required) 31.1% were treated with BDP as monotherapy.

Complete response ratio: 51.1%, partial response ratio: 26.7%.

Survival at 200 days after transplantation ratio: 76.9%

Conclusion

BDP has shown effectiveness for treatment of GI­GVHD as monotherapy and in combination with SDS; it also showed reasonable results at reducing and completely replacing SDS. Multiple courses may be necessary to achieve or maintain response in some patients, and prolonged BDP therapy is a feasible alternative to SDS.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0604 ANOTHER WAY TO COMMUNICATE WITH THE PATIENTS OF THE RETROCESSION

F. THERON1, F. LACAUD1, M. MERLET1, F. VIDAL1 1CENTRE HOSPITALIER DE DAX, PHARMACIE, DAX, FRANCE

Background

Communication has a major role in our current society. In the retrocession of hospital pharmacy (out­patient dispensing of hospital­reserved drugs) this communication is between the health professional and the patient. To improve the welcome and conviviality in the waiting room of our retrocession, we have chosen a new way to communicate with our patients. Before the patient had to make the effort to read the information (posters, flyers, ...). Now the information comes directly to their eyes and ears. How did we transform the waiting into an enjoyable and informative moment?

Purpose

By projecting flash videos: this project called MyTVPharma uses current technologies and strengthens the link between the city and the hospital.

Material and methods

The first video (April­June 2018) communicated on the results of a satisfaction survey and on the opening hours. The second video (since June) informs about the update of drugs available at the retrocession according to the supply tensions. Vaccination awareness was also conducted. The videos (images and sound) have composed of useful reminders and then medical interview or a video extracted from an official website. We have used: Powerpoint 2016, OpenShot Video Editor, voice recorder Samsung Galaxy S6, a Nikon D5600 camera, a TV 51x40 centimeters.

Results

There were 2042 passages recorded at the retrocession from 1 April 2018 to 31 August 2018 (corresponding to 513 patients) and therefore potentially as many views. The videos last 3 to 5 minutes each and their making requires 2 to 4 hours. Two videos have been made, a third is in preparation. A total of 3 to 4 videos will be made each year.

Conclusion

This communication way allows to capture attention of patients and broadcast a lot of messages. It implies some prerequisites: making attractive video, adapted to the waiting time, updated regularly. In the next videos, the physicians will be solicited. Thanks to the sound environment generated in the waiting room, confidentiality area at the retrocession counter has also optimized. MyTVPharma is part of a broader project of optimizing communication within the establishment. A digital team has been created to discuss about the topics covered in these videos.

References and/or Acknowledgements

/

Conflict of Interest No conflict of interest

BAR19­0557 EFFECTIVENESS OF BECLOMETHASONE SOLUTION FOR MANAGEMENT OF GASTROINTESTINAL GRAFT­VERSUS­HOST DISEASE IN CHILDREN

H. RODRÍGUEZ RAMALLO1, N. BÁEZ GUTIÉRREZ1, M. LADRÓN DE GUEVARA GARCÍA1, M. MUÑOZ BURGOS1 1HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO, PHARMACY, SEVILLA, SPAIN

Background

Gastrointestinal graft­versus­host disease (GI­GVHD) remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation in children; treatment with prolonged high­dose systemic corticosteroids (SDS) has limited success and considerable toxicity. Beclomethasone dipropionate (BDP) is a potent topically active steroid which has shown efficacy treating GI­GVHD.

Purpose

To evaluate the effectiveness of formulated BDP 0.5 mg/ml olive oil solution for the treatment of GI­GVHD in children

Material and methods

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 27/60 05/11/2018 Rejected - S4.html Retrospective observational study of children treated with BDP solution within 2013­ 2017.

Data collected: demographics, diagnosis previous to allogenic transplantation, GI­GVHD confirmed by biopsy, dose and posology, treatment duration, concomitant use of SDS, partial/total withdraw of SDS using BDP, response to treatment, survival at 200 days after transplantation.

The information was obtained from the corporate prescription program Athos Prisma® and from the Diraya® clinical station.

Results

Clinical data was obtained for 22 patients, (80% males, average age 10 years range (1­17)); 2 patients were excluded because the absence of data.

Diagnosis: Acute lymphoid leukemia 10 patients, acute myeloid leukemia 4 patients, myelodysplastic syndrome 2 patients, no­hodking lymphoma 2 patients, hodking lymphoma and refractory immunodeficiency one patient each.

GI­GVHD was confirmed on 50% of patients by biopsy, the rest were treated based on symptomatology.

Patients were treated with 2 mg of BDP administered every 6h (45%), 8h (45%), 12h (10%).

Median BDP treatment duration: 97.5 days (range 29­274).

70% of patients were treated with SDS + BDP (55% stopped requiring SDS, 5% reduced the dose required) 40% were treated with BDP as monotherapy.

Complete response ratio: 70%, partial response ratio: 0%.

Survival at 200 days after transplantation ratio: 90.9%

Conclusion

BDP has shown effectiveness for treatment GI­GVHD in children as monotherapy and in combination with SDS, it also showed reasonable results at replacing completely SDS. A prolonged BDP therapy could be a feasible alternative to SDS.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0572 CHARACTERISTICS OF CLINICAL TRIALS OF THE NEUROLOGY SERVICE IN A THIRD LEVEL HOSPITAL

A. RUIZ GÓMEZ1, A. PAREJA RODRÍGUEZ DE VERA1, S. MARTÍNEZ COMENDADOR1, M. SÁEZ GARRIDO1, A. TOMÁS LUIZ1, A. ESPUNY MIRÓ1 1HOSPITAL CLÍNICO UNIVERSIT ARIO VIRGEN DE LA ARRIXACA, PHARMACY, MURCIA, SPAIN

Background

Neurological diseases represent an important social and health problem making it necessary to empower and to promote research projects.

Purpose

Analyze and describe the characteristics of the active clinical trials (CT) of the Neurology Service of a tertiary hospital.

Material and methods

Observational, cross­sectional and descriptive study of the CT in progress, in April 2018, related to the area of Neurology in the Pharmacy Service.

The following variables were collected: number of active CT, start date of the trial, phase of study, type of masking, randomization, comparison drug (placebo or active principle), scope (national or international), study centers, molecule of investigation, route of administration, pathology studied, promoter (industry or independent clinical research), researcher, number of patients included per trial, sex and age of the patients.

Results

A total of 10 active CT were obtained at the time of the study, with a total of 36 patients and a median of 2.5 patients per trial. The median age was 49 years (15­76). 90% of the CT registered were phase III, with the remaining 10% being phase II. In 70% of the cases, the masking was double­blind compared to 30%, which was opened. 70% of the CT were controlled with placebo, 10% with another active principle and 20% were not controlled.

All trials were multicenter and only one was limited to the national level. The promoter was the industry in 90% of the CT analyzed and in 10%, cooperative groups. In 50% of the CT the investigated molecule was not commercialized at the date of the study. The oral route of administration was used in 50%, using the parenteral route in the same percentage. The studies were concentrated in two main researchers: the first in multiple sclerosis, which accounted for 70% of the pathologies studied, and the second in Alzheimer's disease, with 30% of the CT. 20% included only pediatric patients and all of them recruited both men and women.

Conclusion

Research in the Neurology Service focuses on phase III, double­blind, randomized, placebo­controlled, international, multicenter CT, involving adult patients. The most studied pathology is multiple sclerosis. Studies are carried out both with new molecules and with drugs already marketed.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0585 DIFFERENCE BETWEEN PUBLIC AND PRIVATE SECTOR IN THE MANAGEMENT OF PHARMACEUTICALS WITHIN THE HOSPITAL file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 28/60 05/11/2018 Rejected - S4.html

S. BENZEKRI1, M. BOUATIA2, A. CHEIKH3, A. BENNANA1, M.A. EL WARTITI4 1FACULTY OF MEDICINE AND PHARMACY, LABORATORY OF THERAPEUTIC CHEMISTR Y CLINICAL AND HOSPITAL PHARMACY, RABAT, MOROCCO 2FACULTY OF MEDICINE OF RABAT, PHARMACY POLE, RABAT, MOROCCO 3CHEIKH ZAID HOSPITAL, PHARMACY, RABAT, MOROCCO 4PHARMACY CENTER­ MOHAMED V MILITARY TRAINING HOSPIT A, PHARMACY CENTER, RABAT, MOROCCO

Background

The survey is a retrospective study, the methodology adopted is based on adescription of the sample studied. In a first part, we presented the characteristics of theestablishments. In a second step, we determined the inter and intra item correlations, whichwere established between the studied factors of each dimension.

Purpose

In this study, it's about understanding the nature of the relationship betweenpharmacist and unit of care. We achieved this goal by administering the survey topharmacists.

Material and methods

Our target is essentially the pharmacists of SEGMA hospitals, CHUsand private clinics. In order to design our survey, we based ourselves on the theoretical part, with which we couldidentify the nature of the questions and their contents while respecting certain rules ofsimplicity and clarity. For the elaboration of our questionnaire, we took the Sphinx as working software, and for thecounting and processing of the results, we took the Spss as a tool in all the design stages. For the method of administration, the face­to­face method was chosen to assist therespondents and ensure the relevance of the results.

Results

It is a study of 65 health establishments, of which 20% are private establishmentsagainst 80% are public institutions. To search for possible associations, we performed the test of χ² is used to find out if asignificant difference exists between certain variables. A risk of the first species of 5% was chosen for the realization of the statistical tests and risks between 5% and 10% will explainthe trends.

Conclusion

According to khie­two analyzes, it was found that the factors of "overstock, orderfrequency, normal order lead time, urgent order, desired delivery system, storage space,storage and accessibility, stock management manager” have a significant differencedepending on whether it is a CHU, SEGMA hospital or a private clinic.

References and/or Acknowledgements

Reporting of public hospital of rabat Reporting of clinical pharmacy

Conflict of Interest No conflict of interest

BAR19­0594 AUDIT OF THE PRACTICES OF USE OF ALBUMIN

F. BERDI1, Y. TADLAOUI1, N. NCHINECH1, J. IFEZOUANE1, A. BENNANA2, J. LAMSAOURI1 1MOHAMMED V MILITARY TEACHING HOSPITAL, PHARMACY, RABAT, MOROCCO 2FACULTY OF MEDICINE AND PHARMACY RABAT, DEPARTMENT OF THERAPEUTIC CHEMISTR Y, RABAT, MOROCCO

Background

The albumin is a drug with particular status, very prescribed in our establishment,in spite of a checked dispensation.The increase of the consumptions and the highlighting of indications except AMM or except recommendations,led to us to realize a clinical audit

Purpose

The objective of our study is to estimate the prescription of the albumin in our establishment

Material and methods

It is a retrospective study of 12 months.The data collection was realized from the index cards established by pharmacy. By referring to the literature and to the indications of albumin, A railing beforehand tested and validated was established.She resumes the indications found in the literature : Draining of ascite, infection of the liquid of ascite, hypovolémic shock and others. Criteria of good use were validated by the specialists.Data analysis was performed using the SPSS.23 software

Results

The study concerned the prescriptions of albumin from the beginning of August 2017 till fine August 2018. 262 index cards were analyzed among which 27% were not informed.The most customized unit were the Intensive care unit surgical (25 %), The inetensive care medical (22%),the gastrology unit (12%),burn unit (10%) and 31% of the requests from other units.The indications were 20% for hypoalbuminemia not having answered the only cristalloïdes,18% of undernutrition,12% of septic shock associated with a hypoalbuminemia,10% of ascite,6%of septic shock with hypoalbuminemia,4% of cirrhosis with hypoalbuminemia,3% of néphrotic syndrome and 2 cases of exchanges plasmatiques.The duration of treatment varied between one day for the patients having ascite draining and 30 days for the patients having a undernutrition with a septic shock and hypoalbuminémia.The patients having received a prolonged duration of treatment were admitted in intensive care unit.According to the recommendations of the HAS, the prescription of the albumin for ascite was in accordance. In the hypovolemia administered dosage was in accordance in 80% of the cases. In The severe hypoalbuminémia with septentic shock in only 38%.The albumin has no indication in the undernutrition.

Conclusion

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 29/60 05/11/2018 Rejected - S4.html This audit allowed us to establish a current situation of the use of the albumin in our establishment and to reveal the use of albumin in certain cases there except AMM and except recommendations

References and/or Acknowledgements

no one

Conflict of Interest No conflict of interest

BAR19­0595 Comparative Study of glycemia on serum and whole blood of 6 glucometers

F.Z. RAHMAOUI1, M. RHATOUS1, O. EL HAMDAOUI1, H. ATTJIOUI1, A. CHEIKH2, H. MEFTAH3, I. ZENEB1, M. BOUATIA1 1MOHAMMED V UNIVERSITY­ FACULTY OF MEDICINE AND PHARMACY., PAEDIATRIC HOSPITAL­ PHARMACY­, RABA T, MOROCCO 2ABULCASIS UNIVERSITY ­ FACULTY OF PHARMACY RABAT MOROCCO, CHEIKH ZAYD HOSPITAL­ PHARMACY­, RABAT, MOROCCO 3IBN SINA HOSPITAL­ PAEDIATRICS HOSPITAL., PAEDIATRIC HOSPITAL­ PHARMACY­, RABAT, MOROCCO

Background

The measurement of blood glucose using a glucometer is a quick, simple and inexpensive method that requires a small amount of blood. However, the accuracy of the results obtained is sometimes controversial especially with the plethora of brands marketed on the market.

Purpose

Evaluate the interference of the red blood cell and the concentration of glucose on glycemia measurement by the glucometers.

Material and methods

On 30 samples, we made a first measurement of the fasting blood glucose and postprandial on the venous blood and a second measurement on the serum after centrifugation of 3mn by 6 glucometers of different brands.A third measurement as a reference value is performed by an enzymatic method with hexokinase / G­6­PDH on a biochemistry automat. Glucometers 1 to 4 use glucose dehydrogenase as an enzyme, and glucometers 5 and 6 use glucose oxidase as an enzyme. The results are expressed as mean ± SD. The statistical analysis is done by the ANOVA test.

Results

The table shows differences in the results between the glucometers measurements and the reference value in g / L

Devices Fasting Glycemia Difference Postprandial Glycemia Difference Whole blood Serum Whole blood Serum glucometer 1 0,046±0,326 0,141±0,172 ­0,192±0,204 0,147±0,104 glucometer 2 0,084±0,212 0,223±0,090 ­0,045±0,151 0,244±0,081 glucometer 3 0,001±0,277 ­0,133±0,217 ­0,189±0,173 ­0,198±0,196 glucometer 4 0,342±0,306 0,114±0,108 ­0,07±0,180 0,152±0,053 glucometer 5 ­0,445±0,385 ­0,186±0,199 ­0,779±0,518 ­0,302±0,423 glucometer 6 0,172±0,221 0,608±0,296 0,039±0,154 0,805±0,390 Conclusion

The measured blood glucose by the biochemical analyzer and the glucometers (1­2­3­4) are not statistically different. In contrast to glucometers (5­6), the glycemia values are different from the reference values[1] (p <0.001), whether they are used for fasting or postprandial measurements on whole blood or serum. So the result depends on the type of the enzyme. We also note that there is a significant difference between serum and total blood glucose measurements (p <0.05), whereas there is no significant difference (p> 0.05) between the low and high glucose concentrations. Therefore the red blood cell interferes with the measurement of blood glucose contrary to the change in concentration

References and/or Acknowledgements

[1]Fonfrede,M.Lecteurs de glycémie comparaison des résultats de 5 lecteurs et écart par rapport ā la glycémie veineuse du laboratoire 2011

Conflict of Interest No conflict of interest

BAR19­1004 CONTRIBUTION OF THE PHARMACIST IN THE SPECIFIC CARE ACCORDING TO GENOTYPE OF PATIENTS SUFFERING FROM CHRONIC HEPATITIS C IN A UNIVERSITY HOSPITAL CENTER.

F.Z. HADJADJ AOUL1, L. ALLEL1, S. IGUEBLALENE1, Y. TOUHAMI1, A. TEMAM1 1UNIVERSITY HOSPITAL CENTER MED LAMINE DEBAGHINE, PHARMACY, ALGIERS, ALGERIA

Background

Chronic hepatitis C is a liver disease caused by the Hepatitis C Virus (HCV), which can lead to cirrhosis or liver cancer.The national strategy against this disease encourages the hospital pharmacist to participate more closely in the choice of adequate therapy and be an active element in the monitoring of different therapeutic profiles.

Purpose

­Show pharmacist’s involvement for a better management of patients by the continuous monitoring of their response to treatments; ­Compare the conventional and the new therapeutic strategies in terms of efficacy, tolerance, remission, resistance, duration of treatment.

Material and methods

A retrospective observational statistical study carried out by hospital pharmacists on 60 patients with positive HCV viremia.The patient data (epidemiological,clinical,virological,histological,biological) were processed using an exploitation sheet.The follow­up of patients (appearance of undesirable effects and intolerance) is mainly carried out by telephone calls to the patients or during the medical consultations.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 30/60 05/11/2018 Rejected - S4.html Results

30 patients were treated with conventional therapy (peginterferon + ribavirin) for a duration depending on the genotype of the virus and the stage of fibrosis.The term virological response is favorable in 66.7% of cases with 56.7% sustained virological response (genotype1: 47%,genotype 2: 35.3%,genotype 3: 17.6%,genotype 4: 0%),33% failure,10% relapse.The adverse effects were numerous which required the premature discontinuation of treatment in 10% of cases and the reduction of doses in 30% of cases.The remaining 30 patients received the new sofosbuvir therapy.The final virological response is favorable in 93.3% of cases with 90% sustained virological response (genotype 1:59.3%,genotype 2:25.9%,genotype 3:11%,genotype 4:3.7%),6.7% non­responders,3.3% relapse.Less adverse effects were identified.This confirms the benefits of the new anti­HCV strategy on our patients,in terms of better efficacy and tolerance with a half­life of treatment.The best therapeutic response was observed,in both cases,in patients infected with genotype 1 HCV.

Conclusion

The therapeutic revolution in the treatment of chronic hepatitis C and the use of antivirals with more and more specific action appeal to the know­how and in­depth knowledge of the hospital pharmacist,especially with the constant evolution of AMM drug molecules.His skills could be a real contribution to the updating of therapeutic recommendations,as part of a multidisciplinary collaboration with clinicians, biologists and anatomo­ pathologists.

References and/or Acknowledgements

No conflict of interest.

Conflict of Interest No conflict of interest

BAR19­0629 OFF­LABEL TREATMENT IN NEUROPSCYCHIATRIC WARD FOR CHILD: A NEW WAY TO MANAGE DRUG REQUEST AND MONITORING OUTCOMES

L. FANTINI1, L. ROSSI1, C. POLIDORI2, M. MUSSONI1, E. BAGNI1, B. GAVIOLI1 1OSPEDALE INFERMI ­ AUSL ROMAGNA, FARMACIA OSPEDALIERA, RIMINI, IT ALY 2UNIVERSITY OF CAMERINO, DEPARTMENT OF EXPERIMENTAL MEDICINE AND PUBLIC HEA TH, CAMERINO, ITALY

Background

In the last years it has been observed in neuropscychiatry an increase in prescriptions of psychotropic drugs for children. These prescriptions were out of indication and not for the age of the kids. In particular antipsychotic (95.6%) and antidepressive drugs and litium (51.1%). So far off label prescription in pediatry has to follow an evaluation for each kid by the board for drug evaluation. Therapies frequently are given under emergency conditions without any consulting of the literature and without of an evaluation of the effects in a long term.

Purpose

The objective of this work was to prescribe under a consistent literature and to better evaluate in a long term the effects of the drugs.

Material and methods

First has been recognized all the off label treatment, secondly whether the dispensed drugs where present in the region formulary and third whether the treatment had a support by randomized clinical trials of at least of fase II. Toxic effect where monitored and some parameter where evaluated for efficacy and safety of the drug treatment.

Results

The request of drugs from the medical doctor has been simplyfied and the board for drug evaluation is non anymore needed for prescription. The medical doctor needs to evaluate every three month the outcom of drug treatment.

Conclusion

The prescription of off label drugs for kids needs to have solid scientific bases such as randomized clinical trials, the doctor need to monitor the outcome of the treatment as well as its inefficacy and the oxic effects need to be recorded.

References and/or Acknowledgements

NO.

Conflict of Interest No conflict of interest

BAR19­0642 PHARMACEUTICAL CONSULTATIONS FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TREATED BY ORAL TARGETED THERAPY : HOW TO PUT IT INTO PRACTICE ?

E. MATUSIK1, A. LELEUX1, L. INCHIAPPA2, A. SAINT GHISLAIN1, A. DESWARTE1, S. TOMBELLE1, J.M. PIGNON2, F. DANICOURT1 1CENTRE HOSPITALIER DE DUNKERQUE, PHARMACY, DUNKERQUE, FRANCE 2CENTRE HOSPITALIER DE DUNKERQUE, HEMATOLOGY, DUNKERQUE, FRANCE

Background

New oral targeted therapies for chronic lymphocytic leukemia (CLL) are changing patients’ quality of life. Patients have to manage their treatment chronically on their own. However, oral therapy may lead to less compliance, expose to side effects and drug interactions. In the context of limited medical time in our hospital, how pharmacists can assist patients in the management of their CLL oral treatment?

Purpose

Following a hematologist’s request to participate in follow­up of patients with CLL treated by oral targeted therapy, we decided to organize pharmaceutical consultations, but how to put it into practice?

Material and methods

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 31/60 05/11/2018 Rejected - S4.html A multidisciplinary working group was created (hematologists, pharmacists). Because of limited pharmaceutical staff, we decided to focus on patients with CLL treated by ibrutinib, venetoclax and idelalisib. We developed a care pathway for patients in collaboration with hematologists. We organized a multidisciplinary meeting to define how to organize it and which tools could be used, based on recommendations from the “white paper”, the Cancer Plan and bibliographic research. Finally, we wondered how to establish a town­hospital network to follow patients.

Results

We decided to set up 3 pharmaceutical consultations following the medical encounter in the pharmacy. The first one takes place after the medical consultation to initiate the treatment, to teach how to take the drug and how to manage adverse effects. The second consultation is scheduled 1 month after initiation of treatment to check patient comprehension and to expand on some of the points. The third consultation occurs after 3 months, to evaluate the compliance and self­management of adverse effects. To support these consultations, we created documents, such as a patient follow­ up file. We developed a town­hospital networks, thanks to medication reconciliation, analyze of drug interactions and pharmaceutical consultations reports.

Conclusion

We started pharmaceutical consultations 5 months ago. They permit a personalized and multidisciplinary follow­up of patients. While building a therapeutic education program is really time­consuming, these consultations are an interesting alternative. Unfortunately, these pharmaceutical consultations aren’t monetarily valuated and require availability of pharmaceutical staff, so that only few patients may benefit from them. This care pathway will be soon evaluated.

References and/or Acknowledgements

Société Française d'Hématologie. Livre blanc 2016. http://sfh.hematologie.net/hematolo/UserFiles/File/PDF/Livre_Blanc_Hemopathies_malignes%20_Version_Numerique_Nov_16.pdf

Conflict of Interest No conflict of interest

BAR19­0644 ADVANCES IN QUALITY OF TB CARE AND SERVICES: IMPLEMENTATION OF CLINICAL PHARMACY IN TREATMENT OF TUBERCULOSIS IN AUSTRIA

I. LAGOJA1, R. RUMETSHOFER2 1OTTO WAGNER SPITAL, HOSPIT AL PHARMACY, 1145 WIEN, AUSTRIA 2OTTO WAGNER SPITAL, AUSTRIAN CENTER FOR TREATMENT OF RESIST ANT TBC­ PAVILLON SEVERIN, 1145 WIEN, AUSTRIA

Background

The annual incidence of tuberculosis in Austria has decreased from 1007 reported cases in 2005 to 569 cases in 2017 –the lowest number recorded to this day. An increase of TB cases in 2016 can partly be explained by increased migration of people from TBC­high incidence countries. Austria can be called a low­incidence country, however, the population of Vienna is significantly more affected. Particularly an increase of MDR (multiresistant TB) and XDR (extreme drug resistant TB) is observed in recent years.

Purpose

One of the most powerful tools to stop further spread of (resistant)TB is the strict adherence of the patients to therapy. Accordingly, a procedure including the cooperation of medical intervention, care, physiotherapy, and clinical pharmacy could be established as the so called “Viennese Model”. This also includes psychosocial und social assistance to in­ and out­patients.

Material and methods

The main task from the pharmaceutical point of view is the management of adverse effects and clinically relevant interactions of medications. Especially TB treatment of patients who due to co­morbidity or further problems resulting from social environment are additionally prescribed a great number of different medications is complex.

Since TB compared to number of cases in the early 20th century in Austria has decreased, the formally dreaded “white death” was declared an orphan disease. Hence problems with continuous commercial availability of the respective drugs have to be taken into considerationResults

Printed information as brochures and posters have been developed including pictograms to overcome language barriers and have been established with special emphasis to point out how patients can contribute to the success of therapy and why such a long period of treatment is crucial.

Conclusion

An overview of the current situation in Austria and the results from a 5 years clinical pharmacy project and optimization of the drug selection using drug­interaction programs will be shown.

References and/or Acknowledgements

Nationale Referenzzentrale für Tuberkulose ­ Jahresbericht 2017 Flick H, Rumetshofer R, Wurzinger G: Tuberkulose: Wiener Klinische W ochenschrift Education; DOI 10.1007/s11812­012­0018­2

Conflict of Interest No conflict of interest

BAR19­0884 PHARMACEUTICAL FOLLOW UP OF ORAL ANTIBIOTHERAPY IN OSTEOARTICULAR INFECTION: A PRELIMINARY STUDY

S. BELO1, C. MENIGAUX1, A. LECOEUR1, F. LE MERCIER1, T. TRITZ1 1AP­HP HÔPITAL AMBROISE­PARÉ, 92, BOULOGNE­BILLANCOURT, FRANCE

Background

Osteoarticular infection is a serious postoperative complication in orthopedic surgery. The occurrence of such complication requires optimal care to prevent the risk of transition to chronicity. Given the complexity of this type of infection, long duration and high dose antibiotic therapy are recommended. Early discontinuing treatment due to poor tolerance and/or lack of compliance is possible, especially after hospital discharge.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 32/60 05/11/2018 Rejected - S4.html Purpose

This preliminary study aimed to assess the need and feasibility of a pharmaceutical monitoring during the antibiotic treatment.

Material and methods

This is a prospective interventional study performed in a Reference Center for Complex osteoarticular infection. From January to May 2018, patients suffering from osteoarticular infection treated with surgical procedure and oral antibiotherapy were included. During hospitalization, a pharmaceutical consultation (PC) is performed to explain initiated antibiotic treatment. Two telephone consultations (TC) are programmed at day 15 and 30 from initiating treatment. Tolerance evaluation was performed using the WHO ranking toxicity grades, and compliance using the Morisky medication adherence scale. Outcomes measures were: duration of each TC, the rate of medication compliance, medication tolerance, the emergence of adverse effects and classifications of them.

Results

A total of 29 patients were included, mean aged 58 +/­ 12 years old. 25 patients developed at least one adverse event and 5 of them were severe requiring a rehospitalization (neutropenia, hepatitis). Due to the notification by the pharmaceutical team, 7 patients had their antibiotic therapy adjusted following a reassessment in multidisciplinary staff. Pharmaceutical advices during TC improved tolerance in 6 patients. The mean percentage of compliance was 85 +/­ 8% and improved for 18 patients between the two TC. The mean duration of PC + TC was 45 +/­ 12 minutes per patients.

Conclusion

The majority of patients suffered adverse effects. Early cessation of antibiotic therapy and rehospitalization are observed consequences of these problems of tolerance. Pharmaceutical consultations seem beneficial for optimizing patient follow­up.

We’re currently working on defining an optimal organization between the different health professionals to enhance this follow­up, knowing that Pharmaceutical counseling is time consuming and not always compatible with others pharmaceutical activities.

References and/or Acknowledgements

http://dx.doi.org/10.1136/ejhpharm­2016­000875.14

Conflict of Interest No conflict of interest

BAR19­0663 OFF­LABEL TREATMENT IN NEUROPSCYCHIATRIC WARDS FOR CHILD: A NEW WAY TO MANAGE DRUG REQUESTS AND OUTCOMES MONITORING

L. FANTINI1, B. GAVIOLI1, M. MUSSONI1, E. BAGNI1, C. POLIDORI2, L. ROSSI1 1OSPEDALE INFERMI ­ AUSL ROMAGNA, FARMACIA OSPEDALIERA, RIMINI, IT ALY 2UNIVERSITY OF CAMERINO, DEPARTMENT OF EXPERIMENTAL MEDICINE AND PUBLIC HEA TH, CAMERINO, ITALY

Background

In the last years it has been observed an increase in prescriptions of psychotropic drugs for children and adolescents, in particular antipsychotics, antidepressants and lithium. The majority of these drugs are not approved in patients 18 years and younger. So far, off label prescription has required an authorization for each case by the local Drug and Therapeutic Committe (DTC). However, therapies are frequently given under emergency conditions, without an adequate support of evidence and in absence of evaluation of long­term effects.

Purpose

The objective of this work was to plan a new way to manage off­label prescriptions in neuropsychiatry in order to promote evidence­based therapies and to improve outcomes monitoring.

Material and methods

Psychotropic drug use in children and adolescents were divided into: on­label drugs; off­label drugs supported at least by phase II trials; off­label drugs supported by observational studies or no evidence. Specific parameters for efficacy and toxicity monitoring were identified by a multidisciplinary group, involving pharmacists and psychiatrists.

Results

Off­label drugs supported at least by phase II trials can be managed by the Pharmacy, while the others still need DTC evaluation. All off­label prescriptions require patient information and outcomes monitoring every three months.

Conclusion

The new way to manage off­label drugs makes evidence­based prescription easier and inhibit the use of off­label therapies without any literature support. Monitoring of long­term effects, in terms of both efficacy and safety, is improved by means of shared indicators.

References and/or Acknowledgements

NO.

Conflict of Interest No conflict of interest

BAR19­0867 WHAT PLACE OF L'ANGIOJET®, AN INNOVATIVE AND COSTUALLY MEDICAL DEVICE IN THE TREATMENT OF PERIPHERAL AR

T. RODIER1, A.M. PORTELLA2, D. RADU2, C. JUDEL1, A. JACOLOT1 1ASSISTANCE PUBLIQUE DES HÔPITAUX DE PARIS APHP, PHARMACY , BOBIGNY, FRANCE 2ASSISTANCE PUBLIQUE DES HÔPITAUX DE PARIS APHP, VASCULAR SURGERY, BOBIGNY , FRANCE

Background

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 33/60 05/11/2018 Rejected - S4.html The vascular surgery department would like to operate with the Angiojet® rheolytic thrombectomy system (BOSTON SCIENTIFIC).This catheter is indic This innovative and expensive device (2500 € TTC, catalog price), not available into the Assistance Publique – Hopitaux de Paris, treats by simple punc direct surgical approach (Fogarty catheter) and would not require postoperative systemic fibrinolysis

Purpose

Our objective is the assessment of the place of Angiojet® as an alternative to the currently performed surgical and pharmacological practices in our hos thrombosis and to estimate the number of patients and its impact on activity.

Material and methods

We conducted a retrospective study over 7 months (January to July 2018) on patients who would have been able to benefit of Angiojet® to treat acute d

Results

18 patients were identified as eligible (6 women and 12 men).16 patients were hospitalized in a context of leg’s acute ischemia and 13 were admitted by

The patients were hospitalized during 26 days on average [2­130] and 8 of these 16 patients stayed in Intensive Care Unit (ICU) during 7 days on avera

Alteplase was necessary to treat 2 patients peri­operatively and an iloprost course of at least 28 days was initiated for 5 patients post­operatively.

Concerning complications, interventions for amputation (following re­thrombosis) were performed in 2 patients and 3 deaths were observed, including tw

Conclusion

Our study helped us to target the number of patients eligible for Angiojet® thrombectomy to treat leg’s acute ischemia : almost 27 patients for one year. without re­thrombosis after thrombectomy with Angiojet® would be 83% at 12 months, which should limit the risk of complication amputation type (n = 2 hospitalized in ICU, a stay would be possibly avoided with rheolytic technology. However, a comparative study of this innovative device versus conventio

References and/or Acknowledgements

(1)Garcia MJ,LooksteinR,Malhotra R,Amin A,Blitz LR,LeungDA,etal.EndovascularManagementofDeepVeinThrombosiswithRheolytic Thrombectomy:FinalReportoftheProspectiveMulticenterPEARL(PeripheralUseofAngioJetRheolyticThrombectomywithaVarietyofCatheterLengths)Registr

Conflict of Interest No conflict of interest

BAR19­0688 DEVELOPMENT OF AN AID TOOL FOR THE DISPENSING OF RETROCEDABLE DRUGS

M. CUMIN1, E. FARGIER1, T. MOULENAT1, C. FAYARD1, C. MARTIN1, F. SERRATRICE1 1CENTRE HOSPITALIER MÉTROPOLE SAVOIE, 73, AIX LES BAINS, FRANCE

Background

In France, the term “retrocession” describes the drug dispensation by hospital pharmacy to ambulatory patients. Dispensers must provide information and advices to patients for a correct use of medicines. In our hospital, 53 molecules are regularly retroceded. Considering the diversity of these drugs and the turnover of providers (pharmacists and pharmacy technicians), it is essential to secure and standardize the dispensation.

Purpose

Create a dispensing aid tool to promote the proper use of medicines.

Material and methods

1­ Creation and distribution of a questionnaire to collect the dispensers needs about the tool.

2­ Development of the tool. The source of the data is the Summary of Products Characteristics, the french therapeutic dictionary VIDAL®, the database THERIAQUE, and the information notes of “Réseau Espace Santé Cancer”, a regional group of institutions specialized in oncology.Results

After analyzing the questionnaires, the proposed tool is a binder which contains fact sheets on A4­sized paper. The following content has been decided: International Nonproprietary Name and commercial name of the medication, pharmacologic class, galenic form; and then different sections: therapeutic indications, dosage, prescribing conditions, advices to patients, adverse effects and how to prevent them or how to behave if they occur, contraindications, terms of storage and handling. The general appearance is simple and visual: the goal is to quickly find the information during the dispensation. Pictograms have been used for information like dosage or storage and handling. The binder is located in the retrocession office. The fact sheets are approved by a second pharmacist and submitted during the staff meetings as they are set up. To date, 30 fact sheets have been submitted.

Conclusion

This tool is useful to better inform the patients, but also as a training resource: it secures the retrocession by a consolidation of the dispenser’s knowledge about these medicines. It will be necessary to make regular updates to keep it sustainable. The next phase of this work is to estimate how and in which frequency it is used by dispensers, and whether the tool meets their needs and those of the patient.

References and/or Acknowledgements

All staff of our pharmacy service

Conflict of Interest No conflict of interest

BAR19­0794 Phytotherapy in therapeutic education: pharmacists’ contribution on this particular automedication

R. LADARRE1, M. LARRIVIERE1, C. BONNET2, E. AUDITEAU3, C. DUFAURET­LOMBARD2, I. GRANGER2, S. PERIOU2, P. BERTIN2, V. RATSIMBAZAFY1 1CHU LIMOGES, PHARMACY , LIMOGES 87042, FRANCE 2CHU LIMOGES, RHEUMATOLOGY, LIMOGES 87042, FRANCE file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 34/60 05/11/2018 Rejected - S4.html 3LIMOGES UNIVERSITY, INSTITUTE OF NEUROLOGICAL EPIDEMIOLOGY AND TROPICAL NEUROLOGY, LIMOGES 87025, FRANCE

Background

Low back pain remains a global public health problem. Despite researchs, the available treatments trends to produce minor or moderate effects. During therapeutic patient education (TPE) low back pain session group with pharmacist and nurse, for one patient, phytotherapy appeared to be the first treatment choice. Therapeutic education must be focus on patient's expectations and needs so we had to consider this issue.

Purpose

The objective of this case was to know if phyotherapy used by this patient could have pain efficiency and side effects.

Material and methods

Our method mainly consisted in looking for information in the literature. The investigated bases were: Pubmed, European Pharmacopoeia, TheriaqueTM phyto, Stockley (used in pharmacovigilance network), " European scientific cooperative on phytotherapy” (recommended by VidalTM) and one free database, Tela botanica a botanist network.

Results

Plants consumed daily by the patient, in infusion mainly, were identified as: Filipendula ulmaria, Corylus leaf, Plantago lanceolata, Hamamelis virginiana leaf, Urtica dioica.

Filipendula ulmaria contains some acetylsalicylic acid thereby has the same effect than aspirin. TheriaqueTM phyto mentions a strong interaction with antiplatelet and a risk with anticoagulants.

Plantago lanceolata contains some iridoïdes (aucuboside…) which decrease the production of NO. TheriaqueTM phyto mentions a risk of food and medicinal malabsorption and hypoglycemia.

Hamamelis virginiana leaf contains flavonoids in particular the rutoside and its metabolite 3,4 Dihydroxytoluène which inhibits NO, iNOS and cyclooxygenase (COX) 2. Urtica dioica contains flavonoids (quercetin, kaempferol and rutine) which inhibit COX­1 and COX­2, and the biosynthesis of prostaglandines and thromboxane. Corylus leaf contains flavonoids (mytricine…) which inhibits cyclooxygenase and lipoxygenase. No interaction was found for these 3 plants.

Studied plants have direct or indirect anti­inflammatory effects, variable intensity, which can explain their efficiency. However, interactions studies are lacking and no side effects were found, probably because they were not specifically sought, inciting to caution.

Conclusion

Therapeutic education has to give a specific response to each patient, leading us to consider alternative medicines. Evaluations realised at the end of TPE showed that the patient was very satisfied with pharmacist's information (potential efficiency and herbal medicine risk).

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­0816 CLINICAL EXPERIENCE WITH THE USE OF CDK4/6 INHIBITORS IN METASTATIC BREAST CANCER IN A SECOND LEVEL HOSPITAL

N. HERRERO MUÑOZ1, J. LETELLEZ FERNANDEZ1, B. CANDEL GARCIA1, A.B. FERNÁNDEZ ROMÁN1, M. MARTIN LOPEZ1, M.D.M. GARCIA GUTIERREZ1, N. FONT TARRES1, M. GARCÍA GIL1 1HOSPITAL UNIVERSITARIO DE FUENLABRADA, SERVICIO DE FARMACIA, FUENLABRADA MADRID, SPAIN

Background

The recent commercialization of selective and reversible cyclin­dependent kinases 4/6 (CDK 4/6) inhibitors has meant a therapeutic alternative for the treatment of metastatic, hormonal receptor positive and human epidermal growth factor receptor 2 negative breast cancer.

Purpose

To describe the effectiveness and safety profiles of Palbociclib and Ribociclib in a second level hospital.

Material and methods

A retrospetive, observational study between August 2016 and September 2018. Patients who had received at least two cycles of CDK4/6 inhibitors were included and demographic data, previous treatments, clinical parameters and adverse events (AEs) were collected from electronic clinical history.

Effectiveness was evaluated by progression free survival median (mPFS) by using Stata®v.14 and safety was evaluated by detecting AEs.

Results

27 patients were included: 22 received Palbociclib and 5 Ribociclib. The median age at the beginning of the treatment was 57,5 years (39,5­80,5 years). Of the 22 patients who started Palbociclib for metastatic disease, 20 had received a median of 5 (1­6) previous treatment regimens, and 2 patients were treatment­naive. Four of the five patients treated with Ribociclib were treatment naive for metastatic disease, one of them had been treated before.

Patients received a median of 4 cycles (2­14 cycles). Withdrawal of treatment was decided for 17 patients treated with Palbociclib and for one with Ribociclib, as there was cancer progression, the rest continue in treatment. mPFS was 4,3 months for Palbociclib, not being acccomplished for Ribociclib.

The most frequent AEs observed with Palbociclib and Ribociclib were respectively: neutropenia 72,7%­80% (Grade (G) 2 9,1%­0%, G3 54,5%­80%, G4 9,1%­0%) asthenia 36,3%­80% (G1 22,7%­80%, G2 13,6%­0%) and thrombocytopenia 45,5%­60% (G1 45,5%­60%). file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 35/60 05/11/2018 Rejected - S4.html 15 patients (68.2%) in treatment with Palbociclib and 4 patients (80%) in treatment with Ribociclib experienced neutropenia grade 3/4 and they couldn’t receive the next cycle until it was recovered. A dose­reduction was necessary for 12 (54.5%) and 4 (80%) patients respectively, according to the recommendations given for these drugs.

Conclusion

According to our experience, CDK 4/6 inhibitors are effective and safe drugs, although most patients required a dose reduction because of grade 3 neutropenia. None of our patients have reported nausea, a common AE described on clinical trials.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0817 PHARMACOLOGICAL RECONCILIATION AND RECONCILIATION PROJECT IN THE INTERNAL MEDICINE DEPARTMENT

F.N. BERETTA1, D. ZENONI2, D.B. BONZI2 1UNIVERSITÀ DEGLI STUDI DI MILANO, SCUOLA DI SPECIALIZZAZIONE IN FARMACIA OSPEDALIERA, MILANO, ITALY 2ASST BERGAMO EST, FARMACIA INTERNA, ALZANO LOMBARDO, ITALY

Background

The Italian Ministry's recommendation n ° 17 aims to implement the pharmacological recognition process (anamnestic collection of current therapy) and reconciliation (harmonization process between hospital­territory or intra­department therapy). The pharmacist is the most suitable professional figure for the implementation of both decision­making processes.

Purpose

Improve the process of reconnaissance and pharmacological reconciliation.

Material and methods

The project was carried out between December 2017 and May 2018 (6 months). For organizational reasons, were included only patients suffering from heart failure hospitalized in the Internal Medicine department. The pharmacist went to the department every other day to view the patient's medical folder and to discuss with the physician about the current therapy. Therapy data were collected with the respective indications. The analysis was carried out in 3 different times: at the entrance in the ward, during the hospitalization and at the discharge. In addition, drugs interaction were analyzed using the Intercheck web software and Micromedex. Dosage and indications were verified with the Codifa Italian database. The ESC guidelines (European Society of Cardiology) were consulted to verify the posology.

Results

A total of 26 patients were analyzed. In 10 cases, medications have been deemed "unnecessary" or inappropriate by the pharmacist or clinic. These drugs have been suspended. Due to the lack of presence of drugs in the Hospital Pharmaceutical Formulary (HPF), in 6 patients was carried out a "forced" replacement of the therapy. In 4 patients, the therapy was modified at the suggestion of the pharmacist during hospitalization. The most common interaction was "elongation of the QT tract" (11 patients), confirmed by the ECG traces. In patients with lengthened QT (corrected QT> 440 ms) the frequency of diagnostic tests ware increased. There is a bias related to the analysis because the collection data was conducted exclusively in cardiopathic patients.

Conclusion

We found that the pharmacist is not able to manage the therapeutic recognition. The fault is that, nowadays, there is no a department pharmacist that can visit patients during the hospitalization. However, the pharmacist plays a very important role during the reconciliation phase modifying dosages and / or therapeutic schemes.

References and/or Acknowledgements

Raccomandazione n. 17 ­ Riconciliazione farmacologica http://www.salute.gov.it/portale/documentazione/p6_2_2_1.jsp?lingua=italiano&id=2354.

Conflict of Interest No conflict of interest

BAR19­0820 Carfilzomib, lenalidomide and dexamethasone in multiple myeloma treatment: “real­life” retrospective analysis

S. CORRIDONI1, S. MASSACESE1, F. SANTOLERI1, E. RANUCCI2, A. COSTANTINI1 1HOSPITAL SANTO SPIRITO, HOSPITAL PHARMACY, PESCARA, ITALY 2HOSPITAL SANTO SPIRITO, DEPARTMENT OF HEMATOLOGY, PESCARA, IT ALY

Background

Carfilzomib (K) is a second­generation proteasome­inhibitor. The combination of K with lenalidomide (R) and dexamethasone (d) (KRd) is indicated for the treatment of adult patients with refractory/relapsed MM (r/rMM), who have received at least one prior therapy. K is administered on days 1, 2, 8, 9, 15, and 16, every 28 days. Starting from the 13th cycle, the day 8 and 9 doses are omitted. R is administered once daily on days 1 to 21 of each 28­days cycle. d (40mg) is administered orally once a week.

Purpose

The aim of this study is to verify that all the doses received from patients follow the administration schedules provided by the ASPIRE pivotal study.

Material and methods

Patients with r/rMM treated with KRd from December 2016 to September 2018 were classified based on their gender, age, clinical observations, therapeutic lines, prognostic scores for MM (ISS score) and follow­up. PHARMADD software was used for R to analyze doses, prescriptions and dispensations. R’s ADH has been obtained employing RDD/PDD method (daily received dose/daily prescribed dose).Doses of K, number of cycles

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 36/60 05/11/2018 Rejected - S4.html and the administration frequencies have been acquired using CYTOSIFOII (1572 preparations). For each patients has been calculated the average deviation (D = cumulative received dose/expected in the data sheet dose).

Results

We analyzed 34 patients (24 males, 10 females), median age of 61 years (range 42­71); median of cycles: 7 (range 1­20); median of previous lines: 2 (range 1­5); ISS1: 54%, ISS2: 20%, ISS3: 26%. Twenty­four patients were under ongoing treatment during September 2018. Ten patients stopped KRd for: 7 due to progression, 1 lost during the follow­up, 1 due to hepatotoxicity G3 and 1 died for other causes. In 5 patients, KRd has been employed as a transplantation induction scheme. ADH for R was 0.92 (±0.21) and 47% of patients needed a change in R doses. averageDeviation for K was: 0.91 (0.7­1) transplant­patients, 0.88 (0.6­1) ongoing treatment patients and 0.78 (0.2­1) patients stopped.

Conclusion

The resulting deviation for KRd­regime, between real dose and expected dose, will be investigated by further studies to verify the consequences of its outcomes.

References and/or Acknowledgements

https://www.ncbi.nlm.nih.gov/pubmed/25482145.

Conflict of Interest No conflict of interest

BAR19­0821 A PAEDIATRIC CLINICAL CASE OF POMPE DISEASE: PERSONALIZED THERAPY

L. CINGOLANI1, L. SANTORO2, A. MARINOZZI1, E. ANDRESCIANI1, A.M.F. GARZONE1, M.A. BERARDI3, G.B. ORTENZI1, C. POLIDORI3, C. CATASSI2, V. MORETTI1, A. POMPILIO1 1AOU OSPEDALI RIUNITI, PHARMACY, ANCONA, IT ALY 2AOU OSPEDALI RIUNITI, CLINICA PEDIATRICA, ANCONA, IT ALY 3UNIVERSITA' DEGLI STUDI DI CAMERINO, SCUOLA DI SCIENZE DEL FARMACO E DEI PRODOTTI DELLA SALUTE, CAMERINO, ITALY

Background

Pompe disease (PD), or Glycogen Storage Disease type II (GSDII) infantil onset, is an autosomic recessive disorder that involves the enzyme acid alpha­glucosidase (GAA) and its gene on the chromosome 17q23.

Its lack leads to glycogen deposits, particularly in muscular cells, lungs and heart.

It is a rare disease with an incidence of 1/138,000 cases and it is treated with human recombinant enzyme (rhGAA), Enzyme Replace Therapy (ERT).

Cross Reactive Immunologic Material (CRIM)­negative patients have absent residual enzyme activity and less favorable prognosis. They early develop high titers of against ERT that the treatment becomes inactive.

Purpose

To describe a multidisciplinary therapy approach for 1.5­month patient of 4.4 kg, initially hospitalized for bi­ventricular hypertrophy then diagnosed with PD, CRIM­negative.

Material and methods

The actors involved in the prescription of the therapy were pharmacist, cardiologist, paediatrician, neurologist and anesthesiologist.

They acted in: treatment of cardiological emergency; modulation of the immune response; off­label treatment authorization for triple immunomodulatory therapy (ImT) to the “Corporate Commission off­label”; start of treatment, both ImT and ERT; preparation of paediatric compounding formulas supporting basic therapy.

Results

First the cardiological emergency was treated with Furosemide0.5mg/3times/day iv, Potassium canrenoate 5mg/day iv; Amiodarone 7mg bolus and 7.5 mg infusion iv, Propranolol 2mg/4times/day os.

Then the immune response was taken care with therapy off­label, according to the protocol "Banugaria et al.", 3 cycles, duration 6 weeks, in personalized galenic preparation: 12.5mg/Kg once a week iv; 0.4mg/Kg 3times/week/2weeks sq; Immunoglobulin iv 500mg/Kg/1times/2weeks.

The enzyme deficiency was replaced with ERT: rhGAA: 20mg/Kg/2weeks iv.

Oral therapy: Propranolol 5mg/ml solution (2mg/3times/day); Amiodarone capsules (10mg/1times/day), continuative and prepared by the pharmacist as a galenic product.

The present therapy is going on for 10 months and neither interactions nor adverse reactions were observed.

Conclusion

Infantile onset PD is a serious metabolic disease that, if not treated promptly, leads to fatal evolution. CRIM­negative patients represent a minority.

The abovementioned patient with personalized therapy continues ERT in day­hospital and home therapy with galenic formulas. It has a good clinical picture and has significantly improved its cardiac function.

References and/or Acknowledgements

Thanks to Corporate Commission off­label.

Conflict of Interest No conflict of interest

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 37/60 05/11/2018 Rejected - S4.html BAR19­0844 DUPILUMAB IN THE TREATMENT OF MODERATE­TO­SEVERE ATOPIC DERMATITIS

L. LÓPEZ VINARDELL1, L. GRAS MARTÍN1, M. MASIP TORNÉ1, E. SERRA BALDRICH2, B. ZURITA ALONSO1, N. MAS MALAGARRIGA1, N. GARIN ESCRIVÀ1, M.A. MANGUES BAFALLUY1 1HOSPITAL DE LA SANTA CREU I SANT PAU, PHARMACY , BARCELONA, SPAIN 2HOSPITAL DE LA SANTA CREU I SANT PAU, DERMATOLOGY, BARCELONA, SP AIN

Background

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterised by eczema with intense pruritus. Its prevalence is estimated at 7­10% in adults and, in severe cases, may be associated with sleep deprivation and systemic comorbidities.

Topical therapies have limited efficacy and systemic treatments are associated with potential toxic effects. Dupilumab, a fully human monoclonal antibody that blocks IL­4 and IL­13 signalling, is the first biologic drug for the treatment of moderate­to­severe atopic dermatitis (MSAD) in patients who have inadequately responded to topical or systemic treatment.

Since it is an expanded use drug, only a few patients have been treated at our institution.

Purpose

The aim of this study was to evaluate the effectiveness and safety of dupilumab in adults with MSAD and its impact on patients’ quality of life.

Material and methods

A retrospective observational study was conducted in a tertiary teaching hospital during ten months. An initial subcutaneous dose of dupilumab 600mg followed by 300mg every other week was administered. Sociodemographic (age, gender), clinical data (medical history, previous therapies, SCORAD, EASI, adverse effects (AE)) and DLQI were collected.

Results

Eleven patients with MSAD were included. Seven were male with a mean age of 35 years (18­49). Most of them had a history of asthma(n=9) and were allergic to animals(n=5), food(n=8), pollen and dust mites(n=6). Patients had previously received an average of four drugs: cyclosporine(n=11), UVA/B(n=10), (n=6), mycophenolate(n=5).

Prior to dupilumab treatment, all participants had high SCORAD and EASY scores: 62,1(47,2­76,1) and 34,8(21,2­65,7), respectively. At week 20, all patients shown an improvement from baseline: SCORAD 22,7(17,8­29,0); EASI 13,7(3,0­30,0). By week 35­40, SCORAD had been substantially reduced reaching average values of 11,8(3,5­23,4). Additionally, analysis of DLQI showed a positive impact on quality of life ranging from baseline levels of 16,4(12,0­27,0) to 7,8(2,0­14,0) at week 20. Some mild exacerbations were observed in six patients, caused by stressful situations and climate changes. The most common AE were eye complications(n=8), headache(n=3), joint pain(n=2), skin peeling(n=2) and infections(n=2).

Conclusion

Adding dupilumab to standard­of­care treatment substantially improved signs and symptoms of MSAD and quality of life with acceptable mild to moderate AE.

References and/or Acknowledgements

I am thankful to all those who have participated in this study.

Conflict of Interest No conflict of interest

BAR19­0853 PROPER USE OF ORAL ANTINEOPLASTIC AGENTS: INTEREST OF PHARMACEUTICAL INTERVIEW

L. MALJEAN1, M. SAGLIO1, C. BEYRON1, A.S. LEROMAIN1, M. HELLOT­GUERSING1, C. JARRE1, A. GADOT1, C. DERHAROUTUNIAN1, R. ROUBILLE1 1CENTRE HOSPIT ALIER LUSSIEL HUSSEL, PHARMACY DEPARTMENT, 38200 VIENNE, FRANCE

Background

Oral antineoplastic agents (OAA) provide easier treatment modality than parenteral chemotherapy. Therefore, the number of OAA has increased over the years. Patient adherence to the treatment is a major issue since it af fects directly the treatment efficiency. It has been proven that it can be limited by adverse events, lack of information and the complexity of dosing schedule. Therefore, a systematic pharmaceutical interview with patient taking OAA was implemented in our Hospital Drug Sales Service (HDSS).

Purpose

The purpose of this study was to assess the interest of a pharmaceutical interview with patients taking OAA.

Material and methods

For 3 months, a pharmacist or a pharmacist resident interviewed all the patients who came in our HDSS for OAA. The interviewer filled an evaluation form to assess patient issues (organizational issues, adverse effects), interest in pharmaceutical follow­up, expectations (advices, medication plan…). If needed, additional information was given to the patient at the end of the interview.

Results

23 patients were interviewed from June to August 2018. The OAA prescribed were: 13 Lenalidomide (56%), 3 Temozolomide, 2 Pomalidomide, 2 Mitotane, 2 Osimertinib and 1 Brigatinib. There was no initiation, 1 patient had been taking OAA for less than 3 months and 15 patients for more than 6 months. 22 interviews were conducted in our HDSS: 17 with the patients themselves and 5 with their family only . 1 interview was conducted over the phone. 3 issues were detected: 1 bad adherence to the antibioprophylaxis prescribed with Lenalidomide, 1 major side effect (Mitotane) and 1 improper administration (Mitotane). These issues resulted in pharmaceutical interventions transmitted to their doctors. 7 patients asked for more information: 3 medication plans and 4 biological check­ups were explained to them. In addition, 4 patients showed an interest in a pharmaceutical follow­up on each of their visits.

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 38/60 05/11/2018 Rejected - S4.html Conclusion

Although most of the patients did not report any organizational problem nor significant adverse effects, 13% had issues that needed the intervention of a pharmacist and 30.5% of the patients subsequently felt the need for more information and advice on their treatment. These results showed the interest of a pharmaceutical interview to promote a better use of OAA.

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­1113 STAPLED LAPAROSCOPIC APPENDECTOMY VS ENDOLOOP

G. BRIGATI1, E. ORTOLANI1, G. DI SANZA1, N. SARCHIONE1, M. BORSARI1, P. ZUCCHERI1 1MAGGIORE HOSPITAL­ AUSL BOLOGNA, PHARMACEUTICAL DEPARTMENT, BOLOGNA, IT ALY

Background

Laparoscopic appendectomy (LA) is one of the most common procedures in general surgery. The laparoscopic closure of appendix stump can be performed by stapler or endoloop. Both methods are reported as safe and reliable: stapler is more expansive (394€ vs 57€) but it performs sealing with a double row of staples while Endoloop is reabsorbable but in many cases it prolongs operating time and requires surgeon’s training.

Purpose

The aim of this study is to to evaluate the surgical techniques adopted by two surgical units, focusing on the economic implications.

Material and methods

LA procedures performed by two teams (A and B) during years 2013­2017 were analysed thanks to a specific software which records all patient information throughout the surgical workflow including the use of devices and related costs. Team B showed a lower number of interventions because the informatization of the operating block took place only in 2015.

Results

Between January 1, 2013 and December 31, 2017 team A performed 482 procedures; stapler was used in 70% of cases (N=338), while endoloop in 23% of them (N=11); in 34 procedures it has been recorded the use of both devices (7%). Between April 30, 2015 and December 31, 2017 team B performed 203 procedures; stapler was used in the 7% of cases (N=14), while the endoloop in 86% (N=174); in 15 operations both DM were used (7%). The data analysis with clinical users reveeled that the extended adoption of endoloop by team B was mostly due to a greater experience with this technique, while the use of stapler by team A was partly due to the surgeons turn­over and presence of trainees.

Conclusion

The results showed a non­homogeneity in the use of stapler/endoloop between the 2 surgical units. The hypothetical shift from stapler to endoloop would lead to a saving of about € 30,000 per year. The education of clinicians both on the correct use of products and on the economic aspects is certainly fundamental for the clinical governance of medical devices and long­term sustainability of public healthcare systems.

References and/or Acknowledgements

Intended cost reduction in laparoscopic appendectomy by introducing the endoloop M. Mehdorn et al. BMC Surg 2017

Conflict of Interest No conflict of interest

BAR19­0865 EFFICACY AND ADEQUACY OF EVOLOCUMAB IN HYPERCHOLESTEROLEMIA

M. FAGES PEREZ1, J. ROMERO1, A. SORIA MARTIN1, P. VILLANUEVA JIMENEZ1, M.P. QUESADA SANZ1, J.R. AVILA ALVAREZ1 1HOSPITAL TIP OF EUROPE, PHARMACY, ALGECIRAS­ CADIZ, SPAIN

Background

Hypercholesterolemia is the main cause of vascular events. Anti­PCSK9 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 anti­PCSK9 antibodies

Material and methods

All requests to start treatment issued to the anti­PCSK9 antibodies subcommittee between January 2017 until September 2018 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, maximum doses of high­intensity 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 anti­PCSK9 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 file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 39/60 05/11/2018 Rejected - S4.html 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

Technical details: https://www.ema.europa.eu/documents/product­information/repatha­epar­product­information_es.pdf IPT: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT­evolocumab­repatha.pdf

Conflict of Interest No conflict of interest

BAR19­0889 Assessment of vancomycin dosing and subsequent serum concentrations in pediatric patients in a general acute teaching hospital

A. MAGALLON MARTINEZ1, M. MERCHANTE ANDREU1, A. PINILLA RELLO1, B. GARCIA RODRIGUEZ2, L. CAZORLA PODEROSOS1, M. PÉREZ MORENO1, A. CASAJUS NAVASAL1, M.R. ABAD SAZATORNIL1 1UNIVERSITARY MIGUEL SERVET HOSPITAL, HOSPITAL PHARMACY, ZARAGOZA, SP AIN 2UNIVERSITARY MIGUEL SERVET HOSPITAL, BIOCHEMICAL, ZARAGOZA, SPAIN

Background

Therapeutic antibiotic monitoring is a tool that has shown to improve clinical results in patients, nonetheless, data are limited in pediatric population.

Purpose

The aim of this study is to evaluate the number of pediatric patients that achieve the target steady­state through (15­20 mg/L) of serum vancomycin concentration (SVC) at the beginning of the monitoring, and the later influence of recommendations for dosage adjustments.

Material and methods

Retrospective observational study developed from January 2017 to September 2018. Eleven patients in treatment with intravenous vancomycin were included, who underwent pharmacokinetic monitoring with dosage recommendation. Variables of study: age, sex, weight, infectious focus, microorganism, target level, initial dose, trough concentrations after the third dose and results of the pharmacological intervention (recommended dose and trough concentration).

Results

11 patients were included in the study, 6 men and 5 women, with a median of 22 months and 9kg. 100% of the patients were admitted in the intensive care unit (ICU). The treatment was guided in the 54.5% of the cases and empirical in 45.5% of the cases. The diagnoses were: meningitis (n = 4), sepsis (n = 3), infection associated with central catheter (n = 1) fever of unknown origin (n = 3). The microorganisms identified were: Staphylococcus Aureus (n = 4), Streptococcus Pneumonie (n = 2), Streptococcus Epidermidis (n = 1). Cultures were negative in the rest of the patients. The average dosage at the bigining was 53.44 ± 10,09.In the first test results of SVCs were: 63.64% (n = 7) below target, 9% in range (n = 1), and 27.36% over range (n = 3). After the dosage recommendations 54.54% of the patients were in range, while in the 45.46% of the patients the treatment was ended after the first recommendation.

Conclusion

In this study, we reported that 63.64% of our patients showed levels below the target range in the first monitoring evaluation (steady­state through). Although the general recommendations in pediatrics do not recommend routinely monitoring, we consider that pediatric patients in ICU can get a benefit of monitoring programs, considering alternative schedules, such as continuos­infusion.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­0903 EVALUATION OF THE CONSUMPTION OF ANTIBIOTICS DURING THE YEARS 2016 AND 2017, IN A THIRD LEVEL HOSPITAL

E. TEJEDOR1, B. TAUSTE HERNANDEZ1, D. FERNANDEZ GINES1, E. MARTINEZ VELASCO1, F. VERDEJO RECHE1, F. SIERRA GARCIA1 1COMPLEJO HOSPITALARIO TORRECÁRDENAS, PHARMACY, ALMERIA, SPAIN

Background

Antibiotics are responsible for fighting against infections caused by bacteria. His discovery revolutionized medicine in the 20th century, but for some years there has been a great concern about the increase in antimicrobial resistance due to excessive consumption.

Purpose

To evaluate the consumption of the main antibiotics during the years 2016 and 2017, according to the Daily Dose Defined per thousand inhabitants and in percentage.

Material and methods

Retrospective observational study, which included patients treated with antibiotics during their stay in the hospital in 2016 and 2017. Data were obtained from the medical history program (Diraya®) and the outpatient program (Dominion­FarmaTools ® ).The following variables were collected: therapeutic group of the antibiotic and duration of treatment.The antibiotics were prescribed mainly by the Internal Medicine, General Surgery and Intensive Care Unit, and later revised by the Pharmacy Service.

Results

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 40/60 05/11/2018 Rejected - S4.html Retrospective observational study, which included patients treated with antibiotics during their stay in the hospital in 2016 and 2017. Data were obtained from the medical history program (Diraya®) and the outpatient program (Dominion­FarmaTools ® ).The following variables were collected: therapeutic group of the antibiotic and duration of treatment.The antibiotics were prescribed mainly by the Internal Medicine, General Surgery and Intensive Care Unit, and later revised by the Pharmacy Service.

Conclusion

The pharmaceutical action contributed to optimize the use of antibiotics, reducing their use in cases where they were not indicated or there were other alternatives

References and/or Acknowledgements

Strategies for reduction in duration of antibiotic use in hospitalized patients. Hayashi Y1, Paterson DL

Conflict of Interest No conflict of interest

BAR19­0904 HARMONIZATION OF THE PRACTICES OF NEBULIZATION IN AN EAR­NOSE­THROAT SURGICAL UNIT

C. LOUET1, A.S. REMOUÉ FANUEL1, E. CORBINEAU1 1CHU NANTES, PHARMACY, NANTES, FRANCE

Background

The ear­nose­throat (ENT) surgical unit (44 beds) brings together patients treated by nebulization. A clinical pharmacy team has been deployed in this unit in December 2017. The team has been solicited several times by the nurses for questions about nebulization. Moreover, in context of computerization of the prescriptions in the coming months, an inventory of the prescriptions was necessary in order to prepare the computerized prescription protocols.

Purpose

To harmonize the practices of the nurses and the physician prescriptions.

Material and methods

First, from July 2018 to October 2018, each nebulization prescription was identified throughout the medication review. Data collected were related to prescription conformity and to the method of administration.

Second, a summary sheet was prepared for the nurses thanks to a literature review about good practices of nebulization and the results of the data collection.

Third, computerized prescription protocols were proposed to the physicians.

Results

The analysis was made on 18 prescriptions for 10 patients. Five molecules were prescribed: salbutamol, ipratropium, budesonide, methylprednisolone, N­acetylcysteine and epinephrine. The dose schedule was always given. The duration, the volume and the solvent were never given. The drug dosage was present on 17% of the prescriptions. For identical prescriptions, the dilution and the mixing of the drugs were heterogeneous depending on the nurses.

A summary sheet was made containing the recommendations of good practices: minimum volume, nebulization’s duration, drug dosage, solvent and drug mixture approved. The clinical pharmacy team communicated about the good practices to the nurses and the summary sheet was placed in the surgical unit.

Prescription protocols were suggested to the physicians for 6 drugs with the time of nebulization, as well as the drug dosage and the minimum volume required.

Conclusion

This work highlighted the non­compliance of the prescriptions and the heterogeneity of the nurses’ practices. The diffusion of the good practices of nebulization and the harmonization of the prescriptions thanks to the computerization improve the patient healthcare in the ENT surgical unit.

References and/or Acknowledgements

Dautzenberg B, Becquemin MH, Chaumuzeau JP, Diot P. Bonnes pratiques de l'aérosolthérapie par nébulisation. Groupe Aérosolthérapie (GAT) de la Société de pneumologie de langue française; 2005.

Conflict of Interest No conflict of interest

BAR19­0933 Outpatient antimicrobial therapy in bone and joint infections : what happens after hospital discharge ?

A. COSTE1, A. GAHBICHE1, P. RENAUDIN1, F. BOUCHET2, C. DAUMAS1, M. HAMOUI3, A. JALABERT1, F. CANOVAS3, M. VILLIET1 1CHU DE MONTPELLIER, PHARMACIE LAPEYRONIE, MONTPELLIER, FRANCE 2CHU DE MONTPELLIER, MALADIES INFECTIEUSES ET TROPICALES, MONTPELLIER, FRANCE 3CHU DE MONTPELLIER, CHIRURGIE DU MEMBRE INFÉRIEUR ET DU RACHIS, MONTPELLIER, FRANCE

Background

Bone and joint infections (BJI) management require prolonged antibiotic therapy and coordination between hospital and post­hospital facilities.

Purpose

Evaluation of antimicrobial therapy (AT) management in patients with BJI post hospital discharge via analysis of possible discrepencies.

Material and methods file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 41/60 05/11/2018 Rejected - S4.html This is a prospective monocentric study conducted for 2 months in an orthopedic surgery and traumatology unit. All patients with BJI suspicion are included. Discrepancy is defined as any deviation from the ideal management regarding dosage, administration, monitoring and warning/precautions. . They are collected the day ofhospital discharge, during the first days [2­7] after the hospital discharge, at the follow­up visit and at the theoretical end of treatment (EOT) . At the end, AT duration was also evaluated.

Results

Thirty patient were included. . Average age was 61 years [28­98]; 79 % (n=22) of acute BJI, 90% (n=27) of implant­related infections and 82% of ofdocumented infections. An antimicrobial stewardship advices was done before discharge for 89% patients (n=25). Most (n=26) hospital discharges were made in rehabilitation centers. Average rate of discrepancies was up to 10% (n=134) related to warning/precautions and administration respectively in 43% and 8% of cases. The EOT wasn’t respected in of 74% patients (n=17). For 9 patients, AT were extended by 9 days [1­20], and shortenedby 21 days for 8 patients [1­45]. End of treatment 7 could not be evaluated for 7 patients.

Conclusion

This study highlights discrepancies in terms of monitoring, duration and administration of AT. Management of adverse drug reactions due to AT could be better. Information flow regarding treatment duration should be improve. According these results, we propose a pharmaceutical advice letter containing specific A T informations for patients, nurses and physicians.

References and/or Acknowledgements

1. P. Longuet et al, Preparing and administering injectable antibiotics: How to avoid playing God. Médecine et maladies infectieuses 2016; 46: 241­ 268 2. Recommandations de pratique clinique Infections ostéo­articulaires sur matériel (prothèse, implant, ostéosynthèse), SPILF 2009

Conflict of Interest No conflict of interest

BAR19­0938 VITAMIN D DEFICIENCY AMONG ELDERLY HOSPITALIZED PATIENTS, THE OUTCOME ITS SUPPLEMENTATION AND EFFECTS ON RE­HOSPITALIZATION

L. HORVÁTH1, T. CSÁSZÁR2, S. MIRANI1, M. VECSERNYÉS3, B.E. TÓTH1 1UNIVERSITY OF DEBRECEN, DEPARTMENT OF PHARMACEUTICAL SUR VEILLANCE AND ECONOMICS, DEBRECEN, HUNGARY 2ZALA COUNTY ST. RAFAEL TEACHING HOSPITAL, GERIATRICS­ CHRONIC INTERNAL MEDICINE­ REHABILITATION, ZALAEGERSZEG, HUNGARY 3UNIVERSITY OF DEBRECEN, DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY, DEBRECEN, HUNGARY

Background

Vitamin D is essential in human to maintain the health status and the normal function in multiple organs, it is essential for the endocrine system. Deficiency of vitamin D may enhance the development of osteoporosis, reduce the muscular strength, weaken the immune response or increase the risk of certain chronic diseases.

Purpose

To assess in­patients’ vitamin D level, outcome of supplementation, adherence and re­hospitalization.

Material and methods

A cross sectional observational study in a teaching hospital.

Results

Between 2015 and 2017 in total 646 cases were recorded. The average age was 81.0 ±7.1 years. The gender distribution was 22% male and 78% female.

Very­low vitamin D levels were detected in 459 cases (71.4%), low levels in 121 cases (18.8%) and target vitamin D levels were revealed only in 63 cases (9.8%).

As a treatment­related outcome, the effectiveness, the level of adherence and frequency of re­hospitalization were investigated also by the age categories. Average serum 25(OH) D levels in non­supplemented population was 11.12ng/ml and in treated population 28.99ng/ml. Both the daily (1000 IU/day) and the equivalent monthly supplementation was successful. However, the schedule when loading doses applied by a single tablet (30,000 IU/ week) for 8­12 weeks followed by maintenance doses resulted in more powerful increase (21.30 ±9.3ng/ml vs. daily 1000 IU: 12.9 ±11.7ng/ml). From the supplemented group 110 patients (74%) were adherent to therapy over the treatment period (average 24.1 ± 18.7 months). Surprisingly, the level of re­hospitalization during the study period was below 30% in the deficient group and did not improve significantly with adherence to therapy. Although from the population selected for this sample the level of non­adherence turned out to be higher in age group of 75­85 years, compared to more seniors and even to younger patients (41.9% vs. 19%, 18.5%, respectively).Conclusion

Significant vitamin D deficiency was observed. Vitamin D supplementation for this specific population does not reach the level of 50 percent, most patients receiving 1000 IU daily doses in average. Therapies of the current clinical practice may require consideration to establish proper maintenance dosing and loading schedule and assess the adherence of individuals to prescribed therapy.

References and/or Acknowledgements

N/A

Conflict of Interest No conflict of interest

BAR19­0951 VITAMIN SUPPLEMENTS IN PATIENTS WITH HIV INFECTION

L. RUIZ GONZALEZ1, A. LÁZARO LÓPEZ1, A.L. ALVAREZ NONAY1, I. MENDOZA ACOSTA1, M. LAVANDEIRA PEREZ1, M. RODRÍGUEZ ZAPATA2 1HOSPITAL UNIVERSITARIO DE GUADALAJARA, PHARMACY SERVICE, GUADALAJARA, SPAIN 2HOSPITAL UNIVERSITARIO DE GUADALAJARA, INTERNAL MEDICINE SERVICE, GUADALAJARA, SP AIN file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 42/60 05/11/2018 Rejected - S4.html

Background

DIFFERENT STUDIES SUGGEST THAT THE CONSUMPTION OF VITAMINS CAN BENEFIT THE PATIENT WITH HIV INFECTION. HOWEVER, OTHER STUDIES CONCLUDE THAT IF THE PATIENT IS ON ANTIRETROVIRAL TREATMENT NOT ONLY IS IT NOT BENEFICIAL BUT IT CAN BE HARMFUL BECAUSE OF THE INCREASE IN THE NUMBER OF INTERACTIONS.

Purpose

THEREFORE, THE OBJECTIVES OF THE STUDY ARE: DETERMINE THE PREVALENCE OF VITAMIN INTAKE IN THE P ATIENT WITH HIV INFECTION. ANALYZE THE PREVALENCE OF INTERACTIONS BETWEEN VITAMINS AND ANTIRETROVIRAL TREA TMENT (VITAMIN­ TAR) EVALUATE THE IMPACT OF THESE INTERACTIONS ON THE VIROLOGICAL RESPONSE.

Material and methods

PROSPECTIVE OBSERVATIONAL STUDY CONDUCTED IN PATIENTS WITH HIV INFECTION TREATED IN THE PHARMACY SERVICE OF A REGIONAL UNIVERSITY HOSPITAL FROM JANUARY 1, 2014 TO DECEMBER 31, 2015. THE FOLLOWING VARIABLES WERE COLLECTED: AGE, SEX, VITAMIN CONSUMPTION, VIT AMIN­TAR INTERACTION AND PLASMA VIRAL LOAD (VL). THE INCLUSION CRITERIA WERE: BE P ATIENTS WITH HIV INFECTION, AGE EQUAL TO OR GREATER THAN 50 YEARS OLD AND BE ON ANTIRETROVIRAL TREATMENT (ART) FOR AT LEAST 6 MONTHS. THE STATISTICAL ANALYZES WERE PERFORMED USING THE ST ATISTICAL PACKAGE SPSS 15.0.

Results

WE ANALYZED 326 PATIENTS AND A TOTAL OF 914 ACTIVE INGREDIENTS. THE MEDIAN AGE WAS 47 YEARS (RI: 19­88), WITH 71.8% (N = 234) MALE PATIENTS. 66 PATIENTS (20.25%) WERE IN VIT AMIN TREATMENT, ONLY 14 (21.21%) VITAMIN­TAR INTERACTIONS WERE PRESENTED. WHEN THE VL WAS ANALYZED: ­ PATIENTS WITH VL <50 COPIES/ML IN VIT AMIN TREATMENT: 42 PATIENTS (63.64%) ­ PATIENTS WITH VL <200 COPIES / ML IN VITAMIN TREATMENT: 57 PATIENTS (86.4%) ­ PATIENT WITH VL <50 COPIES/ML WITHWITHOUT VITAMIN TREATMENT:160 PATIENTS (61.6%) ­ PATIENTS WTIH VL < 200 COPIES/ML: 222 PATIENTS(85.34%) NO EXISTING STATISTICALLY SIGNIFICANT DIFFERENCES (p>0.05)

Conclusion

­ A SIGNIFICANT NUMBER OF SEROPOSITIVE PATIENTS ARE IN VITAMIN TREATMENT ­ VITAMIN­TAR INTERACTIONS ARE RELATIVELY FREQUENT. ­ VITAMIN­TAR INTERACTIONS DO NOT NEGATIVELY AFFECT THE VIROLOGICAL RESPONSE.

References and/or Acknowledgements

­

Conflict of Interest No conflict of interest

BAR19­0957 CARBAPENEMS CONSUMPTION EVALUATION IN 2016 AND 2017, IN A THIRD LEVEL HOSPITAL

E. TEJEDOR1, B. FRANCO SANDAR1, B. TAUSTE HERNANDEZ1, E. MARTINEZ VELASCO1, F. VERDEJO RECHE1, F. SIERRA GARCIA1 1COMPLEJO HOSPITALARIO TORRECÁRDENAS, PHARMACY, ALMERIA, SPAIN

Background

Carbapenems are β­lactam antibiotics endowed with greater spectrum, activity and resistance to β­lactamases. They are essential in the empirical treatment of numerous serious infections of both community and nosocomial origin. As a spectrum of action in therapeutics, they are directed to multi­resistant gram­negative bacteria

Purpose

To evaluate carbapenems consumption during the years 2016 and 2017, according to the Daily Dose Defined per thousand inhabitants.

Material and methods

Retrospective observational study, which included patients treated with carbapenems during their stay in the hospital in 2016 and 2017. Data were obtained from the medical history program (Diraya®) and the outpatient program (Dominion­FarmaTools ® ).

The antibiotics were prescribed mainly by the Internal Medicine, General Surgery and Intensive Care Unit, and later revised by the Pharmacy Service.

Results

The consumption of the main antibiotics in function Daily Dose Defined per thousand inhabitants increased in the case of meropenem (in 2016 it was 48.86 and in 2017 it was 63.39) and imipenem (in 2016 it was 24.79 and in 2017 it was 26, 08) but decreased in the case of ertapenem (in 2016 it was 6.44 and in 2017 it was 5.62)

Conclusion

The pharmaceutical action contributed to optimize the use of antibiotics, reducing their use in cases where they were not indicated or there were other alternatives

References and/or Acknowledgements

The role of antimicrobial stewardship in curbing carbapenem resistance. Bogan C1, Marchaim D file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 43/60 05/11/2018 Rejected - S4.html

Conflict of Interest No conflict of interest

BAR19­0968 EVIDENCE OF A RISK MANAGEMENT PROGRAM FOR THE USE OF VALGANCYCLOVIR ON AN OUTPATIENT REGIMEN

C. MORTE1, M. CAPOULAS1, T. LOBO1, E. MARQUES1, C. SANTOS1 1HOSPITAL BEATRIZ ÂNGELO, PHARMACEUTICAL SERVICES, LOURES, POR TUGAL

Background

Valgancyclovir is a hospital­exclusive drug whose outpatients use has been mostly intended for disseminated cytomegalovirus infection. Hematologic alterations are the most common adverse effects. For this reason, regular monitorization of analytical values (complete blood cells count and platelets count) is recommended because if an alteration in the results is detected, a treatment with hematopoietic growth factors and/or dose interruption may be necessary.

Purpose

To evaluate the hematological profile of outpatients in valgancyclovir use and the occurrence of frequent adverse reactions described by industry company in the summary of product characteristics (SPC), as well as the importance of a risk management program in this outpatients.

Material and methods

Prospective clinical and laboratorial data collection, since the opening of pharmacy services until July 2018, based on clinical processes of patients undergoing valgancyclovir therapy. Through this analysis it was possible to define the average time of therapy and distribute the patients by degree of anemia, leukopenia, neutropenia and thrombocytopenia.

Results

There were included 48 patients with average age of 45,5 years and predominantly HIV­positive (62,5%). 43,7% of them were male. Infecciology had 69% of the cases and the most prevalent diagnosis was disseminated disease state. The average treatment time was 114 days. In the first week, 17 patients had grade 2 anemia and 4 patients had grade 4 anemia. Also, 1 patient had grade 3 thrombocytopenia and 2 patients had grade 4. Likewise we identified 6 patients with grade 3 and 1 with grade 4 leukopenia and 1 patient with grade 3 neutropenia and another 1 with grade 4.

Conclusion

Knowing that the alteration of hematological parameters, described in the drug's SPC, is frequently observed when patients receive valgancyclovir treatment outside hospital, the need of frequent monitorization of these parameters is very clear. Therefore, it seems to exist a substancial advantage in implementing a Risk Management Program for these cases.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1010 EVALUATION OF METRONOMIC CHEMOTHERAPY WITH ORAL VINORELBINE IN METASTASIC BREAST CANCER

A.C. VINEY1, E. CONESA NICOLÁS1, S. NÚÑEZ BRACAMONTE1, C. JUEZ SANTAMARÍA1, A. LLORET LLORCA1, C.N. GARCÍA MATILLAS1, M. MARTÍNEZ PENELLA1, A.M. CHICA MARCHAL1, M.D.M. SÁNCHEZ CATALICIO1, M.H. GARCÍA LAGUNAR1, L.M. ESCONDRILLAS GÓMEZ1 1HOSPITAL GENERAL UNIVERSITARIO SANTA LUCIA DE CARTAGENA, SERVICIO DE FARMACIA HOSPITALARIA, CARTAGENA, SPAIN

Background

A strategy to control metastatic breast cancer (MBC) and reduce toxicity is metronomic chemotherapy (MTC), consisting of a more frequent administration of low dose drugs, aiming to prevent tumour angiogenesis.

Purpose

To assess the efficacy and safety of MTC with oral vinorelbine (OV) in patients with MBC in a tertiary hospital, comparing the results to those published in the literature.

Material and methods

A retrospective observational study that included all patients with MBC who were treated with MTC using OV. The variables analysed were: age, sex, hormone receptor status, Eastern Cooperative Oncology Group (ECOG) status at baseline, previous treatments, dosage regimen, treatment duration, clinical response and adverse effects (AE).

Efficacy endpoints were progression­free survival (PFS) and overall survival (OS). For safety profile assessment, AE were studied.

Clinical data was obtained from electronic medical records (Selene®) and oncology prescription software Farmis­Oncofarm®.

Results

A total of 5 women were included in the study with a median age of 79 years (range: 70­89). All patients had positive oestrogen receptors and were HER2­negative. Initial ECOG was 0 in 2 patients, 2 in 2 patients and 4 in 1 patient. Two patients received OV continuously as a first line treatment for MBC with a dosage regimen of 40 mg three times a week (Monday, Wednesday and Friday). Three patients with ≥2 previous lines of chemotherapy for MBC, received OV continuously with a dose regimen of 50 mg three times a week (Monday, Wednesday and Friday).

Four of the patients had disease progression, 1 received a new line of treatment whilst the other 3 were referred to palliative care. Median treatment duration and PFS was 2.25 months (range: 0.5­4.00) . OS was 7 months (range: 2­24) (data for 20% of the patients was censored). Four patients were exitus.

The registered AE were grade 2 neutropenia and nausea and vomiting. file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 44/60 05/11/2018 Rejected - S4.html

Conclusion

The use of MTC with OV in MBC is an appealing alternative in advanced stages or in patients with deteriorated general health to prolong disease control and minimize AE. PFS and OS values were lower than those published in the literature, being necessary more studies to demonstrate efficacy and safty profiles.

References and/or Acknowledgements

Conflict of Interest No conflict of interest

BAR19­1016 EFFICACY AND SAFETY OF MODULATORS THERAPY IN THE TREATMENT OF CYSTIC FIBROSIS: A SYSTEMATIC REVIEW.

M.J. GÁNDARA LADRÓN DE GUEVARA1, C. PALOMO PALOMO1, E. RIOS SANCHEZ1, J.C. GARCIA DE PAREDES ESTEBAN1, M.D. GIL SIERRA1, C. SALMARON NAVAS1 1H.U PUERTO REAL, PHARMACY, CÁDIZ, SP AIN

Background

Cystic fibrosis (CF) is a genetic, autosomal recessive disorder, which mainly affects the respiratory system. CF is caused by deficient cystic fibrosis transmembrane conductance regulator (CFTR) protein activity.

Purpose

The CFTR modulators drugs are Ivacaftor and the combinations lumacaftor with ivacaftor(LUM/IVA) and tezacaftor with ivacaftor (TEZ/IVA).These represent a significant challenge in the approach to CF treatments.

Material and methods

Was performed a systematic search in MEDLINE (PUBMED) and Cochrane Library until August 2018, using keywords “cystic fibrosis AND CFTR drugs”. Were included phase 3, randomized, placebo­controlled studies and were excluded no systematic review and clinical practice studies.

Results

Eleven trials were selected, six for ivacaftor, three for LUM/IVA and two for TEZ/IVA. The primary end point was the absolute change from baseline in the percentage of predicted forced expiratory volume in 1 second (FEV1) at week 24. The adverse events in the different studies were revised. The patients included in the Ivacaftor studies had an age ≥2 years and the following mutations: G551D or no G551D (G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N o S549R) and also R117H mutation in adults were included . Ivacaftor has show an improvement in FEV1 of 10­12%. The patients included in the LUM/IVA studies had age ≥6 years and were homozygous for the F508del mutation. These patients have a severe form of the disease. LUM/IVA showed modest, but significant improvements from baseline in FEV1 (2­4%). The patients included in the TEZ/IVA studies had age ≥12 years and were homozygous for one study and heterozygous to the other for F508del mutation. The improvements in FEV1 was 4­6.8% respectively. The majority of patients had adverse events that were considered either mild or moderate in severity. Transaminitis was seen in ivacaftor and combination trials. No adverse events led to discontinuation of the trial regimen

Conclusion

There are more evidence available for ivacaftor than combination treatments. In all clinical trials, treated patients with ivacaftor and combinations therapy showed improved pulmonary function. The increase in seric transaminases should be monitored for patients who are starting these treatments.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1024 A PILOT STUDY OF SCREENING EMOTIONAL BURDEN AFTER LIVER TRANSPLANTATION

R.M. HEEB1, I. KRAEMER1 1UNIVERSITY MEDICAL CENTER MAINZ, PHARMACY DEPARTMENT, MAINZ, GERMANY

Background

In Germany, 5.2% of the total population is suffering from depression regarding a WHO study (1). About 40% of liver transplant patients show symptoms of a depression. In transplanted patients untreated emotional burden correlates with a higher mortality rate (2). Screening of liver transplanted patients for emotional burden and initiation of adequate treatment is important due to a lack of donor organs and frequent organ rejection reactions.

Purpose

The aim of the pilot study is to evaluate the emotional burden of liver transplant patients in the University Medical Center, Mainz and the treatment status of these patients immediately and 6 months after transplantation.

Material and methods

50 liver transplant patients will be recruited during one year at the University Medical Center Mainz, Germany. A validated, German version of the Patient Health Questionnaire (D­PHQ) is used for screening of the emotional burden in terms of anxiety and depression. The D­PHQ will be handed

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 45/60 05/11/2018 Rejected - S4.html out to the patients 7 days and 6 months after liver transplantation. In parallel type and frequency of treatment with antidepressant and anxiolytic medication will be retrieved from the medical records of the liver transplant patients. Results will be stratified according to the gender.

Results

First results will be available at December 2018 and presented.

Conclusion

The expectation of the pilot study is many patients having an emotional burden without a therapy.

References and/or Acknowledgements

(1) Depression and Other Common Mental Disorders: Global Health Estimates. Geneva:

World Health Organization; 2017: Licence: CC­BY­NC­SA 3.0 IGO

(2) DiMartini A, Dew MA, Chaiffetz D, Fitzgerald MG, Devera ME, Fontes P. Early

trajectories of depressive symptoms after liver transplantation for alcoholic liver disease

predicts long­term survival. Am J Transplant 2011 Jun;11(6):1287­95. Conflict of Interest No conflict of interest

BAR19­1028 EFFECTIVENESS OF DALBAVANCIN IN NATIVE MITRAL VALVE ENDOCARDITITS ASSOCIATED WITH BACTERIEMIA: A CASE REPORT

D. RUBIO CALVO1, D. GONZALEZ VAQUERO1, J. URDA ROMACHO1, M. AZNAR GARCIA1, J. CANTO MANGANA1, A. MARTOS ROSA1, M.A. CASTRO VIDA1 1AGENCIA PUBLICA EMPRESARIAL HOSPITAL DE PONIENTE, PHARMACY DEPARTMENT, EL EJIDO ALMERÍA, SPAIN

Background

Dalbavancin is an antibiotic lipoglycopeptide indicated in Spain for the treatment of acute complicated bacterial infections of soft tissues and skin in adults. Dalbavancin has been proved to be more efficient in the treatment of MRSA than others chemical related antibiotic as vancomycin or teicoplanin.

Purpose

To evaluate of the efficacy of dalbavancin in a patient with native mitral valve endocarditis associated with MRSA bacterIemia

Material and methods

The data collected was obtained from the digital clinical history and electronic prescription. A bibliographic search was carried out. We consulted Uptodate database.

Results

A 77­year­old woman Drug allergies: beta­lactam antibiotics and azithromycin. Personal history: systemic lupus erythematosus in treatment with azathioprine 50mg/24hours and prednisone 10mg/12hours, heart failure and recurrent strokes with epilepsy sequels.In April 2018, the patient was hospitalized for ischemic stroke. During the hospitalization she develops phlebitis and its caused a MRSA bacterIemia. Antibiotic treatment was started with daptomycin 700mg/24hours. After 4weeks of treatment and a good clinical course and negative blood cultures she went to discharge with her regular medication and dalbavancin 500mg weekly for 6 weeks. Five weeks after the end of treatment with dalbavancin the patient was re­ hospitalized for high fever. An echocardio was performed and vegetations were observed witch confirmed the diagnosis of native mitral valve endocarditis secondary to MRSA bacterIemia in a patient with immunosuppression by azathioprine. Surgical intervention was rejected due to the patient comorbidities and antibiotical therapy with daptomycin 700mg/24hours was initiated for 2weeks. The treatment was effective with negative blood cultures whiting the first week of treatment. The patient was discharged with a weekly dose of dalvabancin 500mg for 4weeks. Treatment with azathioprine was suspended and the dose of prednisone was reduced to 5 mg/24hours due to the risk of immunosuppression. Since the end of treatment with dalbavancin, there was no recurrence.

Conclusion

Dalbavancin demonstrated to be effective in the resolution of native mitral valve endocarditis secondary to MRSA bacterIemia. Recurrence was associated with concomitant treatment with immunosuppressants (prednisone and azathioprine). The weekly intravenous administration of dalbavancin has been an advantage of ambulatory antibiotic treatment in patients with good clinical evolution who need only intravenous antibiotic treatment.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1106 OVERVIEW OF THE USE OF MELATONIN IN A PEDIATRIC SERVICE

C. LAMBERT DE CURSAY1, R. DE TOURNEMIRE2, A. LECOEUR1 1HÔPITAL AMBROISE PARÉ, PHARMACY, BOULOGNE­BILLANCOUR T, FRANCE 2HÔPITAL AMBROISE PARÉ, PAEDIATRIC WARD, BOULOGNE­BILLANCOURT, FRANCE

Background

In France, melatonin (melatonin receptor agonist psycholeptic) has a Market Authorisation only for the treatment of insomnia in adults. In 2018, the National Agency for the Safety of Medicines and Health Products (ANSM) gave a favorable agreement for the granting of a marketing authorisation file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 46/60 05/11/2018 Rejected - S4.html for a pediatric version of melatonin (Slenyto®).

Purpose

The objective is to make an evaluation of its off­label use in a pediatric ward.

Material and methods

Patients who received melatonin for a sleep disorder during hospitalization from 01/01/18 to 31/08/18 were included. The information collected is: usual treatments, prescribed drugs during hospitalization, doses, efficacy, side effects. A search for drug interactions is done.

Results

Melatonin is used in 14 patients. They are between 13.2 and 16.4 years old, are predominantly female (79%), and have eating disorders (57%). Eight patients completed an internal questionnaire: 7 have trouble falling asleep, 6 often wake up at night, 6 are tired during the day. Only 2 were already on melatonin before hospitalization. The initiation dose is variable (2­6mg), followed by increases up to 10mg. Five patients had one (n=2), two (n=2), or three increases (n=1). The patient who had three increases also had two decreases, included one for headache (known adverse effect, disappearance after dose reduction). Nine patients remained at the same dose. The doses used do not follow those used in pediatrics protocols (before electroencephalogram) like 8mg for children over 25kg. Among the treatments prescribed during hospitalization, the only interactions with melatonin found in the literature concern laxatives (n=3) or gastroesophageal reflux treatments (n=1). Among the 12 patients who had an initiation during hospitalization, melatonin helped to improve sleep for 7 of them, according to the medical report. Eleven patients were discharged with a melatonin prescription.

Conclusion

The prescriptions are reviewed to increase the doses, rarely for a decrease or a discontinuation. The question of the relevance of prescriptions arises, especially since melatonin also has a status of food supplement and can therefore be easily taken by patients after hospitalization without supervision. Even if melatonin could represent a good alternative to hypnotics, its use should be more controlled because there are still few feed­ backs.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1078 Definition of a diagnostic­therapeutic procedure for the desensitization of chemotherapy induced hypersensitivity reactions

F. GUARNERI1, D. BETTONI1, G. CHIODELLI1, E. ZANETTI1, T.E. TESTA1 1ASST SPEDALI CIVILI, FARMACIA AZIENDALE, BRESCIA, ITALY

Background

Some classes of chemotherapeutic drugs, such as Platinum compounds (PT) (cisplatin, carboplatin and oxaliplatin) or paclitaxel and docetaxel (TX) are associated to higher risk of hypersensitivity reactions (HR). In the last years, the continue innovations, has permitted an increasing in the survival of oncological patients. As a consequence, patients could come into contact more often with these drugs with an increased risk of adverse reactions (AR). Data from the Italian pharmacovigilance database related to a large­sized hospital in north Italy during the last 13 years showed 4 serious PT­ induced HR (anaphylaxis) and 5 TX­induced HR on respectively 92 and 46 total AR. Moreoften, alternative therapeutic strategies are't sufficient consolidate or effective, so it is essential identifying patients who can be chosen for a desensitization procedure (DES), in order to induce a temporary tolerance usefool to permit the chemotherapic treatment, although not completely removing the risk of HR.

Purpose

The purpose was the definition of a diagnostic­therapeutic procedure for the management of patients with previous HR to PT or TX.

Material and methods

A multidisciplinary working group was set up between pharmacists, physicians and nurses.

Results

Patients with documented pregress type I, IVa or slight­moderate IVb HR related to PT or TX will be directed to allergological evaluation: if indicated, patch test will be performed. If DES is needed, the allergologist will be determined the dosing regimen based upon the desidered therapeutic dose (TD), according to the Castells M. (2008) protocol. Will be prepared 3 normal saline 250 ml bags, the first containing TD, the second and the third containing rispectively 1/10 and 1/100 of TD, infused starting from the less concetrate, progressively increasing the infusion rate. Since DES duration is unpredictable, this protocol will be applied at each infusion promptly reporting any AR at local responsible of pharmacovigilance. It has been implemented the informatized prescriptions of the patch test and the DES's protocol using the local software, thereby reducing the risk of prescriptions related errors and ensuring traceability.

Conclusion

The standardization of the management of PT or TX­DES, allows to guarantee the safety and the best possible treatment to the patient with previous HR.

References and/or Acknowledgements

­

Conflict of Interest No conflict of interest

BAR19­1102 THE PHARMACIST ROLE IN THE MANAGEMENT OF DRUG INCOMPATIBILITIES AND PARENTERAL NUTRITION IN THE NEW­ BORN

S. BENNIS1, L. YACHI2, M. ALAMI CHENTOUFI2, H. OUHADDOUCH2, A. CHEIKH3, M. BOUATIA4

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 47/60 05/11/2018 Rejected - S4.html 1MOHAMMED V UNIVERSITY ­FACULTY OF MEDICINE AND PHARMACY­ RABAT­ MOROCCO, MOHAMMED V UNIVERSITY ­ FACULTY OF MEDICINE AND PHARMACY­ RABAT­ MOROCCO, CASABLANCA, MOROCCO 2MOHAMMED V UNIVERSITY ­FACULTY OF MEDICINE AND PHARMACY­ RABAT­ MOROCCO, MOHAMMED V UNIVERSITY ­ FACULTY OF MEDICINE AND PHARMACY­ RABAT­ MOROCCO, RABAT, MOROCCO 3ABULCASIS UNIVERSITY­FACULTY OF PHARMACY­ RABAT­ MOROCCO, ABULCASIS UNIVERSITY ­ FACULTY OF PHARMACY­ RABAT­ MOROCCO, RABAT, MOROCCO 4MOHAMMED V UNIVERSITY­ FACULTY OF MEDICINE AND PHARMACY­ ANALYTICAL CHEMISTRY­ PAEDIATRIC HOSPITAL­ RABAT­ MOROCCO, MOHAMMED V UNIVERSITY­ FACULTY OF MEDICINE AND PHARMACY­ ANALYTICAL CHEMISTRY­ PAEDIATRIC HOSPITAL­ RABAT­ MOROCCO, RABAT, MOROCCO

Background

The use of injectable drugs in neonatology poses particular challenges leading to difficulties of preparation and administration associated with a high risk of medication errors. There is a high risk of physicochemical incompatibilities with rare but serious consequences such as pulmonary and renal embolism.The ability of the clinical pharmacist to understand the physicochemical phenomena related to drug incompatibilities is a useful resource for the medical­care staff in the management and prevention of this problem.

Purpose

The main objective of this work is to describe the role of the practicing pharmacist in the risk management of drug incompatibilities and parenteral nutrition in neonatology.

Material and methods

This is a literature review that focuses on the pharmacist's role in risk management of drug incompatibilities and parenteral nutrition in neonatology. We consulted 35 bibliographic references for the realization of this work.

Results

The management of medication compatibility or parenteral nutrition issues is an integral part of the pharmacist's missions providing information about the drug. The practicing pharmacist will be able to develop clinical decision support tools such as dosing orders and protocols. The pharmacist, with his knowledge of drug dosing can prepare solutions with low volume and high concentration to meet the caloric requirements of newborns. The pharmacist studies the container­content interactions in order to avoid the physical drug incompatibility that can appear between the solution and the perfusion bags. He can also prevent the occurrence of chemical drug incompatibility by conducting stability studies.

Conclusion

In conclusion, the practicing pharmacist can bring a real added value by his analysis of the situation in practice and his expertise in the understanding of the physicochemical phenomena in connection with the incompatibilities.

References and/or Acknowledgements

Dr. Mamouni Alaoui Faiçal

Conflict of Interest No conflict of interest

BAR19­1105 ETELCALCETIDE IN PATIENTS WITH SECONDARY HYPERPAPARATHYROIDISM DUE TO RENAL FAILURE: PRELIMINARY STUDY

J.J. ALCARAZ SANCHEZ1, M.J. MORALES LARA1, A. LUNA HIGUERA1 1HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA, HOSPITAL PHARMACY , MÁLAGA, SPAIN

Background

Secondary hyperparathyroidism, a complication of chronic kidney disease, is characterized by high serum (PTH) and disturbances in mineral metabolism. Etelcalcetide binds directly to Calcium­sensing receptor, inhibiting the production and secretion of PTH by parathyroid glands.

Purpose

To describe the use, effectiveness and safety profile of etelcalcetide in patients diagnosed with secondary hyperparathyroidism due to renal failure (SHDRF) undergoing hemodialysis.

Material and methods

Retrospective observational study of all patients with SHDRF undergoing hemodialysis who started treatment with etelcalcetide in our Hospital. Demographic (age, sex) and analytical data (serum levels of corrected calcium (Cac), phosphorus (P), PTH and vitamin D {VitD}) were collected at baseline and 3 months later. Therapeutic parameters (previous treatment, posology of etelcalcetide and adverse effects) were also registered.

Effectiveness was assessed by normalisation of analytical parameters (PTH’s aim was defined as 150­300 pg/ml, or at least a 30% reduction in serum levels).

Results

10 patients with a mean age of 62±20 years (50% men). The mean analytical data were: Cac (9.5±0.9mg/dl), P (5.2±0.7mg/dl), PTH (1379.3±793,7pg/ml) and VitD (21.8±13.19ng/ml).

The starting dose of all patients was 2.5 mg/3 times a week, coinciding with haemodialysis sessions. One month after the beginning of treatment, it was necessary to double the dose to 5 mg in 70% of patients, and up to 10 mg in 10% of patients, always maintaining the frequency of administration.

Previous treatment before etelcalcetide was: cinacalcet (60% of the patients), paricalcitol (20%). 10% of patients had never received treatment for hyperparathyroidism. file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 48/60 05/11/2018 Rejected - S4.html After 3 months of treatment, serum PTH was reduced in 60% of patients, no one obtaining target values (mean after 3 months: 1207.9±662.7 pg/ml). Only one patient reached a 30% reduction in serum levels. Cac levels were reduced in 60% of patients (mean after 3 months: 8.9±0.9mg/dl), P levels decreased by 50% (mean after 3 months: 5±1.1mg/dl).

Adverse effects: only one patient suffered digestive intolerance related to the drug that leaded to treatment suspension.Conclusion

Preliminary results show a poor effectiveness of etelcalcetide in our studied population, although is generally well tolerated by patients. However, a greater sample size and longer periods of treatment are needed to reach definitive conclusions.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1110 UTILISATION STUDY OF DIRECT ORAL ANTICOAGULANTS IN NON­VALVULAR ATRIAL FIBRILLATION PATIENTS WHO ARE CANDIDATES FOR ELECTIVE CARDIOVERSION

M. CASTRESANA1, M. MARIN1, A. VILLACAMPA1, M. PIO1, P. MONFORTE2, M. GUTIERREZ3 1HOSPITAL REINA SOFIA, PHARMACY, TUDELA, SPAIN 2HOSPITAL SAN JUAN DE DIOS, PHARMACY, ZARAGOZA, SP AIN 3COMPLEJO HOSPITALARIO DE NAVARRA, PHARMACY, PAMPLONA, SP AIN

Background

In patients with non­valvular atrial fibrillation(NVAF) electrical cardioversion(ECV) may be performed to restore sinus rhythm. The procedure is associated with an increased risk of thromboembolic events, which can be significantly reduced by adequate anticoagulation. The direct oral anticoagulants (DOACs) usage is increasing in this setting but which DOACs is more appropriate for each patient?

Purpose

To evaluate the prevalence of DOACs usage in electrical cardioversion setting and to establish a relation between the choice of the therapy and the individual clinical characteristics.

Material and methods

Retrospective observational study including all patients were given DOACs as periprocedural anticoagulation at a tertiary care center from January 2016 to October 2018. Patients with NVAF who were eligible for ECV were included.

The clinical characteristics (sex, age and comorbidities), the risk of thromboembolic events using CHA2DS2­VASC Score, the choice of DOACs, the incidence of thromboembolic events in the first 30 days and the safety of the therapy.

Results

A total of 38 patients (79% male, mean age 58 years ±11) were registered. CHA2DS2­VASC Score of 0 was 29% patients, Score of 1 32%, Score of 2 16%, Score of 3 21% and Score of 5 3%. 68% received dabigatran, 15% rivaroxaban, 13% apixaban and 3% edoxaban.

All patients were given DOACs at least for 3 weeks prior and more than 4 weeks after the procedure, irrespective of CHA2DS2­VASC score. The long­ term management of patients post­cardioversion depended on the individual patient’s CHA2DS2­VASC Score.

Thromboembolic and bleeding events did not occur in the first 30 days after cardioversion. In the relation to side­effects, the most common was the gastrointestinal effect. In 2 patients under dabigatran, the gastrointestinal events and alopecia and a major bleeding were the reason modify the therapy to apixaban.

Conclusion

Dabigatran is the first choice and edoxaban is the least prescribed DOAC. A substantial increase of apixaban prescribed throughout the observational period has been recorded.

The evaluation of the clinical characteristics of our patients does not allowed to establish any relation with the choice of DOACs. Further studies in the cardioversion setting will be needed to focus which is the DOACs more appropriate for each patient.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1114 EVALUATION OF BIOLOGICAL THERAPY PRESCRIPTIONS IN ULCERATIVE COLITIS

R. SÁNCHEZ DEL MORAL1, M.T. LÓPEZ MANCHA1, E. RODRIGUEZ MOLINS1, M.M. ROMERO ALONSO1, J. ESTAIRE GUTIÉRREZ1, M.B. CONTRERAS REY1 1HOSPITAL INFANTA ELENA, PHARMACY SERVICE, HUELVA, SPAIN

Background

Ulcerative colitis (UC) is a chronic inflammatory autoinmune pathology. During the last years, the introduction of biological agents has drastically improved the treatment of ulcerative colitis and with them, the quality of life of these patients as well as reducing the risk of hospitalization and surgeries. These drugs suppose a great economic impact for the Pharmacy service.

Purpose

The study aimed to analyse the evolution of use of biological therapy in ulcerative colitis. file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 49/60 05/11/2018 Rejected - S4.html

Material and methods

A retrospective, observational study was performed at a comarcal hospital from January 2012 until September 2018. All patients who recibed any biological therapy dose for ulcerative colitis were included. Data were colleted from Silicon® electronic prescription program and the pharmacy service managing software ( APD­Athos® ).

Results

Biological drugs dispensed were: infliximab, infliximab biosimilar, adalimumab, golimumab and vedolizumab. The total dispensations in the studied period were 336. Separated by years the dispensations were: In 2012 134 infliximab, 60 adalimumab; in 2013 60 infliximab, 58 adalimumab; in 2014 53 infliximab, 30 adalimumab, 17 golimumab; in 2015 58 infliximab, 18 infliximab biosimilar, 64 adalimumab, 20 golimumab; in 2016 136 infliximab biosimilar, 82 adalimumab, 29 golimumab, 7 vedolizumab; in 2017 130 infliximab biosimilar, 86 adalimumab, 62 golimumab, 8 vedolizumab; from january 2018 until september 2018 have been dipensed 50 infliximab biosimilar, 92 adalimumab, 57 golimumab and 11 vedolizumab.

The cost per year was: 77.713,8 (2012), 48.219,6 (2013), 48.081,6 (2014), 71.775,4 (2015), 105.595,7 (2016), 135.827,3 (2017) and 118.800,33 (2018).

Conclusion

Infliximab biosimilar, adalimumab, golimumab and vedolizumab are the biological drugs used in UC in our hospital. Infliximab biosimilar was the drug with lower cost per patient while Vedolizomab was the most costly.

In the studied period, there has been a cost increase of 58.113,5 euros.

Substitutions of infliximab to infliximab biosimilar allowed that the increase in the cost hadn´t been so high.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1115 OBSERVATIONAL CROSS­SECTIONAL STUDY ON HIV­INFECTED PATIENTS WITH DRUG RESISTANCE RESCUE THERAPY

M.E. NAVARRETE ROUCO1, M. DE ANTONIO­CUSCO1, S. LUQUE1, E. GONZALEZ1, H. KNOBEL2, S. GRAU1 1HOSPITAL DEL MAR, PHARMACY, BARCELONA, SPAIN 2HOSPITAL DEL MAR, DEPARTMENT OF INFECTIOUS DISEASE, BARCELONA, SP AIN

Background

The antiretroviral treatment (ART) reduces the morbidity and mortality of HIV­infected patients1. Drug resistance(DR) has been associated with a higher risk of clinical progression and death2.

Purpose

To characterize the patient profile, ART treatment history and DR in HIV­patients with a current DR rescue therapy(DRT).

Material and methods

Observational cross­sectional study including all patients with DRT in our cohort of 2060 HIV­infected patients (September 2018) of our 450 bed­ university hospital. DRT was defined as failure at least of two lines of previous ART3.Only patients with genotypic DR testing were included.

Data collected: demographic, current comorbidities, years HIV diagnosis and ART, viral load(VL) and CD4+ count (baseline, maximum/nadir, current), previous and current ART, ART families/drugs with DR, daily pills and adherence during the previous 6 months

Categorical variables (%), continuous variables as median (Q1­Q3).

Results N 53(2.6) Sex(male) 38(71.7) Age(years) 51(46­57) Ethnicity Caucasian 35(66.0) Sout American 11(20.8) African 4(7.6) Others 3(5.7) HBV 8(15.1) HCV 19(35.9) Liver cirrhosis 2(3.8) Years since HIV diagnosis 22(18­25) Years on ART 19(13.5­19) CD4+/ CD4>200 (cells/ml) Baseline 303.0(206.3­493.5)/40(75.1) Nadir 125.0(37.5­202.0)/42(79.2) Current 627.0(467.0­888.0)/50(94.3) VL / VL>100.000 (copies/ml) Baseline 14000(2350­53250)/9(16.9)

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 50/60 05/11/2018 Rejected - S4.html Maximum 122000(29250­200750)/26(49.1) Current (%IDL/ >100.000) 44(83.0)/9(16.9) Previous ART Nº Families 5(4­5) Nº Drugs 12.5(8.8­14) Adherence 40(75.4)

ART families with DR 47(88.7) NRTI 36(68.0) ZDV 34(64.2) 3TC 32(60.4) ABC 27(51.0) TDF 26(49.1) FTC

42(79.3) NNRTI 40(75.5) NVP 37(69.8) EFV 16(30.2) RPV 12(22.6) ETR

28(52.8) PI 22(41.5) ATV 20(37.7) LPV 8(15.1) DRV 7(13.2) RTV

INSTI 4(7.6) RAL 7(13.2) EVG 4(7.6) DTG 1(1.9)

MVC 0(0) ENF 0(0) Current DRT PI 44(83.0) INSTI 40(75.5) MVC 25(47.2) NRTI 23(43.4) NNRTI 12(22.6) Total families 4(3­4) Total drugs 3(2­3) Total daily pills 5(3­6) Conclusion

The profile of a 53 HIV­patient with multiple­drug rescue therapy of our cohort of 2060(2.6%) was a Caucasian patient with a long median time of diagnosis and ART treatment of 22 and 19 years, respectively.

DRT seems to be efficient because more than 80% of patients had undetectable VL and CD4 count >200.

NRTI was the ART family presenting more resistances.

More than 60% of patients have resistance to NVP, EFV, ZDV, 3TC and ABC.

References and/or Acknowledgements

1.European AIDS Clinical Society. European AIDS Clinical Society (EACS) Guidelines. Version 9 [Internet]. 2017;(October):72. Available from: http://www.eacsociety.org/files/guidelines_9.0­english.pdf%0Ahttp://www.eacsociety.org/guidelines/eacs­guidelines/eacs­guidelines.html

2. Imaz A, Falc V, Ribera E. Antiretroviral salvage therapy for multiclass drug­resistant HIV­1­infected patients: from clinical trials to daily clinical practice. AIDS Rev. 2011;13(3):180–93.

3. Serrano Vicente MC, Navarro Aznárez H, Carrera Lasfuentes P, Abad Sazatornil MR, Horna Oreja O, Rabanaque Hernández MJ. Efectividad y seguridad de la terapia de rescate en pacientes VIH. Farm Hosp [Internet]. 2012;36(4):187–93. Available from: http://dx.doi.org/10.1016/j.farma.2011.03.004

Conflict of Interest No conflict of interest

BAR19­1119 ANTIRETROVIRAL THERAPY ADMINISTRATION IN CLINICAL COMPLICATED SCENARIOS: A CHALLENGE IN SOME HIV­ INFECTED PATIENTS

N. VALCARCE PARDEIRO1, H. ÁLVAREZ2, J.F. GARCÍA2, I. RODRÍGUEZ1, A. MARIÑO2 1COMPLEXO HOSPITALARIO UNIVERSITARIO DE FERROL CHUF, HOSPITAL PHARMACY , FERROL, SPAIN 2COMPLEXO HOSPITALARIO UNIVERSITARIO DE FERROL CHUF, INFECTIOUS DISEASES UNIT, FERROL, SP AIN

Background

There are limited data regarding administration of antiretroviral therapy (ART) in patients with swallowing difficulties however ART exposure and bioavailability are critical to achieve and maintain virologic suppression and to avoid the emergence of genotypic resistance

Purpose

To review patients in clinical practice with difficult to ART delivery and steps to ensure adequate administration

Material and methods

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 51/60 05/11/2018 Rejected - S4.html This retrospective observational study evaluated ART changes in patients with HIV­1 infection and difficulty swallowing solid oral medications between January 2010 and September 2018. Demographic characteristics, ART related data and plasma viral load (VL) prior to and after ART modifications, were collected. Statistical analysis was performed using SPSS (v21).

Results

11 patients (54% male) were included. Median age was 49 years (IQR 46­52), 82% prior injection drug use and 54% were CDC stage C. The average time since diagnosis was four months (27%) and twenty years (73%). Three patients with dysphagia: 1) patient with psychiatric disorder, previous ART discontinuation, started TDF/FTC(disintegrated tablet) plus ETR(dispersed tablet), 2)patient influenced by the size of TDF/FTC/RPV(STR) was switched to TDF/FTC(disintegrated tablet) plus RPV(much smaller sized tablet), 3)patient with ABC/3TC plus ATVr, was switched to ABC/3TC (splitted tablet) plus RAL (crushed tablet). The baseline VL was 12400, 20 and 290 copies/ml. Days 96, 48 and 11 after switching VL was reduced to <50 copies/ml. Eight patients started ART administration using nasogastric tube: intubated in the intensive care unit (4), dysphagia due to neurological disorder(3) and laryngeal cancer(1). Three patients with DRVr and two with ATVcobi changed the pharmacokinetic enhancer to ritonavir solution. NRTI, DRV, RAL and MVC tablets were crushed and ATV capsule was opened. ABC/3TC/DTG(Triumeq®) and DTG tablet were crushed and separated from enteral nutrition. Crushed rilpivirine was mixed with orange juice or administered with enteral feeding. Six patients maintained baseline VL<50copies/ml, two patient reduced VL from 5770 and 889 copies/ml to 285 and 68 copies/ml on day 13 and 27 after tube removal, respectively

Conclusion

alternative methods of administration or antiretroviral formulations were options when patients cannot take pills. Off­label administration of antiretroviral tablets or capsules were considered if no other options were availablea

References and/or Acknowledgements

Am J Health­Syst Pharm 2015; 72: 1555­1565

Conflict of Interest No conflict of interest

BAR19­1121 USE OF SECOND­GENARATION BETA­LACTAM/BETA­LACTAMASE INHIBITOR COMBINATIONS IN TERTIARY HOSPITAL.

J.J. ALCARAZ SANCHEZ1, R. ASENSI DÍEZ1, J.C. DEL RÍO VALENCIA1, I. MUÑOZ CASTILLO1 1HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA, HOSPITAL PHARMACY, MÁLAGA, SPAIN

Background

The rise in infections produced by Multidrug­Resistant (MDR) gram­negative organisms, carbapenemase and/or extended­spectrum beta­lactamase producer, has become an important problem in clinical practice. Ceftazidime/Avibactam(C/A) and Ceftolozane/Tazobactam(C/T) are two recent beta­ lactam/beta­lactamase inhibitors (BL/BLI).

Purpose

To analyze the use of BL/BLI in current clinical practice.

Material and methods

A retrospective observational study that included all patients who received treatment with Ceftazidime/Avibactam or Ceftolozane/Tazobactam since October 2016 to September 2018. The following variables were collected: demographics, inpatient units, pre and concomitant use of antibiotics, posology and treatment duration, days of hospital stay post antibiotic therapy, indication, microbiological agent and clinical result.

Results

The study included 34 patients and 36 hospitalizations.

C/T C/A Nº patients (nº hospitalizations) 13 (13) 21 (23) Mean age 61 57 ICU hospitalization (%) 8/13 (62%) 6/23 (26%) Pre­antibiotics 31% meropenem, 31% colistin, 31% tobramicin 57% meropenem Concomitant antibiotics (AB) 38% no concomitant AB 61% no concomitant AB 1 g/8h (3/13); renal adjustment doses (2/13); Off­ 2g/8h (13/23); renal adjustment doses Posology label increased doses over 1 g/8h (8/13) (10/23); no off­label doses Median completed treatment duration (days)(range) 8 (4­21) 10 (4­22) Median hospital stay post BL/BLI therapy (days)(range). 3 (0­105) 7 (0­62) Excluded patient who died on treatment. Pseudomonas aeruginosa MDR (77%) and Microbiological agent (%) Klebsiella pneumoniae OXA­48 (91%) Klebsiella pneumoniae OXA­48 (23%) % deaths during treatment 31% 9% % deaths during hospitalization 46% 17% Clinical result (%infection recovery) 54% 83% C/T prescription’s reason: 4 urinary tract infections, 3 complicated intra­abdominal infections and 6 off­label uses, mainly respiratory infections and pneumonia (5/6 patients)C/A prescription’s reason: 100% were approved indications, all of them caused by aerobic gram­negative microorganism in adult patients with limited clinical options (6/21 were lung, 3/21 bone marrow and 1/21 liver­transplanted).Conclusion

C/A is a great option in MDR patient’s treatment. However, C/T don’t achieve such as positive results as we would expect (31% deaths during treatment and 46% deaths during hospitalization), mainly because it was reserved for medical emergencies (62% ICU hospitalizations).

References and/or Acknowledgements

.

Conflict of Interest

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 52/60 05/11/2018 Rejected - S4.html No conflict of interest

BAR19­1123 DESIGN OF AN ANTI­HEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT

M. VALERA RUBIO1, M. GÓMEZ DELGADO1, P. NUEVO ORTEGA2, C. ESTAUN1, I. MOYA CARMONA1, J.M. FERNÁNDEZ OVIES1 1HOSPITAL VIRGEN DE LA VICTORIA, HOSPITAL PHARMACY, MÁLAGA, SPAIN 2HOSPITAL VIRGEN DE LA VICTORIA, INTENSIVE MEDICINE, MÁLAGA, SPAIN

Background

Blood coagulation factors and its adequate use can be of particular importance in the treatment of massive hemorrhage, especially in the intensive care units (ICU).

Purpose

To describe the most relevant antihemorrhagic agents regarding their consumption and difficulties experienced in administration and to define an emergency procedure that ensures a correct management in cases of massive bleeding.

Material and methods

We carried out a retrospective study to review databases of the pharmacy service to describe the ICU needs of antihemorrhagic drugs. ICU staff (doctors and nurses) was informed to reach an agreement about eligible drugs for being included in the protocol. We designed this procedure according to the summaries of product characteristics.

Results

During the previous year 2017, ICU had used 10 units of human fibrinogen 1 g vial, 111 units of tranexamic acid 500 mg vial and 15 units of human prothrombin complex. No units of eptacog alfa, Von Willebrand factor or factor VIII/von Willebrand factor complex were used. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of the instructions of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of a schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex; eptacog is stored in Hospital Pharmacy). 2. Indications and dosage according the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable) 3. Recommendations for intravenous administration (maximum flow rate, bolus, loading dose, dilution, mixture stability when applicable)

Conclusion

The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritizing the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. Mapping the information and dividing it into sections is essential for its rapid understanding in a high­stress work environment.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1128 UTILIZATION OF DIRECT ACTING ANTIVIRALS IN THE TREATMENT OF HEPATITIS C VIRUS GENOTYPES 2 AND 3

M.B. CONTRERAS REY1, E. RODRÍGUEZ MOLINS1, M.T. LÓPEZ MANCHA1, J. ESTAIRE GUTIÉRREZ1, M.M. ROMERO ALONSO1, R. SÁNCHEZ DEL MORAL1 1INFANTA ELENA HOSPITAL, HOSPIT AL PHARMACY, HUELVA, SPAIN

Background

Although appearance of direct acting antivirals (DAA) have supposed an important progress in treatment of hepatitis C virus (HCV), therapies in genotypes 2 and 3 were more limited than in other genotypes.

Purpose

To analyse effectiveness and safety of DAA regimens in patients with HCV genotypes 2 and 3.

Material and methods

Prospective, observational study. We included patients with HCV genotypes 2 and 3 who started a DAA (January 2017­September 2018).

Variables: age, sex, HCV­genotype, cirrhosis, HIV/HCV co­infection, previous HCV treatment, DAA treatment and length, co­medication, adverse reactions(AR). Sources of information: electronic health records, outpatient software and interviews with patients.

To assess effectiveness, achievement of virological response at post­treatment week 12 (or if not available, at the end of treatment) was used. Safety was evaluated regarding reported AR. University of Liverpool HEP­Drug Interaction database was also used to detect interactions which could affect effectiveness or safety of DAA.

Results

71 patients included: 62 genotype 3; 9 genotype 2 (25.4% women), mean age 53.2 years (range 40­75; SD 7.5). 35.2% had cirrhosis, 19.7% were HIV/HCV­coinfected, 11.3% had been previously treated of HCV. Median HCV viral load at the beginning was 3,252,550 IU/mL.

Most prescribed DAA: sofosbuvir/velpatasvir(80.3%), followed by glecaprevir/pibrentasvir(8.5%) and daclatasvir+sofosbuvir(7%). Length of HCV treatment was 12 weeks in 88.7%.

76.1% had co­medication (median: 3 drugs). 19 potential interactions were detected with DAA: administration recommendations were made (10), patients were monitored (2) and co­medicated was substituted or retired (7).

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 53/60 05/11/2018 Rejected - S4.html 38% reported any AR during the treatment; of them, most frequents were headache(44.4%), asthenia(25.9%) and nausea or vomiting(22.2%).

At the cut­off date, 56 patients had reached post­treatment week 12: 42 with sustained virological response, 8 with undetectable viral load at the end of treatment (no available analysis at week 12) and 6 with missed data. 15 patients hadn’t reached post­treatment week 12, but of them, 5 had undetectable viral load at the end of treatment (in 10 there wasn’t any viral load analysis after treatment).

Conclusion

New DAA regimens have proved its effectiveness in HCV genotypes 2 and 3, with a high achievement of sustained virological response. They seem to be well tolerated, with none serious reported AR.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1139 EVOLUTION IN PRESCRIPTION AND EXPENDITURE OF DISEASE­MODIFYING THERAPIES IN MULTIPLE SCLEROSIS

M.B. CONTRERAS REY1, E. RODRÍGUEZ MOLINS1, M.T. LÓPEZ MANCHA1, M.M. ROMERO ALONSO1, J. ESTAIRE GUTIÉRREZ1, R. SÁNCHEZ DEL MORAL1 1INFANTA ELENA HOSPITAL, HOSPIT AL PHARMACY, HUELVA, SPAIN

Background

Development of new disease­modifying therapies in multiple sclerosis has conducted to a change in the prescription profile of these treatments.

Purpose

To analyse and compare the evolution of dispensed disease­modifying therapies in multiple sclerosis in an outpatient consultation of a pharmacy service.

Material and methods

Retrospective study which includes all multiple sclerosis patients whom a disease­modifying drug was dispensed at an outpatient consultation of a hospital pharmacy within a local hospital (2013­2017). It covers self­administered drugs (oral,subcutaneous and intramuscular administrations), being excluded the intravenous route. The variables we took into account were number of patients per drug and economic expenditure.

Data were obtained from both outpatients and management softwares.

Results

Following drugs were included: interferon­beta­1a (both intramuscular and subcutaneous), interferon­beta­1b, glatiramer acetate, pegylated interferon­beta­1a, , and .

Number of patients per year:

89 patients in 2013 (36 interferon­beta­1a, 15 interferon­beta­1b, 30 glatiramer acetate, 8 fingolimod).

120 patients in 2014 (47 interferon­beta­1a, 16 interferon­beta­1b, 35 glatiramer acetate, 18 fingolimod, 4 dimethyl fumarate).

143 patients in 2015 (42 interferon­beta­1a, 14 interferon­beta­1b, 21 glatiramer acetate, 20 teriflunomide, 26 fingolimod, 20 dimethyl fumarate).

151 patients in 2016 (38 interferon­beta­1a, 9 interferon­beta­1b, 22 glatiramer acetate, 7 pegylated interferon­beta­1a, 24 teriflunomide, 26 fingolimod, 25 dimethyl fumarate).

164 patients in 2017 (34 interferon­beta­1a, 9 interferon­beta­1b, 22 glatiramer acetate, 7 pegylated interferon­beta­1a, 32 teriflunomide, 29 fingolimod, 31 dimethyl fumarate).

Evolution in the economic expenditure per year: 586,983€ (2013), 940,540€ (2014), 1,259,527€ (2015), 1,326,873€ (2016), 1,469,559€ (2017).

Average cost per patient ranged from 6,595€ (2013) to 8,960 (2017).

Percentage of patients taking oral drugs with respect to the total has increased during the period of study: 8.9% (2013) to 56.1% (2017). Consistently with these results, percentage of expenditure in oral drugs with respect to the total was higher through the years: 12.1% (2013) to 61.6% (2017).

Conclusion

In the period from 2013 to 2017 there has been an important increase in patients treated with self­administered disease­modifying therapies in multiple sclerosis. Comparing routes of administration, it is remarkable that parenteral drugs have decreased its number of patients in favour of oral treatments, probably due to the influence of patients’ preferences to choose the therapies.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1140 EFFICACY AND SAFETY OF AZACITIDINE IN THE TREATMENT OF ACUTE MYELOBLASTIC LEUKEMIA

A. SORIA MARTÍN1, M. FAGES1, J. ROMERO PUERTO1, J.R. ÁVILA ÁLVAREZ1, M.P. QUESADA SANZ1, P. VILLANUEVA JIMÉNEZ1 1PUNTA DE EUROPA HOSPITAL, PHARMACY, ALGECIRAS, SPAIN

Background

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 54/60 05/11/2018 Rejected - S4.html Myeloproliferative syndromes present a poor long­term prognosis, for this reason new drugs are needed to increase survival. Azacitidine is indicated in adult patients who are not candidates for hematopoietic stem cell transplantation with acute myeloblastic leukemia (AML).

Purpose

To evaluate the efficacy and safety of azacitidine in the treatment of AML.

Material and methods

It is a retrospective observational study of patients who started treatment with azacitidine from November 2012 to August 2018 included. The data was obtained from the Farmis­Oncofar® oncology prescription program, and by reviewing clinical and analytical records in Diraya®. The variables collected were: age (years), sex, number of cycles, average duration of treatment (months), neutrophils, platelets, hemoglobin, reduction or suspension of doses, adverse reactions, support therapy and exitus date. The dose of azacitidine was 75 mg / m2, in cycles of 7 days with daily doses + 21 days of rest. The efficacy criteria considered were the overall survival (OS) and the progression­free survival (PFS), obtained by the Kapla­Meier method and defined as the time from the initiation of the treatment to death or disease progression respectively.

Results

The study was done in 12 patients, seven women and five men. Two of these patients were excluded: the first one due to the lack of information about his clinical record, and the other for the denial to receive the treatment. The average age was 77.5 years. Azacitidine was the first line, with a median of 11 cycles. 6 patients progressed during the treatment. The mean of OS was 14.64 months and the mean of PFS was 11.9 months. The cycle was delayed in 8 patients, due to cytopenias, bronchitis and zoster infection. All patients needed filgrastim, and transfusions of red blood cells and platelets, moreover epoetin was administered in 5 of them. 3 patients needed to reduce the dose by half, one for repeat grade 4 neutropenia, other for renal failure and another weight loss.

Conclusion

The azacitidine markedly increases survival in our study, although it is necessary to monitor and control the appearance of adverse reactions.

References and/or Acknowledgements

Vidaza technical sheet. Celgene LaboratoriesEurope Limited. https://www.ema.europa.eu/medicines/human/EPAR/vidaza

Conflict of Interest No conflict of interest

BAR19­1144 EFFECTIVENESS OF PRAZIQUANTEL IN PATIENTS DIAGNOSED OF SCHISTOSOMIASIS

J. URDA1, M.R. ALBA2, C.V. MARIANGELES2, M.M. JOSE ANTONIO2, C.M. JOSE2, M.D.L.P. JUAN ENRIQUE2 1HOSPITAL DE PONIENTE., PHARMACY, EL EJIDO. ALMERÍA, SPAIN 2HOSPITAL DE PONIENTE, PHARMACY, EL EJIDO­ ALMERIA, SPAIN

Background

Schistosomiasis is an acute and chronic parasitic disease caused by parasitic worms of Schistosoma spp. At least, 249 million of patients required preventive treatment in last year. Praziquantel is the recommended treatment against all forms of schistosomiasis. After a single dose of 40 mg/kg, the 70–100% of patients does not excreted eggs.

Purpose

To evaluate the effectiveness of praziquantel in patients diagnosed of schistosomiasis.

Material and methods

Retrospective study in a hospital (2016­2017). We included all patients diagnosed of schistosomiasis or with high suspicion (patients from endemic areas with compatible clinic, positive serology, and eosinophilia). Diagnosis was confirmed by finding eggs or worms in microscopy direct studies or in the vesical /rectal biopsy. All patients were treated with praziquantel (40 mg/kg, one day ­ 2 doses). Praziquantel capsules were elaborated in Pharmacy Department. Data collected: Demographic data (age, sex, geographical origin), concomitant parasites, patients treated with praziquantel, empirical treatments, findings of schistosoma eggs or parasites, signs and symptoms (hematuria, eosinophilia >7,1%), treatment failure, reasons of re­treatment. Data was obtained of the clinical electronic history (Ariadna®).

Results

Patients treated with praziquantel: 137; Males: 127 (92,7%); Age: (range: 15­57); Country of origin: Mali: 43 (31,4%); Senegal: 39 (28,5%); Guinea Bissau: 17 (12,4%); Additional parasitosis: Strongyloides stercolaris: 16 (11,6%); Blastocystis hominis: 14 (10,2%); Entamoeba hystolitica/dispar: 12 (8,8%); Patients with, empirical treatment:110 (80,3%); Eggs: 14 (10,2%); Worms: 13 (9,5%); Hematuria: 55 (40,1%); Eosinophilia: 46 (33,5%); Re­ treatments: 9 (6,6%); Reason of re­treatment: finding of eggs or worms (3); hematuria persistence (2); genital schistosomiasis suspicion (2); eosinophilia persistence (2). All patients resolved the infection.

Conclusion

The high prevalence of schistosomiasis between immigrants, principally sub­Saharan population, demands a high level of clinical suspicion, mainly when they present hematuria. In our series, we do not find any case of resistance. The absence of initial response to the treatment might be associated with the high percentage of patients treated empirically. In our study, praziquantel was a drug with a high rate of effectiveness.

References and/or Acknowledgements

European Centre for Disease Prevention and Control. Rapid risk assessment: Local transmission of Schistosoma haematobium in Corsica, France – 16 May 2014. Stockholm: ECDC; 2014.

Conflict of Interest No conflict of interest

BAR19­1156 CLINICAL OUTCOMES OF HEPATITIS C VIRUS TREATMENT IN A THIRD DEGREE HOSPITAL. AS GOOD AS IN CLINICAL file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 55/60 05/11/2018 Rejected - S4.html TRIALS?

A. MARCOS1, C. NOTARIO DONGIL1, M.M. ALAÑON PARDO1, B. PROY VEGA1, P. NIETO SANDOVAL MARTIN DE LA SIERRA1, J.C. VALENZUELA GAMEZ1 1HOSPITAL GENERAL MANCHA CENTRO, HOSPITAL PHARMACY, ALCAZAR DE SAN JUAN, SPAIN

Background

Hepatitis C has been a chronic disease with a high prevalence and difficult to cure because of the low efficacy of treatments. The development of new drugs with high efficacy and high cost has made important checking the most efficient treatment for every patient and viral genotype.

Purpose

To analyse the sustained viral response (SVR) in patients treated with direct acting antiviral agents and check if it fits with the evidence showed in clinical trials.

Material and methods

Retrospective study, including all patients treated with new agents against hepatits C virus since 2015 until April 2018. We obtained our data from electronic medical history and the dispensation platform. We also analysed the demographic parameters and evolution of the treatments during study time.

Results

140 patients were analysed during the study period. 95 patients (67,8%) were male and 45 (32,2%) female. 25 patients (17,8%) were coinfected with human immunodeficiency virus (HIV). The median age was 51 years. 56% of patients were naïve. 61% were infected by genotype 1 (39 % 1b, 22% 1a, 10% not subgenotype), 14% were infected by genotype 3. Classifying the patients by grade of fibrosis, 41% were F4, 20% F3, 25% F2, 9% F1 and 5% F0.

In 93% of treatments SVR was obtained. 3 patients were lost due to abandonment of treatment. 4 treatments (2,8%) didn´t achieved SVR. 2 of them were retreated and achieved SVR. 1 patient didn´t realized blood test for SVR at the end.

In 2015 71 treatments were done, 30 in 2016, 30 in 2017 y 11 in 2018 by April. The treatments realized in high grade of fibrosis (F3 y 4) were 50 in 2015, 23 in 2016, 18 in 2017 and 3 in 2018.

Conclusion

A high percentage of our patients achieved SVR, as it was expected because of the results carried at clinical trials. Our data shows that efficacy of treatments doesn´t depend on the grade of fibrosis or coinfection with HIV.

Long­term results like regression of fibrosis or development of liver cancer has to be studied in further investigations. Due to this the pharmaceutical rol is important in the follow up of patients.

References and/or Acknowledgements

https://ejhp.bmj.com/content/24/Suppl_1/A174.3

NO CONFLICT OF INTERESTS

Conflict of Interest No conflict of interest

BAR19­1162 PRESCRIPTION OF PROTON PUMP INHIBITORS IN ADVANCED AGE PATIENTS WITH HIV INFECTION

L. RUIZ GONZALEZ1, A. LAZARO LOPEZ1, A.L. ALVAREZ NONAY1, M. LAVANDEIRA PEREZ1, I. MENDOZA ACOSTA1, P. HORRILLO SANCHEZ DE OCAÑA1 1HOSPITAL UNIVERSITARIO DE GUADALAJARA, PHARMACY SERVICE, GUADALAJARA, SPAIN

Background

N THE LAST FOUR YEARS, RESEARCH HAS BEEN PUBLISHED ON THE ASSOCIATION BETWEEN PROTON PUMP INHIBITORS (IBPS) AND FRACTURES BY OSTEOPOROSIS. SOME OF THESE STUDIES HAVE BEEN EXPLICITLY DISCLOSED AND COMMENTED AND HAVE RAISED ALARM BETWEEN PHYSICIANS AND PATIENTS.

Purpose

­TO DETERMINATE THE PREVALENCE OF PRESCRIPTION OF IBPS IN ADVANCED AGE HIV PATIENT ­TO ANALYZE THE ADAPTATION OF THE PRESCRIPTION ACCORDING TO THE INDICATIONS RECORDED IN THE TECHNICAL DA TA SHEET

Material and methods

OBSERVATIONAL STUDY PROSPECTIVE CARRIED OUT IN PATIENTS OF ADVANCED AGE INFECTED BY HIV, ATTENDED IN THE PHARMACY SERVICE OF A REGIONAL UNIVERSITY HOSPITAL FROM JANUARY 1, 2014 TO DECEMBER 31, 2015. THE FOLLOWING VARIABLES WERE COLLECTED: AGE, SEX, COMORBIDITIES AND CONCURRENT MEDICATION. IT W AS CONSIDERED THAT THE PRESCRIPTION OF IBP FULFILLED INDICATION IF IT WAS APPROVED FOR: DISEASE BY GASTROESOPHAGEAL REFLUX (ERGE), ERRADICATION OF HELICOBACTER PYLORI IN COMBINATION WITH AN ADEQUATE ANTIBACTERIAL REGIME, PATIENTS WITH CONTINUED TREATMENT OF NON­STEROID ANTI­INFLAMMATORIES (CICATRIZATION AND PREVENTION OF GASTRIC ULCERS), DISEASE TREATMENT BY REFLUX AND TREATMENT OF CONTINUATION OF THE PREVENTION OF RESANGRADE BY INTRAVENOUS PEDEPIC ULCER INDUCED AND TREATMENT OF ZOLLINGER ELLISON SYNDROME. THE INCLUSION CRITERIA WERE: HIV INFECTION, AGE OR MORE THAN 50 YEARS AND ANTIRETROVIRAL TREA TMENT (TAR) FROM AT LEAST 6 MONTHS THE STATISTICAL ANAL YSIS WAS CARRIED OUT USING THE STATISTICAL PACKAGE SPSS 15.0

Results

file:///Users/henadzisobal/Desktop/SC/Rejected%20-%20S4.html 56/60 05/11/2018 Rejected - S4.html 327 PATIENTS WERE ANALYZED 132(40.37%) OF WHICH WERE PATIENTS OF ADVANCED AGE .IN THE POPULATION TO STUDY (N=132) THE MEDIUM OF AGE WAS 53 YEARS(RI:50­88), BEING 61.4%(N=81) PATIENTS POLYMEDICATED. 73.5% (N=97) OF THE POPULATION WAS MALE. A TOTAL OF 790 ACTIVE INGREDIENTS WERE ANAL YZED, BEING 439 CONCURRENT ACTIVE INGREDIENTS. THE MEDIUM OF ACTIVE PRINCIPLES PER PATIENT WAS 5 (RI:1­21). 67 PATIENTS (50.8%) WERE IN TREATMENT WITH A DRUG FROM THE A TC A GROUP: DIGESTIVE SYSTEM AND METABOLISM, BEING TREATED WITH PROTON PUMP INHIBITORS 21 PATIENTS (15,9%).WITHIN THE PATIENTS WITH IBPS PRESCRIPTION, ONLY 8 (38,1%) HAD INDICATION

Conclusion

­A HIGH PERCENTAGE OF PATIENTS WITH ADVANCED AGE HAVE PRESCRIBED IBPS WITHOUT FULFILLING INDICATION ­THE EXHAUSTIVE REVIEW OF CONCURRING MEDICATION SHOULD BE A HABITUAL PRACTICE, REQUESTING THE DEPRESCRIPTION OF THOSE DRUGS THAT IN ADDITION TO NOT HAVING AN INDICATION CAN BE A RISK IN THIS TYPE OF PATIENT

References and/or Acknowledgements

­

Conflict of Interest No conflict of interest

BAR19­1165 ANTITHROMBOTIC TREATMENT AFTER ACUTE MYOCARDIAL INFARCTION

N. BLAZQUEZ­RAMOS1, B. ESCUDERO­VILAPLANA2, G.M. SILVA­RIADIGOS2, C.M. MESEGUER BARROS2, P. CRESPO­ROBLEDO3, M. BERNIAS­DOMINGUEZ1, E. MAROTO­GARCIA1 1HOSPITAL UNIVERSITARIO DE MÓSTOLES, FARMACIA, MADRID, SP AIN 2DIRECCIÓN ASISTENCIAL OESTE DE LA COMUNIDAD DE MADRID, FARMACIA, MADRID, SP AIN 3AGENCIA ESPAÑOLA DEL MEDICAMENTO, FARMACIA, MADRID, SPAIN

Background

Antithrombotic therapy(AT) is a safety priority. It´s important to verify that the patient takes the correct antithrombotic medication and that the duration of the treatment is adequate.

Purpose

To analyse the adequacy of AT after acute myocardial infarction(AMI) to the guidelines.

Material and methods

Cross­sectional descriptive study in patients on AT treatment[1] after AMI(ICD­9, code 410)[2] T, at a 600.216 inhabitants Primary Care area from April/2017­2018. Collected variables: demographics, medicinal products dispensation based on reimbursement data, diagnosis date. Anonymized data extracted from ConsultaWeb® database.

Treatment after AMI, in the guidelines, is the same despite elevation of ST­segment after hospital discharge.

Results

Se identificaron 133 pacientes con diagnóstico de IAM, 74,4% hombres. La mediana de edad fue 70[IQR:58 a 87]133 patients diagnosed with AMI were reviewed, 74,4%male. Median age was 70[IQR:58­87] years­old.

AMI in the last six months 10.5% (14P): ­ Dual Antiplatelet Therapy(DAPT) 10P(71%)

Aspirin+prasugrel 1P Aspirin+ticagrelor 4P Aspirin+clopidogrel 5P

­ In firm indication for oral anticoagulation(OAC) it is recommended triple therapy(TT). If high bleeding risk, TT for 1 month, followed by OAC and Aspirin/clopidogrel to 12 months:

Acenocoumarol+Aspirin+clopidogrel 2P Acenocoumarol+Aspirin 1P

­ One P(7%) had clopidogrel alone. Noncompliance(NC) with the recommendations.

AMI from 6­12 months 18.8% (25P):

­ DAPT 18P(72%):

Aspirin+prasugrel 5P Aspirin+ticagrelor 7P Aspirin+clopidogrel 6P

­ If high bleeding risk, Aspirin/clopidogrel alone. Aspirin 2P(8%). ­ If firm indication for OAC add Aspirin/clopidogrel. Anticoagulated 5P(20%):

Dabigatran+Aspirin 1P Rivaroxaban+Aspirin 1P Acenocoumarol 3P:

*1P alone.NC

*Clopidogrel 1P

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After the first year of AMI 70.7% (94P):

Aspirin/clopidogrel alone:

Aspirin 70P Clopidogrel 2P Aspirin+clopidogrel 3P.NC

Two P(2%) extended ticagrelor+Aspirin.NC

In patients with a firm indication for OAC:

10P OAC alone (4P acenocoumarol, 2P rivaroxaban and 4P dabigatran) 5P acenocoumarol+Aspirin.NC 1P apixaban+clopidogrel.NC 1P clopidogrel (OAC retired).NC

89% of the treatments were adjusted to guideline recommendations.

Conclusion

The adequacy of the AT to the guidelines is quite high.

From a pharmacist perspective, when validating noncompliance treatments to the recommendations of the guidelines, it would be important to analyze patient records to check if it is a medication error or if it is due to some special feature of the patient.

References and/or Acknowledgements

1.­European Heart Journal (2018) 39, 119–177.

2.­ 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST­segment elevation. European Heart Journal (2016)37, 267–315

Conflict of Interest No conflict of interest

BAR19­1167 GUIDELINES FOR PROPHYLAXIS AGAINST PNEUMOCYSTIS JIROVECI: HOSPITAL USE.

J.J. ALCARAZ SANCHEZ1, C. FERNANDEZ CUERVA1, R. ASENSI DÍEZ1 1HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA, HOSPITAL PHARMACY , MÁLAGA, SPAIN

Background

Pneumocystis jiroveci (PN) is a frequent acquired immune deficiency syndrome­defining diagnosis and is frequent opportunistic pneumonia in our environment. Guidelines por prophylaxis against PN remain us that every patient with a CD4 lymphocyte count <200 cells/µl must be treated with antibiotics.

Purpose

To test out prophylaxis management against PN in a tertiary hospital.

Material and methods

Observational, retrospective and descriptive study. Inclusion criteria: adult patients (> 18 years old) with HIV infection and antiretroviral treatment (ART) admitted to our hospital. Study period: January­December 2017. Demographic variables: age, sex; Clinics: days of hospitalization, number of admissions per patient, CD4 lymphocyte count 6 months before and during hospitalization, and antibiotic treatment with Trimethoprim­ Sulfamethoxazole (TMP­SMX) in the 6 months previous hospitalization and after have been discharged from hospital. We excluded daptone prophylaxis treatments. We analyzed data from prescription hospital and home treatment programs.

Results

A total of 93 patients were analyzed, 73 men and 20 women, mean age of 50 ± 10 years. There were 157 hospital admissions during the year 2017, 1.7 (1­8) admissions/patient, for a total of 1,840 days of hospital stay (mean 11.8 ± 11.5 days/patient). Only in 52% (82/157 admissions) of hospitalizations CD4 lymphocyte levels was made, and approximately 6 months before hospitalization 79% (124/157) of admissions had a CD4 count. Respectively 52,5% (43/82) of these 52% and 24% (30/124) of 79% had a CD4 count <200 cells/µl.TMP­SMX was prescribed in 33% (10/30) of admissions who had CD4 <200 cells/µl 6 months before hospital stay and in 44% (20/45) at the time of beeing discharged from hospital had CD4<200 cell/µl during hospitalization and needed to complete antibiotic therapy with TMP­SMX for prophylaxis against PN penumonia.

Conclusion

Results show a poor management in the prophylaxis against PN. CD4 count is not analyzed in approximately half of hospitalizations and in those where we have levels clinicians don’t follow what official guidelines recommend. Pharmacist could have an important role in the prescription of TMP­ SMX during the stay of patients in our hospitals.

References and/or Acknowledgements

.

Conflict of Interest No conflict of interest

BAR19­1177 THE DIFFERENT MISSIONS OF THE PHARMACIST IN AN ONCOLOGY CENTER

Z. ALIAT1, M. BENABBES1, M. ALAMI1, H. ATTJIOUI1, B. MEDDAH1

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Background

Oncology treatments require the pooling of various skills. Through his knowledge of the drug, the pharmacist is the "natural partner" of prescribing physicians and caregivers who administer pharmaceuticals to patients. Similarly, through interventions with patients in his field of expertise, the pharmacist contributes to the proper use and improvement of the quality of care in oncology.

Purpose

The objective of our study was to highlight the various missions performed by the pharmacist in an oncology center.

Material and methods

During our study, we analyzed the references and literature relating to the roles of the pharmacist in an oncology center, and we presenteted the various missions of the pharmacist within the institute of oncology of Rabat from November 2011 to july 2016.

Results

Within an oncology center, the pharmacist is responsible, in addition to medication management, for the validation of medical prescriptions, the preparation of anticancer drugs, and their controls, the management of anomalies and risk management, dispensing oral chemotherapy and narcotics, as well as therapeutic education for patients. The pharmacist must also notify cases of pharmacovigilance and materiovigilance, and participate and ensure the smooth running of clinical trials during which he is responsible for ensuring in accordance with the operating rules of the establishment, the management, thesupply, the preparation, the control, the detention, dispensing of medicines. He also evaluates the application of good clinical practices and good manufacturing practices, he guarantees the respect of the collected data, the regulation and the protocol, and ensures traceability and archiving of all test documentation.

Conclusion

By focusing on its core work, the science of the drug, the hospital pharmacist is a significant asset in the care of cancer patients.

References and/or Acknowledgements

Rey JB, Parent D, Scotté F. Rôle du pharmacien hospitalier en soins oncologiques de support. J Pharm Clin 2015 ; 34(1) : 7­10 doi:10.1684/jpc.2015.0300

Conflict of Interest No conflict of interest

BAR19­1191 Carbapenems and Quinolones, an endless journey

R. MIRANDA1, A.P. GUIMARÃES1, F. DIMAS1 1CENTRO HOSPITALAR BARREIRO MONTIJO­ EPE, PHARMACY , BARREIRO, PORTUGAL

Background

Resistance to antimicrobials poses a serious threat to public health. Reduction of Carbapenems and Quinolones prescription and consumption monitoring are essential measures to combat this emerging problem.

Purpose

Evaluate the evolution of hospital consumption of Carbapenems and Quinolones in a Portuguese Hospital, during 2016 and 2017

Material and methods

Retrospective analysis of Carbapenem and Quinolone consumption using defined daily dose (DDD), normalized to 100 bed­days, as a reference measure.

Results

Analyzing total Carbapenem consumption in the study period, meropenem accounts for 74.2%, ertapenem 22.2% and imipenem 3.6%.

Comparing homologous periods, in 2017, an increase of total carbapenems (11.9%) was observed, mainly due to meropenem (29.9% variation).

As for Quinolones, ciprofloxacin accounts for 82% of the total consumption and levofloxacin 18%. Comparing homologous periods, in 2017, Quinolones consumption reduced 19%, mainly due to decreased of ciprofloxacin consumption (17.7%).

Quinolones consumption for parenteral route was superior to oral route (66,1% vs 33,9% respectively)

Conclusion

Consumption analysis of Carbapenems and Quinolones serves as a tool for monitoring a program to support antibiotic prescription assessing compliance with the targets established in accordance with Portuguese legislation that aims for a reduction of 50% by 2020.

Measurement consumption in DDD´s, allows comparison between hospitals of the same level and also evaluating individual hospital performance against the national target.

Intravenous administration, despite presenting more risks, is most commonly used when compared with oral route. Strategies should be developed for promoting active intervention regarding switch of intravenous route to oral route, which is one of the antibiotic stewardship pillar.

References and/or Acknowledgements

Centers for Disease Control and Prevention. Core Elements of Hospital Antibiotic Stewardship Programs. https://www.cdc.gov/antibiotic­ use/healthcare/implementation/core­elements.html. Assessed 10/15/2018

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Conflict of Interest No conflict of interest

BAR19­1195 Coronary Stents: State of Play at a university Hospital

W. ENNEFFAH1, M.A. EL WARTITI1, B. EL OUADGHIRI2, N. NCHINECH1, A. CHEIKH3, M. ABOUATIA4, A. BENNANA5, J. TAOUFIK6, J. LAMSAOURI1 1MOHAMMED V MILIT ARY TEACHING HOSPITAL ­ FACULTY OF MEDICINE AND PHARMACY OF RABAT, PHARMACY, RABAT, MOROCCO 2MOHAMMED V MILITARY TEACHING HOSPITAL, PHARMACY, RABAT, MOROCCO 3CHEIKH ZAID INTERNATIONAL UNIVERSITY HOSPITAL ­ ABULCASIS INTERNATIONAL UNIVERSITY OF HEALTH SCIENCES, PHARMACY, RABAT, MOROCCO 4CHILDREN'S HOSPIT AL OF RABAT, PHARMACY, RABAT, MOROCCO 5CHEIKH KHALIFA BEN ZAYED HOSPITAL ­ FACULTY OF MEDICINE AND PHARMACY OF RABAT, PHARMACY, CASABLANCA, MOROCCO 6FACULTY OF MEDICINE AND PHARMACY OF RABAT, PHARMACY, RABAT, MOROCCO

Background

Coronary stents are class III medical devices used in the treatment of certain coronary artery disease. There are two types of stents: bare stents and drug eluting stents (active). The use of these latter is increasingly recommended, but the type of patients who should receive these devices remains controversial.

Purpose

To have reliable data on the prescription of different types of stents which would help to control economic and clinical aspects of this class of pharmaceuticals.

Material and methods

This is a prospective analysis of the data from stents traceability sheets provided by the pharmacy pole to the cardiac catheterization service and completed after implantation to patients during one year.

Results

During the study period, 122 coronary stents were implanted in 103 patients. The sex ratio (M / F) is 4.15 and the age varies between 39 and 84 years with a median of 59 years. Indeed age is a risk factor in arterial coronary artery disease. 75% of implanted stents are active (20% are covered with zotarolimus, 20% with biolimus, 19% with sirolumus and 16% with paclitaxel), compared to only 25% that were bare stents. It should be noted that 16 patients had double implantation and one patient had triple implantation. Compared with bare stents, active stents bring a decrease in the rate of but without a decrease in deaths or myocardial infarction. Otherwise, the average cost of an active stent is 3 times greater than that of a bare stent. therefore, the literature is in favor of limiting its use to patients with high risk of restenosis.

Conclusion

These results motivate the implementation of a survey on the compliance of stent prescriptions with international recommendations in order to help hospital pharmacists to control the cost generated by this type of medical devices and to rationalize their use.

References and/or Acknowledgements

None

Conflict of Interest No conflict of interest

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