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.
Intrahospital circuit of autologous eye drops
European Statement
Patient Safety and Quality Assurance
Why was it done?
The number of patients treated with autologous eye drops has increased significantly in recent years, which has led to the need to create an intra-hospital circuit to ensure the traceability of samples throughout the extraction, processing and dispensing process.
What was done?
Create a circuit to ensure traceability of the patient’s plasma at all times, thus avoiding any confusion.
How was it done?
In order to avoid the transport of samples by patients and consequently the loss of samples or possible errors, the following circuit was developed:
– The extraction and centrifugation of the patient’s blood is agreed with the Biochemistry Service, the orderly is in charge of taking it to the pharmacotechnics laboratory, in the Pharmacy Service, where the time of delivery will be noted.
– If the plasma arrives before 12:00 noon, the patient will be called late in the morning for dispensing. If the delivery is later, it will be scheduled for the following day.
– The eye drops are then prepared.
– Finally, they are dispensed directly from the laboratory by the pharmacists or by the technicians trained for this purpose, always under the supervision of the pharmacist responsible for the area. Traceability is maintained throughout the entire process.
To make everything possible, several training meetings had to be held with Bioquimica.
What has been achieved?
Since the implementation of this circuit at the beginning of 2023, 166 batches of autologous eye drops have been produced for 72 patients, with only one error recorded, where a plasma that was not correctly identified was delivered and discarded.
In addition, the waiting time for dispensing the preparation was reduced by 33%, from 30 minutes to less than 10 minutes, thus achieving greater patient satisfaction.
What next?
The application of this circuit prevents samples from being transported by the patient, avoiding any type of accident, as well as ensuring the correct traceability of the samples. On the other hand, patient waiting times are reduced by dispensing samples directly from the laboratory area, thus avoiding waiting times for consultations.
Analysis of quality indicators in the compounding area through a mobile application
European Statement
Patient Safety and Quality Assurance
Why was it done?
To identify improvement opportunities in the Pharmacy Compounding Area through the analysis of indicators obtained from a traceability App.
What was done?
In 2022, a mobile application (App) was designed and implemented to facilitate the traceability of preparations compounded in the Pharmacy (parenteral nutrition, chemotherapy and other individualized sterile preparations). In addition, the analysis of data registered in the App has provided valuable information about the compounding unit performance.
How was it done?
Monthly reports from May to December 2022 were analysed, focusing only on chemotherapy preparations. The indicators selected were: the average number of monthly preparations, weekly workload distribution, daytime distribution of compounded preparations, preparations returned to the Pharmacy, percentage of treatments prepared on the same day of administration, and percentage of preparations compounded after the scheduled administration time.
What has been achieved?
An average of 139 chemotherapy preparations per day was recorded. The daily distribution highlights that Thursdays and Fridays are the busiest days with the 45% of the total weekly preparations. Furthermore, the morning shift carries out most of the compounding work, with 79% of the preparations being compounded before 3 PM. This information might be useful to the management team to better distribute tasks and resources. Data analysis indicates that 62% of the preparations are compounded in advance, while the remaining 38% are prepared on the same day of administration, which is also valuable information to organize the compounding workflow. On average, 59 preparations were returned per month. Finally, we found that 8.1% of the chemotherapy drugs were prepared with a median delay of 47 minutes from the expected time of administration. All these items are currently being monitored as quality indicators in order to find the way to minimize them.
What next?
The analysis of data recorded in the App provides us valuable management indicators for organizing work in the preparation area.
Tracking these indicators serves as a quality tool for the area and helps us identify opportunities for improvement.
The pharmaceutical approach to the processing of donor human milk in a human milk bank
European Statement
Production and Compounding
Author(s)
Susana Fraga, Cláudia Cunha, Susana Pissarra , Carla Sampaio, Diana Silva, Pedro Soares, Teresa Soares, Renata Barbosa
Why was it done?
Human milk banks (HMBs) must use rigorous quality assurance practices to protect infants and milk processing, and post-pasteurization procedures are important in maintaining high-quality breast milk and safeguarding its quality.
The compounding pharmacist has all the knowledge and experience needed to implement processing circuits based on good handling practices and sterile technique, combined with quality assurance procedures to ensure their safety.
What was done?
Pharmacy implementation of the Donor Human Milk (DHM) processing circuit (by pasteurization) and conditions.
How was it done?
Bibliographical research and critical analysis of the functioning of HMB worldwide, with multidisciplinary meetings to define the best and most secure quality practices.
Equipment choice, in accordance with recommendations and assessment of their technical requirements.
Adaptation of the informatic medical integrated system to the DHM prescription, processing, quality control and dispensing circuit.
Design of the DHM circuit based on good practices for the safe use of products of human origin and on a robust quality assurance plan.
What has been achieved?
A DHM circuit was put into practice, with pharmacist intervention in DHM processing, quality control, and batch release.
Procedures for aseptic handling, quality control with check points and risk analysis, packaging, and labelling of DHM were outlined.
Work instructions were also established for handling equipment (pasteuriser, bottle sealer, laminar flow chamber) as well as procedures for cleaning facilities and material/equipment, with training sessions for the professionals involved.
The multidisciplinary circuit was adapted to the organisational management of the Neonatal Intensive Care Unit (NICU), HMB, and Pharmaceutical Services, certified on 18 April 2023 according to ISO 9001:2015 recommendations.
Guidelines for the correct use of equipment in accordance with its recommendations and technical requirements were established.
What next?
Opening more HMB worldwide is an inevitability. Prevailing know how at the level of hospital pharmacies represent several advantages to these projects, based on experience and expertise in manipulating biological products and maintaining a controlled circuit based on safety and quality standards.
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.
Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection
European Statement
Clinical Pharmacy Services
Author(s)
Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone
Why was it done?
Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.
What was done?
In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.
How was it done?
The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.
What has been achieved?
Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.
What next?
E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.
How we picked drugs for our automated preparation
European Statement
Production and Compounding
Author(s)
Teimori Kaveh, Lunnan Asbjørn , Komnenic Aleksandar, Gleditsch Espen, Duedahl Hende Camilla
Why was it done?
Oslo Hospital Pharmacy is working to standardize and automate 10% of Oslo University Hospital’s annual consumption of two million parenteral medication doses. They aim to provide 200,000 ready-to-administer doses to OUS, starting with a trial in 2025 and scaling up to 200,000 doses by 2028. This initiative addresses efficiency, reduces nurse workload, and minimizes medication errors, addressing healthcare workforce challenges and ensuring timely and accurate medication delivery at Oslo University Hospital.
What was done?
Drugs were selected for inclusion in implementation of automated preparation of ready-to-use syringes and bags.
How was it done?
Oslo Hospital Pharmacy is dedicated to providing market-competitive ready-to-administer medications through a flexible selection process. This process involved a thorough analysis of parenteral medication usage in five reference care units over eight months. We compared consumption in these units (69 beds) to the entire hospital (2,031 beds) to align with Oslo University Hospital’s needs. Collaborations with international partners in the Netherlands and Denmark confirmed shared priorities, especially in ready-to-administer antibiotics, validating their meticulous selection process. Oslo Hospital Pharmacy’s strategy underscores their commitment to addressing healthcare challenges effectively with global validation.
What has been achieved?
The following 12 medications were selected for the initiative: Piperacillin/tazobactam 4g, Ampicillin 2g, Vancomycin 1g, Vancomycin 0.5g, Cefotaxim 2g, Cloxacillin 2g, Cefazolin 2g, Propofol 10 mg/ml, Fentanyl 50 microg/ml, Ketamin 10 mg/ml, Benzylpenicillin 3g and Benzylpenicillin 1.2g.
Results showed that the reference care units consumed 14 ampoules or vials per bed, while Oslo University Hospital consumed 80, suggesting a representative and potentially even larger demand across the hospital.
What next?
The established drug selection procedure offers an organized method for incorporating new medications. This well-defined medication list facilitates the selection of the most appropriate automation system for implementation. Considering the prevalent staff and medication shortages on a global scale, many institutions are increasingly considering the adoption of automation in their drug preparation departments. We aspire that our method can offer valuable assistance in their pursuit.
Residual contamination during semi-automated compounding of paclitaxel and gemcitabine
European Statement
Production and Compounding
Author(s)
Schoening Tilman, May Cornelia , Hoppe-Tichy Torsten
Why was it done?
Results of the wipe tests should be used to adapt the existing cleaning protocols in a way that residual contamination with cytotoxic drugs on parts of the robot, gloves and infusions bags are either reduced or avoided.
What was done?
At Heidelberg University Hospital the semi-automated device “Smartcompounder Chemo” (Smartcompounders, Enschede, NL) has been operated since 2019. We conducted three sets of wipe tests at three consecutive dates to identify contamination on parts of the robot, bags and gloves for selected drugs happening during the preparation process depending upon changes in cleaning protocols.
How was it done?
Wipe tests had been provided by Institute for Energy- and Environment Technics (IUTA, Duisburg, Germany) and analysed according to the published standards. Before and after a preparation run of gemcitabine as well as paclitaxel there had been performed two wipe tests sets of potentially exposed surfaces: Gloves after loading and unloading of the device, robot head, syringe holder, vial adapters, bag adapters, infusion bags and vials. After evaluation of the results of the first wipe test set, we adapted cleaning agent and techniques and a second set was performed.
What has been achieved?
Both wipe test sets did not show any positive results for paclitaxel. For gemcitabine residual contamination was shown on gloves after loading and unloading, syringe holder and robot head before and after preparation run, vial adapter before and after preparation and bag adapter after preparation run. The second wipe test set after adaptation of cleaning procedures showed considerably smaller numbers of positive tests and smaller amounts of gemcitabine contamination as well.
What next?
Results demonstrate that contamination patterns associated with automated preparation of cytotoxic drugs are related to the design of the device and effective cleaning procedures of the robot parts and the vials can result in lower contamination values of surfaces. Therefor it is vital to analyze the effectiveness of cleaning protocols when working with these devices and to adapt them if necessary. We were also able to demonstrate, that the final container was not relevantly affected by residual contamination during automated preparation process of Smartcompounder Chemo meaning a positive impact on staff safety.
Determination of the carbon footprint of morphine tablets and morphine solution for injection – a collaboration between Amgros and the Capital Region Pharmacy
European Statement
Selection, Procurement and Distribution
Author(s)
Bitten Abildtrup, Lone Deleuran, Mira Dysgård, Nina Müller, Sofie Pedersen, Trine Schnor, Ulrik Wøldike
Why was it done?
It is estimated that medicine contribute 20% of the Danish regions total CO2e emissions. Amgros and the Hospital Pharmacies of Denmark are committed to develop carbon reduction initiatives to assist the regions CO2e reduction strategy. It is essential to identify the main contributors of CO2e emissions in the lifecycle of a drug to support CO2e reduction.
What was done?
The Danish procurement organization Amgros I/S is responsible for buying medicine for Danish public hospitals. As part of the ambition for sustainability, The Capital Region Pharmacy (RAP) in collaboration with Amgros has made a bottom-up hotspot life cycle analysis (hLCA) of the carbon-footprint of morphine in tablets and solution for injection. The hLCA identified the main CO2e emission factors from API/excipient production to administration of the drug.
How was it done?
The energy consumption of the production processes was mapped at RAP. Five reference flows were modulated (tablets in three types of primary packaging and solution for injection in two types) and reported. The hLCA data for the API was extracted from literature while data for the excipients and packaging material were calculated using Ecoinvent. Ecoinvent is a life cycle inventory database used to support environmental assessments of products and processes.
What has been achieved?
The preliminary conclusion of the analysis shows the largest CO2e emissions per DDD originates from administering the drug due to the use of single-use materials.
Leaving out administration of the drug, the main CO2e emissions from tablets are API production and packaging materials. Packaging materials are the main CO2e contributor for the solution for injection.
The end report of the LCA was available, end of autumn 2023.
What next?
The hLCA’s are being used internally in Amgros to develop criteria for tenders. The hospital pharmacies can use the hLCA calculations to identify key subprocesses where reduction of the CO2e footprint is greatest.
The results contribute to:
• Danish hospital pharmacies better understand the CO2e emissions when prescribing and administering medicines
• Dialogue with the pharmaceutical industry about their CO2e emissions hotspots
Finally, the results will hopefully encourage other countries to incorporate environmental criteria in future medicinal tendering process for medicines.
The development of hospital manufactured ready-to-use cefazolin 100 mg/mL injections
European Statement
Production and Compounding
Author(s)
Bojan Žagar, Matej Vehovc, Mateja Tršan, Blaž Vehar
Why was it done?
Cefazolin injection 100 mg/mL is a sterile pharmaceutical formulation comprising cefazolin sodium and water for injections. Traditionally, cefazolin injections were prepared on hospital wards by reconstituting cefazolin sodium powder for injections with water for injections and subsequent dilution before intravenous administration.
What was done?
Establish a semi-automatic aseptic preparation process, ensure the production of final products that meet quality standards, develop analytical methodologies for in-process and final product quality control, ensure the reliability and validity of test results, and conduct a stability study to confirm long-term storage.
How was it done?
Product materials include: Pharmacy Bulk Package of Cefazolin for Injection, USP, water for injections, Luer Lock 20 mL sterile polypropylene syringes, steribags. Product is prepared with aseptic technique within a laminar flow unit situated in a pharmaceutical cleanroom. Bulk package is connected to a dispensing device, followed by reconstitution with water for injections. In-process samples are collected and volume-adjusted based on density. Following the preparation and dispensing, syringes undergo labeling and packaging into steribags. They are then promptly stored at -30°C within 4 hours. Final product samples are obtained and analysed (pH value, cefazolin content, endotoxins, sterility) prior to product release.
What has been achieved?
Preparation of cefazolin sodium injections in a controlled, aseptic environment utilizing pre-prepared bags containing the appropriate cefazolin concentration (100 mg/mL) has successfully addressed critical concerns surrounding the safety, efficacy, and quality of these pharmaceuticals when administered on hospital wards. Challenges related to stability and shelf life are being addressed with the storage approach at -30°C within the pharmacy, followed by a carefully monitored transition to ward storage at 5°C for up to 28 days, and subsequent patient administration at room temperature within 2 days.
What next?
This approach not only streamlines the process but also safeguards the well-being of patients, marking a significant advancement in pharmaceutical preparation within our healthcare setting. We are conducting an ICH-compliant stability study with the objective of establishing a combined shelf life of 90 days at -30°C, followed by 28 days at 5°C, and an additional 2 days at room temperature.
The European Paediatric Formulary: a reinforced approach for improved monographs
European Statement
Production and Compounding
Author(s)
Théo Henriet, Jane Francomb, Dirk Leutner, Jörg Breitkreutz
Why was it done?
The PaedForm project was launched as a bibliographical exercise, with the aim of collecting age-appropriate formulations from existing formularies or from established sources in Europe and incorporating them into the PaedForm.
However, the data underpinning existing monographs were not as complete as expected and errors in the source data were observed. Adding an experimental verification step was therefore crucial to ensuring the reliability and the appropriate quality of the formulations described in PaedForm and demonstrating that the monographs could be used in practice.
What was done?
A decision to add an experimental verification to the elaboration process for monographs to be published in the European Paediatric Formulary (PaedForm) was recommended by the experts from the PaedF working party (PaedF WP) – assisted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – and supported by the European Committee on Pharmaceuticals and Pharmaceutical Care and the European Pharmacopoeia Commission.
This verification step involved checking the preparation against the description in the monograph and, where necessary, completing it. Samples prepared during this step were then tested to check that the quality control methods included in the monograph were suitable. The findings were used to determine whether the monograph could be completed.
Where necessary, this experimental verification would include tests such as the microbial challenge test as described in European Pharmacopoeia (Ph. Eur.) general chapter 5.1.3.
How was it done?
Experts from the PaedF WP support the need for practical verification and perform the experimental verification if needed. The EDQM supported this work by sourcing active substances and consumables and by organising analytical testing for techniques not available to the experts.
What has been achieved?
This approach enabled the enhancement of a furosemide oral formulation. The composition of this formulation as described in the source material did not meet the Ph. Eur. requirements for antimicrobial preservation, so it was changed to include a higher concentration of the preservative and comply with the Ph. Eur. requirements.
What next?
The PaedF WP will continue to expand PaedForm by elaborating new monographs covering unmet therapeutic needs. Users are invited to contribute to this process by commenting on texts published in the PaedForm Pharmeuropa public consultation platform.