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.
Preparation of monoclonal antibodies on the pharmacy benchtop – risk assessment and practical considerations
European Statement
Production and Compounding
Author(s)
Aidan Morris, Louise Byrne
Why was it done?
• mAbs were considered hazardous if handled by staff – prepared in a dedicated isolator in the PAU in TUH.
• No widely accepted standards for safe handling of mAbs, although more recent guidance allows preparation of some mAbs outside of PAUs once risks appropriately assessed.
• Significant reduction in production capacity in the PAU in early 2022 for planned repair work. Benchtop preparation of mAbs implemented to maintain patients’ treatment regimens and to reduce costs associated with outsourcing.
What was done?
• Preparation of monoclonal antibodies (mAbs) on the pharmacy benchtop temporarily introduced in the Pharmacy Aseptic Unit (PAU) of Tallaght University Hospital (TUH).
• Guidance from Ireland’s National Cancer Control Programme (NCCP) on Pharmacy Benchtop Preparation of mAbs reviewed and implemented.
• Risk assessment carried out for individual mAbs. List of mAbs suitable for benchtop preparation prepared.
How was it done?
• Implementation of the NCCP guidance on Pharmacy Benchtop Preparation of mAbs. Advice on risk assessments and safety, equipment and facilities, and staffing and training when preparing mAbs on the benchtop.
• Literature review of the hazards associated with handling mAbs – toxicity, immunogenicity, risk reduction measures. Individual mAbs assessed for suitability for benchtop preparation using Health Service Executive (HSE) risk assessment tool. This considered toxicity, immunogenicity and closed system transfer device (CSTD)-compatibility of mAbs, and personal protective equipment required.
• CSTD vial adaptor based on air cleaning (filter) technology replaced with vial adaptor with physical barrier (balloon) – additional safety measure. Dedicated area assigned for benchtop preparation – well-ventilated, clutter-free and easy-to-clean.
• Additional training on new vial adaptor provided to pharmacy technicians already experienced in aseptic compounding.
What has been achieved?
• List of mAbs suitable for benchtop preparation prepared. Conjugated antibody-drug complexes, mAbs of fully murine origin and mAbs not CSTD-compatible deemed unsuitable.
• mAbs prepared on the benchtop during period of reduced capacity, maintaining patients’ treatment regimens and reducing outsourcing costs, wastage.
• Facilitated by risk assessment and risk reduction using PPE, training and CSTDs.
What next?
• Although safety and handling requirements of mAbs not fully known, prudent to handle them with more care than most drugs but less than for cytotoxics.
• Contingency plan for benchtop preparation of mAbs in case of future reduced PAU capacity.
• Can be applied to other organisations experiencing periods of reduced capacity.
Use of a closed-system drug transfer device in the handling and administration of ganciclovir outside the hospital pharmacy unit
European Statement
Production and Compounding
Author(s)
Lucia Ricchi, Gregorio Medici, Porretta Serapiglia Carla, Marzia Bacchelli, Marianna Rivasi
Why was it done?
Hazardous drugs (HDs) may include antineoplastic or cytotoxic agents, biologic agents, antiviral agents, immunosuppressive agents, and drugs from other classes. Healthcare workers, especially nurses and pharmacy personnel, experience occupational exposure to these HDs.
Preparation and administration of ganciclovir should only be performed by health professionals who have been appropriately educated and trained and deemed competent in its use. Until now the preparation of ganciclovir was performed by the pharmacy’s antiblastic drugs unit. However, during closing times, kits for the self-preparation (antiblastic gloves and gowns, FFP3 masks, eye protections and brief instructions for reconstitution) were provided.
Many strategies have been deployed to reduce the risk of occupational exposure to HDs, including control devices designed to act as closed systems and preventing exposure through liquid or vapor leakage. These devices mechanically prohibit the escape of HDs from the system and can be used for preparing and administering these drugs.
What was done?
Some of the intensive care units of our hospital have been enabled to prepare their own ganciclovir bags by using a closed system drug transfer device (CSTDs).
How was it done?
Each nurse involved was instructed by hospital pharmacists on how to handle CSTDs. In addition to this they were also given a short video and an infographic showing the main operations to be carried out.
Ganciclovir bags are prepared using the Tevadaptor® (Simplivia), in a needleless technique, by combination of the Vial adaptor, the Syringe adaptor, the Spike port adaptor and a connector closed male (Spiros, ICU).
What has been achieved?
Use of CSTDs is a simple and effective way to reduce exposure to HDs, provide better protection, better aseptic technique and better containment of waste than the traditional method, as well as allows the preparation of HDs to be carried out outside the antineoplastic drug unit.
What next?
In the future their use could also be extended to the preparation of monoclonal antibodies and antibiotics considering that there is not enough definitive research on the effects of occupational exposure to these agents. And, to date, there is no known safe maximum level of exposure to these drugs.
COMPARISON OF ENVIRONMENTAL CONTAMINATION WITH CYTOSTATICS IN FOUR AUSTRIAN HOSPITALS AND IMPLEMENTATION OF A STANDARDISED TRAINING ABOUT SAFE HANDLING OF ANTINEOPLASTIC AGENTS ON THE WARD
European Statement
Production and Compounding
Author(s)
Martin Munz, Ewelina Korczowska, Maria Costa, Christine Petter, Shahla Farokhnia, Katharina Kronister, Sandra Dunkler, Thomas Schweiger, Martina Anditsch, Martina Jeske
Why was it done?
Several studies show that contamination with cytostatics is found on various work surfaces in hospitals [e.g., Chauchat L et al. 2018, Hon CY et al. 2014]. Wipe sampling for surface residue of antineoplastic and other hazardous drugs in healthcare settings is currently the method of choice to determine the workplace’s environmental contamination with these drugs [Connor TH et al. 2016].
What was done?
Hospital pharmacists of four Austrian hospitals (Vienna General Hospital, Innsbruck University Hospital, Landesklinikum Horn-Allentsteig, and Landesklinikum Zwettl) differing in size, logistic requirements and production capacity, equipment (but all using Closed System Devices), and involved staff participated in the MASHA (Research about Environmental Contamination by Cytotoxics And Management of Safe Handling Procedures) project of the European Society of Oncology Pharmacy (ESOP).
How was it done?
In the first part of the project, surface contamination by cytostatics was investigated using wipe samples. Subsequently, training materials were developed and used for uniform training of medical staff involved in administering antineoplastic drugs. After the training, a second set of wipe samples of the same surfaces were taken and analyzed.
What has been achieved?
All four hospitals’ results in the first series of measurements were below the reference value given in the project of 0,1ng/cm², indicating “low” contamination. Only a small amount of samples show values between the limit of quantification (LOQ), dependent on the substance and analytical method, and 0,1ng/cm². The same is for the second series of wipe samples after the training. Considering that standards, recommendations or trainings by pharmacists or occupational health professionals has already been in place before this project, the impact of further training for the medical staff could not be quantified by measuring the residues. However, feedback from trained staff was exclusively positive, and our main objective to demonstrate that occupational exposure with cytostatics is low to non-detectable on our wards was achieved.
What next?
We want to encourage more hospitals to get involved in similar projects, and we hope that more powerful analytics will give us more answers for proper handling.
HAZARDOUS DRUG ENTERAL DEVICE
European Statement
Production and Compounding
Author(s)
VIDAL CARLOS
Why was it done?
The publication of NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings established that crushing tablets or making solutions
from them means an unasceptable risk at hospitals.
In adtition to this, USP 800 and Directive 2004/37/EC of the European Parliament on the protection of workers from the risks related to exposure to carcinogens or mutagens at work , impose the use of closed system devices and a plastic pouch to contain any dust or particles generated in these operations.
Conversely, there is no closed system device to crush, disperse and administer safely .
What was done?
We developed a new medical device to protect caregivers from exposure risk derived from crushing and dispersing in water hazardous drugs tablets.
How was it done?
We designed a new medical devide by combining existing issues so as to develop a workable solution that could overcome this safety problem and ensure the compliance with occupational regulations , and ensure a complete dosage.
What has been achieved?
We patented a new medical device that will allow a safe administration reducing exposure risk and environmental pollution at : pharmacy departments ( cross contamination in cabinets ) , nursery units and even at patient´s homes to protect caregivers and relatives.
Its design and simplicity of operation will favor its universalization.
This is an initiative of a hospital pharmacist to solve a daily problem and an example of the our potential in healthcare innovation.
What next?
The commercialization of this medical device will fulfill an unmet need in our daily practice at helathcare facilities and patients homes