Author(s)

Esperanza Nieto Mártil
Alicia Abril Cabero
José Antonio Hernández Ramos
Isabel García López
Belén Riva de la Hoz
Esther Algarra Sánchez
Luis Fernández Romero
Marta Echávarri de Miguel
Beatriz Leal Pino
Alejandra Merino Pardo
Maite Pozas del Río

Why was it done?

Paediatric PN requires highly precise and methodical preparation due to its narrow safety margins. For this population very small volumes are handled, thus small deviations in added volumes might have a substantial impact, including clinically significant consequences.
Although gravimetric and volumetric control has shown to provide a rapid and cost-saving tool to detect discrepancies, there are no specific publications evaluating its optimality in the context of paediatric PN. Therefore, its assessment in a paediatric setting is essential to ensure the quality of the compounding process.

What was done?

To analyze the results of gravimetric and volumetric control applied to parenteral nutrition (PN) preparations compounded by the Pharmacy Department in a Paediatric Hospital over a two-month period.

How was it done?

A prospective interventional study was conducted including all PN preparations compounded between June and July 2025 in a tertiary paediatric hospital. In order to perform gravimetric control, actual weight of each PN and deviation from theoretical weight were measured. For volumetric control, prescribed volumes of each component were compared with the actual volumes added by compounders to verify concordance between both records. Additionally, the following variables were collected for every preparation: responsible compounder and the need for re-compounding. Erroneous preparations were defined as exceeding an acceptance limit of ±5% for gravimetric control or proven discrepancies for volumetric control.

What has been achieved?

A total of 135 PN preparations were compounded during the study period. Six preparations (4.44%) produced by three different compounders were classified as erroneous. Of these, five (3.70%) were associated to gravimetric control and one (0.74%) to volumetric control. All the preparations failing gravimetric control were re-compounded and their deviation range was 5.32% to 18.2%, with a median of 6.95%. The remaining erroneous preparation was found to lack 10 mL of a 10% amino acid solution, re-compounding was not required since it was considered clinically irrelevant though.

What next?

The incorporation of gravimetric and volumetric control into routine practice would gather strength as an essential safety measure in the preparation of pediatric PN due to its feasibility and utility, specially for gravimetry. Future lines of research should focus on continuous monitoring of outcomes, including comparisons with other hospitals.

Author(s)

K. Lefèvre (1), Vincent Dubée (2,4), Vincent Lebreton (1,3)
(1) Angers University hospital center, Pharmacy Department, Angers, France
(2) Angers University hospital center, Infectious diseases Department, Angers, France
(3) MINT Inserm 1066, CNRS 6021, University of Angers, France
(4) INCIT-Atomyca, UMR 1302/ERL 6001, University of Angers, France

Why was it done?

Amoxicillin (AMX) is a widely used antibiotic, particularly for severe infections requiring high-dose intravenous administration. The two commonly used solvent are 0.9% NaCl (NaCl) and Ringer’s lactate (RL). NaCl may have been associated with cases of crystalluria following hyperchloremic acidosis, leading to impaired renal function. So RL may be considered as a promising alternative, although stability data are lacking.

What was done?

This study aimed to evaluate and compare the stability of AMX in both solvents at different concentrations for 12h at room temperature.

How was it done?

To evaluate AMX stability, injectable AMX was reconstituted according to the product’s specification and diluted in RL or NaCl. Four concentration levels were prepared (10, 12, 15, 20 mg/mL), stored in a climate-controlled chamber (25±2°C; 65± 5%RH) and analysed at various time intervals (0, 3, 6, 9, 12 hours). The study was conducted with a stability indicating method using reverse-phase high-performance liquid chromatography coupled with diode array UV (250 nm) and mass spectrometry detection. The method validation followed ICH guidelines (Q2R2, Q6A, Q3B). Organoleptic characteristics and pH were also monitored.

What has been achieved?

AMX concentrations remained above 90% of the initial value throughout the 12-hours period, regardless of solvent or concentration. However, the chromatograms reveal additional peaks suggesting the formation of degradation products in both NaCl and RL. These degradation products were quantified (maximum% of main peak surface area) and identified [letter corresponding to European Pharmacopeia identification] as penicilloic acid (4.5) [D], phenylpyrazine (1.3) [F], diketopiperazine (1.8) [C], amoxicillin dimers (6.5) [J] and and adduct species of them (Na+ and K+) (0.5). Despite these findings, there were no notable changes in the appearance or color of the solutions, and pH remained relatively stable, decreasing slightly from 8.8 to 8.6.

What next?

The study concluded that while AMX concentrations stayed relatively stable, some of the identified degradation products exceed limits set by ICH Q3B guidelines and European Pharmacopeia for degradations products in both solvents. Therefore, the results should be interpreted cautiously, pending further toxicological and regulatory assessments. If the degradations products are deemed acceptable, Ringer’s lactate could be a clinically viable alternative to NaCl, especially for high-dose AMX infusions, due to its lower sodium content and buffering effect, which helps reduce the risk of metabolic acidosis.

Author(s)

K. Lefèvre (1), M. Ramond (1), A. Bourges (1), E. Gueret (1), S. Vrignaud (1), V. Lebreton (1,2)
(1) Angers University hospital center, Pharmacy Department, Angers, France
(2) MINT Inserm 1066, CNRS 6021, University of Angers, France

Why was it done?

Lugol’s solution 5% (iodine/iodide) is used to saturate the thyroid before MIBG scintigraphy. Due to iodine’s high volatility, the stability of the solution depends heavily on its packaging. Random shelf life quality controls revealed out-of-specification iodine levels, raising concerns about iodine loss linked to poor packaging.

What was done?

This study aimed to evaluate iodine loss over time from 5% Lugol’s solution depending on the type of packaging, before opening, in order to propose improvements ensuring better stability.

How was it done?

Three packaging types were tested: Type I amber glass bottle with dropper and no secondary packaging, the same bottle with a cardboard secondary packaging and the same glass bottle with a white Bakelite screw cap and secondary cardboard packaging.
Iodine content was measured weekly in triplicate for at least three months using an automatic titrator (Mettler Toledo T5) with a redox electrode and 0.1M sodium thiosulfate titrant. Previously method was validated according ICH guidelines (ICH Q2A). Parameters such as accuracy, precision, linearity and LOQ were evaluated. Iodine loss was calculated and modeled over time (mean ± 95% confidence interval) with following equation A=Aoe-kt (k and t expressed in Day (D).

What has been achieved?

After 9 weeks, iodine losses reached 28.5 ± 0.8% (with secondary packaging) and 58.9 ± 0.3% (without), even before opening, for the dropper bottles. The iodine concentration followed a first-order kinetic degradation for all packaging, k = -0.01D-1 for both with dropper and k=0.004 D-1 with bakelite cap. The Lugol’s solution no longer met specifications after just 1 month. In contrast, bottles with Bakelite caps remained stable for up to 6 months, with less than 2% iodine loss.

What next?

Packaging has a critical impact on the stability of 5% Lugol’s solution. To improve preservation, several changes were implemented: bottles are now closed wtih Bakelite caps, and droppers are supplied separately in cardboard secondary packaging. The shelf-life before opening was reduced from 1 year to 6 months and limited to 1 week after opening.

Author(s)

S. EL DEEB, I. BENNANI, A. CHERIF CHEFCHAOUNI, S. ALAOUI, S. HAJJAJ, S. BOUFARESS, S. EL MARRAKCHI, B. MOUKAFIH, F.Z. BANDADI, Y. HAFIDI, A. EL KARTOUTI.

Why was it done?

In the oncology pharmacy, isolators are vital for aseptic compounding and operator protection. However, daily handling steps can still introduce contamination risks and affect patient safety. We recognized the need to systematically analyse and minimize these risks, especially in a resource-constrained setting, to ensure safer and more standardized chemotherapy preparation practices.

What was done?

We applied Failure Mode and Effects Analysis (FMEA) to identify and reduce risks in isolator handling during chemotherapy preparation. The objective was to evaluate each step of the process, implement corrective measures to lower risk priority numbers (RPNs), and develop a practical model that could be shared with other hospital pharmacies.

How was it done?

An observational checklist was used to evaluate six key isolator handling steps: glove installation, surface cleaning, material transfer, logbook entry, waste removal, and glove removal. During 100 routine preparations, failures were recorded to calculate occurrence scores. Severity and detection were assessed by an interdisciplinary team, and risk priority numbers (RPNs) were obtained by multiplying severity, occurrence, and detection scores.

What has been achieved?

The analysis identified surface cleaning, material transfer, and glove installation as the most critical steps, with RPNs of 240, 210, and 144 respectively. These represented the main contamination and safety risks. After implementing targeted corrective actions, including improved procedures and staff awareness, we projected significant reductions in RPNs to below 80, confirming the effectiveness of the intervention.

What next?

We will continue to apply and monitor the corrective measures through updated SOPs, dedicated monitoring tools, and continuous staff training to ensure sustained improvement. This initiative offers a transferable model that other oncology pharmacies can adopt to harmonize practices and strengthen patient and operator safety in chemotherapy preparation.

Author(s)

Arce Sánchez, M; Álvaro Alonso, EA; Barrueco Fernández, N; Prieto Román, S; López Guerra, L; Sánchez Lorenzo, M; Flox Benítez, MP; Escobar Rodríguez, I.

Why was it done?

Accurate weighing of raw materials(RM) is a fundamental step in ensuring the quality and safety of compounding in a pharmaceutical laboratory(PL).

What was done?

Implement the use of standard masses(SM) to ensure that RM weighings performed in the PL analytical balance are as accurate as possible.

How was it done?

1.Balance employed is class I, with special accuracy, precision 1mg, and weighing range 10mg-220g. For this reason, E2 SM were purchased in accordance with the classification of the International-Organisation-Legal-Metrology(OIML). SM were calibrated by a laboratory accredited by the National-Accreditation-Entity(ENAC), stored under the same conditions as the balance, and handled according to manufacturer’s instructions.
2.A sensitivity test was performed to measure accuracy. The USP and chapter of the European-Pharmacopoeia, establish that the SM must be between 5% and 100% of the maximum weighing capacity of the balance. The test is satisfactory when the result obtained is within 0.1% of the nominal value(control-limit). An alert-limit was also establish(calculated as half control-limit).
3.A record form, standard-operating-procedure(SOP) and working circuit were designed. Before weighing RM, the pharmacy technician(PT) must verify leveling and internal calibration; weigh the selected SM, and record the result.
4.If weight is outside any limits, repeat internal calibration and weigh again. If it remains outside the alert-limit, the balance can be used, but the pharmacist must be notified to request external calibration. If it exceeds the control-limit, the balance cannot be used, and external calibration must be requested while another balance is employed.

What has been achieved?

SM acquired were: 10mg,20mg,20g,50g, and 100g. Those chosen to perform the sensitivity test were 20g and 100g(9.09% and 45.45% of maximum weighing balance capacity).
The range defined for 20g SM was 20g±20mg. Control-limit was 20g±10mg(19.990g-20.010g) and alert-limit was 20g±5mg(19.995g-20.005g).
The range defined for 100g SM was 100g±100mg. Control-limit was 100g±50mg(99.950g-100.050g) and alert-limit was 100g±25mg(99.975g-100.025g).
Since it was implemented in January-2025, all weighings have remained within the range.

What next?

The use of SM has shown to be a satisfactory circuit in ensuring the accuracy of the weighing of RM, used in the preparation of pharmaceutical compounding, thereby guaranteeing their safety and quality. This circuit could be established in other pharmacy departments.

Author(s)

Feriel El Kara1, Tarek Kamergi2, Raoua Souabni1, Sonia Sebai1, Kaouther Zribi3
1 : National Agency for Medicines and Health Products Tunis
2 : Bone Marrow Transplant Center Tunis
3 : Hygiene Laboratory Sfax

Why was it done?

Ensuring personnel competence is essential for the reliability of analytical results and for maintaining regulatory compliance in pharmaceutical control laboratories. In preparation for ISO/IEC 17025:2017 accreditation, the physico-chemical laboratory of the National Agency for Medicines and Health Products (ANMPS) needed to strengthen and formalize its training and qualification system to guarantee analytical quality and ensure the long-term sustainability of its management system.

What was done?

A comprehensive evaluation of the existing training and qualification practices was conducted, leading to the development of a structured and standardized framework covering training planning, competency assessment, and staff qualification. Improvement actions were proposed based on a diagnostic of current gaps.

How was it done?

The study took place from July to December 2024 and relied on three complementary approaches:
• Documentary analysis of procedures, training plans, and competency matrices;
• Semi-structured interviews with technical and supervisory staff;
• Direct observation of work practices in the laboratory.
A SWOT analysis was performed to identify strengths, weaknesses, opportunities, and threats, and to prioritize improvement measures. Targeted training programs were developed on critical analytical techniques (HPLC, spectrophotometry, dissolution testing), safety, and document management. A standardized qualification process integrating theoretical and practical assessments was also implemented.

What has been achieved?

The new system resulted in the deployment of all planned training and qualification activities, reaching a 100% implementation rate. The laboratory’s overall compliance rate increased from 39% to 68% after the adoption of the structured framework. The formalization of the process led to better harmonization of practices, improved technical proficiency, enhanced traceability of competencies, and reinforced team engagement through a participatory approach, contributing to a strengthened quality culture.

What next?

Future work will focus on sustaining this dynamic by integrating continuous competency monitoring, reinforcing advanced training on emerging analytical techniques, and developing digital tools for real-time tracking of qualifications. These actions aim to ensure sustained compliance with ISO/IEC 17025:2017 and to support continuous improvement of analytical performance within the laboratory.

Author(s)

B.Ben Houria, F.ElKara , M.Ben Messaoud, M.Bizid, A.Tabbabi, S.Gmati

Why was it done?

Improving the performance of quality control laboratories is crucial to ensure the quality, safety and regulatory compliance of medicines. Ongoing challenges, including fragmented workflows and limited traceability, highlighted the need for a structured and harmonized operational model. To address this, a technical platform was established within the physicochemical control laboratory of a National Agency for Medicines and Health Products to consolidate resources, streamline work organization and align analytical activities with international standards and best practices.

What was done?

A technical platform was implemented to reorganize analytical activities, restructure laboratory areas by function and strengthen quality assurance practices. The initiative included assessing the existing system, defining functional analytical zones (e.g. spectroscopy, High Performance Liquid Chromatography (HPLC)…), optimizing equipment allocation and appointing an equipment manager to coordinate scheduling, oversee maintenance and ensure operational traceability. Then, a performance evaluation matrix was developed and applied to objectively assess the effectiveness of the newly implemented technical platform and identify areas requiring further improvement.

How was it done?

This descriptive and comparative study combined documentary analysis, on-site observation and review of international guidelines. The methodological approach comprised three steps:
1-Assessment of the existing system : Review of the laboratory’s organization, equipment, analytical processes and human resources to identify factors influencing overall performance.
2-Structuring of the technical platform and performance evaluation: Organization by instrument specialization and the use of structured matrix.
3-Comparison with international standards : Scientific literature and reports from European reference laboratories were reviewed to benchmark the implemented technical platform against international standards.

What has been achieved?

The platform was implemented in July 2025 through a spatial and functional reorganization that improved methodological coherence, reduced unnecessary sample manipulation and increased equipment utilization. The designation of an equipment manager contributed to better planning, coordinated instrument scheduling and enhanced workflow oversight, thereby reinforcing operational continuity. Performance matrix results indicated satisfactory compliance across key domains: infrastructure (100%), human resources (50%), equipment (75%) and quality assurance (50%). These outcomes confirm the solid implementation of the technical platform while highlighting the need to strengthen documentation, staff training and performance monitoring.

What next?

Future developments will focus on digital integration through paperless analytical workflows, automated test scheduling and real-time electronic traceability to enhance data integrity and predictive performance analysis. Gradual introduction of artificial intelligence, while respecting regulatory data confidentiality, offers promising opportunities to predict analytical deviations, optimize equipment use and improve resource management. Ongoing monitoring of Key Performance Indicators (KPIs) and continuous staff development will be essential to maintain and sustain long-term performance improvements.

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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.

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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.

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Author(s)

Diana Monteiro
Luísa Álvares
Sara Brandão Madureira
Patrocínia Rocha

Why was it done?

The confirmation of a clinical diagnosis of brain death requires the demonstration of the cessation of brainstem functions and their irreversibility. Therefore, when this evaluation is incomplete or unreliable, it is necessary to support this diagnosis using diagnostic tests such as brain perfusion SPECT. This is performed after the injection of the radiopharmaceutical technetium-99m hexamethylpropyleneamine oxime (99mTc-HMPAO) and by assessing the obtained images for the lack of cerebral perfusion to confirm the diagnosis.
Given the importance of reliable results, a high radiochemical purity of 99mTc-HMPAO is imperative in quality control to prevent false positives.

What was done?

Selection of a method to evaluate the radiochemical purity of 99mTc-HMPAO.

How was it done?

A literature review was conducted to select the most suitable method for the conditions existing in the institution. The research focused on the Summary of Product Characteristics (SmPC), the European Pharmacopoeia (Ph. Eur. 11.0), the United States Pharmacopeia (USP 42) and several published articles.
After selecting the method, three assays were performed to validate it.

What has been achieved?

For evaluating the radiochemical purity of 99mTc-HMPAO, both the SmPC and Ph.Eur. 11.0 recommend a combination of two thin-layer chromatography (TLC) methods with a high-dimension stationary phase, for which the institution does not have a chromatographic tank.
The USP 42 describes a combination of three TLC methods, using acetonitrile as the mobile phase, which is also unavailable at the institution.
In contrast, the miniaturized method by Fuente et al. uses two TLC methods, with a silica gel stationary phase and sodium chloride (0.9%) and methyl ethyl ketone as mobile phases. This method was selected given that the institution has the required phases, the stationary phase dimensions are suitable for the available chromatography tanks and the execution time for the assay is feasible.
For method validation, three assays were conducted, yielding values exceeding 80% (the reference value).
The selected method represents a rapid, reproducible and reliable alternative for evaluating the radiochemical purity of 99mTc-HMPAO. It was implemented in the institution in October 2022.

What next?

In the future, we aim to develop quality control methods for all radiopharmaceuticals in use at the institution, in order to guaranty the quality of all the exams performed.