Expert panel report
gemcitabine can be purchased and this helps pharmacies to make optimal use of their compounding capacity. In Denmark, compounded cyclophosphamide injection is purchased from the UK because of limited capacity in Demark. One unexpected finding (from Germany) was that the exterior surfaces of infusion bags from some manufacturers were heavily contaminated with micro-organisms and this was difficult to remove effectively. It was suggested that this contamination might decrease during storage.
can only work with one type of transfer device – this is, in effect, a fixed combination. Finally, the software of the compounding robot does not interface with other pharmacy software and users reported that additional staff are needed to support compounding robots.
In the UK and France, positive pressure isolators are widely used for cytotoxic preparation. The isolators are regularly cleaned and tested to ensure that they are functioning correctly.
There was general agreement that products should be wiped (rather than sprayed) when they are transferred in or out of the cabinet or isolator to ensure effective disinfection and
decontamination. There was also general agreement that double-gloving is required and that there should be frequent changes of gloves, although the intervals varied from 15 minutes to two hours. ‘Chemo pins’ or spikes are used for reconstitution of drugs in vials larger than 20ml. In several centres, drug vials are routinely used for more than one patient for reasons of economy. Sometimes this involves storing reconstituted injections for short periods, if they are known to be stable, either in an isolator or in a fridge. Physico-chemical stability information is taken from Stabilis, local lists or from the manufacturers. The production pharmacist is responsible for microbiological stability.
In one centre in the UK, about 50% of cytotoxic doses are prepared in infusions, 40% as bolus doses and 10% in elastomeric devices.
In the UK, RTU injections of cyclophosphamide, epirubicin and
Most countries (except the UK) prepare cytotoxic injections with the administration sets already attached. This does not require a great deal of extra work in the pharmacy - it takes less than one minute to attach the administration set.
Reconstitution and transfer devices Any new reconstitution and transfer device must make the process safer or faster. Critical features of any new device would be the cost, the extent to which it could reduce environmental contamination and the force required to operate it. Evaluation of reconstitution and administration devices cannot be done at the desk – it is important to work with the nurses and technicians who use the products routinely. Training and education of staff about correct use of products and about safety issues is also critical. In addition, it is important to reassess performance regularly – this is routine in microbiology and a similar approach should be adopted to safe handling of cytotoxic drugs.
The panel discussed the impact of the Sharps injury Directive (Council Directive 2010/32/EU of 10 May 2010
implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU) and the Council of Europe Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (CM/ResAP(2011)1).
The Sharps injury Directive is aimed at eliminating the risk of injury or infection to healthcare workers from medical sharps. The Directive has to be incorporated in local law and implemented by May 2013. It specifies the minimum requirements that Member States need to implement to protect
workers. It calls for elimination of “the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms”. It also prohibits the recapping of needles and emphasises the importance of regular, comprehensive and ongoing training for staff in the correct use of protective devices and safe systems of working.
The prohibition of recapping (or resheathing) of needles was a particular cause of concern for pharmacists in the UK. Needles are currently resheathed during the cytotoxic preparation process and there would be problems if this could not be done. Pharmacists believe that a distinction should be made between ‘clean’ needles that are not contaminated with blood or body fluids and contaminated needles that have been in contact with blood or body fluids. Council of Europe Resolution (CM/ ResAP(2011)1 sets out recommendations for quality and safety assurance standards for medicinal products prepared in pharmacies for the special needs of patients. It was inspired by a survey of hospital pharmacy preparation in 19 European countries that identified considerable variation in quality assurance and safety standards across Europe. The working group had concluded that legislation in Europe should be harmonised in order to minimise the risks for patients. The CoE resolution has been accepted by all Member States as a starting point for future legislation. It was formally adopted in January 2011 and pharmacists have been encouraged to approach their
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