§ Mr. BlunkettTo ask the Secretary of State for Health (1) whether the patient information leaflets proposed by her Department will include information relating to appropriate and inappropriate techniques for administering the medicine concerned;
(2) what steps she intends to take to ensure awareness of, and access to, patient information leaflets relating to medicines used within the national health service;
(3) what is the planned time scale for the introduction of patient information leaflets about medicines used within the national health service.
§ Mr. SackvilleUnless all the required information is on the product label, an approved patient information leaflet is required for a new product granted a marketing authorisation on or after 1 January 1994 and for an existing medicine where its marketing authorisation is renewed.
The patient leaflet is to be supplied with the medicine when it is dispensed to the patient. Patient information leaflets provide information on how the medicine should be used including the indication, dose instructions, precautions, warnings and side-effects. Doctors and pharmacists have been informed about the introduction of patient information leaflets in the November issue of "Current Problems in Pharmacovigilance".