When is a Medicine not a Medicine?

The Real Price of Cutting Corners: Endangered Patients and Increased Costs

LONDON, April 19, 2011 - In a report published today with a clear call for action, the European
Alliance For Access to Safe Medicines (EAASM) has uncovered very serious
consequences for patient safety when healthcare decisions are not made in the
best interest of the patient, but as a result of cost cutting allowed by
regulatory vagaries and loopholes. They have led to patient deaths and make
shocking reading.

Jim Thomson, Chairman of the EAASM said: "This report takes the EAASM
into a new area, that of campaigning against institutional malpractice that
compromises patient safety.

"When is a medicine not a medicine?[1] It isn't a trick question, but a
very real one. It should only have one answer. A medicine should be a
treatment prescribed and dispensed with only the best interests of the
patient in mind, and with the patient fully informed and involved in the
decision-making process. This isn't an ideal but it's the very least a
patient deserves.

"Either through taxes, insurance, or directly, patients pay for the
healthcare they receive. Regardless of any economic consideration, it is
unacceptable that they have to risk paying a much higher price, with their
health, wellbeing or even their lives, without their fully-informed consent.

These findings have ethical, legal and economic implications and, from
whichever stance they are considered, are wholly unacceptable."

To ensure that the safety and wellbeing of patients are the paramount
considerations for all treatment decisions, the EAASM is calling on:

- Policy-makers at national and European level to introduce clarifying
legislation in order to:

- Close regulatory loopholes that put patient safety needlessly at risk

- Stop the use of unlicensed medical products when there is no medical
need for such use

- European and national product safety agencies to intervene swiftly
whenever healthcare providers are found to be using unlicensed products
despite licensed products being safer and approved

- Professional bodies and associations of healthcare providers to set
clear standards for their members stating the conditions under which the use
of unlicensed products for a medical reason is warranted

The report's first case study finds that a number of preparations used on
patients in a surgical pre-operative setting are not licensed for use as skin
disinfectants - they are products that are made and intended for use as
multi-purpose hard surface disinfectants and cleansers. The report shows how,
in this of all environments, such dangerous cost cutting is allowed by
vagaries in the regulations, and how it can take precedence over patient
safety. Some hospitals are deciding to use cheaper, unlicensed products for
skin-disinfection and, scandalously, not only the patient but the surgeon can
be unaware that this has happened.

Each year in the EU over 25,000 people die of bacterial infections.[2]
While it is unclear how many are caused by hospital acquired infections, the
number is likely to be high given there are a number of resistant bacteria
which are mostly acquired in a hospital setting. With this in mind, the
highest standards in pre-operative preparation and the use of the appropriate
licensed products for cleaning surgical sites have never been more important
than they are now.

A second case study deals with questionable off-label use of medicines.
It features two pharmaceutical products; both medicines are used to treat wet
age-related macular degeneration (AMD), one of the major causes of visual
impairment and blindness in adults over 50 in the developed world.

Only one of them is licensed for the treatment of eye diseases by the
European Medicine Agency (EMA), yet the other is widely used 'off-label'
(unlicensed).[3,4]

The EMA has already confirmed its dissatisfaction with the practice of
off label usage of medicines. Thomas Lonngren, former Executive Director of
the EMA stated when in office that: "For a Member State to encourage the use
of a pharmaceutical for an indication for which it is not licensed would be a
breach of EU legislation."

In the third case study we see how the recycling and reuse of licensed
single-use medical devices can lead to an increase in hospital acquired
infections, one of Europe's most serious medical challenges. The recycled
devices can retain blood, body fluid and tissue from previous use.[5]

The forthcoming recast of the Medical Devices Directive provides the EU
with an ideal opportunity to address the patient safety, public health and
health inequality concerns posed by the reuse of single-use medical devices.

This all too routine cost containment practice in a cash-strapped
environment can potentially cause harm or death to the patient by infection
or mechanical breakdown. The practice is considered ethically insupportable,
since patients are placed at unnecessary risk, are uninformed and their
interests are subordinated to hypothetical and unsubstantiated economic
benefits to the user, usually a hospital.

The economic benefits, if any, appear to be seriously overestimated. The
costs of dealing with hospital acquired infections, additional complications,
administrative overheads and eventual litigation are rarely calculated or
included in total cost benefit analyses.

In 2001, a nine-year-old boy, from Dagenham, Essex, in the UK, died while
he was being prepared for surgery at Broomfield Hospital, Chelmsford, after
trapping his finger in a bicycle chain.

He was deprived of oxygen because a reused faulty piece of connecting
tube forming part of the anaesthetic apparatus was blocked. Although the
piece was designed to be used only once and then disposed of, the inquest
jury heard that hospital staff often washed and reused them - one member of
the medical staff said that this was common practice throughout the country.
It was concluded that one of the principal factors contributing to the boy's
death was a failure to follow guidelines concerning single use medical
devices.

In the 10 years since the case, the situation has not improved and this
is still an issue affecting the life and death of patients in Europe. It is
utmost importance that these issues are addressed now so that patients are
not subject to the same easily avoidable mistakes that are being made every
day in hospitals around the UK.

Research now documents[5] horrendous incidents where re-used devices
have failed leading to repeat surgery, coma, heart attack and death. The
European trade body for medical equipment, Eucomed, has now called for
Europe-wide measures to ensure patient safety is no longer compromised by
the repeated use of single use devices. The EAASM supports this call in the
interests of its primary objective - patient safety.

To investigate the extent of the problems raised in the report, the EAASM
is collating a database of examples from across Europe. They would like to
appeal to anybody who has any information on the problems raised in the
report to email jim.thomson@eaasm.eu. Any information you provide will remain
confidential.

Notes to editors

1. 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.

2. The report When is a Medicine not a Medicine? can be accessed at the
EAASM website: www.eaasm.eu

———————————

[1] Throughout the report, the term 'medicines' is used in a
non-technical manner and mean all products designed for healthcare usage,
including medical devices and pharmaceuticals

[2] BBC Health News Europe 'losing' superbug's battle:
www.bbc.co.uk/news/health-12975693

[3]
wissen.spiegel.de/wissen/image/show.html?did=60666870&aref=image038/2008/09/27/ROSP200804001400141.PDF&thumb=false

[4] Carneiro AM, Barthelmes D et al in Ophtalmologica 2011,
content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=323943&Ausgabe=254908&ProduktNr=224269

[5] Eucomed White Paper on the reuse of single use devices:
www.eucomed.org/uploads/Press%20Releases/Eucomed%20White%20Paper%20on%20the%20reuse%20of%20single-use%20devices.pdf

(Due to the length of these URLs, it may be necessary to copy and paste
the hyperlinks into your Internet browser's URL address field. Remove the
space if one exists.)

For further enquiries or to request an interview contact: Jim Thomson, Chair, EAASM, T: +44(0)1702-474230, M: +44(0)7901-800608, E: jim.thomson at eaasm.eu; Claire Nicholson, Red Consultancy, T: +44(0)207-025-6524, M: +44(0)07715-002984, E: Claire.nicholson at redconsultancy.com