FROM RISK TO RELIABILITY: ADVANCING HEALTHCARE SAFETY INNOVATIVE WITH SEMI-IV PREMIXED
European Statement
Patient Safety and Quality Assurance
Author(s)
Naila Aljahdali, Hala Al-Buti, Rana AlKhanbashi, Afaf Almalki, Basem Elbehiry, Mohammed El-Kholi, Ahmed Albariqi, Sara Dabab
Why was it done?
Medication errors, particularly in intravenous preparation, delivery, and administration, pose a significant safety concern in healthcare settings. At King Fahd Armed Forces Hospital in Jeddah, delays in IV antibiotic preparation and delivery were identified as critical issues affecting patient outcomes and pharmacy services. The project aimed to decrease the turnaround time between the order and delivery of IV antibiotics to < 20 minutes by December 2025. Also, reduces medication errors and associated costs, and increases healthcare practitioners’ satisfaction with the new Inpatient/IV Pharmacy workflow.
What was done?
Key strategies included tracking short stability and fixed-dose IV antibiotic utilization, configuring the Health Information System for premixed diluent products, incorporating new stock numbers in automated dispensing cabinets, conducting comprehensive training for healthcare practitioners, and satisfaction surveys.
How was it done?
This project implemented semi premixed IV antibiotic bags from August 2023 to August 2025 in Obstetrics and Gynecology, Medical, and Surgical units for Cefazolin 1GM and Meropenem 1GM. Utilized Lean methodology and Plan-Do-Study-Act (PDSA) cycles to optimize workflows. Baseline assessments were conducted to evaluate order-to-delivery times, medication errors, and wastage cost pre/post intervention.
What has been achieved?
The intervention resulted in a significant reduction in turnaround times from an average of 48 minutes to 17 minutes. Medication errors decreased from an average of 47 to 17 incidents, and the number of returned IV medications dropped to zero. The estimated cost savings from reduced waste amounted to approximately 113,382.324 SAR.
What next?
The implementation of semi premixed IV antibiotics significantly improved turnaround time of the medication order and delivery, enhanced patient safety, and increased practitioner satisfaction. The successful application of Lean methodology underscores the potential for broader implementation of this approach across the hospital to further optimize healthcare delivery.
CREATION OF A DATABASE ON THE COMPATIBILITY OF ANTIINFECTIVES FOR SYSTEMIC USE WITH BLOOD DONATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Salvador Llana, I; Sánchez Pascual, B; Vicente Ayuso, MdC; Martín García, V; Sánchez León, MdR; Adeva Antona, S; Pérez Encinas, M
Why was it done?
Our main objective was to optimize donor screening by analyzing the compatibility of ATC code J-Antiinfectives for systemic use with blood donation(BD), addressing the questions raised by donors. It was attended to reduce unnecessary exclusions, improve transfusion safety, and streamline decision-making for healthcare staff in Donor Units(DU) and Pharmacy Services(PS), while also providing open access to information for both healthcare professionals and donors.
What was done?
From the hospital’s PS, a database was created compiling all ATC code J-Antiinfectives for systemic use in Spain up to 2025. The medications were classified according to their compatibility with BD. A color-coded system was implemented for easy interpretation:
-Green: compatible with donation(CD)
-Yellow: requires individual assessment(IA)
-Orange: donation deferred after a washout period(DD)
-Red: incompatible with donation(ID)
Each medication entry also includes an “observations” section to provide additional details.
How was it done?
A detailed literature review was conducted, covering national and international guidelines, scientific articles, and official websites, complemented by direct consultations with pharmaceutical laboratories. To ensure reliability, the database was reviewed and validated by the Hematology Service(HS) and the Regional Blood Bank.
What has been achieved?
– A guide was created with 122 ATC code J drugs(J01-antibacterials for sistemic use(50), J02-Antimycotics for systemic use(10), J04-Antimycobacterials(3), J05-Antivirals for systemic use(34), J06-Immune sera and immunoglobulins(6) and J07-Vaccines(19).
– J01, J02, J04 and J06 were all cassified as DD.
– Ribavirine(J05), amantadine(J05) and sofosbuvir(J05) were ID. The rest of J05 were classifed as DD.
– Live-attenuated vaccines(7) represented the 36.8% of all vaccines and were classifed as DD(1 month). The other vaccines(12) require IA. BD is possible if the donor is afebrile and feels good.
-For medications classified as DD, in cases of discrepancies in the consulted literature, the most restrictive deferral period was selected.
-Exact information can be now provided to donors, making it clear whether they are not currently eligible for BD and, if they may be eligible in the future, giving them the exact deferral period.
What next?
The objective is to continue expanding/updating the database and to make this information available to all DU across the country.
SECURING THE COLD CHAIN: PORTUGUESE HOSPITAL PHARMACY RESPONSE TO THE 2025 NATIONAL BLACKOUT
European Statement
Patient Safety and Quality Assurance
Author(s)
Inês Carmo, Ana Parola, Inês Oliveira, Margarida Carvalho, Marta Carvalho, Ana Mirco.
Why was it done?
On April 28, 2025, a nationwide blackout affected Portugal, disrupting the national power grid and severely compromising the cold chain of vaccines in primary health care facilities, along with all forms of mobile communication. Given this event, the response by the Pharmaceutical Department (PD) of a Local Health Unit responsible for delivering vaccines to 38 Primary Health Care Facilities (PHCF) required evaluation due to major clinical, financial, and operational risks.
What was done?
Vaccines exposed to any temperature excursion during storage were identified and placed under quarantine, preferably using an alternative cold storage unit with an independent power source, when available, and distinctly labeled. Through a standardized notification form, each incident was promptly reported within 48 to 72 hours to the cold chain supervisor and PS. During the first week after the blackout, PS reviewed each report to determine the vaccine’s stability and possible return to the supply chain.
How was it done?
Hospital pharmacists collected key data such as temperature variations, time outside safe range, and affected vaccine batches. They consulted reliable sources (databases and Summary of Product Characteristics) and sought information from the supplier laboratory. Upon analyzing all data, PHCF received precise recommendations on suitability for ongoing use.
What has been achieved?
On April 28, 2025, 40 cold chain incidents were notified, affecting 12,442 vaccines units. After thorough analysis, 12,202 units were authorizes for use, reducing clinical and economic impact. Only 240 units were discarded, resulting in a loss of 6,018.50 € out of a total stock valued at 284 544, 60 €. Joint action by Pharmacist and PHCF assured continuity of patient care and vaccine safety, preventing disruptions to the National Vaccination Program.
What next?
The nationwide blackout exposed vulnerabilities in the PHCF cold chain, highlighting the need for more refrigerators, continuous electronic monitoring, backup generators, refrigerated vehicles, and standardized protocols between PS and PHCF.
ENHANCING PHARMACEUTICAL CARE FOR PEOPLE LIVING WITH HIV AT KING CHULALONGKORN MEMORIAL HOSPITAL (KCMH), THE THAI RED CROSS SOCIETY.
European Statement
Patient Safety and Quality Assurance
Author(s)
Supparat Chanprasert, Watsa Charoenwaiyachet, Thanawan Chuenjit , Katemanee Udomkiattikul, Anut Sakulsupsiri, Thanayu Techa-in.
Why was it done?
Among 3,500 PLHIV treated at KCMH, only one-third accessed infectious disease clinics where clinical pharmacists provide criteria-based pharmaceutical care. The remaining 70% received treatment at other clinics, where medications were dispensed without adherence assessment. Addressing this gap was essential to improve quality of care.
What was done?
A standardized protocol for pharmaceutical care of people living with HIV (PLHIV) was implemented. The initiative introduced structured adherence assessment at outpatient dispensing units and an integrated referral process to clinical pharmacists.
How was it done?
Outpatient HIV care was streamlined by coordinated efforts among physicians, nurses, HIV coordinators, and pharmacists. A clinical pharmacist developed two new tools for dispensing process: “Short Screening” for regimen choice, dosage adjustment, and detection of drug interaction or adverse effect, and “Short Check” for adherence and barrier identification. Any concerns from screening pharmacists were informed to dispensing pharmacists for further review. Simple issues were addressed at the counter with respect to patient rights, while complex cases or PLHIV with poor adherence were referred to clinical pharmacists for in-depth interventions. Cases were evaluated and classified as needed urgent intervention, planned intervention, or no intervention for clinically stable patients or with viral suppression. Pharmacists enhanced a resolute EMR system for follow-up scheduling and monitoring documentation. Training sessions were conducted prior to implementation to promote consistency in practice.
What has been achieved?
From October 2024 to March 2025, 2,732 PLHIV received structured adherence assessment, increasing coverage from 31% to 69%. Ninety-seven percent were good adherence and achieved viral suppression. A small percentage (2.9%) was identified as poor adherence and referred to clinical pharmacist-led interventions. Among the patients reviewed, 54% were clinically stable and needed no further intervention, 28% percent were found at risk of poor adherence and were scheduled for interventions, and 19% needed urgent counseling which half of them experienced virological failure. After intervention, the majority demonstrate improved adherence. Dispensing pharmacists provided essential counseling on ARV timing, food-drug interactions, and safe ARV use per guidance.
What next?
This model shows a scalable approach for high volume super tertiary hospitals by embedding pharmacists into HIV services. This framework can be adapted for other chronic diseases like diabetes to expand its public health benefits.
DESIGNING A PATIENT-CENTERED MODEL FOR CLINICAL TRIALS: INSIGHTS FROM PATIENT JOURNEY MAPPING AND QUALITATIVE RESEARCH IN HOSPITAL PHARMACY
European Statement
Patient Safety and Quality Assurance
Author(s)
Irene Márquez-Gómez, Vicente Escudero-Vilaplana, Fernando Bustelo Paz, José Luis Revuelta Herrero, Roberto Collado-Borrell, Laura Maldonado Yagüe, Alberto Ruiz López-Alvarado, Ana Herranz Alonso, Juana Benedí González, María Sanjurjo Sáez
Why was it done?
Patient experience has been recognized as a critical determinant of healthcare quality, directly influencing adherence, safety, and clinical outcomes. In clinical trials, where investigational drugs and complex protocols often create uncertainty and stress, patients face unique challenges. Enhancing their experience is critical to ensure safety, and engagement throughout the trial. This project aimed to mitigate these vulnerabilities and to foster a more humanized and supportive care environment.
What was done?
A patient-centered model was developed to incorporate patient experience into the pharmaceutical care of clinical trial patients. The initiative sought to redesign care processes within the Pharmacy Department to better address patients’ expectations, needs, and vulnerabilities.
How was it done?
The project followed four phases: (1) Current workflows were mapped to detect bottlenecks in pharmaceutical care (2) Semi-structured interviews with trial participants explored their perceptions, concerns, and unmet needs; thematic analysis was applied to identify key insights. (3) The SAFARI observational method was used to document real-world interactions and organizational dynamics in the drug dispensation area. (4) A Patient Journey Map was created to visualize the care pathway and highlight critical touchpoints requiring improvement.
What has been achieved?
Analysis revealed several unmet needs: insufficient practical information on trial medication, limited visibility of pharmacy as a clinical resource, logistical barriers such as poor signage and physical distance from clinics, and confusion about dispensing procedures. Patients valued close monitoring by the research team but expressed interest in receiving additional pharmaceutical support. Overall, the hospital pharmacy was perceived primarily as a logistical space rather than a clinical partner, underscoring the need to reposition its role within clinical trial care.
What next?
Two key strategies have been defined. First, the establishment of a dedicated pharmaceutical care consultation for trial participants, focusing on critical milestones (pre-screening, treatment initiation, therapy changes), providing structured explanations, written reference materials, and systematic review of interactions and adverse effects. Second, the functional planning of a new Clinical Trials Unit, with improved physical spaces, closer proximity to the research team, and simplified patient circuits. These interventions aim to transform the pharmacy service into a patient-centered and supportive environment, and future evaluation will measure their impact on safety, adherence, and patient-reported outcomes.
COST- AVOIDANCE ANALYSIS OF PHARMACEUTICAL INTERVENTIONS IN HOME STORAGE ERRORS OF REFRIGERATED MEDICINES.
European Statement
Patient Safety and Quality Assurance
Author(s)
Martín Santamaria, A. López Fernández, A. Menchén Viso, B. Sanabrias Fernández de Sevilla, R. Folguera Olias, C. Guerrero Feria, I. Herrero Collado, L. De España Zaforteza, P. Pérez García, E. Sánchez Guerrero, A.
Why was it done?
Unnecessary disposal of high-cost injectables is often triggered by home storage errors, placing a burden on the public health system. The aim was to quantify avoidable expenditure through pharmacist review, and to identify opportunities for the education of targeted patients, prompted by these incidents.
What was done?
A pharmacist-led stability verification program for refrigerated medicines stored at home was implemented. When an out-of-fridge incident was reported, stability was assessed by a pharmacist and, when safe, continued use was authorised, avoiding replacement costs.
How was it done?
A retrospective analysis was conducted of incidents recorded in an Excel database from 2021 to 2024. For each case, the following variables were collected: active drug, units affected, units saved, and costs (potential replacement and avoided cost). Stability decisions were based on summaries of product characteristics (SmPCs), manufacturer information, and published temperature-excursion evidence (Stabilis database, Fridge Stability Tool by NHS) interpreted against the reported time/temperature exposure.
What has been achieved?
From 2021 to 2024, 115 incidents were recorded, involving 288 injectable units; 66 were authorized for continued use, avoiding 18.590€ in replacement costs. Savings by year and share of the total were: 6.922€ in 2021 (37,2%), 5.498€ in 2022 (29,6%), 4.012€ in 2023 (21,6%), and 2.159€ in 2024 (11,6%). By year, injectable units saved/affected were: 2021: 28/46, 2022: 19/150, 2023: 6/33, 2024: 13/59. The most frequently implicated drugs were adalimumab (38), etanercept (10), darbepoetin alfa (10), filgrastim (7), and golimumab (4). These drugs were also the most frequently consumed across this period. A substantial proportion of excursions were cleared for safe continued use through a structured pharmacist verification process.
What next?
An infographic will be developed to standardise patient counselling: correct home storage (fridge placement, do-not-freeze warnings, time-out-of-refrigeration windows by product), safe travel with injectables (cool bags/ice packs, temperature monitoring, air/rail travel tips, hotel-fridge checks), and recommended actions after an incident—product quarantine, time/temperature recording, and immediate contact with the hospital pharmacy (email/phone). The infographic will be provided at first dispense and after any excursion, and its impact will be evaluated through subsequent incident and saved units rates.
OPTIMISING INTRAVENOUS IMMUNOGLOBULIN USE IN HAEMATOLOGY: A COLLABORATIVE PATH TO RATIONAL PRESCRIBING
European Statement
Patient Safety and Quality Assurance
Author(s)
MARIA TERESA ESTEBAN ALONSO, ANA INFANTE CAMARERO, INES BAENA BOCERO, SARA ARNAIZ DIEZ, LAURA IZQUIERDO ACOSTA, OLGA ALAMO GONZALEZ, MARTA UBEIRA IGLESIAS, MPAZ ESPINOSA GOMEZ , AITOR AYASTUY RUIZ , NATALIA REVILLA CUESTA.
Why was it done?
A sustained rise in IVIG consumption, particularly related to new oncohaematologic therapies and off-label situations, raised concerns about clinical appropriateness, economic impact, and national supply shortages. The aim was to ensure rational, safe, and cost-effective use of this therapeutic resource in a context of increasing demand and the introduction of novel treatments such as bispecific antibodies.
What was done?
A collaborative strategy between the Pharmacy and Haematology Departments was developed to review and optimise the use of intravenous immunoglobulins (IVIG) in haematology patients.
How was it done?
All haematology patients treated with IVIG during a reference period were included. Prescriptions were jointly reviewed by pharmacists and haematologists, classifying cases according to clinical justification. A structured review of prescribing practices was required to ensure compliance with approved indications and clinical guidelines. Evidence-based indications were prioritised, while emerging scenarios associated with bispecific antibodies were carefully assessed. In cases lacking sufficient clinical support, treatment discontinuation or alternative management strategies were proposed in agreement with the clinical team. The process was formalised through a management objectives agreement linking clinical outcomes to expenditure control.
What has been achieved?
The initiative enabled early identification of unjustified prescriptions, preventing unnecessary treatments and contributing to significant cost containment. It also strengthened multidisciplinary collaboration and raised awareness among clinicians on the importance of preserving IVIG for evidence-based indications, thereby enhancing patient safety and sustainability
What next?
A joint Haematology–Pharmacy protocol defining priority indications and usage criteria for IVIG is planned, together with the expansion of this model to other specialties with high immunoglobulin consumption. This initiative represents a transferable and scalable example of good practice for hospital settings across Europe.
DEVELOPMENT OF A NATIONAL ORAL ONCOLOGY MEDICINES DATABASE: ADVANCING TREATMENT OUTCOMES THROUGH DATA INTEGRATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Z. Ćetković, I. Popović
Why was it done?
Due to the specific mechanism of action of oral oncology medicines, these patients require advanced clinical pharmacy services facilitated by information technology to deliver better person-centred healthcare. The purpose of this database is to gather all important information on oral oncology medicines and make them easily accessible, to educate patients and improve their treatment outcomes.
What was done?
A hospital pharmacy team created a national database of oral oncology medicines, which was further integrated into a mobile application compatible with both iOS and Android device. This database included 79 medicines grouped by therapeutic indications, along with indications and dosage, information on administration and storage, interactions with other medicines and food, as well as precautions for the use in special populations.
How was it done?
The initiative was first developed during our national Symposium of hospital pharmacists, and within six months, it resulted in a national database of oral oncology medicines, supported by our Ministry of Health. After selecting a list of medicines, the next step involved creating a database in Excel. All information was straightforward and easy to comprehend for the general population. The final version of the database was thoroughly evaluated, and all issues were carefully addressed. In collaboration with the IT sector, the database was incorporated into the mobile application, available for all patients and healthcare professionals.
What has been achieved?
· Oral oncology medicines database provides evidence-based information on oral oncology medicines and offers medical support to patients taking these medicines at home, thus improving adherence and patient safety. · This database improves patient knowledge. · Situations with different scenarios are available to help manage interactions and various adverse reactions. · Instructions for the use of oral oncology medicines in special populations are available with just one click. · Continuous update by the hospital pharmacists is required to ensure data accuracy and optimal use.
What next?
Our next mission is to promote this database to a broader population of patients through the development of specialised pharmaceutical services, and further expand into interactive communication between patients and healthcare professionals. We intend to regularly update it, as new medicines and information become available.
ARE YOU SURE HOW MANUFACTURERS WORK IN THE HOSPITAL PHARMACY CLEANROOM? THE USE OF TWO SIMPLE CHECKLISTS
European Statement
Patient Safety and Quality Assurance
Author(s)
Susana Redondo-Capafons, Laura Soriano, Carmen Roger, Oriol Arroyo, Raquel Mayoral, Ana Morales, Andrés Reyner, Marta Rueda, Rosario Bueno, Mónica Gómez-Valent, Andrés Joaquim Reyner
Why was it done?
In aseptic cleanroom environments, correct donning and doffing of personal protective equipment (PPE) and adherence to hand hygiene protocols are essential to prevent contamination and ensure both patient and operator safety. Despite existing standard operating procedures (SOPs), interindividual variability in compliance often remains undetected, increasing the risk of deviation from aseptic standards. Our pharmacy department identified the need for a practical tool to systematically monitor and improve these critical procedures. With the aim of continuous improvement in clinical practice and service quality, and in the context of incorporating new staff into the cytotoxic preparation area, this initiative was developed.
What was done?
Two structured checklists were designed and implemented to evaluate compliance with SOPs:
1. Donning and doffing of PPE – assessing sequence, technique, and timing.
2. Hand hygiene – assessing product use, duration, and areas of the hands washed.
How was it done?
The checklists were based on international guidelines (WHO, GMP) and local SOPs. Trained observers performed random assessments of pharmacy technicians during routine cleanroom entry and exit. Each step was scored for compliance, and procedure times were recorded.
What has been achieved?
The use of checklists enabled objective, individualized assessment of compliance. The mean compliance score for donning and doffing PPE was 9.4 ± 0.8, while for hand hygiene it was 8.9 ± 1.2. The 100% of pharmacy technicians acquired the minimum score established in the procedure (7/10). The main issues identified were related to the location where PPE was removed (17%), the duration of hand washing (25%), and the volume of alcohol-based hand rub used (42%). These findings guided targeted retraining sessions and continuous quality improvement actions. This approach increased awareness among staff and promoted more consistent aseptic practices in daily operations.
What next?
The checklists have been integrated into routine training and quality monitoring. They are easy to replicate in other hospital pharmacies with cleanroom facilities, requiring minimal resources. The initiative provides a model to strengthen aseptic procedures, reduce contamination risks, and enhance overall compliance with safety standards.
HARDENING THE SAFETY OF AUTOMATED DISPENSING CABINETS: ADDRESSING FAILURES AND PROPOSING A STRUCTURED IMPROVEMENT BUNDLE
European Statement
Patient Safety and Quality Assurance
Author(s)
Bennani I., Cherif Chefchaouni A., Alaoui S., Hajjaj S., El Deeb S., Boufaress S., Hafidi Y., El Merrakchi S., Moukafih B., Bandadi F., El Kartouti A.
Why was it done?
Despite their benefits, ADCs present critical vulnerabilities such as inappropriate overrides, stocking errors, look-alike/sound-alike (LASA) drug confusion, workarounds with barcoding, and incomplete profiling. These failures increase the risk of medication errors, stock mismanagement, and patient harm. A structured, universal improvement method was needed to mitigate risks and enhance sustainability.
What was done?
A safety improvement bundle (SAFE-6) was developed to address recurrent failures of Automated Dispensing Cabinets (ADCs) in clinical units. The approach targeted six critical areas: override governance, smart search and naming, barcode stocking verification, configuration hygiene, workflow integration with BCMA, and monitoring with downtime readiness.
How was it done?
A multi-step audit was performed to identify weaknesses in current ADC use. Root cause analysis guided the development of the SAFE-6 bundle. Each hospital unit implemented one improvement component at a time, followed by data collection and multidisciplinary feedback. Quantitative and qualitative indicators were monitored to evaluate safety gains and operational efficiency.
What has been achieved?
Implementation of SAFE-6 led to measurable safety improvements: reduction of inappropriate overrides, decreased inventory discrepancies through barcode verification, increased use of profiled dispensing linked to electronic prescribing, and reduction of LASA-related risks through smarter search functions. Staff acceptance improved with clear governance tools and training modules, and quality assurance indicators were integrated into routine audits.
What next?
The SAFE-6 approach will be expanded to intensive care and emergency departments, with inter-hospital benchmarking to validate scalability. Future steps include integration of advanced analytics to detect override anomalies and potential diversion signals, as well as collaboration with vendors to enhance user interfaces and standardisation of drug labelling.