The environment in which the Scheme operates is very different now, compared with the 1960s.
RECENT INITIATIVES TO ENHANCE
THE SCHEME
Although
the importance of the Yellow Card Scheme in protecting public health by
monitoring the safety of medicines in routine practice is not in dispute, there
is a need to tackle continually the issue of under-reporting by addressing some
of the factors highlighted in the section on ‘Weaknesses of Yellow Cards’
above. The environment in which the Scheme operates is very different now,
compared with the 1960s. There is ever-increasing public and media interest in
the availability of medicines and their safety, new medicines are delivered
more rapidly to the market place than ever before, and more medicines are
available without a doctor’s prescription. Addi-tionally, it is clear that the
roles of pharmacists and nurses have evolved over recent years. For
pharma-cists, an increasing role in patient care is due at least in part to the
increasing range of medicines being made available without prescription. Nurses
are now able to prescribe a wide range of medicines, and have increasing
involvement in the routine care of patients in the community, particularly in
the management of chronic conditions. These changing roles now place
pharmacists and nurses in a position in which they are increasingly likely to
encounter suspected adverse reactions.
A
number of initiatives have been undertaken recently in order to try to address
some issues raised in the section on ‘Weaknesses of Yellow Cards’ above. These
initiatives fall into three main groups: initia-tives aimed at increasing the
general reporting base, those aimed at increasing reporting in particular areas
where under-reporting is of particular concern, and those aimed at facilitation
of reporting. Developments in interpretation of data protection legislation
resulted in the introduction of anonymised Yellow Card report-ing. Importantly
in 2004, an independent review of the Yellow Card Scheme recommended greater
access to data for research, and increased patient involve-ment. Initiatives in
each of these areas are described below.
The
potential impact of any change to the Scheme has been assessed in relation to
its effectiveness in detecting previously unrecognised drug safety hazards.
Simply increasing the number of reports is not alone of particular value; the
objective is to receive Yellow Card information of suitable quality to enable
signal detection and, where relevant, assessment of individual cases as part of
the investigation of poten-tial safety hazards. Furthermore, although numbers
of reports are important for the identification of new hazards, it is paramount
that reports of serious ADRs are collected, since these are more likely to
impact on the balance of risks and benefits of the medicine than reports of
minor side effects. An increase in the number of reports received also has
resource impli-cations. Yellow Cards are processed rapidly, accord-ing to published
targets, in order to ensure that data from the reports are available on the
database as quickly as possible for inclusion in the signal gener-ation
process. Any large increase in the volume of reports can slow down the time
taken to make reports accessible for risk detection and may increase the
signal-to-noise ratio.
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