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19 Apr 2004 : Column 194W—continued
Medical Devices Agency
Mr. Burstow:
To ask the Secretary of State for Health how many (a) fatal accidents and (b) adverse incident
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reports to the Medical Devices Agency there were in each year since 1997; and if he will make a statement on the most common causes of these incidents. [163505]
Ms Rosie Winterton: The information on total numbers of reported medical device related adverse incidents and reported incidents involving a fatality is shown in table 1.
| Total number of reported incidents | Reported incidents involving a fatality | |
|---|---|---|
| 1997 | 5,383 | 47 |
| 1998 | 6,298 | 79 |
| 1999 | 6,610 | 87 |
| 2000 | 7,249 | 92 |
| 2001 | 7,896 | 141 |
| 2002 | 8,756 | 175 |
| 2003 | 8,795 | 166 |
For summary information and reported purposes, the Medicines and Healthcare products Regulatory Agency groups the causes of medical device related adverse incidents into four categories:
1. Before delivery—issues relating to design, manufacture, quality control and/or packaging.
2. After delivery—relating to performance and/or maintenance failures and device degradation.
3. User error—where the device had not been used in accordance with the instructions for use.
4. No established link to device—where (a) the device was found subsequently to work as intended (possibly due to an intermittent fault, tampering, or user error) or (b) it was not available for inspection, or (c) because the report was made on precautionary basis.
The percentage of incidents falling into each of these categories in 2003 is shown in Table 2.
Cause of incident | All incident reports (number = 8,795) | Reported incidents involving a fatality (number = 166) |
|---|---|---|
| 1. Before delivery | 37 | 12 |
| 2. After delivery | 30 | 11 |
| 3. User error | 18 | 36 |
| 4. No established links to device | 44 | 62 |
Note:
Figures total more than 100 per cent. as multiple causes have been identified in some reports.
Medicines and Healthcare Products Regulatory Agency
Tim Loughton: To ask the Secretary of State for Health (1) whether any members of the expert working group of the Medicines and Healthcare products Regulatory Agency have an interest in GlaxoSmithKline; [162486]
(2) what the reasons were for four separate reviews of Seroxat (paroxetine) by the expert working group of the Medicines and Healthcare products Regulatory Agency; [162487]
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(3) who sits on the expert working group of the Medicines and Healthcare products Regulatory Agency; [162488]
(4) when the Medicines and Healthcare products Regulatory Agency was informed about the recently issued guidance on the recommended prescription doses of Seroxat (paroxetine); [162557]
(5) what plans he has to withdraw Seroxat (paroxetine) from new prescriptions. [162558]
Ms Rosie Winterton: Since paroxetine (Seroxat) was authorised in 1990, its safety has been closely monitored by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government's independent expert advisory committee, the Committee on Safety of Medicines (CSM). The CSM has considered the safety of Seroxat on a number of occasions in response to the receipt of new data in relation to the issues of suicidal behaviour and withdrawal reactions.
The CSM's expert working group on the safety of selective serotonin reuptake inhibitors (SSRIs) was established in May 2003 to review the current available evidence relating to the safety of SSRIs, including paroxetine. The CSM's expert working group comprises the following members whose areas of expertise include psychiatry, child and adolescent psychiatry, epidemiology, statistics and general practice:
Professor Ian V. D. Weller
Professor Deborah Ashby
Mr. Richard Brook (resigned in March 2004)
Professor Mary G. A. Chambers
Dr. Jonathan D. Chick
Professor Colin Drummond
Professor David J. Gunnell
Professor Klaus Ebmeier
Dr. Elizabeta Mukaetova-Ladinska
Mr. Eamonn O'Tierney
Dr. Ross J. Taylor
Dr. Ann York
Dr. Morris Zwi
Members of the Medicines Act advisory committees such as the CSM and its working groups are required to follow a code of practice relating to declarations of interests in the pharmaceutical industry. The code is rigorously followed at each meeting to ensure the integrity of the advice given to the Licensing Authority by those committees. None of the members of the CSM's expert working group have a personal interest in GlaxoSmithKline or any of the other companies which hold marketing authorisations for SSRIs.
To date the expert group has met nine times and has completed the most comprehensive review yet undertaken of the safety of SSRIs in paediatric use. An interim report, which provides information on the key evidence considered by the group up to July 2003 and the action that has been taken as a result of the group's advice, was published on the MHRA/CSM website in September 2003. The expert group is now focused on completing its task of reviewing all the data related to the use of paroxetine and the related drugs in adults, specifically focusing on suicidal behaviour, withdrawal reactions and the dosage recommendations.
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As part of the ongoing in-depth review, the expert group has recently re-evaluated the original dose finding studies carried out for the licensing of paroxetine. The expert group initially reviewed one of the dose finding studies for paroxetine in October 2003. On the advice of the expert group, the manufacturer was then asked to provide data to justify the current dosing recommendations for all indications as part of the European review of the risks and benefits of paroxetine. The expert group reviewed the completed data set at their meeting on 27 February 2004.
This review confirmed that, as stated in the product information provided to prescribers, the recommended daily dose is 20mg, with the exception of obsessive compulsive disorder and panic disorder, for which the recommended daily dose is 40gm.
On 10 March 2004, the CSM confirmed the advice of its expert group and advised that public communication was necessary on the basis of the re-evaluation of clinical trial data and the evidence of prescribing outside of the recommendations in the summary of product characteristics. Ministers accepted the CSM's advice and a communication underlining the recommended daily doses for paroxetine was issued to health professionals on 11 March 2004.
The CSM's current advise is that the balance of risks and benefits of this medicine in the licensed indications is favourable and, on this basis, there are no plans to restrict its use in new patients.
Mental Health Services
Mr. Burstow: To ask the Secretary of State for Health what representations he has received on a negative impact of the four-hour target for total time in accident and emergency on the care of patients with mental health difficulties who present to accident and emergency departments; and if he will make a statement. [159736]
Ms Rosie Winterton: Patients with mental health difficulties benefit along with other patients from the reduction in delay in assessment and treatment the four-hour target requires. Concerns were expressed last year by clinicians about the minority of patients who clinically need more than four hours in accident and emergency (A&E). In response to this the final December 2004 target was adjusted at the end of 2003 to a minimum operating standard of 98 per cent. This gives all trusts up to 2 per cent. headroom to manage clinical exceptions and other patients still in A&E after four hours. The number of patients with mental health difficulties who clinically need more than four hours in A&E is very small.
Tim Loughton: To ask the Secretary of State for Health how many people were resident in mental hospitals or mental institutions in each of the last five years. [163014]
Ms Rosie Winterton:
Information on the numbers of patients resident in national health service hospitals in England under the care of a mental illness or learning disabilities consultant from 31 March 1998 to 2002 is shown in the table.
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| Mental illness | Learning disabilities | |
|---|---|---|
| 1998 | 31,734 | 8,413 |
| 1999 | 30,801 | 7,102 |
| 2000 | 29,891 | 6,030 |
| 2001 | 31,560 | 6,507 |
| 2002 | 31,344 | 5,362 |
Source:
NHS Facilities
Tim Loughton: To ask the Secretary of State for Health how many people were outpatients affiliated to a mental hospital or mental institution in each of the last five years. [163015]
Ms Rosie Winterton: Information is not available in the form requested.
Between 2001 and 2002 there was an increase of over 50,000 in numbers of patients seen by community mental health teams and increases of 1,000 and nearly 3,000 inpatients seen by crisis resolution and assertive outreach teams.
The number of attendances at consultant led outpatient National Health Service clinics for Mental Illness sector is provided in table 1. Taken alone, these figures do not reflect accurately the volume of provision as mental health services are provided in a number of alternative ways as well as through traditional outpatient appointments. Table 2 provides the currently available information on the number of people receiving services from assertive outreach, crisis resolution, and early intervention teams, which provide mental health services to people with mental health problems in the community.
| Year | Quarter | Sector | First attendances seen | Subsequent attendances seen | Total attendances seen |
|---|---|---|---|---|---|
| 1998–99 | (71)— | 287,411 | 1,813,011 | 2,100,422 | |
| 1999–2000 | (71)—; | 281,578 | 1,790,408 | 2,071,986 | |
| 2000–01 | (71)—; | 284,884 | 1,760,399 | 2,045,283 | |
| 2001–02 | (71)—; | 272,599 | 1,684,879 | 1,957,478 | |
| 2002–03 | (71)—; | 276,442 | 1,736,263 | 2,012,705 | |
| 2003–04 | 1 | (71)—; | 61,924 | 381,459 | 443,383 |
| 2003–04 | 2 | (71)—; | 66,997 | 397,497 | 464,494 |
| 2003–04 | 3 | (71)—; | 64,975 | 416,155 | 481,130 |
(71) Mental illness
Source:
Department of Health dataset KH09 (Annual Data)
Department of Health dataset QMOP (Quarterly Data)
| Snapshot at Q3 2003–04 | Q1-Q3 2003–04 | |
|---|---|---|
| Assertive outreach | 11,493 | |
| Crisis resolution | — | 30,650 |
| Early intervention | 1,226 | — |
Source:
Local Delivery Plan Returns
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Tim Loughton: To ask the Secretary of State for Health how many mental health trusts have fully established women-only day care facilities. [163044]
Ms Rosie Winterton: The information requested is not centrally available.
"Following Shifting the Balance of Power", strategic health authorities (SHAs) carry responsibility for the development of local delivery plans that show how proposals for mental health modernisation will be taken forward.
Information to guide local services on applicable service models is available in guidance published by the Department of Health. Women's mental health: into the mainstream was made available to services in September 2002. A copy is available in the Library.
In addition, a programme of work led by the National Institute for Mental Health in England focuses on the development of services for women, including day care provision.
SHAs carry responsibility for the direct management of trust performance, taking account of national guidance and local population needs and resources. Our annual national assessment of local services' self-assessment of development shows that progress is being made but information is not captured centrally on a trust by trust basis.
Tim Loughton: To ask the Secretary of State for Health how many episodes of mental health treatment for minors took place in each of the last five years. [163058]
Dr. Ladyman: Information is not available in the form requested.
A survey of the mental health of children and adolescents in Great Britain, carried out in 1999 by the Office for National Statistics on behalf of the Department of Health, Scottish National Executive and National Assembly for Wales, showed that about 10 per cent. of children aged five to 15 in Great Britain had a mental disorder in that year, of whom half had seen someone from the educational services, about a quarter had used the specialist health care services and a fifth had contact with the social services.
Tim Loughton: To ask the Secretary of State for Health how many (a) consultant psychiatrists, (b) mental health nurses and (c) primary care mental health workers (i) were recruited by and (ii) left the NHS in (A) 2003–04 and (B) in each of the previous five years. [163684]
Mr. Hutton: The Department's workforce census, which takes place each September, does not collect the number of joiners and leavers in the national health service.
The number of consultants in the psychiatry group and the number of all specified mental health nurses in post since 1998 is shown in the table. Separate information is not collected on the number of primary care mental health workers employed in the NHS.
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| Consultants in the psychiatry group | All specified mental health nurses(72) | |
|---|---|---|
| 1998 | 2,627 | 48,877 |
| 1999 | 2,808 | 48,922 |
| 2000 | 2,904 | 49,026 |
| 2001 | 2,959 | 51,315 |
| 2002 | 2,979 | 52,204 |
| 2003 | 3,229 | 53,678 |
(72) Includes nurses employed in learning disabilities, community learning disabilities, psychiatry and community psychiatry areas of work.
Source:
Department of Health medical and dental workforce census
Department of Health non-medical workforce census
Tim Loughton: To ask the Secretary of State for Health how many (a) consultant psychiatrists, (b) mental health nurses and (c) primary care mental health workers are employed by the NHS; and how many of these work (i) part-time and (ii) full-time. [163685]
Mr. Hutton: Information on the number of consultants in the psychiatry group and qualified nurses working in the mental health areas of work is shown in the tables. Separate information is not collected on the number of primary care mental health workers employed in the national health service.
| Consultants in the psychiatry group | |
|---|---|
| Total | 3,229 |
| Whole-time | 2,321 |
| Maximum part-time | 66 |
| Part-time | 643 |
| Honorary | 199 |
| All specified mental health nurses(73) | |
|---|---|
| Total | 53,678 |
| Full-time | 39,497 |
| Part-time | 8,889 |
| Unknown | 5,292 |
(73) Includes nurses employed in learning disabilities, community learning disabilities, psychiatry and community psychiatry areas of work
Source:
Department of Health Medical and Dental Workforce census
Department of Health Non-Medical Workforce census
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