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Introduction


knowledge base on safe exposure limits and, in the UK, the use of externally vented negative pressure isolators for the preparation of chemotherapy has helped to reduce exposure risk and promote safe handling. Negative pressure isolators are effective (if used correctly) at offering maximal operator protection, in case of a breach. They are, however, more difficult to decontaminate and require the additional set-up cost of dedicated air-handling, external venting and higher background cleanroom specification. Aseptic manipulation and reconstitution of drug presentations (for example, vials) to prepare a prescribed dose results in exposure of the drug to the external environment during the venting process. Studies have also shown that small leaks and formation of aerosols are common when using needles and syringes to reconstitute powders and/or transfer liquids into a final container such as an intravenous fluid bag. Good aseptic technique is essential and preparation must be undertaken by skilled, trained and competent staff. The risk of exposure from aerosols has been demonstrated even while using biological safety cabinets, hence the increasing use of negative pressure isolators in the preparation of hazardous drugs. In some countries, preparation of drugs (including hazardous drugs) is still undertaken by nurses and doctors in clinical areas. It is important for pharmacists and pharmacy technicians to highlight the risks to their respective organisations and to demonstrate their professional skill and expertise in managing high-risk drugs, including hazardous drugs. In particular, pharmacists and pharmacy technicians are well placed to ensure that drugs are prepared in controlled aseptic conditions, with expert knowledge of drug compatibility, stability, formulation and drug delivery, to tailor the treatment dose to the individual patients needs. If hazardous drugs are to be prepared in uncontrolled areas (for example, for practical or clinical reasons), then it is essential that this activity be segregated from other drug preparation activities. Preparation of the drug must also be undertaken by suitably trained and experienced staff.


4


In established services, pharmacy aseptic preparation units face the challenge of continuing to deliver treatment in an efficient, safe and economic manner, producing a product fit for purpose while keeping pace with innovation, rapidly rising demand, clinical and pharmaceuticals


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chemotherapy is standardised and rationalised, there is not sufficient economy of scale achievable to make use of the potential of this technology.7 It could also be envisaged that closed docking systems1


(systems that do not


exchange unfiltered air or contaminants with the adjacent environment) could help manage some of the exposure risks during the preparation of hazardous drugs. If a complete closed preparation and administration is used, they could even be used to facilitate the use of vials, concentrated infusion bags or concentrated syringes and dilution, to the final presentation that is ready to administer, without the need for further manipulation.4


This has potential to


development. The preparation and dispensing of hazardous drugs is a risky and technically demanding task undertaken within pharmacy departments. It is therefore imperative that patient pathways and treatment/clinic capacity be devised with consideration given to the capacity and expertise of pharmacy preparation services to deliver patient specific doses of prescribed treatments.


Most recently automated (robotic) preparation has become a focus of interest. At the same time, safe handling guidelines and the use of closed systems for preparation and administration have been developed.6


Automation of


chemotherapy preparation ranges from simple syringe-filling devices to fully automated cabinets, with a range between these extremes. Automation in pharmacy preparation units is not established and most dispensing is still undertaken by pharmacy staff trained in aseptic techniques, and use of barrier technology such as biological safety cabinets and isolators. The use of technology such as automation, robotic preparation and closed transfer systems may help mitigate some of the exposure risks but still need a level of human involvement to manage the preparation processes, validation and control of the technology. This includes filling and cleaning the devices as well as transporting and administering the drug. The major developments in automation of chemotherapy dose preparation have included syringe-filling devices and fully automated devices such as Cytocare and Riva. The fully automated devices are still in their infancy and require some further development before they can provide the benefits hoped for from such automation. Until the range of


minimise the exposure risk for pharmacy and nursing staff involved in preparing and administering the drugs whilst managing workload capacity and ensuring integrity of the drug, for the patient. Finally, hazardous drugs are increasingly being used as homecare treatments or, in the case of oral agents, managed by patients at home. The handling, storage and disposal of hazardous drugs in the home-setting is a need all healthcare professionals should be aware of; they need to get involved in educating and supporting patients to best manage the drugs and diseases. ●


References 1. National Institute for Occupational Safety and Health (September 2004). Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Centers for Disease Control and Prevention. [Cited 2012 August 10 ]. Available from: http://www.cdc.gov/niosh/ docs/2004-165/2004-165d.html.


2. Koltes LA. Healthcare workers’ attitudes, understanding and perceived risk of methicillin- resistant Staphylococcus aureus. ProQuest dissertation 2009.


3. Stevens V et al. Cumulative antibiotic exposures over time and the risk of Clostridium difficile infection. Clin Infect Dis 2010;53(1):42-48.


4. Arfons L, Ray AJ, Donskey CJ. Clostridium difficile infection among health care workers receiving antibiotic therapy. Clin Infect Dis 2005;40(9):1384-5.


5. Safe Handling of Cytotoxic Drugs. HSE Information Sheet MISC615.


6. International Society of Oncology Pharmacy Practitioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract 2007;13 (Suppl):1-81.


7. Zavery B, Burnett B, Oldcorne M. Vision paper on the future of pharmacy technical services and the provision of patient specific parenteral chemotherapy treatments. EJHP Practice 5/2011; 17: 1-8.


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