§ Mr. Llew SmithTo ask the Secretary of State for Health what research has been(a) conducted and (b) commissioned by his Department into the children in respect of whom yellow cards have been issued. [61621]
§ Ms JowellThe Medicines Control Agency is funding, jointly with the National Health Service, Executive Trent, a pilot project for the reporting of suspected adverse drug reactions in children, entailing the establishment of a research unit at Derbyshire Children's Hospital run by Professor Imti Choonara of the University of Nottingham. The objectives of the project are to stimulate reporting of suspected adverse drug reactions occurring in children in the Trent region to the Medicines Control Agency and Committee on Safety of Medicines, to identify and investigate possible signals of new adverse drug reactions occurring in children and to determine the value of extending the scheme to other regions or nationally. The centre commenced work in September 1998 and will report on its progress in mid–1999.
The current processes undertaken by the Medicines Control Agency for the evaluation of reports on yellow cards involve the identification and investigation of patterns suggesting new safety concerns, so that suitable steps can be taken to make sure that medicines are used as safely as possible.
§ Mr. Llew SmithTo ask the Secretary of State for Health what guidance his Department issues to GPs on informing people of potential side-effects of the use of MR or MMR vaccinations. [61610]
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§ Ms JowellA doctor must decide what information to pass on to a patient about the possible adverse reactions to any drug, including vaccines, and we would expect them to pass on all the relevant information to each patient. Full details of the contraindications to vaccination and the adverse reactions associated with measles, mumps and rubella (MMR) vaccine are set out in the United Kingdom Health Departments' memorandum "Immunisation against Infectious Disease" which is issued to doctors. The chapter on MMR states
Parents should be told about possible symptoms after immunisation".In addition, the Health Education Authority (HEA) produces a range of leaflets on immunisation, which give information on possible side effects. Details of possible adverse reactions to MMR vaccine are included in the leaflet "A Guide to Childhood Immunisations", which is given to new parents, and in the leaflet "Immunisation for School Leavers". The HEA also produces a range of factsheets, including two on MMR, to assist healthcare professionals in responding to more detailed queries from parents.
Measles/rubella (MR) vaccine was used during the 1994 immunisation campaign. During the campaign all parents received an information leaflet/consent form and parents who were worried were advised to talk to their family doctor or school nurse. A letter from the Chief Medical and Nursing Officers, information and question and answer sheets were issued to all doctors and nurses either involved in giving the vaccine or in giving information on the campaign.
§ Mr. Llew SmithTo ask the Secretary of State for Health what guidance his Department has issued to GPs on conducting follow-up inquiries after the reporting of adverse health reactions on a yellow card. [61611]
§ Ms JowellOn receipt of a yellow card, the Medicines Control Agency (MCA) sends out a letter to each reporter which reminds them to forward any further relevant information when available. Each yellow card report of a suspected adverse drug reaction is evaluated by the MCA. Where the information provided on a report is insufficient, the reporter is contacted for further details.
257WReporters can at the time of reporting request an overview of the adverse reactions already reported in association with the suspect drug and this may stimulate the doctor to provide further information.