A new report warns of “very serious consequences” for patient safety when health care decisions are made not in the best interests of the patient but as a result of cost-cutting allowed by “regulatory vagaries and loopholes.”
The study, published by the European Alliance for Access to Safe Medicines (EAASM), warns of the dangers to the public posed by the use of unlicensed medicines, questionable off-label use of drugs and the recycling and re-use of licensed single-use medical devices.
A case study included in the report examines the use of two drugs used in the treatment of wet age-related macular degeneration (AMD), one of the major causes of visual impairment and blindness in adults aged over 50 in the developed world.
Only one of the drugs has been licensed by the European Medicines Agency (EMA) for use in the treatment of eye diseases, yet the other is widely used off-label and this, says the report, 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 with use of the unlicensed product compared to the licensed therapy, it adds.
The EMA has already confirmed its dissatisfaction with the practice of off-label medicines use, with the Agency’s former executive director, Thomas Lonngren, having stated while in office that “for a European Union (EU) 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.”
Another case study reports on the pre-operative use on patients of preparations which are not licensed as skin disinfectants but are in fact intended for use as multi-purpose hard-surface disinfectants and cleansers. Some hospitals are deciding to use these cheaper, unlicensed products for skin disinfection, and such dangerous cost-cutting is allowed by “vagaries” in the regulations and can take precedence over patient safety, says the report, which adds that not only the patient but also the surgeon can be unaware that this has happened.
The EAASM, which campaigns against the counterfeit drugs trade, says the findings of its new study take it into a new area of working against “institutional malpractice that compromises patient safety.”
The findings “have ethical, legal and economic implications and, from whichever stance they are considered, are wholly unacceptable,” said EAASM chairman Jim Thomson.
“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,” said Mr Thomson.
“Either through taxes, insurance or directly, patients pay for the health care 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,” he added.
To ensure that the safety and wellbeing of patients are the paramount considerations for all treatment decisions, the EAASM is calling on: – policymakers at national and European level to introduce clarifying legislation in order to close regulatory loopholes that put patient safety needlessly at risk and stop the use of unlicensed medical productions when there is no medical need for such use; – European and national product safety agencies to intervene swiftly whenever health care providers are found to be using unlicensed products despite licensed products being safer and approved; – and professional bodies and associations of health care providers to set clear standards for their members stating the conditions under which the use of unlicensed products for a medical reason is warranted.
