19 June 2003

New guidance on injectable heroin and injectable methadone treatment for opiate misusers

The NTA released the long-awaited guidance on the prescribing of injectable diamorphine and methadone on Friday 13th June 2003. Such an inauspicious publication date was matched with an equally inauspicious publication. While recognising that diamorphine and methadone prescribing has a limited role in substitute prescribing, the guidelines bind such restrictions around the prescribing of diamorphine as to make it more difficult, rather than less difficult to achieve than it is at present.

So, rather than extending the prescribing of diamorphine, the NTA has effectively done the reverse. Responses from the field have, to date, been muted. Discussions on the UKHRA boards have been vocal and critical of the guidance, asking how "how can the NTA have got it so wrong?"

Roger Howard, the soon-to-depart head of Drugscope, provided a quote of stunningly anodyne quality, even by his own standards. Presumably, in anticipation of a move to Crime Concern, he has no wish to upset Blunkett or AInsworth. Anyway, his comment on the guidelines was: "We welcome the NTA guidelines on heroin prescription and hope that they will lead to the situation found in other countries where, when other treatments have failed, there is an increase in users potentially being prescribed heroin."

How the report was developed:
The Guidance describes itself as a "majority consensus approach" which presumably means that there was some dissent from the expert groups, but this was the consensus of the majority, and the views and concerns of the minority have not gone on record.

Our understanding was that, in the final document, the views of the medical consultants, were given higher prominence and the report reflects their views rather than all the experts consulted.

The Eight "key principles."
The report outlines 8 key principles that underpin prescribing of injectables, as follows:
1. Drug treatment comprises a range of treatment modalities which should be woven together to form integrated packages of care for individual patients.

2. Substitute prescribing alone does not constitute drug treatment. Substitute prescribing requires
assessment and planned care, usually with other interventions such as psycho-social interventions. It should be seen as one element or pathway within wider packages of planned and integrated drug treatment.

3. Within the substitute prescribing modality, a range of prescribing options are required for heroin misusers requiring opioid maintenance. Some options may carry more inherent risks than others (e.g. injectable versus oral options). Patients who do not respond to oral maintenance drug treatment should be offered other options in a series of steps. This would normally include:
• oral methadone and buprenorphine maintenance, specifically optimised higher dose
oral methadone or buprenorphine maintenance treatment, then
• injectable methadone or injectable heroin maintenance treatment (perhaps in combination with oral preparations)

4. Injectable maintenance options should be offered in a local area that can offer optimised oral methadone maintenance treatment including adequate doses, supervised consumption and psycho-social interventions.
This is essential to ensure oral drug treatment options have been fully explored prior to a trial of injectable maintenance treatment and to ensure smooth transition back to oral treatment if required.

This is an interesting clause and appears to be an interesting piece of sleight of hand. On the one hand it places a level of obligation on providers to make options other than oral methadone available to people who do not respond to oral methadone. This would appear to suggest that local areas would be expected to make such resources available. However, subsequent clauses provide a number of limitations on this.

The requirement to provide "optimised higher dose oral methadone" is an interesting development. It suggests a tacit acknowledgement that methadone is still being prescribed at insufficiently high levels, and without necessary support in place. So before local agencies can explore any other options such as injectables, increases in levels of methadone and additional support will need to be explored.

Given that a number of regions still have ridiculously low caps on methadone, increasing this will require substantial movement from local prescribers.

5. Injectable and oral substitute prescribing must be supported by locally commissioned and provided mechanisms for supervised consumption. Injectable drugs may present more risk of overdose than oral preparations and have a greater value on illicit markets and hence may require greater levels of supervision.

6. Injectable maintenance treatment is likely to be long-term treatment with long-term resource implications. Clinicians should consider the move from oral to a trial of injectable preparations carefully, including long-term implications for the patient and drug treatment systems and involvement of services.

7. Specialist levels of clinical competence are required to prescribe injectable substitute drugs.
Heroin prescribing also requires a Home Office licence.

So despite Blunkett's assertion that an aim was to increase access to diamorphine prescribing, no changes to the archaic licensing system.

In the main body of the report, there is a proposal that all injectable opioids would require Home Office licence if being used for the treatment of addiction which could, in turn, have an impact on people currently prescribed injectable methadone.

8. The skills of the clinician should be matched with good local systems of clinical governance, supervised consumption and access to a range of other drug treatment modalities.

The detail and key areas of concern:

The requirements around supervised consumption are the most odious aspects of the guidance, and the aspect that will reduce stability and make the guidelines unworkable. Provision of supervised consumption - even for a short initial period, will dramatically increase the cost of the intervention. While diamorphine is already a more expensive option compared to methadone, the cost of twenty-plus supervised injections per week, at an average of 10+ worker hours per week, will cost in excess of £150/client/week in terms of supervision, before the cost of converting suitable premises are bourne in mind.

Certainly, supervised consumption on pharmacy sites would be difficult: it is hard to envisage many pharmacies would want to undertake this task, and the same is probably true for GP surgeries. Which means that such consumption will need to take place in drug projects.

The guidance proposes "there was great potential in providing injectable drug treatment from highly centralised injectable clinics" which is fine in large inner-city areas but means that, in rural areas, such provision is not feasible.

While the report notes that supervised consumption will require multiple daily attendances, but perceives this to be a welcome development:

The requirement for daily or multiple daily attendance was also discussed as requiring a significant change in current British provision (particularly out-of-office hours). Whilst such requirements may encourage the patient to progress towards improved outcomes, they are also very restrictive of liberty and represent a significant, but positive, change from previous practice in England. (emphasis added).

But, as policy development work for the Soho Rapid Access Clinic highlighted, this brings with it some complications around storage of CDs on site. Daily doses of drugs have to be delivered to the clinic and CD cabinets installed. Staff authorised under the MD regulations will need to be on site to dispense, and medically trained staff on site for emergencies. Three times a day. For maybe one or two clients who have to travel in three times a day.

Although this guidance says that local provision will need to be commissioned, there is no additional money to make such provision available. Again, the NTA will be able to blame the local providers for their failure to provide rather than looking at their own responsibility.

Eligibility Criteria:
The guidance provides strict limits as to eligibility, as follows:
Inclusion criteria for injectable opioid maintenance:
Clients should meet all of the following inclusion criteria in order to be eligible for injectable
opioid maintenance:
• The client should have a protracted history (> 3 years) of heroin dependence and regular daily injecting.

This was to be expected but also means that some clients for whom injectable methadone or heroin may be appropriate will be excluded. For example, amongst homeless drug users in central London, a high proportion had rapidly escalated habits over a short period of time, but had built up substantial injecting habits over less than three years.

• The client should be aged 18 or over.
• The client should be able to provide informed consent. This includes no active medical or psychiatric condition impairing the patient’s capacity to provide informed consent
• The client should be willing to comply with the conditions of injectable opiate treatment, including:
  •  a treatment plan
  • regular supervision and monitoring
  • avoidance of persistent injecting in high risk areas (e.g. neck or groin veins)
This is a big concern and excludes long-term femoral injectors. Again, looking at Central London homeless populations, the extent of femoral injecting is as high as 80%. This group would be excluded from such treatment, even where it may be an effective intervention.

• continuation of injectable treatment being conditional upon positive healthy response to treatment (which includes other treatment elements in a package of planned, co-ordinated care)
• diversion of the prescribed injectable drugs and “double scripting” being grounds for discontinuation of injectable treatment.
• The client should first have received optimised oral maintenance treatment - an adequate period (normally at least six months and for some this could be significantly longer) of optimised conventional substitution maintenance treatment and associated package of care.
• There should be a persistence of poor treatment outcomes despite a current optimised oral maintenance treatment episode. Indicators of poor outcomes may include:
• continued frequent (daily or almost daily) injecting of illicit heroin or other opioids
• patients at continuing high risk of the transmission of HIV, HBV or HCV to themselves or others
• continuing injecting-related health problems (e.g. abscesses, cellulitis, systemic infections), poor general health, poor psychosocial functioning and drug-related criminality.

This is a catch 22 and a nasty one at that. In order to get on to a diamorphine prescription, a patient would have to engage with optimised oral methadone for at least six months. Failure to adhere to such a programme (e.g. use on top, missed appointments) is likely to result in being dropped from treatment. But if someone does adhere to the optimised methadone treatment, then it seems likely that the clinician will adjedge the methadone as being effective and, as such, there would be no need to switch to injectable diamorphine.

This is the drugs equivalent of the ducking stool; if you sink and drown, you weren't a witch; if you float you are and get burned.

If the inclusion criteria are met injectable opioid maintenance treatment may then legitimately be considered by the clinician, in consultation with the patient, key carers and the relevant multidisciplinary team.

The guidance seems to be a work in progress. It restricts and hampers the work of prescribing injectables without exploring how to overcome these barriers. The document offers no guidance on how supervised consumption can be practically achieved and creates substantial new obligations before injectables can be considered.

There is a failure to explore potential other routes of administration, including heroin reefers or other strategies for administration, or proposals for weekend take-home doses.

The model of thrice-daily supervision is hugely unworkable, and the exclusion of the most ill, those with impaired liver function and habitual femoral injectors excludes those most at need.

After a long period of waiting, there is no sign here of more treatment, better treatment or fairer treatment. This report sides heavily against those who wish to see diamorphine made available on prescription in a practical and accesible way.

This is a case of style not substance. The Government will claim credit for more flexible prescribing policy, and will blame practitioners for failing to deliver what they have, in fact, made impossible.

To view the complete guidance, follow this link:
Press Release: http://www.nta.nhs.uk/news/020115.htm