The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Early access to the drug: the role of the pharmacist in the management of CNN drugs in oncology
European Statement
Introductory Statements and Governance
Author(s)
Aldo De Luca, Andrea Ghiori, Cecilia Orsi, Michele Cecchi
Why was it done?
CNN drugs are drugs that have obtained authorisation from EMA and AIFA (Italian drugs authority) but that have not been negotiated for the purposes of the reimbursement of the National Health System. These drugs are often clinical innovations that fill therapeutic gaps. In our Region, access to these therapies is allowed only on a special request made by the clinicians at the Pharmacy that is evaluated positively, presents it to the Regional Authority. The regional assessment is also implied by the presence of specific contractual agreements with the pharmaceutical companies. Requests have been considered for enfortumab vedotin (EV), indicated for urothelial carcinoma, and trastuzumab deruxtecan (T-DXd), indicated for breast cancer. The objective of this article is to highlight the activity of the pharmacist in the management of drugs in the CNN range.
What was done?
A pathway has been developed at regional level to promote early access to new drugs and further therapeutic possibilities.
How was it done?
All requests for CNN drugs received in the semester November 2022 to May 2023 to our Operations Unit and subsequently included in the regional portal were analysed on the basis of approved indications, bibliography, clinical reports, and eligibility card (for T-DXd only) validated by the medical division of the pharmaceutical company.
What has been achieved?
During the period analysed, 25 applications were made (11 for EV, 14 for T-DXd) for a total of 30 treatments (11 for EV, 19 for T-DXd). Of the 25 requests received by the Pharmacy, 24 (96%) were sent to the region for treatment authorisation; one was not submitted because the patient did not comply with the approved indication. We obtained 100% of the required treatment approvals.
What next?
The hospital pharmacist is configured as a collector of clinical requests with an important function as a filter of prescriptive appropriateness in requesting regional authorisation for the treatment of drugs in the CNN range; moreover, the pharmacist is a necessary reference figure between the need for clinical innovation and the need to guarantee sustainability of the system in order to ensure early access to innovative therapeutic opportunities. This model could be exported to other regions at national and European level.
Rethinking pharmacy and therapeutics committee procedures to achieve the efficiency required to overcome hospital complexity
European Statement
Clinical Pharmacy Services
Author(s)
Sara Rodrigues, Sofia Pinheiro, Vandewalle Björn, Paulo Martins, Sofia Ferreira, Paulo Pereria, Jorge Félix
Why was it done?
Shared decision-making between pharmacists and physicians is key to PTC functioning and efficiency. Responsibilities include managing policies and procedures for appropriate use of high quality and cost-effective health technologies at hospitals. PTC performance is paramount to overall hospital efficiency.
What was done?
This project seeks to assess and redesign (optimize) existing Pharmacy and Therapeutics Committees (PTC) procedures within a University Hospital Centre (UHC – six public hospitals). The goal is to enable sound decision-making that significantly contributes to UHC key performance indicators, all while ensuring timely patient access to effective medication.
How was it done?
The project comprises four phases: (1) gathering feedback from stakeholders (PTC members; hospital service/pharmaceutical department directors) regarding their current involvement in PTC information flows, procedures, and decision-making; (2) developing a value-based criteria-matrix, across stakeholders, in a multiple-criteria decision analysis context, to guide future PTC decision-making; (3) rethinking PTC procedures and information flows; (4) assessing the effectiveness of the redesigned PTC model after 12 months. First phase included: a Likert-scale based survey1 for PTC members to evaluate their involvement in activities described in the internal PTC regulation, and a semi-structured interview-based survey2 for all stakeholders to characterize existing information flows and PTC mediated decision-making processes.
What has been achieved?
First phase: eight of 10 PTC members participated in survey1. Activities with 100% engagement of PTC members: prescription reviews; coordination with National PTC; monitoring of medicine utilization, antibiotics resistance and safety; advise the UHC management board. Activities with major non-engagement: monitoring/reporting of complementary diagnostics prescription (87.5%); medication therapy management programs (62.5%); National pharmacovigilance system activities (62.5%); therapy cost assessment (50%). In survey2 (n=14) authorization process for medicines utilization was accurately characterized, clearly identifying responsibilities for all clinical and pharmaceutical departments. Heterogeneity exists between urgent and non-urgent utilization requests. PTC members and pharmacy departments were more likely to use electronic platforms than clinical departments.
What next?
Next phases are under way to better support current competencies, information flows, procedures, and the shared decision-making processes offering an opportunity to rethink the PTC procedures in the University Hospital Centre and leverage efficiency over hospital complexity.
Lean management optimisation of the patient care pathway in an onco-haematology outpatient hospital
European Statement
Introductory Statements and Governance
Author(s)
Florent MARTY, Sephora BELO-KIBABU, Driss CHAOUI, Jean-Luc PONS, Romy LINOSSIER-ROCHER
Why was it done?
Over the last few years, French healthcare establishments have been moving towards a more ambulatory approach to medical care. The growing number of patients treated in OPH has necessitated a reorganisation of these units. Staff at the onco-haematology OPH and the team at the centralised cytotoxic preparation unit in our hospital have reported organisational problems affecting the care pathway for patients admitted to the unit, leading to excessive delays in treatment and long waiting times for patients. Waiting time is one of the best measures of the quality of care provided.
What was done?
The project is to improve the overall patient flow within the outpatient hospital (OPH) service by reducing so-called non-value-added and compressible waiting times, without affecting the quality of patient care. This should have an impact on the flow of onco-haematology patients and therefore enable the OPH to operate more smoothly. Improvement actions must be simple, quick, easy to implement and inexpensive.
How was it done?
Data collection (waiting times, volume of activity) was carried out using: patient pathway mapping, observation grid, nurse and haematologist questionnaire, Actidiag software. Application of Lean through the development and facilitation of Kaizen workshops. The improvement actions were chosen during a brainstorming session between haematologists, pharmacists and nurses. A new data collection is then carried out and the results compared.
What has been achieved?
The stays of 64 patients were studied before optimization and compared with those of 79 patients after optimization. Improvement actions include : creation of a shared file, installation of a giant screen in the department connected to the new file, anticipation of preparations. Countermeasures reduced overall waiting times by 42%, cutting the patient’s length of stay by 53 minutes. The care time represents 54.6% of the time spent in the OPH, compared with 41.2% previously. This has also enabled the department to take on 18% more patients.
What next?
Healthcare professionals have noted a smoother flow of activity, making the care pathway more fluid and enabling patients to spend less time in the department, without impacting on patient care. This results in better rotation of OPH beds using a simple and easily reproducible method.
« S’cape Pharm: Can you keep your cool? » Design and implementation of an educational escape game in Chirec’s distribution departments
European Statement
Education and Research
Author(s)
Pascaline Hubot , Elise Francq, Guy Stichelbaut
Why was it done?
Hospital pharmacy is a constantly evolving field that requires ongoing training. New teaching strategies based on the gamification of educational objectives have been making headlines for several years. These include EG.
What was done?
An educational escape game (EG) has been designed and implemented for hospital pharmacists and pharmaceutical-technical assistants (Apth) working in one of Chirec’s distribution departments (Belgium). The objectives were : to provide continuing education and to improve various cross-disciplinary skills such as communication, team cohesion and critical thinking.
How was it done?
After considering the various constraints (dedicated time per session, number of players, etc.), a non-linear scenario was constructed. Distribution-specific themes were chosen for the creation of 12 enigmas, some in paper format and others in virtual format using Genially platform (November 2022 version). To ensure that the training sessions ran smoothly, hint envelopes containing the updated procedures were provided. Finally, the EG was pilot tested to get an idea of the game’s timing, to identify and correct any practical problems, and to adapt certain enigmas deemed too complex if necessary.
What has been achieved?
Nine sessions were held between December 2022 and September 2023. Each session included : briefing (5’), EG session (45’), debriefing (10’) and the distribution of an anonymous satisfaction survey at the end of the session (2’). Pharmacists (n = 24) and Apth (n = 15) respectively agreed (37.5% (n = 9) ; 66.7% (n = 10)) and strongly agreed (54.2 % (n = 13) ; 20% (n = 3)) that the EG improved their knowledge, and all participants found the EG to be a good teaching tool. Feedback was also very positive on cross-functional skills such as communication, team cohesion and critical thinking.
What next?
Futures sessions will be planned for newcomers to the pharmacy. Given the popularity of this educational tool and the suggestions for new topics, a new EG theme will certainly be on the agenda for 2024 pharmacy continuing education.
An algorithm for the process of selecting pharmaceutical companies in a pharmacy department
European Statement
Clinical Pharmacy Services
Author(s)
Moisés Couñago-Fernández, Marisol Samartín-Ucha, Ana María Regueira-Arcay, Sonia González-Costas, María Alfonsín-Lara, Paula Prado-Montes, Iván Agra-Blanco, Elena Cerdeira-Regueira, Noemí Martínez-López de Castro
Why was it done?
When a new pharmaceutical product should be introduced in a hospital, a multitude of factors must be considered in order to choose a specific brand. A lack of uniformity in the criteria for the selection of new medicines has been detected. To avoid selection errors or arbitrary decisions, a selection structured algorithm was developed using quality tools according to management quality system ISO 9001-2015.
What was done?
To ensure that the process of selecting from several pharmaceutical companies fulfil the requirements of quality and lower cost, a decision-making process for these purchases was designed, through a structured method for the evaluation of new pharmaceutical products based on standardised evaluation criteria.
How was it done?
A multidisciplinary group was created focused on making decisions about criteria. All stakeholders were represented (management pharmacist, quality experts, management assistant and pharmacy director). Also, a survey was given to different specialist pharmacists to complete the criteria. Second, criteria were categorised according to their importance or potential impact in pharmacy practice or patient.
What has been achieved?
The algorithm took into account aspects related to: a)pharmaceutical company and b)aspects related to the pharmaceutical product. Each of these aspects is valued as a percentage.
a)Pharmaceutical company: 40% of the score was based on not having a repeated history of stock-outs, 45% on the evaluation of the provider according to an internal file based on incidences registered, and 15% if the provider was already a known supplier.
b)Pharmaceutical product: 50% was based on the cost of the medicine, 15% unit dose presentation (if applicable), 10% expiry conditions of the medicine, 5% allergens, 5% if it was presented in a pre-filled pen (if applicable), 5% if it could be stored at room temperature, 5% if the drug is supplied in diluted vials (in the case of parenteral medicines) and 5% if it had all the possible indications in the technical data sheet.
This methodology has been used successfully in recent months with the pharmaceutical supplier changes of abiraterone and sugammadex.
What next?
This tool will be used for all changes of medicine brands and new drugs purchased in the hospital, enabling uniformity in the purchasing process for all new drugs.
Development of a compact, disposable filter to reduce the discharge of pharmaceutical waste into the sewer
European Statement
Production and Compounding
Author(s)
Annemarie Aart van der – Beek van der, Mattijs Maris, Erwin Koetse, Alex Hol, Meilof Feiken
Why was it done?
Hospital Pharmacies and especially the laboratories produce wastewater containing medicine residue. When this wastewater is discharged into sewage it contributes to the load of pharmaceutical residue and ultimately to pollution of surface-, ground and drinking water. To reduce this load, waste can be collected and transported to a processing facility for incineration and deactivation or alternatively treated locally. Our goal was to develop a practically applicable method that could effectively reduce the pharmaceutical sewage load locally, at the source.
What was done?
We developed a practical, compact, disposable filtration system that can be used on-site to reduce the amount of pharmaceutical residue in wastewater of our pharmaceutical laboratory. We tested and optimized the composition of the filter to effectively collect organic substances from locally produced wastewater (influent). We monitored filter performance and durability by analysis of filtrates (effluent).
How was it done?
Laboratory wastewater was collected during one month to yield 10 L influent. Portions of influent were filtered through 9 different types of filter packing and the effluents collected for analysis.
The influent reference and effluent samples were analysed using an iontrap LC/MS screening method using diazepam-D5 as an internal standard. The signal abundance 12 most relevant substances was chosen to evaluate the level of reduction by filtration. Based on these analyses, the optimal filter packing was determined.
What has been achieved?
In the effluent of the best performing filter packing, the abundance of 9 substances was reduced by 91,5-99,9%. The abundance for the other 3 substances was below detection limit.
Substances removed more >99%: atorvastatine, carbamazepine, clarithromycine, diclofenac, granisetron, midazolam, naproxen, propranolol and rocuronium. Substances removed between 91-99%: cefazolin, ephedrine and ropivacaine.
What next?
The optimal filter composition will be tested in practice in a test setup. In addition, cost effectiveness and sustainability compared to alternative waste collection methods will be evaluated.
Optimising medication procurement through integrated database
European Statement
Selection, Procurement and Distribution
Author(s)
Irene Ruiz-Jarabo Gómez, Marcos Gómez Bermejo, Rocío Vázquez Sánchez, Antonio Illescas Bermudez, Elena Martín Suarez, Teresa Molina García
Why was it done?
Digitization was considered essential in reducing costs related to inventory management and improving responsiveness in critical situations, such as supply shortages. Traditional manual inventory checks and order verifications were time-consuming and error-prone, prompting the need for a digital transformation.
What was done?
In our quest for enhanced medication procurement efficiency within our Hospital Pharmacy Service, we have developed an integrated database.
How was it done?
We have developed a database by consolidating data from two primary sources: our automated medication storage system, Smart Ulises®, and the Economic Management software, Farmatools®. This database encompassed information related to medications falling below predefined minimum stock levels, historical acquisition records, pending medication orders, and warehouse capacities for each medication. Additionally, it seamlessly integrated data obtained from the Spanish Agency of Medicines and Medical Devices (AEMPS) regarding medication shortages.
This database enabled several essential functionalities:
It generates reports suggesting orders for medications below the minimum stock levels, recommending quantities based on historical acquisitions and available storage space.
By considering the suppliers for medications at minimum stock levels, it also identifies medications in alert status (1/3 above the minimum stock) for these suppliers.
Cross-referencing with AEMPS’ medication supply problem database swiftly detects critical medications during shortages
It permits agile identification of pending medication orders.
It identifies locations with incomplete medication inventories and propose medication grouping within our automated medication storage system.
What has been achieved?
The outcomes of our project were transformative:
We streamlined medication procurement significantly and maximized each medication supply request while promoting sustainability by reducing laboratory-specific medication orders.
We optimized storage space within our automated medication storage system, aligning medication orders precisely with storage capacities for each medication, leading to more efficient space utilization and reduced storage costs.
Early detection of medication shortages enabled proactive preparation of alternative solutions to effectively mitigate shortages.
Simplification of tracking pending medication orders enhanced operational efficiency in claim processing or supplier changes.
What next?
Our next phase focuses on continuous system improvement. This involves incorporating additional data sources to refine medication supply predictions and exploring the potential for complete automation of the medication ordering process. We will also enhance performance measurement to evaluate the effectiveness of our improvements.
Use of an integrated research management system on a clinical trials unit of a Portuguese hospital
European Statement
Education and Research
Why was it done?
The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)
What was done?
Evaluation of the use of an Integrated Research Management System based on a retrospective analysis of all clinical trials introduced into the software since 2020.
How was it done?
The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)
What has been achieved?
With the introduction of an integrated management system as a registration platform of investigational product receipt, dispensing and return, were introduced into the software 204 clinical trials.
Since its implementation in 2020, the integrated system has been authorised by the sponsor as a registration platform in 55 clinical trials, corresponding to 79% of clinical trials initiated since that date.
The clinical trials Unit grants remote access to the clinical trials information to CRAs through the filling out of a declaration. Since the adoption of this system, remote access to the platform has been granted to 35 CRAs.
According to the survey distributed between July and August:
-85.7% of CRAs use the system in their monitoring work.
-The use of System has been exclusively approved to replace paper records in 88.9% of active clinical trials (with the exception of receipt confirmation via IWRS – Interactive Web Response System).
-All the CRAs who answered the questionnaire consider remote access to clinical trial data to be an advantage.
– 77.8% believe that by using the platform the time spent on presential visits has been reduced.
What next?
The use of this type of system is essential to ensure the efficiency of the tasks carried out by research teams. The approval of system by the sponsor allowed a significant reduction of paper records and the CRA’s remote access to the platform has allowed the early detection of errors, as well as a substantial reduction on time spent on presential visits. The CRA’s remote access to the movements associated with the experimental product like temperature records, calibration certificates, CVs (Curriculum Vitae) and GCP’s (Good Clinical Practices). Although use of the platform has been increasing, some sponsors still do not authorise the exclusive use of the system. It is therefore essential to share the platform’s added value in order to change the traditional ways of management of clinical trials information.
Empowering home hospitalisation with comprehensive pharmaceutical care: a model programme for medication management and patient monitoring
European Statement
Clinical Pharmacy Services
Author(s)
Beatriz Somoza-Fernández, Vicente Escudero-Vilaplana, Cristina Ortega-Navarro, Ana de Lorenzo-Pinto, Ana Herranz-Alonso, María Sanjurjo-Sáez
Why was it done?
HH units have experienced an extraordinary period of growth over the past few years and are already considered the preferred option of care model for most patients. However, its full potential is actually limited by some challenges both demanding and ripe with opportunities for pharmacy engagement, such as patient clinical complexity (usually elderly and chronic patients at greater risk of poor adherence and suffering from medication errors) and lack of medical staff physically available for monitoring patients’ evolution.
What was done?
We developed and implemented a comprehensive pharmaceutical care programme in a home hospitalisation (HH) unit.
How was it done?
The project was conceived by a multidisciplinary team (physicians, pharmacists, and nurses) that conducted a literature review and developed a new home medication management standardised operating procedure. The team worked in the design of a HH pharmaceutical care guideline and the implementation of an e-health care tool for remote patient monitoring.
What has been achieved?
1. HH pharmaceutical care guideline: it included the directions for the following measures: (1) a comprehensive pharmaceutical assessment and medication reconciliation, (2) standardised recommendations for optimising acute and chronic treatments at home, (3) daily interviews with patients or caregivers to explain medication changes, and (4) follow-up calls 7 days after discharge in order to assess medication adherence.
2. HH monitoring app: this new tool ensures pharmacotherapeutic monitoring by setting medication schedules and intake notifications. The platform includes a patient recording for vital signs, side effects, medication intake, and health status (functional status and quality of life). The system enables online access for pharmacists and physicians in real-time and continuous two-way communication.
What next?
Since our programme is easily applicable to any HH unit, we are working on implementing it in other hospitals in our country, in order to overcome HH medication management complexity nationally. We aim to conduct a multicentre study to evaluate its external validity in terms of increasing medication errors detected and optimising hospital resources.
Development of bags ready to use for parenteral nutrition in the preterm patient
European Statement
Production and Compounding
Author(s)
Eleonora Castellana, Simonetta Felloni, Matilde Scaldaferri, Giuseppina Bonfante, Elena Maggiora, Francesco Cresi, Maria Francesca Campagnoli, Alessandra Coscia, Maria Rachele Chiappetta, Francesco Cattel
Why was it done?
The purpose was to provide the Neonatal-Intensive-Care-Unit (NICU) with ready-to-use bags that could improve patient safety by minimizing procedural incidents and maximize resource efficiency while providing clinically appropriate nutrition for the single PP.
What was done?
Seven standard bags (SSB), ready-to-use, have been formulated and developed for parenteral nutrition (PN) in preterm patients (PP). An assisted prescribing software was developed for selecting the most appropriate standard bags (SB).
How was it done?
The project was carried out in collaboration between pharmacists, nurses and neonatologist of NICU.
The composition of the SB was identified from the retrospective analysis of the types of individualized bags requested from the Pharmacy and from the analysis of the recommended ESPGHAN-Paediatric-Parenteral-Nutrition-2018 contributions.
What has been achieved?
SSB ready-to-use were identified:
The bags have been produced by an industrial partner according to Good Manufacturing Practice-Annex 1. The shelf life is 90 days.
The SSB were implemented successfully on the PP. Starting from 2021, approximately 250 bags/month have been used, with a reduction in individual preparations by the Pharmacy of approximately 80%.
This approach showed results in terms of clinical results and economic outcomes. The computer program guided the physician to the most appropriate standardized solution.
Early and timely administration of ready-to-use PN showed reduced weight loss and a shorter duration of PN than individualized bags (21 vs 25 days).
What next?
The project described has shown benefits including improved nutrient supply, fewer prescribing and administration errors, lower risk of infection, cost sav-ings, ready availability of the bags 24/7 and safe and effective supply of SB. This project will be strengthened in our hospital.