Keep yellow cards at hand
Periodic attempts are made to increase the number of reports of adverse reactions to drugs. The original yellow card scheme — launched
over 40 years ago — was exclusive to doctors but other health
professionals and patients have since been included (p537).
The scheme for patients is now being rolled out across the UK although
it is still called a pilot, which suggests the Medical and Healthcare
products Regulatory Agency is still not certain that this scheme will
bring the returns it hopes. The MHRA working group responsible for patient
reporting was said, at the end of last year, to be in the process of
designing the best systems to enable patients to report suspected ADRs
and predicted there would be final systems in place by 2006.
Fortunately, the yellow card scheme is not the only method that the Committee
on Safety of Medicines relies on to check the safety of marketed medicines.
Nevertheless, it is an important part of the process because it is more
likely to reveal the true scale of both trivial and significant side
effects once a drug is available throughout the NHS.
There is no question, however, that ADRs are under-reported. Health care
professionals are often reluctant to report seemingly trivial experiences
faced by patients, particularly if they believe the problems are unlikely
to affect the licensing of the drug involved or its summary of product
characteristics. Pharmacists may believe more significant problems will
be reported by medical colleagues. In both instances, information that
would be of value to the CSM may be lost.
With the inclusion of patients in the scheme, pharmacists probably need
reminding that this is not an excuse for them to report even fewer ADRs.
The information that patients provide will inevitably be of a different
nature to that given by a health professional. So if a patient believes
a side effect is worth reporting, so should those people involved in
his or her care. As reported in The Journal in 2002 (6 July p14) the
merest suspicion of an ADR should have pharmacists reaching for a yellow
card. This still applies if the system is to be effective.
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What do you know about confidentiality?
Most people will have had some direct experience of the workings of recent data protection legislation. Pharmacists, in particular, need to be aware of how it impacts on record-keeping and other aspects of practice. The Royal Pharmaceutical Society has put together some guidance that encompasses the Data Protection
Act, the Human Rights Act, the NHS code of practice on confidentiality and,
in the light of the new community pharmacy contracts, what pharmacists need
to do to be fully compliant with the various pieces of legislation (p555).
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