Misuse of Drugs Act 1971 (Ketamine etc.) (Amendment) Order 2014

Lord Colwyn Excerpts

Monday 31st March 2014 Grand Committee

[Lord Ahmad of Wimbledon (Con)]

My Lords, this order was laid in Parliament on 5 March. If made, the order will specify two groups of new psychoactive substances from the N-BOMe and benzofuran families, as well as their simple derivatives, as drugs subject to permanent control under the Misuse of Drugs Act 1971. The order will also control a number of medicines, namely lisdexamphetamine, zaleplon, zopiclone, and tramadol. It will also reclassify ketamine under the 1971 Act.

The Government have received recommendations from the Advisory Council on the Misuse of Drugs that these drugs are being misused, or likely to be misused. In the ACMD’s view their misuse is having, or is capable of having, sufficiently harmful effects to warrant legislative action under the 1971 Act. My honourable friend the Minister for Crime Prevention was satisfied after consideration of the latest available evidence and the ACMD’s assessments that the conditions that have to be satisfied in order to place these drugs under permanent control were met.

Legislative action is necessary as a result of the potential harms identified by the ACMD. This action will send out a strong message to those who are considering experimenting with these drugs and enable us to target our public health messaging in order to protect the public. It will also enable enforcement partners to prioritise resources accordingly to tackle the availability of these drugs.

N-BOMe compounds are highly potent, new psychoactive substances that are regarded as legal alternatives to the class A drug LSD. Noble Lords will recall that a number of these compounds are currently subject to a temporary class drug order approved by the House. These compounds are permanently controlled as class A drugs under the 1971 Act. Clinically observed health effects of the N-BOMe compounds include hypertension, agitation and aggression, visual and audio hallucination and seizures. Anecdotal evidence from self-reported users also highlighted highly negative effects and unwanted feelings including confusion, shaking, nausea, insomnia, and paranoia. These compounds are extremely potent in powder and liquid form and have a high risk of overdose when misused.

On benzofuran substances, compounds such as 5-APB and 6-ABP are marketed as legal forms of ecstasy. They are most commonly sold under the brand name Benzo Fury. Noble Lords will recall that a number of these compounds are also controlled as temporary class drugs. These compounds are being permanently controlled as class B drugs. The effects of the benzofuran compounds include insomnia, increased heart rate and anxiety, with some users reporting ecstasy-like symptoms. Several deaths and hospitalisations in the UK have been associated with the use of these compounds. There are also risks associated with the long-term use of these compounds, such as cardiac toxicity. As in previous cases, the N-BOMe and benzofuran compounds will be controlled using generic, or group, definitions which capture closely related compounds. This will reduce the risk of chemists tweaking the chemical structures of the compounds being controlled to circumvent our drug laws.

Lisdexamphetamine, a drug closely related to the class B controlled drug dexamphetamine, was introduced to the UK medicines market in March 2013. When administered orally, lisdexamphetamine gradually converts to dexamphetamine, the class B drug. Lisdexamphetamine is being controlled as a class B drug. The ACMD reports that lisdexamphetamine has the potential to occasion the physical and social harms associated with amphetamines as a group, although there may be more differences. Physical effects can include anorexia, insomnia, dizziness, headaches and hypertension. After chronic or high doses, convulsions, heart attacks, strokes and death have also been reported.

Zopiclone and zaleplon are sedatives closely related to the benzodiazepine family of drugs and zolpidem, controlled as class C drugs. The ACMD reports that the number of UK prescriptions for these drugs compared to prescriptions for benzodiazepines has been on the increase. The ACMD reports that the harms from the misuse of these two drugs include a risk of coma, respiratory depression and death associated with the use of excess doses of the drugs in combination with alcohol or other central nervous system depressants. Other reported psychosocial effects include depressed mental activity and alertness, memory loss and amnesia, and personality and mood changes through drowsiness, disinhibition, chronic paranoid behaviour and aggression. Data from the national program on substance abuse deaths—NPSAD—also suggests that these drugs play a minor role in drug-related deaths in the UK, mainly in combination with other central nervous system depressants and principally implicated in episodes of intentional poisoning. The ACMD report concludes that, due to the similarities in the chemical structure and effects of these drugs and benzodiazepines, the potential social harm from the misuse of zopiclone and zaleplon would be similar to the social harms associated with the misuse of zolpidem and the benzodiazepines.

Turning to tramadol, it is of significant medical use for treating moderate to severe pain. It has wide-ranging applications, including the treatment of chronic widespread cancer and musculoskeletal pain. However, tramadol, similar to other psychoactive agents, can be misused. Tramadol’s pharmacological profile increases the risk of adverse effects seen in overdose. Overdose results in drowsiness, constricted pupils, agitation, rapid heartbeat, hypertension, nausea, vomiting and sweating. Seizures are more common with tramadol overdose than with other opioids and occur in up to 15% of cases. In severe poisoning coma, seizures and hypotension—low blood pressure—can occur.

The ACMD’s consideration of tramadol was prompted by concerns from healthcare professionals about the growing misuse of the drug. It revealed an increase in the number of NHS prescriptions for tramadol—from 5.9 million in September 2005 to 11.1 million in September 2012—wide availability on the internet, and an increasing number of deaths in which tramadol was mentioned: 87 mentions on death certificates in 2009 went up to 154 in 2011, representing an increase of 77%. The ACMD reports that the majority of tramadol-related deaths occur where it has been obtained through non-prescribed means. However, overprescribing is also believed to contribute to diversion and misuse.

Ketamine is a synthetic drug used in medical and veterinary practice. It is used as a dissociative anaesthetic and a pain reliever. The ACMD first considered the recreational use of ketamine in 2004, and following its advice ketamine was brought under class C control in 2006. The ACMD reports that evidence of harms from misuse has developed over the years. In addition to well known harms such as increased heart rate and cardiac output, high blood pressure, hallucinations and experiences of alternate realities similar to those found in schizophrenia, long-term ketamine misuse is now known to be associated with a range of chronic problems including chronic bladder and other urinary tract pathology, and damage to the gall bladder, central nervous system and kidneys. The ACMD also reports evidence of acute and chronic toxicity associated with ketamine misuse.

Social harms associated with ketamine use are reported to include a negative impact on families, social skills and participation in social activities. Large doses of ketamine are also known to induce dissociation—intense detachment that can be unpleasant and frightening and can put the user in a position of vulnerability to robbery, assault or, in extreme cases, rape. For all of these reasons, the Government accepted the ACMD’s advice to permanently control these drugs under the 1971 Act and reclassify ketamine as a class B drug. It is intended to make two further related statutory instruments that will be subject to the negative resolution procedure.

The Misuse of Drugs (Designation) (Amendment) (No. 2) Order 2014 will amend the Misuse of Drugs (Designation) Order 2001 to place the N-BOMe and benzofuran compounds in part 1 of the order as compounds to which Section 7(4) of the 1971 Act applies, as they have no known legitimate use outside research. Their availability for use in research will be enabled under a Home Office licence. Drugs that have legitimate uses as medicines will be scheduled appropriately in one of four schedules under regulations to ensure their continued availability and use in healthcare. Specific requirements will be applied to each of these depending on the schedule in which they are placed under the regulatory framework to prevent their diversion and misuse.

The Misuse of Drugs (Amendment) (No. 2) and the Misuse of Drugs (Safe Custody) Regulations 2014 will amend the Misuse of Drugs Regulations 2001 to place lisdexamphetamine in Schedule 2, zopiclone and zaleplon in Part 1 of Schedule 4, and tramadol in Schedule 3 to the 2001 Regulations. These regulations will further place tramadol in Schedule 1 to the Misuse of Drugs (Safe Custody) Regulations 1973, which means that tramadol will be exempted from the safe custody requirements. Ketamine is not being rescheduled immediately after reclassification. It will remain a Schedule 4 Part 1 drug, and will remain available for use in healthcare and veterinary practice pending a public consultation to assess the impact of Schedule 2 status, as recommended by the ACMD, later this year.

These instruments will be laid in time to come into force at the same time as the Order in Council, if it comes into force as proposed. The Government will publicise the approved law changes through a Home Office circular. I commend the order to the Committee.

[The Deputy Chairman of Committees (Lord Colwyn) (Con)]

My Lords, I must congratulate the noble Lord on his pretty well faultless pronunciation. The question is that the Grand Committee do consider the draft Misuse of Drugs Act 1971 (Ketamine etc.) Amendment Order 2014.

[Baroness Finlay of Llandaff (CB)]

My Lords, I echo the Deputy Chairman’s congratulations. Those are pretty difficult drug names to cope with. I have a few comments and a question. The review of zopiclone is welcome. It has often been used inappropriately as a sleeping tablet and viewed as being very safe. The evidence, actually, is not that good for it in terms of patients getting off to sleep. There are lots of other things with sleep hygiene that need to happen to help people sleep. Tramadol has escalated in its prescription and has been viewed as being very safe in the way that physicians have looked at it as an analgesic. I have had a concern for some time that morphine is viewed, with caution, as inappropriate—and more cautiously than may be necessary, because it is a very good analgesic. Therefore, some of these other analgesics, such as tramadol, tend to get prescribed almost too readily and without due caution.

The one I would like to focus on is ketamine. I must declare an interest, having been on the advisory committee of the misuse of drugs sub-committee that was looking at ketamine at the time. I think it is important to record that as a group we were divided on whether ketamine needed to be reclassified. That was because of its clinical use. It is a very useful drug in an emergency. It is a battlefield drug. It has been used in major accidents when you have to get trauma victims out. The safety feature of ketamine is that patients conserve their airway: when you are operating in a collapsed building or on an accident site, when you cannot get access to the person, you may be able to do an amputation under ketamine that otherwise you would not be able to do, because the person will continue to breathe and protect their airway. In fact, they will appear to be conscious. Clinically, I used to use it when I did anaesthetics with children who had severe burns. You could give what is called dissociative anaesthesia: they could turn over and move, but they could tolerate having their dressings changed because they had the analgesia from it.

My question relates to the supply, after reclassification, to hospices where ketamine is used for neuropathic pain. There is a concern—which just fell into my inbox this morning, as it happens—that hospital pharmacies that supply hospices with drugs, particularly morphine, will now have to purchase a licence, at a cost of £5,000. They are concerned that it will make it more difficult for them to have the supply of drugs that they need. I would like a reassurance from the Minister that the legitimate therapeutic supply of ketamine, particularly to hospices and in the community for patients with severe neuropathic pain from malignant disease and from other conditions that are progressive, will not be impeded by reclassification. For some of these patients it is the only drug that will get control over their complex neuropathic pain.

I also ask the Minister whether it will fall under this licensing requirement and whether he will undertake to look at the charge for this licence, which seems to be very high. Voluntary sector hospices are trying to provide a high level of care to patients on behalf of the NHS, bearing a lot of the cost out of their own fundraising, and they want to be linked to a hospital pharmacy because of the quality control and governance assurances that go along with being linked to a hospital pharmacy.