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

 

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

Click here to read article

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European Medicines Agency recommends suspending medicines including clonazepam

GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies

Products for which the marketing authorisations are recommended for suspension by the EMA on 22 January 2015

MHRA’s response to EMA’s recommendations to suspend medicines

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