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Expert panel report


national authorities to discuss implementation of the Resolution. It has been suggested that, if such discussions do not take place, it is possible that alternative, less satisfactory, arrangements could eventually be imposed.


Two important points arising from the Resolution are, first, reconstitution of injections is not considered to be magistral preparation and second, although reconstitution should preferably take place in the pharmacy, ‘low risk’ products could be reconstituted on the ward. It follows that all products and processes should be risk assessed and a suggested risk assessment scheme is provided in the Resolution. The panel was reminded that ‘reconstitution’ means preparing the product according to the Summary of Product Characteristics (SPC) and that, if there is any deviation from this procedure, than it is considered to be compounding process.


In the UK, The National Patient Safety Agency (NPSA) has devised a risk assessment scheme for injectable medicines that identifies high-, medium- and low-risk products. However, it is not always possible to compound the high-risk products in hospital pharmacies because there is insufficient capacity. Panel members suggested that additional factors should be built into the risk assessment, such as the training and quality of the staff involved, whether or not a CSTD is used and the intrinsic toxicity of the drug. In addition, some countries have local risk assessment schemes that give a lower risk weighting to products that are used in-house. It was also noted that, regardless of risk level, some drugs are too unstable to prepare in the pharmacy. A further complication is that, for some drugs, the


shelf lives quoted in SPCs differ from country to country. Panel members agreed that pharmacists should challenge the pharmaceutical industry over this because it is not acceptable to have different values in different countries for the same product.


There were differing views on the future of hospital compounding activity. One viewpoint was that the workload for compounding units could increase over the next ten years because economies of scale will be possible. The alternative viewpoint was that the workload could


Roundtable participants Dr Ahmet Bosnak


Chief of Central Antineoplastic Preparation and Administration Unit, Gaziantep University Oncology Hospital, Turkey


Dr Maria Cammarota


Pharmacist Manager of Antiblastic Unit, A Cardarelli Hospital, Naples, Italy Dr Bertrand Favier


Pharmacy Department, Centre Léon Bérard, Lyon, France Dr Severine Foucher


Pharmacist, Hospital Antoine Béclère, Clamart, France Dr Vagn Handlos


Senior Scientist, Capital Region Pharmacy, Herlev, Denmark Dr Ana Herranz


Department of Pharmacy, General Hospital Gregorio Maranon, Madrid, Spain Dr Torsten Hoppe-Tichy


Chief Pharmacist, University Hospital of Heidelberg, Germany Dr Irena Netikova


Head of Clinical Pharmacy, Hospital Na Bulovce, Prague, Czech Republic


Mr Martin Rees-Milton Principal Pharmacist Aseptic Services, Velindre Cancer Centre, Cardiff, UK Dr Isabelle Roland


Pharmacist, CHU Liège, Belgium


decrease because the availability oral chemotherapy will increase and the industry could provide more RTU or RTA injections.


The panel concluded that practices relating to the preparation of cytotoxic drugs vary across Europe and, to a certain extent, this is influenced by the availability of products in different countries. Two questions of immediate interest are the optimal frequency with which gloves should be changed and the need for changes of practice to avoid recapping of needles. l


8 www.hospitalpharmacyeurope.com


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