A report published by the European Alliance For Access to Safe Medicines (EAASM) highlights the consequences for patient safety when healthcare decisions are made as a result of costcutting allowed by regulatory vagaries and loopholes.
Jim Thomson, chairman of the EAASM said: “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.” 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. However, a case study in the report found that a number of preparations used on patients in a surgical pre-operative setting are not licensed for use as skin disinfectants – they are in fact products that are made and intended for use as multi-purpose hard surface disinfectants and cleansers. The report shows that dangerous cost cutting is allowed because of vagaries in the regulations, and how it can take precedence over patient safety. Some hospitals are using cheaper, unlicensed products for skin-disinfection. 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”. Another case study highlights how the recycling and reuse of licensed single-use medical devices can lead to an increase in hospital acquired infections. The recycled devices can retain blood, body fluid and tissue from previous use. The European trade body for medical equipment, Eucomed, has called for Europewide 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. The report states that the case studies demonstrate the all too routine cost containment practice in a cash-strapped environment which could 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. 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
