Medicines Control Agency (Hansard, 23 May 2003)

§ Ms Blears

The Yellow Card Scheme is recognised to be one of the best in the world in terms of the level of reporting, 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 (MHRA) and the Committee on Safety of Medicines (CSM). From April 2003, the first phase of patient reporting of suspected adverse drug reactions (ADRs) through the Yellow Card Scheme via NHS Direct was introduced. This will enable the first hand experiences of patients to be utilised in the identification and assessment of drug safety issues.

Under-reporting of ADRs is an inherent feature of spontaneous reporting schemes. Although this means that data from the scheme have limited usefulness in terms of quantifying the frequency of an ADR, it does not detract from the ability of the scheme to identify new drug safety hazards. It has been estimated from various surveys that only 10—15 per cent. of serious ADRs are reported through the Yellow Card Scheme, but the true extent of under-reporting is unknown and is likely to vary considerably between different drugs and different reactions.

The effectiveness of the Yellow Card Scheme is reviewed regularly. CSM is updated twice monthly on the progress of the Yellow Card Scheme and the impact of new initiatives. Formal reviews of the scheme are carried out and presented to CSM annually. External reviews of the Yellow Card System were carried out in the 1980"s by Grahame-Smith and earlier this year by the National Audit Office as part of their Value for Money study of the Medicines Controls Agency.

The following table lists the number of reports of suspected ADRs received per year for the last three years through the Yellow Card Scheme for paroxetine (Seroxat) and the number of cases of suicide reported as suspected adverse drug reactions in association with paroxetine in this time.

	Number of reports of suspected adverse reactions association with paroxetine	Number of cases of suicide reported as suspected adverse drug reactions in association with paroxetine
2000	427	2
2001	329	1
2002	320	5

It is important to note that the suspected reactions are not necessarily caused by the drug and may relate to other factors such as other illnesses or other medicines taken concurrently. In addition the reporting of suspected ADRs is influenced by the seriousness of the ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity.

Paroxetine is one of a group of medicines called the selective serotonin reuptake inhibitors (SSRIs) which are used in the treatment of depressive illness and 77W anxiety disorders. The possibility of a causal association between SSRIs and suicidal behaviour has been reviewed by the CSM on a number of occasions, most recently in 2001. CSM concluded that the current evidence is insufficient to confirm a causal association between SSRIs and suicidal behaviour and advised that the issue should be kept under review. Product information for prescribers and patients contains warnings that suicidal behaviour may increase in the early stages of treatment with any antidepressant, and that if this occurs, medical advice should he sought immediately.

The CSM has convened an expert group to look again at all available data, including reports of suspected adverse reactions from patients.