§ Mr. Greville Jannerasked the Secretary of State for Social Services if she will make a statement concerning the Medicine Commission's report "Presentation of Medicines in Relation to Child Safety."
§ Dr. OwenAs I told my hon. and learned Friend during the Adjournment debate in the House on 18th March 1974—[Vol. 870, c. 815–22.]—the Government were concerned about the number of children admitted to hospital from suspected poisoning from medicines—averaging for children under five 16,000 a year over the previous four years, though the number of deaths from this cause fortunately was no more than six per million of children under five—and I said that I was prepared to examine anything that could reduce the risk of accidental poisoning.
326WOn 8th August 1974 I announced, on behalf of all Health Ministers, that the Government had initiated urgent consultations with a wide range of professional and trade associations and consumer interests about the recommendations in a report from the Medicines Commission on the Presentation of Medical Products in relation to Child Safety, the main recommendation being the need to introduce as soon as practicable unit packaging for medicines containing specified ingredients.
The comments received on the commission's report claim that it would take at least two or three years from now to extend the use of suitable unit packaging to all medicines containing ingredients in the commission's priority list. The necessary packaging machinery would have to be obtained from abroad and installed, and time allowed so that output is not interrupted.
Some firms in Britain already have manufacturing capacity for reclosable containers that are claimed to have passed the American test, or the test proposed in the British Standards Institution draft for development for reclosable containers. In the United States as reclosable containers of limited size have come into wider use for aspirin there appears to have been a reduction in the incidence of suspected poisoning of young children attributed to this product; but other factors, such as the publicity campaigns that also took place, may also have contributed to this result.
In these circumstances the Government think it right to introduce limited measures that can be put into effect without waiting for two or three years to implement the full range of the commission's recommendations and will encourage appropriate types of reclosable containers to be used.
Discussions are being initiated with the British Standards Institution with regard to a modification in relation to the test for reclosable containers, and the possibility of designing suitable specifications or tests for materials for unit packaging, and how soon these could be published.
The representatives of the pharmaceutical profession and of dispensing doctors are being consulted on the implications for them of introducing a requirement to use dark tinted child-resistant 327W containers when dispensing for children preparations of aspirin and paracetamol which are not in unit packaging. 'This could be done either through regulations under the Medicines Act 1968 or, in addition to such regulations, by amending National Health Service terms of service for the provision of pharmaceutical services, together with guidance to health authorities in relation to hospital out-patients.
Urgent steps will be taken by means of statutory instruments under the Medicines Act 1968 to secure that, if possible by 1st January 1976, the preparations of aspirin and paracetamol for children, which the commission's report indicated as the product mainly giving rise to suspected poisoning of young children, shall be sold in suitable opaque or dark tinted unit packaging or in child-resistant reclosable containers that meet the requirements of the British Standards Institution draft for development modified to reduce the extent of testing by young children. Such preparations specially promoted for children should be put up for retail sale with not more than 25 tablets per pack or container and with a maximum ingredient strength of 90 milligrams for aspirin and 150 milligrams for paracetamol. The firms holding product licences for these products are being approached to see whether this result can be achieved earlier. In fact some brands are already in unit packaging. The incidence of suspected poisoning from these products is, however, not so great as to justify the withdrawal of existing stocks from wholesalers or retail outlets.
So far as other medicinal products are concerned, it is proposed subject to consultation to secure by means of statutory instruments under the Medicines Act that by 1st January 1977 all tablets, capsules and pills containing aspirin—except effervescent tablets containing not more than 25 per cent. aspirin—or paracetamol, and, as soon as possible thereafter, those containing tricyclic anti-depressant drugs, barbiturates, and phenothiazine derivatives, and such preparations of iron salts containing more than 24 milligrams of
328W
Authority Places in Local Authority day nurseries per 1,000 population under 5 Permitted number of children in registered premises per 1,000 population under 5 Places in Local Authority day nurseries and permitted number of children per 1,000 population under 5 Cheshire … 6.1 1.9 8.0 Cumberland … — 1.9 1.9 Lancashire … 13.1 1.8 14.9 Westmorland … — 5.9 5.9 elemental iron per dosage-unit, shall, subject to some exceptions, be sold or supplied only in opaque or dark tinted child-resistant reclosable containers that meet the modified requirements of the British Standards Institution draft for development, or else in opaque or dark tinted unit packaging made of materials that meet the appropriate specification or test. To meet the exceptional cases provision would be made for supplying conventional containers to adults who would experience difficulty with the special types of packaging.
The representatives of the pharmaceutical profession and of dispensing doctors, as well as being consulted on this proposal, are also being invited to commend the use of child-resistant reclosable containers for dispensed medicines on the priority list on a voluntary basis as soon as possible, subject to agreement on the detailed arrangements to be discussed with them.
The Health Education Council has already sponsored together with the Proprietory Association of Great Britain a publicity campaign to bring home to the public the importance of keeping medicines safely.