NHS England has now published the first set of product specifications to support the production and supply of ready-made chemotherapy. 4 The addition of the dose-banded chemotherapy standardised product specifications means that hospitals should be purchasing exactly the same products from licensed suppliers, with no variation. Previously, each pharmacy department or regional purchasing team negotiated their own product specifications with the suppliers and there were variations across different areas in terms of the final product. Examples of variation include syringe sizes selected as final product storage, that is, should volumes between 25ml and 30ml be stored in 30ml or 50ml syringes, whether to remove the same volume of a fluid bag to match the amount of active drug being added, and what volume to state on the final product label. These variations and others have led to a large product catalogue being present across suppliers to NHS hospitals. With a known capacity issue for specials manufacturing in both commercial and NHS facilities, removing variation helps to free up capacity by limiting the number of different items or presentations that need to be manufactured.Decreasing the variation and having set product specifications for dose- banded products helps to increase the need for those specific products and doses. This is needed if we are to take the next logical step of trying to get some of these products licensed. For there to be a financially viable product for pharmaceutical companies to consider investing in licensing, there first needs to be a market and sufficient need or usage to make it a worthwhile investment. National dose banding implementation and the production of product specifications information by NHS England are all initiatives that are hoped will encourage the development of licensed ready-made standardised chemotherapy doses. Table 1 outlines some of the advantages of dose banding for chemotherapy. Benefits of licensed standardised doses The benefits of having licensed standardised chemotherapy doses (LSCDs) are wide ranging. Unlicensed medicinal products are, by their nature, high risk. All injectable medicines must undergo a risk assessment to determine the level of risk (high–low) associated with the preparation of the injectable medicines. This allows for targeting of high-risk injectable medicines to be manufactured within pharmacy aseptic units. 5 Cytotoxic injectable medicines are high risk in nature. NHS hospital aseptic units that are not licensed for manufacturing are operating under section 10 exemption of the Medicines Act 1968; this requires them to manufacture chemotherapy under the supervision of a pharmacist for all medications prepared. Only patient-specific doses of chemotherapy in response to a signed prescription must be prepared and there is a maximum expiry of seven days for any product. The injectable cytotoxic and monoclonal antibodies prepared in hospital aseptic units therefore tend to be bespoke, have a fast turnaround, a short expiry, and fewer doses. This leads to a relatively high cost per dose manufactured, whereas in contrast standard dose and formulation, batch manufacture with a long The benefits of having licensed standardised chemotherapy doses are wide ranging. Licensed standardised chemotherapy doses reduces a vast proportion of the risk of using unlicensed medicines table 1 Advantages of dose banding of chemotherapy • Reduction in variation of doses • Reduction in variation of presentation of doses of chemotherapy • Uniform requirements in presentation and doses equates to better price negotiations with commercial and NHS licensed units • Increased capacity for manufacturing of complex compounds and participation in clinical trials (both commercial and non-commercial) 25 HHE 2018 | hospitalhealthcare.com expiry and high volume either by a ‘specials’ manufacturer or as a LSCD would lead to lower costs per dose manufactured. By law, before a medicine can be placed on the market, it must be given a marketing authorisation (product licence) by a medicines regulator (the Medicines and Healthcare products Regulatory Agency in the UK). 6 This process guarantees that all those involved in bringing products to market are accountable for their actions, ensure that processes, supplies and quality can be thoroughly monitored, and enable swift corrective action to be taken when needed. LSCDs would also have to undergo the rigorous process of obtaining a marketing authorisation. Where LSCDs doses are used in accordance with their Summary of Product Characteristics, the liability would lie with the manufacturer. The introduction of LSCDs removes the need for managing the quality of unlicensed medications on receipt and it ensures that the product can be used as soon as it has arrived rather than having to go through local quality assurance process prior to release for general use. Increasing the number of agents available as LSCDs frees up capacity through the supply chain. At a local individual hospital aseptic unit, this could free-up capacity to concentrate on the bespoke and highly specific items that are not suitable for licensing. It could potentially provide capacity to either start or expand a centralised intravenous additive service (CIVAS) within the hospital to improve quality of care in therapy areas other than cancer. With an increased number of new advanced therapy medicinal products coming to market, this will allow aseptic units to focus on these newer treatments, which tend to be high cost, highly complex, and having a short shelf life. It could also release time to be put into clinical trials and research, particularly with the recent national tender for seven genomic sites; 7 this released capacity for units would greatly advantageous. The Carter report states, “Overall, the standardisation of doses should reduce costs for providers, while releasing capacity within local units to support other activities and, in particular, clinical trial and research.” 2 A greater number of licensed products would help to achieve this. If many of the dose-banded items currently supplied within the commercial ‘specials’ sector were no longer needed (by the introduction of LSCDs), this would free up their capacity at a time when there is a struggle to meet the required demand. Initial finding from the recent NHS Improvement pharmacy aseptic service review 7 revealed that the dose banded items outsourced to them in England tend to have low profit margins and are not allowing companies to invest in future investments and capital projects. Removing these would allow commercial suppliers to look at diversifying what they offer and providing different services to the NHS as required. With licensed products should come less waste and longer times for use because they would have a much longer shelf life then items made in an unlicensed hospital pharmacy aseptic unit or a specials unit. In the event of a dose not being used for a particular patient, the LSCD could be returned to local stock holding and re-assigned to another patient.