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EVALUATION AND DECISION-MAKING RELATED TO QUALITY AND WORKLOAD ASSESSMENT OF PARENTERAL NUTRITION COMPOUNDING

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European Statement

Patient Safety and Quality Assurance

Author(s)

Jorge Esquivel Negrín, Amara Magdalena Pérez, Josephine Peña Hernández, Jenifer González Chávez, Carmen Lidia Díaz Díaz, Silvia González Suárez, Alba Domínguez Hernández, Jaime Muñoz Manrique, Esther González Carrillo, Pilar Díaz Ruiz

Why was it done?

PN is a high-risk preparation that carries a significant risk of iatrogenesis, making it essential for staff responsible for its prescription, validation, and preparation to be well-trained, and for a reliable quality assurance plan to be in place. Monthly quality indicators include errors by pharmacists during transcription to nutrition software, errors by technicians in tray preparation, and nursing errors during PN preparation. Acceptable monthly error thresholds were set at 2 for transcription, 25 for tray preparation, and 6 for sterile PN preparation. Additional activity indicators, such as the number of PN preparations per month, episode duration, and reasons for suspension, were also analyzed.

What was done?

A training program centered on audiovisual resources related to parenteral nutrition (PN) procedures was implemented in a tertiary hospital after a quality assessment within the PN department revealed a decline in certain indicators between 2020 and 2022. A shared folder with video tutorials covering various processes was made available to pharmacy staff, mainly intended for nursing staff and pharmacy technicians, who typically have high turnover rates between departments.

How was it done?

The indicators showed a steady increase in PN preparations, rising from 411±74 per month in 2020 to 475±51 in 2023, with a record of 634 preparations in March 2024. Notably, 18.1% of episodes in 2023 lasted over two weeks, partly due to the underutilization of home PN and a lack of hospital beds despite increased outpatient activity. Errors in tray preparation increased from 2020 to 2022, peaking in 2021. This coincided with high staff turnover and an increased workload. In response, the implementation of video tutorial training for rotating staff was introduced in 2022.

What has been achieved?

This initiative reduced tray preparation errors, which decreased to an average of 12±4.9 between January 2023 and March 2024.

What next?

These measures could be adapted and implemented in other departments within the pharmacy service. Regarding PN, we are now aiming to optimize the workload by promoting home PN, and implementing semi-automated systems such as barcodes and gravimetric control, which are also recommended to improve safety and traceability.

CIRCUIT FOR THE PREPARATION, CONTROL, AND DISPENSATION OF AUTOLOGOUS SERUM EYE DROPS IN A PHARMACY SERVICE

European Statement

Production and Compounding

Author(s)

Eva Gómez-Costa; María Begoña Feal-Cortizas; María Mateos-Salvador; Sandra Rotea-Salvo; Andrea Luaces-Rodríguez; Laura Caeiro-Martínez; Clara Fernández-Diz; Andrés Torres-Pérez; Luis Margusino-Framiñán; María Isabel Martín-Herranz

Why was it done?

Implement a circuit for the preparation, microbiological control, analytical control of patients, and dispensation of autologous serum eye drops in the Pharmacy Service (PS) of a tertiary-level hospital.

What was done?

Autologous serum eye drops are classified as a special medication that must be prepared in authorized centers with an up-to-date patient registry. This initiative aims to ensure the safe use of autologous serum eye drops, guaranteeing quality and safety in their preparation and administration.

How was it done?

The circuit was established in the PS in 2015. After prescription by the Ophthalmology Service, pharmaceutical validation confirms that the treatment is optimal and complies with regulatory requirements. Blood samples are collected from patients under controlled conditions, and the serum is prepared in a vertical laminar flow hood. Once prepared, the eye drops are stored frozen in the PS until dispensation to the patient. The pharmacist reviews the microbiological control of each batch and the patient’s serological results. When collecting the eye drops, the pharmacist records batch traceability and provides the patient with necessary information on storage and administration.

What has been achieved?

Between January and August 2024, 294 patients were treated, with 477 blood extractions performed and a 11,925 eye drops prepared. Autologous serum concentration: 20%(76.9%), 30%(11.5%), 50%(11.2%), and 100%(0.4%). Microbiological control of the eye drops: 98.1% negative and 1.9% false positives, confirmed by a second negative control. Infectious diseases were detected in the serology of 3 patients: hepatitis C(1), hepatitis B(1) and syphilis(1). These data reflect a high success rate in the preparation and quality control, as well as the effectiveness of the implemented circuit. Additionally, the system has allowed for the early detection of viral infections, reinforcing treatment safety.

What next?

The implementation of this circuit has proven effective in ensuring the safety and efficacy of autologous serum eye drops, providing rigorous control over treatments and the quality of dispensed products. Future steps will involve pharmacists requesting serological tests and developing protocols for managing patients with identified infections. Furthermore, patient surveys will evaluate treatment effectiveness and overall patient experience.

ANALYTICAL CONTROL OF INJECTABLE PREPARATIONS: TAKE THE TIME TO ANALYZE YOUR ACTIVITY

European Statement

Production and Compounding

Author(s)

Guillaume BOUGUEON1,2 ; Mélissa WANG1 ; Jean-Marc Bernadou1, Maîté Sangnier 1, Aude BERRONEAU1
1 Pharmaceutical Technology Department, Bordeaux University Hospital, Avenue de Magellan, 33604 Pessac, France
2 ARNA Laboratoire ChemBioPharm U1212 INSERM – UMR 5320 CNRS, Université de Bordeaux, France

Why was it done?

We work within a university hospital, in an injectable drug production unit. We produce around 55,000 preparations a year, and ten years ago decided to implement analytical control (identification and dosing) (i.e. HPLC then followed by UV-Raman spectrophotometry (QCRX®)) as a post-process control method. To date, around one hundred assays are carried out daily (representing 50% of preparations produced), and some thirty different active substances are analyzed.
For the past 4 years, a monthly meeting has been devoted to monitoring the compliance of analytical assays for our preparations.

What was done?

We felt it was essential to take a step back from our control activity, to enable us to monitor and analyze assay compliance in detail, to distinguish between preparation errors and errors linked to control equipment, and to detect upstream any deviations in assay methods or material damage.

How was it done?

Monthly one-hour meetings have been set up. These multidisciplinary meetings are attended by 6 people, including senior and student pharmacists, pharmacy technician and a laboratory technician.
During these meetings, the following are presented: the number of assays and their nature (1st assay or 2nd assay following a 2nd sample); the number of non-compliant assays (outside the limit of +/- 15% of the target concentration), the overall compliance rate; an analysis of rejected and destroyed preparations, with an investigation into the causes of non-compliance.
Corrective action may then be taken: early maintenance of equipment, quarantine of analytical methods and research into the causes of drift, implementation of new dosing methods. Feedback is then given to the whole team.

What has been achieved?

These monthly meetings have enabled us to anticipate analytical drifts and reinforce our team’s compliance to this type of control. They also enable us to limit the downtime of dosing methods and the need for double visual checks, a potential source of errors.

What next?

The aim is to eventually increase the proportion of analytical control to over 50% of preparations produced. This will involve the introduction of new dosing methods for preparations usually controlled by double visual inspection, and the acquisition of additional equipment

RELOCATING A UNIVERSITY HOSPITAL’S INJECTABLE CHEMOTHERAPY PREPARATION PROCESS TO A MOBILE UNIT: A CHALLENGE MET!

European Statement

Production and Compounding

Author(s)

K.LEROUET; M. DELAMOTTE; F.VITET. S.CRAUSTE-MANCIET; A.LEBRETON; F.LAGARCE

Why was it done?

Our Chemotherapy Reconstitution Unit (CRU) needed to replace its two double workstation isolators and high efficiency particulate air filters, taking the unit out of service for six weeks. With 40,000 injectable chemotherapy treatments performed each year, outsourcing was not an option. We had to find a solution to temporarily relocate the activity to a new area within our facility.

What was done?

Our aim was to ensure continuity of the manufacturing process for injectable anticancer drugs in accordance with Good Preparation Practices in a temporary CRU.

How was it done?

Eighteen months ahead of schedule, we set up multidisciplinary working groups consisting of pharmacists, pharmacy technicians, biomedical and technical service staff and health care managers.
Inspired by the few french hospitals that had already carried out this project, we studied the process and the choice of space and equipment required. We also drew up procedures and a backlog schedule.

What has been achieved?

Twenty-three work sessions of 1 hour were organised. We chose a chemo-truck (ModuGuard®), with three workstations inside two positive pressure isolators. We acquired new equipment to adapt to the spaces created specifically for this project (transport crates, walky-talkies, operating room gowns). We planned the qualification of the mobile grade D controlled area and isolators. The production flow was rethought, with extended production hours and more human resources. Our production was divided into 4 zones with different tasks: tray preparation and pharmaceutical validation, chemotherapy preparation, pharmaceutical release and preparation dispatch. Good communication between the different areas was essential to the success of our project. In comparison to the reference process, no additional non-conformity where noticed. We communicated with the care units many months ahead to anticipate logistic issues.

What next?

The overall feedback from the teams was good, thanks to the cohesiveness that was created, although staff were tired. No adverse events were reported, although occasional delays in preparation were noted. Anticipation of needs and day-to-day adaptability were essential to the success of this project. A budget of €80,000 was required to complete our project. This organisation allowed us to maintain a level of production equivalent to our CRU. This publication is intended to help inform healthcare organisations undertaking similar projects.

Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection

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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.

Electronic prescription protocols for personalised sterile preparations for the paediatric surgery department

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European Statement

Production and Compounding

Author(s)

Isabel María Carrión Madroñal, Concepción Álvarez del Vayo Benito , Begoña Balboa Huguet , Santiago Lora Escobar , Paloma Barriga Rodríguez

Why was it done?

-Improve security, planning, and access to information for correct prescription, administration, and management.
-Guarantee the traceability of all processes.
-Improve the satisfaction of the services involved, preventing forgetfulness and therefore management of emergency calls, unjustified need for the prescribed preparations, and incorrect packaging.
-Improve communication and the work circuit from PD.

What was done?

To prepare a protocol with the processes of prescription, validation, preparation and dispensing of personalised sterile formulations in the Paediatric Surgery Department (PSD: Otorhinolaryngology, Ophthalmology and Neurosurgery) from the Pharmacy Department (PD).

How was it done?

1. Creation of a multidisciplinary team in which a circuit for the prescription, validation, preparation and dispensing of sterile preparations was agreed.
2. Analysis with the departments involved of the personalised sterile-medications prepared by PD for use in paediatric-surgical-rooms, and the most frequent doses used.
3. Bibliographic review: PubMed®, Cochrane®, Uptodate®, Stabilis® and other sources such as the Good Clinical Practices (GCP) and the book ‘Preparation of Drugs and Magistral Formulation for Ophthalmology (JM Alonso).
4. Creation of electronic prescription protocols in ATHOS-Prisma®, containing:
• help notes and preconditions for the prescription.
• information for the administration and management of waste.
• detailed brew sheet and custom label for the PD.
5. Review of the protocols created and the circuit proposed for the prescription, preparation and dispensing.
6. Start-up of the circuit: review and validation of prescriptions, preparation of sterile formulations centralised in PD through laminar flow hoods and dispensing directly to the surgical-room on the scheduled date.

What has been achieved?

Piloting began with sterile otorhinology formulations in 2021, expanding to ophthalmology and neurosurgery in 2022-2023.
– Creation of three groups of protocols that will contain those related to each specialty to facilitate location and prescription by surgeons:
*Paediatric ophthalmology:
• Mitomycin 0.2mg/ml intraoperative-solution-trabeculectomy
• Fluorouracil 5mg/0.1ml intraoperative-solution-trabeculectomy
• Intracameral-cefuroxime 2mg/0.2ml (antibiotic-prophylaxis)
*Paediatric otorhinology:
• Cidofovir 5mg/ml intralesional (laryngeal-papillomatosis)
• Bevacizumab 2.5mg/ml intralesional (laryngeal-papillomatosis)
• Mitomycin 0.5mg/ml (choanal-atresia)
*Paediatric neurosurgery:
• Interferon-alpha 3MIU/0.6ml intralesional (craniopharyngioma)
– Sixty-two preparations have been prepared and dispensed for a total of 30 children; average age of 4 years (1-10). No adverse events were reported in any patient after the administration of these sterile preparations.
– A study limitation was sample size. Circuit under development.

What next?

The protocol is applicable to any hospital with electronic-prescription and surgical-area.

Design and implementation of a course on “Improving the understanding of biosimilar formulation science through Real-World Training”

European Statement

Education and Research

Author(s)

Paola Minghetti, Giuseppe Danilo Norata, Francesca Selmin, Paolo Rocco, Vito Ladisa, Margherita Galassi

Why was it done?

The availability of mAbs to treat different pathologies is steadily growing, causing a steep increase in the level of training needed in different areas of pharmacists’ intervention, including compounding, handling and storage. As this process will be sustained by the increasing availability of biosimilars, pharmacists, the key health professionals responsible for their compounding and handling, will face new challenges.
The aim of this project is to overcome the common problems encountered by hospital pharmacists in obtaining education on biosimilars, included limited financial support, heavy workload or inadequate educational resources.

What was done?

A self-paced educational course has been designed and implemented with the aim of providing a fundamental grounding in the physical chemistry, pharmacology and technology of monoclonal antibodies (mAbs)-based medicines in oncology, both originators and biosimilars and the methodology associated with their compounding and handling.
The primary target audience for this project consists of hospital pharmacists in the EU, though students in the specialization in Hospital Pharmacy and community pharmacists may benefit from the course.

How was it done?

The course has been designed and developed to address, previously assessed, unmet educational needs. The resulting format comprises both theoretical and remote real-world training on the pharmacology, technology and stability of mAbs, the technology and rationale of biosimilars and the regulatory aspects of biotechnological medicinal products.

What has been achieved?

A series of webinars in on demand movie format has been produced. The webinars contain a comprehensive theoretical section – covering biosimilar mAbs pharmacology and formulative and regulatory aspects – and a practice section in which the preparation steps of oncology mAbs are filmed and discussed in a hospital setting. All training activities have been recorded in remote both in Italian and in English. Every module is designed to be used as a single unit and has a duration of approximately 30 minutes. The total duration of the course is 8 hours.

What next?

The course will be CME accredited in Italy through Fondazione Francesco Cannavò, nonprofit CME provider of the Federation of Italian Pharmacists Associations. It will be made available to pharmacists through national and international CME platforms, providing fundamental grounding in the methodology associated with oncology monoclonal antibody biosimilar formulation.

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