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GREEN BREATH PROJECT: A COMPREHENSIVE APPROACH TO REDUCING THE ENVIRONMENTAL IMPACT OF INHALER USE IN SPAIN

European Statement

Clinical Pharmacy Services

Author(s)

Noe Garin Escriva, Borja Zarate Tamames, Unax Lertxundi Etxebarria, Jose Javier Martínez Simon, Rocio Tamayo Bermejo, Eguzkiñe Ibarra Garcia, Olaia Serna Romero, Anna Pelegri Pedret, Yolanda Torremorell Alos

Why was it done?

The GREEN BREATH Project aimed to reduce the environmental impact of inhaler use in Spain. It consisted of three components: (1) a sustainable inhaler prescription framework with a database on the environmental impact of inhalers, scenario projections to estimate benefits of alternative inhaler use and a decision-support algorithm for greener prescribing in Spain; (2) a nationwide patient education project across 40 hospitals focusing on proper inhaler disposal, assessing pharmacists interventions; and (3) a hospital pilot project for optimizing the disposal of used inhalers, reducing hydrofluorocarbon emissions.

What was done?

Inhalers contribute to global CO2 emissions, with over 15 million pMDIs used annually in Spain, generating 400,000 tonnes of CO2 equivalent. Prescription practices often ignore sustainability, and improper disposal exacerbates this problem. The project aimed to integrate environmental criteria into prescribing practices and raise awareness to improve disposal methods, without compromising patient care.

How was it done?

We contacted pharmaceutical companies to develop the carbon footprint database. The prescribing algorithm was designed by a multidisciplinary team. We used data from the Ministry of Health to calculate national projections. We also conducted a study across 40 hospitals focusing on asthma patients, using a questionnaire with a 3-month follow-up. Finally, we piloted an in-hospital inhaler waste management program in a single hospital.

What has been achieved?

The project demonstrated significant impact. We provided the first environmental database on inhalers in Spain. We estimate that shifting 10% of pMDI prescriptions could reduce CO2 emissions by 40,000 tonnes annually. Preliminary results show that over 50% of patients were unaware of inhaler disposal’s environmental impact, and that pharmacists interventions doubled proper inhaler waste disposal. Additionally, the hospital pilot project prevented up to 341 tonnes of CO2 emissions annually by optimizing inhaler waste management.

What next?

Educational resources have recently expanded to four languages used in Spain (Spanish, Catalan, Basque, Galician). We continue disseminating and collaborating with institutions to implement these and other activities. Additionally, sustainable prescribing should be integrated into electronic medical records to drive broader healthcare sustainability and reduce inhaler-related emissions. The project offers a replicable model for other healthcare systems.

DESIGN AND IMPLEMENTATION OF AN INTEGRATED PHARMACEUTICAL CARE MODEL IN PATIENTS UNDERGOING ASSISTED REPRODUCTIVE TREATMENTS

European Statement

Clinical Pharmacy Services

Author(s)

A.M. AGUI CALLEJAS1, C. REDONDO GALÁN1, S. MANRIQUE RODRIGUEZ1, C. MARTINEZ FERNANDEZ-LLAMAZARES1, Y. RIOJA DIEZ1, L. MORENO OCHOA2, F. PEREZ MILAN, A. HERRANZ ALONSO1, M. SANJURJO SAEZ1.
1 GREGORIO MARAÑON UNIVERSITY GENERAL HOSPITAL, PHARMACY, MADRID, SPAIN.
2 HOSPITAL GREGORIO MARAÑON, OBSTETRICS AND GYNAECOLOGY, MADRID, SPAIN.

Why was it done?

Patients undergoing AR treatments face a substantial information burden and complex drug regimens, including injectable self-administration, which complicate understanding and adherence while increasing the risk of errors. A single-visit care programme was developed, integrating medical consultation, nursing-led administration training, pharmaceutical care, and treatment dispensing. This coordinated model aims to enhance follow-up, reduce patient burden, and improve healthcare quality, resulting in safer, more effective, and efficient outcomes.

What was done?

A pharmaceutical care programme was developed and implemented to monitor treatment and dispense medication to patients undergoing assisted reproduction (AR) procedures.

How was it done?

A multidisciplinary team was established, including gynaecologists, clinical pharmacists, and advanced practice nurses. Patients were selected according to local healthcare criteria. The programme addressed logistical coordination, pharmacotherapeutic monitoring, and patient support. A mobile application (including medication management, adverse events and bidirectional messaging) was developed from March to August 2025 and launched in the final month. Medication was dispensed in exact patient-specific amounts, following quality and traceability protocols, to reduce costs and minimise home waste. Main limitations were the short implementation period and small sample size, related to the app’s recent launch.

What has been achieved?

93 patients were included (mean age: 40 years, SD=3.9). 102 treatment initiation consultations and 194 follow-up visits were recorded (7 patients with > 1 cycle). Medication dispensing was based on Madrid Health Service criteria: In Vitro Fertilisation (IVF) in women over 40 years (45%) or with previous children (30%), fourth IVF cycle (7%), artificial insemination (AI) in patients with previous children (13%), and oocyte preservation (OP) in patients with previous offspring (5%). Eight patients were enrolled in the app: 12.5% sought supplement compatibility advice, 37.5% reported adverse effects, and 50% recorded medication intake. Median treatment duration was 8 days [interquartile ranges: 4–10 (IVF and AI); 8-10 (OP)]. The estimated savings, derived from the difference between the units supplied in full medication packs and those actually consumed by patients, amounted to €15,441.

What next?

This initiative exemplifies good practice by integrating medical consultation, nursing-led training, pharmaceutical care, and dispensing in one visit, reducing burden while improving safety and efficiency. A digital tool enhanced monitoring and communication, making the model transferable to other outpatient settings.

REINVENTING PHARMACOTHERAPY IN PROSTATE CANCER THROUGH STRATIFICATION AND PERSONALIZED DEPRESCRIPTION: OPTIM-CP PROYECT

European Statement

Patient Safety and Quality Assurance

Author(s)

Mª Antonia Meroño Saura
Rebeca Añez Castaño
María García Coronel
Francisco Valiente Borrego
Elena Urbieta Sanz

Why was it done?

Prostate cancer patients are often elderly, frail, and chronically medicated. The introduction of new hormonal therapies has increased treatment complexity and the risk of drug-related problems. Despite evidence linking excessive polypharmacy to poor outcomes, structured deprescribing models are rarely applied in oncology. OPTIM-CP was introduced to address this unmet need by integrating validated stratification tools (Risk stratification model (EM) for the pharmaceutical care of oncology patients with solid or hematologic neoplasms (SEFH)) into routine practice to prioritize patients at highest risk and guide pharmacist-led interventions.

What was done?

The OPTIM-CP initiative was developed to improve the safety and quality of pharmacotherapy in patients with prostate cancer. It implemented a structured pharmaceutical care model based on clinical-pharmacological risk stratification and individualized deprescribing.

How was it done?

A multidisciplinary working group of clinical pharmacists reached consensus on the practical adaptation of the EM to prostate cancer patients, ensuring consistency and clinical validity. Eligible patients receiving oral hormonal therapy were identified and stratified during pharmaceutical care consultations in the Hospital Pharmacy Department through. According to their assigned risk level, follow-up intensity was adapted. Medication reconciliation was performed using the regional electronic prescribing system to ensure accuracy and coherence across hospital and primary care records.

What has been achieved?

The initiative achieved full integration into the hospital’s outpatient pharmacy circuit. A total of 111 patients were stratified during pharmaceutical care consultations. The mean age was 78,25 ± 9,6 years, and most were treated for hormone-sensitive metastatic disease. According to the ME, 4.5% were classified as high risk, 38.7% as intermediate, and 56.8% as low risk. Polypharmacy was present in 73% of patients, and 72% used at least one high-risk medication. Treatment-related variables were the main contributors to overall risk.
The implementation of the stratification model improved communication with patients, reduced medication discrepancies, and allowed prioritization of high-risk patients for closer follow-up.

What next?

OPTIM-CP is now being consolidated as a permanent part of routine care. The next phase focuses on the systematic deprescribing of potentially inappropriate medications identified during stratification, using validated decision-support tools (CheckTheMeds®) and shared decision-making with clinicians. Future steps include expanding the model to other oncologic populations.

MODERNIZING CYTOSTATIC PRODUCTION: A DATA-DRIVEN APPROACH TO DECISION-MAKING FOR SELECTING A COMPOUNDING SYSTEM

European Statement

Production and Compounding

Author(s)

Stefanie Fuchs, Michele Tadiotto

Why was it done?

Compounding cytotoxic therapies in hospital pharmacies is a complex and safety-critical process. As part of a planned modernization of the production site, which handles around 40.000 preparations annually, the project was launched to investigate the impact of integrating an automated compounding technology (ACT).
This project also provided decision-makers with structured, data-driven insights to support the selection of the most appropriate technology for the specific production needs.

What was done?

A comprehensive analysis to identify the most suitable ACT for our chemotherapy production was conducted.
The approach taken was twofold: first, production data was used to run simulations, allowing for the evaluation of how the different ACTs would perform in our environment.
Second, interviews with international ACT users with hands-on experience were conducted to gather valuable, pragmatic insights.

How was it done?

A detailed examination of the production data was conducted, assessing each ACT’s compatibility with our portfolio (approx. 100 chemotherapy substances). Customized MS-Excel calculation sheets were developed and used to cross-reference drug-specific production metrics (for each drug: total annual preparations, average production time, average transferred volume, other critical parameters). Based on this analysis, the drugs best suited for compounding with each ACT candidate were identified.
Simulations were then run to compare theoretical performance both against current manual compounding and among ACT candidates.
Additionally, the information collected during the interviews was used to develop a comprehensive evaluation of process impacts including: maintenance of quality standards, personnel requirements, potential contamination risks, software integration, microbiological and cleaning aspects, and GMP compliance requirements.

What has been achieved?

This dual methodology enabled a robust evaluation of both theoretical and practical aspects of each system.
Critical technical limitations that could hinder system applicability were identified and the potential proportion of the total compounding workload realistically manageable by ACTs was assessed.
Furthermore actionable, data-driven insights were collected and provided to decision makers to guide strategic decisions.

What next?

The findings are tailored for management decision-makers, enabling them to select the ACT best suited to the pharmacy’s needs without requiring in-depth pharmacy expertise.
Additionally, the methodology from this project can serve as a replicable framework for other hospital pharmacies interested in adopting an ACT.

IMPLEMENTATION OF A CLINICAL PHARMACIST-LED ELECTRONIC MONITORING SYSTEM FOR SURGICAL ANTIBIOTIC PROPHYLAXIS

European Statement

Clinical Pharmacy Services

Why was it done?

Before this initiative, surgical antibiotic prophylaxis (SAP) monitoring was paper-based and mainly handled by nursing staff, with little pharmacist or surgeon engagement. Entries were often incomplete or inaccurate, with frequent confusion between prophylactic and therapeutic use. Critical parameters—timing, duration, and patient-specific factors—were inconsistently recorded, and data were rarely analysed, so protocol compliance went unmonitored. Consequently, surgeons paid limited attention to guideline adherence or to the contribution of suboptimal prophylaxis to antimicrobial resistance. These gaps exposed patients to unnecessary antibiotic exposure and avoidable infection risk. The project was therefore launched to create a reliable, accountable monitoring process that would improve data quality and enable systematic feedback and stewardship.

What was done?

A clinical pharmacist-led, electronic monitoring system for SAP was developed. A comprehensive data-capture form (demographics, surgery type and duration, wound class, antibiotic choice, dose, timing, and duration) was designed after benchmarking similar tools and implemented in the hospital information system (HIS). Clinical pharmacists reviewed all SAP entries, verified completeness before discharge, and generated reports shared with the Infection Control Committee and hospital management to support data-driven interventions.

How was it done?

A multidisciplinary team of pharmacists, infection control experts, IT staff, and surgeons collaborated under hospital leadership to design and implement the process. All patients undergoing surgery and receiving SAP were monitored by trained pharmacists in the wards, and data entries were completed before discharge to ensure accuracy. The collected information was analysed by clinical pharmacists, and discrepancies between clinical practice and established protocols were flagged. The Infection Control Team, in collaboration with hospital management, provided feedback to surgeons and developed targeted training programmes where needed. Initial barriers—limited familiarity with digital forms and resistance to workflow changes—were overcome through structured training, ongoing communication, and continuous on-ward support.

What has been achieved?

Documentation completeness and accuracy improved markedly, enabling routine compliance assessment across antibiotic choice, dose, timing, and duration. Analysis identified delays in administration; corrective actions, education, and protocol updates followed. Surgeon awareness of correct timing increased, and the pharmacist’s role in antimicrobial stewardship was strengthened.

What next?

Next steps include embedding the revised SAP protocol across all surgical units, regular audits, and continued pharmacist-led monitoring to sustain improvements. By integrating SAP monitoring data with patient readmission data for surgical site infections, we aim to evaluate whether improved documentation, training, and protocol revision lead to measurable reductions in infection-related readmissions. The model is effective, scalable, and transferable to other hospitals. Integration with AI-assisted decision-support tools within the HIS is being explored to further optimise prophylaxis management.

ADAPTA: ADAPTED ORAL DRUG FORMULATIONS FOR PREANESTHETIC USE IN CHILDREN WITH AUTISM SPECTRUM DISORDER

European Statement

Production and Compounding

Author(s)

Carlota Mestres Gonzalvo
Juan José Lázaro Alcay
Ángela Pieras López
Marta Duero Adrados
Carlos Javier Moreno Pérez

Why was it done?

Children with ASD frequently reject standard oral medications due to sensory sensitivities, which increases distress and drives the use of invasive routes (intramuscular and/or intravenous), undermining safety, family wellbeing, and perioperative efficiency. Current forms are not adapted to ASD needs; the aim is to maximize acceptability and minimize distress through patient-friendly formulations and calming environments, ensuring equitable, high‑quality preanesthesia care.

What was done?

The project is creating and preparing to clinically evaluate novel, palatable oral formulations—such as sensory-friendly gummies—co-designed by hospital pharmacists, anesthesiologists, and university formulation experts using advanced flavor–texture modification. In parallel, dedicated sensorial rooms with direct street-access entry, adjustable lighting and sound, and tactile comfort features are being incorporated to reduce overstimulation during preanesthetic preparation.

How was it done?

The first phase addresses obstacles such as heterogeneity in ASD sensory profiles and stringent pharmaco-technical and safety requirements. The team is overcoming these through stakeholder engagement with families, sensory mapping, iterative prototyping with in‑house stability and sensory testing, and multidisciplinary collaboration for rapid, compliant development. Hospital infrastructure supports integration, regulatory documentation, and implementation of sensorial rooms and staff training.

What has been achieved?

A multidisciplinary team has been established, equipment and consumables planned, and formulation development initiated, alongside design parameters for sensorial rooms and workflow integration. Expected outcomes include improved medication acceptance, reduced preanesthetic distress, fewer invasive interventions, greater perioperative efficiency, and higher staff confidence in ASD care, with internal dissemination and readiness for pilot evaluation.

What next?

The ADAPTA initiative is developing tailored oral drug formulations and implementing sensorial rooms to improve preanesthesia care for children with autism spectrum disorder (ASD), integrating pharmaceutical innovation with patient-centered strategies in a multidisciplinary hospital setting.
ADAPTA represents good practice by uniting pharmaceutical innovation with environmental and behavioral adaptations, offering a scalable, replicable model for inclusive pediatric anesthesia. Next steps include completing prototype validation, pilot clinical and sensory acceptability studies within sensorial rooms, standardizing operating procedures, and preparing for scale‑up across additional services and pediatric populations.

GALENIC DEVELOPMENT AND STABILITY EVALUATION OF AN ORAL SUSPENSION OF CLOBAZAM FOR THE TREATMENT OF LENNOX-GASTAUT SYNDROME

European Statement

Production and Compounding

Author(s)

A. Telma Leal, António Daniel Mendes, Teresa Cunha, Paula Barbeita, Patrocínia Rocha

Why was it done?

Lennox-Gastaut syndrome is a severe, drug-resistant epilepsy with childhood onset, characterised by irregular brain activity, cognitive impairment and behavioural changes. Given its complexity and major impact on quality of life, therapy requires continuous adjustment, possibly involving valproate, clobazam, lamotrigine, rufinamide, topiramate, felbamate or cannabidiol.
No clobazam formulations are commercially available for paediatric use and data on extemporaneous oral formulations are limited. Regarding this, stability evaluation is essential to ensure quality and safety before therapeutic application.

What was done?

Galenic development, preparation and stability evaluation of a Compounded Formulation (CF) with clobazam for paediatric treatment of Lennox-Gastaut syndrome and other refractory epilepsies.

How was it done?

Development began with a literature review on the pharmacological and physicochemical properties of the drug, followed by election of an oral liquid formula.
Two samples were prepared and assessed for physical stability by an internal protocol on days 7, 14, 21, and 28: one (CF1) stored at Room Temperature (RT) <25 °C, the other (CF2) refrigerated (2–8°C).

What has been achieved?

Based on our findings, a clobazam suspension was designed using xanthan gum as a suspending agent, with pH around 5. According to literature-reported shelf lives and usage periods of CF and raw materials, one batch was refrigerated and the other stored at RT. Also, CFs were prepared at 1 mg/mL concentration (suitable for Paediatrics), packaged in 100 mL type III amber glass bottles and the final product should be whitish suspensions, homogeneous after shaking, with pH around 4–6.
Evaluation showed CF1 developed microbiological contamination on day 14, with gas, fermented odour and pH 6–7 by day 21, then 5–6 (day 28). Other features — sedimentation time, dispersibility, homogeneity and crystal growth—remained normal. CF2 kept colour and appearance until day 28. Mold odour occurred at day 21. pH rose from 6–6.5 to 6.5–7 after day 14. Other parameters remained normal.

What next?

Clobazam CF proved to be suitable for paediatric Lennox-Gastaut syndrome or refractory epilepsy use. Stability evaluation demonstrated physical appropriateness for up to 14 days under refrigeration; for longer use is not recommended.

OPTIMISING INTRAVENOUS IMMUNOGLOBULIN USE IN HAEMATOLOGY: A COLLABORATIVE PATH TO RATIONAL PRESCRIBING

European Statement

Patient Safety and Quality Assurance

Author(s)

MARIA TERESA ESTEBAN ALONSO, ANA INFANTE CAMARERO, INES BAENA BOCERO, SARA ARNAIZ DIEZ, LAURA IZQUIERDO ACOSTA, OLGA ALAMO GONZALEZ, MARTA UBEIRA IGLESIAS, MPAZ ESPINOSA GOMEZ , AITOR AYASTUY RUIZ , NATALIA REVILLA CUESTA.

Why was it done?

A sustained rise in IVIG consumption, particularly related to new oncohaematologic therapies and off-label situations, raised concerns about clinical appropriateness, economic impact, and national supply shortages. The aim was to ensure rational, safe, and cost-effective use of this therapeutic resource in a context of increasing demand and the introduction of novel treatments such as bispecific antibodies.

What was done?

A collaborative strategy between the Pharmacy and Haematology Departments was developed to review and optimise the use of intravenous immunoglobulins (IVIG) in haematology patients.

How was it done?

All haematology patients treated with IVIG during a reference period were included. Prescriptions were jointly reviewed by pharmacists and haematologists, classifying cases according to clinical justification. A structured review of prescribing practices was required to ensure compliance with approved indications and clinical guidelines. Evidence-based indications were prioritised, while emerging scenarios associated with bispecific antibodies were carefully assessed. In cases lacking sufficient clinical support, treatment discontinuation or alternative management strategies were proposed in agreement with the clinical team. The process was formalised through a management objectives agreement linking clinical outcomes to expenditure control.

What has been achieved?

The initiative enabled early identification of unjustified prescriptions, preventing unnecessary treatments and contributing to significant cost containment. It also strengthened multidisciplinary collaboration and raised awareness among clinicians on the importance of preserving IVIG for evidence-based indications, thereby enhancing patient safety and sustainability

What next?

A joint Haematology–Pharmacy protocol defining priority indications and usage criteria for IVIG is planned, together with the expansion of this model to other specialties with high immunoglobulin consumption. This initiative represents a transferable and scalable example of good practice for hospital settings across Europe.

MANAGEMENT OF DRUG THERAPY IN HIV-POSITIVE PATIENTS: SYNERGY BETWEEN THE IMMUNOLOGY DEPARTMENT AND THE HOSPITAL PHARMACY

European Statement

Clinical Pharmacy Services

Author(s)

Noemi Tatti, Melania Rivano, Giacomo Bertolino, Valentina Mureddu, Raffaele Deidda, Arianna Cadeddu

Why was it done?

Patients are required to attend a follow-up visit every three months for viral load testing. A collaborative protocol has been implemented to facilitate treatment adherence, monitoring, and access to medication.

What was done?

Collaboration between the immunology department and the hospital pharmacy facilitated the management if drug therapy in HIV-positive patients, enhancing access to care and improving treatment adherence.

How was it done?

The visit schedule is shared monthly. Each patient is assigned an alphanumeric code to ensure anonymity. Any change in appointments, test results, visits, or therapy regimens is also communicated. Through the hospital’s electronic system, pharmacists can access each patient’s treatment plan, review the dates of medication pickups, and verify treatment adherence. In case of discrepancies, these are promptly reported to the physician before the patient’s next visit. Additionally, sufficient medication to cover three months of therapy is prepared in advance for each patient, simplifying the dispensing process and preventing unnecessary hospital visits.

What has been achieved?

This initiative has optimized adherence monitoring, which is particularly important for this category of patients. It has also facilitated the drug dispensing process. By reducing waiting times and hospital visits, it has improved treatment compliance and ensured the protection of their privacy. This project was implemented on 792 patients, and from 01/10/2024 to 01/10/2025, a total of 1,369 dispensations of antiretroviral drugs were carried out.

What next?

This approach has been used to improve the quality of care and overall experience of this patient group. We hope that it will soon be extended to all patients who collect their medication at our hospital.

COST-EFFECTIVENESS OF PERSONALIZED THERAPY IN A RARE CANCER CASE AT END-OF-LIFE: A REAL-WORLD EXPERIENCE

European Statement

Clinical Pharmacy Services

Author(s)

Rossella Centola, Elisabetta D’Amico, Stefano Morabito, Maria Alfieri, Maria Giovanna Elberti, Lucilla Grisi, Giorgio Lilla, Amelia Filippelli, Francesco Sabbatino

Why was it done?

Precision Medicine (PM) in oncology remains a highly debated topic within Italian healthcare institutions. Currently, Next-Generation Sequencing (NGS) tests are not included in the Essential Levels of Care (LEA), and reimbursement policies vary across regions. Moreover, most targeted therapies based on mutational profiling are prescribed off-label.

What was done?

This study aimed to conduct a cost-effectiveness analysis of a personalized cancer therapy administered in an end-of-life setting.

How was it done?

Clinical and prescription data were collected for a targeted treatment with olaparib. Data were presented as a case report, and median progression-free survival (PFS) and overall survival (OS) were calculated in months. A cost-effectiveness analysis was performed comparing standard care with NGS-driven therapy, using company management software to estimate healthcare expenditure. The Incremental Cost-Effectiveness Ratio (ICER) was calculated and compared against a willingness-to-pay (WTP) threshold of €60,000, considering the rarity of the tumor.

What has been achieved?

The case involved a 56-year-old male diagnosed with cholangiocarcinoma in 2017. After multiple treatments, an NGS test revealed a BAP1 gene mutation associated with a BRCA-like phenotype. Off-label treatment with olaparib 300 mg BID began in June 2019. The personalized therapy resulted in a PFS of 21 months compared to approximately 2 months with best supportive care (standard treatment), and an OS of 48 months versus 29 months, respectively. The cost-effectiveness analysis, conducted from the Italian National Health Service perspective, considered direct healthcare costs including disease management, drug administration, and management of serious adverse events. Personalized therapy showed a survival gain of 2.5 life-years (LY) compared to 1 LY with standard care. The resulting ICER was approximately €45,000 per LY gained—well below the €60,000 WTP threshold.

What next?

This case illustrates that applying PM in end-of-life care for a rare cancer can yield significant survival and economic benefits. These findings highlight the need for greater integration of PM into clinical trials, structured data-sharing networks, and the establishment of solid evidence-based and pharmacoeconomic frameworks.