The public health importance of controls on the safety of medicines was dramatically brought to the attention of the public in the early 1960s by the thalidomide tragedy.
BACKGROUND
INTRODUCTION OF THE
YELLOW CARD SCHEME
The
public health importance of controls on the safety of medicines was
dramatically brought to the attention of the public in the early 1960s by the
thalidomide tragedy. In the wake of this tragedy, many countries introduced
systems for the systematic collection of reports of adverse drug reactions. In
the United Kingdom, the Committee on Safety of Drugs (subsequently the
Committee on Safety of Medicines (CSM) and now the Commission on Human
Medicines (CHM) was set up. One of the responsibilities of this new committee
was to collect and disseminate information relating to suspected adverse
effects of drugs (Griffin, 1992). To address this objective, the United
Kingdom’s spontaneous reporting Scheme was introduced in 1964, when Sir Derrick
Dunlop (the chairman of the Committee on Safety of Drugs) wrote to all doctors
and dentists in the United Kingdom to announce the launch of the new Scheme
(Griffin and Weber, 1992).
In
his landmark letter, Sir Derrick asked ‘every member of the medical/dental
profession in the United Kingdom’ to report ‘promptly details of any untoward
condition in a patient which might be the result of drug treatment’ and stated
that ‘All the reports or replies that the Committee receive from
doctors/dentists will be treated with complete professional confidence by the
Committee and their staff.’
This
established four key principles of the Scheme, namely:
1.
Suspected adverse reactions should be
reported; reporters do not need to be certain or to prove that the drug caused
the reaction.
2.
It is the responsibility of all doctors and dentists to report.
3.
Reporters should report without delay.
4.
Reports could be made and would be treated in confidence.
Reports
were to be made on specially provided yellow reporting forms, a supply of which
was provided with Sir Derrick’s letter. The significance of the yellow colour
of the card is probably no more than that there was by coincidence a large
supply of yellow paper unutilised at that time; however, as a result, the Scheme
has come to be known as the Yellow Card Scheme. In almost 40 years since the
introduc-tion of this Scheme, the design of the reporting form has changed
progressively, to include guidelines on reporting and to ask for additional
specific pieces of information (e.g. Lawson, 1990; Griffin and Weber, 1992;
Anon, 2000a). Reports are also received via the pharmaceutical industry, which
has a statutory obli-gation to report suspected adverse reactions (Waller,
Coulson and Wood, 1996). The CHM continues to be responsible for the Yellow
Card Scheme, which is run on the Commission’s behalf by the MHRA, using a
specialised database to facilitate rapid processing and analysis of reports and
detection of signals of drug safety hazards. Four Regional Monitoring Centres (RMCs),
introduced in the 1980s, provide valuable support for the running of the Scheme
in Merseyside, the Northern region, Wales and the West Midlands (e.g. Houghton et al., 1996). A fifth RMC was opened in
Scotland in October 2002 and the Northern RMC expanded its activities into
Yorkshire in the Septem-ber of the same year. The RMCs are now known as Yellow
Card Centres.
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