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INFLUENCE OF PACKAGING ON STABILITY: EXAMPLE OF 5% LUGOL’S SOLUTION

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European Statement

Production and Compounding

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, 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 to ICH guidelines (ICH Q2A). Parameters such as accuracy, precision, linearity and LOQ were evaluated. Iodine loss was calculated and modelled 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 with 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.

STRUCTURING THE TRAINING AND QUALIFICATION OF TECHNICAL STAFF IN A PHARMACEUTICAL LABORATORY: AN APPROACH ALIGNED WITH ISO/IEC 17025:2017 REQUIREMENTS

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European Statement

Patient Safety and Quality Assurance

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.

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.

IMPLEMENTING NEW CHEMOTHERAPY COMPOUNDING WORKFLOW USING SEQUENTIAL PDSA CYCLES TO INCREASE PRODUCTION CAPACITY, REDUCE WAITING TIME, IMPROVE RESOURCES UTILIZATION, AND MINIMIZE THE RISK OF ERRORS

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European Statement

Production and Compounding

Author(s)

A Elsheashaey, A Elshishiny, A Orabi, A Almutairi, A Aboulwafa, H Alobaid, F Dashti, D Saeed, R Yassin, M Salama

Why was it done?

Kuwait Cancer Control Center (KCCC) is the only oncology hospital in Kuwait. Chemotherapy Preparation Unit (CTPU) was unable to meet the increased orders; causing delivery delay and more patients’ waiting time. Moreover; rework and more waste due to defective and faulty processes of current workflow resulting in frequent incident reports of wrong final products dispatched.

What was done?

Shifting to a systematic multi-step production workflow to increase compounding capacity, minimize risk of errors, reduce processing time, and maximize utilization of integrated technological resources.

How was it done?

Using multiple PDSA cycles, a comprehensive educational and practical training was conducted, proceeded by staff rotation with newly trained team. Every three weeks a new pharmacist trained and assigned to CTPU. Raw materials stores were rearranged for better accessibility and diminishing unnecessary staff movement. A staging step as the first independent double-check before the start of compounding, and for assembly of raw materials and supplies required for compounding. A verification Step as the second independent double-check upon compounding, using bar-code scanners, touchscreens and cross-checking with the chemotherapy order to assure the quality and integrity of the finished product. Production workload were restructured over three parallel line of manual stations and one automated preparation unit. Pharmacy Information System (PIS) screens were customized to give a first and second audio-visual alarms after 30 and 45 minutes of transcription time respectively. Chemotherapy sessions appointment system were established to assess the daily chemotherapy compounding needs from CTPU in advance with an incremental increase of production capacity to reach 100~120 patients/day or 180~200 preparations/day.

What has been achieved?

Number of preparation compounded by CTPU was increase by 8%, where more than 43% of preparations were validated to release in less than 30 minutes and approximately 88% of preparations were delivered in less than 45 minutes. Number of preparation by automation was increased by 82%, Furthermore, all production incidences has been completely eliminated after full implementation of final verification and validation step.

What next?

The new workflow has increase the workload capacity with less production errors and zero incident reports. Patient experience was improved by comparable preparation time to other international Pharmacy Workload Unit and average time required per patient visit.