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Needle-free systems


Needle-free systems


Needlestick injury amongst healthcare workers is accepted as a fact of life but the implementation of a European Directive is likely to introduce important safeguards


Christine Clark PhD FRPharmS FCPP(Hon) Editor, HPE


All hospitals have policies for avoiding, managing and reporting needlestick injuries but audits repeatedly show that there is under-reporting. Such injuries continue to occur both to front-line healthcare workers and to others, including hospital porters and cleaning staff. The major concern here is the risk of blood-borne infection and the possible far-reaching consequences, but minor injuries should not be overlooked. Common sources of sharps injuries are needles used in the preparation or administration of injections and the needles and spikes used to connect intravenous administration systems. Re-capping or re-sheathing of needles to prevent accidental injury during transport or disposal is one of the most common situations in which needlestick injury occurs, especially if the worker involved is tired or stressed – hardly an unusual situation in healthcare. EC Directive 2010/32 is focused on eliminating, as far as possible, the risk of injury or infection to healthcare workers from medical sharps. It is scheduled for implementation by 11 May 2013, and as it is a Directive, it has to be incorporated in local law. It specifies the minimum requirements that Member States need to implement to protect workers. This Directive provides for “eliminating 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 expressly prohibits the recapping of needles and it emphasises the importance of regular,


comprehensive and ongoing training for staff in the correct use of protective devices and safe systems of working. What has this to do with pharmacy? Although at first glance this appears to concern healthcare workers in clinical areas, careful reading shows that it also has implications for pharmacy personnel in aseptic compounding units and for subcontractors providing compounded injections. Pharmacies are involved in preparation of injections and therefore handle sharps routinely. Although these are unlikely to be contaminated with blood products, accidental injection of small quantities of cytotoxics could cause local necrosis and the accidental injection of small amounts of monoclonal antibodies could provoke allergic reactions in some individuals. The prohibition of recapping of needles could be particularly problematic in pharmacy compounding units. The aseptic preparation of cytotoxic chemotherapy, parenteral nutrition, radiopharmaceuticals and CIVAS products relies on meticulous application of the no-touch technique together with systematic, in-process checking. In order to check the volume of a product in a syringe, for example, prior to addition to compounded parenteral nutrition, the needle is resheathed to avoid contact with a potentially contaminated surface. During the production of radiopharmaceuticals, the radioactivity in a prepared syringe is measured in a dose calibrator before it is injected into a patient. During the measurement the needle is resheathed. Removal of the needle and subsequent refitting of a needle for administration could expose healthcare staff to additional radiation. For these reasons, some organisations have argued that pharmacies


and radiopharmacies should be exempt from the Regulations. At present the draft UK Regulations indicate that recapping will only be permitted if “the risk of injury to employees is effectively controlled by use of a suitable appliance, tool or other equipment”. Many pharmacies are also involved in the procurement of medical devices and this Directive provides the opportunity for pharmacists to play a decisive role here. The application of pharmaceutical expertise to the selection and purchase of needle-free systems is very much in line with thinking behind this Directive.


Recent advances in safe use of injectable medicines have involved pharmacists making risk assessments of products and taking steps to reduce the possibility of medication errors occurring. Arguably, the selection of appropriate, safe reconstitution and administration devices is a logical extension of this function.


There is now less than one year before the Directive has to be implemented and the messages for pharmacy are clear: ● If you run a compounding unit, ensure that your procedures and equipment are up to date so that recapping of needles is no longer necessary or can be done without using a two-handed technique


● If you employ a subcontractor on your premises to provide ready-to-use compounded injections, ensure that they also comply with the Directive


● Take an active part in the risk assessment of procedures and determination of products to be bought by your institution. Let us hope that this Directive is a decisive step on the road to making needlestick injuries a historical curiosity rather than an everyday event. ●


www.hospitalpharmacyeurope.com


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