§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the Committee on Safety of Medicines is satisfied with the estimated level of adverse reactions that are reported through the yellow card system; and whether any steps have been or are being taken to encourage a higher level of reporting;
(2) if he is satisfied that communications from the Committee on Safety of Medicines are receiving the full attention of most doctors; whether discussions on methods of improving communications are still taking place; and whether past discussions led to any change in procedure;
(3) what steps the Committee on Safety of Medicines takes to validate reports of suspected adverse reactions made through the yellow card system; what percentage of reports is further investigated by interview or by letter to the reporting physician; and what are the criteria for further investigation;
(4) if he is satisfied with the feedback of information on suspected adverse reactions reported by doctors to the Committee on Safety of Medicines; and if there is any evidence that prompt and comprehensive feedback of information leads to an increased motivation to report;
(5) what evidence he has that doctors are more likely to report a suspected adverse reaction to a drug to the drug company than to the Committee on 187W Safety of Medicines; and if it is mandatory for all reports from doctors to drug companies to be passed on the Committee on Safety of Medicines.
§ Dr. VaughanThe Department and the Committee on Safety of Medicines (CSM) are constantly seeking ways of improving the monitoring of adverse reactions to medicinal products, including the level of reporting. While the present level enables possible causal relationships between reported adverse reactions and drugs to be considered, I am aware, as is the CSM that this is an area in which improvement is always desirable and consideration is being given currently to the possibility of stimulating an increase in the level of reporting.
There is some evidence to suggest that a combination of reminders to doctors to report and of feedback to those who submit reports does increase the level of reporting of adverse reactions. (The level has increased from 2,824 per annum in 1970 to over 8,000 in 1977 and 1978.) For this reason, information on reported adverse reactions to particular drugs and groups of drugs is made available to members of the medical profession on request and doctors submitting a report are offered further data about the drugs they report on. Occasional publications, such as "Current Problems", also help to promote awareness of the importance of reporting and provide information on some of the drugs on which reports have been received.
I am satisfied that generally doctors do give proper attention to communications from the CSM, though I appreciate that in the past there was some evidence to suggest that busy doctors might overlook CSM material. Discussions took place in 1978 with a number of professional bodies and other organisations about proposals to minimise the difficulties but proposals to mark envelopes containing adverse reactions materials with a distinctive symbol were not pursued. No discussions are currently taking place with representative bodies on changes to the present procedures.
Pharmaceutical companies are legally required to notify the licensing authority of reports they receive from doctors of suspected adverse reactions to their products. These reports account for about 25 per cent. of the total known to the 188W CSM, a proportion which does not suggest that doctors are more likely to report suspected reactions to the company concerned than to the CSM.
All reports received by the CSM are studied and evaluated by the committee's professional advisers, who may seek further information from the reporting practitioner. This may be done by telephone, by correspondence, or by asking one of the committee's part-time medical officers in the field to visit the doctor concerned. The percentage number of reports investigated is not available; action is prompted, not in relation to set criteria, but by the clinical circumstances, which may relate to a previously unreported or serious reaction to a newly introduced drug, or to any situation in which further clinical information is considered desirable.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will give the number of medical products about which reports of suspected adverse reactions were received in (a) 1978 and (b) 1979; and for how many of these there has been no previous report of an adverse reaction;
(2) pursuant to his reply of 15 April to the right hon. Member for Stoke-on-Trent, South, how many of the 1,777 medical products about which 65,268 reports of suspected adverse reactions were received between January 1970 and March 1980 were referred by the professional secretariat of the Committee on Safety of Medicines to the sub-committee on adverse reactions for its attention; for how many of these 1,777 products (a) further investigation and (b) other action was required; and in what proportion of the cases requiring action was (i) the availability of the product restricted and (ii) warnings inserted in the product literature.
§ Dr. VaughanI regret that it is not possible to provide this information without disproportionate effort and cost.
§ Mr. Ashleyasked the Secretary of State for Social Services whether the recommendation of the Committee on the Review of Medicines, in its annual report for 1976, that on the data sheets which companies are legally required to provide for doctors there should be separate and distinct entries for contra indications, 189W precautions, warnings and adverse effects, has been included in any revised regulations for data sheets.
§ Dr. VaughanNo. The existing regulations already require that this information is included, but not the form in which it should appear. Consideration is continuing on a revision of the format and content of information that would be desirable and practical for inclusion on data sheets.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what consultations he has had on the record linkage method of post marketing surveillance of drugs;
(2) what is the estimated cost of a pilot study of the retrospective assessment of drugs safety plan as suggested by the Committee on Safety of Medicines, and approved by the General Medical Services Committee in April 1979;
(3) if he will give the reasons for the delay in carrying out a pilot study of the retrospective assessment of drugs safety plan which was suggested by the Committee on Safety of Medicines and approved by the General Medical Services Committee in April 1979; whether the delay is for financial reasons; or because of objections to the plan as a whole or to details of it; and if it is because of objections, if he will give the names of those organisations or bodies which are objecting.
§ Dr. VaughanI am currently considering a variety of measures to improve the methods of post marketing surveillance of drugs. These include proposals by the Committee on Safety of Medicines (CSM) to establish pilot studies to test the feasibility of two schemes known as retrospective assessment of drug safety (RADS) and record linkage. No consultations have taken place on RADS since those undertaken by the CSM in 1979. I have not, nor has the CSM, held any consultations on record linkage. Both pilot studies would have substantial financial and other resource implications though these are difficult to quantify. It is estimated, however, that a pilot study of RADS might cost up to £500,000. The decision whether to carry out either scheme will be taken in the light of all the factors involved, including the cost and the outcome of the consultations pre-190W viously undertaken by the CSM on RADS.
§ Mr. Ashleyasked the Secretary of State for Social Services, pursuant to his reply of 24 January to the right hon. Member for Stoke-on-Trent South, if he will give the reasons for the decline in the cost of reviewing medicines from £600,000 in 1976–77, to £520,000 in 1977–78.
§ Dr. VaughanI regret that my hon. Friend's reply of 24 January—[Vol. 977, c.335–36.]—was in error as to the cost for 1976–77. It had been overlooked that the figure given (£600,000) covered the 17 months from 1 April 1976 to 31 August 1977 arising from a change in accounting during this period from the financial year (April to March) to the licensing year (September to August). A comparable figure on the same basis for the 12-month period ending 31 August 1977 would be of the order of £420,000. It follows that the cost of the review did not fall but rose over the succeeding 12-month period.
The figures quoted include salaries, national insurance, superannuation, allowances, on-costs, and common services.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether any steps have been taken to allay the concern of the Committee on the Review of Medicines, expressed in its 1978 annual report, that attention be given to the recruitment and appointment of appropriately qualified staff;
(2) whether there has been any change in the shortage of experienced medical staff in the medicines division of the Department of Health and Social Security which was reported to be handicapping the work of the division in the annual report for 1978; and if he will give the number of (a) doctors, (b) pharmacists and (c) scientists who are in post and the number of vacancies in each category;
(3) if he will give the number and nature of the professional people working full and part time for the Committee on Safety of Medicines and the Committee on the Review of Medicines; and if he will indicate any changes that have taken place in the last two years.
§ Dr. VaughanI shall write to the right hon. Gentleman.
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§ Mr. Ashleyasked the Secretary of State for Social Services if he will estimate the current annual cost of supporting the activities of (a) the Committee on Safety of Medicines and (b) the Committee on the Review of Medicines; if he will give comparable figures adjusted for the declining value of money for the last five
£000s Committee on Safety of Medicines Committee on the Review of Medicines Actual Revalued† Actual Revalued† 1974–75* 493 1,020 85 176 1975–76* 565 934 267 442 1976–77‡ 613 838 423 579 1977–78§ 706 880 518 646 1978–79§ 682 770 523 596 1979–80§║ 784 784 606 606 1980–81§¶ 907 907 690 690 * Financial years 1 April to 31 March. †Revalued to November 1979 prices, using the retail price index. ‡Figure estimated from actual expenditure 1 April 1976 to 31 August 1977. § Licensing years 1 September to 31 August. ║ Estimate ¶ Forecast Costs are recoverable from fees in the proportions of 80 per cent. for the Committee on Safety of Medicines and 60 per cent. for the Committee on the Review of Medicines respectively.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will place in the Library the report of the advisory panel on serious reactions to vaccines under the chairmanship of Professor Dudgeon which was seeking to establish clinical criteria or patterns of reactions which might serve to distinguish between a vaccine-associated event and a naturally occurring one;
(2) whether the advisory panel on the collection of data relating to adverse reactions to pertussis vaccine which was investigating several hundred cases of suspected reactions to vaccination, including those submitted by the Association of Parents of Vaccine Damaged Children, has reported to the Committee on Safety of Medicines; and if so, if he will place a copy of the report in the Library;
(3) if he will give the number of adverse reaction reports related to pertussis vaccine which were sent to the Committee on Safety of Medicines for each year from 1964 onwards; and whether the committee has any grounds for supposing that the incidence of yellow card reporting following vaccination is likely to differ widely from the average figure of 10 per cent. of
192Wyears; what proportion of the cost is borne by the Government and what proportion by other services; and if he will give the forecast cost of these two committees in real terms for the next two years.
§ Dr. VaughanThe information is as follows:
suspected adverse reactions to drugs which he estimates are reported through the yellow card system.
§ Dr. VaughanIt is proposed to publish together the reports of the two advisory panels and I shall arrange for copies to be placed in the Library of the House in due course. The report of the advisory panel on the collection of data relating to adverse reactions to pertussis vaccine, however, has not yet been submitted to the Committee on Safety of Medicines.
The numbers of reports of suspected adverse reactions to pertussis vaccine received by the Committee on Safety of Medicines is shown below. It should be noted that in all but a very few of these cases, pertussis vaccine was given in combination with diphtheria and tetanus toxoids.
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1964 104 1965 68 1966 39 1967 64 1968 39 1969 49 1970 36 1971 45 1972 39 1973 23 1974 67 1975 53 1976 80 1977 158 1978 165 1979 166 1980 (to mid-June) 57 TOTAL 1,252 I have no reason to suppose that the level of reporting of suspected adverse reactions to vaccines differs significantly from that related to all drugs.
§ Mr. Ashleyasked the Secretary of State for Social Services what advice has been sent to doctors concerning (a) the counselling of patients on the risks involved in immunisation and (b) ensuring that there are no contra-indications to immunisation; and whether he has produced leaflets or literature for circulation to parents giving an official view of the benefits, risks and contra-indications relating to vaccination and immunisation.
§ Dr. VaughanThe Department's advice to doctors and nurses emphasises the importance of paying scrupulous attention to contra-indications to vaccination and draws attention to the Health Education Council leaflet which contains advice to parents on the benefits and risks of vaccination. Further guidance will be included in the memorandum on immunisation against infectious disease when it is revised shortly.
§ Mr. Ashleyasked the Secretary of State for Social Services why the pertussis vaccine was not considered by the Committee on the Review of Medicines when it reviewed other vaccines in 1978.
§ Dr. VaughanThe committee judged it necessary to defer full consideration pending the report of the Meade panel on the data supplied by the Association of Parents of Vaccine Damaged Children and other current studies relevant to assessment of the safety of these vaccines.
§ Mr. Ashleyasked the Secretary of State for Social Services whether the sleeping pill Unison manufactured by Pfizer Laboratories in the United States of America is available in the United Kingdom.
§ Dr. VaughanThe sleeping pill Unison is not generally available in this country and no applications for a licence to authorise its marketing have been received by the Department.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will estimate the proportion of pregnant women that suffer from (a) nausea and (b) vomiting; what evidence there is that (i) nausea and (ii) 194W vomiting damage the foetus; and if he will indicate his sources.
§ Dr. VaughanWhile it is not possible to make such an estimate, I am advised that all standard textbooks refer to nausea, which in many instances is accompanied by vomiting, as one of the most common symptoms of pregnancy. In certain cases vomiting becomes uncontrolled and may lead to a condition called hyperemesis gravidarum which, if left unchecked, can lead to severe maternal dehydration and emaciation with consequent harmful effects on the foetus: this condition can usually be prevented by good antenatal care.
§ Mr. Ashleyasked the Secretary of State for Social Services what percentage of the reports of adverse reactions to drugs sent to the Committee on Safety of Medicines through the yellow card system relates to congenital abnormalities which are suspected to be due to drugs taken by the pregnant mother; and if the Committee on Safety of Medicines has any grounds for supposing that the incidence of yellow card reporting of congenital abnormalities is likely to differ widely from the average figure of 10 per cent. of suspected adverse reactions to drugs which it is estimated are reported through the yellow card system.
§ Dr. VaughanA total of 1.6 per cent. of adverse reactions reports from all sources received by the CSM relate to congenital abnormalities where the drug was prescribed to the mother. The precise incidence of reporting by doctors is not known. However, the Committee on Safety of Medicines is not solely reliant on this input for reporting of congenital abnormalities but also utilises data supplied by the Office of Population Censuses and Surveys.
§ Mr. Ashleyasked the Secretary of State for Social Services whether the Department of Health and Social Security or the Committee on Safety of Medicines has issued any guidelines to general practitioners and hospital doctors on the use of drugs in pregnancy; and whether the Department and the committee are satisfied that the correct level of drug use in pregnancy is no more than is necessary to safeguard the health of the mother and unborn child.
§ Dr. VaughanNo. The decision as to drug usage in pregnancy is a clinical matter on which it would be inappropriate for 195W the Department to issue guidelines. However, data sheets contain appropriate warnings if necessary; the Committee on the Review of Medicines regularly includes in its recommendations a statement as to use in pregnancy; and the next issue of the "Current Problems" publication of the Committee on Safety of Medicines will discuss the subject. Further, Prescribers Journal, an independent publication sponsored by the Department, has recently had a number of articles on the topic.
§ Mr. Ashleyasked the Secretary of State for Social Services if there is evidence of a decline in the number of prescriptions for tranquillisers since the Committee on Safety of Medicines published tighter guidelines for their use in March.
§ Dr. VaughanI regret that figures are not yet available to show whether there has been any decline in the number of prescriptions for tranquillisers since the issue of the guidelines produced by the Committee on the Review of Medicines.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will estimate the percentage of pregnant women who take drugs, other than iron, in pregnancy, and if he will give the source of information for his estimate.
§ Dr. VaughanI regret that I have no means of estimating either the extent of self-medication by women in pregnancy or the number of complaints for which women might consult their doctor during pregnancy and properly be prescribed drugs other than iron.
§ Mr. Ashleyasked the Secretary of State for Social Services what progress has been made with the consideration of methods of providing patients with further information about their prescribed medicines; whether the working party to which reference is made in the 1978 annual report of the medicines division of the Department of Health and Social Security is still meeting; who are its members; and what recommendations it has made.
§ Dr. VaughanThe provision of information to patients about their prescribed medicines is a subject on which there are a number of differing opinions. The working party consists of 12 persons with an interest in the subject including those who,196W as individuals, are representative of general practice and hospital doctors, dentists, general practice and hospital pharmacists, nurses, the community health councils and the patients. They last met in October 1979 and they reported to the Medicines Commission in January 1980. Proposals which they made for a pilot study, designed to assess the value to patients of improved written information, are currently under consideration together with other possible approaches to the problem.
§ Mr. Ashleyasked the Secretary of State for Social Services if any attempt has been made by the Department of Health and Social Security, the Committee on Safety of Medicines or any other body to establish levels of acceptable risk for (a) fatal reactions and (b) serious reactions to drugs used in various situations such as life saving, potentially serious cases and cases which are painful and uncomfortable but less serious.
§ Dr. VaughanIt is not practicable to lay down generally applicable levels of acceptable risk for reactions to drugs. All potent drugs inevitably carry some risk of adverse reactions and in each case a judgment has to be made on the risk/benefit ratio in the light of the particular circumstances, including the nature of the illness and the anticipated incidence and severity of the reactions.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) by what year he estimates that all product licences of right will have been reviewed by the Committee on the Review of Medicines;
(2) how many product licences of right currently are awaiting review by the Committee on the Review of Medicines; and if he will give comparable figures for the end of 1979, 1978 and 1977.
§ Dr. VaughanThe numbers of product licences of right awaiting review are of the order of:
31 December 1977 23,000 31 December 1978 22,000 31 December 1979 20,000 (revised figure) 30 June 1980 19,500 (estimated) Our European Community obligation is to review all proprietary medicinal products by 1990. Progress depends on a number of factors, such as the nature of the products and the problems they pose in assessment.
197WTo estimate a completion date would, therefore, be entirely speculative.
Changes were introduced in 1978–79 to expedite the review and to bring forward for early consideration products of apparent potential hazard. This system must be given a reasonable period of operation before possible further changes are considered. Progress is, however, closely monitored and our European and other commitments are kept firmly in view.
§ Mr. Ashleyasked the Secretary of State for Social Services what percentage of product licences, granted in the last year for which figures are available was for products containing new chemical entities; what percentage was primarily newer variations of drugs already having licences; and if he will give the corresponding percentages for which applications were withdrawn, returned or rejected.
§ Dr. VaughanDuring 1979, 608 product licences were granted of which 48 (7.89 per cent.) were for products containing new chemical entities. Departmental records are not kept in a way which would enable the information requested on newer variations of drugs to be obtained without disproportionate expenditure. During 1979, 922 applications were received and 352 applications (38.18 per cent.) were withdrawn, returned or rejected. Some of the 352 applications were made prior to 1979. Information about particular types of applications withdrawn, returned or rejected could not be obtained without disproportionate expenditure and these figures do not include applications received following review by the Committee on the Review of Medicines.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will give monthly or quarterly figures for the last year showing the number of prescriptions for tranquillisers issued to pregnant mothers in the first three or last months of pregnancy; and
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Study Early pregnancy Middle and late pregnancy Total treated women in study Rothman et al 70 — 70 Smithells et al 1,713 585 2,298 Shapiro et al 824 — 1,317 Milkovitch et al 628 — 628 Birmingham Research Unit — — 243 Bunde and Leyland — — 2,218 Practitioner 72 — 72 le Van — — Not stated Smith et al 14 13 27 Greenberg, Inman et al 151 — 151 whether he has made any special arrangements to monitor the issue of prescriptions in such circumstances, following the recommendation of the Committee on Safety of Medicines that they should not be used unless there are compelling reasons for doing so.
§ Dr. VaughanI regret that the Department has no means of identifying the information requested, since prescriptions carry no reference to the therapeutic purpose for which the drugs are prescribed, and identification of pregnant women is not possible from the prescription form itself. For the same reasons, it is doubtful whether reliable data could be ascertained by an—inevitably costly—special monitoring exercise such as the right hon. Gentleman suggests.