The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.
The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of the medical emergency presented by COVID-19. Participants discussed COVID-19 clinical trials, in particular the use of master protocols, around the world to accelerate the development and approval of potential treatments and vaccines against coronavirus disease. The World Health Organization (WHO) shared insights into the Solidarity Trial, which aims to compare multiple treatment options against standard of care in different countries. It plans to enrol in-patients suffering from COVID-19 across more than 100 countries.
There is broad agreement among regulators that such large multi-centre, multi-arm clinical trials need to be prioritised because they are most likely to generate the robust evidence needed to enable rapid assessment and authorisation of COVID-19 therapeutics and vaccines. In addition, participants discussed regulatory considerations in relation to exploratory clinical trials and pivotal studies with investigational or repurposed medicines for the treatment of COVID-19. They raised concerns about the growing number of underpowered clinical trials and observational studies, which compete for essential resources and patients, and might not generate the conclusive evidence needed to draw firm conclusions on the safety and efficacy of medicines intended to treat or prevent COVID-19. ICMRA members stressed the need for stringent regulatory requirements for COVID-19 studies and agreed to provide further guidance on the prioritisation of clinical trials and on serology in order to promote a harmonised approach. ICMRA members also exchanged information about high-level regulatory flexibilities and extraordinary measures applied to address some of the constraints posed by the pandemic.
They emphasised that the uninterrupted supply of medicines used for the treatment of COVID-19 patients in intensive care units (ICUs) and personal protective equipment (PPE) is of critical concern. Regulators committed to continuously monitor and exchange information on the impact of COVID-19 on medicine supply chains to prevent and mitigate shortages, while ensuring a high level of quality, safety and efficacy of medicines around the world. The discussion was moderated by Dr Janet Woodcock, Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA). This was the third in a series of bi-weekly ICMRA meetings organised to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and for preventing and mitigating medicine shortages. These strategic discussions build on the knowledge and experience gained from the series of ICMRA workshops on COVID-19 medicine development held in March and April 2020. EMA and FDA are taking turns to chair these meetings.
A review by the PRAC found that handling errors resulted in some patients receiving insufficient amounts of their medicine. The errors reported included incorrect use of the needle or syringe, causing the medicine to leak from the syringe, and failure to inject leuprorelin properly.
The Committee is therefore recommending that only healthcare professionals familiar with the preparation steps for leuprorelin depot medicines should prepare and administer the medicines to patients. Patients should not prepare or inject these medicines themselves.
The Committee also made recommendations for particular leuprorelin depot medicines. For the medicine Eligard, the product information is to be updated with warnings to strictly follow the instructions for preparation and administration and to monitor patients if a handling error occurs. In addition, the company marketing Eligard must replace the current device used to administer the medicine with one that is easier to handle by October 2021.
For another medicine, Lutrate Depot, the PRAC recommended that instructions for handling the medicine be revised to make them easier to follow and its packaging changed so the instructions are easier to find.
Depot formulations of leuprorelin are used to treat prostate cancer, breast cancer, certain conditions that affect the female reproductive system, and early puberty. Several formulations require complex steps to prepare the injection.
Information for patients
- Errors in using leuprorelin depot medicines (which are designed to work over a long period) may make treatment less effective.
- These medicines should only be prepared and given by a doctor or nurse with experience in using them. You should not prepare or inject these medicines yourself.
- If you have concerns about your treatment, please discuss these with your doctor or pharmacist.