THE CLINICAL PHARMACEUTICAL SERVICE IT TEAM: ENHANCING MEDICATION WORKFLOWS AND PATIENT SAFETY IN EPIC
European Statement
Patient Safety and Quality Assurance
Author(s)
Christina Theil Schnor and Saranya Loganathan.
Why was it done?
In 2018, hospitals in Region Zealand (RZ), Denmark, transitioned to the electronic health record (EHR) system, EPIC. Following this, hospital pharmacists faced repeated medication order challenges causing adverse events such as inappropriate medication orders, dispensing and administration errors, and insufficient workflow coordination. These issues resulted in complex, time-consuming workflows impacting quality and patient safety. Additionally, collaboration between corporate IT and clinical staff was challenged by a lack of understanding of practical issues. To address this, pharmacists of RZ established the Clinical Pharmaceutical Service IT Team (CPS IT Team) to build specialised knowledge of the EHR medication module, aiming to assure quality, optimise workflows, strengthen interdisciplinary coordination, and support safer and more efficient clinical use.
What was done?
CPS IT Team standardised workflows, enhanced coordination of medication order tasks, and created a forum to effectively utilise professional knowledge and networks across areas.
How was it done?
To address diverse Clinical Pharmacy challenges, CPS IT Team became the bridge between internal organisation (RZ Hospital Pharmacy and corporate IT) and external partners (EPIC and The Capital Region of Denmark (CRD)). For this reason, CPS IT Team was established with one team manager and two units: Internal and External unit. CPS IT Team continuously adapts to evolving Clinical Pharmacy needs.
What has been achieved?
The establishment of CPS IT Team has driven significant internal optimisation and standardised workflows. Acting as a coordinating unit, it optimises medication processes from ordering to dispensing and administration. Dialogue with IT has been strengthened, enabling more efficient, targeted communication across professional groups.
Collaboration with EPIC and CRD has enhanced quality assurance and optimised workflows. CPS IT Team efforts have helped prevent medication-related adverse events, improve workflows, and optimise medication processes. Interdisciplinary collaboration and professional consultation networks between regional clinics, hospital pharmacies, IT, and EPIC have been notably strengthened. These efforts have increased patient safety and fostered a safer, more coherent workflow in EPIC.
What next?
Fusion of RZ and CRD into Region Eastern Denmark will change CPS IT Team’s working conditions, opening new opportunities such as an expanded collegial network and broader range of tasks and needs. Systematic data use will support Hospital Pharmacy’s work, improving efficiency and quality in daily operations.
OPTIMIZATION OF PATIENT RECRUITMENT IN CLINICAL TRIALS THROUGH ARTIFICIAL INTELLIGENCE INTEGRATION (TRIALGPT PROJECT)
European Statement
Education and Research
Author(s)
Laura Maldonado Yagüe, Claudia Ramos Álvarez, Ana Herranz Alonso, Fernando Bustelo Paz, Eva González-Haba Peña, María Sanjurjo Saez
Why was it done?
Patient recruitment is still nowadays one of the barriers that the clinical investigation encounters: almost 80% of the clinical trials experiment delays and around 30% close due to the difficulties to identify candidates. Currently, the recruitment process in many of the hospital sites is based on the manual review of electronic medical records (EMR), which results in higher workload and higher errors and omissions. This tool aims to reduce manual screening time by 50% and increase recruitment by 20% always ensuring regulatory compliance (ICH-GCP, RGPD and national biomedical investigation laws).
What was done?
The Pharmacy Department led the initiative to evaluate TrialGPT, an Artificial Intelligence (AI) system designed to optimize clinical trials patient recruitment, in the hospital setting. Natural Language Processing (NLP) and Large Language Model (LLM) are advanced techniques used by TrialGPT which enables the automatic detection of potential eligible patients through their Electronic Medical Records (EMR) matching their profile to the inclusion and exclusion criteria for each clinical trial.
How was it done?
The project was coordinated by a Clinical Trials Unit of a tertiary hospital with multidisciplinary collaboration between pharmacist, investigators and IT specialists. Anonymized data of 50 active clinical trials from oncology, neurology and rare diseases areas were used. Technical challenges such as data heterogeneity, algorithmic bias and staff acceptance were encountered, in order to address these, an iterative training model, multidisciplinary workshops and ethical evaluation were used.
What has been achieved?
Preliminary simulations indicate that TrialGPT is able to reduce half the necessary time for patients screening and improve recruitment efficiency without compromising data security or clinical precision. The model achieved high sensitivity and specificity identifying eligible patients, demonstrating a high potential to optimize hospital investigation flowcharts.
What next?
A validation phase will evaluate the real-world performance and scalability in multiple sites. This initiative exemplifies an innovative digitalization and automatization of a process which could be transferred as a model for European hospitals in order to improve patient access to clinical trials, thus, advanced therapies.
SOFTWARE FAILURE IN A RADIOPHARMACY: IMPLEMENTATION OF A BUSINESS CONTINUITY PLAN AND DEVELOPMENT OF SUPPORT TOOLS
European Statement
Patient Safety and Quality Assurance
Author(s)
A. BRUYÈRE1, A. DESCHAVANNES1, C. RIOUFOL2, M. PIQUEMAL1.
1GROUPEMENT HOSPITALIER SUD – HOSPICES CIVILS DE LYON, RADIOPHARMACY, LYON, FRANCE.
2GROUPEMENT HOSPITALIER SUD – HOSPICES CIVILS DE LYON, PHARMACY, LYON, FRANCE.
Why was it done?
Following an IT failure in our radiopharmacy and nuclear medicine departments, the professional software system became unavailable for over two hours. This incident led to the establishment of a Business Continuity Plan (BCP) to ensure preparedness for similar future events. The BCP aims to guarantee the resumption and continuity of operations in the event of disruptive situations.
What was done?
This study aims to ensure operational continuity and safety of radiopharmaceutical workflows during IT failures through the development of a BCP and support tools.
How was it done?
A multidisciplinary staff meeting, using a Focus Group approach, was organized to reach a consensus on service organization during degraded operating conditions. The workflows of both radiopharmaceuticals (RPs) and patients were analyzed. A feedback analysis of the initial incident was also conducted to adjust the proposed tools to daily operational constraints.
What has been achieved?
A specific procedure was developed, detailing the overall organization of the department during degraded conditions and defining the tasks of each professional group: patient reception, paper-based prescription, scheduling of injections and imaging sessions, RP preparation, quality control, dispensing, and traceability. Paper versions of all necessary documents were compiled into a “BCP binder,” including pre-filled labels, RP quality control batch records, prescriptions, and dispensing registers. A preparation support chart for RP activities was also included. Additionally, digital tools were designed to support dispensing, such as an Excel spreadsheet allowing automated decay calculations and volume determinations for each dispensation.
What next?
This organizational work, along with the development of both paper-based and digital tools, has strengthened the safety and continuity of the RP circuit during IT outages. However, real-life testing of the BCP is required to confirm its feasibility. Given their reliance on digital systems, professionals may face adaptation challenges in crisis situations, increasing the risk of error. Regular training sessions and simulation exercises are therefore essential to ensure BCP effectiveness. In parallel, a broader BCP is being developed to address other identified risks, including cybersecurity threats, network failures, and equipment or facility malfunctions (e.g., automated system breakdowns or air supply interruptions).
DETECTION OF PHARMACOKINETIC/PHARMACODYNAMIC DRUG INTERACTIONS OR PATHOPHYSIOLOGICAL CONTRAINDICATIONS WITH INJECTABLE CHEMOTHERAPIES: IMPLEMENTATION OF THE SOFTWARE PHARMACLASS® IN ONCOLOGY
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry
Why was it done?
Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.
What was done?
Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.
How was it done?
An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.
What has been achieved?
Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.
What next?
Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.
COMPUTERIZED QUALITY CONTROL OF THE TABLET SPLITTING PROCESS
Pdf
European Statement
Production and Compounding
Author(s)
María Lourdes Recio Blázquez, Alberto Pérez Morales
Why was it done?
It was necessary to establish a quality control of this pharmaceutical process.
What was done?
A computer method of gravimetric quality control of the tablet splitting process was designed.
How was it done?
The procedure consists on a precision scale connected to a computer in which, according to the uniformity of mass assay of the European Pharmacopoeia, the weights of 20% of a batch of whole tablets destined to be split are automatically recorded in a spreadsheet, carrying out the following formulas:
=AVERAGE: provides the average weight of the sample of whole tablets.
=MAX and =MIN: selects respectively the largest and the smallest of the weights.
=STDEV: calculates the standard deviation of the sample weights.
With the average weight of the whole tablets, the theoretical weight of the half-tablets is calculated, establishing a maximum and a minimum admissible limit with the following formulas:
=AVERAGE(whole tablets)/2: determines the theoretical average weight of each half-tablet.
=AVERAGE(whole tablets)/2 ± 7.5%: establishes upper and lower gravimetric limits that cannot be exceeded by any half-tablet.
All the half-tablets need to be weighted, as the tablet-splitting process is carried out tablet-by-tablet and this modus operandi is not reproducible enough. In case of non-compliance with maximum and minimum weight criteria, the half-tablet must be discarded.
Conditional functions were established such that the spreadsheet itself reflects the half-tablet acceptance/rejection decision.
Basic technical computer skills, training in the technique of tablet splitting, appropriate clothing and environmental measures to avoid risks to the operator and the medications are required.
What has been achieved?
Since 2015, two different medicinal products were subjected to the tablet splitting technique. A total of 10,536 halves of suitable tablets were obtained, which permitted safe dosing at lower doses than commercialized, and also generated a financial asset of 101,724 Euros. 566 halves were discarded. The splitting efficiency was of 94.9%.
What next?
This quality control procedure is applicable to all divisible solid oral dosage forms. The standardization of the technique and the quality controls will allow to extend it to other medicinal products with dosing and economic purposes.
INTEGRATION OF THE PHARMACEUTICAL CARE RECORD INTO THE MULTIDISCIPLINARY ELECTRONIC OUTPATIENT RECORD
European Statement
Patient Safety and Quality Assurance
Why was it done?
So far, only pharmacists could access the pharmaceutical care record. The creation of the electronic medical record in the Health System has allowed patient data to be centralised and can be accessed easily and quickly. It is an opportunity to integrate our care service as pharmacists within the multidisciplinary care as well as to facilitate data consultation to other professionals that care for the same patient.
What was done?
Integrate the outpatient pharmaceutical care record to the electronic patient record via an application form included in the process of each pathology.
How was it done?
First question was where the application form should be included when the patient came in for a consultation. In order to unify all the actions relating to the process, it was decided to include the form in the main process instead of creating a specific process for the pharmacy department. For example, a form for an HIV patient should be included in his Infectious Disease Consult process.
Another issue was to define what items should be taken into account for the follow up.
Finally, the following items were included: reason for the visit, pathology, clinical data, outpatient treatment, regular treatment, drug-related problems, adverse drug allergies/past issues, adherence, checks to mark whether the patient has received the oral and written information, the leaflet from the host to the Outpatient Pharmacy Service and a free text to write down given recommendations.
What has been achieved?
Improvement of patient care, increased safety in the use of drugs and in the avoidance of medical errors has all been achieved, as well as the promotion of teamwork amongst professionals who attend to the patient. From the information technology perspective, data export can be provided for future researches.
What next?
All professionals should integrate their activities to take advantage of collaboration and increasing synergies.