Supply of Pre-Prepared Radiopharmaceuticals

The preparation of radiopharmaceutical kits is regulated under the terms of the Medicines Act 1968, and the activity must be carried out by a provider licensed by the Medicines Regulatory Agency under a ‘Specials’ license. Due to the short half-life and expiry of radiopharmaceutical kits, the providers holding ‘Specials’ licenses are limited to NHS licensed providers, which are generally acute Trusts with large Nuclear Medicine Department within a 2 hour distance from the contracting Trust. Salisbury NHS Foundation Trust ("SFT") awarded a contract under Regulation 32(2)(b)(ii), to University Hospital Southampton NHS Foundation Trust (hereafter referred to as "UHS") in respect of the Supply of Pre-Prepared Radiopharmaceutical Kits, for a period of one (1) year, with no option to extend. This is to maintain continuation of the Nuclear Medicine service delivery for patients both currently receiving and due to receive treatment and/or diagnostics at SFT. This will also align this contract with a similar contract at Great Western Hospitals NHS Foundation Trust (hereafter referred to as "GWH") for the Supply of Pre-Prepared Radiopharmaceutical Kits, provided by University Hospitals Bristol & Weston NHS Foundation Trust. UHS is the incumbent supplier for Pre-Prepared Radiopharmaceutical Kits at SFT and the new contract will ensure that the current service is maintained until the time a re-tender is required, without risk to patient care or the accumulation of cost and resource pressures. To award another supplier a temporary arrangement of this nature may result in the following: Trust Turnaround Times and Patient Care: Variations in turnaround time for the delivery of these kits, while new systems for ordering, receipting and payment are set up. Currently UHS routes for the supply of Pre-Prepared Radiopharmaceutical Kits are established and consistent, with adequate governance surrounding Data Protection in place. Risking this could lead to increased turnaround times for the delivery of these kits, and kits being unnecessarily disposed of if an unsuitable level of radioactive decay has occurred. Furthermore, if a contract is not awarded to the contracting authorities' incumbent supplier, no other provider is currently able or willing to provide this service at the time needed as its time sensitive. Packaging and Transport: New routes of transport for Pharmaceuticals would have to be set up. This would create uncertainties for both the Trust and the patients that existing processes could be upheld, including delivery times, delivery windows, care for packaging and prevention of breakages. Packaging requirements may also vary, leading to additional costs of purchase, and increased time to carry out alternative packaging requirements. Accreditation: A supplier of Radiopharmaceuticals would need to possess an appropriate license granted by the MHRA to enable them to supply radioisotopes, either in the form of a Manufacturers/importers License (MIA license) or a Manufacturer ‘specials’ licence (MS License). The time required to adequately review an alternative provider would further delay this process leading to a drop in patient care whilst Radiopharmaceutical Kits could not be obtained. SFT has reviewed the factors described and considers that for the technical reasons listed, awarding to UHS is the only reasonable solution as it mitigates the risk of a detrimental effect on the service and the accumulation of preventable cost and resource pressures until a re-tender can be undertaken. The requirement covers the provision of the following radiopharmaceuticals: Tc99m (Technetium), MAA, HDP/HMDP, MAG3, DMSA, SESTAMIBI, NANOCOLLOID and PERTECHNETATE. These are provided in the form of multi injection vials.