Select Committee on Health Minutes of Evidence


Annex B

THE YELLOW CARD SCHEME/REVIEW OF ACCESS TO THE YELLOW CARD SCHEME

REPORTS RECEIVED PER YEAR

  1.  In 2003, 19,272 reports of suspected adverse drug reactions (ADRs) within the UK were reported to the MHRA/CSM. This level of reporting has generally been consistent over the last few years. The sharp increase in reporting seen in 2000 was associated with a nationwide Meningitis C vaccination campaign where Nurses were encouraged to report for the first time. Table 1 below demonstrates the number of UK and foreign reports received since 1999.

Table 1


Received Year
UK Reports
Foreign Reports
Total

1999
18,486
28,338
46,824
2000
33,153
32,184
65,337
2001
21,468
40,319
61,787
2002
17,620
45,569
63,189
2003
19,272
43,332
62,604
2004 (reports received by 20/09/04)
14,122
31,862
45,984

UNDER REPORTING

  2.  The value of spontaneous reporting schemes, such as the Yellow Card Scheme, in early detection of drug safety issues is universally recognised. It has a proven track record of identifying new drug safety hazards and is recognised to be one of the best in the world in terms of the level of reporting. 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.

ELECTRONIC REPORTING

  3.  The MHRA and CSM launched a new electronic Yellow Card on their website on 31 October 2002, to provide a rapid and convenient way to report suspected adverse drug reactions (ADRs) for health professionals. To date, the MHRA has received 598 reports of suspected ADRs via the Internet. A one-year evaluation has been carried out and electronic reports were found to be comparable with paper reports, with respect to the proportion of serious ADRs reported and reports associated with new, intensively monitored drugs. Table 2 below demonstrates the number of Internet electronic reports received quarterly since October 2002.

Table 2


Quarter
Number of Reports

October—December 2002
32
January—March 2003
56
April—June 2003
77
July—September 2003
79
October—December 2003
66
January—March 2004
83
April—June 2004
106
July—September 2004
99
Total
598


  4.  To encourage and promote awareness of electronic reporting, a new, distinctive website providing rapid and direct access to the electronic Yellow Card (yellowcard.gov.uk) was launched on 19 February 2004. The Agency is working to promote and increase the awareness and usability of the electronic Yellow Card.

THE REVIEW OF ACCESS TO THE YELLOW CARD SCHEME

  5.  On 21 July 2003, Ministers announced an independent Review into the access to and use of data collected by the Yellow Card Scheme. The Review was led by—Dr Jeremy Metters—former Deputy Chief Medical Officer.

  6.  The "Report of an Independent Review of Access to the Yellow Card Scheme" was published on 4 May 2004 to coincide with the 40th anniversary of the Scheme. The full report includes 24 main recommendations including to allow greater access to the data generated by the Yellow Card Scheme to ensure the full potential of the data is realised. A full public consultation exercise (MLX 308) was commenced on the recommendations and ended on 28 July 2004. The MHRA is currently reviewing the responses received and in light of the results the MHRA/CSM will consider each of the recommendations of the Review.

  7.  One recommendation has been accepted immediately by Ministers—the introduction of patient reporting to the Scheme. A Working Group has been set up to advise on the piloting of different arrangements for patient reporting of suspected ADRs and on methods to gauge their effectiveness.




 
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