Currently for the majority of dose-banded items outsourced to specials manufacturers , a minimum quantity ( five of one particular drug and strength ) has to be ordered . With licensed products , it is likely that minimum orders would not be needed . LSCDs could become part of a normal delivery from a wholesaler . Often orders placed to wholesalers are available the next day rather than the usual five-day turnaround from specials ; this would allow a smaller stock holding as fewer items could be ordered ( but more frequently ) to meet the local need .
LSCDs would have product branding and design incorporated into their marketing authorisation applications . This process ensures that product licence holders ensure a risk reduction in their labelling and identification of different product strengths , and which would reduce the chance of picking errors within the pharmacy as the majority of products from a single specials supplier would usually look the same and might only be differentiated by reading the label for drug and dose . At present , there is an individual licensed ready-made chemotherapy agent – Sun Pharmaceuticals ’ gemcitabine – available on the market . 8 The product was
table 2
Key implications for the introduction of licensed standardised chemotherapy doses
• Extended product shelf life – helping with reduction of ‘ wasted ’ doses
• Removal of unlicensed product quality assurance processes
• Increased capacity for NHS aseptic units to participate in / expand CIVAS service , complex IMP manufacture in clinical trials
• Quicker turnaround times , for ordering licensed standardised chemotherapy doses in contrast to outsourced chemotherapy batch ordering
• Reduction in picking errors – as licensed products must undergo branding and design
• Release of aseptic unit staff to participate in other activities and service development , for example , Research and Development , staff training and development introduced to the market in line with national dose bands . Doses currently range from 1200mg to 2200mg and each individual dose of gemcitabine ( 1200mg / 120ml ; 1600mg / 160ml ; 1800mg / 180ml ; 2000mg / 200ml ; 2200mg / 220ml ; a 1400mg dose will be available in Summer 2018 ) is presented in a different coloured outer box .
Our experience and implementation At Milton Keynes University Hospital NHS Foundation Trust , we implemented the use of the licensed ready to administer gemcitabine bags and this has been beneficial in a number of ways . No longer having to manufacture on average 50 doses of gemcitabine per month has freed time to be spent on other activities . For example , our organisation was one of the initial UK NHS Trusts to be involved in the OCEAN clinical trial : a randomised , controlled , open-label study where one of the investigational medicinal products ( IMPs ), melflufen , required manufacturing under strict conditions owing to its high sensitivity to light and short expiry time .
The difference in time taken per one dose in our unit equates to 24 minutes of time saved ( this is primarily on production tasks such as label and worksheet generation , spray and wipe sanitisation and manufacturing ). This one product in a medium-sized district general has therefore saved 20 hours per month of staff time to be focused on other tasks . We have found the ordering , supply and use of the product very easy and straightforward . We are able to keep just a few of each strength in stock to limit the space required as we are confident of receiving deliveries at our stated times and there is no need to assess them against a product specification when they are received . Therefore , there is no delay in being able to use the doses . As previously mentioned , the five available strengths come in colour coded boxes to aid in picking the correct strength and in the last 12 months since using the product , there have been no reported picking or dispensing errors .
Conclusions Table 2 lists the key positive implications for the introduction of LSCDs and their potential impact to NHS Trusts . At our facility , we have implemented the use of the licensed ready to administer gemcitabine bags and the benefits are evident .
26 HHE 2018 | hospitalhealthcare . com
References 1 NHS England Chemotherapy Clinical Reference Group . www . england . nhs . uk / commissioning / spec-services / npc-crg / group-b / b02 / ( accessed May 2018 ). 2 Operational productivity and performance in English NHS acute hospitals : Unwarranted variations . An independent report for the Department of Health by Lord Carter of Coles . February 2016 . 3 NHS Pharmaceutical Quality Assurance Committee with British Oncology Pharmacy Association . 2016 . Guidance on managing the sourcing and supply of ready-to-administer chemotherapy doses for the NHS . A How to guide . Version 1 A . 4 NHS England . Dose banded chemotherapy product specifications . www . england . nhs . uk / commissioning / specservices / npc-crg / group-b / b02 / dose-banded-chemotherapystandardised-productspecifications / ( accessed May 2018 ). 5 Beaney A . Quality assurance of aseptic preparation services standards . Part A . Chapter 3 : Minimising risk with injectable medicines . 5th Edition . Royal Pharmaceutical Society and NHS Pharmaceutical Quality Assurance Committee ; 2016 . 6 Medicines and Health products Regulatory Agency . My medicine , marketing authorisation information leaflet . www . mhra . gov . uk / home / groups / comms-ic / documents / websiteresources / con025908 . pdf ( accessed May 2018 ). 7 NHS Improvement . Pharmacy aseptic services review summary of key findings . March 2018 . www . sps . nhs . uk / wp-content / uploads / 2018 / 04 / NHSI-Aseptic- Summary-and-Findings _ 280318 . pdf ( accessed May 2018 ). 8 Clinical Trials . gov . OCEAN . A randomised , controlled , open-label , Phase 3 study of melflufen / dexamethasone compared with pomalidomide / dexamethasone for patients with relapsed refractory multiple myeloma who are refractory to lenalidomide . EudraCT number 2016-003517-95 . https :// clinicaltrials . gov / ct2 / show / NCT03151811 ( accessed May 2018 ).