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28 Jan 2003 : Column 808W—continued
Hospital Shift Patterns
Mr. Norman: To ask the Secretary of State for Health what assessment he has made of the impact of shift patterns of working in acute hospitals on (a) continuity of patient care and (b) overall quality of patient care. [92108]
Mr. Hutton: The majority of health professionals have always worked on shift patterns. The main exception has been the provision of resident out of hours medical cover, which has been largely provided by doctors in training. The most common arrangement is for these doctors to work a 'resident on call' where the doctor is resident on hospital premises for the full 24 hour period but only deemed to be working when actually called.
With the extension of the European Working Time Directive (EWTD) to doctors in training from August 2004, current resident on call working patterns are unlikely to represent the best use of available resources. Doctors providing out of hours cover will generally have to either move on to some form of shift pattern or provide cover through non-resident on call working.
The Department recognises the need to introduce these changes to working patterns in a way that maintains or improves the continuity and quality of patient care. To this end guidance on the implementation of EWTD for Doctors in Training has
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been issued (HSC 2003–001) and the Department is funding a programme of pilot projects to test a range of solutions. These pilots will be rigorously evaluated to ensure that standards of patient care have been maintained or improved. The key to continuity of care is the implementation of effective shift hand-over arrangements and good record keeping and this will also be evaluated in the pilot programme.
Hyperactivity
Mr. Burstow: To ask the Secretary of State for Health what training is provided within the health and social services system on attention deficit hyperactivity for workers with personal contact with sufferers. [93163]
Jacqui Smith: In recent years, the Department has supported a number of initiatives taken by professional bodies and other agencies to raise awareness of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) and to facilitate accurate diagnosis and appropriate treatment. These include an evidence-based briefing for clinicians on the use of stimulant medication (1999) and fact-sheets for parents, teachers and young people on attention deficit problems and hyperactivity, both produced by the Royal College of Psychiatrists.
We have also collaborated with the Department for Education and Skills in issuing guidance for teachers on promoting children's mental health, including attention deficit/hyperactivity, within early years and school settings, in 2001. The Department has also grant-aided the ADHD UK Alliance, an organisation which helps to co-ordinate voluntary sector activity and development work in this field.
In general the content of professional training is a matter for the relevant professional bodies. However the Department's requirements for social work training from September 2003 will include elements covering child development and mental health and communication skills with children.
Irwell Mill, Bacup
Janet Anderson: To ask the Secretary of State for Health what the cost is of the proposed development by the Burnley, Pendle and Rossendale primary care trust on the site of Irwell Mill, Rochdale Road, Bacup; who will be responsible for the demolition and at what cost; and what payments in connection with the purchase of this site will be made to Stylegleam Ltd. [91935]
Jacqui Smith: The Burnley, Pendle and Rossendale primary care trust will be the owners of Irwell Mill in the very near future. The site was purchased at an auction, at an overall purchase price of £36,500. £14,500 was paid to the part owners, who are not Stylegleam Ltd., but may be associated with them. The purchases have been agreed by the district valuer.
Most of the mill will be demolished, with the Burnley borough council acting as the agents. The Regional Development Agency is funding the demolition work as part of its contribution to the regeneration of the town. A grant of £292,880 has been made available for this purpose.
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From September 2003, the site will be transferred into a new public/private company. The primary care trust will have to repay any betterment value to the Regional Development Agency. This is likely to be in the region of £60,000. Any payments to the Regional Development Agency will be paid out of enabling monies, which have been made available to the East Lancashire local investment finance trust project. Thus, the cost of the acquisition and demolition to the primary care trust will be nil.
Once the site has been transferred into the public/private company, the latter will construct a new health centre on the site, estimated at £4.087 million including equipment, to provide health care facilities to national standards.
Kava-kava
Chris Grayling: To ask the Secretary of State for Health (1) what health risks have led to the decision to ban Kava-kava; and how many incidences of health-related problems arising from such risks there have been in each of the past 10 years; [91484]
- (2) how many deaths in the past 10 years in the UK have been attributed to consumption of Kava-kava; [91482]
(3) how many medical products containing Kava-kava are licensed; [91481]
(4) how the Medicines Control Agency determines what is an acceptable level of risk for the voluntary consumption of a medical product; [91470]
(5) what recent discussions he has had with other countries about safety issues related to Kava-kava; and how many have also banned products containing Kava-kava. [91483]
Ms Blears: In the United Kingdom, there are three licensed products containing the herbal ingredient Kava-kava (Piper methysticum). The majority of medicinal products containing Kava-kava sold in the UK are unlicensed and are exempt from licensing under section 12 of the Medicines Act 1968.
Evidence has emerged that consumption of medicinal products containing Kava-kava may be associated with liver toxicity in rare cases. To date, 70 cases of liver damage, suspected to be associated with the consumption of Kava-kava, have been reported worldwide. The case reports originate from Switzerland, Germany, Australia, Canada, France, the United States and four from the UK.
The severity of the liver damage suffered varies widely. Suspected adverse reactions include abnormal liver enzyme activity, jaundice, hepatitis and liver failure. In seven cases the patients suffered irreversible liver failure and received liver transplants. Four patients have died, including two of the patients who received liver transplants. None of the UK cases were associated with a fatal outcome.
The following table provides a breakdown of the number of cases of suspected liver damage associated with Kava-kava submitted to regulatory authorities in the last 10 years.
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| Year reaction reported | Number of cases of hepatotoxicity |
|---|---|
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 0 |
| 1996 | 0 |
| 1997 | 1 |
| 1998 | 4 |
| 1999 | 4 |
| 2000 | 10 |
| 2001 | 22 |
| 2002 | 11 |
In addition the Medicines Control Agency (MCA) received 13 case reports of hepatotoxicity associated with Kava-kava in 2002 from regulatory authorities world wide, where the date of the adverse reaction or received date were not specified.
A report of a suspected adverse reaction does not necessarily mean that it was caused by the herbal medicine. The number of reports received cannot be used as a basis for determining the incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the herbal medicine is known. Herbal medicines are often supplied without prescription and are taken without advice from doctors or pharmacists. It is generally recognised that the reporting rate for medicines supplied over the counter is lower than that of suspected adverse reactions associated with prescription medicines. Therefore, data obtained on suspected adverse reactions associated with herbal medicines through the Yellow Card Scheme cannot be directly compared to reporting for licensed pharmaceutical medicines.
The acceptable level of risk for a medicine will depend on the seriousness of the disease it is being used to treat and its efficacy in treating that disease as well as the availability of alternatives. A risk of an adverse effect that would be acceptable for a life saving treatment such as an anti-cancer medicine would not necessarily be acceptable in a treatment for a non-serious or self-limiting condition.
Each safety issue is considered on a case by case basis. In the case of Kava-kava the limited evidence of efficacy, the unpredictable and serious nature of the adverse reactions, the difficulty in regularly monitoring liver function without medical supervision and the lack of regulatory powers to require label warnings for unlicensed medicines were taken in to account.
The safety of Kava-kava has been discussed with European member states via the pharmacovigilance working party of the Committee for Proprietary Medicinal Products. The MCA has in addition communicated with the regulatory authorities of the USA, Australia and Canada. Other European member states have revoked or suspended the licences and Australia and Canada have initiated recalls of all products containing Kava-kava.
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