Naloxone Prospective Observational Cohort Research Study (NalPORS)

King's College London (KCL) requires access to NHS England data for the purpose of the following research project:

Naloxone Prospective Observational Cohort Research Study (NalPORS)

The following is a summary of the aims of the research project provided by KCL:

Research has shown that Take home Naloxone (THN) can lead to improved survival rates among programme participants and reduced heroin overdose mortality rates in the community. The NalPORS study will provide information on the real-life effectiveness of naloxone administration by lay-persons in reversing an opioid overdose. By conducting a mortality database search of those participants who were not followed up at the 6-month stage, researchers can clarify whether opioid users provided with THN are at greater risk of an opioid overdose.

The NaLPORS study is investigating the effectiveness of Take-Home Naloxone (THN) administered by non-medical persons who have witnessed an opioid overdose. People who use opioids have a high risk of premature mortality than the general population. It is possible that study participants who are opioid users may have experienced a premature death over the course of the study and will be lost to follow-up. This proposal will allow the study investigators to determine whether these participants have died, and whether their cause of death is an opioid overdose.

The following NHS England Data will be accessed:

> Civil Registration Mortality – necessary to analyse whether the participant died over the course of the study and whether the cause of death was an opioid overdose.

The level of the Data will be:

> Identifiable.

Although only pseudonymised data fields have been requested from NHS England, KCL hold the identifiers for the cohort, and therefore, though no attempt will be made, KCL have the technical means to reidentify participants.

The Data will be minimised as follows:

> Limited to a study cohort identified by KCL – 282 participants who were recruited to the NaLPORS study between June 2021 and March 2024, and who a) provided consent for a mortality database search, b) were current opioid users and c) were lost to follow-up 6 months post enrolment.

KCL is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it is expected to increase the body of knowledge on how to prevent accidental opioid overdoses.

The funding is provided by Mundipharma. The funding is specifically for the study described.

The funders will have no ability to suppress or otherwise limit the publication of findings.

Microsoft Limited provides IT hosting services to KCL and will store the Data as contracted by KCL.

The organisations that are involved in the wider project include:

> South London & Maudsley NHS Trust

> Humber Teaching NHS Foundation

> Birmingham & Solihull Mental Health NHS Foundation Trust

> Public Health Wales, Cardiff

These organisations supported KCL in participant recruitment. They have no role in data processing and will have no access to NHS England Data.

During the design phase of the NalPORS study which included the proposal to access participant death data, there was a total of three 1-hour consultations with the Addictions Service User Research Group regarding the feasibility of the study design. In addition, all study questionnaires were piloted with two service users. The outcome of the PPI discussions explicitly fed into the design of the study. For instance, the PPI group suggested that when conducting the witnessed overdose questionnaires and interviews, KCL allowed for the participants to have short breaks if the information they were discussing was of a sensitive nature. KCL also allowed the participants to request a call back if they were feeling overwhelmed when discussing the event. The feedback provided by the PPI group was incorporated into the protocol.

The study is funded by Mundipharma a pharmaceutical company that developed nasal naloxone, Nyxoid. The findings will be used for their Post Marketing Authorisation (monitoring information about the safety of a drug) for Nyxoid.

Research has shown that Take home Naloxone can lead to improved survival rates and reduced heroin overdose mortality rates in opioid users. The NalPORS study will provide information on the real-life effectiveness of naloxone administration by lay-persons in reversing an opioid overdose. By conducting a mortality database search of those participants who were not followed up at the 6-month stage, KCL can clarify whether opioid users provided with THN are at greater risk of an opioid overdose. This information will provided to Mundipharma who are applying for post-authorisation of their nasal naloxone product Nyxoid, if authorised Nyxoid can be distributed to clinical sites, included those used by the NHS  to reverse opioid overdoes. This study is of benefit to the public by contributing to an increased body of knowledge on how to prevent accidental opioid overdoses and the development of potential new treatments.

The Nyxoid product produced by Mundipharma is already available in the UK for use. Munidpharma will use the summary information for post-authorisation marketing, however, not all participants were provided with Nyxoid. The NalPORS study is an independent, prospective cohort study that assessed the recognition, and response to opioid overdose among different populations of lay people provided with a range of different types of naloxone in different settings and countries.

Mundipharma will only receive a table of results stating how many participants have died of an opioid overdose. Mundipharma may benefit from access to this aggregated data with small numbers suppressed mortality data related to their product as part of ongoing post-marketing authorization activities. For instance, this data may support future clinical development plans, safety protocols or risk minimization strategies.

KCL will transfer data to NHS England. The data will consist of identifying details (specifically Date of Birth, Gender, Name and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the deaths dataset to KCL. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at KCL.

KCL stores Data on the Cloud provided by Microsoft Limited.

The Data will be accessed by authorised personnel on-site and via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The data will not leave England at any time.

Access is restricted to employees of KCL who have authorisation from the Co-Investigator.

Access to confidential patient identifiable data is restricted to the KCL co-investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with survey data collected from participants as part of the NalPORS study.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the KCL will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> Submissions to peer reviewed journals

> Presentations at appropriate academic conferences

> Presentation at a one-day conference held at King's college London for stakeholders such as clinical staff and public sector organisations

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

> Findings will be disseminated to staff and service users at all recruitment sites through presentations and one page plain English summaries

Outputs are expected to be generated within a year of data receipt for dissemination to relevant policy makers and practitioners. Conferences are expected in Summer 2026.

Research has shown that take home naloxone can lead to improved survival rates among programme participants and reduced heroin overdose mortality rates in the community. The NalPORS study will provide information on the real-life effectiveness of naloxone administration by lay-persons in reversing an opioid overdose. By conducting a mortality database search of those participants who were not followed up at the 6-month stage, KCL can clarify whether opioid users provided with naloxone are at greater risk of an opioid overdose. Therefore, this study is expected to be of benefit to the public by contributing to an increased body of knowledge on how to prevent accidental opioid overdoses.

The use of the data could:

- help the system to better understand the health and care needs of populations.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

- inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

- support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Research has shown that Take home Naloxone can lead to improved survival rates among programme participants and reduced heroin overdose mortality rates in the community. The NalPORS study will provide information on the real-life effectiveness of naloxone administration by lay-persons in reversing an opioid overdose. By conducting a mortality database search of those participants who were not followed up at the 6-month stage, KCL can clarify whether opioid users provided with THN are at greater risk of an opioid.

This study is expected to be of benefit to the public by contributing to an increased body of knowledge on how to prevent accidental opioid overdoses.

To optimise the potential public benefits from the use of the data, findings will be presented to clinics who work with opioid users, and disseminated to addiction charities.

Yielded Benefits is not a requirement for new applications.