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DEVELOPMENT OF A CENTRALIZED CLINICAL TRIALS UNIT: THE STRATEGIC IMPORTANCE FOR HOSPITAL PHARMACY

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European Statement

Clinical Pharmacy Services

Author(s)

Mafalda Cavalheiro 1
Joana Simões 1
Carolina Marques 1
Patrícia Batalha Silva 1
Miriam Capoulas 1
Cláudia Santos 1
1 – Pharmacy Department, Hospital da Luz Lisboa, Portugal

Why was it done?

Due to the connection with the clinical area and innovation, trials in our pharmacy services were previously assigned to each pharmacist specialized in the corresponding therapeutic area. In the beginning of 2024, the increasing number of clinical trials, coordination and investigational drug management challenges emerged and proved that the previous model was inefficient. Our aim is to develop a centralized unit that is the key to coordinate pharmaceutical activity and improve patient care in clinical trials. In addition to dispensing process, pharmacists become responsible for ensuring therapeutic reconciliation, patient education and treatment adherence, improving medication safety.

What was done?

During a time of continued growth in clinical trials number, it was defined as a pharmacy services’ goal the creation of a centralized clinical trial unit. Additionally, the need to structure a pharmaceutical consultation has arisen.

How was it done?

The process unfolded in three phases: team structuring, logistical reorganization and consolidation of the pharmaceutical care process. A lead pharmacist was appointed as coordinator, supported by a backup and three pharmacists in oncology and three in non-oncology. The major limitation was the establishment of the pharmaceutical team and their training for the several ongoing trials. The unit was reorganized into a larger area, including workstations, medication storage and a meeting room. The pharmaceutical consultation was structured into an initial evaluation and follow-ups. During the first consultation, the pharmacist conducts patient assessments, medication education, toxicity management information and drug/herbal interactions checking. Follow-up consultations focused on medication dispensing, compliance, adverse effects and patient concerns.

What has been achieved?

The centralized unit currently manages 66 clinical trials (37 oncologic; 29 non-oncologic). Seven oncologic trials regularly include pharmaceutical consultations, representing an average of 10 appointments per month. Given the benefits of pharmaceutical intervention, particularly in terms of increased adherence, reports of drug safety and compliance, the importance of this centralization is clear.

What next?

Due to logistical challenges, pharmaceutical consultations have only been implemented for oncologic oral medications. With the robustness of the centralized unit, the next goal is to expand pharmaceutical consultations to oral non-oncologic trials, following the successful model used for oncologic trials.

ANALYSIS OF MOTIVATED REQUESTS FOR ANTIBIOTIC MONITORING

European Statement

Clinical Pharmacy Services

Author(s)

Lanzone E. (1), Baldessarelli D. (2), Tinebra A. M. (1), Albini E. M. E. (1), Panarotto A. (1), Rossi C. (1) – (1) SC Farmacia Ospedaliera ASL Novara, (2) Scuola di Specializzazione Farmacia Ospedaliera Novara.

Why was it done?

A comprehensive analysis of systemic antibiotic use in hospitals during the first half of 2024 was conducted, revealing a significant increase in the consumption of WATCH class drugs, specifically carbapenems (ATC J01DH) and fluoroquinolones (J01MA). This prompted the implementation of rigorous monitoring for prescriptions of these drug classes.

What was done?

These antibiotics are key targets of the National Plan Against Antimicrobial Resistance (PNCAR 2022-2025), which mandates a reduction of at least 10% in consumption by 2025 compared to 2022. The initiative aimed to address the rising consumption and enhance antibiotic stewardship.

How was it done?

Data were extracted from the regional IT system, with consumption expressed in Defined Daily Doses (DDD) per 100 patient days. The project monitored the use of systemic antibiotics (ATC J01), focusing on carbapenems and fluoroquinolones. Motivated requests received by the Hospital Pharmacy (FO) were reviewed for therapeutic indications, dosage, treatment duration, and the availability of an antibiogram. All requests were recorded in an Excel sheet for effective data analysis and management.

What has been achieved?

In the first half of 2024, the Hospital Pharmacy received a total of 277 motivated requests for antibiotic prescriptions. Among these, 177 requests were aligned with the objectives of the PNCAR. Specifically, there were 54 requests for fluoroquinolones, including 35 for ciprofloxacin and 19 for levofloxacin. Within this subset, 16 requests included an antibiogram, while 27 were based on empirical data. Additionally, there were 6 requests for surgical prophylaxis, 1 for continuation of therapy, 1 accompanied by a positive urine culture, and 3 that were incorrectly filled out.
The analysis of requests also highlighted a significant number related to carbapenems, with a total of 123 submissions. Of these, 120 were for meropenem, 2 for imipenem in combination with cilastatin, and 1 for ertapenem. Notably, 80 of these requests included an antibiogram, with 74 deemed appropriate based on the established criteria.

What next?

Based on the collected data, modifications to the personalized motivated request form were proposed, introducing stricter criteria for empirical use of these antibiotics. This aims to limit their use to serious and well-defined cases, representing a significant step toward more effective antibiotic therapy and improved clinical outcomes while reducing the risk of resistance. The new form specifies that ciprofloxacin and levofloxacin requests can only be made under certain conditions, and carbapenems are restricted to cases of hemodynamic instability or severe respiratory failure.

PHARMACY STUDENT PRACTICAL FORMATION TO PHARMACEUTICAL HEALTHCARE IN HOSPITAL CARE UNIT

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European Statement

Education and Research

Author(s)

Elisa Vitale, Quentin Perrier, Arnaud Tanty, Claire Chapuis, Armance Grevy, Agathe Landoas, Dorothée Lombardo, Prudence Gibert, Lénaik Doyen, Benoit Allenet, Pierrick Bedouch, Sébastien Chanoine

Why was it done?

In France, during their 5th year of study, pharmacy students complete a six-month full-time equivalent internship in a hospital setting. At our hospital, most students spend six months in a care unit to perform pharmaceutical care and promote quality use of medicines. These missions are carried out in collaboration with all healthcare professionals, either under the direct supervision of a pharmacy resident, senior pharmacist, or independently. While tasks assigned to pharmacy students in the care unit with direct pharmaceutical supervision were well known, other students reported difficulties in understanding what was expected of them, as well as a lack of confidence when integrating an established interprofessional team.

What was done?

The aim was to create and evaluate a specific training session for all pharmacy students joining a care unit for the first time.

How was it done?

Four hospital pharmacists collaborated to define the learning objectives and select the appropriate teaching tools. A pre- and post-training self-assessment questionnaire consisting of seven questions was created to evaluate students’ self-efficacy regarding the learning objectives and their satisfaction with the training.

What has been achieved?

A four-hour training session, divided into five sequences, was created. The objectives were: 1) Highlighting the challenges of joining an interprofessional team, 2) identifying the tasks and learning opportunities for pharmacy students, 3) simulating a medication reconciliation, 4) managing pharmaceutical issues through problem-solving exercises.
Regarding the evaluation, students reported that they: a) were more enthusiastic about the idea of working in a care unit after the training course (85% vs. 74%, p=0.001); b) had a clear understanding of their mission (84% vs. 53%, p<0.001); c) felt more confident in performing a medication reconciliation (93% vs. 35%, p<0.001); d) were more aware of the pharmaceutical resources available to them (95% vs. 27%, p<0.001); e) had a better understanding of how hospital pharmacy is organized (58% vs. 19%, p<0.001). Additionally, 99% found the training useful, and 94% felt that the training methods aligned with the training objectives.

What next?

Assess the long-term impact of the training and its effectiveness in ensuring that pharmacy students perform pharmaceutical care successfully and confidently

SIDE EFFECTS OF CHEMOTHERAPY: INFORMING TO ACT BETTER

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European Statement

Clinical Pharmacy Services

Author(s)

Margot DESCHAMPS, Nejib BORGAAOUI, Jimmy ROSE, Jennifer LE GRAND, Louise NICOLAS

Why was it done?

Digestive cancers represent about 25% of new cancer cases diagnosed in France each year. The medical management of these cancers mainly relies on cytotoxic drugs. Side effects of these medications (fatigue, hair loss, nausea, or digestive issues) can affect negatively patients quality of life. These symptoms can make daily life challenging.

What was done?

As part of a patient therapeutic education program, the goal of our project was to develop an innovative educational tool to help patients better understand these side effects and find ways to manage them.

How was it done?

As part of the implementation of a multidisciplinary therapeutic education program, bringing together oncologists, pharmacists, sophrologists, osteopaths, and nutritionists, designed for patients treated for digestive cancers, the pharmacy is responsible for a workshop focused on the side effects of chemotherapy. The main molecules used to treat digestive cancers were listed, along with their most common side effects. Based on this analysis, playing cards were created, each corresponding to a specific side effect.

What has been achieved?

The developed tool is an educational and interactive board game, consisting of a board, a dice, and 56 cards. These cards are divided into 6 categories: general symptoms, neurology-psychology, heart-lungs, gastroenterology, dermatology, and real-life scenarios. The cards were designed to be understandable and accessible to all patients. The workshop takes place in two parts, with the pharmacist as the main facilitator. In the first part, patients are encouraged to share their personal experiences related to the drawn card. Then, the scenario cards are presented to help patients manage these challenges in their daily lives.

What next?

The decision was made to limit the number of participants to 6, in order to allow everyone to express themselves and exchange freely. The duration of the workshop was theoretically set at 1.5 hours but will need to be adjusted during the first workshops. It will be necessary to implement satisfaction surveys and patient follow-up on various criteria, such as emergency room visits, the number of calls after the session, and the rating of side effects.

A COLLABORATIVE APPROACH TO IMPLEMENT SHARED CARE AGREEMENTS FOR AMIODARONE THERAPY

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European Statement

Patient Safety and Quality Assurance

Author(s)

K. Joyce, D. Jukes, F. Stewart

Why was it done?

In 2023, the drug formularies across Northeast and North Cumbria integrated care system were merged, with amiodarone allocated an ‘amber’ shared care status.

NHS England guidance recommends that existing patients taking amiodarone in primary care should be reviewed to ensure prescribing remains safe and appropriate and that a shared care agreement is introduced.

The pharmacy team aimed to implement this guidance, with minimum impact on clinician workload. The approach was steered by NHS England’s comments, in June 2024, regarding the importance of teams working together to meet the pressures and demands of primary and secondary care under the direction of the integrated care board (ICB).

What was done?

County Durham and Darlington Foundation Trust (CDDFT) pharmacy team worked collaboratively across the primary-secondary care interface to implement shared care agreements.

How was it done?

The ICB medicines optimisation team worked with the CDDFT pharmacists to engage GPs and cardiologists across the interface, creating a work-plan to share resources.

An audit tool was designed to capture patients prescribed amiodarone in the 61 GP practices across County Durham, which was completed by pharmacy staff within primary care networks.

Cardiology pharmacists in secondary care reviewed the data, triaging patients according to: indication, monitoring requirements, those requiring consultant review and those who could potentially stop treatment.

What has been achieved?

The audit, returning data for 129 patients, identified 93 patients without shared care. For half of these, discontinuation was considered as the National Institute for Health and Care Excellence explicitly recommends against use in atrial fibrillation. For the remaining, shared care agreements have been implemented with minimal impact on clinician time, primary care capacity and secondary care referrals.

The audit found 21% of patients without a shared care agreement were not receiving the recommended monitoring, compared to 100% receiving correct monitoring when one was in place. It may be anticipated that implementation will improve patient safety and experience through detection and avoidance of adverse events.

What next?

This initiative demonstrates the ICB and pharmacy successfully bridging care settings to improve patient care and experience and overcome challenges.

Building on these established relationships across the interface this work provides a model for sustainable collaboration on future shared care work.

INTERNSHIP OF RESIDENT PHARMACISTS IN NEONATOLOGY CARE UNIT AT ULSSA: A COLLABORATIVE APPROACH

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European Statement

Clinical Pharmacy Services

Author(s)

Rita Sofia Conde Lopes, Rita Manuel Neves Lopes, Ana Paula Barbeita, Teresa Cunha, Patrocínia Rocha

Why was it done?

Improving the training of PRs and supporting the neonatal medical team by addressing their needs.

What was done?

The Pharmaceutical Residency (PR) lasts four years, during which the Resident Pharmacist (RP) must acquire skills in various areas. In the PR, one of the longest functional areas is pharmacotechnics, which includes the handling of sterile and non-sterile medicines. At the Unidade Local de Saúde de Santo António (ULSSA), which includes the Centro Materno Infantil do Norte (CMIN), this type of preparation is crucial due to the type of population it serves — pediatrics. With this in mind, the RP had the opportunity to complete a one-month internship in the neonatology unit (NU), where, in addition to familiarizing with the unit’s routine, they assisted with various needs of the service.

How was it done?

PRs attended morning routine specialist doctors during the morning routine, participating in both the night-morning and morning-afternoon shift handovers and follow-ups. The schedule was coordinated between the Pharmaceutical Services (PS) and the NU to ensure this was the most productive time for both parties. During shift changes, any issues from the previous period were discussed. When these topics involved the FS, the PR provided assistance.

What has been achieved?

During their presence NU, PR were able to intervene in several key areas, including expediting Pharmacy and Therapeutics Committee authorizations (e.g., everolimus for a neonate with rhabdomyoma), managing the logistics for obtaining non-commercialized medication in Portugal (e.g., erythromycin oral suspension for prokinetic use), supporting clinical decisions regarding the prescription of parenteral nutrition bags, updating the medical prescription system for dressing materials (e.g., maltodextrin powder dressings) and creating a spreadsheet for prescribing protein supplements.

What next?

This collaboration has fostered a stronger connection between pharmaceutical and clinical services and underscores the vital role of multidisciplinary teams in healthcare, where experts from different fields contribute with their specialized knowledge. Such collaboration not only enhances patient outcomes but also optimizes workflows by reducing service duplication, increasing productivity, and saving valuable time. In the future it is expected continue this collaboration.

72-HOUR TREATMENT RESPONSIBILITY AFTER DISCHARGE: CHARACTERIZATION OF MEDICATION-RELATED CALLS

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European Statement

Clinical Pharmacy Services

Author(s)

Daniel Rasmussen* and Morten Baltzer Houlind

Why was it done?

72-hour treatment responsibility (72H-TR) after hospital care is established to create a safe transition for the patient between hospital treatment and their home. After the implementation of 72H-TR, Copenhagen University Hospital, Amager and Hvidovre (AHH), experiences many calls from the municipalities related to patients’ medications. The purpose of this was to characterize calls related to medication in relation to 72H-TR.

What was done?

We reviewed logs from incoming calls made by Copenhagen and Høje-Taastrup municipalities regarding 72H-TR.

How was it done?

Calls related to patients discharged from the orthopedic or pulmonary medicine departments from AHH during the period from September to November 2023 were included. Further, two senior clinical pharmacists assessed whether calls related to medication was potentially preventable. In case of disagreement, consensus was reached between the reviews.

What has been achieved?

The results showed that 27 out of 50 (54%) calls were medication-related, and 22 out of 27 (82%) were potentially preventable. Of the medication-related calls that were potentially preventable, suboptimal communication was responsible for 11 out of 22 cases (50%), lack of a prescription accounted for 8 out of 22 cases (36%), and incomplete medication reconciliation accounted for 3 out of 22 cases (14%).

What next?

The next step will involve cross-sectoral and interdisciplinary workshops to identify barriers and facilitators and optimize the discharge process. We will also continue improving the online medication discharge reports available to municipalities to eliminate any ambiguities.

SETTING UP A LOCAL COOPERATION PROTOCOL TO ENABLE PHARMACISTS TO RENEW AND ADAPT PRESCRIPTIONS: FIRST RESULTS OF AN EXPERIMENT IN A PERIPHERAL HOSPITAL CENTRE

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European Statement

Clinical Pharmacy Services

Author(s)

S Hurel, H Benoist, N Guesdon, S Niemczyk, A-P Gaumon, A Perdriel, E Labbe
Hospital Center of Falaise, Falaise, FRANCE
sylvelie.hurel@orange.fr

Why was it done?

Implementation of a local cooperation protocol (LCP) to enable pharmacists to renew and adapt prescriptions within the hospital.

What was done?

In France, a decree published in February 2023 allows pharmacists working in hospital pharmacies to renew and adapt therapies (RAT) in a concerted manner (RATC) or directly (RATD). Previously, pharmacists could not intervene directly in prescriptions, but could only recommend changes to the prescriber, which were often time-consuming and never made. The aim of setting up this protocol was to improve patient care and optimise pharmacist and medical time.

How was it done?

The LCP was implemented on 8 July 2024 in a 600-bed hospital on three long-term geriatric test units (100 beds) following validation by the hospital medical committee in June 2024. A prospective study was carried out over three months on seven indicators: number of patients included, RATCs, RATDs, physician acceptance rates, adverse event (AE) and serious AE rates, and pharmacist and physician satisfaction rates. The indicators were collected in real time using a dynamic cross-tabulated Excel table, and satisfaction was assessed using a survey comprising five multiple-choice questions.

What has been achieved?

The number of patients included over the three months implementation period was 58. A total of 153 RATs were performed, including 53.6% (n=82) RATDs and 46.4% (n=71) RATCs. The main interventions concerned drugs prescribed but not referenced in hospital (n=38), inappropriate treatment durations (n=23) and supra-therapeutic dosages (n=18). The acceptance rate by doctors was 100% (n=153). There were no AEs or serious AEs reported. The satisfaction rate of doctors (n=3) and pharmacists (n=2) showed an overall satisfaction rate of 100% (n=5).

What next?

This three-month feedback showed that healthcare professionals were completely satisfied with the service provided by this LCP and the indicators have proved that this protocol can be applied safely. Thanks to this results, the LCP will therefore be continued in the three test units before being rolled out to other departments. Implementing this LCP in departments such as surgery will make it possible to secure prescriptions in a partnership between doctors and pharmacists.

MONITORING OF PRESCRIPTIONS FOR VOLUNTARY INTERRUPTION OF PREGNANCY AND SPONTANEOUS ABORTION WITHIN THE FIRST TRIMESTER OF PREGNANCY

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European Statement

Clinical Pharmacy Services

Author(s)

V. Mureddu, G. Ledda, G. Adamu, M. Rivano, A. Cadeddu. Hospital Pharmacy Department, Azienda Ospedaliero Universitaria, Cagliari.

Why was it done?

Mifepristone and misoprostol are provided for Voluntary Pregnancy Interruption (VPI) and Spontaneous Miscarriage (SM) according to different reimbursement schemes, based on different gestational age. According to Summary of Product Characteristics (SPC), the use of mifepristone and misoprostol is approved only within the first 63 days of pregnancy. Recently, access to treatment for VPI and SM has been extended by the Italian Medicines Agency by the I trimester of pregnancy. VPI within the first 49 days of gestation, the use of mifepristone and misoprostol is authorized according to SPCs. From 50th to 63th days is guaranteed under the law 649/96, that allows and reimburses the use of medicines for off-label indications. From 63th to 90th is considered an off-label prescription. Regarding SM, mifepristone and misoprostol can be used within the I trimester under the law 648/96. All these different reimbursement schemes are used as part of the Italian pricing-reimbursement system.

What was done?

To ensure appropriateness, a specific prescription form has been drafted to support clinicians in prescribing according to the correct reimbursement scheme gestational age, therapeutic indication and dosage must be reported in the prescription form.

How was it done?

The development of the prescription form required a deep knowledge of both the law under which the right of abortion is guaranteed and Italian reimbursement schemes. The prescription form was introduced in October 2022.
Prescriptions of all pharmacological treatments are ordinarily made through electronic software; therefore the prescription form was uploaded. Prescriptions from 01/01/2024 to 30/06/2024 were collected and retrospectively analyzed.

What has been achieved?

Prescription forms analysis showed that a total of 83 women were treated. In 53 cases the treatment was used for VPI and in 30 for SM. In 27% of cases, prescriptions were considered as per in-label. In 66% cases, prescriptions were allowed according to Law 648/96. In 7% of cases, prescriptions were off-label.

What next?

According to the development of reimbursement schemes, the prescription form will be implemented. Italy provides universal coverage for all citizens and residents; keeping it sustainable is one of the hardest challenges of these day. The contribution of hospital pharmacists in monitoring prescriptions has a pivotal role in making equal access to these treatments.

CHEMOTHERAPY MEETS HERBAL MEDICINE: NAVIGATING THE INTERACTION MAZE IN THORACIC ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Margot DESCHAMPS, Nejib BORGAAOUI, Jimmy ROSE, Jennifer LE GRAND, Louise NICOLAS

Why was it done?

One of the clinical pharmacy activities in the thoracic oncology department is the analysis the interactions between chemotherapy and Complementary and Alternative Medicine (CAM). Cancer patients often seek alternative treatments which requires a rigorous evaluation of potential interactions. The goal of this study is to assess the methods used to analyze these interactions.

What was done?

To ensure traceability of the analysis, a tracking table for requests was created. The requests, coming from doctors, nurses, or patients, are recorded with key information such as name, date of birth, and the purpose of the analysis. Five information sources were selected, including the Herbal Medicine section of MedlinePlus, the website of the Memorial Sloan Kettering Cancer Center (MSKCC), a database of plants and dietary supplements published by the French National Agency for Food, Environmental and Occupational Health Safety, a database from the European Scientific Cooperative on Phytotherapy, and a publication from the journal Medical Oncology (Vol 36, number 45, 2019).

How was it done?

In nine months, 25 interaction requests were processed, 70% of which were from doctors. The analysis took an average of 30 minutes and were completed within 24 to 48 hours. The interactions mainly concerned oral chemotherapies (n=18), particularly Osimertinib (n=13). The requests involved various CAM (essential oils, medicinal plants, dietary supplements), with an average of four products per request. Desmodium was the most frequently analyzed product (n=5). In total, for 24 CAM, including Desmodium, was not recommended for use after analysis due the drug interaction risk and modification of liver metabolism of chemotherapies.

What has been achieved?

It is difficult to prohibit CAM to patients, and most substances can be taken at recommended doses. However, determining the precise dosage at which an interaction with chemotherapy occurs is complex due to the lack of a single reference. Using various sources allows for cross-referencing expertise and obtaining complementary information. For instance, MedlinePlus offers a generalist approach, while MSKCC focuses on interactions in oncology. Using international sources broadens the analysis and fills geographical or cultural gaps.

What next?

For the future, we would like to develop a tool that compiles the five data sources in order to be exhaustive in our future analysis.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.