20 Greenacre Court
Lancaster
LA1 4LE
Dora East
Dept of Health
Richmond House
79 Whitehall
London, SW1A 2NS
28th July 2010
Your Ref: TO00000499504
Dear Ms East,
I am writing to you as I am seeking further clarification regarding the progress of the Department’s Addiction to Medicines Review and these related issues:
- The Terms of Reference of the review.
- Professor Steven Field’s (Chair RCGP) statement on ITV West last year regarding benzodiazepine addiction.
- The Product Licence for Ativan and related issues concerning the MHRA.
- I would also like an answer to questions in my previous letter (your Reference TO00000506802) as this was not answered due to the impending election.
1. Terms of Reference:
Prior to the election the review was looking at the following areas:
- prevalence: to help to determine the extent and severity of the problem of dependence on prescribed and OTC drugs;
- prevention: to assess the effectiveness of clinical governance in this field, including the provision of guidance for prescribers of benzodiazepines and other drugs;
- provision of treatment services: to find out what services are available to support people needing treatment for dependence on these drugs;
- policy leadership: to establish how the Department might improve its communication between interested branches; and
- discrimination against people who may have become disabled as a result of their dependence on medicine.
The report itself is now scheduled for the end of 2010 with policy discussions to take place into 2011. Three key pieces of work have been commissioned by the review team and are apparently underway:
- A review of the published literature on the subject by the National Addiction Centre.
- An audit of the prescribing records held by a sample of local NHS Primary Care Trusts to gauge the extent of over-prescribing.
- A survey of addiction specialists to map the services that are currently available to help people withdraw from prescribed and over-the counter-medicines.
Are these terms of reference new because they appear less detailed than in your previous letter and exclude considering discrimination issues and assessing clinical governance effectiveness? Does this mean the scope of the review has been reduced?
Why is the Drugs Misuse team now coordinating this review because it is not an issue of drugs mis-use. It has also been accepted by the Dept in past correspondence that drug misuse terminology is inappropriate for involuntary tranquilliser addiction.
2. Professor Field’s statement
I refer to an extract from Professor Field’s television interview last year:
‘Professor Steven Field, Chair of the Royal College of General Practitioners, said:
“We now try to prescribe (benzodiazepines) only for a few days because we know that it’s very difficult to get people off these drugs ….….. in some people, it can be three or four days of the drug before they get hooked. …… So each patient is very different. Bringing people off the drug is very different and you have to do it slowly and really tailor it to the patient.”
(ITV West interview, March 09)’
If patients can become addicted in 3-4 days then where does this leave the 2-4 weeks maximum period stated in all previous guidelines?
Problems with addiction to benzodiazepines were emerging in the 1960s and various guidelines have been issued to GPs since, the main ones being:
The Committee on Review of Medicines report in 1980; the Committee on Safety in Medicines publication in 1988; the Mental Health National Service Framework (NSF) guidelines in 1994 and their publication in 1999; the Dept of Health publication in 1999; NICE’s publication in 2004 and the Chief Medical Officer’s update 37 also in 2004. All these guidelines stated that ‘benzodiazepines should be prescribed for just two to four weeks for relief of severe or disabling anxiety or severe or disabling insomnia in patients who are extremely distressed’.
NHS Clinical Knowledge Summaries ‘benzodiazepines and z drug withdrawal’, largely based on Professor Ashton’s work, have also been available on-line for GPs’ guidance.
Doctors have largely ignored these guidelines and my current and last PCT (Lancashire and Cumbria) were unaware of the CKS guidelines on-line. Prescriptions for benzodiazepines are actually on the increase. Diazepam prescriptions are up 11% this year and 17% over a decade. In 2007 Dept of Health statistics show that there were 11.5 million prescriptions for benzodiazepines, 5.5 million for z drugs and a third of these were for 56 tablets or more suggesting large numbers of patients on long-term treatment; 852,000 of these were for lorazepam which is one of the more problematic benzodiazepines and 10 times the strength of diazepam.
It has recently been brought to my attention that there is a lack of pharmacology in medical education. Students qualify with little requirement for, or examination on, competence to prescribe, let alone recognition and treatment of adverse drug reactions (ADRs), recognition of withdrawal reactions as opposed to return of original problem, or knowledge about safe methods of withdrawal. Withdrawal protocols for addictive medicines provided by Professor Heather Ashton and Professor David Healy, as well as those developed by support groups such as CITA and BATAID are not provided to doctors or patients by the Department.
The MHRA also does not take responsibility to provide withdrawal protocols or require manufacturers to provide them either.
3. The Product Licence for Ativan
Firstly, can you clarify what role the MHRA are playing in the current review?
Secondly, Dr Raine informed me in her last correspondence of 3rd June that the MHRA is a government agency of the Dept of Health. I am therefore bringing these licensing issues to your attention as they are ultimately the Dept’s responsibility and I am not satisfied with the agency’s licensing and enforcement decisions.
Dr Raine stated in her response to my enquiries regarding the licensing and monitoring of Ativan that the MHRA do not have any records relating to the product licence application. They have also ‘bridged’ subsequent generic lorazepam licences under Directive 2001/83/EC Articles 10.1 and 10c. Therefore, no safety data were required to support these generic applications.
Also, Marketing Authorisation Holders have the responsibility to update their own product information so we have a situation where pharmaceutical companies supposedly monitor the safety of their own product and update their own information.
It is my belief that Ativan received its licence with little more than promotional literature and that all subsequent licences have been granted on this information alone. Safety does not seem to be an important issue to the MHRA and they could not answer most of my questions due to destroyed or lost records. Considering Ativan (lorazepam) is 10 times the strength of diazepam and highly addictive with increasing prescription use, this seems a very cavalier attitude towards public safety.
Responsibility for this situation has been moved around between government departments and professional bodies for too long. Please can you explain to me where accountability for this public health crisis lies?
Thanking you for your continuing help in this matter,
Yours Sincerely
John Perrott
CCs:
Anne Milton MP Minister for Health – Your response please
Jim Dobbin MP Chair of the All Party Parliamentary Group for Involuntary Tranquilliser Addiction
Eric Ollerenshaw MP Lancaster and Fleetwood – Please contact Jim Dobbin to offer your support
Tim Farron MP Westmorland and Lonsdale– Please contact Jim Dobbin to offer your support
Lord Sandwich Vice Chair All Party Parliamentary Group for Involuntary Tranquiliser Addiction
Professor Heather Ashton
CITA