Author(s)

Manon Dumoulin, Pharmacy
Caroline Chirk, Pharmacy
Claire Jouans, Pharmacy,
Sylvain Auvity, Pharmacy
Robert Ratiney, Pharmacy
Lamia Haï, Pharmacy
Scarlett Wise, Pharmacy

Why was it done?

This initiative began in March 2024, when patients started treatment.
The necessity of optimizing reconstitution was apparent quickly, to absorb activity increase.
The goal was to optimize reconstitution steps, in terms of time dedicated (human resources) and syringe quality (volume, bubbles quantity).

What was done?

Reconstitution of this first topic gene therapy (GT) consists of mixing the active substance (AS) with the gel excipient and drawing four syringes per vial, total volume 2ml.
Extractable volume is less than 2.5ml due to gel viscosity, making it complex to extract final syringe.
This topic GT is applied weekly, which makes it a time-consuming activity impacting the pharmacy’s advanced therapy medicinal product department.
As a result, the most efficient ways to manipulate the vials have been identified.

How was it done?

All manipulators trained on factice vials to apprehend gel texture. This dry run phase allowed identification of reconstitution process key steps.
Manipulator pairs were followed for 6 months: data on each step was collected (duration, reconstitution tips).

What has been achieved?

Reconstitution process is cut down to four steps: thawing (a), AS and gel mixing (b), vial resting (c) and syringe drawing (d).
a) Keep the gel vial right side up: avoids gel accumulation on the septum when punctured.
b) Use an air intake device; avoids overpressure in the vial and syringe.
c) Gel vial should rest at least 5 minutes after being mixed with AS. When more than one vial is reconstituted, prioritize mixing step in a series: increases vial resting time.
d) Draw syringes right side up: avoids gel loss on vial sides. When volume is adjusted, inject gel excess in the vial while needle bevel in the air: prevents injecting bubbles in the remaining volume.
Data collection on steps duration showed a learning curve for all manipulator pairs. Reconstitution duration for 3 vials decreased by 10 minutes after 3 reconstitutions. Each pair arrived up to an incompressible duration: 1 hour for 1st vial (bio-cleaning, dressing) and 20 minutes more for each additional vial.

What next?

Training videos are being created to highlight key steps for reconstitution campaigns.
Process and time standardization, allows fluid organization of a complex activity and improves production efficiency.

Author(s)

A. Sousa; B. Martins; J. Gonçalves
ULSGE, Unidade Local de Saúde Gaia e Espinho, Vila Nova de Gaia, Portugal
ana.luisa.sousa@ulsge.min-saude.pt

Why was it done?

The quality and effectiveness of surface cleaning in the Clinical Compounding Unit (CCU) directly impacts the quality and safety of compounded medications. As a routine task, cleaning is often undervalued, and its effectiveness uncertain. The need for a reliable, real-time monitoring method led to the implementation of ATP testing, ensuring cleaning processes are effective and reproducible. Standard operating procedures, work instructions, and audit tools were developed to support its integration, based on the hospital-wide protocol.
High ATP levels indicate poor cleaning performance and increased microbiological risk, enabling immediate corrective action before any clinical compounding takes place.

What was done?

The “Hospital Cleaning Verification Procedure – ATP Bioluminescence Method”, developed by the Local Unit for Infection Prevention and Control and Antimicrobial Resistance (UL-PPCIRA), was adapted and implemented in the CCU of the Hospital Pharmacy Service.
The test is simple and can be performed by any trained healthcare professional. It involves swabbing a surface, followed by luminometric reading. The light intensity from the enzymatic bioluminescent reaction correlates with the amount of ATP, indicating organic contamination.

How was it done?

Key challenges included the time needed for staff training and initial resistance to procedural changes, with some perceiving the tests as personal performance evaluations. These were addressed through training sessions and awareness efforts focused on promoting a culture of quality and collective responsibility. At the end of the year, the test results will be presented to the team during a training session, as part of the annual training program.

What has been achieved?

Monthly internal testing and bimonthly external audits by UL-PPCIRA are conducted, with approximately 120 tests/year. Non-compliant results lead to immediate cleaning repetition. So far, 17% of tests exceeded acceptable ATP levels. The goal is to reduce this to 10% by year-end. The project has actively engaged a multidisciplinary team of pharmacists, pharmacy technicians, and support staff in improving service quality and patient safety through shared responsibility.

What next?

The aim is to maintain a dynamic, continuously improving process and expand ATP testing to other areas: Cytotoxic Preparation Unit, Repackaging Area, and eventually the entire Pharmacy Service. Future goals include identifying contamination sources to complement ATP testing, further enhancing process control.

Author(s)

FERNANDEZ LOPEZ, ELISA GEORGINA; SANTOS FAGUNDO, ANDREA; ESQUIVEL NEGRIN, JORGE; PEÑA HERNANDEZ, JOSEPHINE; GONZALEZ CRESPO, ALVARO; MAGDALENA PEREZ, AMARA; MARTIN CONDE, JOSE ANTONIO; DIAZ RUIZ, MARIA PILAR

Why was it done?

Training in hospital pharmacy involves numerous critical technical processes (e.g. sterile preparations, parenteral nutrition, cytotoxic drugs, automated dispensing). These procedures demand high precision and adherence to protocols. Variability in training methods may lead to errors and reduced efficiency. To standardize training and provide residents and professionals with an accessible reference, a structured video library was developed.

What was done?

A comprehensive training video library covering key technical processes in hospital pharmacy was designed and implemented in a tertiary hospital. The goal was to improve resident education, ensure adherence to protocols, and provide a rapid consultation tool for daily practice.

How was it done?

Training videos were produced for the following areas: sterile preparations (intravitreal injections, intrathecal, collyria, subcutaneous and intravenous re-dispensing, analgesia pumps), parenteral nutrition (adult and neonatal), cytotoxics (IV, SC, chemoembolization particles, elastomeric devices, intrathecal), laminar flow cabinet operation, pharmacy software tutorials, automated dispensing systems (Athos, carousels, outpatient robot), and logistics management (orders, forecasts). Each video followed a technical and regulatory script. Content was validated by professionals and residents through a pilot phase. The final materials were integrated into the hospital’s internal platform, with controlled access. Impact was assessed via satisfaction surveys and monitoring of procedural execution.

What has been achieved?

After one year, 85% of users reported improved learning and knowledge retention, while 100% of residents stated increased confidence in performing procedures. The tool has contributed to training standardization, greater adherence to protocols, and facilitated quick access to updated resources.

What next?

Future steps include producing additional videos, updating existing content according to regulatory/technological changes, and expanding the model to other hospital pharmacy departments. While it does not replace supervised practical training, this tool complements it and has strong potential for replication in other hospitals to improve quality and safety in pharmaceutical care.

Author(s)

Maria Teixeira; André Maia; Ana Catré; Inês Margalho; Joana Duque; Marisa Costa; Marta Susana; Miguel Paulo; Tomás Sousa; Vânia Pereira; Teresa Pereira

Why was it done?

Thermolabile drugs require special storage conditions(2°C-8°C).[1] They represent a group with relevant economic value in Pharmaceutical Services(PS), therefore, processes must be guaranteed to maintain the storage temperature throughout the entire circuit.[2] CBR can cause changes in the characteristics of drugs and compromise their stability, efficacy and safety.[1,2] It is the responsibility of the PS to establish procedures and assess whether or not drugs exposed to a temperature excursion can be used.[3]

What was done?

We analyzed the economic impact of Cold Chain Breaks (CRB) occurring in Primary Health Care (PHC) at the Local Health Unit (ULS).

How was it done?

A spreadsheet document was developed for action in cases of CRB for PHC, and a database was created with the responses provided by the laboratories. The document is sent to the PHC unit, to be completed by the nurse in charge, who identifies the cause, duration, temperature reached, and medications in the refrigerator. After analysis by the PS, a report is sent with information on stability studies and respective conclusions per item. The excursion is then valued based on the average price of the item and the available quantity. A database was created with the valuation of all CRBs.

What has been achieved?

Between April 2024 and July 2025, 14 temperature excursions were recorded, of which 7 in 2025. The total number of affected items was 2,327, representing a total value of €55,595.6. Of these, it was possible to avoid the waste of 1,722(74%), corresponding to €40,652, and 605(26%) were eliminated, with a total of €14,943.6. The CRB occurred due to anomalies in the power supply to the equipment 80%(12) and refrigerator breakdown 20%(3). The number of vaccines subject to CRB per month in 2024 was 257 units(U), and in 2025 it was 80U.

What next?

An analysis of the causes of CRBs reveals that they are mostly related to infrastructure, with only 20% related to equipment failures. Therefore, emergency plans for equipment must be developed. It is essential to establish preventive actions collaboratively among all professional groups involved, with an emphasis on sustainability and efficient resource management, to minimize risks and avoid significant losses.

Pdf

Author(s)

Adeline HERLIN, Hermine ZIGA, Pauline PAYOT

Why was it done?

The aim is to continuously improve quality and efficiency.

What was done?

In the interests of continuous quality improvement, we have set up a suggestion box in the pharmacy’s unit repackaging sector.

How was it done?

We have set up a suggestion box for technician and pharmacists.
Each person can submit ideas or questions, anonymously or not.
After one month, the box was unpacked. The ideas and queries were analysed and discussed.

What has been achieved?

Eight points were raised.
 One point concerns procedures.
The existing procedures on the intranet network are not well known to users. We have provided an easy-to-access binder.
 Three points relate to packaging methods (list of products according to packaging method, removal of expired packaged products, mismatch of the Eticonform® label with the blister pack).
A decision tree was made (Euraf®: large quantities, multi-dose vials, magistral formula, small blister packs). The printing of the ledgers indicates the packaged products and their expiry dates. The removal of expired products is done according to the ledgers. A precaution must be taken when editing labels Eticonform® “laboratory” labels. Indeed, the size of the blister packs differs from one laboratory to another.
 The fifth point concerns the organization.
Technicians wish a storage area dedicated to repackaged specialties to compensate for stock errors.
After discussion, we did not retain this proposal.
 The other point concerns the lack of equipment.
A stool and a ruler were provided.
 The penultimate point concerns the use of returns from services in multi-dose vials.
We propose the packaging of small units with expiry dates < 3 months with the Euraf® bagging machine.
Otherwise (e.g. Carbimazole), we propose the packaging of sufficient quantities for 7 days in the vials with pre-printed labels with an expiry date of one week.
 The last point concerns the labelling of blisters with desiccant capsule (e.g. Nicorandil).
We offer Eticonform® re-labelling with a statement: USE BY xx/xx/202x (30 days after re-labelling).

What next?

The involvement of the technician team in a proactive approach to risk management is essential. We wanted to harness their practical expertise and energize the team.
The box will be integrated into our current practice.

Pdf

Author(s)

Delphine BODEN, Laura RODRIGO, Rachel MAHE, Olivier SELLAL, Maxime PARE, François RONDEAU

Why was it done?

The main objective was to test the activation of our Pharmacy-Sterilization-Operational-Unit (PS-OU), established in December 2022, and to work on its interaction with the others OU of the different hospital services. The second aim was to continue the training of pharmaceutical teams on exceptional health situations (EHS).

What was done?

In March 2024, our hospital pharmacy (HP) took part in an inter-departmental exercise based on the scenario of managing a massive influx of polytrauma victims at our hospital. The quick engagement of mobile medical units and sterilization department, dependent on the HP, is indeed a key element in the optimal care of victims, whether in hospital or pre-hospital.

How was it done?

Two interns and one pharmacy technician, with an analysis framework, were in attendance as observers through the exercise. During the PS-OU activation, various points were observed: global crisis management, task assignment and communication between the members, data centralization and communication with the others OU, efficiency and speed of response to problems… A feedback questionnaire was then sent to the 9 main players (PS-OU members, on-call pharmacist…). Intra-HP and inter-departmental feedback were provided immediately, then a posteriori.

What has been achieved?

For 3 hours, our HP had activated its OU to provide the best possible response to this exercise. The observation of this exercise pointed out the rapid activation and efficiency of the PS-OU (by the on-call pharmacist, on the order of the head of department), so a great intern and extern communication. Areas for improvement were raised, such as the optimization of available tools. 89% of players answered the feedback questionnaire. The communication was considered operational and the PS-OU essential by all the respondents. They also feel that this type of exercise is needed (75%) and helps prepare them for EHS (88%).

What next?

Aims of this exercise were achieved. Preparing, hosting and then analyzing this kind of exercise, although seemingly time-consuming, enables us to validate and, where required, consolidate the intended organization for EHS. These results also strengthen our determination to pursue our annual exercise program. Shortly, an exercise with the supply members of our PS-OU will be organized, in order to train the less experienced members as well.

Pdf

Author(s)

AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI

Why was it done?

It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.

What was done?

Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.

How was it done?

Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.

What has been achieved?

A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.

What next?

The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.

Pdf

Author(s)

Mélanie Hinterlang, Mona Assefi, Pauline Glasman, Delphine Brugier, Meriem Charfi, Fanny Charbonnier-Beaupel, Marie Antignac, Carole Metz

Why was it done?

Clinical trials in critical care sometimes demand swift inclusion and administration, often occurring at any hour of the day or night. To enhance patient care, the experimental drug may be provided in a non-nominative manner directly from the pharmacy unit to the care unit for storage before any inclusion as a stock. This dispensing pathway is considered less secure than the conventional named dispensing but can be necessary. The objective of this risk analysis for this dispensing process was to identify the risks, determine the number of them with unacceptable criticality, and propose actions to reduce criticality of these risks.

What was done?

A risk analysis of non nominative dispensation of experimental drugs process was conducted to streamline, secure, optimize, and standardize this dispensing process.

How was it done?

Following a preliminary investigation, three pilot services were chosen: surgical intensive care, post-interventional recovery room (SSPI), and cardiology. The Failure Mode, Effects, and Criticality Analysis (FMECA) method was applied to the non-nominal dispensing circuit of experimental drugs from reception at the pharmacy unit to the administration of the drug to patient. Investigators, clinical research associates, nurse, and pharmacists participated.

What has been achieved?

Following the FMECA, 281 risks were identified. The majority were either acceptable (123 or 44%, 110 or 39%, 147 or 52%) or tolerable (139 or 49%, 148 or 53%, and 130 or 46%) for the intensive care, SSPI, and cardiology services, respectively. Unacceptable risks numbered 19 (7%), 23 (8%), and 4 (1%) for intensive care, SSPI, and cardiology services, respectively. The process identified as most critical for all three services was communication. After risk prioritization, a plan comprising 17 actions was implemented.

What next?

This risk analysis demonstrated that control over the non-nominal dispensing circuit is achievable. Once the actions are in place, a reduction in criticality is anticipated due to a decrease in the frequency. Theoretically unacceptable risks are now at 0%. In the long term, this project has the potential to participate to improve the care of patients enrolled in emergency clinical trials and boost research in the concerned units.

Pdf

Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

Pdf

Author(s)

Adrian Viudez-Martinez, Ana Ramirez-Lopez, Javier Lopez-Nieto, Geronima Riera, Eduardo Climent-Grana

Why was it done?

Medication errors harm at least 1.5 million people every year. According to the Institute for Safe Medication Practice (ISMP), ongoing errors with oral methotrexate (MTX) for non-oncologic use suggest that more needs to be done to reduce the risk of patient harm, especially considering its potentially severe side effects.

What was done?

Identification and prevention of MTX-related medication errors for non-oncologic use by medication reconciliation at hospital admission. Analysis of errors’ type prevalence were also performed.

How was it done?

Design: prospective cohort performed in a tertiary hospital from September 2021 to April 2023.
Inclusion criteria: Inpatients with weekly methotrexate for non-oncologic use.
Intervention applied: medication reconciliation comparing inpatient’s e-prescription, clinical record, outpatient medication history and pharmacist-driven interview.
Data analysed: demographic data (age, sex, admission cause) treatment-related data (indication, methotrexate and folic acid posology, administration route, day of the week).

What has been achieved?

Out of 79 admission episodes (53.1 % men, median age: 72 years (range: 18-96 years), 63 (80% )were urgent.
Most patients had been prescribed methotrexate for rheumatoid arthritis (n=56), but also for polyarthritis (n=9), psoriatic arthritis (n=8), pulmonary sarcoidosis (n=2), pemphigus (n=1), spondylarthritis (n=1) and Still syndrome (n=1).
Methotrexate doses’ frequency were: 15 mg (28.9%), 10 mg (27.6%), 20 mg (11.9%), 7.5 mg (9.2%), 25 mg (7.9%), 12.5 mg (6.6%), 17.5 mg (5.3%) and 5 mg (2.6%).
Medication errors were identified and prevented in 38 out of the 77 episodes recorded (49.4%). There were classified as follows: dose (38.5%), day (17.9%), dose and day (17.9%), dose and administration route (10.3%), omission (10.3%), administration route (2.6%) and lack of indication (2.6%).
Folic acid doses’ frequency was: 10 mg the day after MTX (47%), 5 mg the day after MTX (28%), 5 mg daily except the same day as MTX (17%), 15 mg the day after MTX (8%).

Medication errors were identified and prevented in 51 out of the 77 episodes recorded (66.2%). There were classified as follows: omission (38.8%), day (33.3%), day and dose (16.7%), dose (9.3%) and drug (1.9%).

What next?

Performing medication reconciliation in every admission, measuring its potential benefits using validated tools for clinical pharmacists’ intervention assessment, such as the CLEO tool, which can, ultimately, serve as preamble to objectively measure the pharmacists’ impact in healthcare efficiency and patients’ safety.