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Early access to the drug: the role of the pharmacist in the management of CNN drugs in oncology

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European Statement

Introductory Statements and Governance

Author(s)

Aldo De Luca, Andrea Ghiori, Cecilia Orsi, Michele Cecchi

Why was it done?

CNN drugs are drugs that have obtained authorisation from EMA and AIFA (Italian drugs authority) but that have not been negotiated for the purposes of the reimbursement of the National Health System. These drugs are often clinical innovations that fill therapeutic gaps. In our Region, access to these therapies is allowed only on a special request made by the clinicians at the Pharmacy that is evaluated positively, presents it to the Regional Authority. The regional assessment is also implied by the presence of specific contractual agreements with the pharmaceutical companies. Requests have been considered for enfortumab vedotin (EV), indicated for urothelial carcinoma, and trastuzumab deruxtecan (T-DXd), indicated for breast cancer. The objective of this article is to highlight the activity of the pharmacist in the management of drugs in the CNN range.

What was done?

A pathway has been developed at regional level to promote early access to new drugs and further therapeutic possibilities.

How was it done?

All requests for CNN drugs received in the semester November 2022 to May 2023 to our Operations Unit and subsequently included in the regional portal were analysed on the basis of approved indications, bibliography, clinical reports, and eligibility card (for T-DXd only) validated by the medical division of the pharmaceutical company.

What has been achieved?

During the period analysed, 25 applications were made (11 for EV, 14 for T-DXd) for a total of 30 treatments (11 for EV, 19 for T-DXd). Of the 25 requests received by the Pharmacy, 24 (96%) were sent to the region for treatment authorisation; one was not submitted because the patient did not comply with the approved indication. We obtained 100% of the required treatment approvals.

What next?

The hospital pharmacist is configured as a collector of clinical requests with an important function as a filter of prescriptive appropriateness in requesting regional authorisation for the treatment of drugs in the CNN range; moreover, the pharmacist is a necessary reference figure between the need for clinical innovation and the need to guarantee sustainability of the system in order to ensure early access to innovative therapeutic opportunities. This model could be exported to other regions at national and European level.

Use of an integrated research management system on a clinical trials unit of a Portuguese hospital

European Statement

Education and Research

Why was it done?

The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)

What was done?

Evaluation of the use of an Integrated Research Management System based on a retrospective analysis of all clinical trials introduced into the software since 2020.

How was it done?

The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)

What has been achieved?

With the introduction of an integrated management system as a registration platform of investigational product receipt, dispensing and return, were introduced into the software 204 clinical trials.
Since its implementation in 2020, the integrated system has been authorised by the sponsor as a registration platform in 55 clinical trials, corresponding to 79% of clinical trials initiated since that date.
The clinical trials Unit grants remote access to the clinical trials information to CRAs through the filling out of a declaration. Since the adoption of this system, remote access to the platform has been granted to 35 CRAs.
According to the survey distributed between July and August:
-85.7% of CRAs use the system in their monitoring work.
-The use of System has been exclusively approved to replace paper records in 88.9% of active clinical trials (with the exception of receipt confirmation via IWRS – Interactive Web Response System).
-All the CRAs who answered the questionnaire consider remote access to clinical trial data to be an advantage.
– 77.8% believe that by using the platform the time spent on presential visits has been reduced.

What next?

The use of this type of system is essential to ensure the efficiency of the tasks carried out by research teams. The approval of system by the sponsor allowed a significant reduction of paper records and the CRA’s remote access to the platform has allowed the early detection of errors, as well as a substantial reduction on time spent on presential visits. The CRA’s remote access to the movements associated with the experimental product like temperature records, calibration certificates, CVs (Curriculum Vitae) and GCP’s (Good Clinical Practices). Although use of the platform has been increasing, some sponsors still do not authorise the exclusive use of the system. It is therefore essential to share the platform’s added value in order to change the traditional ways of management of clinical trials information.

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.

Medication reviews conducted by clinical pharmacist in emergency ward

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European Statement

Clinical Pharmacy Services

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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WHY NOT CHANGING PDCA BY PTDCA FOR REALIZING HOSPITAL PHARMACY PROJECTS

A NATIONALLY COORDINATED APPROACH TO DEVELOPING HOSPITAL PHARMACY SERVICES IN DENMARK

European Statement

Introductory Statements and Governance

Author(s)

L. Jeffery

Why was it done?

Approximately 450 people work within clinical and ward pharmacy in hospitals in Denmark. Despite Denmark being a relatively small country, these services have developed at differing paces, and sometimes in different directions. The initiative was set up to coordinate development and innovation in this field, across the whole country.

What was done?

A national group was established to coordinate and develop clinical and ward pharmacy services throughout Denmark. The working group consists of pharmacists and pharmaconomists representing the eight hospital pharmacies in Denmark.

How was it done?

In 2012/2013 fifteen people representing pharmacists and pharmaconomists from the five Danish regions were selected to the working group. These people were typically known to be experienced drivers of innovation and development in the field of clinical and ward pharmacy. The working group meets quarterly and additional work is carried out between meetings. There are no extra resources available to members of the group or their workplaces.

What has been achieved?

The group has produced and implemented minimum standards for ward pharmacy across Denmark. Benchmarking has been carried out using these standards and the baseline has been set. Progress will be measured regularly.

New standards for how often medicine shelf-life checks should be carried out on wards have been developed, resulting in the task being carried out less frequently on most wards, thus releasing resources to more clinically related tasks, at a time where extra resources are scarce.

Two national networking days for pharmacists and pharmaconomists have been held, where good initiatives are shared to all the regions and hospital pharmacies in Denmark.

What next?

The group is working on national standards for competency development of clinical pharmacy staff. Other logistics tasks will be scrutinized to see whether resources can be found for further investment in clinically related activities.

More benchmarking will be carried out, measuring other clinical and ward pharmacy activities throughout Denmark.

The work has just begun!

IMPLEMENTING PHARMACIST PRESCRIBING AT SCALE ACROSS A UNITED KINGDOM NHS HOSPITAL TRUST

European Statement

Introductory Statements and Governance

Author(s)

D. Campbell, W. Baqir, O. Crehan, R. Murray, N. Wake, R. Copeland

Why was it done?

Supplementary prescribing was implemented as an attempt to reduce prescribing errors at the point of admission. Pharmacists working in more ‘traditional’ clinical roles would identify errors and then ask junior doctors to correct the mistakes made. Not only did this expose patients to unnecessary risks but this was an inefficient use of resources. Prescribing allowed pharmacists to work much more autonomously.

What was done?

Our initiative was to implement pharmacist prescribing across an NHS hospital trust. We focused on developing and using generalist prescribing pharmacists to enhance their current ward based role. We have adopted an “anytime, anywhere” approach to prescribing, where the prescribing pharmacist, like their medical counterparts, can prescribe any medicine, for any patient, for any condition and in any setting.

How was it done?

Pharmacist supplementary prescribing commenced on a single ward, with staff working within a care plan, managing patients. Independent prescribing allowed prescribing service to be rolled out across the Trust. We now expect all pharmacists to obtain a prescribing qualification as a condition of employment. The pace of development was very much dependent on the rate at which pharmacists could be trained.

What has been achieved?

Supplementary prescribing on the admissions unit showed 39% (127/326) of patients audited were prescribed medication that otherwise would have been omitted. In 2014, of the 49 pharmacists employed, 29 (59.2%) are actively prescribing, with seven also having specialist roles. Seven pharmacists (14.3%) are currently in training. An audit of prescribing showed that pharmacists prescribed for 40% (182/457) patients accounting for 13% (680/5279) of all items. In a separate audit, 4 (0.3%) errors from 1413 items prescribed were detected.

What next?

This process has become embedded across our Trust. Regionally, other Trusts agreed a workforce strategy which included the development and deployment of prescribing pharmacists in the way we have described above.

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