RISK-DRIVEN TRANSFORMATION: INTEGRATED RISK MATRIX WITH PDCA AND KPIS IMPROVES MEDICATION SAFETY AND OPERATIONAL PERFORMANCE
European Statement
Patient Safety and Quality Assurance
Author(s)
Vanusa Barbosa Pinto, Andréa Cássia Pereira Sforsin, Cleuber Esteves Chaves, Carolina Broco Manin, Priscila Faria França, Amanda Magalhaes Vilas Boas Cambiais, Carolina Ferreira Dos Santos, Lidiane Baltieri Gomes, Priscilla Alves Rocha, Maria Cleusa Martins
Why was it done?
The Pharmacy Division of a large tertiary hospital implemented structured risk governance, anchored by a risk matrix integrated into strategic planning and monitored by Key Performance Indicators (KPIs). The primary goal was to reduce risks across the entire medication use process—from selection to administration—using the matrix to guide continuous improvement cycles (PDCA) and ensure proactive, predictive risk management.
What was done?
Tertiary hospitals with complex medication processes often face a high incidence of adverse events and waste due to fragmented risk management. The aim was to proactively mitigate risks classified as high and extreme, not only enhancing medication safety but also improving efficiency and operational response time. The initiative also sought to strengthen the internal safety culture by encouraging increased near-miss reporting.
How was it done?
The project involved an end-to-end mapping of pharmaceutical care in 2024, with risk scoring (probability x consequence). Critical KPIs were defined: service level, prescription evaluation rate, adverse event reports for compounded products, and near-miss reports. Results were reviewed in multi-professional committees to guide PDCA improvement cycles. One specific action plan involved implementing Personal Digital Assistants (PDAs) in medication distribution to enhance traceability.
What has been achieved?
Between 2024 and 2025, the absolute number of risks classified as extreme decreased, and five risks reduced their criticality. The intervention demonstrated objective gains: service level increased from 77.82% to 84.40%; adverse event reports for compounded products decreased from 11 to 6; and the average monthly near-miss reports increased from 34 to 44, strengthening the safety culture. Notably, the PDA implementation contributed to the medication traceability rate increasing from 12.5% to 50.2%.
What next?
This governance model, focused on risk mitigation through PDCA cycles and critical KPIs, proved to be a practical and effective strategy for achieving sustainable gains in medication safety and efficiency. The practice is highly transferable and scalable, reinforcing the strategic role of the hospital pharmacy in integrating planning, quality, and technological innovation, and serving as a benchmark for other high-complexity institutions.
FAILURE MODE AND EFFECTS ANALYSIS OF A TERTIARY LEVEL HOSPITAL ANTIDOTE STORAGE
European Statement
Patient Safety and Quality Assurance
Author(s)
Sánchez Suárez MM¹, Montero Lázaro M², Martín Roldán A², Maganto Garrido S², Sánchez Sánchez MT²
Affiliations
¹Pharmacy Department, Hospital Comarcal de Baza, Granada, Spain
²Pharmacy Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
Why was it done?
Antidote availability is critical for the management of poisoning and overdose cases. Although hospital protocols for antidote use exist, they are often inconsistent or incomplete, and there is no universal consensus on the essential antidotes that hospitals should stock. This initiative aimed to assess and optimise the antidote inventory in a tertiary hospital to ensure adequate supply and management.
What was done?
A comprehensive review of all antidotes stored in the hospital pharmacy was conducted, focusing on quantity, expiry date, and compliance with national and international recommendations. A failure mode and effects analysis (MFEA) was developed to identify potential risks and propose corrective measures.
How was it done?
A prospective cross-sectional study was performed. The antidote stock was compared with reference lists from other hospitals and published guidelines to evaluate discrepancies in composition and quantities. Data accuracy in the electronic stock records was assessed, and errors in inventory management were categorised. Improvement actions included updating the antidote list, correcting electronic records, defining minimum and maximum stock levels, and implementing a poisoning management protocol. One year after these measures, the stock was re-evaluated.
What has been achieved?
The initial audit identified 48 antidotes (3 compounded formulations); 10% were out of stock, 16% below the required minimum, and 2% expired. Digital record review revealed 64% with data inconsistencies, including missing quantity limits, mismatched real and computerised stock, and incorrect expiry or batch details. After implementing corrective actions, no expired antidotes were found, only two compounded formulations were missing, and all others met minimum stock requirements.
What next?
Continuous monitoring of antidote stocks and regular data validation are necessary to maintain readiness for toxicological emergencies. Extending this model to other hospitals could support the establishment of unified national standards.
IMPLEMENTING FAILURE MODE AND EFFECTS ANALYSIS TO IMPROVE ISOLATOR HANDLING PRACTICES IN CHEMOTHERAPY PREPARATION: A TRANSFERABLE MODEL FOR HOSPITAL PHARMACIES
European Statement
Patient Safety and Quality Assurance
Author(s)
S. EL DEEB, I. BENNANI, A. CHERIF CHEFCHAOUNI, S. ALAOUI, S. HAJJAJ, S. BOUFARESS, S. EL MARRAKCHI, B. MOUKAFIH, F.Z. BANDADI, Y. HAFIDI, A. EL KARTOUTI.
Why was it done?
In the oncology pharmacy, isolators are vital for aseptic compounding and operator protection. However, daily handling steps can still introduce contamination risks and affect patient safety. We recognized the need to systematically analyse and minimize these risks, especially in a resource-constrained setting, to ensure safer and more standardized chemotherapy preparation practices.
What was done?
We applied Failure Mode and Effects Analysis (FMEA) to identify and reduce risks in isolator handling during chemotherapy preparation. The objective was to evaluate each step of the process, implement corrective measures to lower risk priority numbers (RPNs), and develop a practical model that could be shared with other hospital pharmacies.
How was it done?
An observational checklist was used to evaluate six key isolator handling steps: glove installation, surface cleaning, material transfer, logbook entry, waste removal, and glove removal. During 100 routine preparations, failures were recorded to calculate occurrence scores. Severity and detection were assessed by an interdisciplinary team, and risk priority numbers (RPNs) were obtained by multiplying severity, occurrence, and detection scores.
What has been achieved?
The analysis identified surface cleaning, material transfer, and glove installation as the most critical steps, with RPNs of 240, 210, and 144 respectively. These represented the main contamination and safety risks. After implementing targeted corrective actions, including improved procedures and staff awareness, we projected significant reductions in RPNs to below 80, confirming the effectiveness of the intervention.
What next?
We will continue to apply and monitor the corrective measures through updated SOPs, dedicated monitoring tools, and continuous staff training to ensure sustained improvement. This initiative offers a transferable model that other oncology pharmacies can adopt to harmonize practices and strengthen patient and operator safety in chemotherapy preparation.
Securing the management of experimental product in investigator services in case of non-nominative dispensing: a risk based approach
Pdf
European Statement
Patient Safety and Quality Assurance
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.
90% reduction of medication waste by reusing returned medication from medical wards
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Douwe van der Meer, Peder Nygard
Why was it done?
In our hospital 30% of the daily distributed medication for individual patients was not administered. Reasons for not administering were for example lack of need because of patients clinical performance, discontinuation of prescriptions or early discharge. Because of safety concerns, like mix-ups, our standard procedure was to discard all returned medication. This resulted in a waste of about 220.000 pills annually.
What was done?
We reduced medicine waste by 90% by reusing returned medication from our medical wards. With this result we made an important step for our hospital to meet the national sustainability goals in the Dutch ‘Healthcare Green Deal (3.0)’.
How was it done?
Reusing returned medication brings multiple safety concerns. By performing a prospective risk analysis we identified three major risks: mix-ups, expired medication and accepting non-qualitative packages (like slightly opened blisters or incomplete labels). With these risks identified we redefined our distribution process on four key elements: 1) Every medication has a barcode on unit level and if not, is labelled by our team through duplicating the ‘Falsified Medicine Directive’-barcodes to small 2D barcode labels which includes expiration date. 2) All returned medication is checked by a pharmacy employee on major quality aspects. 3) Returned medication is placed in a separate ‘return-box’ in front of the original stock inside the distribution cabinet. 4) Expiration dates are checked more frequently and are checked upon distribution and administration through barcode scanning.
What has been achieved?
The new distribution process was implemented in all of our eight distribution cabinets and resulted in saving 90% of the returned medication; witch amount to 200.000 pills and 70.000 euro savings annually. On average we work with 6 employees daily, who need 15 minutes extra per person per day to process returned medication.
What next?
Our goal is to save all returned medication that meets our quality standards. 5% of the returns that are not reused are medicines not included in the assortments of the specific distribution cabinet, so extra logistic and administrative steps are needed to place them back in the pharmacy stock. We are exploring new ways to make this next step in reducing medication waste further.