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.
|
