§ 42. Mr. Carter-Jonesasked the Secretary of State for Social Services, if he will publish in the Official Report the reply to the letter from the hon. Member for Eccles to the Minister for Health regarding the monitoring of drugs.
§ Dr. VaughanThe text of my reply to the hon. Member is as follows
Thank you for your letter of 20 June about the investigations which you and your researchers have carried out regarding adverse reactions to the injectable contraceptive Depo-Provera.You have given no particulars of the suspected adverse effects reported to you and I cannot therefore make any comment on them. The Committee on Safety of Medicines welcomes any additional clinical data on suspected adverse reactions to this drug. I would be pleased to receive any data which you may have in the form of yellow card reports from the doctors of the patients concerned—if the doctors consider that such a report would be appropriate. Any such reports would, of course, be treated as strictly confidential.At present I feel there is no reason to justify my taking any action which would have the effect of restricting the freedom of doctors to prescribe Depo-Provera for the limited short term indications for which it is currently licensed. An application for a licence for its use as a long term contraceptive is, as you know, currently being considered by the CSM and I cannot therefore comment on this at the moment.Turning to the CSM's present monitoring system I am totally unable to accept your suggestion that the system is "slipshod, unprofessional and unscientific". On the contrary it is amongst the best systems in the world and some would say the best. I am well aware, as is the CSM, that improvements to the present system are desirable. It is well known that only a minority of all 488W suspected adverse reactions to drugs are reported to the CSM. The number of reports however received from all sources including yellow cards, amounting to 10–12,000 per year, are regarded as adequate to enable many potentially serious problems with drugs to be identified and investigated in greater depth.But I am not complacent about this country's drug monitoring system. The Department and the CSM itself are constantly seeking ways of improving the level of reporting and the efficiency of the analysis of the data obtained. Moreover, a variety of proposals are currently being considered including pilot studies for two schemes, Retrospective Assessment of Drug Safety and RADS and Record Linkage, put forward by the CSM. It must be remembered, however, that drug monitoring is an important and complex subject with very substantial resource implications and it is essential that any proposals are given very careful thought to ensure that the methods adopted provide the best value for money. I will, however, make a statement on this matter as soon as possible.
§ Mr. Mike Thomasasked the Secretary of State for Social Services what response he proposes to make to the Committee on Safety of Medicines' proposals, of December 1979, to improve post-marketing surveillance of licensed drugs.
§ 40. Mr. Ashleyasked the Secretary of State for Social Services if he will make a statement on the progress that has been made with the establishment of a system for the post-marketing surveillance of drugs.
§ Dr. VaughanVarious proposals for improving the present methods of post-marketing surveillance, including those suggested by the Committee on Safety of Medicines and known respectively as retrospective assessment of drug safety and record linkage, are currently under consideration. This is an important and complex matter, with substantial resource implications, which requires very careful thought to ensure that the return from any scheme that may be introduced would justify the resources employed. As my hon. Friend indicated in the House on 23 April, a statement will be made as soon as possible.—[Vol. 984, c. 673–74]
§ Mr. Mike Thomasasked the Secretary of State for Social Services if he will list in the Official Report all drugs having product licences or licences of right which contain as their sole therapeutically active ingredient diazepam, and in each case 489W the name of the company holding the product licence.
Product name Number of licences* Company Atensine Tablets … … … 2 Berk Pharmaceuticals Ltd. C-PAK Diazepam Tablets … … 3 Sterling Winthrop Group Ltd. Diazepam Capsules and Tablets … 4 Regent Laboratories Ltd. Diazepam Tablets and Syrup … 4 Arthur H. Cox and Co. Ltd. Diazepam Tablets … … … 2 Approved Prescription Services Ltd. Diazepam Tablets … … … 3 DDSA Pharmaceuticals Ltd. Diazepam Tablets … … … 3 Evans Medical Ltd. Diazepam Tablets … … … 3 Harris Pharmaceuticals Ltd. Diazepam Tablets … … … 3 Thomas Kerfoot and Co. Ltd. Diazepam Tablets … … … 3 Laporte Industries Ltd. Diazepam Tablets … … … 3 MA Steinhard Ltd. Diazepam Tablets … … … 2 UAC International Ltd. Diazepam Tablets … … … 2 G. O. Woodward and Co. Ltd. Evacalm Tablets … … … 2 Unimed Pharmaceuticals Ltd. Sedapam Tablets … … … 3 Duncan Flockhart and Co. Ltd. Solis Capsules … … … 3 Galen Ltd. Tensium Tablets … … … 1 DDSA Pharmaceuticals Ltd. Valium Roche (Capsules, Ampoule Syrup and Tablets). 8 Roche Products Ltd. * Separate licences are held for different dosage strengths.