International experts in hospital pharmacy participate in a scientific meeting at the UGR
In the attached image, the participants and members of the group "Leachables / Extractables Group for Hospital Pharmacies in Europe" in the meeting held in the Carmen de la Victoria of the UGR. From left to right, Paz Vallés-Moreno (Spain), Antonio Salmerón-García (Spain), Jennifer García-Blanco (Spain), Lina Berger (Switzerland), Lina Berger (Switzerland), Armin Hauk (Switzerland), Graham Sewell ( UK), Iben Larson (Denmark), Natalia Navas (Spain), Miguel Curto (Spain) and Rainer Trittler (Germany).
El Carmen de la Victoria has hosted the celebration of the II working meeting of the international group "Leachables / Extractables Group for Hospital Pharmacies in Europe", a specialized group that brings together professionals in the field of hospital pharmacy, academia, as well as the industry, to deal with aspects related to the risks caused by the migration of unwanted compounds to pharmaceutical preparations made in hospitals.
The purpose of the meeting has been to seek collaboration between hospital pharmacy units, academic and business areas to obtain information on products that may suffer migration or extraction of plastic materials - mainly syringes, elastomeric pumps and infusion bags - in contact with drugs and pharmaceutical preparations made and used in hospitals.
The meeting has been organized by doctor iben larson from Danish State Agency Amgros (http://www.amgros.dk/en), and the teacher Natalia Navas-Iglesias, from the Department of Analytical Chemistry of the UGR, together with the professionals of the Pharmacy of Granada UGC in the University Hospital Complex of Granada, the doctors Jose Head y Antonio Salmerónas well as the teacher Luis Cuadros Rodriguez, all of them members of the Biosanitary Research Institute of Granada. The meeting has been financed through Amgros and the UGR's Own Plan.
Justification of the meeting
Generally, the hospital pharmacy of the European Union needs a longer expiration date for the medicines than that which appears in the technical data sheet of the same. This need is determined by the automated production of medicines in the hospital, for example, using robotic technology, a desired increase in the preparation of “ready-to-use” medicines and / or an increase in demand for medicines administered intravenously, for example, cytostatics. With this advance preparation, the contact time between the drug and the container is increased, causing an undesired risk of migration of components of the container material into the drug solution.
To deal with this problem, it is necessary to know the technology both theoretically and in each specific case with a real packaging and this is not information that the supplier of the packaging provides easily.
The reasons for dealing with leachables / extractables (called as L / E) are: • Risk that L / E will interfere with drug assays, for example how long they have the same retention time as the drug in HPLC assays. • Irrigation that L / E may increase the level of impurities of the drug to an unacceptable level • Irrigation of accumulation of L / E in the human body • Irrigation that L / E may cause disease or prevent healing if the treatment is carried out.
The challenges in this area are the same for all hospital pharmacies in the EU and it is therefore opportune to cooperate to find common solutions.
Group tasks
Among others, and as results of the working group, the proposal of the following tasks stands out:
• Cooperation in tests / trials / analysis in the L / E area for packaging used by hospital pharmacies
• The exchange of experiences in the area of L / E in Europe.
• Identify and gather knowledge of the main aspects and critical issues related to packaging.
• Raise awareness among international regulatory bodies about the magnitude and importance of the problem in question, directing the proposals towards greater transparency in the information provided by the manufacturers of the plastic materials and devices in question.
Contact:
Natalia A. Navas Iglesias
Department of Analytical Chemistry of the UGR
Phone: 958 243388
Email: natalia@ugr.es