Letter from Citizens of France, Belgium, United-Kingdom, Germany, Spain, The Netherlands, Romania, Bulgaria, Austria, Poland, Hungaria to the European Medecines Agency (EMA)
The 29th of November 2022,
Subject: Serious danger to tens of millions of patients in Europe following large-scale non-compliance with restrictions on the use of antibiotic of the fluoroquinolones family
Madam Emer Cooke, Executive Director of EMA,
Madam Sabine Straus, Chairman of the EMA’s PRAC,
Sir Martin Huber, Vice-Chairman of the EMA’s PRAC,
Following the review in 2018 by the EMA’s PRAC of the long-lasting, disabling, and potentially irreversible serious adverse drug reactions of systemic fluoroquinolones, severe restrictions on the use of this class of antibiotics (taking into account their very degraded benefit/risk ratio for the health of patients) were announced by your agency in April 2019 and relayed to the various European countries by their national agencies or national health authorities.
This decision was intended to improve the safety of European patients facing the dramatic effects of the adverse non-bactericidal reactions of fluoroquinolones.
Following this decision, which was widely anticipated by many patient associations, your agency announced a Drug Utilisation Study into the prescribing of fluoroquinolones to ensure control and to measure the implementation of the new restrictions in Europe.
This study (attached) was carried out by your services and finalised on May 18, 2022. We have only recently been informed of it and, as representatives of the patient associations concerned, we have read it with particular care.
The results of this EMA study indicate that for France, approximately 66% of prescriptions are made "Off-Label". That is to say without marketing authorisation. For a medication with such serious adverse effects, this means 2/3 more dangerous prescriptions than necessary. Off-label prescription rates (i.e. outside of the marketing authorisation) are approximately 70% for Belgium, 83% for Germany, 81% for The Netherlands and 78% for Spain.
Figures from “Santé Publique France” (attached) indicate that in community medicine there were around 2.4 million prescriptions for fluoroquinolones in 2021, about the same as in 2020. If we extrapolate this number over 3.5 years, approximately the duration since the usage restrictions of April 10, 2019 in France, this makes 8.4 million prescriptions, 2/3 of which are dangerous for the health of French people, i.e. 5.5 million dangerous prescriptions without marketing authorisation. To this should be added the prescriptions without marketing authorisation made in hospital settings. I leave you to do the calculation for the other European countries in the study and to do the projection for the whole of Europe.
These figures are simply unimaginable for the European Union and in particular for developed countries such as France, Germany, The Netherlands, Belgium, United Kingdom or Spain.
If, from the German Wido Fluoroquinolone risk study (attached), we take the total incidence rates of adverse effects of 1.202% and 4 deaths per 100,000 prescriptions, during the last 3.5 years there have been around 66,110 French patients whose health has been altered or even destroyed by simple negligence of the medical profession plus 220 cardiovascular deaths, all of which could have been avoided. I will let you do the calculation for the other European countries discussed in the Drug Utilisation Study and also the projection for the whole of Europe.
Have the consequences of these figures been analysed by the EMA and the Pharmacovigilance Risk Assessment Committee? What conclusions does the EMA draw from these catastrophic figures for European patient safety, not only for the last 3.5 years but also for the future?
These figures show a complete failure of drug safety organisation in Europe.
From our point of view, these figures also demonstrate that a legal drug alert and restriction on the use of dangerous drugs issued by the EMA via a single communication and relayed via a “Drug Safety Update and Usage Restrictions” in all the EU countries, doubled in some countries by personal letters to all medical practitioners from the drug agencies or health authorities of each country, largely does not work and is absolutely not in keeping with your remit of protecting the public’s health.
In the EU, a significant proportion of medical practitioners, either unaware of the risks or disrespectful of the clear rules on the severe restrictions of fluoroquinolone use, continue to ruin the health of thousands of patients each year, often for no reason (e.g.“suspected” infections) and in all good faith. When adverse reactions happen (and nobody can predict when), they either lie to the patients to hide the causal link, or are simply unaware of it – which is not acceptable. Colleagues cover for each other in the name of professionalism and they refuse to report the adverse reactions to the manufacturers, the EMA or their Medicines Agency.
A simple “legal drug alert and restriction on the use of dangerous drugs” without any constraint or sanction does not pass in the medical profession. Many doctors have prescribing habits, some of which are erroneous, and they do not want to question these habits despite the fact they can be dangerous for the health of their patients. Many doctors do not keep themselves informed and continue to prescribe fluoroquinolone dangerously against restriction’s rules or believing they know better than everyone else.
Much more significant measures need to be put in place by the EMA to enforce rules that are simple to read and understand. In the industrial and business worlds, this is called “Change Management”. Human beings are inherently resistant to changing their habits and it is no different for a prescribing doctor.
In the world of road safety, would we be satisfied with a single press release to announce a change in traffic rules that implements strict alcohol limits for drivers but with no controls nor any punishment for drivers breaching the limits? Would it be conceivable that a study commissioned to assess the impact of such a measure, on showing that the majority of drivers were breaching the limit and causing avoidable death and disabilities, should then conclude that no corrective actions be taken?
In any organisation, “Change Management” is a long and complex process that must be associated with any significant procedure or organisational change. In particular, this involves repetitive communication, individual meetings to explain the motivations to the people concerned, training and possibly sanctions for non-compliance with any new rules put in place. Change management was obviously not utilised during the implementation of your agency's decision of April 2019 concerning Fluoroquinolone prescribing.
A safer alternative could be, as is already the case for a number of dangerous drugs, to put in place a process where prescribing practitioners have to co-sign an information letter with each patient for each prescription. This signed letter would then have to be verified by a pharmacist before the drug is supplied. We would hope that the pharmacist should be well enough informed to check each patient’s records for contra-indicated conditions or medication in order to prevent needless risk of “long-lasting, disabling, and potentially irreversible serious side effects”.
Freedom of practitioner’s prescriptions must stop when patient’s health is put in serious danger.
We are asking EMA and the PRAC for a meeting about fluoroquinolones to be arranged quickly in the presence of the patient associations concerned with the aim of correcting this situation of a serious public health danger with such significant impacts.
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