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DEVELOPMENT OF AN INFORMATIC SYSTEM FOR THE FOLLOW-UP OF PATIENT-REPORTED OUTCOMES FOR PEOPLE LIVING WITH HIV

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European Statement

Patient Safety and Quality Assurance

Author(s)

Feijoo-Vilanova P (1,3), Cid-Silva P (1,3), Mena de Cea A (3), Sanclaudio-Luhía AI (3), Luaces-Rodríguez A (1,3), Caeiro-Martínez L (1,3), Gómez-Costa E (1,3), Fernández-Diz C (1,3), Torres-Pérez A (1,3), Martín-Herranz I (1,3), Margusino-Framiñán L1,3

1. Pharmacy Department.
2. Informatic Department.
3. Research Group of Hospital Pharmacy. Biomedical Research Institute A Coruña (INIBIC). A Coruña University Hospital (CHUAC), Sergas. A Coruña University (UDC).

Why was it done?

An informatic program was developed for the clinical follow-up of clinical and patient-reported outcomes (PROs) of people living with HIV (PLWH) on antiretroviral treatment (ART).

What was done?

Pharmaceutical follow-up and outcomes research of PLWH must incorporate innovative solutions that allow the data optimization from electronic medical record (EMR) and PROs data, since traditional manual methods are insecure and inefficient.

Our objective is to describe a software (SiMON-PRO: Intelligent Monitoring System; acronym in Spanish) based on EMR data digitization and the PRO telematics data registry, and to describe the data collection procedure since June 2023.

How was it done?

A multidisciplinary group of clinicians (pharmacists and infectologists) transferred the following software requirements to the hospital’s informatic engineers: automatic incorporation of patient data from the EMR; generation of events related to clinical occurrences and alerts regarding the efficacy and safety of ART; documentation of pharmacist consultations; data analytics by business intelligence for investigational purposes.

Regarding the data capture procedure, during each visit to the outpatient clinic at hospital’s pharmacy department, a record is created that incorporates the latest digitized EMR data and the PROs data completed by patients on a mobile device, which is transferred to the software through a cyber-secure Wi-Fi connection and then to the EMR.

What has been achieved?

A software solution, SiMON-PRO, structured into six sections, was developed. 1/demographic data; 2/ epidemiology; 3/events; 4/analytics; 5/ART; 6/PROs questionnaires: about quality of life (EQ-5D-5L, HAT-QoL, MOS-HIV), chronic treatment acceptance (ACCEPT) and injection tolerance (PIN).

The software allows outcomes to be exported to the usual operating systems through Big Data and Business Intelligence. It also automatically generates alerts for assisted prescription validation and produces reports for exporting to the EMR.

What next?

SiMON-PRO is an innovative solution for the clinical follow-up and research of PLWH, increasing the quality, efficiency, and safety of healthcare. The following steps include the use of the data, events and alarms generated for better pharmaceutical care of PLWH and, gradually, design this software for other pathologies.

RISK ANALYSIS OF THE ADMINISTRATION CIRCUIT FOR ANTICANCER PREPARATIONS USING THE C-LOG® SYSTEM

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European Statement

Patient Safety and Quality Assurance

Author(s)

S. Arraki Zava (1), A. Kandel (1), S. Herioux (1), C. Monpagens (1), L. Capayrou (2), C. Tailhades (1), V. Grenouilleau (1), S. Ferrari (1)
(1) Pharmacy Department, Pau Hospital Center, 64000, France
(2) Quality Department, Pau Hospital Center, 64000, France

Why was it done?

In the current context of rising production of anticancer preparations (AP), our hospital has adopted the C-log® tool to improve the safety and traceability of AP administration.

What was done?

Evaluation of the integration of the C-log® solution into the AP administration circuit in the oncology day ward.

How was it done?

From June to September 2024, a risk mapping (RM) using FMEA (Failure Mode and Effect Analysis) for the AP administration circuit was conducted by a multidisciplinary team (quality and IT departments, hospital pharmacists, pharmacy technicians, logisticians, nurses, and healthcare managers). After evaluating the circuit, failures, their causes and effects were identified. A residual criticality score was calculated (C=F*S*M) for each failure, considering its frequency F, severity S, and level of control M, and classified into 3 categories: acceptable (C<4), vigilance (4≤C<10), unacceptable (C≥10). An action plan was developed with corrective measures (CM).

What has been achieved?

RM identified 39 failures: 34 acceptable, 4 unacceptable, and 1 classified as vigilance. First unacceptable risk was related to disruptive patient episode identifier (PEI) scanning due to wristband opacity. Another came from mismatches between the wristband PEI and that on the AP label, when patients had multiple administration days with different PEIs for each, while AP labels only contained the first PEI. Third one is related to nurse’s lack of training which led them to miss important administration information on the software. The last unacceptable risk was increased time to trace all protocol administrations (checkpoints, premedication, AP…). The vigilance risk was due to the inability to trace anticipated premedication intake on the software.
CM includes the use of clearer wristbands and permanent ID number instead of PEI solving unacceptable failures. We decided to use C-log® for AP administration traceability only, while CHIMIO® remains to trace all other protocol administrations. New training sessions for nurses will be scheduled.

What next?

RM highlighted C-log’s contribution to reinforce identity vigilance. It demonstrated the importance of nurse’s acceptance of the software and therefore the need for sufficient training time on the tool. Focusing on an entire protocol administration traceability, C-log® couldn’t replace CHIMIO® yet. Once all the CM are implemented, the RM will be re-evaluated to assess their impact.

PHARMACEUTICAL CARE FOR PATIENTS WITH NASOGASTRIC TUBES: HOW SHOULD I TAKE MY MEDICATION NOW?

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European Statement

Patient Safety and Quality Assurance

Author(s)

PAULA HERNANDO MARTÍNEZ, VIOLETA LAFARGA LAPIEZA, DAVID JAMES BOARDMAN GONZÁLEZ, GRACIA PICAZO SANCHÍZ, CARIDAD MARTÍ GIL, DOLORES BARREDA HERNÁNDEZ

Why was it done?

The administration of medications through NGT is a common practice in the hospital setting. However, it cannot be assumed that this route of administration shares same properties as the oral route. Proper administration requires considering the pharmacokinetic and pharmacodynamic proper1es and adapting recommendations to the medication’s pharmaceutical form(PF). Incorrect manipulation can lead to undesirable effects, such as a reduction or loss of therapeutic efficacy, as well as an increase in adverse effects, toxicity or mechanical, metabolic, and/or infectious complications.
Despite the wide bibliography on this topic, there is a lack of knowledge among patients, caregivers, and hospital staff when there is not adequate training on the use and care of the NGT.

What was done?

Development of a pharmaceutical care project for patients with nasogastric tubes(NGT) to ensure the proper administration of medications through the tube and their correct handling.

How was it done?

In May 2024, a working group of pharmacists was formed in the Hospital Pharmacy Department (HPD) with the aim of creating a protocol for the adjustment of medications for administered through a NGT in hospitalized patients. A document was developed with general recommendations on maintenance, interactions with drugs, food and enteral nutrition, aimed at patients, caregivers and healthcare professionals to ensure the correct use of the tube. Additionally, a literature review was conducted on the various available manipulation guidelines (Technical sheets, dysphagia Guide from La Paz Hospital 2021 and the Guide for Drug Administration through Tubes Reina Sofía Hospital 2023), as well as validated apps such as (Deglufarm®, Medisonda®) which provide handling and administra1on instructions for each PF.

What has been achieved?

A daily search was conducted for hospitalized patients with nasogastric tubes to identify the need of instructions on medication handling. A fillable document was designed with the necessary recommendations for the handling of each prescribed medication during the hospitalization. During the pharmaceutical validation, patients with NGT were reviewed, and personalized reports were created according to the prescribed treatments.

What next?

To evaluate the level of patient sa1sfaction and including new needs. In addition, the aim is to implement this protocol upon discharge, in order to offer a personalized report with recommendations for the prescribed medications.

OPTIMIZATION OF THE STERILIZATION CIRCUIT FOR SURGICAL INSTRUMENTS USING THE FMECA RISK ANALYSIS METHOD: EXPERIENCE OF THE CENTRAL STERILIZATION DEPARTMENT AT TANGIER UNIVERSITY HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

Hamza TAJRI, Abdelhafid BENOMAR, Houda ATTJIOUI, Majda BENABBES, Madiha ALAMI CHENTOUFI

Why was it done?

The sterilization of reusable medical devices is important for ensuring patient safety in hospital environments. However, the complexity of this process poses significant risks. The Failure Modes, Effects, and Criticality Analysis (FMECA) method offers a systematic approach to identify and mitigate these risks, thus enhancing the overall safety of sterilization practices.

What was done?

This work aimed to optimize the sterilization process at our hospital by applying the FMECA method. The focus was on evaluating each stage of the sterilization process, from pre-disinfection to storage and distribution.

How was it done?

A comprehensive FMECA was conducted on the eight main stages of the sterilization process: pre-disinfection, washing, rinsing, drying, packaging, sterilization, batch control and release, and storage and distribution. Each potential failure mode was evaluated in terms of severity (G), occurrence (O), and detectability (D) on a scale from 1 to 5, enabling the calculation of the Risk Priority Index (RPI).

What has been achieved?

The analysis revealed that contamination during drying and ineffective sterilization had the highest Risk Priority Numbers (RPNs), indicating the most critical risks in the process. As a result, these stages require special attention and priority corrective actions. The study also highlighted significant risks in other sterilization steps, underlining the importance of a comprehensive approach to risk management.

What next?

The application of FMECA has enabled us to identify critical areas within the sterilization circuit. Moving forward, we will implement targeted improvement strategies focusing on increased monitoring, preventive maintenance of instruments, and enhanced staff training, particularly regarding drying and sterilization processes.

RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

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European Statement

Patient Safety and Quality Assurance

Author(s)

A. HERREROS FERNÁNDEZ, P. FERNÁNDEZ-VILLACAÑAS FERNÁNDEZ, R. AÑEZ CASTAÑO, P. ORTIZ FERNÁNDEZ, M.A. MEROÑO SAURA, I. GARCÍA MASEGOSA, R. GUZMÁN LAIZ, P. SELVI SABATER, C. CABALLERO REQUEJO, L. RENTERO REDONDO, E. URBIETA SANZ.

Why was it done?

The preparation of sterile magistral formulas involves significant risks due to complex processes, material handling, and sterility requirements. A systematic risk assessment was essential to identify vulnerabilities, classify risk levels, and implement preventive measures to improve safety and compliance with regulatory standards.

What was done?

Sterile magistral formulas are personalized medications prepared in hospital pharmacy services to meet individual patient needs. In 2023, a risk matrix was implemented to systematically evaluate the risks associated with their preparation. This initiative aimed to enhance patient safety and ensure compliance with the “Guide to Good Practices for the Preparation of Medications in Hospital Pharmacy Services” (GGP).

How was it done?

Sterile magistral formulas prepared in the pharmacotechnics area of a hospital during 2023 were identified from a Microsoft Access® database. A Microsoft Excel® database was specifically designed to apply the GGP-based risk matrix, categorizing formulas into low, medium, or high risk. Each formula was evaluated across six key criteria: preparation process, route of administration, drug safety profile, number of units prepared, preparation vulnerabilities, and distribution process. Risk levels were assigned using a combination of letters (A-D) based on the matrix. Challenges included standardizing data collection and ensuring multidisciplinary collaboration to refine the matrix and ensure its applicability.

What has been achieved?

A total of 80 sterile magistral formulas were assessed. Of these, 38.75% were classified as medium risk, 36.25% as high risk, and 25% as low risk. Among medium-risk formulas, 67.7% included a “C” in the matrix, while 96.6% of high-risk formulas contained at least one “D.” The most frequent risk combinations were “BBAAAA” (11.25%) and “BBBAAA” (10%). The preparation process and administration route were the primary contributors to overall risk. Medium- and high-risk formulas, primarily intravenous mixtures of antibiotics and biological drugs, required preparation in a cleanroom environment, as recommended by the GGP.

What next?

This initiative demonstrated the value of a risk matrix in identifying and managing risks in the preparation of sterile magistral formulas. It represents a best practice model with significant potential for adaptation in other healthcare settings, enhancing patient safety and standardizing risk management in hospital pharmacy operations.

IMPLEMENTATION OF THE NOA-DIGITAL APPLICATION IN THE OPHTHALMOLOGY CIRCUIT: WHAT IS THE IMPACT?

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European Statement

Patient Safety and Quality Assurance

Author(s)

Catarina Diogo, Rui Caceiro, Catarina Canário, Sónia Camões, Sofia Bastos, Cláudia Silva, Maria Helena Duarte, Armando Alcobia

Why was it done?

To improve the medication circuit in Ophthalmology at our hospital—which has grown exponentially and was largely paper-based, and prone to errors—a digital application called NOA-Digital was developed in 2023.

What was done?

Assess the impact of implementing the NOA-Digital application.

How was it done?

A retrospective comparative study was done. Data was collected through the application and Excel files between June and August 2024 and the corresponding period of the previous year.

What has been achieved?

The use of the application eliminated paper prescriptions and their transcription to Excel files, which previously generated a document with over 120,000 fields filled by the pharmacist annually. In a total sample of 701 patients, 1,384 prescriptions were entered into the application, and 1,800 injections were prepared. The implementation of the application reduced by 80% the time pharmacists spent on administrative tasks. This was achieved through the automation and centralization of processes and easy access to information. The optimization of the workflow facilitated the inclusion and monitoring of more patients, leading to increased production. Additionally, it improved the pharmacist’s organization and availability, allowing for the refinement of production techniques, which optimized vial usage and generated savings (€27,058.50 – about 13%). The application also eliminated common errors from the previous system – incomplete and duplicate prescriptions – and provided access to previously unrecorded information.

What next?

The implementation of the NOA-Digital application proved to be an effective solution for improving the ophthalmic medication circuit, promoting greater safety, efficiency, and quality while contributing to cost reduction. Continued monitoring and analysis of its use is recommended to identify additional improvement opportunities and assess its adaptability for implementation in other pharmaceutical services.

BRAIN DEATH: RADIOCHEMICAL PURITY OF THE RADIOPHARMACEUTICAL 99mTc-HMPAO STABILIZED WITH COBALT

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European Statement

Patient Safety and Quality Assurance

Author(s)

Diana Monteiro
Luísa Álvares
Sara Brandão Madureira
Patrocínia Rocha

Why was it done?

The confirmation of a clinical diagnosis of brain death requires the demonstration of the cessation of brainstem functions and their irreversibility. Therefore, when this evaluation is incomplete or unreliable, it is necessary to support this diagnosis using diagnostic tests such as brain perfusion SPECT. This is performed after the injection of the radiopharmaceutical technetium-99m hexamethylpropyleneamine oxime (99mTc-HMPAO) and by assessing the obtained images for the lack of cerebral perfusion to confirm the diagnosis.
Given the importance of reliable results, a high radiochemical purity of 99mTc-HMPAO is imperative in quality control to prevent false positives.

What was done?

Selection of a method to evaluate the radiochemical purity of 99mTc-HMPAO.

How was it done?

A literature review was conducted to select the most suitable method for the conditions existing in the institution. The research focused on the Summary of Product Characteristics (SmPC), the European Pharmacopoeia (Ph. Eur. 11.0), the United States Pharmacopeia (USP 42) and several published articles.
After selecting the method, three assays were performed to validate it.

What has been achieved?

For evaluating the radiochemical purity of 99mTc-HMPAO, both the SmPC and Ph.Eur. 11.0 recommend a combination of two thin-layer chromatography (TLC) methods with a high-dimension stationary phase, for which the institution does not have a chromatographic tank.
The USP 42 describes a combination of three TLC methods, using acetonitrile as the mobile phase, which is also unavailable at the institution.
In contrast, the miniaturized method by Fuente et al. uses two TLC methods, with a silica gel stationary phase and sodium chloride (0.9%) and methyl ethyl ketone as mobile phases. This method was selected given that the institution has the required phases, the stationary phase dimensions are suitable for the available chromatography tanks and the execution time for the assay is feasible.
For method validation, three assays were conducted, yielding values exceeding 80% (the reference value).
The selected method represents a rapid, reproducible and reliable alternative for evaluating the radiochemical purity of 99mTc-HMPAO. It was implemented in the institution in October 2022.

What next?

In the future, we aim to develop quality control methods for all radiopharmaceuticals in use at the institution, in order to guaranty the quality of all the exams performed.

OPTIMIZATION OF THE ADMINISTRATION METHOD FOR LUTETIUM (177Lu) OXODOTREOTIDE IN THE TREATMENT OF NEUROENDOCRINE TUMORS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Luísa Álvares
Sara Brandão Madureira
Diana Monteiro
Patrocínia Rocha

Why was it done?

Lutetium (177Lu) oxodotreotide is indicated for treating subtype 2 somatostatin receptor-positive (SSTR2) gastroenteropancreatic neuroendocrine tumors, well-differentiated G1 and G2, progressive, inoperable or metastatic. This radiopharmaceutical targets cells with SSTR2 overexpression, emitting radiation that causes cell death.
Initially, the Summary of Product Characteristics (SmPC) included the gravity method for intravenous administration, using a system with two needles, one connected to a NaCl 0.9% solution, with or without a perfusion pump, using gravity to facilitate the flow of the radiopharmaceutical.
This method was adopted and optimized due to incidents during administration.

What was done?

Optimization of the administration method of lutetium (177Lu) oxodotreotide to maximize the administered radioactivity and enhance protection for healthcare professionals.

How was it done?

The first administration using the described method occurred in October 2022.
Subsequent treatments required transferring the radiopharmaceutical to a syringe and using a syringe pump due to incidents during administration.
A perfusion pump was later introduced to manage the flow of NaCl 0.9% solution.
In May 2024, a three-way stopcock was connected to the short needle.

What has been achieved?

Since October 2022, 23 administrations have been conducted. In the first, the percentage of remaining radioactivity in the vial was 2.19%.
The use of a syringe pump increased handling and exposure risks and was rejected due to the lack of protective barriers.
Adding a perfusion pump to the NaCl 0.9% line didn’t fully resolve perfusion issues. This was resolve by adding a three-way stopcock connected to the short needle. The additional third line allows for a syringe to be attached and force air into the system, promoting the radiopharmaceutical flow.
The average remaining radioactivity improved from 1.71% to 0.98% after final optimization.
No incidents, such as leaks or perfusion issues, occurred after optimization.
This optimization reduced the remaining radiopharmaceutical activity values, ensuring complete administration. It also minimizes professional exposure and contamination risks, as the radiopharmaceutical remains in the original vial, as indicated in the SmPC.

What next?

We aim to apply this optimized method in other treatments with the same radionuclide.

EVALUATION OF PROFESSIONAL PRACTICES: CLINICAL AUDIT OF DRUG PREPARATION AND ADMINISTRATION IN A NURSING HOME

European Statement

Patient Safety and Quality Assurance

Author(s)

Gulseren Lafci
Magali Ferro
Valerie Chaminant

Why was it done?

In accordance with french legislation concerning the quality of drug management in healthcare establishments, an assessment of professional practices was carried out within our nursing home. The aim was to study the compliance of drug preparation and administration methods with good practice in our nursing home.

What was done?

A clinical audit has been set up in our nursing home. It was carried out by 2 hospital pharmacists over 3 half-days to consider the preparation of weekly doses, daily doses, and an administration.

How was it done?

One of the 4 sectors of the nursing home was randomly selected. The medication management of all its residents was evaluated. The evaluation criteria were divided into 2 main parts: “drug preparation” and “drug administration”. The part on drug preparation was divided into 4 sub-sections (person in charge of preparation, room and hygiene, preparation, conditioning). The part on drug administration was also divided into 4 subsections (concordance between prescription and administration, identitovigilance, administration, traceability).

A criterion was defined as compliant if all the responses to the items were in line with the procedure, and as non-conforming if only one of the responses was not.

A conformity rate was defined for the entire audit (overall conformity), for each part (partial conformity) and sub-part (average conformity).

What has been achieved?

The care of the 19 residents in the sector was assessed (23.4% of nursing home residents).

The overall conformity rate of our clinical audit was 38.6%. Partial conformity of the “drug preparation” part was 32.3% (the average conformities of sub sections were: 50% for “person in charge of preparation”, 25% for “premises and hygiene”, 22.5% for “preparation” and 56.25% for “packaging”). Partial conformity of the “drug administration” part was 47.8% (the average conformities of sub-sections were: 100% for “concordance prescription/administration” and “identitovigilance”, 27.3% for “administration” and 42.8% for “traceability”).

What next?

The majority of non-conformities were due to a lack of human and material resources. In addition, a lack of knowledge was observed for substitution equivalence and galenic. The results were presented and proposals for improvement, such as raising staff awareness and providing resources, were made to the hospital’s medical committee.

Initiative for sequential antibiotic therapy: enhancing antimicrobial stewardship in hospitalised patients

European Statement

Patient Safety and Quality Assurance

Author(s)

Ignacio Javier Tamboleo Sánchez, Julia Fernández Vela, Fernando Lago Ballester, Mª CARMEN MIRA SIRVENT, Elena Conesa Nicolas

Why was it done?

The initiative started in October 2022, it was a response to the challenges associated with prolonged intravenous antibiotic use. The overarching goals were to enhance patient care, mitigate unnecessary intravenous antibiotic prescriptions, and foster a culture of responsible antimicrobial stewardship. Recognizing the need for a systematic and collaborative approach, the Antimicrobial Stewardship Program (ASP) pharmacist played a central role in implementing interventions across various medical specialties, with a clear focus on improving patient outcomes.

What was done?

The initiative promoted the adoption of sequential antibiotic therapy among hospitalised patients undergoing intravenous treatment for more than three days. Leveraging the Wise Antimicrobial Stewardship Support System® (WASPSS®) and detailed analysis of medical records, the programme identified eligible patients based on criteria such as clinical stability, oral bioavailability, infection specifics, and antibiotic suitability.

How was it done?

The ASP pharmacist’s central role proved instrumental, with 74% of alerts resulting in actionable recommendations. WASPSS® detects every patient with intravenous antibiotic more than 3 days and the ASP pharmacist decides which patients will benefit from sequential therapy. Choosing the recommendation criteria is essential to have a good response from medical specialties ensuring a more efficient and tailored approach to intervention implementation. The main obstacles to the introduction of this initiative were the establishment of refined communication routes and the targeted training to the different specialties which are not yet fully implemented.

What has been achieved?

Results revealed that 74% of alerts met the criteria for transitioning from intravenous to oral administration. Among the 573 alerts reviewed, 45.1% witnessed a successful switch to oral antibiotics, 21.2% showed no change, and 16.7% of patients were discharged. Notably, higher acceptance rates were observed in specific specialties, such as pneumology (61.3%) and general medicine (54.4%). Nevertheless, oncology (35,3%) general and digestive surgery (25,8%) had the lowest acceptance rate. In conclusion, the global acceptance rate was lowest than expected (43,8%) but there are many improvements measures that are being carried out.

What next?

This initiative serves as a beacon for responsible antibiotic management, making noteworthy contributions to patient safety, cost-effectiveness, and the overall quality of healthcare delivery. Recommending ongoing collaboration, continuous training, and regular analysis of recommendation criteria will enhance its impact.