IMPLEMENTATION OF A CRITICALITY TOOL FOR MEDICAL DEVICES IN A UNIVERSITY HOSPITAL
European Statement
Selection, Procurement and Distribution
Author(s)
C.ALINOVI, J.ZAMPA, D.PECANI
Toulouse University Hospital, FRANCE, Toulouse
Why was it done?
To set up tools to better manage medical device (MD) supply shortages, given the significant increase in the number of shortages in recent years.
What was done?
To better manage MD supply shortages in hospitals, a score has been developed to classify devices by their criticality during supply disruptions. This score considers various factors, such as : number of hospital departments using the product, average daily consumption rate, single-use vs. reusable nature of the product or Availability of alternatives.
How was it done?
A set of criteria and their interrelations were tested to establish a criticality score that categorizes MD into three levels : ‘supercritical’, ‘critical’, and ‘non-critical’. These categories reflect the potential impact on patient care in the event of a shortage. Thresholds, such as the daily consumption rate, were particularly important in defining this score.
What has been achieved?
To validate the scoring method, 33 combinations of criteria and 1,257 threshold variations were tested on a sample of 66 products. These products had previously been rated by expert pharmacists for criticality. Sensitivity and specificity calculations were used to compare the test results with expert evaluations. After testing, three combinations achieved the desired accuracy, and one of these was selected.
The final scoring method was applied to 764 MD in stock at the hospital, identifying 44 as ‘supercritical’. The security storage thresholds were increased for these 44 MD so that they would be less affected in the event of a shortage, and are MD targeted during order delays, so that they can be relaunched as a priority.
What next?
A similar scoring system will be developed for MD managed in non-stock mode to classify the most critical items in the event of a supply shortage.
ANALYTICAL CONTROL OF INJECTABLE PREPARATIONS: TAKE THE TIME TO ANALYZE YOUR ACTIVITY
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European Statement
Production and Compounding
Author(s)
Guillaume BOUGUEON1,2 ; Mélissa WANG1 ; Jean-Marc Bernadou1, Maîté Sangnier 1, Aude BERRONEAU1
1 Pharmaceutical Technology Department, Bordeaux University Hospital, Avenue de Magellan, 33604 Pessac, France
2 ARNA Laboratoire ChemBioPharm U1212 INSERM – UMR 5320 CNRS, Université de Bordeaux, France
Why was it done?
We work within a university hospital, in an injectable drug production unit. We produce around 55,000 preparations a year, and ten years ago decided to implement analytical control (identification and dosing) (i.e. HPLC then followed by UV-Raman spectrophotometry (QCRX®)) as a post-process control method. To date, around one hundred assays are carried out daily (representing 50% of preparations produced), and some thirty different active substances are analyzed.
For the past 4 years, a monthly meeting has been devoted to monitoring the compliance of analytical assays for our preparations.
What was done?
We felt it was essential to take a step back from our control activity, to enable us to monitor and analyze assay compliance in detail, to distinguish between preparation errors and errors linked to control equipment, and to detect upstream any deviations in assay methods or material damage.
How was it done?
Monthly one-hour meetings have been set up. These multidisciplinary meetings are attended by 6 people, including senior and student pharmacists, pharmacy technician and a laboratory technician.
During these meetings, the following are presented: the number of assays and their nature (1st assay or 2nd assay following a 2nd sample); the number of non-compliant assays (outside the limit of +/- 15% of the target concentration), the overall compliance rate; an analysis of rejected and destroyed preparations, with an investigation into the causes of non-compliance.
Corrective action may then be taken: early maintenance of equipment, quarantine of analytical methods and research into the causes of drift, implementation of new dosing methods. Feedback is then given to the whole team.
What has been achieved?
These monthly meetings have enabled us to anticipate analytical drifts and reinforce our team’s compliance to this type of control. They also enable us to limit the downtime of dosing methods and the need for double visual checks, a potential source of errors.
What next?
The aim is to eventually increase the proportion of analytical control to over 50% of preparations produced. This will involve the introduction of new dosing methods for preparations usually controlled by double visual inspection, and the acquisition of additional equipment
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.
RELOCATING A UNIVERSITY HOSPITAL’S INJECTABLE CHEMOTHERAPY PREPARATION PROCESS TO A MOBILE UNIT: A CHALLENGE MET!
Pdf
European Statement
Production and Compounding
Author(s)
K.LEROUET; M. DELAMOTTE; F.VITET. S.CRAUSTE-MANCIET; A.LEBRETON; F.LAGARCE
Why was it done?
Our Chemotherapy Reconstitution Unit (CRU) needed to replace its two double workstation isolators and high efficiency particulate air filters, taking the unit out of service for six weeks. With 40,000 injectable chemotherapy treatments performed each year, outsourcing was not an option. We had to find a solution to temporarily relocate the activity to a new area within our facility.
What was done?
Our aim was to ensure continuity of the manufacturing process for injectable anticancer drugs in accordance with Good Preparation Practices in a temporary CRU.
How was it done?
Eighteen months ahead of schedule, we set up multidisciplinary working groups consisting of pharmacists, pharmacy technicians, biomedical and technical service staff and health care managers.
Inspired by the few french hospitals that had already carried out this project, we studied the process and the choice of space and equipment required. We also drew up procedures and a backlog schedule.
What has been achieved?
Twenty-three work sessions of 1 hour were organised. We chose a chemo-truck (ModuGuard®), with three workstations inside two positive pressure isolators. We acquired new equipment to adapt to the spaces created specifically for this project (transport crates, walky-talkies, operating room gowns). We planned the qualification of the mobile grade D controlled area and isolators. The production flow was rethought, with extended production hours and more human resources. Our production was divided into 4 zones with different tasks: tray preparation and pharmaceutical validation, chemotherapy preparation, pharmaceutical release and preparation dispatch. Good communication between the different areas was essential to the success of our project. In comparison to the reference process, no additional non-conformity where noticed. We communicated with the care units many months ahead to anticipate logistic issues.
What next?
The overall feedback from the teams was good, thanks to the cohesiveness that was created, although staff were tired. No adverse events were reported, although occasional delays in preparation were noted. Anticipation of needs and day-to-day adaptability were essential to the success of this project. A budget of €80,000 was required to complete our project. This organisation allowed us to maintain a level of production equivalent to our CRU. This publication is intended to help inform healthcare organisations undertaking similar projects.
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.
DEVELOPMENT AND IMPLEMENTATION OF A POST-AUDIT IMPROVEMENT PLAN IN A PARENTERAL NUTRITION PRODUCTION UNIT
Pdf
European Statement
Production and Compounding
Author(s)
F. Gaume, A. Ifrah, S. Vrignaud
Why was it done?
In 2023, an evaluation of professional practices (EPP) targeting the risk of microbiological contamination was carried out in our parenteral nutrition production unit. This EPP took the form of an internal observational practice audit and revealed several non-conformities (compliance with disinfectant exposure time, identification of right times for change gloves and performance of surface sampling) requiring the implementation of a structured and collaborative improvement plan.
What was done?
From January to October 2024, an improvement plan in 3 phases has been performed.
How was it done?
Phase 1 – Audit results: Presentation to unit technicians by pharmacists, followed by a discussion session.
Phase 2 – Development of improvement actions: Brainstorming sessions with the team to generate ideas for corrective actions / Evaluation of proposals collected according to 6 criteria (speed, relevance, feasibility, motivation, safety and cost) using an impact matrix / Creation of a structured action plan based on the selected proposals.
Phase 3 – Implementation of actions: Creation of working groups / Monitoring of the improvement process / Development of a plan to assess the effectiveness of actions.
What has been achieved?
Phase 1 – Audit results presentation: 2 sessions were held in January 2024 with the 13 technicians of the unit. The discussions allowed us to discuss the non-conformities observed during the audit and ensured understanding of the challenges identified.
Phase 2 – Development of improvement actions: 2 sessions were held in March 2024 /10 improvement actions were listed and evaluated. 4 actions were considered as priority, 4 as recommended and 2 as non-priority / Setting up of a Gantt chart to give an overview of the actions to be carried out, their estimated duration and deadlines.
Phase 3 – Implementation of actions: implementation of the 4 priority actions and the 4 recommended actions / Creation of a quality document concerning glove changes and modification of 8 quality documents / Consideration of ways of evaluating actions: quick audit, questionnaire, etc.
What next?
As a follow-up to this work, a questionnaire will be prepared for the technicians to assess the overall approach. A quick audit focusing on glove changes will be introduced soon to assess the impact of the improvement plan.
EXPREM PROJECT: TRANSFORMING THE PHARMACEUTICAL EXPERIENCE FOR MULTIPLE SCLEROSIS PATIENTS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Ranz Ortega P; Martín Barbero ML; Escudero Vilaplana V; Lobato Matilla E; Carrillo Burdallo A; Del Barrio Buesa S; Herranz Alonso A; Sanjurjo Sáez M.
Why was it done?
The EXPREM project aimed to enhance the patient experience for individuals with Multiple Sclerosis (MS) undergoing pharmacotherapeutic follow-up at our hospital.The project involved designing a Patient Journey Map,conducting patient interviews at key touchpoints,and identifying strategies to improve service quality and patient satisfaction.
What was done?
Due to the chronic and complex nature of MS,patients often fase challenges throughout their healthcare journey.The fluctuating symptoms and long-term treatment regimens require frequent interactions with healthcare providers,making the patient experience a critical component of disease management.This project aimed to identify gaps in pharmaceutical care,improve service efficiency,and create a more patient-centered healthcare environment.
How was it done?
The project was conducted in five phases from January-April 2024:
1.Defining the pharmaceutical care process:a detailed map was designed to outline the pharmaceutical care process,including:before arriving at the pharmacy service(PS), patient visit and post-visit
2.Patient Interviews:three MS patients receiving treatment—one newly diagnosed,one with stable chronic treatment,and one with a recent medication change—were interviewed by a pharmacist in semi-structured,open-ended conversations to capture their perceptions and experiences with the Pharmacy Service
3.Direct Observation(SAFARI Method):the pharmacist working group simulated the patient experience to understand what patient hear,see and feel during their journey, identifying areas for improvement in the facility
4.Designing the Patient Journey Map:information from interviews and observations was used to create the Patient Journey Map,highlighting key areas for enhancement
5.Proposals for Improvement:based on the findings,specific actions were proposed to improve the patient experience
What has been achieved?
The project identified areas for improvement, such as:
Before arriving at PS
•The need for a digital appointment management system to reduce waiting times and and improve medication dispensing efficiency.
•Improvements in the physical infrastructure ensuring privacy,better signage,accessible facilities and developing health education programs,such as audiovisual health material for waiting times.
Patient visit and follow-up
•Expanding the use of health apps,videoconsultation to improve real-time communication and ensure the efficacy and safety of medication at home
•Home medication dispensing to save time and reduce costs for patients
What next?
The methodology will be shared with other pharmacy services for broader implementation and the impact of these improvements on patient satisfaction and health outcomes will be systematically evaluated
Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI
Why was it done?
It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.
What was done?
Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.
How was it done?
Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.
What has been achieved?
A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.
What next?
The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.
Acceptance of pharmaceutical interventions in a resuscitation unit
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Xabier Larrea Urtaran, Elisabet Nogué Pujadas, Alba Couso Cruz, Guillem Pla Escriva, Carol Batlle Perales, Carla Subirana Batlle, MIreia Bruguera Teixidor, Carmen Ortí Juan, Anna Dordà Benito, Mireia Vila Curris
Why was it done?
The aim of the study is to analyze pharmaceutical interventions (PI) carried out by a hospital pharmacist in a Resuscitation Unit (RU) in terms of number and degree of acceptance.
What was done?
The integration of a pharmacist in the critical care unit allows optimizing pharmacotherapy, prevent s medication errors in critical patients and working in a multidisciplinary methodology .
How was it done?
It is a prospective study carried out from 1 August 23 to 15 September 23 on weekdays, in which patients with a minimum of 48 hours of admission were included, recording the PIs conducted during the daily clinical activity of a pharmacist at the RU. The variables collected were: age, sex, type of PI, medication involved, acceptance of PI and day since admission. The percentage of acceptance of the PIs and activity indices (PI/patient, PI/days and day of PI in respect to admission to the RU were calculated. For the descriptive analysis, the means and standard deviation (SD) were used.
What has been achieved?
80 patients were included during a total of 31 weekdays, mean age ± SD of 59.6 ± 18.4, 46.3% were women (n=37). Patients had 8.9 ± 3.0 drug prescriptions and 3.8 ± 2.0 infusions and on-demand drugs. There were 5.9 patients admitted per day in the RU .107 IPs were carried out, with activity indices of 1.3 IP/patient, 3.45 IP/day and 3.21 IP days compared to admission to the RU.
The groups of drugs with the highest IP were: anti-infective agents for systemic use (n=57), blood and hematopoietic organs (n=17) and nervous system (n=15).
The interventions carried out were: adjustment of anti-infective therapy (n=21); pharmacokinetic adjustment (n=18); administration (n=17); conciliation (n=16); dose adjustment by glomerular filtration rate (n=16); dose adjustment (n=10); duplicity (n=5); no need (n=2); compounding (n=1) and allergy (n=1).
The degree of acceptance of the IP was 92.5% (n=99).
What next?
The acceptance of PIs in the RU is very high , being greater than 90%, with an activity of more than 3 PIs per day, reinforces the integration of a hospital pharmacist in a multidisciplinary team to ensure patient safety and improve the pharmacotherapeutic profile. It is necessary to have a pharmacists integrate in the RU.
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.