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Published on 19 April 2011

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When is a Medicine not a Medicine?

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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? It is not 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 is not an ideal but it is 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, well-being 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 well-being 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. 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), and has given rise to horrifying adverse reactions in patients – for example complete loss of vision. There are also indications of other safety issues such as a potential increase in stroke of the unlicensed product compared to the licensed therapy.

The EMA has already confirmed its dissatisfaction with the practice of off label usage of medicines. Thomas Lӧnngren, former Executive Director of the EMA, when in office, said: “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.

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 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.

NICE



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