HC Deb 26 June 1980 vol 987 cc273-4W
Mr. Mike Thomas

asked the Secretary of State for Social Services what steps he is taking to ensure that the revised British national formulary will provide prescribers with clear information as to the comparative costs of different brands of the same drug.

Dr. Vaughan

The British national formulary is an independent publication: but I understand that the revised version, which is expected to be published early next year, will indicate the relative prices of preparations.

Mrs. Renée Short

asked the Secretary of State for Social Services (1) how often in the past three years the Committee on Safety of Medicines has refused a licence for a drug because it was dissatisfied with the information contained in the data sheet of the manufacturer;

(2) if the Committee on Safety of Medicines will make routine checks on the information contained in the data sheets issued by drug manufacturers about their products to ensure that the information is accurate and up to date;

(3) if the Committee on Safety of Medicines will as a matter of urgency review the data sheets issued by drug manufacturers about their products in order to ensure that there is complete, accurate and up-to-date information contained in them about drug over-dosage.

Dr. Vaughan

[pursuant to his reply, 19 June 1980, c. 638]: Although the granting of a number of product licences has had to be delayed until the required entry has been made in the relevant data sheet, I am not aware of any case in which ultimately a licence has been refused.

In so far as the Medicines (Data Sheet) Regulations 1972 require data sheets to contain a reference to the action to be taken in the event of an overdose, I will arrange for product licence holders to be reminded of the need for suitable up-to-date entries to meet this requirement.

I will ensure also that attention is paid to the subject of treatment of overdose when considering new applications arising from the work of the Committee on Safety of Medicines, and from the review of products by the Committee on the Review of Medicines.