OPTIMIZING STERILE AND IMPLANTABLE MEDICAL DEVICE CIRCUITS: CONTRIBUTION OF THE INTERDIAG DMS® TOOL
European Statement
Patient Safety and Quality Assurance
Author(s)
Khalil MEDDINE, Yasmine EL YOUSSOUFI, Madiha ALAMI CHENTOUFI, Houda ATTJIOUI, Driss TANANI, Abdelhafid BENOMAR
Why was it done?
To identify performance gaps and critical points within the sterile and implantable medical device circuits, with the aim of guiding targeted improvements and ensuring safer, more reliable management of these devices.
What was done?
A multidisciplinary self-assessment of the sterile and implantable medical device circuits was carried out using the Interdiag DMS® evaluation tool.
How was it done?
The evaluation was conducted using the Interdiag Excel file, which includes dedicated modules for sterile and implantable medical devices. The analysis focused on the tool’s implementation, the objectives of the self-assessment, the resulting action plans, and feedback obtained throughout the process.
What has been achieved?
The assessment highlighted strong performance in information systems and traceability for implantable devices, but weaknesses were identified in their documentation management. For sterile medical devices, major deficiencies were observed in quality management, transport, and return/disposal processes (10–20% compliance), while pharmacy premises and demand management showed moderate performance (50–60% compliance). These findings allowed for the implementation of targeted corrective actions.
What next?
The findings will guide ongoing targeted improvements, enhance coordination among healthcare stakeholders, and foster a sustainable culture of quality and safety in medical device circuits.
IMPLEMENTATION OF THE USE OF STANDARD MASSES CIRCUIT IN A PHARMACEUTICAL LABORATORY
European Statement
Patient Safety and Quality Assurance
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.
PHARMACY TECHNICIANS SATISFACTION SURVEY ABOUT PROCEDURE IMPROVEMENT PROCESS IN SAFE DISPENSING MEDICATION
European Statement
Patient Safety and Quality Assurance
Author(s)
L. DE AGUSTIN SIERRA, P. FLOX BENITEZ, B. MONTERO PASTOR, A. SUCH DIAZ, P. TEJEDOR PRADO, E.A. ALVARO ALONSO, E. IZQUIERDO GARCIA, N. FONT TARRES, M. SANCHEZ LORENZO, I. ESCOBAR RODRIGUEZ.
Why was it done?
Medication dispensing errors were detected more frequently in our Pharmacy Department. This errors were related with procedures among pharmacy technicians (PT).
Formation programs bettween PT are implemented in our Pharmacy Department in other critical areas such as compounding or cytotoxic drugs but not dispensing.
It its known that a lack of knowledge of established work procedures among pharmacy technicians (PT) can contribute to a potential increase in medication dispensing errors. On the other hand, medication dispensing errors are preventable incidents in the process of distributing and administering drugs that can cause avoidable harm to patients.
What was done?
Implementation of a procedure manual to define operative procedures carried out by PT that need improvement in the safe dispensing medications and establish appropriate measures for safer and efficient work.
How was it done?
Observational, prospective, descriptive study conducted by pre and post survey (1-5) during July and september 2025 among PT. The total number of surveys was 28 (15 pre and 13 post).
A structured questionnaire was developed with closed question (pre and post) about: (1) medication distribution and dispensing, (2) knowledge of stablished operative procedures, (3) clinical pharmacy services and medicine information, (4) personal abillities and skilss and (5) necesity for training and information.
Surveys included 11 questions using Google Forms Likert scale of 1-5, being 5 maximum score.
Post-survey was conducted after three-months period training for PT.
What has been achieved?
In pre-survey, medication distribution and dispensing received the lowest score (3 on five-point scale). The rest of responses showed a satisfaction degree (4) also for necesity for training and information.
After manual implementation, post-survey questionnaire shows that manual enhanced work procedures and medication distribution, dispensing (3 pre Vs 4 post), self-confidence and autonomy in established procedures. (4 on five-point scale). Moreover, overall satisfaction about was satisfied (4).
What next?
The implementation of a procedure manual has enhanced generally satisfied between PT. Although our survey shown this enhances, we are conscious about importance and necessity of reglated formation in Pharmacy Department in order to safe dispensing medications and safer and efficient work. For that reason, reglated formation has been scheduled among PT.
IMPROVING PATIENT SAFETY IN THE USE OF OPHTHALMIC DRUGS AND CONTACT LENSES: DEVELOPMENT OF EVIDENCE-BASED COUNSELLING RECOMMENDATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
Javier Mata Alonso, Paula Ruiz Briones, Carlos Jiménez Villarón, Andrés Prado Lozano, Gonzalo Domínguez Chaparro, David Samitier Samitier, Juan Manuel Montes Gómez, Félix García Moreno, Sagrario Pernía López, Ana Herranz Alonso, María Sanjurjo Sáez
Why was it done?
Concomitant use of ophthalmic drugs and contact lenses (CL) is frequent in clinical practice. However, product data sheets usually provide limited or unspecific guidance regarding compatibility. This information gap may lead to inappropriate use, discomfort, or ocular toxicity. Pharmacists can play a key role in ensuring safe use through structured, evidence-based counselling. This initiative was developed to identify existing safety gaps and to establish practical recommendations for clinical decision-making.
What was done?
A review was conducted of ophthalmic drugs authorised and marketed in Spain to determine available information on their compatibility with CL. The objective was to compile regulatory data, identify inconsistencies, and design a reference framework of recommendations for pharmacists advising patients who use CL and require topical ocular treatment.
How was it done?
Data were obtained from the CIMA database (Spanish Medicines Agency). Among 301 registered eye drops, 186 were authorised and marketed. Products containing benzalkonium chloride (BAK) were excluded due to known incompatibility. The remaining 96 formulations (52 unique presentations) were reviewed using technical data sheets (sections 4.4 and 6.1) and compared with evidence from clinical guidelines and major ophthalmology literature. Information was synthesised into practical counselling recommendations.
What has been achieved?
Most data sheets lacked clear guidance. Three patterns were identified: no mention of CL, a generic 15-minute delay, or explicit contraindication. Only two products (bilastine 6 mg/mL and sodium chloride 0.9%) explicitly allowed CL use. Based on pharmacological class, evidence-based recommendations were developed to guide pharmacists in advising patients on safe CL use with ophthalmic drugs.
What next?
This practice model is ready to be implemented in hospital pharmacy services. Future steps include incorporating the recommendations into clinical protocols, developing patient information materials, and collaborating with ophthalmology departments to enhance safety and consistency in pharmaceutical counselling.
IMPLEMENTATION OF A TECHNICAL PLATFORM IN A PHYSICOCHEMICAL CONTROL LABORATORY : OPERATIONAL OUTCOMES AND FUTURE OPTIMIZATION
European Statement
Patient Safety and Quality Assurance
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.
EXCEPTIONAL HEALTH SITUATIONS: OBSERVATION OF AN IMMERSIVE EXERCISE IN THE HOSPITAL PHARMACY AND FEEDBACK
Pdf
European Statement
Patient Safety and Quality Assurance
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.
INTEGRATING ARTIFICIAL INTELLIGENCE: STREAMLINING MEDICATION HISTORY DOCUMENTATION WITH CHATGPT AT ODENSE UNIVERSITY HOSPITAL
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Fjóla Høg Nielsen, Gine Cecilie Stobberup
Why was it done?
The initiative was driven by the need to support a growing number of patients who require medication history. To ensure that pharmacy technicians could complete as many medication histories as possible, have enough time to thoroughly investigate potential issues, and maintain the desired quality of medication history, we initiated the use of ChatGPT to handle the journal note-writing aspect. This initiative was launched in January 2024 and implemented in August 2024.
What was done?
At Odense University Hospital, pharmacists and pharmacy technicians conduct daily reviews of hospitalized patients’ regular medication based on data from the Danish Medicines Agency’s system “The Shared Medication Record”, prescription deliveries, and patient statements. The patient’s usual medications are reviewed to determine what they are taking at home and to identify potential issues, such as compliance problems. A note is written in the medical journal for the attending physician, providing an overview of the patient’s regular medications and any concerns. To improve efficiency and consistency in this process, we implemented the use of ChatGPT to write these notes after the pharmacy technician has completed the medication history, ensuring standardized documentation, increased safety, and for saving time.
How was it done?
ChatGPT was programmed to document the medication history following the standard note format previously used. One of the key challenges was ensuring that ChatGPT could meet the specific documentation needs and minimizing errors in the generated notes. After the initial programming, pharmacy technicians were asked to use ChatGPT and keep track of how many medication histories were written with its assistance, as well as to identify any recurring errors. Based on their feedback, ChatGPT was adjusted to reduce the occurrence of similar errors in future notes.
What has been achieved?
Pharmacy technicians have reported that the time required to complete a medication history has decreased, particularly for patients with long medication lists. The system also ensures that the notes are always written in a consistent manner, reducing the likelihood of missing important information.
What next?
Moving forward, we will continue refining the system to further eliminate errors and improve accuracy. This initiative showcases the successful integration of advanced technology into healthcare, with potential applications across other healthcare settings.
FIVE YEARS OF A BIG CONTRIBUTION FOR THE SMALLEST AMONG US – THE IMPLEMENTATION OF AN INTRAVENOUS-SERVICE ON NEONATAL INTENSIVE CARE UNITS BY THE HOSPITAL PHARMACY
Pdf
European Statement
Production and Compounding
Author(s)
Boglárka Lengyel
Nadine Haubenwalllner
Ingrid Sattlecker
Why was it done?
The global shortage of nursing staff increases the risk for medication errors due to higher workload and stress. The intravenous (I.V.)-service, launched in March 2020, alleviates nurses’ workload and minimizes application errors by standardizing concentrations and providing pharmaceutical training. Producing all infusions with producing pumps in the hospital pharmacy’s clean rooms improves microbiological quality and dosing accuracy. Standardized concentrations with defined stability and proper documentation practices ensure consistent quality.
What was done?
We implemented the production of patient-specific I.V.-infusions and total parenteral nutrition (TPN) for neonatal intensive care units (NICU) to meet the specialized needs of neonates and enhance individualized care. Additionally, pharmacy staff assembles patient infusion sets daily, focusing on Y-Site compatibility and catheter types tailored to each patient.
How was it done?
After discussing demand with physicians and nurses, data on NICU medications and dosages were systematically collected. Standard infusion concentrations were harmonized, considering fluid intake and physical-chemical stability. Protocols for automated compounding of continuous infusions and TPN were established, alongside standard operating procedures for additional volumetric preparation. I.V. compatibility of the drugs was researched, and compatibility tables were created.
What has been achieved?
The project successfully implemented individualized compounding of infusions and TPN with established standards in the hospital pharmacy’s clean rooms. Complete traceability and continuous monitoring during production ensure high product quality. The initiative enhanced interprofessional collaboration, strengthening confidence among physicians, nurses, and pharmacists and significantly reduced nurses’ workload for preparing medications, TPN, and assembling patient sets. The service currently supports five wards, producing an average of 98 infusions and TPN daily. The assembly of patient sets is provided for 44 care beds across NICU and Intermediate Care (IMC) wards, averaging 25 sets daily.
What next?
The service aims to maximize automated production by implementing new compounding pump plans, increasing output to supply more wards. Plans also include expanding the service to the Pediatric Intensive Care Unit (PICU), where both intermittent infusions and patient set assembly will be offered in addition to the existing continuous infusion supply.
IMPLEMENTATION OF A CLINICAL PHARMACIST IN THE PAIN MANAGEMENT UNIT TEAM
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MC. SÁNCHEZ ARGAIZ, A. TRUJILLANO RUIZ, E. MÁRQUEZ FERNÁNDEZ, M. GALLEGO GALISTEO, E. CAMPOS DÁVILA
Why was it done?
A multidisciplinary approach is essential for addressing chronic pain from multiple perspectives, ensuring that treatment is personalized and effective for each patient. This structure enables faster, more coordinated solutions for patients whose chronic pain is difficult to manage.
What was done?
The Pain Management Unit(PMU) is a multidisciplinary team responsible for the comprehensive treatment and management of patients with chronic pain. The team includes: anesthesiologists, traumatologists, rehabilitation specialists, rheumatologists, internists, primary care physicians, and now a clinical pharmacist.
How was it done?
When a physician is unable to adequately manage a patient’s chronic non-oncologic pain, the patient is referred to the PMU. The unit holds weekly meetings to discuss cases and propose medical solutions, including interventional procedures such as injections or nerve blocks. The clinical pharmacist plays a key role in this process by reviewing the patient’s current analgesic therapy and chronic medications in advance, assessing their appropriateness, potential drug interactions, and considering alternative analgesic strategies. Additionally, the pharmacist provides recommendations on the temporary suspension of antiplatelet and anticoagulant therapy for patients scheduled for procedures. On a quarterly basis, the pharmacist also identifies patients with chronic non-oncologic pain who are prescribed high-dose opioids, facilitating a review by the treating physician to promote safer and more rational opioid use.
What has been achieved?
-Optimization of analgesic therapy: Through collaborative reviews with the team, analgesic treatments have been more precisely adjusted, reducing unnecessary opioid use and favoring safer, multimodal approaches.
-Prevention of hemorrhagic and thromboembolic complications: Timely recommendations on the suspension of antiplatelet and anticoagulant therapy before invasive procedures have minimized risks.
-Promotion of safe opioid use: The quarterly identification and review of patients on high-dose opioids has reduced the risk of overdose, dependence, and adverse effects, ensuring safer pain management.
What next?
The integration of the clinical pharmacist into the PMU has shown a clear positive impact on the safety and effectiveness of chronic pain treatments. Moving forward, it would be beneficial to evaluate, at six-month intervals, the interventions proposed by the pharmacist and accepted by the medical team. This evaluation would provide valuable insights into the long-term benefits of pharmacist involvement and help refine the collaborative approach to pain management.
TO IMPROVE TIMELY MEDICINES PROVISION AND ENSURE SAFE PRESCRIBING AS WELL AS SUPPORT EARLY DISCHARGE PLANNING TO IMPROVE FLOW INSIDE AND OUTSIDE AN NHS TRUST
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Christina Anastasiadou – Lead Pharmacist Acute & Emergency Medicine
Karen Dicks – Chief Pharmacy Technician Medicines Management
Radhika Patel – Pharmacy Technician MMS
Why was it done?
Until October 2023, the A&E department in Croydon University Hospital in London lacked a full-time pharmacy service, unlike other London trusts. This has contributed to suboptimal medicine management and a delay in the identification of prescribing errors. This has resulted in longer stays, missed medication doses, and a rise in patient safety incidences. At a hospital level this reduces flow and increases cost due to medication wastage. Ultimately, the aim is to improve the flow of patients within the hospital via timely medicines provision, early clinical pharmacy intervention and early discharge planning.
What was done?
We have obtained funding from the Better Care Fund for a period of 2 years. This funding is aimed at assisting local systems in effectively achieving the integration of health and social care in a manner that promotes person-centred care, sustainability, and improved outcomes for individuals and caregivers. Therefore, we introduced a full-time pharmacy service including one pharmacist and two medicines management technicians (MMTs)—one full-time and one part-time. This initiative was implemented as a 2-year trial period, using key performance indicators (KPIs) to evaluate its effectiveness.
How was it done?
Data has been collected against the below KPIS:
1) Number of drug histories completed on admission, before patient is allocated a ward (by MMT or pharmacist) per calendar month.
2) Number of medicines reconciliations completed (by pharmacist) per calendar month.
3) Number of clinical interventions completed by all members of the pharmacy team.
4) Savings secondary to the use of patient’s own drugs (PODs) brought from home for administration to reduce medicines wastage.
5) Savings due to the return of medicines to inpatient pharmacy for re-use from other patients when appropriate.
6) Time between request of medicines from pharmacy dispensary and medicine being dispensed, checked and released to A&E.
7) Review of stock lists in all areas in A&E.
8) Reduction in omitted doses.
9) Discharge medicines supply and screening from A&E to streamline discharge.
10) Number of patients counselled on their medicines and provided with patient-friendly information on them.
11) Number of referrals to community teams i.e allocated chemist via Discharge Medicines Service, Integrated Care Network (ICN) pharmacists or specialty teams (i.e anticoagulation clinic for newly initiated anticoagulant) to provide continuation of care.
12) Liaising with specialty teams within the hospital to expedite review and treatment in a time efficient and cost-effective way.
What has been achieved?
The current pharmacy team is fully integrated into the A&E service and has contributed significantly towards advancing patient experience, via early pharmacy engagement with patients. During the first 10 months of the project, we have data to show:
1) A 540% increase in drug histories and medicines reconciliation on admission.
2) A 19.525% increase in clinical interventions and early detection of medication errors.
3) We have completed 5 teaching sessions so far, in order to tackle common prescribing and medicines management inaccuracies and embedding solutions into nurses and doctors training.
4) We have contributed towards the reduction in omitted doses by 6%.
Positive contribution towards tackling medicines wastage has been shown too. Our team contributed towards saving £13.110 from April to September 2024 by using PODs for administration in hospital and £10.483 by returning dispensed medications to the inpatient pharmacy for recycling and use for other patients for the same time period.
In addition, the team has completed 66 referrals to the community pharmacy team for follow up on newly started medicines, stopped medicines, adherence concerns and polypharmacy. This is in order to provide continuous care and establish follow-up after discharge from hospital.
All in all, improved safe patients flow in and out of hospital.
What next?
Work towards a business case for a permanent pharmacy service in A&E, to continue further developing the above. Utilise all the skills our MMTs hold, in order to continue working on patient safety, improved flow and cost improvement plans. Introduce a pharmacist-prescriber who will be able to tackle arising problems as soon as possible and provide high quality care in liaison with doctors, nurses and advanced care practitioners.