Since the Yellow Card Scheme was established in 1964, reporting of ADRs has been restricted to health professionals of specific disciplines.
FOCUS ON PATIENTS
Since
the Yellow Card Scheme was established in 1964, reporting of ADRs has been
restricted to health professionals of specific disciplines. With increasing
responsibilities the roles of health professionals, such as pharmacists and
nurses described previously, have evolved to place them in more appropriate
positions to report suspicions of ADRs and as a result the number of reporters
who can contribute to the Scheme has increased. Likewise patients, with easy
access to the Internet, have greater knowledge about the medicines they receive
and take a more active role in their health. This attitude is also reflected in
the govern-ment’s current policy to provide patients with greater choice over
decisions affecting their health. As part of this strategy the government
launched its NHS Plan in 2000 and within this programme to modernise the National Health Service (NHS) a
range of initia-tives to improve patient information, patient choice and
patient and public involvement in the NHS are proposed. The government
recognises that ‘choice is central to modernising and improving the delivery of
services. In essence, it is about treating people as active, responsible
citizens, not passive recipients of services, enabling them to exercise genuine
choice over key aspects of their lives’ (The NHS Plan – a progress report. The
NHS Modernisation Board’s Annual Report 2003). The government also encour-ages
wider availability of medicines and the number of drugs that have been
reclassified from Prescription Only Medicines (POM) (available only on a
prescrip-tion) to Pharmacy (P) (available under the supervision of a
pharmacist); and the number of drugs that have been reclassified from P to
General Sale List (GSL) (available in general retail outlets such as
supermar-kets) has risen in recent years. Before a change in legal status is
granted, pharmaceutical companies have to demonstrate levels of safety
dependent on specific criteria and provide appropriate prescribing
informa-tion. Examples of recent POM to P switches include chloramphenicol 0.5%
eye drops for the treatment of acute bacterial conjunctivitis and Zocor Heart
Pro (simvastatin 10 mg) to reduce the risk of a first major coronary event in
people who are likely to be at a moderate risk of coronary heart disease, while
clotri-mazole for the treatment of Candidal
vulvovaginitis (thrush) is an example of a P to GSL switch.
The
potential benefit of patient reporting to the Yellow Card Scheme was realised
by the MHRA prior to the Independent
Review of Access to the Yellow Card
Scheme, although there were some concerns that the Scheme may become flooded with recognized non-serious
ADRs. To investigate this further, the MHRA undertook a pilot study of patient
reporting in South East London with NHS Direct in April 2003, involving staff
at the NHS Direct call centre making the reports on behalf of patients. This
was not partic-ularly successful as by the end of March 2004 only 39 reports
had been received from the NHS Direct centre. During the Review, stakeholders
criticised the pilot for not collecting the patient perspective directly from
patients who would provide their own account of their experience. The Review
recommended that ‘A system should be set up for patients to report ADRs
directly to the MHRA. Different approaches to patient reporting should be tried
but, initially, patient reports should be kept separate from those of health
professionals through a parallel system until experi-ence indicates the best
method of linking patient and health professional Yellow Card reports to the
same ADR. ’The MHRA and the government welcomed this recommendation to
introduce direct reporting of ADRs from patients to the Scheme, and in
Septem-ber 2004 the CSM Patient Reporting of Adverse Drug Reactions Working
Group was established to advise the MHRA and CSM on the development of
different arrangements to pilot direct reporting by patients or their carers of
suspected ADRs and to communicate about this new initiative. Although patient
reporting is still in pilot phase, as from October 2005 patients have been able
to report their experiences directly through the Scheme.
Benefits
of patient reporting include the identifica-tion of ADRs not previously
reported and/or specific features of ADRs that health professionals had not
considered. For example, it was patients who identi-fied ‘electric shock’
sensations following the use of selective serotonin reuptake inhibitors
(SSRIs). Intro-duction of patient reporting has also increased general
awareness about the Scheme.
The
MHRA is continuing to focus on involving patients as it looks towards the
future. In association with the CSM Patient Information Working Group the
report Always read the leaflet – Getting
the best information with every
medicine was published in July
2005. This report concentrated on strategies to improve the quality and
accessibility of medicine information, addressed risk communication and
deliv-ered new guidance and recommendations to help improve the quality of
Patient Information Leaflets.
Empowering
patients with knowledge to understand the risks and benefits of medicines will
help patients to make informed choices about the medicines that they are
taking. With the introduction of patient reporting, the nature of the Scheme
will undoubtedly change in the future.
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