§ Baroness Masham of Ilton
asked Her Majesty's Government:
How the yellow card reporting system is submitted to the Medicines and Healthcare products Regulatory Agency; and what communication patients or their carers have with the healthcare staff who fill in the cards; and [HL2289]
How many yellow card reports are received each year by the Medicines and Healthcare products Regulatory Agency; and how the information is used for research to benefit patients; and [HL2290]
How long the yellow card reporting system for health care data has been in existence. [HL2291]
§ Lord Warner
The yellow card scheme is the United Kingdom system for collecting and monitoring information on suspected adverse drug reactions (ADRs). The scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Committee on Safety of Medicines (CSM). The scheme relies upon voluntary reporting of suspected ADRs by health professionals.9WA
The yellow card was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine post-marketing surveillance of medicines. Since then almost 500,000 reports of suspected ADRs have been submitted to the CSM/MHRA.
The following table contains the total number of suspected ADR reports received via the yellow card scheme from 1997 to 2003 inclusive.
Year Total No. Reports 1997 16,627 1998 18,054 1999 18,482 2000 33,151 2001 21,466 2002 17,178 2003 18,080
It is important to note that a report of a suspected adverse reaction does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease.
Levels of reporting are affected by media interest in a particular drug or reaction. Additionally, in situations where large numbers of people are exposed to a new drug, high levels of reporting for the drug in question may have a large impact on the overall numbers of yellow cards received.
The yellow card scheme primarily acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised ADRs, allowing the CSM and MHRA to identify and refine the understanding of risk factors that may affect the clinical management of patients. The value of the scheme has been demonstrated identification of numerous important safety issues.
In evaluating a possible drug safety issue, yellow card data are considered in conjunction with relevant information from other sources such as clinical trial data, published studies and the medical literature. When necessary, the MHRA, on the advice of CSM, may take regulatory action to ensure that medicine is used in a way which minimises risk and maximises benefits to the patient.
Reports are submitted by healthcare professionals and it is good practice, where possible, for the contents of the report to be discussed with the patient.
A review of access to data generated by the scheme is due to report later this year. The report of the review will also consider how the scheme might be strengthened and will consider the reporting of suspected ADRs directly from patients.