Correspondence regarding independent prescribing of controlled drugs

Dear Jasmine Ganesh,

Thank you for your reply (below) of 6 May 2015.

You say that “Therefore, at the time of the review, there would have been no patients in receipt of controlled drugs prescribed by allied health professionals” but this is not the point.

The point is that when the Department announced a policy review on addiction to medicines in July 2009 it was at the same time leading contradictory work to deregulate the prescribing of the addictive drugs which were the subject of the review, including the benzodiazepines temazepam, lorazepam and diazepam. To claim that the drugs in question were not actually prescribed by allied professionals at the time of the review is just playing with words.

In 2009 the Department produced a scoping document and in September 2011, Ministers agreed to a public consultation on proposals for independent prescribing by podiatrists and physiotherapists. The subsequent risk assessment in 2012 was led by the Department of Health.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213480/DH-1019-Proposals-to-introduce-independent-prescribing-by-podiatrists.pdf

On page 5 the Policy objective is described in the following terms “The objective of introducing independent prescribing for podiatrists is to enhance patient care by improving access to medicines through an increased and more flexible approach.”

Would you explain why on the one hand the Department was conducting a policy review on addiction to medicine including benzodiazepines and on the other hand leading contradictory work to deregulate the prescribing of these drugs?

Secondly, would you please explain how the introduction of independent prescribing for podiatrists and physiotherapists will enhance patient care by improving access to medicines (including lorazepam, diazepam and temazepam) through an increased and more flexible approach as stated in the Department’s impact assessment, when many hundreds of thousands of patients have already become addicted caused by doctors not complying with existing prescribing guidelines?

Thirdly, in answer to a PQ by my MP Eric Ollerenshaw (below), George Freeman said “The Department is looking into the feasibility of commissioning further research on patterns of long-term prescription of dependency-forming medicines, including analyses of relevant prescribing data.”

Why is the Department allowing further deregulation of the prescribing of these drugs when by its own admission it has no idea how many patients are addicted to them? There is plenty of evidence on the harms caused by benzodiazepines so surely their prescribing should be more controlled, not less?  Research by benzodiazepine expert Professor Ashton and also by BBC Panarama in 2001 pointed to over a million patients on these drugs long-term, with most likely to be addicted.

Would you also provide more information regarding this feasibility study?

Lastly, regarding your comment that “the Department of Health and Public Health England have undertaken to address this important issue”, no effective action has been taken to date and my survey of PCTs in 2012 proved that 83% of local areas had no prescribed tranquilliser withdrawal services and my survey of 152 local authorities conducted in 2013 proved that involuntary tranquilliser addiction is not being treated and that it is still incorrectly treated by DH and PHE as a substance misuse issue.

http://www.appgita.com/wp-content/uploads/2013/08/Survey-of-PCTs-in-England-recording-provision-of-services-for-involuntary.pdf

http://www.appgita.com/index.php/2014/09/survey-of-152-local-authorities-in-england-recording-numbers-treated-since-april-2013-for-involuntary-tranquilliser-addiction/

Yours sincerely,

John Perrott

 

Your email of 6 May 2015

Our ref: DE00000933295

Dear Mr Perrott,

Thank you for your further correspondence of 23, 24 and 25 April to Una O’Brien about prescription medicines.  I have been asked to reply.

In 2011, two reports on addiction to prescription and over-the-counter medicines were published, and are available to view at:

https://www.gov.uk/drug-safety-update/addiction-to-benzodiazepines-and-codeine

A consensus statement was then published in January 2013, which predated the decision to amend regulations to allow independent prescribing of controlled drugs by allied health professionals.  Therefore, at the time of the review, there would have been no patients in receipt of controlled drugs prescribed by allied health professionals.  From previous correspondence, you will be aware of the work that the Department of Health and Public Health England have undertaken to address this important issue.

Now that Parliament has been dissolved before the General Election, any future decisions about this matter will be for the incoming Government.

I am sorry I cannot be more helpful.

Yours sincerely,

Jasmine Ganesh
Ministerial Correspondence and Public Enquiries
Department of Health

 

 

The Department of Health has provided the following answer to your written parliamentary question (227804):

Question:
To ask the Secretary of State for Health, whether the General Practice Research Database includes data on the prescribing of tranquillisers; and if he will use this database to calculate the number of patients with a long-term dependency on tranquillisers. (227804)

Tabled on: 17 March 2015

Answer:
George Freeman:

The CPRD GOLD primary care database (former GPRD) includes information about all prescriptions issued in primary care for a subset of approximately 8% of the United Kingdom population. This database has previously been used to study prescribing of anxiolytic, hypnotic and psychotropic medication, commonly referred to as tranquilisers.

It would be possible to use the database to estimate the number of patients in the UK with a long-term dependency on prescription tranquilisers. However, as dependence will not be systematically identified by general practitioners, expert clinician advice would also be required to develop a definition. This could be based on frequency of prescribing and medication strength but could also include clinical codes for medical conditions including indications for these products, drug dependency and substance abuse, if recorded.

This work would represent a research project and as such, a scientific protocol would need to be submitted to the Medicines and Healthcare products Regulatory Agency’s Independent Scientific Advisory Committee for assessment and possible approval.

Even with such an approach, the rate of drug dependency in the population could only be estimated, and in order to assess whether this estimate was a true representation of the actual rate of drug dependency in this population, a validation study would be encouraged.

The Department is looking into the feasibility of commissioning further research on patterns of long-term prescription of dependency-forming medicines, including analyses of relevant prescribing data.

The answer was submitted on 24 Mar 2015 at 16:16.

DH response 18 May 2015

Our ref: DE00000934760

Dear Mr Perrott,
Thank you for your further correspondence of 12 May to Una O’Brien and the Department of Health about prescription medicines.  Please accept this as a response to each of your emails.

I was sorry to read that you were not satisfied with the Department’s earlier response of 6 May (our ref: DE00000933295), and note your continuing concerns about independent prescribing by podiatrists and physiotherapists.

The Addiction to Medicine review was set up to consider the extent of drug dependence and harm, and the service responses to it.  The legislative changes made to allow appropriately qualified and registered physiotherapist and podiatrist independent prescribers to prescribe some benzodiazepines were undertaken to enable patients who might benefit from these medicines to have readier access to them.  These are not contradictory positions, as the work of the review and current guidance applies to any prescriber, including any allied health professionals (AHPs) who are independent prescribers.

The changes only apply to independent physiotherapist and podiatrist prescribers, not all AHPs.  Prescribers are expected to follow current guidance on the prescribing of benzodiazepines and to only use them when there is a clear, clinical need.  They will also discuss the effects of the medication with the patient before a decision to prescribe is made.  The possibility that increased availability on these restricted terms could lead to increased dependence and demand for services is slim.

You will be aware from previous correspondence of the actions that the Department, Public Health England, the relevant Royal Colleges and others have taken to increase awareness of the addiction potential of some medicines, such as benzodiazepines, and to ensure that local health services are aware of their obligation to meet the needs of anyone in their populations who has become addicted to a prescribed or over-the-counter medicine.

There are entry requirements to ensure only advanced practitioner physiotherapists and podiatrists can enrol on prescribing education and training programmes.  The programmes are based on demonstrating competencies as detailed in the single competency framework for all prescribers.

Applicants for the programmes must:

–       be registered with the Health and Care Professions Council;

–       be professionally practising in an environment where there is an identified need for the individual to regularly prescribe independently;

–       be able to demonstrate support from their employer/sponsor, including confirmation that the entrant will have appropriate supervised practice in the clinical area in which they are expected to prescribe;

–       be able to demonstrate medicines and clinical governance arrangements are in place to support safe and effective independent prescribing;

–       have an approved medical practitioner to supervise and assess their clinical training as a prescriber;

–       normally have at least three years relevant post-qualification experience in the clinical area in which they will be prescribing; and

–       be working at an advanced practitioner or equivalent level.

Further information about the training programme is available online at:

http://anp.org.uk/2012/06/npc-publishes-single-competency-framework-for-prescribers/

Once successful applicants have been trained and their registration with the Health and Care Professions Council is annotated to record their training as an independent prescriber, physiotherapists and podiatrists will be covered by local governance arrangements.  These include the responsibility of controlled drugs accountable officers for registering prescribers of controlled drugs, issuing prescriptions pads and monitoring prescribing patterns.  The arrangements may also include use of local, organisation and personal prescribing formularies.

The changes in prescribing described above are largely aimed at addressing ‘one-off’ episodes of care, with immediate supply/administration of a single dose, or as part of end-of-life care.  In addition, the changes do not represent a large-scale expansion of prescribing, with independent prescribing being introduced to address specific patient or service needs and not across the whole physiotherapist and podiatrist workforce.  These changes add a flexible approach to prescribing and will enhance patient care by allowing AHPs who are independent prescribers to:

–       maximise the treatment intervention through better pain management;

–       improve quality of care in palliative services – fine tuning the needs of the patient as they change;

–       manage pain in pre and/or post-operative treatment;

–       improve quality of care through the potential to reduce controlled drugs as the benefits of the physical treatment and health outcomes are recognised;

–       prevent delays in early intervention for first time and acute setting patients; and

–       treat specific episodes or long term conditions.

The changes in prescribing are not deregulation.  Regulations have been amended with the aim of enhancing patient care by making better use of the skills of these highly experienced healthcare professionals.  The following case studies describe real life circumstances in which flexibility in who can prescribe temazepam, lorazepam and diazepam would enhance patient experience:

Case Study – temazepam

Temazepam may be prescribed for the management of acute anxiety prior to undergoing scanning diagnostics for the investigation and management of spinal pain and/or other long term musculoskeletal conditions.  Patients are often managed in physiotherapy-led spinal services whereby the physiotherapist requests an out-patient diagnostic scan as part of the patient pathway. When the patient suffers from acute anxiety and/or claustrophobia, performing the scan may not be possible without some sedation.  The patient may be prescribed 10mg to take the night before the scan, followed by another 10mg one hour prior to the procedure.

Case Study – lorazepam/diazepam

These may be used in palliative or end of life care for the management of acute anxiety or respiratory distress at the end of life.  The physiotherapist is often the healthcare professional with expertise in managing respiratory function, and managing anxiety may be part of managing the decline in respiratory function.  Dosage will be according to British National Formulary guidelines and individual patient circumstances where either long or short acting sedation is required.

With regard to your concerns about commissioning further research on patterns of long-term prescription of dependency-forming medicines, as the commissioning process is not yet complete, the Department is unable to provide this information.

I hope this reply is helpful.

Yours sincerely,

Jasmine Ganesh
Ministerial Correspondence and Public Enquiries
Department of Health

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email to Una O’Brien, Permanent Secretary, Department of Health

Dear Una O’Brien,                                                                                             24 April 2015

Further to my email of yesterday I have since received a response from the Chartered Society of Physiotherapists (below).

The links show that the Department of Health supported deregulation of benzodiazepine prescribing allowing physiotherapists, chiropodists and podiatrists to prescribe temazepam, lorazepam and diazepam. These proposals were underway in 2009 and developed during 2011 – 2012 but were not disclosed during the Department’s policy review on addiction to medicines including prescribed benzodiazepines.

Would you please explain why the proposals, the “public consultation” and amendments were not disclosed during the policy review or in the Department’s dealings with the All Party Parliamentary Group on Involuntary Tranquilliser Addiction?

Yours sincerely,

John Perrott
Our ref: DE00000933295                                               6 May 2015

Dear Mr Perrott,
Thank you for your further correspondence of 23, 24 and 25 April to Una O’Brien about prescription medicines.  I have been asked to reply.

In 2011, two reports on addiction to prescription and over-the-counter medicines were published, and are available to view at:

https://www.gov.uk/drug-safety-update/addiction-to-benzodiazepines-and-codeine

A consensus statement was then published in January 2013, which predated the decision to amend regulations to allow independent prescribing of controlled drugs by allied health professionals.  Therefore, at the time of the review, there would have been no patients in receipt of controlled drugs prescribed by allied health professionals.  From previous correspondence, you will be aware of the work that the Department of Health and Public Health England have undertaken to address this important issue.

Now that Parliament has been dissolved before the General Election, any future decisions about this matter will be for the incoming Government.

I am sorry I cannot be more helpful.

Yours sincerely,

Jasmine Ganesh
Ministerial Correspondence and Public Enquiries
Department of Health
Dear Mr Perrott,                                                                                                          24 April 2015

Thank-you for taking the time to write to the CSP.

The decision to allow physiotherapists to independently prescribe was taken by Government, after a period of Public Consultation, in 2013. This  included the decision in principle, made by The Advisory Committee for the Misuse of Drugs which advises the Home Office, to  allow physiotherapists to prescribe from a limited list of 7 controlled drugs. The Home Office recently announced plans for the Misuse of Drugs Regulations 2001 to be amended to incorporate this recommendation.

The issues you raise about training and regulation are all covered in the Public Consultation documents and the Government Reponses to the Public Consultation these changes which occurred in 2011 and 2012:

https://www.gov.uk/government/news/proposals-to-introduce-independent-prescribing-for-physiotherapists-and-podiatrists

https://www.gov.uk/government/news/summary-of-public-consultation-on-proposals-to-introduce-independent-prescribing-by-physiotherapists

Physiotherapist have been able to use controlled drugs in their practice via other medicines mechanisms for many years and the introduction of very limited independent prescribing is the next step in delivering effective health care. There is to date, no evidence of physiotherapists misusing these prescribing privileges . Only approximately 500 of our 53,000 members are registered as prescribers, and not all physiotherapists will  choose to undertake this activity.

Best wishes

Pip

Pip White BSc, MSc, MA(Law), MCSP| Professional Adviser | Chartered Society of Physiotherapy, 14 Bedford Row, London WC1R 4ED               

Tel: 0207 306 6666| : E-mail: enquiries@csp.org.uk | web www.csp.org.uk

(Also sent to the Society of Chiropodists and Podiatrists)

Dear Sir/Madam,                                                                                   23 April 2015

I am writing about the recent decision to allow chiropodists, podiatrists and physiotherapists to prescribe controlled drugs including the benzodiazepines temazepam, lorazepam and diazepam under The Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015.

http://www.legislation.gov.uk/uksi/2015/891/made/data.pdf

These drugs are highly addictive and were the subject of the recent Department of Health policy review on addiction to medicines. Doctors have ignored the 1988 CSM 2 – 4 prescribing guidelines which has caused mass addiction to prescribed tranquillisers in the UK dwarfing numbers addicted to illegal drugs. There are more deaths and hospital admissions caused by prescription drugs than illegal drugs. Withdrawal from benzodiazepines is often more prolonged with more psychological and physical withdrawal symptoms than heroin. There are no NHS tranquilliser withdrawal services with patients addicted to prescribed tranquillisers forced to cope on their own or seek help from under half a dozen charities including CITAp in Liverpool which is due to close soon due to lack of funding.

These are patients who have become addicted through following medical advice and are not to be confused with illicit drug users.

You may not be aware but there has been a campaign of nearly 30 years against the mis-prescribing of these drugs, more recently by the All Party Parliamentary Group on Involuntary Tranquilliser Addiction. Campaign work is documented on these websites – www.appgita.com andwww.benzo.org.uk

I would be grateful if you would clarify the following please:

  1. Why was it thought necessary that physiotherapists would need to prescribe these three benzodiazepine drugs?
  2. What conditions will they be prescribed for?
  3. What training are physiotherapists to be given regarding prescribing these drugs safely?
  4. Doctors have ignored the 1988 CSM 2 – 4 tranquilliser prescribing guidelines causing an estimated 1 million patients to be on these drugs long-term, some for decades, with most likely to be addicted.

The Department of Health’s recent policy review included a consensus statement on addiction to medicines http://www.rcgp.org.uk/news/2013/january/~/media/Files/News/RCGP-Addiction-to-Medicine-consensus-statement.ashx

Point 6 states, “Longer term prescribing can increase the risk of dependence, and with some medicines, such as tranquillisers like benzodiazepines, should only be considered under exceptional circumstances and with regular review by practitioners with suitable expertise and understanding of the risks.”

What safeguards have been put in place to avoid further iatrogenic addiction caused by physiotherapists?

  1. Will physiotherapists be directed to the Ashton manualhttp://www.benzo.org.uk/manual/before prescribing benzodiazepines so that they understand ADRs and withdrawal symptoms and the pharmacology of these drugs?

Campaigners and patients are very concerned about deregulation of the prescribing of these drugs and any further information you can give would be appreciated.

Yours sincerely,

John Perrott

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email to Professor Les Iversen, Chair ACMD and Una O’Brien, Permanent Secretary, Department of Health

Dear Professor Iverson and Una O’Brien,

I am writing about the recent decision to allow chiropodists, podiatrists and physiotherapists to prescribe controlled drugs including the benzodiazepines temazepam, lorazepam and diazepam under The Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015.

These drugs are highly addictive and were the subject of the recent Department of Health policy review on addiction to medicines. Doctors have ignored the 1988 CSM 2 – 4 prescribing guidelines which has caused mass addiction to prescribed tranquillisers in the UK dwarfing numbers addicted to illegal drugs. There are more deaths and hospital admissions caused by prescription drugs than illegal drugs. Withdrawal from benzodiazepines is often more prolonged with more psychological and physical withdrawal symptoms than heroin. There are no NHS tranquilliser withdrawal services with patients addicted to prescribed tranquillisers forced to cope on their own or seek help from under half a dozen charities including CITA which is due to close soon due to lack of funding.

  1. What is the reasoning behind the decision to allow chiropodists, podiatrists and physiotherapists to prescribe these three benzodiazepines?
  1. Why was it thought necessary that these therapists would need to prescribe these drugs?
  1. What conditions will they be prescribed for?
  1. What training are they to be given regarding prescribing these drugs safely?

5. Doctors have ignored the 1988 CSM 2 – 4 prescribing guidelines causing an estimated 1 million patients to be on these drugs long-term, some for decades, with most likely to be addicted.

The Department of Health’s policy review consensus statement on addiction to medicines point 6 states, “Longer term prescribing can increase the risk of dependence, and with some medicines, such as tranquillisers like benzodiazepines, should only be considered under exceptional circumstances and with regular review by practitioners with suitable expertise and understanding of the risks.”

What safeguards have been put in place to avoid further iatrogenic addiction caused by these therapists and why is there no mention of benzodiazepines or the 1988 CSM tranquilliser prescribing guidelines in correspondence from the Department of Health below?

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/410923/2015-02-03-Dan_Poulter_-_LF.PDF

Will these therapists be directed to the Ashton manual before prescribing benzodiazepines so that they understand ADRs and withdrawal symptoms and the pharmacology of these drugs?

Yours sincerely,

John Perrott

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THE MISUSE OF DRUGS (AMENDMENT) (No. 2) (ENGLAND, WALES AND SCOTLAND) REGULATIONS 2015

These amendments will enable further deregulation of benzodiazepine prescribing. From June 2015, physiotherapists will be allowed to prescribe some controlled drugs for treatment of organic disease or injury, including diazepam, dihydrocodeine, fentanyl, lorazepam, morphine, oxycodone and temazepam; chiropodists/podiatrists will be allowed to prescribe diazepam, dihydrocodeine, lorazepam and temazepam.

http://www.legislation.gov.uk/uksi/2015/891/made/data.pdf

http://www.legislation.gov.uk/uksi/2015/891/pdfs/uksiem_20150891_en.pdf

“7.27 This instrument provides for limited independent prescribing authorities to physiotherapists and chiropodists under these changes to improve safety and health outcomes for patients through improved access to medicines and more timely treatment. Physiotherapists are being given authority to prescribe temazepam (oral), lorazepam (oral), diazepam (oral), dihydrocodeine (oral), morphine (oral and injectable), fentanyl (oral) and oxycodone (oral). Chiropodists are authorised to prescribe temazepam (oral), lorazepam (oral), diazepam (oral), and dihydrocodeine (oral). Both professions are authorised to administer the specific drugs they are authorised to prescribe, but are not authorised to possess, stock or supply these drugs.”

Letter from Dan Poulter, Under Sec State Health to Minister for Crime Prevention about amendments 3 February 2013

Letter from Professor Les Iverson Chair, ACMD to Jeremy Browne, Minister for Crime Prevention on proposals 13 February 2013

Parliament approves changes to regulations governing controlled drugs – Pharmaceutical Journal

 

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Recovering from benzodiazepines – a guide by Peter Hayes-Davies

Click here to read the guide

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Andreas Lubitz was on prescribed antidepressants and the benzodiazepine Lorazepam (Ativan)

Click here to read article in the Telegraph

Also, transcript below is from the International Business Times, 2 April 2015

What Drugs Was Andreas Lubitz On? Lorazepam, Antidepressants Could Have Affected Germanwings Pilot by Elizabeth Whitman

Medical records indicate that Andreas Lubitz, the co-pilot who crashed the Germanwings plane last week in the French Alps, was on medications for depression, anxiety and panic attacks, including lorazepam, a tranquilizer that can have dangerous side effects, German newspaper Bild reported.Federal drug information advises that “patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles” and that “in patients with depression, a possibility for suicide should be borne in mind.

Lubitz, 27, was also reportedly taking an antidepressant, Reuters reported. He lied to his doctors, saying that he was taking sick leave rather than working and flying planes. When he resumed pilot training in 2009, he provided medical papers showing a “previous episode of severe depression,” Lufthansa, the parent company of Germanwings,  confirmed Tuesday.

Lorazepam is a drug that is typically prescribed to treat anxiety that works by “slowing activity in the brain to allow for relaxation,” according to an information page by the National Institutes of Health. The NIH warned that the drug can be “habit-forming,” or addictive, and should not be stopped suddenly, as doing so can cause “anxiousness, sleeplessness, and irritability.” There are a host of side effects, including restlessness and blurred vision.

The Food and Drug Administration’s drug information page for Ativan, a brand name for lorazepam, noted that the drug’s effectiveness for long-term use — a period defined as more than four months — has yet to be clinically assessed. It remains unclear how long Lubitz had taken the drug. The FDA warned that “pre-existing depression may emerge or worsen during use of benzodiazepines [a class of tranquilizer drugs that includes Valium and Xanax], including lorazepam.” It highlighted as well that lorazepam can have an even more depressive effect depending on what other drugs are taken simultaneously. Brand names for lorazepam include Ativan and Lorazepam Intensol.

The plane Lubitz was flying was en route from Barcelona, Spain to Dusseldorf, Germany. All 150 people on board were killed when it crashed last week in a remote mountainous area of southern France.”

Click here to read article online

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Pregnant woman was killed by train after doctor “failed to warn her an anxiety drug could cause suicidal feelings” Daily Mail 26 February 2015

Click here to read article

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email to Jane Ellison, Public Health minister and Duncan Selbie, CEO, PHE

Dear Jane Ellison and Duncan Selbie,

I am writing regarding the Parliamentary Question below in which Liz McInnes MP asks for the declaration of interests for members of the expert group responsible for updating the Drug misuse and dependence – UK guidelines on clinical management to be made available.

 

Prescription Drugs: Misuse                                                 27 January 2015

Liz McInnes To ask the Secretary of State for Health, if he will publish the declarations of interest submitted by members of the expert group with responsibility for updating the UK guidelines on clinical management of drugs misuse and dependence.

Jane Ellison: The expert group updating the United Kingdom guidelines for the clinical management of drug misuse and dependence consists of a broad spectrum of stakeholders, including practising clinicians, pharmacists, service users, carers, psychologists, commissioners and academics. Each is required to complete a declaration of interests and keep this updated.

Public Health England, which provides the secretariat for the group, has reviewed these declarations and on the basis of the information provided believes that no expert group members have a financial interest in the prescribing of specific medicines for the treatment of dependence.

Clinicians’ declarations will be published alongside the updated clinical guidelines by early 2016.

It is not reasonable for the public to have to wait for over a year to see if there is a legitimate objection to anyone’s inclusion on the expert group on grounds of conflict of interest when it can be addressed now. By the time the revised guidelines are published, it will be too late to do anything other than seek to have the entire findings overturned, which would be most unlikely.

Conflicts of interest are considered to be undesirable because they can give rise to bias and corruption in academic work, or the perception of bias and corruption in academic work.

Professor Strang, who is chair of the expert working group, has financial relationships with many pharmaceutical companies, including the following companies which manufacture drugs to treat dependence:

Martindale/Cardinal, the leading UK supplier of methadone and naloxone

Auralis which manufactures diamorphine

Reckitt Benckiser which manufactures Suboxone

The Department of Health has in the past ignored concerns raised about conflicts of interest. For example, the late Jim Dobbin MP wrote to Andrew Lansley MP, when Secretary of State for Health, raising concerns about Professor Strang’s non-declaration of interests with pharmaceutical companies manufacturing benzodiazepines, z drugs and codeine containing products when co-authoring the NAC report commissioned by the Department of Health to inform its policy review on addiction to medicines. These drugs were the subject of the report.

The NAC report was biased making no mention of protracted or post-benzodiazepine withdrawal syndromes; scant mention of benzodiazepine related ill-health; no inclusion of literature on tranquilliser related deaths; no mention of benzodiazepine teratogenicity or “benzo babies” causing birth abnormalities by exposure to benzodiazepines in utero; dismissed Professor Lader’s study in 1980 linking brain damage to long-term benzodiazepine use in one sentence and; “missed” 129 academic papers stating the risks associated with benzodiazepine use easily accessible on the www.benzo.org website.

Do the Department of Health and PHE acknowledge that at least one member of the expert working group has conflicts of interest and will declarations of interest for all members of the expert working group be made available now rather than at time of publication next year?

Yours sincerely,

John Perrott

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Parliamentary Questions asked by Liz McInnes MP

26 February 2015

Prescription Drugs:

Liz McInnes: To ask the Secretary of State for Health, how many private prescriptions for (a) benzodiazepines, (b) z drugs and (c) antidepressants were issued in 2013; and whether such private prescriptions are included in the analysis by the NHS of prescription costs.

George Freeman: Information is held by the NHS Business Services Authority (NHSBSA) on the numbers of original private prescriptions for controlled drugs that are listed in Schedules 2 or 3 to the Misuse of Drug Regulations 2001 (as amended) (“the 2001 Regulations”) and dispensed in the community in England by NHS community pharmacies. These pharmacies submit regular returns to the NHSBSA for monitoring purposes only with no cost information collected.

No benzodiazepine drugs are listed in Schedule 2 to the 2001 Regulations. The benzodiazepines, flunitrazepam, midazolam and temazepam are listed in Schedule 3 to the 2001 Regulations. In 2013, the NHSBSA recorded 3,021 private prescriptions for these drugs, as defined within the British National Formulary Section 4.1.1 Hypnotics, Section 4.8.2 Drugs used in status epilepticus and Section 15.1.4Sedative and analgesic peri-operative drugs. Other benzodiazepine drugs are listed in Schedule 4 to the 2001 Regulations. No “Z” drugs or antidepressants are listed in Schedules 2 or 3 to the 2001 Regulations.

27 January 2015

Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, if he will publish the declarations of interest submitted by members of the expert group with responsibility for updating the UK guidelines on clinical management of drugs misuse and dependence.

Jane Ellison: The expert group updating the United Kingdom guidelines for the clinical management of drug misuse and dependence consists of a broad spectrum of stakeholders, including practising clinicians, pharmacists, service users, carers, psychologists, commissioners and academics. Each is required to complete a declaration of interests and keep this updated.

Public Health England, which provides the secretariat for the group, has reviewed these declarations and on the basis of the information provided believes that no expert group members have a financial interest in the prescribing of specific medicines for the treatment of dependence.

Clinicians’ declarations will be published alongside the updated clinical guidelines by early 2016.


Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, what steps he plans to take to reduce addiction to prescribed benzodiazepines and z drugs.

Jane Ellison: Public Health England (PHE), NHS England and others are working together to deliver a wide-ranging programme of work to reduce addiction to medicines. This includes completed work such as publishing a guide to commissioning services to respond to addiction to medicines, factsheets for general practitioners (GPs) (Royal College of General Practitioners) and delivering face-to-face training for GPs and other healthcare workers. Looking ahead, PHE is supporting a number of pilots of improved local commissioning.

There is now better awareness of these issues among GPs and clearer prescribing guidelines.


Tranquillisers: Misuse

Liz McInnes: To ask the Secretary of State for Health, if his Department will make an assessment of the implications for its policies of the survey of treatment services provided by local authorities for involuntary tranquilliser addicts conducted by the All Party Parliamentary Group on Involuntary Tranquilliser Addiction.

Jane Ellison: The Department has taken into account the All Party Parliamentary Group on Involuntary Tranquilliser Addiction’s survey in its deliberations in this policy area.


Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, what steps he plans to take to ensure that patients prescribed benzodiazepines and z drugs are provided with recent Medicines and Healthcare Regulatory Authority advice on those drugs’ addiction potential and the time taken to withdraw safely from taking such drugs.

George Freeman: The Medicines and Healthcare products Regulatory Agency (MHRA) has not recently issued any new advice on the addiction potential or the safe withdrawal from benzodiazepines or “z drugs”.

Benzodiazepines and “z drugs” (zaleplon, zolpidem and zopiclone) are recognised to be associated with an addiction potential particularly when taken for longer than the recommended 2-4 weeks. Over the years action has been taken by the MHRA, the Department of Health and professional bodies to provide extensive warnings about the risks of dependence limit prescribing and issue advice about gradual withdrawal.

The risk of dependence on a benzodiazepine (or zaleplon, zolpidem and zopiclone) can increase with higher doses and longer duration of use; therefore, the time it takes to completely stop the medicine varies and withdrawal programmes may sometimes need to be individually tailored.

Patients receive a patient information leaflet in their pack of benzodiazepine (or zaleplon, zolpidem and zopiclone). The leaflet includes information and advice about their medicine, which will support the vital discussions they have with their doctor and pharmacist about their treatment or stopping treatment.

Benzodiazepines and “z drugs” are considered acceptably safe and effective when used in accordance with the approved indications and for the recommended duration of use.

An online learning module for healthcare professionals on benzodiazepines was published on the MHRA’s website in March 2013. The module’s section on dependence and withdrawal gives general guidance on the principles of benzodiazepine withdrawal. The online learning module reflects the product information for these medicines.

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BBC News – Warning over drug-driving law and prescribed medication

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