DHSC: Finance: Naloxone Buffer Stock - Storage & Management FY25/26

Description

1. Purpose DHSC is conducting a market engagement exercise to understand more about the companies and services in the UK that can, or that are seeking to produce, distribute, supply and store different formulations of take-home naloxone that can reverse the effect of an opioid overdose. In particular, we are looking to understand how these suppliers and manufacturers could potentially meet the future of needs of a UK Buffer Stock of Naloxone. The outcome of the market engagement will inform decisions around potential future procurement and storage of a naloxone buffer stock as well as providing information on how the market could meet a potential increase in demand across the UK. 2. Summary Naloxone is a lifesaving medicine that reverses the effects of an opioid overdose. Opiate related deaths remain the highest cause of Drug Misuse Deaths in the 2023 Office for National Statistics data on drugs related deaths. Since 2019, DHSC has maintained a buffer stock of naloxone to enable a rapid deployment in response to an opioid crisis including adulteration of other drugs with synthetic opioids. The department is considering plans to review this arrangement and needs to understand how the market might meet its future needs. DHSC is seeking to further understand the capacity of the market to meet potential changes in the demand for naloxone. In particular: • current domestic and foreign production of naloxone, supply points, and potential ability to flex production and supply. • the nature of the naloxone products produced (e.g., nasal vs injectable), the amount of the active ingredient contained in different products and the bioavailability of the drug after administration. • how suppliers can meet the changes in the take-home naloxone market that may be brought about by the changes in Human Medicines Regulations. Naloxone is a prescription-only medication regulated by the Human Medicine Regulations 2012. This means that there are controls on who can legally administer, sell, and supply naloxone. DHSC has amended the Human Medicines Regulations in 2024 to expand access to take home naloxone without prescription. The impact that this may have on demand remains unknown, but we anticipate that this, combined with the increased prevalence of synthetic opioids, will increase demand for naloxone. 3. Background Naloxone is a prescription only medicine, but the Human Medicines Regulations (HMR) allow drug and alcohol treatment services and professionals named in the legislation to supply naloxone to an individual without a prescription. The regulations also allow anyone to administer naloxone in an emergency. Opioid-related deaths make up the largest proportions of drug-related deaths across the UK. Numbers of Deaths involving opiates in 2023; • England – 2378 (41.6 per million population) • Scotland – 937 (172.0 per million population) • Wales – 166 (53.0 per million population) • Northern Ireland – 103 (54.0 per million population) Naloxone forms a key part of the strategy to reduce the number of deaths from overdoses, which is becoming particularly important as the prevalence of synthetic opioids in the illicit drug market increases. These synthetic opioids are more potent and potentially can be more deadly than other opioids currently and previously available through illicit drug supply. While the exact impact of synthetic opioids on opioid related deaths is yet to be fully understood, work is ongoing to assess the impact of the rise of synthetic opioids and the necessary steps to reduce harm including increased use of naloxone. Business-as-usual supply of take-home naloxone has primarily involved drug treatment services purchasing naloxone from the funding provided to them by local authority public health as part of their commissioned services. Supply has been extending and expanding in recent years to include police forces, prisons, probation, named professionals and services in route 1 of the latest changes to the Human Medicines Regulations and further changes planned for route 2. 4. Formulation and Supply Naloxone has been in production for many years and comes in a variety of different forms and drug delivery mechanisms. Naloxone for use in the community currently comes in 3 forms: • one pre-filled syringe (injectable) • nasal sprays (nasal) • ampoules for injection Although ampoules could be (and previously have been) used in the community, their use is very rare now that there are 3 formulations with a specific community indication (injectable and 2 x nasal). All currently licenced products have a shelf-life of around 3 years after which they should be replaced, which in addition to rates of usage, dictates rate of production needed. This provides a cycle for modelling purposes that can help inform management of stock maintenance. There is also recognition that procurement of the active pharmaceutical ingredient (API), usually as a salt of naloxone (such as naloxone hydrochloride) is a major deciding factor in how rapidly and in what quantity batches of naloxone products can be produced. This is also applicable to the delivery devices: syringes and nasal sprays. These supply chains are reliant on existing international supply chains which, if impacted by manufacturing problems or multi geography demand, could be unable to supply the UK at a time of need. 5. Buffer stock DHSC has historically maintained a buffer stock of intramuscular naloxone in the form of a pre-filled syringe as a precautionary measure to help support a response to a potential crisis. Stock can be released from the buffer stock into business-as-usual stock to meet outstanding contractual demand, or to meet increased demand arising from localised or widespread increases in opioid overdoses. DHSC is in the process of reviewing the potential options for a new emergency buffer stock contract considering the new legislation, the everchanging nature of the illicit drugs market and changes in the provision and availability of take-home naloxone over the past 5 years and more. DHSC is open to innovative and responsive mechanisms for meeting potential sudden increases in demand for naloxone or shortages in the market. We are looking into both Intramuscular and Intranasal formulations of take-home naloxone, and therefore we welcome responses from providers that supply either or both of these formulations of response. We will be looking to understand more about how the buffer stock can be operationalised to deliver to local areas in need at short notice as well as part of national supply. This market engagement will contribute to informing future decision around how best DHSC meets present and future demands. 6. Amendments to the Human Medicines Regulations Act 2024 DHSC has amended the Human Medicines Regulations to further widen access to take home naloxone without prescription. This legislation came into force on 2 December 2024 and is UK wide. This expansion includes: • A list of named professionals and services that can supply take home naloxone without prescription. • The legal framework for a registration service that would enable individuals and organisations not specifically named in the legislation to supply naloxone, subject to appropriate training and safeguarding. 7. Overview of Requirements Legal and other requirements for the licencing (marketing authorisation) of naloxone products in the UK sits with the Medicines and Healthcare products Regulatory Agency and are summarised in Public Assessment Reports. DHSC is interested in learning more about products that are appropriate for community use, not a clinical setting including the provision of appropriate packaging and instructions such that a lay person with adequate training is able to administer it in an emergency. We would also require an appropriate level of training on administration and safe storage to be available for the specific product to meet the safety standards set out in the Human Medicines Regulations.