§ Mr. GodsiffTo ask the Secretary of State for Health what approach her Department has made to Upjohn, the manufacturer of depo-medrone, to request it to vary the provisions of the licence so as to include epidural use; and if she will publish the details of discussions and correspondence that have taken place between her Department and Upjohn.
§ Mr. SackvilleNo such approach has been made to Upjohn. The present product licence for depo-medrone does not recommend the use of the product by the epidural route. The company holding the licence for the product would be required to provide the necessary supporting information to the Medicines Control Agency to support any changes to the licence. Correspondence between companies and the Medicines Control Agency regarding product licences are commercially confidential.
§ Mr. GodsiffTo ask the Secretary of State for Health (1) what assessment she has made of the frequency with which(a) depo-medrone and (b) other drugs are used for purposes for which they are not licensed;
(2) what is her Department's policy regarding the use of (a) depo-medrone or (b) other drugs for purposes which are not licensed.
§ Mr. SackvilleInformation regarding the use of medicines in an unlicensed manner is not available centrally since doctors are not obliged to report such usage. In accordance with the exemption in section 9 of the Medicines Act 1968, if a doctor believes that the use of an unlicensed medicine, or use of a licensed medicine in a manner which is not specified in the product licence is appropriate for a patient, he or she may administer it on their own responsibility. They may also seek advice from relevant professional bodies, but it is for doctors to use their training, knowledge and experience to weigh carefully the likely benefits of a medicine against the anticipated risks before choosing the most appropriate treatment for a particular patient. It is also for doctors to discuss the risks and alternatives of any proposed treatment and to obtain the patient's consent before administering it.
§ Mr. GodsiffTo ask the Secretary of State for Health what was the outcome of discussions between departmental officials and relevant medical professional bodies concerning current clinical practice referred to in her answer to the hon. Member for Sheffield, Brightside (Mr. Blunkett), on 21 October 1993,Official Report, columns 315–16; and what specific advice her Department has issued to doctors on this issue.
§ Mr. SackvilleI refer the hon. Member to the reply I gave the hon. Member for Hartlepool (Mr. Mandelson) and to the hon. Member for Sheffield, Brightside (Mr.32W Blunkett) on 2 March 1994, column 757. We have decided that no further guidance on depo-medrone is needed at present.
§ Mr. GodsiffTo ask the Secretary of State for Health what assessment has been made of the use of polyethylene glycol as one of the constituent parts of depo-medrone.
§ Mr. SackvillePolyethylene glycols of various molecular weights and grades have been used extensively in the pharmaceutical industry, as solvents, vehicles and solubilising agents. Depo-medrone is a licensed medicinal product. A product licence is granted only after the careful consideration of evidence to demonstrate to the licensing authority that the product is safe, efficacious and of satisfactory quality for the indications and routes of administration intended. The assessment includes not just the active drug substance but an assessment of the whole formulation of the product, in the context of the terms of the licence. This includes the safety of any excipients such as polyethylene glycol.