System to categorise drug safety proposed
A drug safety grading system to enable prescribers and patients to make rational decisions about treatment is proposed in an article published
in the BMJ (2006;333:143). The system comprises a warning about the
degree of potential harm from a drug, and the action to take, along
with an indication of the quality of the evidence for the association.
Robin Ferner, of the West Midlands Centre for Adverse Drug Reaction Reporting,
and Jeffrey Aronson, of the University Department of Clinical Pharmacology,
Radcliffe Infirmary, Oxford, say that information currently provided
in prescribing manuals is of uncertain validity, is often inconsistent
between sources and gives little or no indication of its importance.
They propose that the grading system includes three categories: red,
meaning danger, do not prescribe; double amber, meaning danger ahead,
act to avoid the danger; and amber, meaning possible harm, be aware and
make patient aware of potential danger. In addition, each drug is assigned
a letter, which indicates the quality of evidence for the association:
A (anecdotes: case reports or case series), D (data from laboratory [animal
or cellular] experiments or extrapolated from theory) or R (randomised
trials or observational studies). They emphasise that this is not a hierarchy
of evidence and the type of evidence that is most convincing should be
considered in all cases.
“Assigning different pieces of information to different categories
will be a challenge, but it is one that we need to face if prescribers
and
patients are to make informed therapeutic choices,” they conclude. |
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