HL Deb 15 May 2003 vol 648 cc369-71

3.22 p.m.

Lord Clement-Jones

asked Her Majesty's Government:

In the light of the concerns about the antidepressant drug Seroxat, whether they plan to review the yellow card scheme for reporting drug side effects.

Baroness Andrews

My Lords, the yellow card scheme is recognised to be one of the best in the world in terms of the level of reporting. It has a proven track record of identifying new drug safety hazards and enables the monitoring of all medicines, including Seroxat, in clinical use. The effectiveness of the scheme is under continuous review by the Medicines and Healthcare Products Regulatory Agency and the Committee on Safety of Medicines. From April 2003, the first phase of patient reporting of suspected adverse drug reactions via NHS Direct was introduced. That will enable the first-hand experiences of patients to be utilised in the identification and assessment of drug safety issues.

Lord Clement-Jones

My Lords, I thank the Minister for that reply. I thought that she was somewhat congratulatory of the yellow card scheme, despite the substantial under-reporting noted in the "Panorama" programme and the associated papers by Social Audit. I welcome the NHS Direct innovation, but we must go further. Will the Minister confirm that the MHRA and the Committee on Safety of Medicines will be encouraged to seek direct patient experience, not simply via health professionals, and that that experience will be taken on board in the committee's review of SSR I drugs such as Seroxat?

Baroness Andrews

My Lords, in response to the first point, the yellow card system has been tried and tested over many years. It serves as the model for other countries and is recognised to be the best of its kind. One should not confuse under-reporting with ineffective reporting. One does not want to report every adverse reaction. But, through the yellow card system, we pick up the reactions that we need to know about so that we can do enough about them. In recent years, the number of people who can make adverse reports has expanded; for example, nurses can now do so. We welcome that.

On the second point, the Committee on Safety of Medicines has set up an expert working group, which will look at the safety of Seroxat. It has received the patient reports generated by the "Panorama" programme. It will look at protocols on how best to evaluate the evidence, which it will take extremely seriously. It will look at what needs to be done potentially to improve the leafleting. It will test those improvements with a user panel. Sir Gordon Duff, who chairs the CSM, is extremely anxious to do that.

Lord Winston

My Lords, I declare an interest as the director of research and development at Hammersmith Hospitals NHS Trust. Does the Minister not agree that Seroxat and the class of drugs that deal with serotonin in the brain are the most effective anti-depressants that we currently know? Seroxat has been in use for more than 12 years and is available in more than 100 countries where none of the side effects mentioned has been highlighted. The "Panorama" programme has not always been noted for its accuracy in other areas. It would be premature to condemn what is an extremely good drug. The side effects reported are those commonly reported in recovering depressive patients who are not taking the drug.

Baroness Andrews

My Lords, I can hardly improve on that description. Seroxat is an effective treatment for depression and anxiety disorders. Four million prescriptions are made every year in this country alone. We have a wealth of evidence from Europe and the United States that it is a safe and very effective drug. Nevertheless, we want to respond to the concerns raised in the "Panorama" programme. We do not want people suddenly to stop taking their medication. That is why the Committee on Safety of Medicines has set up an expert working group to see how it can address some of the issues as appropriately as possible.

Lord Naseby

My Lords, when the assessment has been made by the Committee on Safety of Medicines, will the Minister report it publicly? Many noble Lords believe that the yellow card system has worked extremely well over many years. As the noble Lord, Lord Winston, said, the "Panorama" programme does not quite have consistency of reporting.

Baroness Andrews

Yes, my Lords, we will certainly make the conclusions public. The most recent development of the yellow card system is its going online. That is being piloted in one area, and we will have the results in a few months. We hope that it will be a national initiative in the autumn. That will make it even easier for doctors, pharmacists and nurses to report. They may prefer to use the yellow card, which is very popular and very easy to use.

Lord Ashley of Stoke

My Lords, what evidence does my noble friend have for claiming that the yellow card system is one of the best in the world? My impression has been that under-reporting under the yellow card system was very serious.

Baroness Andrews

My Lords, there are two sorts of evidence. First, the system was picked up by other countries. They have not introduced it in its full capacity, but it has served as a model. Secondly, it has a proven track record of identifying safety issues. Let me give just one example: reports of sudden death in patients receiving the schizophrenia treatment Sertindole led to suspension of the product pending a full review. Sertindole has now been reintroduced under very controlled conditions. I could give the noble Lord several examples. I am very happy to write to him on both issues.

Earl Howe

My Lords, does the Minister agree that inquests do not generally take account of contributory factors such as drug treatment, and that there is no mechanism for collating information arising from inquests that might be in the public interest? Will the Government consider that?

Baroness Andrews

My Lords, I know that only one coroner's inquest has alluded to the drug as having been a potential factor in a suicide. I shall consider the serious issues raised by the noble Earl.