SUSTAINABLE PHARMACY 5.0: MEASUREMENT AND REDUCTION OF THE CARBON FOOTPRINT IN THE COMPOUNDING PHARMACY OF A HIGH COMPLEXITY PHARMACEUTICAL SERVICE. ONE MORE STEP TOWARDS DECARBONIZATION
European Statement
Production and Compounding
Author(s)
Viviana Montoya, Camilo Fuertes, Viana Berdugo, Mercedes Meneses, Monica Castaño.
Why was it done?
Greenhouse gas (GHG) emissions associated with the health sector represent approximately 4.4% of global net emissions, equivalent to two billion tons of carbon dioxide. It is estimated that the processes carried out in the compounding pharmacy contribute greatly to greenhouse gas emissions and high costs associated with their execution.
What was done?
1.Establish the activities and consumables with the greatest impact on the carbon footprint from the compounding pharmacy processes.
2.Carry out a comparison between the consumables with the highest greenhouse gas (GHG) emissions versus a more SUSTAINABLE alternative.
3.Determine the reduction of the environmental and economic impact achieved through the implementation of SUSTAINABLE strategies.
How was it done?
The activities and consumables with the greatest environmental impact were characterized and sustainable strategies focused on reducing and optimizing these resources were proposed. The necessary information was collected to calculate the carbon footprint of each consumable (annual consumption, weight, emission factors) and the costs from its acquisition to final disposal to evaluate the total carbon footprint avoided and the economic savings achieved.
What has been achieved?
The implementation of SUSTAINABLE strategies in the pharmaceutical service compounding pharmacy showed a considerable decrease in the carbon footprint, in addition to significant economic savings. It is estimated for the year 2024 to reduce the carbon footprint by a total of 161.133 Kg CO2eq and achieve economic savings of 906.324.240 COP (214.212 US dollars), which is equivalent to 663,225.15 Km and represents 24 round trips from Cali, Colombia to Dubai, United Arab Emirates and 16,5 trips around the world.
What next?
It was possible to establish a baseline to evaluate the environmental impact that the compounding pharmacy currently has and with this, continue searching for strategies that allow achieving a totally sustainable compounding pharmacy. In addition, the results allowed us to raise awareness about the importance of small actions in an objective as large as the decarbonization of the health sector.
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
RELOCATING A UNIVERSITY HOSPITAL’S INJECTABLE CHEMOTHERAPY PREPARATION PROCESS TO A MOBILE UNIT: A CHALLENGE MET!
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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.
DEVELOPMENT AND IMPLEMENTATION OF A POST-AUDIT IMPROVEMENT PLAN IN A PARENTERAL NUTRITION PRODUCTION UNIT
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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.
DEVELOPMENT OF PHARMACY CRRT SOLUTIONS SERVICE AT KING CHULALONGKORN MEMORIAL HOSPITAL, THE THAI RED CROSS SOCIETY
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European Statement
Production and Compounding
Author(s)
Phontep Wongkrasoe; Wongsathorn Padungsupalai
Why was it done?
Premixed customize CRRT solutions were compounded by sterile pharmacy.
What was done?
According to the medication management policy, CRRT solution was defined as
High Alert Drugs that require the independent double check throughout the
medication use system. Conventional methods (prepared by nurses) take many
risks and may affect the quality of ICU-patients care by spending more time
for preparing.
How was it done?
Nephrologists, nurses, and pharmacists made a consensus for standard
customized CRRT solution formulas and clarified the ordering (for physician),
dispensing (for pharmacist) and preparing (for nurse to add potassium)
instructions. The procedure for compounding CRRT solutions by sterile
pharmacy was established to optimize traceability aspects as a quality
assurance. With the large batch size compounding, we mockup the preliminary
batch to identify the risk and assure the consistency of compounding process.
Quality control was planned to measure electrolyte content and test sterility
at D0, D7 and D14 at room temperature and refrigerated storage. After the
preliminary batch test was accepted, we started a pilot service in one ward
and reached the maximum service capacity at only one patient per day. The
pharmacists redesigned the compounding process, and the repeater pump was
introduced to increase capacity. Because the product was changed in total
volume from one liter to 1.2 liter, we conducted the preliminary batch test
again. Teams revised the ordering, dispensing, and preparing instructions and
expanded the service to 7 ICU wards.
What has been achieved?
We formulated 2 CRRT solutions in the name of “Chulasol-22 1.2 liter” and
“Chulasol-35 1.2 liter” with BUD 14 days at room temperature storage. The
results were (1) we can provide the CRRT solution for maximum 5 patients per
day compared to only one patient per day in the initial period, (2) the cost
of pharmacy compounded solution was much lower than conventional method or
comparable commercial solution and (3) most nurses (91%) were satisfied in
product quality and had more time for patient care.
What next?
The success of this model was a multidisciplinary engagement that resulted in
improvement of patient care. We use this model in other services such as pain
preparations and eye preparations.
The pharmaceutical approach to the processing of donor human milk in a human milk bank
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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
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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.
Development of bags ready to use for parenteral nutrition in the preterm patient
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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.
How we picked drugs for our automated preparation
Pdf
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
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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.