HPE Drug stability: What do we need to know?

OUTCOMES How extending shelf lives impacts on daily workload Workload is increasing for many aseptic preparation units, particularly those providing cytotoxic chemotherapy, and robust extended stability data are important to enable efficiencies to provide timely treatments Mark Santillo MRPharmS Regional Quality Assurance Officer South West England, Torbay & South Devon NHS Foundation Trust, UK Workload within most aseptic services units is increasing year on year, a situation borne out by the NHS England aseptic services review conducted in 2018. 1 The main focus of the increase was on cancer chemotherapy but in some areas there has also been an increase in parenteral nutrition. Added to this, there are more increasingly complex products coming to market, many biopharmaceuticals including monoclonal antibodies and antibody drug conjugates, which often have specific reconstitution and handling directions. Workforce issues in other parts of the healthcare sector have put increasing pressures on aseptic units to provide additional products (traditional CIVAs products) in a ready-to-administer presentation; within the UK this has been termed as meeting the unmet need. The Council of Europe Resolution CM/Res(2016) 2 on good reconstitution practices in health care establishments for medicinal products for parenteral use has reinvigorated the process of risk management and reduction of intravenous medicines preparation in clinical areas and this is likely to result in an increased demand for ready-to- administer products to be provided to these areas. Furthermore, the wish to reduce hospital stays and the availability of homecare services and more localised clinics has added to the requirement for aseptically compounded products, and particularly those with extended shelf lives. Additional shelf life on aseptically compounded products means fewer deliveries for patients and hence reduces costs and increases convenience of this treatment option. In the outpatient parenteral antimicrobial therapy (OPAT) area, the move towards 24-hour continuous infusions has a patient benefit hospitalpharmacyeurope.com | 2019 | 19

HPE Drug stability: What do we need to know? | Page 19