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Mlx 291

Volume 404: debated on Wednesday 30 April 2003

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To ask the Secretary of State for Health (1) what research his Department has undertaken on the implementation of MLX 291 by the Medicines Control Agency and its effect on (a) morbidity and (b) mortality in patient groups; and if he will make a statement; [109529](2) what assessment he has made of the possibility of MLX 291 causing medicines to be decanted into unsuitable containers, with particular reference to those more easily accessible to children; and if he will make a statement; [109531](3) what representations he has received on MLX 291; and if he will make a statement. [109530]

Consultation letter MLX 291 contained proposals to introduce new regulations relating to paracetamol, aspirin and iron supplements in order to take account of the British Standard on Child Resistant Packaging for non reclosable packaging for pharmaceuticals—BS 8404. It also proposed that medicines containing more than 24mg of elemental iron per unit does as well as liquid paracetamol preparations will also, for the first time, i.e. current requirements applying to reclosable containers of solid dosage and paracetamol.The proposals contained in MLX 291 were based on advice from the Committee on Safety of Medicines (CSM) which considered published data from Hospital Episode Statistics (HES) for England and Wales and from Hospital Accident Surveillance System (HASS) data, from the Department of Trade and Industry's (DTIs) consumer safety unit. The aim of the amended legislation is to reduce or prevent toxicity from accidental drug overdose in children, which results in nearly 150 hospital admissions per week.The existing requirements for child resistant packaging in the Medicines (Child Safety) Regulations 1975 (as amended) already contain a provision to allow patients to receive these medicines in a container which is not child resistant, if they wish to do so and make a specific request to a pharmacist or doctor to that effect. The proposed new regulations include an extended adult test on accessibility for those up to 75 years rather than 60 years of age under the old standard. There is currently no proposal to remove the existing provision to dispose these medicines in non child resistant containers given the many and various ways in which elderly patients now receive their medication, including home delivery from the pharmacy.

The public consultation on the proposals started on 26 November and closed on 18 February 2003. A large number of responses have been received and the Medicines Commission will be consulted shortly. Once this process is complete, in accordance with the terms of the Code of Practice on Access to Government Information, the Agency intends to make copies of replies received publicly available.