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14 Dec 2006 : Column 1369Wcontinued
Anne Main: To ask the Secretary of State for Health how many drugs have (a) been identified as hazardous and (b) required regulatory action as a result of the Yellow Card reporting scheme in each of the last six years; and if she will make a statement. [102597]
Andy Burnham: Adverse drug reaction (ADR) data from the United Kingdom spontaneous reporting scheme, the Yellow Card Scheme, underpins the process of pharmacovigilance in the UK. Pharmacovigilance systems do not rely solely on ADR reporting via the Yellow Card Scheme. The other data sources regularly used in the monitoring of drug safety in the UK include formal safety studies, the published medical literature, information from pharmaceutical companies and other regulatory authorities throughout the world together with information on the level of drug prescribing. There is also an international database of around 1.5 million ADR reports operated by the World Health Organization to which the MHRA has on line access. In addition, as laid down in European Community legislation, the regulatory authorities of the European member states exchange information and work closely together on drug safety matters.
The value of spontaneous reporting schemes like the Yellow Card Scheme is in the early detection of possible drug safety hazards, (signals). Once a hypothesis has been generated that a particular medicine is associated with an adverse effect other methods are used to confirm and quantify the risk before regulatory action is taken. The objective of regulatory action is to ensure that the benefits of the medicine continue to outweigh risks, by restricting indications for use, adding contraindications, warnings or precautions, or additional information about adverse effects. Only when risk minimisation measures are considered unlikely to be effective in maintaining a positive benefit risk balance is withdrawal from the market necessary.
The table identifies for the last six years, the number of medicines that were withdrawn from the market in the UK, the number of letters sent to healthcare professionals in England to advise on drug safety issues and the number of changes (variations) to individual national marketing authorisations (MAs) requested by MHRA for safety reasons linked to pharmacovigilance activity.
The number of medicines withdrawn from the market in the UK, the number of letters issued to healthcare professionals in England and the number of changes (variations) to individual national marketing authorisations (MAs) requested by MHRA for safety reasons
Number of medicines withdrawn from the market in the UK for safety reasons | Number of healthcare professional letters issued in England about drug safety issues | Number of changes (variations) to individual national MAs requested by MHRA for safety reasons (rounded figures) | |
Sarah Teather: To ask the Secretary of State for Education and Skills (1) how much the United Learning Trust has (a) pledged and (b) paid to each of the academies that it sponsors; [107604]
(2) how much each of the operational city academies (a) was pledged and (b) has received from its sponsor. [107606]
Jim Knight: The following table shows, for each academy open at September 2006: the sponsor; the total amount of capital sponsorship due to that academy based on its funding agreement; the amount paid to the end of the 2004/05 academic year as recorded in the audited accounts, and the expected sponsor contributions to the end of November 2006 based on the profile set out in funding agreements. Accounts for the 2005/06 academic year are not yet available. For some recently opened academies, sponsorship funds are not yet due.
The Department does not hold records of sponsorship actually paid to academy trusts, including sponsorship not given for capital purposes. The table identifies United Learning Trust (ULT) academies separately, and in addition a footnote to the table identifies the expected sponsorship level for three further ULT-sponsored academies which are not yet open.
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