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2 Mar 2006 : Column 919W—continued


Mr. Sanders: To ask the Secretary of State for Health how many incidents involving incorrect insulin doses have occurred in hospitals in each of the last five years; and how many resulted in the death of a patient. [49107]

Ms Rosie Winterton: We do not collect data on the number of incidents involving incorrect insulin doses in hospitals. However, we do collect data on accidental overdose of insulin in general, irrespective of where the event occurred. The two events on which data are collected are: poisoning by insulin and oral hypoglycaemic drugs and insulin and oral hypoglycaemic drugs causing adverse effects in therapeutic use, which is shown in the table.
All diagnosis count of finished consultant episodes for selected diagnoses national health service hospitals, England 2000–01 to 2004–05Discharge Method

DeathLiveN/A—patient still in hospitalNot knownTotal

All diagnoses count of episodes—these figures represent a count of all finished consultant episode's (FCE) where the diagnosis was mentioned in any of the 14 (seven prior to 2002–03) diagnosis fields in a Hospital Episodes Statistics (HES) record.
Finished consultant episodes—an FCE is defined as a period of admitted patient care under one consultation with one health care provider. Please note that these figures do not represent the number of patients, as a person may have more than one episode of care within the year.
Deaths—HES data cannot be used to determine the cause of death of a patient while in hospital. Deaths recorded on the HES database may be analysed by the main diagnosis for which the patient was being treated during their stay in hospital, which may not necessarily be the underlying cause of death. For example, consider a patient admitted for a hernia operation (with a primary diagnosis of hernia), but who died from a heart attack. The Office for National Statistics (ONS) collect information on the cause of death, wherever it occurs, based on the death certificate and should be the source of data for analyses on cause of death.
Diagnosis (primary diagnosis)—the primary diagnosis is the first of up to 14 (seven prior to 2002–03) diagnosis fields in the HES data set and provides the main reason why the patient was in hospital.
Secondary diagnosis—as well as the primary diagnosis, there are up to 13 (six prior to 2002–03) secondary diagnosis fields in HES that show other diagnosis relevant to the episode of care.
Selected diagnosis—T383: Insulin and oral hypoglycaemic (anti-diabetic) drug and Y423: Insulin and oral hypoglycaemic (anti-diabetic) drug
Grossing—Figures are grossed for both coverage and missing or invalid clinical data, except for 2003–04 and 2004–05, which is not yet adjusted for shortfalls.
Hospital Episode Statistics (HES), NHS Health and Social Care Information Centre

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Involuntary Automaticity

Steve Webb: To ask the Secretary of State for Health what assessment her Department has made of the part played by involuntary automaticity on adverse incidents in the health care system; and if she will make a statement. [51905]

Jane Kennedy: We recognise the systemic nature of many health care errors and are aware that a number of factors including involuntary automaticity and unconscious behaviour can contribute to adverse incidents in the national health service.

The Department therefore welcomed the recent report following an independent review of a serious adverse radiotherapy incident that occurred at Cookridge hospital which highlighted circumstances where involuntary automaticity may be triggered. Following the publication of the report, the deputy chief medical officer met with the report's authors to discuss the specific circumstances leading to the incident together with the wider implications. In the light of that, we have facilitated debate about involuntary automaticity, including a discussion at the European Union patient safety summit in November 2005.

As yet, it is difficult to determine the proportion of adverse incidents where involuntary automaticity is a contributing factor. However, overcoming this and other factors is built into our patient safety agenda and the work of the National Patient Safety Agency (NPSA). For example, the NPSA's publication 'Right Patient, Right Care' included work on the bedside identity checking of patients receiving care.

Macmillan Nurses

Mr. Jenkins: To ask the Secretary of State for Health what measures she is taking to increase the numbers of Macmillan nurses working for the NHS in Staffordshire. [51223]

Ms Rosie Winterton: It is for trusts to decide how many nurses including palliative care nurse specialists, are employed in each specialty within hospitals. It is for local cancer networks working in partnership with primary care trusts, strategic health authorities and their workforce development directorates to assess, plan and review their workforce, education and training needs for all staff linked to the delivery of local and national priorities for cancer.
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Mammography Screening

Mr. Stewart Jackson: To ask the Secretary of State for Health what plans she has to increase the availability of mammography screening for younger women in (a) Peterborough and (b) Cambridgeshire. [54355]

Ms Rosie Winterton: Primary care trusts are responsible for commissioning health services to meet the needs of the local population.

The Forrest report, on which the national health service breast screening programme is based, recommended further research to assess the clinical and cost-effectiveness of screening women under 50. This research, the Age Trial", began in 1990 and is nearing completion; and full results are expected later in 2006.


Mrs. Maria Miller: To ask the Secretary of State for Health whether the targets for granting marketing authorisations detailed in the Medicines and Healthcare Products Regulatory Agency's business plan for 2005 are being met for over-the-counter medicines; and how many application files were open on the last date for which figures are available. [53024]

Jane Kennedy [holding answer 27 February 2006]: In the published business plan for the Medicines and Healthcare products Regulatory Agency (MHRA) for 2005–06, assessment time targets are given for various types of licensing work, including variations to licences and new licences based on abridged dossiers. Specific targets are not given for over-the-counter medicines because these would be included with the abridged dossier applications.

On 21 February 2006, there were 2,490 new product licence applications at various stages of assessment, of which 356 related to products potentially for over-the-counter supply.

I am aware that the MHRA's performance regarding licence and variation approval times during the last nine months has been affected by a combination of adverse factors, including increases in work load, difficulties in recruiting professional assessment staff, especially medically-qualified staff, and transitional implementation problems during the introduction of a new information management system. Though statistics for the full year 2005–06 are not yet available, it is likely that some of the target assessment times given in the plan will not be met.

The MHRA is taking a number of steps to improve service levels. These include organisational restructuring, additional recruitment, re-training of staff, voluntary schemes for extended working hours, and information system performance enhancements.

Mrs. Maria Miller: To ask the Secretary of State for Health how much time was taken on average to grant applications for marketing authorisation for (a) new, (b) abridged and (c) variations of over-the-counter medicines, from initial receipt of the application to its final approval in the last period for which figures are available. [53090]

Jane Kennedy [holding answer 27 February 2006]: The most recent full-year figures for new medicines approval times by the Medicines and Healthcare
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products Regulatory Agency (MHRA) are for 2004–05. These show an average approval time, from receipt of the application to grant of the licence, of 288 calendar days. This period, however, includes the time taken by applicants to supply any necessary new or correcting information following the initial assessment of their application. When this is taken into account the actual number of net working days taken by the MHRA reduces to an average of 122 days. These figures apply to all types of new product licensing including products for over-the-counter (OTC) supply.

For the relatively small number of completely new medicines, for example, those containing new drugs and with the potential for meeting unmet medical needs in major diseases, the MHRA, during the same period, has maintained its record of assessing these in under 40 days.

For variations to OTC product licences, whether straightforward or complex, and again in the most recent full year for which figures are available, 2004–05, the average time taken to approve, from receipt of the application to grant of the variation, was 58 calendar days. This includes the time taken waiting for the company to provide any further information needed.

Mrs. Maria Miller: To ask the Secretary of State for Health when she expects the Better Regulation of Over-the-Counter Medicines Initiative to make its recommendations; and if she will make a statement; [53197]

Steve Webb: To ask the Secretary of State for Health what progress is being made on the Better Regulation of Over-the-Counter Medicines Initiative; and if she will make a statement. [53759]

Jane Kennedy [holding answer 27 February 2006]: The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to developing regulation which is proportionate, accountable, consistent, transparent and targeted and is considering how unnecessary regulatory burdens, primarily in relation to over the counter (OTC) medicines, could be eased.

To take this important initiative forward the MHRA is leading the better regulation of OTC medicines initiative (BROMI)—a broad ranging strategy group, which includes representatives from the Proprietary Association of Great Britain (PAGB), the non-proprietary sector, the National Pharmacy Association (NPA), and wider Government.

The group first met in December 2005 at which the terms of reference were agreed and a work plan developed. The group is considering a range of options for easing unnecessary regulatory burdens in relation to OTC medicines and I have asked that BROMI delivers its first proposals to simplify regulatory burdens for OTC medicines in April 2006.

Mrs. Maria Miller: To ask the Secretary of State for Health what mechanisms the Medicines and Healthcare products Regulatory Agency (MHRA) uses to ensure that deadlines for the granting of marketing authorisations for medicines are being met; and what mechanisms are in place to ensure the MHRA assessors are held to account. [53616]

Jane Kennedy [holding answer 27 February 2006]: The Medicines and Healthcare products Regulatory Agency (MHRA) uses a number of information technology (IT)
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system and staff management mechanisms to monitor the progress and completion of marketing authorisation applications. These include the automatic system flagging of applications when critical dates are due and weekly status checks by the assessment managers. In addition, applications processed through European approval procedures are monitored using a Eudranet IT system which links all of the European Community medicines regulatory agencies.

The accountability for ensuring that licensing deadlines are met is shared between MHRA managers and assessors. The quality, quantity and timeliness of work completed are among the primary measures of their individual performance management.

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