Letter from Jim Dobbin, MP, to Chris Heffer, Department of Health (13 March 2012)

Chris Heffer
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS

Dear Chris,

I am writing to you in your capacity as Deputy Director of Drugs and Alcohol and further to your attendance at meetings between the Public Health Minister, Anne Milton MP and the All Party Group on Involuntary Tranquilliser Addiction and most recently the Expert Patients Group on Involuntary Tranquilliser Addiction.

At all of these meetings the Minister has heard the long standing complaint from our campaign that no services are provided by the Department of Health for involuntary tranquilliser addiction. We have established through Parliamentary Questions, Parliamentary debates, correspondence with Ministers, FOI’s and discussions at meetings attended by you that the Department of Health is unable to confirm that any services are provided for iatrogenic tranquilliser addiction.

On 29 February 2012 in the House of Lords, Earl Howe rejected amendment 107 to the Health and Social Care Bill, which was tabled by Earl Sandwich, to create an obligation for the Department of Health to provide appropriate services for those suffering from involuntary tranquilliser addiction. Part of the reason Earl Howe gave, for rejecting the amendment, was his belief that drug and alcohol teams are commissioning help for people dependent on prescribed medicines. Earl Howe has since confirmed by email that his answers in Parliament on the subject of iatrogenic addiction are based on briefings from the Department of Health.

The inescapable conclusion has to be that the briefing received by Earl Howe contained inaccurate information and that this inaccurate information was provided by the drug policy team within the Department of Health. I would ask that you confirm the source of this information, whether it originates from within your own section or has been supplied by the National Treatment Agency or the drug and alcohol teams.

In my view, it is unacceptable that Parliamentary legislation should be informed by an inaccurate briefing. It is also unacceptable that the continuing review of policy on addiction to prescribed drugs should be distorted by the inaccurate assertion that government funded addiction centres provide any help for involuntary tranquilliser addicts.

I look forward to your reply.

Yours sincerely,

Jim Dobbin MP

cc.  Earl Howe
Earl Sandwich

Click here to view a PDF copy of the letter

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Letter from Jim Dobbin, MP, Chair APPGITA to Anne Milton, Parliamentary Under Secretary of State for Public Health (05 March 2012)

Rt Hon Anne Milton MP
Richmond House
79 Whitehall
London
SW1A 2NS

Dear Anne,

I am writing to thank you for the recent meeting with the Involuntary Tranquilliser Addiction Expert Patients Group, for the interest you have shown in this issue and the commitment you have given to work on this issue. However, I also have to inform you that our group was disappointed with the position set out on behalf of the Department of Health by Earl Howe in the House of Lords in his response to proposed Amendment 107 to the Health and Social Care Bill.

The Earl of Sandwich
107:
(1)Each clinical commissioning group shall have a duty to provide services to those suffering from addiction to and withdrawal from benzodiazepines, selective serotonin reuptake inhibitors and Z-drugs.
(2)In fulfilling this duty, clinical commissioning groups must co-operate with and take account of the good practice of specialised agencies in this field.
This amendment represents the APPGITA proposal for specialised tranquilliser withdrawal services which we have discussed with you. Members of our group were therefore surprised and disappointed with the blunt rejection by Earl Howe of this reasonable suggestion, which we believed was under your consideration.

Not only did Earl Howe reject the proposal, he also insisted that withdrawal services are available for involuntary tranquilliser addiction within existing PCT services. As you know, the APPGITA has contended for many years that such services are non-existent within NHS local services. We have requested details of any such services by Parliamentary Question, correspondence and at meetings. Caroline Montagu’s recent research confirmed there are no services and this has been common knowledge amongst involuntary addicts and campaign groups for decades.

Further to this, upon the rejection of amendment 107 by Earl Howe, both Baroness Findlay and Earl Sandwich suggested the content of amendment 107 should be included within the guidelines provided to the new commissioning bodies. Earl Howe did not agree to that suggestion.

The rejection of amendment 107 effectively returns responsibility for iatrogenic tranquilliser addiction back to where this illness has always resided untreated, with local commissioners. In a time of reorganisation and budget cuts, it seems unlikely that commissioners will be inclined to introduce a new service for so many people, particularly when there is no guidance or allocated funding provided by the Department of Health.

Please will you explain the apparent inconsistencies between Earl Howe’s statement in the Lords and our own discussions. For your assistance, I have attached a list of all existing tranquilliser services in the UK known to the APPGITA.
Yours Sincerely
Jim Dobbin MP
Chair APPGITA

cc. Earl Sandwich
Earl Howe
Eric Ollerenshaw MP
Melanie Davis (Camden Mind)
Chris Heffer (DoH)
Professor Heather Ashton
John Perrott
Barry Haslem
Ian Singleton (Bristol Tranquiliser Project)
Baroness Finlay

List of specialised services for Involuntary Tranquilliser addiction in UK

Click here to view a PDF copy of the letter

 

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Email from John Perrott to Mark Edgington, Senior Policy Advisor, Department of Health (02 March 2012)

Dear Mr Edgington,

Thank you for your email of 29 February 2012.

I would like to address a number of issues raised in your correspondence with Professor Ashton and myself.

Firstly, I would like to refer to your email to me and these comments:

“Whilst I am more than happy to respond directly to you in this instance, please note the usual process is for correspondence to be processed via the customer service centre. I would be most grateful if you could direct all future correspondence to the customer service centre who are established to deal with enquires about the department and its policies. Any future enquiries not sent to the customer service centre will not be acknowledged.”

In the summary notes of your telephone meeting with Professor Ashton of 23 January 2012, you named and misrepresented me. In future, if you do not wish to be contacted by me directly, then would you please refrain from naming and misrepresenting me in correspondence and distributing this to others?

Secondly, you refer me to the evidence provided in the NHS Clinical Knowledge Summaries that suggests that CBT can be useful in benzo withdrawal. This clearly states that the evidence is limited and came from two meta-analyses; it also makes clear that the studies were “generally small and heterogeneous.”

Perhaps you can explain why you are drawing attention to two obscure studies and ignoring the wider literature. More importantly, why you are ignoring the practice of the withdrawal charities which are highly successful in tranquilliser withdrawal and which will confirm that CBT is not useful during withdrawal?

As previously explained, most studies have found that CBT is ineffective whilst a person is still on benzodiazepine drugs because benzodiazepines inhibit the learning of certain new skills, especially cognitive and emotional skills.

Unlike you, the withdrawal charities are highly experienced in tranquilliser withdrawal and therefore, what they propose should be followed.

Thirdly, thank you for clarifying that when you referred to psychosocial interventions you actually meant psychological support. Both these terms have completely different meanings and I would like to point out that psychosocial interventions are intended for illnesses that derive from psychological or social origins. In your updated notes I see that you have added a paragraph in the section “Psychological Interventions” as it was not clear what you meant by this term in your original notes; this additional paragraph reads as follows:

“Context: Psychosocial interventions – interventions between a range of professionals and their patients to elicit changes in behaviour, cognition and emotion, grounded in psychological theory.”

Tranquilliser withdrawal symptoms are not a psychological condition but a physiological problem as a result of tolerance and drug toxicity and therefore psychosocial interventions are useless. Withdrawal symptoms get better regardless of such interventions. However, as I explained previously, psychological support is crucial in the form of reassurance, relaxation techniques, breathing exercises and any other simple techniques which help people endure the withdrawal symptoms.

The withdrawal charities do not use psychosocial interventions and as I stated, they are highly successful and have decades of experience; you are not experienced and do not understand tranquilliser withdrawal.

I did request that you correct inaccuracies in your notes. Professor Ashton has kindly sent me your latest communication to her and a copy of your updated notes, and I see that these inaccuracies still remain and would ask you once again to correct them.

1. Professor Ashton did not agree that current evidence suggests that patients benefit from psychosocial interventions throughout withdrawal and she made this clear to you in her last email.

2. Professor Ashton was not in overall agreement with the outcomes from the roundtable meeting because she was not aware that there were any, as was also made clear to you in her last email.

In my opinion, you are trying to impose substance misuse theories on involuntary tranquilliser addiction and ignoring the best practice and years of experience of organisations which are highly successful in treating ITA.

I will be posting this correspondence on the APPGITA website and also any future correspondence whether you acknowledge it or not.

Yours sincerely,

John Perrott

Click here to view the notes referenced above

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Earl of Sandwich debate, House of Lords (29 February 2012)

Amendment 107

Moved by

107: Clause 25, page 38, line 23, at end insert—

“14YA Duty as to addiction to benzodiazepines, selective serotonin reuptake inhibitors and Z-drugs

(1) Each clinical commissioning group shall have a duty to provide services to those suffering from addiction to and withdrawal from benzodiazepines, selective serotonin reuptake inhibitors and Z-drugs.

(2) In fulfilling this duty, clinical commissioning groups must co-operate with and take account of the good practice of specialised agencies in this field.”

The Earl of Sandwich:My Lords, this is a non-political amendment. However, by the end of our discussion, it may become more political; it depends what happens in this short debate.I am very grateful for the support and encouragement I have received from my noble friends and noble Lords on all sides of the House in raising this issue now and on previous occasions; that is, prescribed drugs such as sleeping pills and antidepressants. I moved a similar amendment after midnight on 30 November. In that debate the noble Lord, Lord Alderdice, said:

“I hope my noble friend the Minister will be able to give some reassurance that this is regarded seriously as an iatrogenic disorder that the health service is in some cases responsible for bringing into play through absence of proper monitoring and, in some cases, errant prescribing”.—[Official Report, 30/11/11; col. 372.]

If the health service does carry responsibility for iatrogenic disorder—as I believe it does—surely this makes it imperative that it moves faster on the issue than it otherwise would, even during a recession. The Minister did not respond to that point on that occasion. I would be grateful if he could acknowledge it today, if he can.

It may be helpful to remind the House that the singer, Whitney Houston, may have been under the influence of Xanax, which is a popular benzodiazepine, when she died. Without it, she may have survived. She had also taken Ativan and valium—drugs which I am sure are familiar to all noble Lords. Amy Winehouse took Librium. I mention them as two prominent recent examples of what is happening. Many thousands of people—not drug addicts but ordinary, mainly young, people living ordinary lives—are suffering from a diet of benzodiazepines, selective serotonin reuptake inhibitors called SSRIs, and z-drugs that all may initially have been prescribed for very good reasons and for a limited period of between two and four weeks as standard, but now blight their lives to the point of dark despair.

The Centers for Disease Control and Prevention in the US reported 37,485 deaths from prescribed medication in one year, 2009. It is recognised as a leading cause of death, in front of deaths from road traffic accidents, from firearms and from all illegal drugs put together. This information came only in the past few days, and we now hear from the British Medical Journal that sleeping pills, even taken lightly, can treble the risk of an early death.

5.45 pm

I know that the Minister takes these issues very seriously and I wish I could say that our own Department of Health is now actively on the case, but I cannot. The Government have not even got the numbers together from their two major reports. The Bill is completely silent on prescribed medication, although the noble Earl did refer in a previous debate to new structures that will help the health service to respond—and he may repeat that today. After all, this is mentioned in the national drugs strategy. We have been waiting for nearly three years for action on an issue that was first publicised more than 30 years ago.

There has been some progress. I have been to see the Minister, Anne Milton, and one or two things have happened since Committee stage, but the noble Earl will himself admit that they are nothing to boast about yet. The withdrawal charities are at last being consulted, thanks largely to pressure from the all-party group in Parliament, and two of them, in Oldham and Bristol, are to receive a ministerial visit.

The Minister asked me in November if I would accept that this was an indication of the Government’s good faith. Yes, of course, every little helps, but people in pain are waiting for proper services. At the moment, there is no policy, no proper service, and they have to fend for themselves and depend on dedicated people. Perhaps I may quote from the Minister’s previous reply on 30 November, when he was describing existing provision. He said:

“There is access to support and treatment services for addiction to medicines in most local areas”.

That is simply untrue. He added,

“but some local areas are woefully short of such services”.—[Official Report, 30/11/11; col. 374.]

That is also untrue, because most areas are woefully short of such services. I know that the Minister is conscientious, and that has been demonstrated throughout the Bill, but he has been misinformed. My wife and I have researched this and have given a copy of the research to Anne Milton. The truth is that there are very few areas in the UK with such services, and almost all are voluntary. That is no bad thing, as I argued last time, because support for the voluntary sector may well be the best route towards a new government strategy for prescribed drugs, based on the good practice that already exists. The knowledge is out there to be used.

What we do not want is a pretence that because there are government-funded addiction centres—I know one in Roehampton, for instance—with proper budgets behind them for addiction to hard drugs, and because they are there to help people suffering from hard drugs, such centres cater for prescribed drugs at the same time. They emphatically do not. There is no government budget for that at all. Will the Minister assure me that there will soon be a policy—I am sure that there will be—and that there will be a statement from Anne Milton that preferably has the support of the Royal College of General Practitioners, which is what she is seeking. I can understand that there are little local difficulties at the moment, but this is something that GPs could get behind publicly. That is what she told us; I cannot see what could be the delay for making a statement such as that.

Finally, on a more positive note, I expect the Minister to confirm that the process of consultation on the withdrawal of charities and user groups is properly under way. The expert group at the round-table meeting, which has had two meetings and is meeting again next month, must prepare not for future research or more action points but for a proper programme of services nationwide. That programme will draw on and reflect the genuine success of the voluntary sector, using the direct experience of patients in places such as Bristol, Oldham, Bradford, Belfast and the London boroughs of Camden and Islington—incidentally, those are the only boroughs served in the whole of the London area at present.

The second part of my Amendment 107, which we discussed in Committee, deals with the voluntary sector itself. I will not repeat what has been said by many noble Lords. It requires the CCGs not only to take account of good practice but to co-operate with the sector, because it often knows better. The noble Lord, Lord Rooker, and others, including the Minister, have already made that point forcefully during debate. I endorse that and I beg to move.

Baroness Masham of Ilton:My Lords, I support my noble friend’s amendment. Only yesterday, there were headlines in the press about the American study in the BMJ Open which found that sleeping pills were linked to increased death risks. It was found that death risk among users was about four times higher than among non-users. UK guidelines for NHS staff state that hypnotic drugs should be used for only short periods of time, because of tolerance to the drug and the risk of dependency, but they make no mention of an associated death risk, despite other studies having already reported that potential risk.Many of your Lordships will know that doctors often do not review their patients’ drugs enough. Patients can have repeat prescriptions for years, putting them at great risk. Addiction to prescribed and over-the-counter drugs is an enormous problem. Groups which give support to the unfortunate people who become addicted themselves need support. Will CCGs be able to do that? Does the Minister think that that serious problem will get worse? My noble friend’s amendment is an effort to make that worrying situation better. I hope that the Minister will accept the amendment.

Lord Williamson of Horton:My Lords, the amendment deals with the distressing and serious problem of addiction to certain prescription drugs and, as is specified in the text, the problem of withdrawal from those drugs, because when such efforts are made, on many occasions they unfortunately fail and result in other difficulties for the patient in question.Without going into detail about what may happen to the amendment, I hope that the Minister will be able to confirm that there should be an appropriate priority for the services available to treat that distressing problem. I do not press the point more than that, but it would be useful if we could have that sort of assurance from the Dispatch Box. In particular, whether the Minister agrees with this or not, some of us believe that in the past the issue has been allowed to fall into the shadows. That is what has happened in practice. It has been neglected and people have suffered in consequence. Perhaps we are improving but we could improve more, and I hope that the Minister will give an encouraging reply about the appropriate priority that ought to be given to the problem.

Baroness Finlay of Llandaff:My Lords, this is a clear example of an iatrogenic condition, very often originating in primary care. When patients have presented with insomnia, instead of being taken through the more complex and time-consuming aspects of sleep hygiene and possibly talking therapies to discover the cause of their insomnia, a prescription has been given all too quickly and readily. If we are looking at responsibility falling back to clinicians in primary care, it seems inordinately sensible that the clinical commissioning group should consider its responsibility to provide support to patients who end up with an iatrogenic problem.I can see that the Government may feel that this is a very specific amendment targeted at a very specific area, but the guidance that needs to go out to clinical commissioning groups on their responsibility for the behaviour of all those prescribing on their patch may well deal with some of the principles behind this amendment and ensure that the necessary services are provided to patients who, completely inadvertently, fall foul of taking the drugs that they were prescribed and as they were told to take them.

Baroness Hollins:My Lords, I pay tribute to the work of my noble friend Lord Sandwich, who has done so much to raise awareness of the often unmet needs of people whose addiction originated in a legal prescription. There is some progress in training doctors—for example, in undergraduate medical education with a new national curriculum on substance misuse. This guidance provides learning objectives on rational prescribing and iatrogenic addiction. The fact that such a curriculum is only just being introduced shows the need for the attention of clinical commissioning groups to be brought to this issue.There seems to be a special responsibility on the National Health Service to provide better care for people affected by medical prescribing practice, and I hope that the Minister will be able to suggest how such a responsibility could be emphasised in the Bill.

Baroness Thornton:My Lords, I intend to make only two remarks. We have a great deal to get through tonight, so I shall exercise great self-discipline. I think that I will come in at under a minute and a half.The noble Earl needs to be commended for his determination and hard work in this area. We think that it is an important issue. This is a growing problem and the noble Earl makes very reasonable requests, for which he has widespread support. I agree with the noble Baroness, Lady Masham, in that I fear this problem may get worse before it gets better, but I hope that the Minister will have good news for us about it.

Earl Howe:My Lords, we return to an issue of enormous significance for the individuals and families affected. I refer of course to those suffering from addiction, or withdrawal from addiction, to certain prescribed drugs. I am grateful to the noble Earl, Lord Sandwich, for his amendment, which would put in primary legislation a requirement for clinical commissioning groups to provide a specific service and, in so doing, to co-operate with and take account of the good practice of specialised agencies.I think that the desire for good practice and for improving practice is common ground between us. The noble Earl will know that local areas are currently responsible for the design and provision of treatment and support services. We think that that is right. Having said that, it is clear that we need to do all we can to prevent dependence occurring in the first place. I am fully with him on that. For those who do develop dependence, it is important that they have access to the services they need to help them to recover, rebuild their lives and contribute productively to society. By placing the funding and responsibility for commissioning services to support people to recover from dependence with the local authorities, the Bill will provide local areas with opportunities to improve integration of commissioning and provide more effective joined-up services to meet local needs.

6 pm

I heard what the noble Earl said about generic drug and alcohol services and his view that they are not appropriate for people who are addicted to benzodiazepines. I beg to disagree with him on that. Drug and alcohol action teams are the people best placed to help people addicted to drugs of whatever kind. They commission to provide help for a wide range of drug users, including people dependent on medicines like tranquilisers, sleeping pills and painkillers. It is not a one-size-fits-all approach. In many cases, services for people dependent on such drugs are provided at different sites or times than those for people dependent on illicit drugs.

The noble Earl has put forward an extremely powerful case and I do not wish to detract from that in the slightest. He is right to highlight the particular needs of this patient group. Nevertheless, we remain of the opinion that it is not appropriate to require in the Bill that CCGs commission particular services for all persons. CCGs are already under a duty to commission services to meet the reasonable needs of all the people for whom they are responsible. As noble Lords will be aware, they have a duty to ensure that they obtain appropriate advice in support of that. That was the theme of the last group of amendments. There are also duties to engage with their health and well-being boards to find out what local needs actually amount to, to prioritise the strategies that are required to address them and to develop those strategies and plans accordingly.

The Government believe that local bodies have greater knowledge and understanding of local health needs and that they are best placed to assess the need for services, including rehabilitation and support services within their areas. Moreover—and this is the most fundamental point—under the arrangements set out in Healthy Lives, Healthy People: Consultation on the Funding and Commissioning Routes for Public Health, local authorities will be responsible in the future for commissioning services to support people to recover from dependence in line with local need.

In terms of the work of my department, I can again confirm to the noble Earl that a great deal of thought and effort is being given to this important issue. As he knows, we are working with a range of experts in doing so. If I may, I would like to write to him to set out fully our future plans in this area. I hope he will understand the stance that we have taken on this. Having received my letter, he is very welcome to meet me, if he would like to, to enable me to update him on the work that we are doing on this important issue.

The Earl of Sandwich:My Lords, as the noble Baroness, Lady Thornton, implied, we are moving to the fast-track of this Bill, and I do not want to hang around for too long. I thank my noble friend Lady Masham for bringing to our attention the issue of early death, and my noble friend Lord Williamson, who has a lot of experience, for his support. My noble friend Lady Finlay made the important point that the responsibility falls within primary care, and I am encouraged by what she said about guidance. However, the Minister did not even pick that up. One might have thought that he could have just said, “Yes, we are going to do something in the guidance”, but I do not know whether he actually heard the point.
Earl Howe:I am happy to pick that up, because it was a point that arose in connection with an intervention from the noble Baroness, Lady Finlay, in the previous group of amendments. Of course, we will be relying on the NHS Commissioning Board to issue guidance in a number of clinical areas. Again, when the noble Earl and I meet, I will update him to the extent that I am able to on the thinking in that regard. The point of such guidance—which will relate to numerous areas of care and services—is that it should inform joined-up commissioning in local services, so that we really do get a step change in the quality of commissioning in local areas.
The Earl of Sandwich:It is quite true that the CCGs are going to be overwhelmed with guidance from all directions, but I maintain that this is an important aspect.I thank my noble friend Lady Hollins for the very important point that she made. I did not even talk about prescribing today but I hope to come back and talk about it later—the whole question of training and what young doctors are being told. “Rational prescribing” is a phrase that I will now be able to repeat.

I know that the Minister accepts the arguments, and of course there are many things that we have in common—good practice and the use of the voluntary sector. I take the point about the duty that falls on local authorities, but I still maintain that we have to separate this out from the mainstream of drug addiction and alcohol treatment. It is the kind of treatment that only the very careful, experienced volunteers can describe. I do not think that I can begin to describe the actual treatment. However, the NHS will soon get to grips with what is happening. I welcome the chance of having a meeting. I will of course come to talk, and I hear that there is to be a range of experts. I feel that the Minister has given a little bit of a Civil Service answer, because there are only but one or two people who follow this subject in the department. I do not mind talking only to two people—it will be a very good opportunity to take this further. Meanwhile, I beg leave perhaps to consider this again at a later stage of the Bill, and to withdraw the amendment.

Amendment 107 withdrawn.

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Email from John Perrott to Edward Corbett, Customer Service Centre, Department of Health (02 February 2012)

Our ref: DE00000672350

Dear Mr Corbett,

Thank you for you response to my email. The Department of Health in its previous response offered to answer all my outstanding questions, however, I asked you just to answer one question, and unfortunately you have been unable to do even that.

I asked to be provided with a list of dedicated involuntary tranquilliser addiction services referred to on many occasions by Earl Howe and the Department of Health, however, you have referred me to services provided by the National Treatment Agency (I believe Authority was a misquotation on your behalf).

The NTA deals with drug misuse and will not treat patients with iatrogenic tranquilliser addiction only.

This list has now been asked for many times, and I therefore resubmit my request, and emphasise that it is for a list of services or specialists referred to by Earl Howe and the Department of Health in meetings, Parliamentary Questions, debates and correspondence for involuntary tranquilliser addicts.

If you are unable to specify these please would you confirm that there are no services.

Yours sincerely,

John Perrott

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Email from Edward Corbett, Customer Service Centre, Department of Health to John Perrott (02 February 2012)

Our ref: DE00000672350

Dear Mr Perrott,

Thank you for your email of 16 January about benzodiazepine addiction. I have been asked to reply.

With regard to a list of dedicated involuntary tranquiliser addiction service, the data from the National Drug Treatment Monitoring System demonstrate that most areas in the country have services in place to support people who develop dependence on over-the-counter and prescribed drugs. This was made clear in the National Treatment Authority’s report which was published in May 2011.

These services are commissioned by local areas and support is provided in a range of different ways; through GP support, access to specialist addiction or through dedicated withdrawal services. The Department of Health does not keep a national list of these services, which are commissioned locally, nor has it claimed to keep such a list.

Yours sincerely,

Edward Corbett
Customer Service Centre
Department of Health

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Parliamentary Questions by the Earl of Sandwich (26 January 2012)

Health: Addiction to Prescribed Drugs

Questions

Asked by The Earl of Sandwich

To ask Her Majesty’s Government what action they have taken regarding addiction to prescribed medication following the points agreed at the Round Table meeting on 15 September; and when that group will be reconvened.[HL15005]

To ask Her Majesty’s Government when they will make a statement on their policy on tranquilliser addiction.[HL15006]

To ask Her Majesty’s Government whether they have plans for the Parliamentary Under-Secretary of State for Public Health, Anne Milton, to visit specialised prescribed medication clinics and centres of excellence in the United Kingdom, in addition to the centre in Oldham.[HL15007]

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My honourable friend the Parliamentary Under-Secretary of State, (Anne Milton) met the noble Lord on 13 December 2011 to discuss future action on addiction to medicines. The Parliamentary Under-Secretary of State will be reconvening the roundtable meeting in March 2012, to review the progress against the points agreed at the round table meeting on 15 September 2011.
26 Jan 2012 : Column WA268
The Parliamentary Under-Secretary of State will be meeting patients to discuss addiction to medicines on 31 January and is planning to visit a dedicated tranquilliser withdrawal service in June 2012.

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Parliamentary Questions by Eric Ollerenshaw, MP (23 January 2012)

Benzodiazepines

Eric Ollerenshaw: To ask the Secretary of State for Health what warnings his Department has issued on possible teratogenic effects of the use of benzodiazepines; when such warnings were issued; and on what scientific evidence they were based. [90539]

Mr Simon Burns: There are limited data relating to the safety of use of benzodiazepines in pregnancy and the implications for the unborn child. Clinical trials or
23 Jan 2012 : Column 65W
studies are not routinely conducted in pregnant women. Consequently, the data available in relation to safety in pregnancy mainly comes from animal studies, spontaneous case reports and practical experience with the medicine over time. Evidence from these sources is carefully evaluated and the relevant information is reflected in the product information.

In 1980, guidance on the use of benzodiazepines was published by the Committee on the Review of Medicines, this included use during pregnancy. In September 1997, the medicines regulatory authority and its advisory committee published further information in the bulletin Current Problems in Pharmacovigilance. This guidance strengthened the guidance previously provided that benzodiazepines are associated with a risk of neonatal withdrawal symptoms if benzodiazepines are used during the latter stages of pregnancy. In addition, it advised that high doses administered during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression. It advised that benzodiazepines can also pass into the breast milk of mothers in sufficient doses to cause side effects in the babies and therefore should be avoided, if possible, during breast-feeding.

Benzodiazepines are therefore not recommended for use during pregnancy unless there is clear clinical need for which the benefits to the mother, such as seizure control, are considered to outweigh the risk to the foetus. Any woman of childbearing potential, should be advised to speak with her doctor about stopping the product if she intends to become pregnant or suspects that she is pregnant.

Information regarding use during pregnancy, is provided in the product information for each product. Guidance is also provided in the British National Formulary which is provided free to all prescribes in the NHS.
Taken from Parliament’s website: http://www.publications.parliament.uk/pa/cm201212/cmhansrd/
cm120123/text/120123w0003.htm#12012333001827

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Email from John Perrott to Dr June Raine, Director, Vigilance, Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (24 January 2012)

Dear Dr Raine,

Would you please explain why 11 new licences for benzodiazepines were issued in the last three years, as this group of drugs has been identified as a risk in the recent Department of Health review on addiction to prescribed medicine, and the more licences that are issued, the more an upward pressure will be caused on prescribing as each Market Authorisation Holder works to increase their share of the market?

Yours sincerely,

John Perrott

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Parliamentary Questions by Jim Dobbin, MP (19 January 2012)

Benzodiazepines

Jim Dobbin: To ask the Secretary of State for Health pursuant to the answer of 20 December 2011, Official Report, columns 1137-42W, on benzodiazepines, how many companies hold licences for the manufacture or distribution of (a) Nitrazepam, (b) Flurazepam, (c) Loprazolam, (d) Lormatazepam, (e) Temazepam, (f) Clonazepam, (g) Medazepam and (h) Midazolam; and how many of those licences were issued in the last three years. [90391]

Mr Simon Burns: The current position is that:

16 products are authorised in the United Kingdom containing nitrazepam and 16 different companies authorised to manufacture and distribute them;

Two products are authorised in the UK containing flurazepam and one company authorised to manufacture and distribute them;

One product is authorised in the UK containing loprazolam;

Six products are authorised in the UK containing lormetazepam and three different companies authorised to manufacture and distribute them;

10 products are authorised in the UK containing temazepam and six different companies authorised to manufacture and distribute them;

Nine products are authorised in the UK containing clonazepam and four different companies authorised to manufacture and distribute them;

There are no authorised products in the UK containing medazepam; and
19 Jan 2012 : Column 933W
23 products are authorised in the UK containing midazolam and 10 different companies authorised to manufacture and distribute them.

Four clonazepam, two lormetazepam and five midazolam products have been authorised in the last three years.

Details are as follows for all benzodiazepines.

There are currently 173 products authorised in the UK containing benzodiazepines. There are 46 different companies authorised to manufacture and distribute them. 11 new marketing authorisations for benzodiazepines have been authorised in the last three years. Details for each benzodiazepine have been placed in the Library.

This supersedes the information given to the hon. Member on 20 December 2011, Official Report, columns 1137-42W.

 

Taken from Parliament’s website: http://www.publications.parliament.uk/pa/cm201212/cmhansrd/
cm120119/text/120119w0001.htm#12011944000395

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