1. Background And Purpose Of This Study
On May 1st 2020, the Scottish Government requested that all patients in custody who were on daily oral Opioid Substitution Treatment (OST) and currently serving a sentence of six months or longer, be moved onto Buvidal (a slow release OST injection) where clinically appropriate. This was intended as a contingency measure in prisons to respond to Covid-19. The daily administration of oral OST places a considerable burden on the Scottish Prisons Service (SPS) and those who live and work in prisons. At this time, there were significant concerns about how this could be sustained while SPS officers and prison health centre staff were also responding to the pandemic. To support the Buvidal programme, the Scottish Government also issued National Clinical Guidance and indicated support for Health Boards to incur emergency contingency plan expenditure of up to £1.9 million to enable transitioning to Buvidal in prison settings which was also included in NHS Board Mobilisation Plans. The funding covered the cost of the medication for a four-month period from May to August 2020, which was then extended to September to accommodate one month lead-in time.
This report delivers on the commitment by the Scottish Government to undertake a rapid evaluation of the Buvidal programme to inform decision-making about what should happen beyond the initial contingency period (May - September 2020).
1.2 Policy Background
Opioid Substitution Treatment (OST) has been used in Scotland's prisons for approaching twenty years. Research has demonstrated a very strong association between receipt of OST and lowered mortality among opioid-dependent people in prison. Treatment most commonly consists of daily oral doses of Methadone administered under supervision throughout the prison stay. In a small number of cases, different treatments, such as Buprenorphine, are used instead. It has been estimated that approximately 25% of people in prison in Scotland receive a daily supervised dose of OST. This is resource intensive in terms of healthcare and prison officer staff time and also has a detrimental impact on patients' daily routine and limits their ability to participate in prison life. In comparison, Buvidal is a sustained release depot injection (i.e. an injection formulation of a medication which releases slowly over time) of OST, available as a 7-day or 28-day dose, which reduces administration and treatment episodes.
To ensure continuity in the administration of OST for patients and to support prison and healthcare staff during the Covid-19 pandemic, the Scottish Government worked with partners to explore OST contingency options and identified Buvidal injections as the most pandemic-appropriate alternative to daily OST arrangements. Buvidal is fully licensed and has been approved, on a restricted basis, by the Scottish Medical Consortium (SMC) for use by NHS Scotland for the treatment of opioid dependence. The introduction of Buvidal in prisons as part of contingency planning and response is consistent with SMC recommendations.
It was anticipated that rolling out Buvidal injections would remove the need for daily OST administration, therefore ensuring no gaps in treatment in the event of significant disruption to prison operations due to Covid-19, and avoid unplanned and unmanaged withdrawal among OST patients. Further anticipated benefits from the wider prescribing of Buvidal were a rapid reduction in the number of daily patient-staff interactions, freeing up resources to carry out other essential patient care and SPS activities, and reducing the risk of Covid-19 transmission within prisons.
A summary of evidence about Buvidal produced by the National Institute for Health and Care Excellence in 2019 suggested that it may have a place in treating opioid dependence in people in custodial settings, where the risk of diversion and time needed for supervised consumption currently leads to challenges in supplying supervised medicines safely. Recent research has documented that Buvidal may offer specific benefits for OST patients in custody because of the practical elements (i.e. not having to receive medication everyday) and the discretion of the treatment, which could lead to a reduction in the amount of bullying and intimidation encountered as a result of being an OST patient. The switch to Buvidal may also reduce incidences of people diverting their OST medication, which is commonly reported in prisons and is associated with bullying and drug misuse. Buvidal also exerts a blocking effect when taking other opioids which means it could prevent some drug related overdoses and deaths in prison and after a person is liberated. Additionally, offering Buvidal increases the treatment options for people on OST in prison, thus widening patient choice. Allied to this, the guidance issued by the Scottish Government set out how people could switch back to their previous OST if they felt Buvidal was not an effective treatment option for them.
A number of factors related to the short timescale of the Buvidal contingency programme (May-September 2020) have limited the potential for the programme to demonstrate significant impacts on the prescribing of OST in prisons. Some boards chose not to provide Buvidal and no board has moved all eligible and willing patients from daily OST to Buvidal. The research illustrates that moving patients over from Methadone to Buvidal takes time, particularly if they were on higher daily doses, which can impact, practically, on the number of patients who can be transitioned to it at one time. Health centre staff also needed to be trained. Added to this, there appeared to be a reluctance among some OST patients to switch over to Buvidal because of the newness of the treatment.
Based on the outcome of this rapid evaluation report and a review of NHS Boards' spend to date, the Scottish Government took the decision to extend support for NHS Boards to incur emergency contingency plan expenditure for the cost of Buvidal medication in prison settings until the end of this financial year, to 31 March 2021. This support is to cover expenditure on the medication costs only and should be scored in NHS Board's local mobilisation plans. Scottish Government communicated this decision to Health Board Chief Executives, Local Authority Chief Executives and Health and Social Care Partnership Chief Officers on 13 November. When communicating on this we have been clear that funding from 2021-22 onwards must come from NHS Board's pharmacy budgets.
1.3 Study Objectives and Methods
The key objectives of this evaluation were to explore:
- The extent to which patients on OST had been moved onto Buvidal between May and August.
- Any impacts of the Buvidal programme on patients, and prison and healthcare operations, and as a Covid-19 contingency measure.
- Reasons for patient uptake, non-uptake, and reverting back to previous OST
- Lessons from implementation.
Data-collection, analysis, and reporting for the rapid evaluation were undertaken in-house by Scottish Government Health and Social Care Analysis over July and August 2020. The Scottish Government's National Clinical Guidance document for the Buvidal contingency programme had proposed a number of initial evaluation objectives and measures. However, following discussion between government researchers undertaking the study and policy officials, it was agreed that not all of those measures were relevant for the purposes of the current evaluation and it was established that data were not available for some of the original measures.
As a service evaluation, the study did not need NHS Ethics approval; it was screened using the NHS Ethics decision-making tool and a Scottish Government Social Research Ethics Checklist was completed. The SPS Head of Research was content that it did not need to go to their research ethics panel, and the study was supported by the SPS Head ofHealth Strategy, who helped make the necessary contacts for data collection and interviews, and by the Healthcare Improvement Scotland (HIS) National Prisons Pharmacy Advisor. A Data Protection Impact Assessment was completed.
The evaluation is based on quantitative and qualitative evidence. As it was being planned, information from Health Boards had already made clear that patient numbers in the programme were low, not all boards were implementing the switch, and that there was a significant lead-in time involved in moving some patients across from daily OST. These factors, alongside the limitations on activities within prisons and additional Covid-19 pressures on both SPS and Health Board staff, limited the potential for quantitative data to address the evaluation objectives, thus it was recognised early on that qualitative data were key.
The quantitative measures used in this report consist of: existing data on the prison population and OST prescribing; and data gathered for this evaluation, which include patients numbers moved onto Buvidal and staff time. These are discussed in sections 2 and 3.
Qualitative methods and sample
A qualitative component of this evaluation was included to assess the acceptability, effectiveness and feasibility of Buvidal as a Covid-19 contingency response. Qualitative data was gathered using semi-structured interviews with a purposive sample of stakeholders with knowledge and experience of Buvidal, OST in prisons more widely, and prison operations.
Twenty-four interviews were undertaken (via telephone or MS Teams) between 14th and 23rd July with: six SPS Governors in Charge (GiCs) in Scotland; 15 healthcare staff; and the researcher also spoke with three patients in a single prison via the NHS Near Me video consulting platform.
The six GiCs interviewed (out of a total of 15 prisons in Scotland) managed a mixture of national and local institutions. Collectively they were responsible for populations that covered all categories of offenders in custody in Scotland, including young people with very low levels of OST needs, and women, where OST patients make up a higher proportion of the population. The number of people on OST in these prisons varied from under 50 to several hundred.
The 15 healthcare staff interviewed included prison health centre managers, nurses and addiction workers, GPs, and pharmacists from across 5 Health Boards. The staff interviewed had a range of experience of healthcare in prisons, with most having worked in prison settings for several years.
At the time of their interviews, two of the three OST patients interviewed were still taking a monthly dose of Buvidal, while the other patient had since reverted to their previous OST prescription. The number of patients interviewed is too small to draw on for the report, but will help to shape research questions about patient experiences, which should be addressed through future evaluation or research.
Interview data comprised notes taken by the social researcher during the interviews. The interview notes were then anonymised and analysed for common emergent themes using Excel. The processing of personal data was in line with GDPR and fully documented in the Data Protection Impact Assessment.