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.
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.
Analysis of quality indicators in the compounding area through a mobile application
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
To identify improvement opportunities in the Pharmacy Compounding Area through the analysis of indicators obtained from a traceability App.
What was done?
In 2022, a mobile application (App) was designed and implemented to facilitate the traceability of preparations compounded in the Pharmacy (parenteral nutrition, chemotherapy and other individualized sterile preparations). In addition, the analysis of data registered in the App has provided valuable information about the compounding unit performance.
How was it done?
Monthly reports from May to December 2022 were analysed, focusing only on chemotherapy preparations. The indicators selected were: the average number of monthly preparations, weekly workload distribution, daytime distribution of compounded preparations, preparations returned to the Pharmacy, percentage of treatments prepared on the same day of administration, and percentage of preparations compounded after the scheduled administration time.
What has been achieved?
An average of 139 chemotherapy preparations per day was recorded. The daily distribution highlights that Thursdays and Fridays are the busiest days with the 45% of the total weekly preparations. Furthermore, the morning shift carries out most of the compounding work, with 79% of the preparations being compounded before 3 PM. This information might be useful to the management team to better distribute tasks and resources. Data analysis indicates that 62% of the preparations are compounded in advance, while the remaining 38% are prepared on the same day of administration, which is also valuable information to organize the compounding workflow. On average, 59 preparations were returned per month. Finally, we found that 8.1% of the chemotherapy drugs were prepared with a median delay of 47 minutes from the expected time of administration. All these items are currently being monitored as quality indicators in order to find the way to minimize them.
What next?
The analysis of data recorded in the App provides us valuable management indicators for organizing work in the preparation area.
Tracking these indicators serves as a quality tool for the area and helps us identify opportunities for improvement.
Application of new indicators of antimicrobial agent use based on consumption in a tertiary hospital
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Saúl Herrera Carranza, Carlos Sanz Sánchez, Sira Sanz Márquez, José Francisco Valverde Cánovas, Leonor Moreno Núñez, Ana Vegas Serrano, Rafael Hervás Gómez, Oriol Martín Segarra, Juan Emilio Losa García, Montserrat Pérez Encinas
Why was it done?
Spanish Society of Hospital Pharmacy(SEFH) proposed 13 indicators(bibliography:Gutiérrez-Urbón JM, Gil-Navarro MV, Moreno-Ramos F, Núñez-Núñez M, Paño-Pardo JR, Periáñez-Párraga L. Indicators of the hospital use of antimicrobial agents based on consumption. Farm Hosp. 2019;43(3):94-100) which could help to improve the quality of antimicrobial use.
Indicators are related directly(dir): higher value-better practices; indirectly(ind):lower value-better practices; or heterogeneity: homogeneous percentages(%)-better practices.
What was done?
The creation of a tool for calculating new indicators of antimicrobial agents based on consumption using Defined Daily Dose per 100 hospital stays(DDD/100s).
How was it done?
We built an Excel tool to input required data in order to calculate the indicators with the formulas defined for their automated estimation:
-Overall antibacterial consumption(ind)
-Overall consumption of antifungals(ind)
-Consumption of carbapenemics(ind)
-Consumption of fluoroquinolones(ind)
-Ratio macrolides-p/fluoroquinolones-p(dir)
-Ratio metronidazole-p/piperacillin-tazobactam+carbapenemics(dir)
-Fosfomycin consumption(dir)
-Sequential therapy(dir)
-Ratio anti-SRSA/anti-MRSA agents(dir)
-Ratio amoxicillin/amoxicillin-clavulanic acid(dir)
-Ratio amoxicillin-clavulanic acid/piperacillin-tazobactam(dir)
-Diversification of anti-pseudomonas beta-lactam(heterogeneity): %anti-pseudomonal carbapenemics, %piperacillin-tazobactam and %anti-pseudomonal cephalosporins+aztreonam.
— Ratio fluconazole/equinocandins (dir)
DDD/100s for the years 2018-2022 were calculated in order to see the annual evolution. Required data: antibiotic (ATC Group: J01) and antifungal (ATC Group: J02) consumption by drug and route of administration (oral (o), parenteral (p) and others). Calculation of DDD/100s according to grammes consumed (obtained with Hospital Pharmacy software) and ATC/DDD-Index (World Health Organization). To visually analyse results, graphs were included.
What has been achieved?
We realised that our hospital improved by decreasing consumption of antibacterial, antifungal, carbapenemics and fluoroquinolones; and so, an early parenteral-oral switch.
However, the other ratio-based indicators are stable or worsening yearly: macrolides-p/fluoroquinolones-p, metronidazole-p/piperacillin-tazobactam+carbapenemics, fosfomycin consumption, anti-SRSA/anti-MRSA agents, amoxicillin/amoxicillin-clavulanic acid, amoxicillin-clavulanic acid/piperacillin-tazobactam, fluconazole/equinocandins and diversification of anti-pseudomonas beta-lactam.
What next?
These indicators provide possible improvement actions to enhance the use of antimicrobial agents. Consumption of fosfomycin or amoxicillin/amoxicillin-clavulanic acid ratio should be cautiously analysed due to outpatient (or in emergencies) management of uncomplicated infections. As improvement actions in our hospital, increase the use of metronidazole-p in anaerobic infections or cloxacillin and cefazolin de-escalation can be promoted as soon as sensitivity is confirmed by antibiogram-test. Diversify antibiotic pressure on pseudomonas, trying to reduce piperacillin-tazobactam by prescribing ceftazidime or cefepime, and reserving aztreonam for beta-lactams allergics. Similarly, decrease piperacillin-tazobactam use by prescribing amoxicillin-clavulanic acid if anti-pseudomonal coverage is not necessary.
Implementation of a dashboard within a quality management system in the pharmacy department
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.
What was done?
The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.
How was it done?
The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.
What has been achieved?
Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.
What next?
These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.