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Adequacy and effectiveness of thromboembolic prophylaxis in multiple myeloma patients treated with inmunomodulatory drugs.

European Statement

Clinical Pharmacy Services

Author(s)

Alba María Fernández Varela, Laura López Sandomingo, Nieves Valcarce Pardeiro, Isaura Rodríguez Penín

Why was it done?

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What was done?

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How was it done?

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What has been achieved?

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What next?

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DEVELOPMENT AND IMPLEMENTATION OF A CAR-T CELL THERAPY PROGRAM IN ADULTS

European Statement

Clinical Pharmacy Services

Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, María Leonor Oliva Hernández, Nayra Sangil Monroy, Marta María Piñero González, María Victoria Morales León

Why was it done?

The implementation would allow access to this novel therapy to patients who have already exhausted all lines of treatment. The Ministry of Health decides to establish an administration point in the hospital, since due to its geographical location (European ultra-periphery) it would avoid the transfer of patients to other reference centers.

What was done?

Development and implementation of a CAR-T cell therapy administration program in adults.

How was it done?

In November 2018, the Ministry of Health authorized the center to use CAR-T treatment in adult patients with relapsed or refractory diffuse large B-cell lymphoma or with B-cell acute lymphoblastic leukemia. The hospital was prepared to meet specific quality criteria (JACIE Accreditation). Interhospital protocols were developed for the referral, transport, and study of candidate patients from other centers.

What has been achieved?

1. A multidisciplinary team was created made up of professionals from Hematology, Intensive Care Medicine, Neurology and Pharmacy Services, with the aim of assessing candidate patients. A qualified team oversees the clinical management, follow-up, analysis of adverse effects and results obtained.
2. The professionals involved were trained to ensure safe administration and to identify and treat possible complications.
3. Due to the special storage conditions of the drug, a circuit was established. It is storage in the Hematology Service under the supervision of the hospital pharmacist specialized in onco-hematology.
4. One of the most frequent complications of the therapy is cytokine release syndrome. Depending on the gravity, drugs such as tocilizumab should be given as soon as possible. To ensure its availability, the Pharmacy Service permanently reserves two doses. At the time of performing a CAR-T, the automated dispensing system of the hematology ward is provided with the first dose, along with a preparation sheet and its corresponding label in order not to delay its administration. The second dose remains in the Pharmacy Service.

To date, 8 infusions have been made. 100% of the patients had diffuse large B-cell non-Hodgkin lymphoma.

What next?

Facilitate access to this therapy to more patients. Generate data that support its efficacy and safety in real life.
Obtain the accreditation of the center to use the new therapies authorized by the European Medicines Agency.

IMPLEMENTATION OF DRUG RECONCILIATION WITHIN THE DEPARTMENT OF PAEDIATRIC HEMATO-IMMUNOLOGY AT THE UNIVERSITY HOSPITAL CENTER ROBERT DEBRÉ (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Marguerite VAILLANT, Sophie GUILMIN CREPON, Benoit BRETHON , Julie ROUPRET-SERZEC

Why was it done?

In order to obtain a safe patient care pathway, we wish to implement proactive and/or retroactive DR for patients followed in the Hemato-Immunology Department of the University Hospital Center Robert Debre.

What was done?

Formalise and integrate drug reconciliation (DR). Evaluate the feasibility of the project, the impact of DR on the safety of patient care and the satisfaction of patients and health professionals.

How was it done?

Prospective cohort study. The different steps are: identification of eligible patients, collection of information on the patient’s drug history and ongoing treatments from the health partners involved in his or her care, entry drug reconciliation (EDR) during the entry pharmaceutical consultation, conciliation of exit drugs during the return pharmaceutical consultation, transmission of information to the local center and pharmacist or home hospitalisation, evaluation of stakeholder satisfaction and the impact of the intervention.

What has been achieved?

Thirty patients included between August and October 2019, or 30 conciliations performed. Concerning the EDR: all hospitalisation reports and previous prescriptions are consulted (100%), 6 EDR (20%) take place in pro-active mode, the average duration of an EDR is 43 minutes. Concerning the discharge drug reconciliation (DDR): 30 DDR (100%) take place in pro-active mode, the average duration of a DDR is 52 minutes, all prescriptions and intake plans are sent to community centres and pharmacists or home hospitalisation (100%). Of all the conciliations performed: 4 sources of information used by conciliation, 11 drugs prescribed on average per prescription, 8 intentional and 6 unintentional discrepancies identified by prescription. Concerning the evaluation of satisfaction: all community centres are satisfied (100%), 26 city professionals (87%), 21 hospital professionals (70%), 27 patients (90%).

What next?

In order to ensure that DR is permanently included in the service, a communication and information tool must be developed. This, made available to the entire team, will serve as a traceability support, decompartmentalise practices and improve patient care.

ESTABLISHING AN ACTIVE WORKING GROUP FOR PHARMACISTS WORKING WITHIN PAEDIATRIC ONCOLOGY AND HAEMATOLOGY IN SWEDEN, FINLAND, NORWAY AND DENMARK

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European Statement

Clinical Pharmacy Services

Author(s)

Ranaa El Edelbi, Joacim Götesson, Sanna Veijalainen, Mari Vanhatalo, Taija Heikkinen, Ulla Taipale, Gunn-Therese Lund Sørland, Margrete Einen, Magnus Dahlander

Why was it done?

There is a great need for pharmaceutical expertise within the field of pediatric oncology and hematology, where chemotherapeutic regimens and supportive therapy often require intense treatment with drugs from many therapeutic groups. The complex drug environment created requires competence in diverse pharmaceutical subjects and many centers of pediatric oncology and hematology within NOPHO has concluded that hiring a pharmacist can cover the perceived knowledge gap and also increase the quality of the drug treatment. However, working as a single clinical pharmacist in a very specialized hospital setting such as pediatric oncology and hematology can be very difficult and time-consuming as everything depends on your own knowledge and experience. In most pediatric oncology and hematology centers it is not feasible to have more than one pharmacist and thus collaboration and discussion between different hospitals and countries are necessary.

What was done?

A working group for pharmacists was established within the Nordic Society of Paediatric Haematology and Oncology (NOPHO).

How was it done?

The need for a group of pharmacists working within pediatric oncology and hematology was raised by pharmacist Ranaa El Edelbi at Astrid Lindgren’s Children’s Hospital, Stockholm, during the autumn of 2014. She sent out an email to all the pediatric oncology and hematology centers within NOPHO and asked if they had any pharmacists involved in the care setting. She got a positive reply from a few centers and invited the pharmacists for at first meeting in Stockholm in November 2014 and a working group for pharmacists with NOPHO was created in early 2015. The network has since then grown to 17 pharmacists from 4 countries and 10 centers.

What has been achieved?

An active working group with regular email discussions as well as Skype and physical meeting to facilitate the exchange of knowledge and experience. The group has also undertaken and finished a project to develop a guideline for extravasation of chemotherapeutic drugs, which was published in December 2016.

What next?

Developing a guideline for safe and accurate administration of oral chemotherapeutic drugs to children.

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