Patient Safety Group Renews Call for Urgent Action to Protect Patients From Harm

London (ots/PRNewswire) –

The European Alliance for Access to Safe Medicines (EAASM) is
calling for authorities to act now to clarify the conditions under
which medicines can be used outside of their approved status.

For example, the recent report from the US-based “CATT” study
shows an increased risk of serious adverse events with the unlicensed
(but widely-used) drug for wet AMD, when compared to the licensed
(but more costly) drug. In the wake of the publication of a second,
this time UK-based IVAN study report, and although the drugs were
found comparably effective, the AMD Society commented that

“The trials cannot provide definitive safety information and the
overall question of the safety of Avastin is, unfortunately, not
answered to everyone’s satisfaction by these trials.

“The use of Avastin will remain a matter of judgement for
clinicians, with some satisfied with the evidence and others not.”

Reacting to the study results, EAASM Chair, Jim Thomson, said:

“This is not an issue solely for the discretion of physicians. Of
course it is a complex issue, with hard-pressed budgets involved, but
that should not cloud the fact that patients deserve to be given the
choice of the licensed medicine. We are talking about an elderly
population and these patients should be fully informed and give
written consent if they are to be treated with an unlicensed

There has been much debate about the widespread practice of using
Avastin (a medicine licensed for the treatment of various cancers) as
an unlicensed treatment in ophthalmology. Neither of these studies
addresses a key argument against its use, that being that bacteria
can be introduced during the preparation of Avastin for intra-ocular
use. A single dose is drawn up from the larger vial, with the
remainder of the contents potentially stored for future use, which
has led to vials becoming contaminated. This has been proven to be a
patient safety risk, with numerous patients blinded. Indeed The
Department of Veterans Affairs – one of the largest healthcare
providers in the world, now insists that if Ophthalmologists use
Avastin, they must use a single vial per treatment having drawn up
the required amount with the remainder of the vial’s contents being

Of course, the CATT study points to increased risk of serious
adverse events, regardless of that process.”

Whilst the debate around the use of medicines outside of their
approved status is bound to continue to rage, what remains extremely
worrying is that there is very little formal regulation. The EAASM is
one of a growing number of organisations campaigning to

– Establish a framework to research and publish the number of adverse events
related to unlicensed or off-label use of medicines
– Introduce a professional framework to govern mandatory reporting of adverse
events related to unlicensed or off-label use of medicines
– Improve public awareness so that patients are aware of when they are
prescribed an unlicensed or off-label medicines, how to make sure that adverse events
are reported, and that they give their consent for those medicines to be used

Jim Thomson comments: “The very idea that a healthcare
professional could prescribe an unlicensed medicine to a patient
without his or her fully informed consent, is unthinkable. We met
with the MHRA recently and they assured us that they plan to
strengthen the adverse drug reaction reporting requirements in this
area. That is extremely welcome. Our recent report “When is a
Medicine not a Medicine” highlighted two additional case studies –
the reprocessing and re-use of single use medical devices and the use
of unlicensed substances in pre-operative situations – that shouldn’t
be overlooked whilst attention is focused on the wet AMD debate.
These are serious patient safety issues and right now, today,
patients remain not only at risk but uninformed about those risks.
The Lucentis / Avastin debate is just the tip of a barely visible
patient safety iceberg and whilst any savings at all might seem on
the surface to be attractive in the current economic climate, that
isn’t in itself reason enough to disregard two important factors.

First, there is a regulatory process for a very good reason.
Second, patients should, of course, be fully informed and, together
with their healthcare professional, make choices that are based on
the best treatment option, rather than the cheapest.”

Notes to editors

The European Alliance for Access to Safe Medicines (EAASM) was
founded in 2007 with the aim of improving patient safety around
Europe by fighting against unlicensed products and counterfeit
medicines. The EAASM is a registered Community Interest Company (CIC)
in the UK. This legal structure ensures that everything it does is
specifically for community benefit or the wider public interest

For further enquiries or to request an interview contact:

Jim Thomson
Chair, EAASM
T: +44(0)1702-474230
M: +44(0)7901-800608

ots Originaltext: EAASM
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