IMPLEMENTATION OF A PHARMACOKINETIC MONITORING UNIT FOR PSYCHIATRIC MEDICATIONS IN A SPECIALIZED MENTAL HEALTH HOSPITAL
European Statement
Clinical Pharmacy Services
Author(s)
Ana Puebla Villaescusa, Elena Rodríguez del Río, Elena López Lunar, Sonia Fraile Gil, Eduardo Tejedor Tejada, José Diéguez Gómez, José Manuel Carrascosa Bernáldez
Why was it done?
Due to the high interindividual variability in response to psychiatric treatments (age, weight, comorbidities, polypharmacy, diet, addictions, genetic polymorphism), pharmacokinetic monitoring is essential to individualize and optimize drug dosages, improve clinical efficacy, and reduce adverse effects.
What was done?
A pharmacokinetic monitoring unit for psychiatric medications was established in a specialized mental health hospital.
How was it done?
• Design: Prospective study of plasma psychiatric drug levels in patients from a specialized mental health hospital between June and September 2025.
• Drugs monitored: valproic acid, lithium, clozapine, carbamazepine, risperidone+9-hydroxy-risperidone, olanzapine.
• Data collection: anthropometric and laboratory data, comorbidities, plasma levels, dosing history, drug interactions, addictions, dosage adjustment recommendations.
• Pharmacokinetic software: Bayesian and population pharmacokinetic models.
What has been achieved?
n= 129 patients (and 284 level measurements): 12 patients (9.3%) had levels above the established therapeutic ranges, and 35 (27.1%) had levels below range in at least one measurement.
• Valproic acid (n = 49): 5 (10.2%) above range (4 due to hypoalbuminemia); 14 (28.6%) below range. Among those, 5 using it as a mood stabilizer remained clinically stable without dose increase; 2 reduced their doses due to adverse effects while remaining stable. The rest had low levels due to different factors (drug interactions, clinical circumstances, poor adherence).
• Lithium (n = 34): 6 (16.7%) below range, half of them clinically stable; 1 (2.7%) above range due to an interaction with enalapril.
• Clozapine (n = 14): 9 (64,3%) below range due to several factors (poor adherence, adverse reactions that requires lower doses, possible genetic polymorphism). Despite below range, some patients remained clinically stable. The majority of patients were smokers, which significantly increases the drug’s metabolism, complicating dose adjustment without pharmacokinetic monitoring.
• Carbamazepine (n = 2): both within therapeutic range.
• Risperidone + 9-hydroxy-risperidone (n = 19): 2 (10.5%) below range; 7 (36.8%) above range, three of whom required monitoring for renal impairment, and the rest needed dose reductions to avoid supratherapeutic levels.
• Olanzapine (n = 9): 2 (22.2%) below range, one due to suspected non-adherence.
What next?
Ongoing optimization of pharmacokinetic monitoring of psychiatric medications, in which individualized dosage adjustment is required in a high percentage of patients to improve treatment efficacy and reduce adverse reactions in these patients.
IMPLEMENTATION OF A CLINICAL PHARMACY ACTIVITY IN RADIOPHARMACY: A TRIPARTITE CONSULTATION HOSPITAL APPROACH FOR PLUVICTO® RADIOLIGAND THERAPY IN ELDERLY PATIENTS
European Statement
Clinical Pharmacy Services
Author(s)
J. BERGÉ, S. BRILLOUET, C. LAMESA
Why was it done?
Tripartite consultation (TC) activities are well established in oncology for chemotherapy, and are progressively emerging in radiopharmacy, where there is a clear need to support elderly and polymedicated patients receiving RLT. This therapy is costly and complex, with additional radioprotection requirements, making multidisciplinary coordination essential.
What was done?
A new activity of clinical pharmacy in radiopharmacy is developed as TC for Pluvicto® radioligand therapy (RLT) in our comprehensive cancer center.
This activity was set as TC with the nuclear physician, radiopharmacist, and nuclear medicine technologist. The initiative was done on our institutional software, with dedicated templates creation and harmonized tools.
How was it done?
Three main axes guided implementation: (1) integration into institutional software with customized reporting templates; (2) reorganization and structuring of the patient pathway; (3) harmonization of practices and training, with the involvement of pharmacy residents under senior supervision. Moreover, specific supports were developed to structure patient counseling, including interview templates and patient-oriented documents (radioprotection instructions, explanatory treatment diagrams).
What has been achieved?
The initiative enabled the standardization of reporting, the improvement of patient pathway coordination, and the reinforcement of their educational support. The integration of patient counseling tools strengthened patients’ understanding of a complex therapy, sensitization to radioprotection, and adherence to their care, while improving overall coordination. It also made possible the systematic performance of medication reviews, particularly relevant for an elderly and polymedicated patient population. Since its implementation, 40 patients have already been managed within this framework by residents under systematic senior supervision. Finally, the TC allowed the institutional financial valorization of this activity.
What next?
This activity represents an interesting and transposable example of good practice. Its implementation demonstrates that such an TC structure can be extended to other RLT to improve efficiency and harmonization of both professional practices and patient management. In parallel, we are currently driving a French multicenter study (Pharma-RIV) assessing the impact of pharmaceutical consultations in the management of patients receiving RLT. A broader preliminary effort is in progress to structure the RLT care pathway at the national level, in collaboration with the French Society of Nuclear Medicine.
THE CRUSHING FACTORY SAFE PHARMACOTHERAPY THROUGH ENTERAL FEEDING ACCESS – EXPERIENCES AND GOOD PRACTICES FROM THE UNIVERSITY CLINICAL CENTRE IN GDAŃSK
European Statement
Clinical Pharmacy Services
Author(s)
Ewelina Lubieniecka – Archutowska, Bogusława Szmaja, Dorota Świtkowska, Agnieszka Prusko, Magdalena Jaśkowska, Marzena Mielczarek – Kęska, Urszula Dobrzycka – Magulska, Wioletta Kaliszan
Why was it done?
Enteral nutrition therapy plays a crucial role in the management of patients who cannot meet their nutritional needs orally. Besides providing essential nutrients, enteral feeding access often serves as a route for drug administration, which requires specific knowledge about drug compatibility and pharmacotherapy safety among healthcare professionals.
The aim of this project was to improve the safety and effectiveness of pharmacotherapy administered through enteral feeding access at the University Clinical Centre in Gdańsk (UCC).
What was done?
Based on literature review and institutional experience, the main challenges identified were related to the selection of appropriate medicines and pharmaceutical forms, as well as to the preparation and administration techniques used by nursing staff. To address these issues, several measures were implemented within UCC to enhance pharmacotherapy safety in patients with artificial enteral access.
How was it done?
A procedure titled “Principles of Administering Medicinal Products to Patients Receiving Enteral Nutrition via Feeding Tube or Gastrostomy” was developed and implemented. Within the hospital information system (Clininet), a dedicated list of medicines that must not be crushed or administered via enteral routes was introduced and made visible to physicians and nurses to support safe prescribing. Clininet also allows physicians, nurses, and dietitians to request pharmacotherapeutic consultations from hospital pharmacists. Pharmacists analyze and, when necessary, modify patients’ therapy. Medicines suitable for administration through enteral access were added to the hospital formulary, enabling physicians to choose formulations appropriate for crushing or alternative routes of administration. The hospital pharmacy introduced the so-called “Crushing Factory” – a centralized service where pharmacists prepare R.PEG-labeled medicines in safe forms and doses for enteral administration. Each administration is recorded in the patient’s medical documentation.
What has been achieved?
The implemented system led to:
• fewer prescribing and administration errors
• reduced drug loss and preparation mistakes
• fewer interactions and adverse effects
• compliance with accreditation standards for medication safety
• lower treatment costs and fewer pharmacological interventions
• reduced nursing workload and improved efficiency
What next?
Expand staff education on enteral pharmacotherapy, standardize training materials, monitor outcomes, introduce patients pharmaceutical discharge summaries and implement solutions hospital -wide to improve safety and continuity of care.
PHARMACOKINETIC-GUIDED HIGH-DOSE METHOTREXATE PROTOCOL: MULTIDISCIPLINARY COLLABORATION AND OUTCOMES IN REAL-WORLD PRACTICE
European Statement
Clinical Pharmacy Services
Author(s)
Anais Carrillo Burdallo
Cristina Villanueva Bueno
Maria del Pilar Montero Antón
Isabel Regalado-Artamendi
Beatriz Torroba Sanz
Jose Luis Revuelta Herrero
Eva González-Haba Peña
Daniel Gomez Costas
Yeray Rioja Díez
Antonio Prieto Romero
María Martín Bartolomé
Xandra García Gonzalez
Ana Herranz Alonso
Maria Sanjurjo Saez
Why was it done?
High-dose methotrexate (HD-MTX) carries substantial toxicity risk. Safety hinges on timely, appropriately dosed leucovorin rescue plus high-volume hydration and urinary alkalinisation. Pharmacokinetic monitoring with proactive follow-up enables early detection of delayed clearance and better-informed decisions.
What was done?
A protocol for the administration and pharmacokinetic monitoring of HD-MTX was developed and implemented in a tertiary hospital in coordination with the Haematology Department.
How was it done?
Standardised procedures for administration were defined (hydration/alkalinisation strategies; rescue timing/dose; infusion start; sampling schedule). Adults with leukaemia/lymphoma received short (5µmol/L; long: 42h, >1µmol/L).
Pharmacist-led interventions were classified as: enhanced elimination (intravenous fluids/furosemide; bicarbonate/acetazolamide; cholestyramine), rescue optimisation (dose guided by the prediction, readjusted after the measured level, and withheld when appropriate), and monitoring (additional levels and duration).
Continuous accuracy was assessed with the individual percentage error (IPE)=[(predicted−observed)/observed]×100; we report MDIPE (median IPE; accuracy), MAIPE (median absolute IPE; precision), and the proportion within 1.5-fold. Classification against thresholds was summarised with sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
What has been achieved?
In 24 administrations (13 short, 11 long), pharmacist-led interventions were implemented in every cycle: enhanced elimination 88%, rescue optimisation 54%, monitoring 71%.
Continuous accuracy: MDIPE +35% (IQR 9–80), MAIPE 38% (IQR 11–80); 54% within 1.5-fold. Threshold performance (short/long): accuracy 69/91%; sensitivity 100/100%; specificity 67/86%; PPV 20/80%; NPV 100/100%.
Protocolised monitoring improved safety by standardising decisions and reducing errors. The predictive tool achieved 100% sensitivity and NPV, supporting early rule-out of delayed clearance; positive alerts should be interpreted cautiously given moderate overprediction and false positives near thresholds, with confirmation and close follow-up.
What next?
Next steps are full rollout, recalibration and threshold tuning in larger cohorts, and extension to Oncology and Paediatrics, tracking efficiency endpoints (time to <0.05-0.2 µmol/L, length of stay).
DEVELOPMENT OF DEDICATED INFORMATION BROCHURES TO IMPROVE THE MANAGEMENT AND SAFETY OF PAEDIATRIC GALENIC MEDICINAL PREPARATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
S. GAMBA1, M. FRANCHINA1, M. GIACONIA1, C. INTRA1, M. CASTIGNONE1, E. PANETTA1, G. D’ARENA1, C. PERASSO1, P. BARABINO1, G. SPIGA2.
1IRCCS GASLINI, HOSPITAL PHARMACY, GENOVA, ITALY.
2IRCCS GASLINI, CLINICAL GOVERNANCE, GENOVA, ITALY
Why was it done?
Paediatric galenic preparations are essential for neonates, patients with rare diseases, and those requiring highly individualised treatments or unable to swallow solid dosage forms, for whom no commercial alternatives exist. Despite widespread use, there is a significant need for accessible, user-friendly guidance to support correct home administration. Lack of clear instructions increases the risk of dosing errors—particularly during dose conversion or with multi-dose containers—a safety concern highlighted by regulatory bodies such as the Italian Medicines Agency (AIFA). To address this, the initiative aims to improve the safety and effectiveness of home administration through a personalised educational brochure for patients, caregivers, and healthcare professionals.
What was done?
A personalised brochure was created to guide patients and caregivers in the safe home administration of paediatric galenic medicines. It covers therapeutic indications, composition, storage, dosage and conversion, posology, management of missed doses, potential interactions and side effects, and instructions for medicine collection from the hospital pharmacy. A satisfaction questionnaire is distributed at dispensing to gather feedback for iterative improvements.
How was it done?
The brochure was developed collaboratively by pharmacists and prescribing physicians to ensure accuracy and consistency, so that all patients receive standardised information. Written in plain language and supported by icons, it is easy to understand. A QR code linking to a digital version allows continuous access via smartphone. Feedback from the questionnaire informs ongoing refinements.
What has been achieved?
This initiative reflects the evolving role of hospital pharmacies toward a clinical, patient-centred, and collaborative model. The brochure serves as both an informative resource and a practical tool for patient empowerment, improved communication, and enhanced care quality. In paediatrics—where treatments require heightened attention—this tool bridges the information gap, supporting patients and caregivers and increasing medication safety.
What next?
Ongoing feedback will be used to refine the brochure and digital resources. The initiative will expand to additional paediatric units and be adapted for other patient groups requiring complex or individualised therapies. Collaboration between healthcare professionals and families will continue to ensure accuracy, usability, and patient-centred design. Long-term monitoring will assess the impact on medication safety, adherence, and clinical outcomes, with potential wider application across other therapeutic areas and hospital settings.
INTEGRATING CLINICAL PHARMACY INTO DAILY WARD OPERATIONS: A TAILORED APPROACH ACROSS SPECIALTIES
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Adina Elihu, Claudia Wunder
Why was it done?
In Austria, there is growing recognition of the vital role clinical pharmacists play in healthcare teams. However, the current structure of the Austrian healthcare system does not adequately support the establishment of sufficient clinical pharmacist positions. Consequently, it is imperative to strategically integrate the limited available resources into patient-centered medication processes and fully harness their potential to enhance drug therapy safety.
The initial project was conducted in 2018/2019, and the present retrospective study was completed in 2022.
What was done?
This study explores the efficient integration of clinical pharmaceutical services across various medical disciplines, including both surgical and conservative fields. It specifically addresses how the integration of clinical pharmacy in surgical settings differs from that in conservative settings, and what success factors and obstacles need to be considered.
How was it done?
Through a retrospective analysis of outcomes from a comprehensive polypharmacy project, coupled with surveys of participating pharmacists and physicians, we delineate the procedures and methodologies essential for effective implementation.
What has been achieved?
It was demonstrated that a “one size fits all” approach, or a single process for all departments, is not practical. The study highlights specialty-specific considerations, such as the necessity for written communication on surgical wards and the inappropriateness and appropriateness of accompanying ward rounds in some cases.
Groundbreaking considerations for the approach were developed, including preparation, differences in approaches between surgical and conservative specialties, information sharing, communication pathways, necessities in the implementation phase and prerequisites for de-escalation.
The initiative paved the way for the introduction of electronic consultation systems to improve information transfer and documentation.
What next?
By identifying pitfalls and essential success factors, this initiative stands as a model for establishing clinical pharmacy services across various medical specialties, particularly in the context of limited personnel resources. It provides valuable guidance for colleagues involved in establishing these services.
IMPROVING ACCESS TO CARE: PATIENT PROFILES AND SATISFACTION IN HOME MEDICATION DELIVERY SERVICES
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Sánchez Cerviño, AC; Rivera Ruiz, María; Sanabrias Fernández de Sevilla, R; Menchén Viso, B; Folguera Olias, C; López Fernández, A; Pérez García, E; Martín Santamaría, A; Guerrero Feria, I; Sánchez Guerrero, A.
Why was it done?
Informed medication delivery at home, managed by the Hospital Pharmacy Service and facilitated by information technologies, aims to improve access to medication and enhance patients’ quality of life by avoiding unnecessary trips to the hospital. Although it incurs additional costs, it is essential to carefully select and prioritize candidates for this service.
What was done?
1. Analyze the profile of patients requesting medication delivery to establish priority criteria.
2. Evaluate patient satisfaction with this service in a tertiary care hospital.
How was it done?
An observational, retrospective, non-interventional, descriptive study was conducted on patients receiving medication delivery at home for two months upon their request.
Information was collected from electronic medical records and prescription systems, recording gender, age, underlying conditions, prescribed medications, and employment status.
Patient satisfaction with the service was also evaluated, and descriptive statistical analysis was performed.
What has been achieved?
During the study, medication was delivered to 443 patients (55.1% women) with a mean age of 57.3 years. Central nervous system disorders accounted for 16.0% of deliveries, followed by rheumatological diseases (15.1%) and oncohematological patients (9.3%).
Specifically, patients with multiple sclerosis represented the highest demand for this service (12.9%), due to mobility limitations. Additionally, medication was sent to patients with HIV (6.1%), attributable to stigma-related issues.
Analyzing patients’ employment status, 61.2% were pensioners (retired or with permanent disability).
Satisfaction assessment was conducted with 122 patients, who rated the service with an average score of 6.9 out of 10.
What next?
The results indicate that most patients utilizing informed medication delivery at home face difficulties traveling to the hospital. These patients often have disabilities, reduced mobility, or are unable to attend the hospital due to age, work-life balance, or family responsibilities, demonstrating an acceptable level of satisfaction. This patient profile should be prioritized for informed medication delivery services.
IMPLEMENTATION OF AN ATYPICAL MEDICATION ROOM TO OPTIMIZE MEDICATION MANAGEMENT AND REDUCE WASTE AT HERLEV GENTOFTE HOSPITAL, DENMARK
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Henrik Kjer, Christina Laustsen, Rasmus Riis, Caroline Rasmussen, Jeanette Bajrami, Christian Rubek, and Steffen Jørgensen
Why was it done?
An atypical medication room (AMR) was established at Herlev Gentofte Hospital, Denmark to centralize the storage and handling of medications not part of the standard assortment (i.e. atypical medication). The project aimed to improve the efficiency of medication management, reduce medication waste, and streamline workflows associated with the use of atypical medicines. To enhance the accuracy and efficiency of inventory control, the ScanPill technology was developed as a tool for digital tracking and updating of medication stock.
What was done?
Atypical medications are often stored across various departments with low turnover, leading to potential waste and time-consuming retrieval processes. Centralizing these medications in an AMR and using ScanPill aimed to reduce waste due to expiry, improve stock management, and simplify medication retrieval for healthcare professionals.
How was it done?
Atypical medications from multiple departments were collected and stored in the AMR. The ScanPill system was developed to facilitate the scanning of QR codes and barcodes on medication packaging, allowing for precise tracking of stock levels and easy updates to the atypical medication list. Staff were trained to use the AMR and ScanPill to ensure smooth transitions in retrieving, returning, and documenting atypical medicines. Regular inventory checks and updates were conducted to maintain an accurate database of available medications.
What has been achieved?
The AMR, supported by ScanPill, led to improved handling and management of atypical medications. The centralized storage reduced the need for duplicate stock across departments and enabled quicker access to necessary medications, reducing retrieval time and potential waste. The ScanPill technology improved inventory accuracy and streamlined the process of checking medication in and out, ensuring up-to-date records. Staff feedback has been positive, noting enhanced workflow efficiency and reduced medication waste.
What next?
Future steps include evaluating the economic impact of the AMR and its effectiveness in reducing medication waste. Efforts will be made to refine the use of ScanPill, enhance staff training, and explore potential applications of the AMR model across other departments. Continuous monitoring will ensure optimal performance and identify further areas for process improvement.
MANUAL COUNTING IN CONNECTION WITH THE MIXING OF INTRAVENOUS ANTIBIOTICS IS NOW BEING REPLACED BY A SOFTWARE ROBOT
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Michelle Ann Matzen, Linda Jeffery, Mette Juul-Gregersen, Bente Jonassen, Lene Juhl Biltsted
Why was it done?
At the regional hospitals in Horsens and Randers, the pharmacy helps mix selected intravenous (IV) antibiotics for patients admitted to inpatient wards (piperacillin/tazobactam, cefuroxime, and cloxacillin).
The mixing takes place centrally and is then distributed to the relevant wards.
Our electronic prescribing system does not help us to identify which/how many patients require these antibiotics so the number of prescriptions for each ward was manually counted before the mixing process.
To reduce medication waste, the manual counting was done every morning and noon, with an estimated time consumption of about 1 hour per day per location.
The goal was to move away from manual counting and towards an automated solution.
What was done?
The pharmacy assists wards in mixing IV antibiotics. There was a desire to digitize and streamline the workflow through development of a software robot.
How was it done?
The pharmacy assembled a team from two locations and reached out to the region’s robotic process automation (RPA) developers.
The pharmacy set requirements and expectations for the RPA solution with the developers.
Throughout the development, the programming was revised and adjusted several times to obtain the most accurate prescription data.
To verify the robot’s counting, manual counts were conducted multiple times during the process, leading to adjustments in the robot’s programming.
The development of the RPA solution spanned 9 months.
What has been achieved?
The fully developed RPA solution is now used at both locations. A report is emailed twice a day, after which antibiotics are mixed and distributed to the relevant wards.
Benefits:
• Frees up time for other tasks
• Data is more up-to-date regarding changes in patients’ medications
• Medication waste is minimized
What next?
There are plans to create a similar setup for a central mixing unit at Aarhus University Hospital, where the RPA solution can be implemented from the start.
There is potential for the RPA solution to be used at other locations/departments, with different medications. For example, monitoring of inhalation preparations or anticoagulant medications.
IMPLEMENTATION OF A MULTIDISCIPLINARY PHARMACOKINETIC-PHARMACOGENETIC UNIT
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Jose Luis Sánchez Serrano, Ana Valladolid Walsh, Andrea Drodz Vergara, Carolina Andrés Fernández, Laura Navarro Casado
Why was it done?
Due to a reorganization of health professionals in our hospital, we identified an opportunity to include in our clinical services the preparation of pharmacokinetic reports for all drugs for which blood levels were carried out both at the hospital and external laboratories.
What was done?
We have implemented a multidisciplinary pharmacokinetic-pharmacogenetic unit with the Laboratory Department in our hospital. Until the end of 2023 we participated in the preparation of pharmacokinetic reports for a limited number of drugs in inpatients, basically in haematological and critical patientes. After this, we have included this clinical service for all drugs for which levels were carried out at the hospitalization and outpatient level.
How was it done?
The first step was to present a joint project to the hospital management to reorganize this activity and meet with medical departments to identify their needs and areas of improvement.
At the same time we acquired and implemented a specific software to assist us with the elaboration of recommendations.
We included training sessions in pharmacokinetics for pharmacists in the Pharmacy Department´s annual training program, in addition to offering an external course on Pharmacogenetics Course for staff pharmacists.
As to the clinical services offered, the project has gone through two stages:
• First stage (1 month duration): We reviewed all requests for drug levels obtained both from hospital and primary care level.
• Second stage (10 months duration): The pharmacist monitors all drug serum levels of narrow therapeutic margin and monoclonal antibodies both at the hospitalization and outpatient level. We have updated the available catalogue of drug serum concentrations tests in our center including Voriconazole, Linezolid, Ustekinumab, Adalimumab and Infliximab.
What has been achieved?
We have improved the whole process from ordering tests to sample extraction, serum level determination, and making recommendations in both inpatients and outpatients.
An average of about 160 pharmaceutical interventions per month are done with a 95% acceptability.
What next?
Our future objectives include updating the available pharmacogenetic testing in this unit in order to include recommendations based on test results.