The FAMHP Medication errors working group has received 112 notifications of proven or potential errors since 2016. Thanks to these notifications, corrective or preventive measures were put in place, in collaboration with the pharmaceutical industry. The Agency encourages healthcare professionals and patients to report any actual or potential medication error.
From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.
PRAC September 2020 – Revocation of marketing authorisation of ulipristal acetate (Esmya) for uterine fibroids
During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals facing difficulties with supplies of medicinal products used in the treatment of COVID-19 patients. In addition, given the specific context of use of these medicinal products, the FAMHP has ensured close monitoring of adverse reactions.
Coronavirus: hydroxychloroquine: off-label use strongly discouraged and new benefit-risk assessment for clinical trials
The new COVID-19 treatment recommendations from Sciensano strongly advise against any off-label use of hydroxychloroquine outside of a clinical trial. Applicants for ongoing clinical trials must also update their benefit-risk assessment and demonstrate to the FAMHP that their risk reduction strategies during the trial are sufficiently adequate.
The FAMHP restates the risks linked to the use of chloroquine and hydroxychloroquine to treat COVID-19 following the publication of a retrospective analysis of a patient monitoring register in the medical journal The Lancet on 22 May 2020. The analysis did not highlight any benefits from these drugs in patients with COVID-19 and revealed adverse cardiovascular effects.
PRAC May 2020 – New measures to avoid handling errors with Leuprorelin depot medicines and completion of signal evaluation for ibuprofen, ketoprofen and fixed-dose combinations
During its meeting of May 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.
In order to help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.
Coronavirus: reminder of risk of serious adverse effects associated with chloroquine and hydroxychloroquine
The European Medicines Agency (EMA) recommends that healthcare professionals monitor cardiac adverse effects and consider pre-existing heart conditions in COVID-19 patients treated with hydroxychloroquine or chloroquine. It should also be borne in mind that there may be an increased risk of cardiac adverse effects when these treatments are administered in high doses or in combination with certain medicinal products, such as azithromycin.
Flash VIG-news: risk of haemolysis associated with the use of hydroxychloroquine (PLAQUENIL) in the treatment of COVID-19
Physicians should be alert to the signs and symptoms of haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency treated with hydroxychloroquine for the treatment of COVID-19.