A harmonized European approach to the off-label use of medicinal products?

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EU has a role to play in regulating the use of off-label medicines, says Cyrus Engerer

The COVID-19 pandemic has shown us how important coordination between countries is in responding to health threats. It also revealed the crucial role the EU can play in promoting common health responses that fully respect the role of each Member State in the governance of their health systems.

During the pandemic, we have seen that the most promising vaccine candidates, which have played a key role in our response to the pandemic, have been developed and produced in Europe. We can all be proud, as Europeans, of the existing legal framework for pharmaceuticals, which rewards innovation and ensures that new medicines are proven safe and effective before they reach patients.

Above all, we must credit this regulatory system for providing us with the most effective COVID-19 vaccines, and in the years to come the EU must strive to remain the world leader in health policy, setting standards. and high standards of quality and safety. This is exactly what we will do with the pharmaceutical strategy for Europe. We will also seek to ensure that patients can benefit from future innovative health technologies by ensuring that the regulatory system remains adequate and that Europe remains an attractive place for research and development of new pharmaceuticals.

However, the COVID-19 pandemic has also illustrated that increased regulatory flexibility and innovative approaches to drug development and approval are sometimes needed. When Europe rushed for a possible COVID-19 treatment, there was, for example, a growing call to identify the effectiveness of existing drugs to treat COVID-19, a practice called reorientation. In October, the European Medicines Agency launched ‘Reuse of authorized medicines: a pilot project to support non-profit organizations and universities’, a project that is part of the pharmaceutical strategy which aims to support the reuse of medicines existing for a wide range of disease areas.

“EU patients should have the same access to safe and effective treatment, regardless of where they live in the Union”

However, despite this strong EU approval system, drugs are commonly used that are not approved, this is called “off-label” use (meaning the drug is not approved). used for their indication or approved method). This is a legal practice and above all necessary in many pathological areas, where there is currently no suitable approved alternative available. This means that doctors are free to determine, at their own discretion, whether an individual patient will benefit more from an alternative drug not listed on the label.

However, some authorities are taking advantage of the existence of this freedom of the prescriber to promote large-scale use outside of Marketing Authorization, aimed at lowering health care costs. This is unacceptable as it increases the risk for patients who would otherwise have received an approved and safe alternative and compromises the EU regulatory system for drug approval.

EU patients should have the same access to safe and effective treatment regardless of where they live in the EU. We should therefore take the opportunity of the Pharmaceutical Strategy and the ongoing discussions on the role of the EU in health policy in the aftermath of the COVID-19 pandemic, to consider how we can formulate a common approach to off-label use which guarantees that it is carried out in complete safety and is limited to places where it is strictly medically necessary.


The large-scale use of off-label drugs poses serious safety concerns, says Frédéric Destrebecq of the European Brain Council. This is why we have joined forces with other Brussels health players to propose common European guidelines on when and how out-of-marketing prescription should take place.

Many people are aware of the tragedy of thalidomide and its use by pregnant women in the 1950s, an event that prompted European governments to dramatically change the drug approval process. The very strict drug authorization process that exists today in Europe, now centered around the European Medicines Agency, was created after the thalidomide tragedy. Although there are still rare problems with medicines authorized in Europe, it has generally proven to be a very robust and rigorous system, primarily focused on the safety of the patients who take medicines.

However, this system is gradually being bypassed, causing real risks for patients in Europe. In May of last year alone, EURACTIV reported that the practice of using ‘off-label’ drugs to induce labor in pregnant women had serious health consequences and even death. There is always a varying risk of side effects if and when people are prescribed drugs not approved for that particular use – a practice that is commonly referred to as the use of “off-label” drugs.

Doctors are free to prescribe the use of an “off label” drug, when there is no good alternative medicine, and the doctor believes that the potential benefit to the patient outweighs the risk to safety. . This occurs in many pathological fields including oncology, psychiatry, pediatrics, and rare diseases, to name a few.

Everyone agrees that this concept of “off-label” use is positive, as it is based on a patient’s individual medical need and the trust placed in physicians to make the best decision for their patients. An important part of this exception is the discussion between the doctor and the patient – it is the doctor’s responsibility that the patient is fully aware that the medicine is “off-label” and understands the risks involved.

“In most cases, patients are not sufficiently informed of what is happening, nor informed of the risks involved, and are therefore unnecessarily exposed to increased risks of adverse events”

However, off-label use is now increasingly used in healthcare systems to save money, with off-label drugs being deliberately given to patients while already approved drugs are available. And in most cases, patients are not sufficiently informed of what is going on, nor informed about the risks involved, and are therefore unnecessarily exposed to increased risks of adverse events.

In response to these disturbing developments, together with other European healthcare players, we call for good practice of off-label use, a model for a clear European-wide framework to ensure patient safety and help professionals. health professionals to make more informed decisions when prescribing “off-label” drugs. The practice states that the off-label should only be used when a qualified healthcare professional finds that there is a clear medical need; if there are no other treatments available on the label or if the authorized treatments have failed, if there is scientific evidence in the literature that supports the use, if the patients are sufficiently informed of the risks and benefits possible medication, and the results should be reported by the healthcare professional in the patient’s chart as well as by the patients themselves.


Best Practices for Patient Safety: Discussion on Off-Label Use

You are invited to join us on November 30, between 2:30 p.m. and 4:00 p.m. (CET) for a discussion between patients, clinicians and policy makers on how we can ensure greater awareness of the use of off-label drugs through the exchange of ideas and best practices from different European countries.

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This content was commissioned by Good Off-Label Use Practice (GOLUP) and produced by Dods


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