Overview of 2019 surveillance methods
NICE's surveillance team checked whether recommendations in drug misuse in over 16s: opioid detoxification (NICE guideline CG52) remain up to date. The 2019 surveillance followed the static list review process, consisting of:
Feedback from topic experts via a questionnaire.
A search for new or updated Cochrane reviews and national policy.
Examining related NICE guidance and quality standards and NIHR signals.
A search for ongoing research.
Examining the NICE event tracker for relevant ongoing and published events.
Consulting on the proposal with stakeholders.
Considering comments received during consultation and making any necessary changes to the proposal.
For further details about the process and the possible update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.
We searched for new Cochrane reviews related to the whole guideline. We found 11 relevant Cochrane reviews published between August 2010 and July 2018.
Some reviews covered choice, dosage and duration of detoxification medication (Amato et al. 2013, Gowing et al. 2017, Minozzi et al. 2014 and Rahimi-Movaghar et al. 2018) but this area is covered by NICE's technology appraisal guidance on methadone and buprenorphine for the management of opioid dependence and therefore no immediate impact is anticipated on NICE guideline CG52.
One review (Gowing et al. 2017) covered opioid antagonists (naltrexone, naloxone) with minimal sedation to manage opioid withdrawal. However, this area is covered by NICE's technology appraisal guidance on naltrexone for the management of opioid dependence and therefore no immediate impact is anticipated on NICE guideline CG52.
Further reviews in the following areas were either inconclusive or consistent with current recommendations, with no impact anticipated on the guideline:
Supervised dosing relative to dispensing of medication for off‐site consumption (Saulle et al. 2017).
Lofexidine for detoxification (Gowing et al. 2016).
Topic experts identified further studies covering choice of medication, including safety of methadone and buprenorphine for opioid substitution therapy (Gao et al. 2016, Law et al. 2017, Wright et al. 2011, Marteau et al. 2015, Evans et al. 2015, Sigmon et al. 2013 and Pierce et al. 2018). A further in press study was identified on the safety of methadone and buprenorphine (Steer et al. 2018). However, this area is covered by NICE's technology appraisal guidance methadone and buprenorphine for the management of opioid dependence and therefore no immediate impact is anticipated on NICE guideline CG52.
Topic experts also identified further studies covering the effectiveness of naltrexone for opioid dependence (Tanum et al. 2017, Sullivan et al. 2017 and Krupitsky et al. 2011). However, this area is covered by NICE's technology appraisal guidance naltrexone for the management of opioid dependence and therefore no immediate impact is anticipated on NICE guideline CG52.
A further 2 studies were highlighted by experts and were considered relevant to the guideline. One study (Sanders et al. 2013) suggested that gabapentin as adjunctive detoxification treatment with buprenorphine was effective in opioid withdrawal. However, as a small pilot study, the findings would need to be substantiated by further adequately powered and high quality studies to establish any potential impact on the guideline. Another study (Day et al. 2011) assessed the effectiveness of inpatient compared with outpatient settings of detoxification but the findings were inconclusive and unlikely to impact on the guideline.
We checked for relevant ongoing research; of the ongoing studies identified, 2 small studies were assessed as having potential relevance to the guideline; therefore we plan to check the publication status regularly, and evaluate the impact of the results on current recommendations when they become available. These studies are:
We considered the views of topic experts, including those who helped to develop the guideline. For this surveillance review, topic experts completed a questionnaire about developments in evidence, policy and services related to NICE guideline CG52.
We sent questionnaires to 12 topic experts and received 7 responses; 4 indicated that the guideline should be updated and 3 indicated that it should not. The topic experts were recruited to the NICE Centre for Guidelines Expert Advisers Panel to represent their specialty.
The main areas highlighted by topic experts for potential update were:
The need for inclusion of other components of psychosocial interventions. However, NICE guideline CG52 does cross refer to NICE's guideline on drug misuse in over 16s: psychosocial interventions, which covers approaches other than contingency management. Both guidelines are also covered in the current NICE Pathway on drug misuse management in over 16s.
Significant growth in dependence and misuse of over the counter and prescribed opioids. The experts considered that detoxification of patients in this group needs a different approach, since the doses of opioids are often lower than for patients using illicit opioids. In addition, the socioeconomic circumstances and contexts for individuals using prescribed opioids are different from those of a typical illicit opioid user. However, since this area will be covered by the planned NICE guideline on safe prescribing and withdrawal management of prescribed drugs, evidence in this area is unlikely to impact on NICE guideline CG52.
Publication of the updated Department of Health and Social Care's Drug misuse and dependence: UK guidelines on clinical management. This document is considered by topic experts to be more comprehensive than NICE guideline CG52. It covers a wider use of opioid substitution therapy and management of clients, not just a focus on detoxification; therefore in clinical practice it has a tendency to be viewed as a preferred resource. A cross reference is proposed to the updated version of the Department of Health and Social Care guidelines to address areas not covered by NICE guideline CG52. A planned workshop for discussing the broader care pathway for the management of drug misuse will also help to determine the best way to present NICE and government guidance in these areas.
Lofexidine is temporarily unavailable because of a change in manufacturer. Experts were not aware of the date of future availability or what its cost will be, but did expect it to become available again. Lofexidine was considered by experts to be rarely used in the UK and that its unavailability would be unlikely to impact on the guideline recommendations. Experts also highlighted a lack of research and innovation in alternative non-opioid detoxification medications to lofexidine. As such, the related research recommendation on adjunctive medications during detoxification was considered by experts to remain ongoing. There is unlikely to be any impact on recommendation 184.108.40.206 advising that lofexidine may be considered for those who have decided not to use methadone or buprenorphine for detoxification, have decided to detoxify within a short time period or have mild or uncertain dependence (including young people).
The age of opiate users is rising and many users have comorbid physical health problems. An expert highlighted that the issues are not covered sufficiently by the guideline. No evidence was cited. Recommendation 220.127.116.11 advises that comorbid physical or mental health problems should be treated alongside opioid dependence in line with related NICE guidance, and is likely to remain valid. Cross reference to the Department of Health and Social Care's Drug misuse and dependence: UK guidelines on clinical management from NICE guideline CG52 will also ensure alignment with national advice relating to older people who are dependent on opioids.
We considered all other correspondence received since the guideline was published.
Safety of methadone. A stakeholder highlighted drug-related mortality data from a retrospective administrative data study (Marteau et al. 2015), published since the guideline, relating to the safety of methadone and buprenorphine. Drug-related mortality data were drawn from the Office for National Statistics, and prescription data for methadone and buprenorphine were obtained from the NHS for the years 2007–2012. The Medicines and Healthcare products Regulatory Agency (MHRA) did not take any regulatory action at the time, partly because of concerns about poor methodology of the study. In addition, there is already awareness of the risks of fatal poisoning with methadone and appropriate warnings are provided in the product information. The MHRA suggested that the findings of the study may warrant a review of any relevant NICE guidance. The evidence was not considered in the surveillance review but was passed on to the NICE technology appraisal team for consideration in reviewing the guidance on methadone and buprenorphine for the management of opioid dependence. No further new evidence in this area has been highlighted by topic experts or stakeholders, and no impact is anticipated on NICE guideline CG52. However, this area may be explored further in a planned workshop for discussing the broader care pathway for the management of drug misuse.
Stakeholders are consulted on all surveillance reviews except if the whole guideline will be updated and replaced. Because this surveillance proposal was to not update the guideline, we consulted with stakeholders.
Overall, 11 stakeholders commented, of whom 7 agreed with the proposal to not update the guideline, 3 disagreed and 1 did not state a response. The stakeholders included professional bodies, charities, government organisations and pharmaceutical companies.
Public Health England stated the need to assess the benefits of the depot route for buprenorphine (FluidCrystal depot injection [CAM2038] for opioid abuse/dependence), subcutaneous injection of buprenorphine (RBP-6000) and maintenance treatment overall for opioid dependence. This has not been included in this surveillance review because the NICE medicines team is already reviewing evidence for these formulations of buprenorphine. However, this area will be explored further in a planned workshop for discussing the broader care pathway for the management of drug misuse.
Three stakeholders commented on the potential prolonged unavailability of lofexidine. Topic experts were not aware of the date of future availability of lofexidine or what its cost will be, but did expect it to become available again.
Several stakeholders highlighted areas not covered by the guideline that need to be addressed, including take home naloxone; psychosocial interventions; adjunctive and relapse prevention medications; overdose prevention and management training; and novel psychoactive substances. We will add a cross reference to the Department of Health and Social Care's Drug misuse and dependence: UK guidelines on clinical management which will align with national advice in these areas (see the editorial amendments section for details).
See appendix A for full details of stakeholders' comments and our responses.
See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.
During surveillance of the guideline we identified the following points in the guideline that should be amended.
The text and link in the introduction section of the guideline to Department of Health and Social Care guidance on drug misuse and dependence should be replaced by Drug misuse and dependence: UK guidelines on clinical management.
The broken link in the same section to the National Treatment Agency for Substance Misuse should be replaced with a link to Public Health England's Alcohol and drug misuse prevention and treatment guidance.
After considering all evidence and other intelligence and the impact on current recommendations, we decided that no update is necessary. Although no new evidence impacts on the current guideline recommendations, we recognise a need to clarify the broader care pathway for the management of drug misuse. We are therefore engaging with system partners with the aim of developing NICE guidance that is comprehensive and accessible.
This page was last updated: 03 January 2019