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.
TAKE A BREATH, MAKE IT MULTI! INVOLVEMENT OF A CLINICAL PHARMACIST IN THE MULTIDISCIPLINARY CARE OF PATIENTS WITH CYSTIC FIBROSIS.
European Statement
Clinical Pharmacy Services
Author(s)
Gilak G., Lakatos-Krepcik A., Breyer-Kohansal R., Sailer G.
Why was it done?
In Austria, people with Cystic Fibrosis (CF) receive interdisciplinary care from various professional groups at specialized treatment centers. The European Cystic Fibrosis Society recommends the integration of pharmacists into the multidisciplinary CF team, emphasizing medication management, patient education, and adherence support. Increased access to CF transmembrane conductance regulator modulator therapies in recent years has conferred significant benefits to patients in multiple ways. However, these highly effective drugs are known to have a high potential for drug–drug interactions.
What was done?
The current medication of adult patients was reviewed by a clinical pharmacist. Individualized medication counselling, education, and specialized support in cases of drug shortages were provided to patients. To evaluate the quality of the pharmaceutical consultation and the benefits derived from it, patients were invited to complete an anonymous questionnaire.
How was it done?
During their visit to our specialized CF outpatient clinic, patients were offered the opportunity to consult a CF pharmacist. Together with the patient, a comparison was conducted with the previously documented medication list. Additional or differently taken medications, as well as the results of the interaction analysis, were documented in the electronic patient record and logged in a specifically developed data collection tool. Once a week, the respective data of these patients were discussed within the multidisciplinary team.
What has been achieved?
37 patient consultations took place between 11/24 and 04/25. Patients took an average of 9.7 medications, additionally 1.6 medications were recorded following inquiry by the clinical pharmacist. In total 120 drug related issues were identified. These issues included adverse drug reaction management (25%), instructions for use (25%), formal criteria for written prescriptions and drug shortage (17%), patient adherence concerns (13%), indications/contraindications (13%), and dose adjustments (7%).
An average of 2.7 drugs per medication, which were not taken in accordance with the current prescription plan, were identified by the clinical pharmacist.
All patients stated that the consultation with the clinical pharmacist was very helpful or helpful and 96% of patients indicated that they now feel confident in taking their medications correctly.
What next?
In the future, pharmaceutical CF care will be formally established in the form of a periodic review at the CF center of our clinic.
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.
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.
IMPLEMENTATION OF PRIORITIZATION CRITERIA IN MEDICATION REVIEW ACTIVITY IN GERIATRIC MEDICINE: AN EIGHT-MONTH STUDY
European Statement
Clinical Pharmacy Services
Author(s)
A. GHORBEL, C. KONN, J. CATROUX, J. TISSERAND, P. ROCANIERES
Why was it done?
Polypharmacy and multimorbidity make medication safety a major challenge in geriatric medicine. Medication reconciliation and review are essential but time-consuming processes that cannot be systematically performed for all patients. Prior, we made a systematic review of the French literature which identified multiple prioritization approaches – empirical, statistical, and consensus-based – but no harmonized tool. Common criteria included advanced age, polypharmacy, psychotropic use, high-risk medications, and chronic diseases such as heart failure. Then, we aimed to translate these findings into a pragmatic, locally adapted prioritization grid to improve targeting and workflow efficiency.
What was done?
An initiative was developed in the geriatric department of a French University Hospital to introduce prioritization criteria for medication review (MR) at admission. The aim was to optimize pharmacists’ clinical activity by identifying high-risk patients most likely to benefit from a MR, given the limited available resources.
How was it done?
A prospective, observational, comparative study was conducted over 13 months (early June 2024 – end June 2025) in neuro-geriatrics and onco-geriatrics. During the 8 last months, pharmacists applied a prioritization grid daily based on clinical and pharmacological criteria (≥ 5 medications, renal impairment, psychotropics, high-risk drugs). Indicators before and after its implementation were compared using a two-sample Z-test (α = 0.05).
What has been achieved?
After implementation, 295 admission and 48 discharge MR were performed (vs 272 and 31 before prioritization). The initiative allowed the targeted inclusion of patients with a mean age of 87 ± 6 years and an average of 10 ± 4 chronic medications. The most frequent prioritization criteria identified were renal impairment, use of “never-event” drugs (methotrexate, insulin, colchicine, oral chemotherapy and anticoagulant drugs), antibiotic therapy, electrolyte disorders, and diabetes. Average MR time rose (113 vs 105 min; 89 vs 47 min), reflecting higher case complexity.
What next?
Defining common prioritization criteria could support national recommendations and enable the development of digital tools integrated into hospital information systems to automatically identify high-priority patients. In the future, it is planned to use these results to create decision rules from artificial intelligence software: it could generate dynamic prioritization models based on real-time clinical, biological, and therapeutic data, embedded into dispensing software to improve patient safety and optimize pharmaceutical care.
IMPROVING MEDICATION SAFETY IN PATIENTS WITH HEPATIC CIRRHOSIS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
ANDREA RODRÍGUEZ ESQUÍROZ, AMAYA ECHEVERRÍA GORRITI, Mª CONCEPCIÓN CELAYA LECEA, MARTA MARÍN MARÍN, LOREA SANZ ÁLVAREZ, PATRICIA GARCÍA GONZÁLEZ, JAVIER GORRICHO MENDIVIL, JAVIER GARJÓN PARRA.
Why was it done?
A prescription alert system was developed in our region for the management of drugs in patients with hepatic cirrhosis.
What was done?
A preliminary study made in our region showed that around one in four prescribed medications in cirrhotic patients are contraindicated or overdosed. Besides, it is estimated that around 38% of cirrhotic patients suffer any adverse effect despite approximately 70% of them are preventable.
In addition, safety problems can emerge due to the lack of data regarding drugs management in patients with cirrhosis.
For these reasons, it was essential to develop a tool that helped clinicians during the prescription process and pharmacists while pharmaceutical validation and medication review.
How was it done?
A computer-generated prescription alert system was developed. This system provides security data and dosing recommendations according to Child-Pugh classification of each patient. Besides, the tool suggests safer alternatives when an unsafe drug is prescribed. These recommendations were extracted from the product information and three databases: UpToDate, RxCirrhosis and Geneesmiddelen bij.
According to last laboratory data available from the electronic medical records such as bilirubin, prothrombin time and albumin, this tool estimates the Child-Pugh score, that must be completed with ascites and encephalopathy grade.
At this time, this tool is only available for clinical pharmacists for validation, and it is expected to be implemented for physicians soon.
What has been achieved?
From May to September 2024, a total of 202 drugs were included, 59 (29.2%) were considered contraindicated in some degree of cirrhosis, so it was recommended not to use. Dose adjustment was proposed in 109 (54.0%) drugs, while in 13.9% the tool recommended a safer alternative drug.
In order to complement this issue, information and training sessions were given about safe management of drugs in cirrhotic patients.
What next?
We are working in order to include safety data about more drugs in this alert system.
We hope this tool can help professionals of other regions and countries.
SEMI-AUTOMATED PHARMACEUTICAL CARE CIRCUIT IN NURSING HOMES: EXCEEDING MAXIMUM DOSE PRESCRIPTIONS IN ELDERLY PEOPLE
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Amaia Martiarena Ayestaran, Ane Ros Olaso, Iosu Barral Juez, Cristina Saiz Martinez, Ane Latasa Berasategui.
Why was it done?
Detection of potentially inappropriate prescriptions (PIPs) exceeding maximum dose in elderly patients. Communicate these findings to nursing home´s (NH) medical staff adding information to make easier the review. Evaluate the results obtained after the pharmaceutical intervention (PI).
What was done?
Pharmaceutical care provided in NH includes systemic reviews and drug adjustments in collaboration with clinical team to enhance the rational use of drugs.
It is designed a semi-automated pharmaceutical care circuit to detect exceeding maximum dose PIPs due to high prevalence in this population. The objective of this practice is to reduce, after a PI, PIPs to improve patient’s safety.
How was it done?
Selection of the most prevalent exceeding maximum dose PIPs based on STOPP-START criteria, safety notes and technical sheets from Spanish Agency for Medicines and Health Products: omeprazole, esomeprazole and rabeprazole ≥ 40 mg/day, pantoprazole ≥ 80 mg/day, lansoprazole ≥ 60 mg/day (PPIs); zolpidem (ZLP) > 5 mg/day; acetylsalicylic acid > 100 mg/day (AAS); citalopram > 20 mg/day; escitalopram > 10 mg/day (SSRIs); iron > 200 mg/day (Fe).
Automatic data extraction.
Registration in medical records and email notification to NH´s physicians including drug and dosage, adjustment recommendation and bibliographic reference.
Results evaluation after 2 weeks.
Limitations: way of communication and drug prescribing doctor different from NH´s doctor. To solve the first issue, an email has been sent after 1 week. On the second case, no action could be taken.
What has been achieved?
155 residents with one or more exceeding maximum dose PIPs are included from 22 centers with 2,223 elderly people linked to hospital pharmacy service. The mean age is 85.3 years and 69.7% are women.
After PI, PIPs are reduced by 66.5%.
PIPs TOTAL PPI ZLP Fe SSRI AAS
INITIAL 164 73 51 18 17 5
AFTER PI 55 20 21 5 8 1
Dose reduction and prescription discontinuation are the reasons of the PIPs reductions. Physicians justify don´t change prescriptions on 8 cases.
What next?
This semi-automated circuit is focused on PIPs. That is why the tool allows easy and rapid detection of a higher amount of patients with drug safety problems at once. In the future, it will be used for other PIPs and other NH.
Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone
Why was it done?
Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.
What was done?
In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.
How was it done?
The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.
What has been achieved?
Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.
What next?
E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.
The European Paediatric Formulary: a reinforced approach for improved monographs
Pdf
European Statement
Production and Compounding
Author(s)
Théo Henriet, Jane Francomb, Dirk Leutner, Jörg Breitkreutz
Why was it done?
The PaedForm project was launched as a bibliographical exercise, with the aim of collecting age-appropriate formulations from existing formularies or from established sources in Europe and incorporating them into the PaedForm.
However, the data underpinning existing monographs were not as complete as expected and errors in the source data were observed. Adding an experimental verification step was therefore crucial to ensuring the reliability and the appropriate quality of the formulations described in PaedForm and demonstrating that the monographs could be used in practice.
What was done?
A decision to add an experimental verification to the elaboration process for monographs to be published in the European Paediatric Formulary (PaedForm) was recommended by the experts from the PaedF working party (PaedF WP) – assisted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – and supported by the European Committee on Pharmaceuticals and Pharmaceutical Care and the European Pharmacopoeia Commission.
This verification step involved checking the preparation against the description in the monograph and, where necessary, completing it. Samples prepared during this step were then tested to check that the quality control methods included in the monograph were suitable. The findings were used to determine whether the monograph could be completed.
Where necessary, this experimental verification would include tests such as the microbial challenge test as described in European Pharmacopoeia (Ph. Eur.) general chapter 5.1.3.
How was it done?
Experts from the PaedF WP support the need for practical verification and perform the experimental verification if needed. The EDQM supported this work by sourcing active substances and consumables and by organising analytical testing for techniques not available to the experts.
What has been achieved?
This approach enabled the enhancement of a furosemide oral formulation. The composition of this formulation as described in the source material did not meet the Ph. Eur. requirements for antimicrobial preservation, so it was changed to include a higher concentration of the preservative and comply with the Ph. Eur. requirements.
What next?
The PaedF WP will continue to expand PaedForm by elaborating new monographs covering unmet therapeutic needs. Users are invited to contribute to this process by commenting on texts published in the PaedForm Pharmeuropa public consultation platform.
Design, build and implementation of electronic prescribing and medicines administration in neonatal units across four UK hospital trusts
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Holly Jones, Nicola Vosser
Why was it done?
Neonatal units were out of scope during the initial EPMA go-lives due to the complexities in prescribing and the specialist resource required for implementation. This project therefore brought neonatal units in line with all other areas, transitioning from paper drug charts to EPMA. In addition, it supported an ICS wide goal to align practice between trusts, standardising prescribing and facilitating effective use of digital systems in healthcare.
What was done?
A neonatal formulary was developed on an existing Electronic Prescribing and Medicines Administration (EPMA) system shared by four hospital trusts that make up a regional Integrated Care System (ICS). This involved interdisciplinary collaboration and shared decision making to align practice and prescribing guidelines. Complex protocols included continuous variable rate drug infusions, intravenous fluids and parenteral nutrition.
How was it done?
Key guidelines were shared with a collaborative approach to identify and harmonise differences in local practice, including syringe volumes and dose calculation ‘factors’. The EPMA team (comprising specialist pharmacists and medicines management technicians) completed a thorough gap analysis of the existing adult and paediatric drug catalogue and managed all new build work for neonates. Clinical decision making and validation were multidisciplinary tasks with input from specialist clinicians, pharmacists and nurses. Training, go-live planning and implementation were led by the EPMA team.
What has been achieved?
A bespoke neonatal medication build has been successfully implemented, supporting safe and efficient prescribing in neonates across the ICS. The development provides the ability to prescribe medications and document administration clearly and safely, including adjustment of infusion rates. Clinical pharmacists have full visibility of this information and are able to accurately complete pharmacy reviews, interventions and verification. In addition, alignment of practice and standardisation of care has been reached across the ICS, with benefits to both staff and patients.
What next?
The neonatal build is updated and optimised based on feedback from users to maintain the usability and safety of the system. Development of electronic fluid balance charts for neonates, including drug infusion volumes, is also in progress. Details of the neonatal project are being shared with other UK hospital sites using the same EPMA system.